While pharma has raced to develop COVID-19 vaccines, US-based company NeuroRx is taking a different approach to treating the virus. CEO Dr. Jonathan Javitt tells pharmaphorum about the science behind the company’s Zyesami, which targets the alveolar type II cells in the lung that are critical for transmission of oxygen.
Zyesami was developed in conjunction with partner Relief Therapeutics, and NeuroRx is currently awaiting results from a Phase 2b/3 trial (COVID-AIV) evaluating the therapeutic for the treatment of respiratory failure in COVID-19 patients.
Based on years of research by Professor Sami Said at New York’s Stony Brook University, the drug is a synthetic formulation of Vasoactive Intestinal Peptide (VIP), a naturally occurring peptide that is highly concentrated in the lungs. VIP is known to have potent anti-inflammatory effects and can inhibit coronavirus replication and block the formation of inflammatory cytokines.
“Every air-breathing warm-blooded animal makes this peptide to protect the lungs from the toxic effects of breathing air,” NeuroRx CEO, Jonathan Javitt, MD, MPH, told pharmaphorum. “It protects the lungs against all injuries and turns out it has some extraordinarily valuable properties for patients with COVID-19.”
“The cytokine storm story became popular, but it was mostly popularised by companies who already had drugs against cytokines. They created the story and then threw their monoclonal antibodies against COVID-19 but there is real scepticism now about whether COVID-19 is really a cytokine storm problem”
‘A fish out of water’
When SARS-CoV-2 invades the body, it attacks the alveolar type II (ATII) cell in the lining of the lung which shuts down the production of surfactant and stimulates a cytokine response.
“This is how you go from somebody who is infected by the virus but not particularly sick to somebody who’s on a ventilator dying of COVID-19,” explained Dr. Javitt.
“For example – when a fish swims through water, seawater goes across its gills and oxygen is then absorbed from the seawater. The fish derives enough oxygen from that to carry out all the functions it needs to live. However, the minute you put that fish on the land, the fish dies. But why? There is more oxygen in the air than there is in the sea, so why would the fish die?”
The problem, he says, is due to the fact the atmosphere is toxic to the fish’s epithelial cells.
“In humans it is the same. The mixture of gases that we breathe all the time are toxic if it touches the lung’s cell, so the lung is covered by this layer of fluid that creates a barrier between the atmosphere, the air, and the cell membrane.”
The minute the ATII cells die due to the SARS-CoV-2 virus, the lung is no longer capable of oxygenation and the patient dies as well.
“It is like a fish out of water.”
Zyesami works by binding to receptors on ATII cells in the lung and protecting the surrounding pulmonary epithelium by blocking cytokines, preventing apoptosis, and upregulating the production of surfactant.
By targeting the vulnerable ATII, NeuroRx and Relief Therapeutics believe they can help the most critically ill COVID-19 patients. “Until we focus on the specific lesion associated with this virus, we’re not going to have any real cures,” concluded Dr. Javitt.
While other COVID-19 therapeutics, such as Gilead’s Veklury (remdesivir) have focused on controlling the cytokine storm triggered by COVID-19, Dr. Javitt believes this is only one piece of the puzzle.
“The cytokine storm story became popular, but it was mostly popularised by companies who already had drugs against cytokines. They created the story and then threw their monoclonal antibodies against COVID-19 but there is real scepticism now about whether COVID-19 is really a cytokine storm problem.
“Personally, I don’t think it is. I think cytokine storms are a secondary problem and until we really face the lesion that occurs when the SARS-CoV-2 virus infects the lungs and causes COVID-19, we’re not going to have a solution.”
The next steps
Top line data from Zyesami’s Phase 2b/3 trial is expected by the end of January/beginning of February and if successful, the drug could quickly receive emergency use authorisation from the FDA.
The multicenter, randomised trial was initially conducted at a single centre and expanded to 196 patients at 12 study sites. Patients were administered with escalating doses of Zyesami by intravenous infusion and compared to a placebo control group.
Early data from trials were encouraging, with results from a study at Houston Methodist hospital in Texas showing approximately 81% of the patients who received the drug survived beyond 60 days, compared to just 17% of control patients. Those who had the treatment also demonstrated a nine-fold increased probability of survival and recovery from respiratory failure.
“These patients included in our study are those who were too sick to be admitted to any other clinical trial,” said Dr. Javitt. “There were extremely ill patients who had had lung transplants, severe lung disease, heart disease, renal failure and kidney transplants so the results we have seen bring a lot of hope for how we can treat COVID-19 in future.”
Although the arrival of COVID-19 vaccines is providing hope for people, there is still a need for effective treatments. “We hope that the vaccine will reduce the number of COVID-19 cases. However, we believe it likely that population wide vaccination will be slow in coming and the vaccine is not 100% effective,” said Dr. Javitt.
NeuroRx is also gearing up for a phase of rapid expansion after closing a deal in December to combine with investment firm Big Rock Partners. The merger created a company with an estimated post-transaction equity value of more than $500 million.
The deal is expected to complete in the first quarter of 2021 and will increase NeuroRx’s access to capital for Zyesami and spur development of its other drug pipeline targeting treatment of bipolar depression.
The company is also looking at advancing trials for Zyesami in other countries around the world, with a Phase 2b/3 trial set to begin in Europe.
“One thing about our drug compared to all of these monoclonal antibodies is we can make it at enormous scale relatively inexpensively and it’s within the cost range that works for the rest of the world,” said Dr. Javitt.
About the interviewee
Dr. Jonathan Javitt is founder, chairman and CEO of NeuroRx. He is a physician with a background in information technology, health economics, and public health. His scientific publications have been cited by more than 17,000 people and he is ranked among the top 1% of quoted scientists worldwide.
Pharma’s reputation is currently riding high as the industry comes together to tackle COVID-19, but GSK’s UK general manager Neale Belson says there is always more companies can do to build their culture and make sure employees and customers trust they are doing the right thing.
When we spoke with Belson about the GSK’s response to COVID-19, he pointed out how the pandemic has allowed him to get to know his colleagues even better than he anticipated. Now, speaking to him as the first vaccines are deployed in the UK, he highlights the importance of GSK’s employees and culture to the future of the company post-COVID.
Despite becoming UK GM at a difficult time – right before lockdowns came into effect in March – Belson says he was excited to start the role, which he describes as his “dream job”.
“It’s an incredibly humbling experience. When I was young, I had a strong desire to make a difference, and making a difference is right at the heart of GSK’s mission.”
As GSK’s UK lead, Belson is responsible for promoting and implementing the company’s three core priorities – Innovation, Trust and Performance – in the country. He believes the most important aspect of doing this is to develop the business by building its people.
“Our employees’ friends and colleagues understand the great work we’re doing, which has changed how they feel about working for GSK and how they are engaged in our mission”
“To me that’s all about the environment we create,” he says. “We want people to enjoy working for GSK in the UK, to feel valuable, and to feel excited about being part of something.
“What we do as an industry is really special, and it’s important to me that people feel proud of what we do and see that we can achieve an awful lot together.”
The COVID-19 pandemic, he says, has been a key catalyst in helping people both outside and inside the company understand its purpose and build on the Trust agenda.
“People now recognise what the industry has done to help tackle COVID. Our employees’ friends and colleagues understand the great work we’re doing, which has changed how they feel about working for GSK and how they are engaged in our mission. It’s been lovely to see that.
“There’s never been a better time to be in pharma. If we build on that, our Trust agenda can have a very strong future.”
Trust and Performance
Building this trust among employees involves improving a company’s culture from the ground up, Belson says.
“We are looking to build a purpose-led, performance-driven culture to enable us to make the biggest difference possible. To us, that means making a difference to what matters to people.
“We want to focus on things like development, diversity, health and wellbeing – and all of that underpins our goal to be one of the most innovative, high-performing, and trusted companies in the healthcare space.”
The same is true for the company’s Performance agenda.
“Our performance agenda is all about investing in our people and our capabilities,” Belson says. “At the beginning of the pandemic we ramped up our training, and our capabilities developed significantly as a result. We wanted to get people match-fit, and they really enjoyed and appreciated that.
“As part of that we also sought to understand the challenges people were having and how we could help them. This is not only good for health and wellbeing, but also for overall performance.”
Sustainability and joint working
But Belson notes that building trust must go beyond internal projects and involve external efforts as well.
He highlights GSK’s recently announced sustainability ambitions as an example of how the company is aiming to “do the right thing” for wider society.
With the new goals, GSK aims to have a net zero impact on climate and a net positive impact on nature by 2030.
Underpinning these goals, the company has set new targets across its different businesses, including: 100% renewable electricity usage and good water stewardship at all GSK sites; 100% of materials sustainably sourced and deforestation free and transitioning to 100% usage of electric vehicles by sales reps worldwide.
“We’re investing in restoration projects where we can and are looking to put back into nature more than we take out,” Belson explains.
“We don’t have all the answers yet, but I’m proud of the agenda and the ambition.”
Similarly, Belson believes it is important to make sure that GSK is “part of the solution” in addressing patient needs in the UK through joint working initiatives with the NHS.
Some examples where GSK have done this include a collaboration with Health Innovation Manchester to deliver asthma care to patients within a pharmacy community setting, and an initiative with the Federation of Family Practices in Belfast to help improve the care of COPD patients who remain symptomatic.
“It’s also important that we continue to learn and understand what patients need throughout the ecosystem, from early drug development all the way through to how patients are diagnosed and treated and their journey through these processes.”
Overall, Belson says the Trust agenda is about making sure people genuinely feel that GSK is doing the right thing.
“I think people are proud to work for a company that has that as one of the core pillars of its strategy. Fundamentally, I want to lead an organisation where people genuinely feel they are connected with our purpose.”
He says he would like to see employees become even more connected to this purpose in the future.
“We’re trying to drive a culture where people feel valued and respected, and where they’re genuinely part of the solutions we’re providing.
“That involves listening, understanding and making sure they have a voice and feel confident about speaking up – as well as making sure they can feel part of where we’re going as an organisation.”
About the interviewee
Neale Belson is senior vice president and general manager UK and Ireland at GSK, and leader of the GSK Pharmaceuticals affiliate in the UK. Neale has performed several significant leadership roles encompassing many therapeutic areas working in the United States, Europe and most recently as vice president and area director GSK Nordic and Baltic Cluster, based in Copenhagen, Denmark. Prior to GSK, Neale held senior commercial roles at AstraZeneca.
About the author
George Underwood is pharmaphorum’s Deep Dive magazine editor, leading the content for the bi-monthly magazine. He has been reporting on the industry for seven years and has worked at a number of leading publications in the UK.
There is a huge, ongoing shift in how health and wellness is approached in the UK, and the changes will have important implications for NHS-industry partnerships.
Transformative change is coming to the NHS and is set to radically alter how the UK’s health service cares for people at a population level.
The NHS Long Term Plan signposted this change, with its emphasis on preventative health, and the forthcoming expansion of the Integrated Care Systems programme continues this direction of travel on a path towards the long-cherished hope of joining up health and social care.
As new approaches to healthcare attainment take hold there will be some degree of uncertainty among pharmaceutical companies about where they fit into the new structures and the holistic care they seek to provide.
But they’re not the only stakeholders working to map out how to enable new models of care and what their role should be.
In this second ‘Nine for 2021‘ article, IQVIA’s Sarah Rickwood looks at four issues which will directly impact pharma in 2021: the permanent changes in customer engagement models, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.
Focus on customer engagement impact
The customer engagement story of 2020 could be summarised in three themes: trend break, agility and remote interaction. The trend break was the most immediately measurable commercial model impact. For April 2020 almost all face-to-face contact with healthcare professionals (HCPs) ceased. Preventing virus transmission, as well as “getting out of the way” of healthcare professionals pivoting to address the virus was key, and HCPs largely welcomed the way pharma reacted as responsible and necessary.
However, qualitative interviews conducted by IQVIA with HCPs in the top 5 European countries on their experience of engagement with pharma during 2020 show that doctors still valued interaction, including face to face interaction, with pharma and missed it when it was absent.
Pharma moved rapidly to remote interactions, even to the point of all virtual launches of new products. The overall volume of interactions fell, and those remaining became more remote and less interactive. The agility of many organisations effecting this rapid change was impressive, and a more resilient hybrid model seemed to be emerging as face-to-face interactions returned post the first wave.
This has, of course, been more recently challenged in Europe by second wave infections and new lockdowns, but this masks more fundamental and as yet unresolved challenges for 2021’s commercial model, which could be defined by environment divergence and the need to achieve impact.
The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts. The ways in which country promotional environments recovered from the first lockdowns has accentuated that divergence. This has implications for the commercial model companies employ by geography.
Environment divergence has been accelerated by recovery post the first infection wave – IQVIA ChannelDynamics data shows that in Europe, countries have recovered to a different promotional mix.
The UK has diverged most – it was always the country with the lowest volume of face-to-face contacts, and those contacts remain at negligible levels, replaced (but not completely) with remote rep contacts, creating a near 100% remote engagement model.
Other European countries have seen face to face contacts recover, then fall back because of second waves, but the model that emerged towards the end of 2020 was lower in volume and much more hybrid – a greater proportion of interactive contact was remote. The US, Japanese and Chinese promotional environments saw contact volumes recover to close to or greater than 2019 levels, with a channel mix that was more heavily remote.
The divergence of promotional environments is especially stark in the difference in the total interactive time the pharma industry had with healthcare professionals in 2020, compared to 2019. Up to November, the US and Japan actually saw increases in interactive time in 2020. Not so China, and especially not so the lead five European countries – on average European pharmaceutical companies saw a loss of 30% of the interactive time they previously had with healthcare professionals in 2020. Much of this lost time would have ordinarily been spent introducing and establishing new innovations and building growing products.
The need to achieve impact
As interactive time with HCPs is likely to be scarce, companies need to be even more ruthless in prioritising content and in deciding what content to generate in the first instance – for example, in Real World Evidence, as outlined in IQVIA’s white paper, ‘Excellent Launches are winning the Evidence battle’.
CNS (re) emerges
The 2010s were the decade of oncology: the decade started with oncology tipping hypertension off the top spot as the world’s most valuable therapy area, and during the next ten years, via continuous introduction of significant innovation, oncology grew its share of global prescription medicine value from 8% to 13% of sales. Oncology will continue to dominate the world market in the 2020s, albeit with slower growth, but that is not news. Instead, we will focus on therapy areas which will take on new significance in the 2020s. Of these, the most significant in terms of the conditions’ prevalence, and unrealised therapeutic potential, is CNS.
CNS is a “Back to the Future” story – scroll back to the 1990s and 2000s and CNS was one of the largest segments of the Rx market by value, driven by anti-depressants, atypical neuroleptics, anxiolytics and hypnotics. Then, by the 2010s, a wave of genericisations took down the blockbusters across all leading classes, and innovation stalled. Hopes for an effective disease modifying Alzheimer’s treatment, the holy grail of CNS research, were repeatedly dashed by late stage failures. By the end of the 2010s, CNS as a whole was highly genericised, with low innovation and few important launches. From 2021 onwards, this will change. Over the next five years we expect the global CNS market to accelerate ten-fold in list price value from near-flat historical growth of 0.4% CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade.
The drivers behind this transformation are two classic elements – perennial unmet need and innovation, but with some very specific 2020s twists. The pandemic and consequent lockdowns have led, in some countries, to an explosion of mental health disorders. The pandemic has accelerated the trend to remote and digital healthcare at a time when the development and use of digital diagnostics and biomarkers has become possible and very relevant to many CNS conditions. Psychiatry has proven one of the areas of clinical practice most amenable virtual delivery.
Underlying this all, long term innovative investment is finally yielding fruit in a range of CNS therapy areas, for example new therapies for treatment-resistant depression (e.g. Janssens’s Spravato), the novel CGRP inhibitors for migraine, or dual orexin receptor antagonists (DORAs) developed for insomnia. Two of the three largest selling products launches in 2020 by 2020 sales were CNS products: the oral migraine treatments Ubrelvy and Nurtec. Progress on the holy grail of an effective disease modifying Alzheimer’s treatment is also possible in 2021, but not a foregone conclusion.
CNS will end 2021 with a renewed relevance and powered by new innovation, both molecular and digital, placing the therapy class in a strong position to re-ascend the rankings as one of the most valuable therapy areas for the remainder of the 2020s.
Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. As economic crisis leads to healthcare spend constraints, the proportion of product value that will lose exclusivity in the next five years that is biologic has never been higher, at 44% of the $200m of the 2019 pharmaceutical market which will lose exclusivity in the next five years.
Counting from infliximab, the first of the monoclonal antibodies to face biosimilar competition, uptake of the biosimilar into the originator molecule has improved significantly, with the last volley of biosimilar launches reaching 40% of all treatment days within 12 months of in Europe, compared to nearly three years for infliximab to reach that level. Bevacizumab (Avastin) is on track to achieve 40% average European biosimilar treatment day penetration in six months, the first to do so. However, biosimilar uptake is not evenly distributed, and savings are still not always realised where they are most needed. Given the very powerful incentives that especially European countries will have to realise savings on medicines budgets where they can, we expect further measures to be implemented to promote the use of biosimilars in 2021.
Pharma pivots East
Increasingly, pharmaceutical companies add China to their launch priority countries group, typically the US, EU, and Japan, and from 2021, this trend is likely to accelerate. Europe, still in the throes of lockdowns and second waves will be living with healthcare system disruption for much of 2021, as well as economic austerity. Fragmentation of the European top 5 as the UK pursues its own regulatory regime post Brexit may also impact Europe’s attractiveness. The US, also still to effectively manage the infections crisis, will enter a new phase with the Biden presidency, and that could mean changes to healthcare system and pharmaceutical pricing reform.
China entered the first wave of the pandemic crisis earliest and emerged earliest, and (as at January 2021) has so far managed to avoid the debilitating second waves which have precipitated further lockdowns and healthcare system disruption in Europe and the US. Whilst the details of China’s economic recovery have been disputed, one forecaster, the Centre for Economics and Business Research, has predicted that China will now overtake the US as the world’s leading economy in 2028, five years earlier than was previously forecast.
China has been the world’s second most valuable pharmaceutical market since 2013, but it has not been an important market in terms of contribution to the sales of the newer innovative pharmaceutical products – in fact, whilst China ranked second on total Rx market sales, it ranked below 30 in terms of sales of newly launched innovative products. This is now changing and will be accelerated in 2021 by how China exits the pandemic crisis.
Pre-pandemic, China had already worked hard to reform its regulatory systems, reducing the backlog of medicines applications under or awaiting review by 80% by the end of 2019. New Active Substances, as monitored by IQVIA audits, entered the Chinese market in 2020 at historically high rates – by August 2020, 27 new active substances were in the Chinese market, as opposed to a five-year historic average of 15 by that point in the year for China.
Approval is not everything, and there remain significant market access and pricing challenges for innovative launches in China, but China’s domestic appetite for innovation is growing fast – the innovative branded products segment of the market grew by 12% in value between 2015 and mid-2020, while the remainder of the market grew by 3%. In addition to China, Japan, already one of the key country contributors to early innovative launch sales, has also accelerated the introduction and uptake of innovation in recent years. Japan has also emerged from the pandemic relatively unscathed, in terms of healthcare system, although economic recovery might be slow.
Because of these trends, from 2021, the importance of China and Japan to innovative product value is likely to progressively increase, driven both by increases in attractiveness of these two markets, and challenges in the European (and possibly US) environment. This will tip the geographic balance of the global pharmaceutical industry east, which will not just influence where pharmaceutical companies get their value from, but also usher a new collection of Chinese innovators into the global market.
If 2020 was the crisis year, 2021 is the year of transformation. Some of our nine 2021 trends were set pre-crisis, for example the re-emergence of CNS, but may see some acceleration or change because of the crisis. Others, for example the transformation of the commercial model and the renewed focus on impact, have been dramatically shaped by the events of 2020, leading the industry into a much-accelerated change and possibly taking commercial environments in directions they would not have moved without the pandemic. Others, and especially the pandemic-accelerated tilt towards the East in terms of innovative market, have ramifications that will be decades long in realisation. 2020 was a year in which, by rising to the challenge of the pandemic, the pharmaceutical industry demonstrated it can accomplish that which would previously have been labelled impossible. Whatever the challenges, the pharmaceutical industry enters 2021 with a new sense of purpose.
About the author
Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.
The acute phase of the COVID-19 pandemic tested the UK’s capacity and capability to rapidly deliver crucial clinical research at a time of immense pressure and stress on personnel and resources.
It triggered a system-wide response which took the UK’s collaborative culture to new levels. This multi-agency approach enabled unprecedented speed and efficiency in trial approvals, set-up and recruitment. By eliminating delays and duplication, and optimising all available resources throughout our NHS, the UK was able to answer questions of global importance about COVID-19, including treatment and management.
Having successfully demonstrated our ability to coordinate, expedite and accelerate research delivery there is now an opportunity to reflect on what the UK did well and what this means for the future.
This pharmaphorum webinar, held in association with the National Institute for Health Research (NIHR), will take place on Thursday 25th February13:00 GMT / 14:00 CET and discuss the UK’s approach to delivering research during the COVID-19 pandemic. It will examine lessons learnt from implementing complex design trials on a national scale and question what the UK could have done differently.
The webinar will also cover:
How research was prioritised
Processes for streamlining approvals
Learnings on site selection and set-up
Strategies for successful and rapid recruitment
View the webinar* by clicking on the link in the window above or by clicking here.
Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA, having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous first-in-human studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials, particularly for Developmental Safety Update Reports (DSURs) and Reference Safety Information (RSI). She was also an EMA expert for the update of the First-in-Human guideline. Other recent work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs: she is leading on this aspect for the MHRA in order to implement that aspect of the Life Sciences Industrial Strategy and was a contributor to the EU CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. More recently Kirsty has overseen the clinical trial work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the government Vaccine Taskforce.
Sir Terence Stephenson is an eminent clinical academic and took up the position of chair at the Health Research Agency on 1 September 2019. He is Nuffield Professor of Child Health at the University College London Great Ormond Street Institute of Child Health and Honorary Consultant Paediatrician at UCL Hospitals NHS Foundation Trust & Great Ormond Street Hospital for Children NHS Foundation Trust. Sir Terence is also a former Dean of the University of Nottingham’s Medical School, President of the Royal College of Paediatrics and Child Health, Chair of the Academy of Medical Royal Colleges, and most recently of the General Medical Council.
Professor Nick Lemoine is medical director of the National Institute for Health Research Clinical Research Network for England. Nick has recently been appointed chair of the COVID-19 urgent public health studies group for the UK. The group’s remit is to consider all clinical studies relating to COVID-19 and to fast-track those with the greatest promise. Nick also chairs the NIHR Invention for Innovation Challenge Panel. Nick is director of the Barts Cancer Institute, Queen Mary University of London, and director of research & development for Cancer at Barts Health NHS Trust, the largest NHS Trust in the country. Among other commitments, he is the chair of Trustees of the Medical Research Foundation (the MRC’s independent charity), and executive dean of the Academy of Medical Sciences, Zhengzhou University, People’s Republic of China. He was elected as a Fellow of the Academy of Medical Sciences in 2006, and as a Foreign Academician of the Chinese Academy of Engineers in 2017.
Dominic Tyer, interim managing editor, pharmaphorum [moderator] Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as interim managing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative and editorial director at the company’s specialist healthcare content consultancy, pharmaphorum connect.
Everything, from exercise classes to pub quizzes, went online last year – and medical education was no exception. In their droves, congresses, conferences, and masterclasses went virtual in a bid to ensure healthcare professionals were supported, up to date, and socially distanced.
But is this change here to stay? Are the days of queuing for coffee, rushing to symposiums, and the glitzy conference dinner a thing of the past? We asked those in the know.
Online learning makes medical education more accessible but presents challenges in terms of networking opportunities and sponsor exposure.
That is according to Jamie McGregor, head of policy, intelligence and operations at the Neurology Academy, which provides education programmes and masterclasses across a range of neurological specialisms.
“We have gone worldwide,” he says. “We have had people from Indonesia, West Africa – places where people usually find it very hard to access medical education. A recent international masterclass in MS had 53 delegates from 11 countries.”
Geography is not the only accessibility consideration, as healthcare professionals have less time than ever. For most, study leave is a distant memory, and many are juggling long working hours with childcare and other family commitments.
“People can dip in and out of online content, rather than block three days out of their calendar to attend a course. They also avoid all the travel time and the expense.
“But in terms of disadvantages, we are always at the mercy of the IT gods, and from a delivery standpoint, there’s a lot more to organise. You’ve got potentially hundreds of people you need to make sure can log on and take part.”
Online can also be more difficult for speakers because they are unable to gauge their audience’s reaction, and the loss of networking opportunities has also been noted.
“We have really tried to drive engagement and give delegates the opportunity to get involved – we have had question and answer functions, Twitter feeds and dedicated inboxes. For the smaller events, we have set up WhatsApp groups so they can talk amongst themselves,” says McGregor.
“We want to try to make them feel as though they are in the room.”
Sponsor engagement was also a concern for the academy, and McGregor admits this is something they are still working on.
“We want to give sponsors as much exposure as possible, and make sure delegates understand that without the sponsorship, the events either would not be happening at all, or would certainly not be free.
“So far, we have tried virtual networking cafes, where pharma reps can sit and chat to people, and we are doing online sponsored symposiums. There is more that we want to do, and we will work with our sponsors on that, but it’s definitely a learning curve.”
The pivot from “in real life” to virtual wasn’t an easy one for the team at the British Society of Echocardiography, but they were determined that the “vital educational event” would go ahead.
“A virtual conference is a completely different beast to a face-to-face event – the project plan needs turning on its head,” says Jo Sopala, executive director at the society, adding that she was “immensely grateful” to work with a trusted platform supplier who could provide expertise and support.
“I think digital will always have a part to play. I suspect for the next year we will remain predominantly virtual, but once we can socialise again, there will be a call for face-to-face events. People, and particularly the medical fraternity, will need the personal connection”
“There was a huge amount of work to do. We had a full programme and had already invited speakers. To facilitate a virtual event, we had to go right back to the drawing board: revising the programme, the structure and pretty much everything.”
The hard work paid off, and the virtual conference was deemed a success with a 50% increase in audience and wider international reach when compared to the previous year.
“We received overwhelmingly positive feedback about the content, platform, engagement and accessibility, and were very proud of the result,” Sopala says.
They worked hard to recreate the social element of conference, opting for a platform with inbuilt networking abilities and even throwing a virtual “conference disco”.
“You cannot underestimate the value of networking and informal clinical supervision/support that people get at conferences – something which is probably needed now more than ever,” Sopala says, adding that this had been difficult to recreate in the digital setting.
“The other slight downside was that our sponsors did not receive the level of engagement they would usually expect, but we will work with them and providers to improve on that.”
Asked if virtual medical meetings were the future, Sopala says she envisions a hybrid model, post-2021.
“I think digital will always have a part to play. I suspect for the next year we will remain predominantly virtual, but once we can socialise again, there will be a call for face-to-face events.
“People, and particularly the medical fraternity, will need the personal connection,” she says.
While educational content lends itself to the virtual model, translating sponsor exposure into the online space has posed something of a challenge.
Fiona Robinson, director of exhibition design company Discovery Events, says: “We have looked into various virtual platforms for clients for exhibition stands, including virtual tours, downloaded videos, brochures and information.
“But it is a really different way of disseminating information.”
Many clients have diverted spend from conferences to online content generation and are “taking the opportunity to profile themselves in different ways”.
“Websites are playing an even more important role than ever before, certainly as a sales tool. It is every company’s shop window to the world, and promoting expertise has never been more critical,” says Robinson.
The pandemic-driven shift to digital communications has demonstrated it is possible to maintain contacts while working from home, and people have adapted quickly. But, Robinson says, that will not spell the end of face-to-face conferences in the future.
“What I’m continually hearing is that people are sick of Zoom meetings and that it’s just not the same as in-person comms,” she says.
“Many a deal has been made in a bar after congress and this kind of social interaction plays a huge part of the business world. People like a good conference giveaway, and even the most seasoned travellers do still get a buzz from visiting a foreign country.
“Can we really imagine a world without face-to-face congresses? Without that personal networking touch? I, for one, hope they will not be lost to a virtual world.”
About the author
Amanda Barrell is a health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.
Trial sites have adapted swiftly to the restrictions of COVID-19, and patients have seen many knock-on benefits as a result. The next step is ensuring the industry does not regress to old ways of working once the pandemic is over, say Karen McIntyre and Allyson Small.
COVID-19 has changed everything for clinical trials – but in most cases these are changes that were well overdue.
“For years and years, the industry has debated the practicalities and safety of decentralising clinical trials, using telemedicine, and where study activities should take place,” says Karen McIntyre, executive director, global lead Catalyst Program & site relationships at Syneos Health. “We were always having these discussions, but nothing moved forward.”
When the pandemic hit, regulators around the world rapidly updated their guidelines to reflect the realities of conducting trials amidst lockdowns and social distancing mandates.
“For example, drugs are now able to be delivered directly to patients to allow for a clinical trial visit to take place remotely,” says McIntyre.
With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. Looking back at key market access news from the last year, Leela Barham takes stock of what the next twelve months could bring for UK market access.
Whilst regulatory approval is only a starting step on market access, the UK has made steps to put the UK on the priority list for companies seeking marketing authorisation. The UK joined two initiatives in October 2020 that should bear fruit in the future: Project Orbis and the Access Consortium.
Project Orbis is coordinated by the US Food and Drug Administration and includes Canada, Australia, Switzerland, Singapore and Brazil and focuses upon review and approval of cancer treatments that offer promise. The Access Consortium includes some of the same players – Australia, Canada, Switzerland and Singapore – and looks more broadly at securing patient access to high-quality, safe and effective medicines. The ABPI has seen these as another way to help the UK deliver faster access.
The promise of faster market access
Announced in December 2020, and beginning from 1 January 2021, the new licensing and access pathway (ILAP) at the Medicines and Healthcare Regulatory products Agency (MHRA) offers the chance – for a fee – for faster access for medicines that meet the criteria for the scheme. Criteria include that the condition is life-threatening or seriously debilitating or there is a significant patient or public health need.
“The UK has sought to provide incentives for development of new antibiotics by offering a volume neutral deal, also termed a Netflix approach”
Additional criteria include being an innovative medicine, such as an advanced therapy medicinal product (ATMP), significant new indication or a treatment for a rare disease or other special populations such as neonates, children, elderly and pregnant women and aligning with priorities of the UK, be that from the chief medical officer, the Department of Health and Social Care (DHSC) or those from the UK’s Life Sciences Sector Deal.
What is probably most exciting about ILAP is the bringing together of expertise from the MHRA with that of key HTA agencies NICE and the Scottish Medicines Consortium (SMC), as well as NHS England and NHS Improvement (NHSE&I), and, of course, patients too. It’s the first time that all these agencies are working together (much else draws on what has been available for some time; early advice and in parallel between NICE and MHRA).
2021 will reveal just how the ILPA will be operationalised and whichever product will be the first to go through the Innovation Passport stage – a new designation as part of ILAP – will help everyone understand how the criteria for the passport will apply in practice. It’ll also reveal just what the Target Development Profile (TDP) living document will cover and how it can evolve over time. This rolling review features is also another new element on offer under ILAP.
The Netflix approach
Antibiotics are vital to modern health care, yet there have been warnings for years that the economics at play simply don’t incentivise the development of new antibiotics; new antibiotics should be kept in reserve to limit antibiotic resistance and aren’t likely to be used in large volumes. The lack of new antibiotics is a problem when the existing antibiotics stop working.
The UK has sought to provide incentives for development of new antibiotics by offering a volume neutral deal, also termed a Netflix approach. In June 2017, NICE and NHSE&I launched a novel payment approach; offering up to £100 million to companies developing and marketing novel antibiotics based on the value of their products, regardless of volume sold.
2021 will see NICE trialling their adapted HTA approach for assessing the value of new antimicrobials. This will not only interest companies researching and developing new antibiotics, but other countries who will want to see whether the UK approach could work for them too. Where NICE leads, others will want to learn and adapt from.
Key access commitment due to report in VPAS
The UK has a unique approach to managing the pricing of branded medicines through the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). The deal balances affordability commitments that benefit the UK government – where NHS spend on branded medicines cannot go above a pre-agreed level – with access commitments to industry.
A key commitment in the deal is to reach the upper quartile of uptake in relation to comparator countries for the five highest health gain categories of treatments. A timeline is set for hitting this too; it should be met during the first half of the scheme. That makes it a target for June 2021. Whilst there isn’t a timeline against it, there is also a commitment for the Department of Health and Social Care, NHSE&I and the industry association, the Association of the British Pharmaceutical Industry (ABPI) to better understand national and international variation on uptake and where that is unwarranted.
Realistically it’s seems unlikely that the timetable for the upper quartile target can be met. That’s because so far, based on desk research, there doesn’t appear to be a public list of the five highest health gains, and meeting minutes from operational reviews of the scheme suggest discussions have faced difficulties in agreeing them. It’s difficult both from a methods side (which countries, which treatments, etc) as well as data and time; COVID-19 has been a higher priority for many staffers involved. Expect a delay that may even see this reporting in 2022.
More change at NICE
2020 saw NICE consult on a variety of changes and set out plans on cross-cutting market access issues.
NICE started 2020 with the January publication of their principles; essentially a framework for how the agency goes about its work – from working on national priority areas through to publishing their work and updating as necessary.
NICE followed these in March 2020 with their final statement of intent on increasing the use of health and social data in their guidance. The statement covers one of the buzz phrases in market access – ‘real world data’ – and signals a greater willingness for NICE to consider its use in their work. The agency will keep working on how this will be implemented during 2021; this can only help, as much in the statement is aspirational and there’s not a great deal of clarity on exactly what NICE will accept, or not, as the case may be.
In June 2020, NICE let industry know about their changes to the process used in Single Technology Appraisals (STAs), moving from technical reports from Evidence Review Groups (ERGs) – independent academics – to present issues. That allows for easier engagement but also offers companies a right to reply to ERGs. With this change applied from STAs starting in May 2020, 2021 should see more companies seeing the difference. Efficiencies are the gain NICE hopes to see and that ties in with commitments to make NICE faster set out in VPAS. NICE hadn’t yet reached their targets according to metrics set out in July 2020 relating to appraisals up to Q1 of 2020, so 2021 could see NICE really getting to grips with getting faster.
NICE kept up the pace of consulting in 2020, setting out proposals to change the selection of treatments for evaluation in October 2020. The aim is for simplification as well as confirming promises made in VPAS that NICE will appraise all new active substances and significant new indications.
Arguably the most important consultation from NICE in 2020 was a six week consultation on the evidence and considerations for changing their methods, including those used in Technology Appraisals. According to experts at market access consulting firm, Bresmed, the changes being tabled that are likely to have a high potential impact include the removal of End of Life criteria to be replaced with a severity modifier, a change to the discount rate from 3.5% to 1.5% as well as greater emphasis on real world data.
Yet there is still more work for NICE and all stakeholders who will want to shape the final changes, as the agency plans to consult for another six weeks from February to March 2021 as well as consult with stakeholders on the draft programme manual which will encompass the reformed methods in June to July 2021.
The final changes won’t bear fruit for a little more time; implementation will be for treatments assessed from October 2021. This will also be when changes to selection processes will be implemented too. Companies are going to need to keep refining their inputs to NICE as they consult as well as run scenarios and review strategies to make the most of any opportunities for treatments that will be reviewed under the new approach.
Less clear is the ‘what and when’ of changes to the criteria that determine which treatments are reviewed through the NICE Highly Specialised Technologies (HST) programme, another area that NICE is reviewing. This is of interest as it offers a wider set of value components to be considered, as well as more flexibility on the cost-effectiveness threshold, for ultra-orphan treatments.
It’s likely NICE will set out details on this review during 2021. However, anyone hoping that the door will be open for the rarer end of common treatments could be disappointed as NICE say that they want to make the criteria clearer and more specific but not increase, or decrease, the number of HST topics. NICE is funded to do three a year.
NICE, building on their international links, was one of seven agencies who took part in the first ever World Evidence-based Healthcare Day in October 2020. We can expect to hear more on the global initiative in 2021. It’s also likely that their 2020 agreement with Colombia’s IETS will start to bear fruit, shaping how HTA is done in Colombia.
Pulling all this work together will also be a test of NICE’s 2020 appointed chief executive Gillian Leng. She’ll likely bring a steady hand to the consultation and the next steps, reflecting her over 13 years at NICE. 2021 could see big changes that should provide opportunities for faster NICE appraisals but as ever, the devil is in the detail and the full impact won’t be possible to see until a number of treatments have gone through the new methods and processes.
Medicines and Medical Devices Bill and a new Innovative Medicines Fund
The Medicines and Medical Devices Bill is still going through Parliament and should become law in 2021. It’s part of the legal homework necessitated by the UK leaving the EU and covers a range of regulatory issues.
The importance of the Bill from a market access perspective is not however just about regulation but has also seen discussion of the establishment of an Innovative Medicines Fund. Whilst a proposed amendment to the Bill on establishing such a fund was withdrawn during December 2020, the discussions in the House of Lords suggested that NHSE&I and NICE will be engaging during the first quarter of 2021 on the fund.
The fund will replace the Cancer Drugs Fund (CDF), and widen the treatments that can be funded on an interim basis. The CDF as it has been run from 2016 helps generate evidence for treatments that have the potential to be cost-effective but face uncertainties that can be addressed through evidence generation. It’s proved to be a key enabler for market access for cancer drugs and many – although not all – drugs funded under the CDF have gone on to go into routine commissioning, although often with a hefty price cut. Just how the Innovative Medicines Fund will work is something to watch as it may provide new access opportunities previously not available.
More change ahead in 2022
There will be yet more change in the future with major shakeups expected in the way NHS England is structured, with the potential to abolish Clinical Commissioning Groups (CCGs) and Integrated Care Systems to be put on a statutory footing in 2022. That means much planning could be on the cards and, as ever, a need for the pharma industry to keep up to date and ensure that they’re engaging with those that matter for access on a local level.
About the author
Leela Barham is researcher and writer who has worked with all stakeholders across the health care system, both in the UK and internationally, on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).
2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay.
I think it is fair to say that 2020 will not be particularly missed by anyone. Many started the year with big plans, whether for overseas trips, weddings, or industry events, and then the unthinkable happened. While the world first heard of the novel coronavirus in late 2019, it was not until 11 March 2020 that it was declared a global pandemic and it finally sank in just how serious of a threat it was. But how will the world continue to change in 2021?
Major global events
COVID-19 has amplified many of the issues that society was already facing. Although the pandemic has largely taken the media’s focus away from the climate crisis, it has given us a preview of what is to come if we do not stop exploiting the planet and our wildlife. Indeed, 2020 brought new record forest fires and extreme weather events.
In addition, 2020 was the year where social justice (not least in the form of Black Lives Matter protests) was brought into focus. Racial discrimination and bias were also uncovered in healthcare, with stark differences in COVID-19 rates and mortality between different ethnicities in many countries.
COVID-19 has widened the already large class divides seen between white-collar and service workers, with the former typically having the option of working from home and taking the recommended social distancing precautions. Conversely, the latter group is largely being forced to carry on with their work with little protection and low compensation, if they even have a job to go to after many smaller businesses closed their doors.
Public health has been politicised
Somehow, in 2020, wearing a mask to prevent the spread of a highly contagious disease became a controversial and political issue. People were asked to stay home, watch Netflix, and bake sourdough bread to protect those who are vulnerable, yet photos of packed bars and sports stadiums soon emerged and anti-masking protests were held across the world.
Epidemiologists, researchers, and clinicians are now household names, with people like Dr Anthony Fauci and Sweden’s Anders Tegnell drawing their fair share of both praise and criticism domestically and internationally. Countries’ strategies to contain the spread of the virus have been debated and criticised, and it will likely be years before we will be able to say which approaches were “right” and “wrong”.
“On the upside, the pandemic has brought enhanced focus to mental health issues and innovative approaches on how to best address these. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma around mental health can be lifted and better treatment strategies can emerge”
Mental health focus
The secondary effects on mental health during the pandemic are vast. We are already seeing increased rates of depression and anxiety because of the pandemic, and there are no signs of this slowing down. Women are especially impacted, disproportionately having to take on childcare or home-schooling compared to their male counterparts.
On the upside, the pandemic has brought enhanced focus to these issues and innovative approaches on how to best address mental health. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma can be lifted and better treatment strategies can emerge.
United global research
Another positive note is that the pandemic has accelerated laboratory and clinical trial collaboration far beyond what has ever been seen before. From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centres or countries. It has also shown that the time it takes to get a drug to market can be substantially reduced when there is enough funding and political will. How this will affect clinical trials and regulatory approvals in the future remains to be seen, but there is reason to be optimistic.
Healthcare goes virtual
Before 2020, telehealth appointments were few and far between, with many clinics not set up for these services. Since then, the growth of telemedicine has been exponential. Another aspect of healthcare that has had to adapt is the way we monitor chronic conditions. Older patients or those with co-morbidities are at higher risk of severe COVID-19, so frequent clinic visits for routine blood pressure measurements are not always feasible. As a result, we have seen a dramatic increase in the interest and uptake of remote monitoring devices such as wearables and mobile health apps. I predict that this is just the beginning of healthcare’s virtualisation and am excited to see what the new year has in store.
Remote work is the future
Another major change in 2020 was of course the sudden move to remote work. For many, it was a 180-degree shift from business as usual. Interestingly, in a Canadian survey, the majority of respondents (55%) expected at least some of the workforce to remain remote in a substantial way after the pandemic is over, while only 17% expected all staff to be onsite five days a week. Further, major companies like Twitter have announced that employees will be able to work from home permanently, signalling a clear change in the way that we do work. While not without challenges, I see remote work becoming a mainstay due to its greater flexibility and convenience for workers.
Virtual events are rapidly improving
Finally, the ways that pharmaceutical and scientific communities attend meetings and events completely changed in 2020. Virtual meetings such as advisory boards and steering committees were already popular before this year but were often accompanied by in-person meetings. We have now seen without a doubt that it is possible to meet the same objectives virtually, often more effectively and at a lower cost.
The biggest change, however, is the way we now attend larger events such as conferences, congresses, and medical education events. There is no shortage of online conference solutions available, but there is still much to improve on. For example, some aspects of in-person events are not always there or are poor substitutes for the real thing.
Ideally, virtual event platforms should be comprehensive so that everything you need is in the same place. The layout, branding, and inclusions should be completely customisable to your needs, and it should come with all aspects of in-person events such as networking, breakout workshops, exhibitor booths, and poster sessions. The good news is that these types of platforms are getting better by the day, and so are the virtual events that they host.
What have we learned from the last year?
The past 12 months have shown that firstly, we live in a highly polarised world where science and public health are up for debate. Secondly, crisis leads to innovation and finally digital health technologies are the future with remote work and virtual meetings here to stay.
Wishing you all a safe, happy, and healthy 2021.
About the author
Natalie Yeadon is the CEO and co-founder of Impetus Digital, where she helps life science clients virtualise their meetings and events and create authentic relationships with their customers.
Patients have been asking for patient-centric trial solutions for years – the industry just hasn’t been listening. That’s according to Medidata’s Anthony Costello, who was bringing patient feedback into product design long before COVID-19. He tells us what insights pharma has been missing out on and how they can be harnessed to build better solutions.
COVID-19 might have forced the industry to leave behind its reticence around remote and decentralised trials, but according to Anthony Costello, senior vice president of mobile health at Medidata, this reticence wouldn’t have existed in the first place had the industry been genuinely listening to patients.
“Patients have not been saying anything new during COVID-19, but the difference is that the industry has woken up and started paying attention,” he says.
“Patients have long wanted more and better technology to use in studies so that they don’t have to visit sites so often, but the industry has been very reluctant to go in that direction.”
The global pandemic has caused pharma companies to invest in digital marketing, as healthcare systems across the world adapt to strict lockdown rules. Once the global emergency ends, this trend will continue, argues pharmaphorum’s Richard Staines.
The global outbreak of COVID-19 has forced businesses to radically change their way of working. Healthcare companies have been in the vanguard of this change, with an enormous rise in the use of telehealth and all forms of digital communications.
With medical staff working tirelessly and lockdown restrictions in place across the world, the way pharma markets medications has changed, too.
Until 2020, pharma had lagged other industries in its investment in digital marketing. According to ethoseo, spending on digital projects is starting to catch up with levels in other industries.
In the US, TV advertising for pharma products is still a big business, but this is mainly aimed at patients. According to the figures compiled in the third quarter of last year, pharma brands were projected to spend around $10 billion in 2020 on digital advertising aimed at all groups including doctors, a compound annual growth rate of more than 13% since 2014.
A report from eMarketer came to an identical conclusion, estimating that US pharma would spend $9.53 billion on digital advertising in 2020, based on figures from the first nine months of the year.
“When pharma companies are trying to interact with doctors and inform them about the latest developments with medicines, the onus is on them to produce information in a format that suits the needs of today’s digitally savvy medics”
This is an increase in 14.2% compared with 2019, and the digital spend is forecast to increase to $11.25 billion in 2021, an 18% increase.
According to Ian Hale, vice president of commercial content at Veeva, the change is driven by the sudden migration to digital services because of the pandemic.
Speaking from the company’s online European Veeva Commercial and Medical Summit late last year, he highlighted how more than three quarters of doctors now use iPads to find information. This switch to digital technology is meaning the pharma industry is having to change the way it communicates with physicians.
When pharma companies are trying to interact with doctors and inform them about the latest developments with medicines, the onus is on them to produce information in a format that suits the needs of today’s digitally savvy medics.
Gone are the days of long lunches with reps – what’s needed is accurate information that is fully compliant with marketing regulations, presented in most cases in a digital format, according to Hale. He added that information can be broken down into modules for use across global organisations and tailored to meet the needs of individual countries and their rules on marketing.
The way that reps engage with doctors will be very, Hale said, with an emphasis on efficiency. However, overall reps will engage more with healthcare professionals thanks to this change in approach.
“They are going to share content ahead of meetings. I don’t think there is going to be back-to-back zoom meetings,” said Hale.
Dan Atkins, vice president of digital innovation and insight at Shionogi Europe, told the conference in a keynote address that the company needed to get better insights into its customers as the company built its business in the region.
Using digital technology has allowed the company to keep track of its interactions with customers, with senior management and area managers also able to get feedback from the system.
David Herron, head of global digital platforms and operations at Teva, added that the company’s sales force was primarily working from home as a result of the pandemic. Digital tools have therefore become essential for the company to continue to interact with doctors.
The company had to use digital technology to link its sales workforce, who were already facing uncertainty because of rapidly evolving pandemic last year, with medics who were also experiencing similar anxieties. Herron added that the company is using strategies such as approved emails to interact with customers.
“Our ultimate goal is to be easy to do business with,” said Herron, focusing on areas such as digitising order management with pharmacies to streamline the sales process.
Going forward, Veeva’s Ian Hale said the processes are now available to reach out to medics using various different digital channels. With a robust compliance approval system in place the information can be sent out to many different geographies efficiently.
This can ensure the company is singing from the same hymn sheet across all areas and with all different media, while at the same time complying with varying marketing regulations.
Hale added: “Delivery across omnichannels is going to be key. You can approve compliantly and use that module to go in many areas.”
His message is that the shift towards digital marketing will remain in place after COVID. He concluded: “This is the way the industry is going. Many are asking how long to return back to the norm. For industry this means huge amounts of face-to-faces with customers.”
This was always a hugely expensive way of working and once pharma companies realise the cost savings and efficiencies through digital technology, they will be unlikely to let go of them once the pandemic recedes.
“Will we go back to that? I don’t think we will,” Hale said.
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses.
When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.
After months of turbulent lockdown measures, the dawn of approved vaccinations signalled hope COVID-19 could finally be under control.
Sadly, the chaos is continuing as the UK grapples with the emergence of a new variant of SARS-CoV-2, estimated to be up to 70% more transmissible than the previous form of the virus.
As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinical trials is causing widespread concern. Many believe the strategy is too risky – prioritising political expediency over science and using the British public as laboratory subjects during an already severe crisis.
The advice, which first came from the UK’s Joint Committee on Vaccination and Immunisation (JCVI), stated a maximum interval of 12 weeks should take place between the first and second doses of both Pfizer and AstraZeneca’s vaccines.
JCVI said this is likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19.
“The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity,” said the committee. “An extended interval between vaccine doses together with initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier.”
The advice has been endorsed by the UK’s four chief medical officers but has been met with backlash from the medical community. Many healthcare workers have aired grievances on Twitter protesting the changes.
Just received this email cancelling my 2nd dose of the Pfizer vaccine. On the basis of UK government guidance yesterday. This means that the vaccine is not being delivered as licensed. I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. pic.twitter.com/ZDtIjm1z8W
The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.
“The Government must see that it’s only right that existing bookings for the oldest and most vulnerable members of our society are honoured, and it must also as soon as possible publish a scientifically-validated justification for its new approach,” said the BMA.
“As doctors, we believe this can and should be done even as practices and the wider NHS step up the COVID-19 vaccination programme to deliver initial doses of vaccination to other vulnerable people, including frontline healthcare professionals – many of whom still have not even received their first vaccination.”
‘Erosion of public trust’’
The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorised dosing schedule for each COVID-19 vaccine”
“Protecting frontline staff from infection is vital to help them care for patients with COVID, as well as delivering the vaccination programme,” said NHS Confederation director Layla McCay. “However, there has been concern about changes to the vaccination schedule, which were announced at short notice and led to confusion and anxiety for patients and could lead to an erosion of public trust in healthcare providers. As always, NHS teams will pull out all the stops to respond to changing guidance, but the government must do more to explain the rationale for this change.”
Internationally, the decision has been met with scepticism. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccines to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”
In a joint statement Pfizer and BioNTech warned there was no data to demonstrate that protection after the first dose is sustained after 21 days. “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” said the companies.
The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response. The combined trial results published in the Lancet showed that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).
Andrew Pollard, head of the Oxford Vaccine Group and chief trial investigator vaccine told the BMJ that extending the gap between doses made sense.
“Generally, a longer gap between vaccine doses leads to a better immune response, with the second dose causing a better boost. (With HPV vaccine for girls, for example, the gap is a year and gives better responses than a one-month gap.) From the Oxford vaccine trials, there is 70% protection after the first dose up to the second dose, and the immune response was about three times greater after the second dose when the second dose was delayed, comparing second dose after four weeks versus second dose after two-three months.”
Akiko Iwasaki, professor of immunobiology at Yale Medical school also tweeted support for the changes, stating the new SARS-CoV-2 variant as the deciding factor.
I am still a proponent of 2 dose vaccine but given the urgency, we can delay the 2nd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me. (8/n)https://t.co/qrwvtOLyGv
“I am still a proponent of two-dose vaccine but given the urgency, we can delay the seconnd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me,” said Iwasaki.
David Grainger, chief scientific advisor at life sciences investment firm Medicix, also expressed confidence in the strategy, referring to modelling by the University of Toronto that predicts increasing the number of people protected, by limiting individuals to a single dose, reduces severe COVID events (ICU stays and death) by between 30-40% over a 6-month period. This could amount to over 20,000 lives saved.
“The vaccine only must be 50% effective in two people to reduce the overall risk of infection that is achieved with 95% protection in one person,” said Grainger. “If I protect 10,000 people out of a population of 20,000 with 1% risk of infection at 95% efficacy, I get five cases from the protected subgroup and 95 cases in the unprotected subgroup for a total of 100 infections; if I protect all 20,000 people with 50% efficacy, again I get 100 infections. The existing data strongly suggests that a single dose will deliver at least 50% protection for at least a few months.”
He added that during the pandemic, decisions often needed to be made in the absence of proper data. “It teaches us that we cannot just ‘follow the science’ because that pathway is way too conservative (at least if that means only do things for which there is clear, direct evidence).
“This is why we should have scientific advisors, but not rely on scientists to make decisions. It is why scientists rarely make good investors or businessmen – too many decisions need to be made in the absence of much information.”
How can pharma improve the patient-centricity of its trials during COVID-19 and beyond? Experts from across the sector give their thoughts on the key approaches and technologies that are driving patient engagement forward.
With COVID-19 presenting new barriers to running and recruiting for clinical trials, making studies patient-centric is more important now than ever before.
According to one analysis, conducted by Global Data, approximately 67% of trial disruptions during the early stages of the pandemic were due to the suspension of enrolment, followed by the delayed start of planned trials at 18.4% and slow enrolment at 14.4%.
Ensuring that trials are easy to access and don’t overly burden the patient is essential amidst these potential disruptions – but a truly patient-centric trial has benefits beyond enrolment.
Trials that are engaging and easy to partake in can lead to higher adherence, higher satisfaction, improved data quality and overall performance, and can even give participants a more positive view of the sponsor company in terms of their commitment to bring new treatments to patients.
Research from a large-scale survey of 1000+ senior pharma professionals has highlighted the divide between digitally adept companies and those that have been slow to adopt technologies. We look at how the customer experience is changing due to COVID-19.
Historically, pharma has lagged behind other industries in adopting digital solutions, but with COVID-19 catapulting the sector, and healthcare in general, into a new digital era, the landscape is changing significantly and rapidly. What will this transformation mean for pharma’s customer experience?
In an April survey conducted by Reuters and Omnipresence, 1,363 senior professionals mostly working in pharma (82.8%) in the EMEA region (73%) and biotech, medtech/device or consumer health companies reported on how life sciences organisations were adapting to the ‘new normal’.
With severe restrictions on face-to-face engagements during the pandemic, digital engagement has been one of the few ways companies have been able to connect with customers. Findings from the report highlighted an urgent need for investments in customer relationship management (CRM) capabilities.
A unified approach
According to Sanjay Virmani, CEO of Omnipresence, a key struggle for pharma companies comes from the lack of a common data model, preventing them from having a connected and holistic view of the individuals they’re trying to engage with.
“When an organisation looks at an HCP or customer, are they a marketing customer, a medical affairs customer, a sales customer?”
“If different departments are not coordinated, how can the customer get all the information they need with the proper context? And if the company does not provide that seamless experience, the customer has to glue it together themself or not get it” – Sanjay Virmani
“It is not as if companies have not invested in the infrastructure and are not generating this data. The problem may be that there is no unification that is so essential to going in that agile, omnichannel direction.”
Unified platforms that can pull in data from multiple digital channels can help create a better customer experience according to Virmani. “There is a need to reinvest in the technology stack to be able to drive unification, but there is also a need to reinvent the cultural stack so that different departments are working in a coordinated manner,” he said.
“If different departments are not coordinated, how can the customer get all the information they need with the proper context? And if the company does not provide that seamless experience, the customer has to glue it together themself or not get it.”
In the report, 70% of respondents said they needed better ability to surface customer insights from various channels into digital workflows/CRM. 75% said they needed a more agile method to ingest and consolidate insights across channels and 65% said their CRM needed to improve the method and quality of data collection.
Pharma is also failing to utilise engagement tools, such as chatbots, even though many sectors are using them on some level. According to a report by Juniper Research, the banking sector is expected to automate up to 90% of customer interactions using chatbots by 2022.
“About 40% [of respondents] were not doing that at scale across multiple countries, regions, languages, and products,” said Virmani.
Hybrid strategies that enable companies to have the flexibility to shift between virtual and in-person engagement are likely to be where the industry is heading, Herman De Prins, chief information officer at UCB, explained, adding: “I don’t think we will have complete virtual HCP engagement post-pandemic. We already saw this in the first few months of the pandemic; there was an immediate move towards complete virtual HCP engagement, but once the pandemic restrictions were slightly loosened, we saw face-to-face coming back relatively strong. We do believe that remote engagements will continue — but they will be a hybrid engagement and not a purely virtual one.”
This survey also showed how companies were putting specific strategies in place to improve HCP engagement through modern digital channels, that were considered “non-traditional” pre-pandemic. 73.6% of respondents said they expected the use of social media to engage with HCPs to increase over the next 12 months. However, the transition to digital commercial operations has proved challenging for some companies with 32.3% of respondents saying their organisation did not have the commercial data and analytics capabilities to support digitisation of sales and marketing operations and 28.6% stating their organisation did not have the right technology/platform/channel capabilities to support the digitisation of sales and marketing including virtual sales capabilities.
“CRM is only a minor part in the broader omnichannel approach. Changing only the CRM would achieve nothing but spend more money. What is truly needed is a deep change in the analytical and go-to market approaches and optimising the new channels” – Florent Edouard
Florent Edouard, SVP, global head of commercial excellence at Grünenthal Group, commented: “The 60% or so who think they are ready for complete digitisation of sales and marketing operations say so because they have not truly tried it.
“This is probably the most challenging part of the digital transformation, as we need to acquire skills such as advanced analytics that we currently do not have, turn our customer model fully around, and implement tools that are able to create sophisticated AI-powered models that can manipulate billions of data points. Very few companies are equipped to do that in their commercial entities.”
Time for change
Commercial teams should now address the gaps they have in data and analytics and accelerate the adoption of omnichannel capabilities. While CRM was traditionally built for a time where there were only one or two channels, it is now becoming a thing of the past.
Omnichannel approaches that allow bi-directional engagement on all modern channels provide a seamless and individualised customer experience that will soon become the ‘better normal’. Key benefits could be medical chatbots answering simple dosing questions, HCPs triggering inbound virtual meeting requests and ensuring compliant social media engagement from field teams to HCPs.
But what exactly does this mean for life sciences companies? “This means we need much better CRM capabilities than pre-pandemic. That does not mean these capabilities are not available. It just means they have not been exploited” said De Prins.
Organisations have started to recognise the urgency, with 79.7% of survey respondents stating the pandemic will influence priorities towards investments in customer experience.
“CRM is only a minor part in the broader omnichannel approach,” said Edouard. “Changing only the CRM would achieve nothing but spend more money. What is truly needed is a deep change in the analytical and go-to market approaches and optimising the new channels.”
Virmani agreed that the pandemic has made the need for better insights and analytics from CRMs and other CX systems much clearer and more urgent. “There will be a greater emphasis on the connected customer journey. Many companies are already thinking about customer experience as a competitive edge.”
Maximising the best management of customer experiences is one of the essential strategies that pharma companies can take to stand out from the competition. Indeed, companies that will triumph in the post COVID-19 world are the ones that continue to allocate resources, execute omnichannel development, remove silos and move towards a more unified and agile digital approach.
As the pandemic continues to accelerate the pace of digital change around healthcare, organisations need to grasp the opportunities this shift presents to make far-reaching improvements to their customer experience.
Omnipresence is a unified and intelligent customer experience management platform (CXM) for healthcare and life sciences organisations with CRM, omnichannel engagement, advanced analytics, and AI capabilities in a single platform.
Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work
This thought leadership series has been paid and developed by Kite, a Gilead Company.
In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer.
Roll on two years and the team has achieved what at the time appeared a major challenge, putting 1,000 tonnes of steel, 1,800 solar panels and 176km of network cable into the creation of a centre of excellence for cell therapy near Amsterdam in the Netherlands.
In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years. Our ambition was always to do this within two years, a goal we achieved despite the unprecedented challenge of a global coronavirus pandemic.
Indeed, while undoubtedly putting new hurdles in our path, the arrival of COVID-19 into our lives has transformed our business and operations by presenting an opportunity to be adaptable, flexible and responsive – and to continually evaluate and mitigate risk.
“There is huge complexity involved in cell therapy manufacture, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells”
It’s been a complex process that’s required highly technical and skilled personnel. Not only did we build a specialised facility from the ground up, but we built an organisation, from 10-15 people two years ago to more than 400 now. We put energy and emphasis into creating the right team and a culture where everyone understands the values and drivers, allowing us to operate in a collaborative and cohesive way.
Now the new €130 million, 19,000m2 manufacturing facility near Amsterdam is able to support delivery of up to 4,000 cell therapies each year for eligible cancer patients across Europe.
But backtrack to August 2018 and the very first European patients were also receiving treatment, part of an expertly crafted operation that ran in parallel to the build. Our supply chain group worked with the existing US team to manage the shipment of patients’ cells to the US for modification and their return for treatment.
Having a fully operational site in Europe versus the US has several advantages; reducing transportation time, strengthening the chain of custody and, potentially, cutting lead time to the patient by approximately one week. This allows us to potentially provide the therapy quicker for eligible cancer patients who have stopped responding to or have progressed despite other treatments. At this stage of their disease, for patients who have no other options, a week can make a difference.
The journey of the cell
The very nature of cell therapy manufacture means employees work in tightly controlled environments to ensure adherence to good manufacturing practice standards and, ultimately, to ensure the quality and integrity of the product.
Ultimately, it’s a team sport between Kite and Gilead and the 100-plus qualifying hospitals across Europe, all of which have been individually trained and assessed to ensure they are fully compliant with the necessary procedures and meet exacting standards.
So, what does the journey of the cell look like?
To achieve consistent, timely delivery of a high-quality product requires a robust and efficient approach to engineering patient’s own T cells, which in itself encompasses apheresis, cell modification and final formulation – coupled with rigorous quality control testing throughout – reflecting the highly complex nature of the manufacturing process.
Understandably, teamwork is vital and requires an integrated network and seamless communication between Kite and the treating hospital. The journey starts with the hospital making a treatment reservation through KiteKonnect and shipping of the apheresis kit to enable the process of extracting the patient’s own white blood cells, kickstarting both the chain of identity and chain of custody.
Here, our quality and supply chain experts are integral to every stage of the cell therapy manufacturing continuum to ensure the product is returned to the patient in a timely manner.
As soon as apheresis has completed, the cells are shipped in temperature-controlled conditions to our facility near Amsterdam where they are assessed for quality and condition. One patient equals one individual treatment, so it is critical to preserve the chain of custody and chain of identity to ensure the product comes back to the same patient.
Why chain of custody and identity is critical
The chain of custody and chain of identity must, therefore, go hand-in-hand. In this way, not only do we know which cells belong to which patient, but we have precise location and up-to-the-minute feedback on storage conditions to ensure quality and safety is paramount at all times.
Once the cells have completed this first stage, the manufacturing process can begin, with T cell selection, activation, and genetic modification using viral vector technology to ensure the ability to recognise the patient’s cancer cells. Cell expansion follows to multiply the modified cells into their millions.
Further critical quality testing then takes place to ensure the cells are of a required standard and to create a finished purified product, which will be stored and returned to the originator hospital in temperature-controlled conditions (see diagram below).
Several quality attributes will be tested at this stage and the cells must meet these rigorous criteria and specifications. There is huge complexity involved in cell therapy manufacturing, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells.
As part of this process, the supply chain team simultaneously coordinate with the hospital to prepare the individual so when the cells are infused back to the patient they are primed to potentially fight the cancer.
Individualising the approach
In stark contrast to basic biopharmaceutical products with a robust starting material, the cells of a patient with cancer who has already undergone multiple treatments will not have the same quality. Consequently, there can be unforeseen hurdles during the process and I am proud that the team has managed each situation to safeguard the patient’s cells and ensure they receive treatment in an efficient and timely way.
This is particularly important when you consider the turnaround for each individualised product from starting material to the patient is typically four weeks – versus months or even years for a standard biopharmaceutical product.
Additionally, each patient equals one product batch – we do not keep inventory – and the potential impact on the patient if something happens to that batch is why we are so passionate. From quality manufacturing, facility engineering, supply chain, we’re driven to make sure the batch is returned to the patient safely and effectively.
What of the future? For me, it’s all about leadership, clarity, direction, and commitment of the entire team. It’s about the opportunity to be involved in an innovative field of cancer therapy where the body is stimulated to fight cancer cells. It’s about optimising the manufacturing process to become more effective and efficient. But, most of all, it’s about the patients, their care partners and families
This was supported by Kite, a Gilead Company
UK-CTH-2020-11-0075 | Date of preparation: December 2020
New research from Accenture has revealed that adoption of patient support services hasn’t improved since 2015 despite increasing pharma investment. The company’s Jennifer Spada tells us how companies can boost awareness of their programmes to improve patient outcomes.
As part of its drive towards patient centricity, the pharma industry has increasingly been building patient support programmes that can offer beyond-the-pill services to patients. The market for patient engagement solutions was worth $8.8 billion in 2017 and is projected to reach $18.68 billion in 2022, an annual growth rate of 16.2%.
These programmes can help guide a patient through complex information about diagnosis and treatment choices, or aid them with information on the medical and financial aspects of care, and also include day-to-day care management such as medication reminders, symptom monitoring, and nursing support.
Research has shown that when patients utilise these services, adherence increases, quality of life improves, hospitalisations and ER visits are reduced, and survival rates rise.
Episode two of the Alderley Park Discovery Podcast covers access to skills in the life sciences sector, with a focus on support for aspiring scientists and UK staffing trends.
In this instalment Dominic Tyer’s guests on the podcast are Sai Life Sciences’ head of global R&D Dean Edney, Joynes & Hunt’s managing director Steve Joynes and Dr Kath Mackay, managing director at Bruntwood SciTech’s Alderley Park.
Dr Mackay talks about why university connections are vital for a life science and tech cluster like Alderley Park and how the campus works to inspire the next generation of scientists.
From Dean Edney there’s a look at the expansion story of India-headquartered Sai Life Sciences and what the research development services company needed when it came to setting up its first European base of operations.
The podcast also features a rundown of recruitment trends in UK life sciences from Steve Joynes from specialist staffing solutions provider Joynes & Hunt. He discusses how recruitment has changed over the past decade and reveals some of the impacts from the COVID-19 pandemic on staffing.
The Alderley Park Discovery Podcast, produced in partnership with pharmaphorum, presents perspectives on UK and global bioscience innovation trends, with input from leading experts at Alderley Park in the North West of England.
In episode one of the podcast Dr Mackay talked about the challenges of rapidly building capacity to test thousands of patients a day for coronavirus at the Alderley Park Lighthouse Lab.
Alderley Park, a development by Bruntwood SciTech, is the UK’s largest single-site life science campus and offers bioscience facilities for R&D-focussed life science companies at every stage of their lifecycle, from start-up to global corporate.
Episode two of the Alderley Park Discovery Podcast is available in the player below, where you can listen to it, download it to your computer or find – and subscribe to the series, and other pharmaphorum podcasts – in iTunes, Spotify, acast and Stitcher.
In the first of a two part series, IQVIA’s Sarah Rickwood covers nine key trends and events that will affect the global healthcare and pharmaceutical industries in 2021.
One bright spot in an otherwise dreadful year: the pharmaceutical industry has discovered it can do things it never dreamed possible. Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at.
If they had also predicted that the second person to receive the vaccine out of trial would be a gentleman named William Shakespeare, they would certainly have been dismissed as a fantasist. Yet these things have happened. The pharmaceutical industry has been through extraordinary times, and responded magnificently.
2021 will of course be a year of aftermath as the world resolves the COVID-19 infection crisis. It will also be a year of challenge, because the healthcare system crisis and the economic crisis triggered by the COVID-19 infection crisis will last longer than the infection crisis which caused them. It will also be a year of opportunity: trends which existed pre-COVID-19 have been accelerated by the changes wrought by the pandemic, and events and trends unaffected by COVID-19 will come to fruition in 2021.
“This may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings”
With the roll out of vaccination across population tiers, starting with the most vulnerable, there will be a progressive reduction in social distancing and pandemic imposed restrictions, but since vaccination will necessarily take time and different countries will move at different rates, it is unrealistic to expect that the restrictions of 2020 will rapidly disappear.
The crises that the pandemic has triggered will also become much more apparent in 2021 as the infection crisis recedes. These are the crisis of healthcare system capacity and non COVID-19 patient backlog, and the economic crisis, still largely to come in impact, which will constrain healthcare spend, both public and private, across countries and have knock-on impacts for medicines spend. These crises will provide the backdrop to both 2021 and the years beyond, and the nine trends that we will discuss must, of course, be viewed in their context, but we will focus on trends of opportunity and positive change for healthcare and the pharmaceutical industry.
Healthcare systems reconfigure
Around the world, the infection crisis put healthcare systems into shock. The prospect of overwhelming hospital ICU capacity was the primary driver of lockdowns, as governments sought to “flatten the curve” and manage infections. Certain countries were also forced to respond by building new capacity-dedicated facilities for severe COVID-19 patients, like the largely unused “Nightingale” hospitals in the UK.
All countries also created capacity within the existing hospital provision by cancelling elective surgeries and non-urgent hospital treatment. Where treatment continued, such as in cancer cases, it was where possible, shifted to a homecare setting, creating a rapid and substantial shift of care from hospital and into primary care and homecare. Primary care itself saw significant reconfiguration- for many patients, routine consultations became virtual- although not necessarily all digital or telemedicine as might be conceived by innovators.
Healthcare systems ended 2020 in a very different place to where they were in 2019, with hospital capacity (and hospital finances) challenges. These changes are likely to reduce only slowly in the Vaccine+ environment, and will not be entirely reversed.
For pharmaceutical companies there are a number of implications. As face to face visits with healthcare professionals declined, so did new diagnoses and new treatment starts, and also evaluations of current patients and switching of treatments. This has built a backlog of non COVID-19 patients in the system, patients who have either not seen treatment, or whose treatment has been delayed or sub-optimal. It varies by country and by therapy area, but is pervasively present, and its consequences play out both now and long into the future. In the near term, launch products, which rely for establishment on new and switch patient opportunities, have, with a few notable exceptions, had a dreadful year.
In the long term, the health impact of delayed or absent treatment for patients could play out as more severe or advanced disease presentation, higher co-morbidities and even earlier deaths. It will take a decade to fully evaluate the true impact.
For pharmaceutical companies, this may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings. Products which allowed patients to self-administer had a differential advantage which was quite variable before- in some cases it was an obvious advantage, in others the institutional inertia which promoted administration in facilities was slow to change. Now, the playing field is very clearly slanted toward self-administration as a consistently attractive advantage, with oral treatments (such as the oral migraine agents) clear winners.
Expect to see self-administration and oral presentations become a bigger factor in health technology assessment in the future.
The non COVID-19 patient backlog
The non COVID-19 patient backlog which has built across conditions and countries is something addressed in another in-depth article for pharmaphorum.
Throughout 2020, IQVIA data, both secondary and primary research pointed to often substantial share of non-COVID-19 patients receiving no, or suboptimal treatment. An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed. IQVIA’s survey of oncologists and haematologists in the top 5 European countries on their experience of treating their cancer patients before and during the pandemic showed specialists reported their patient caseload fell to 41 patients a week (from 77/week pre-pandemic) at the height of the first wave of the pandemic. The June period, which coincided with lows of infection numbers in these countries, was little improved, at 50 patients/week, and as countries faced the second wave of infection in October, the number of patients reported seen per week had fallen back again, to 45.
“The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent”
In 2021, and beyond, addressing the patient backlog (and the consequences of failing to do so) will be an increasingly prominent healthcare topic, as the health impact for untreated, disengaged and sub-optimally treated patients becomes apparent. This will become especially acute with the COVID-19 vaccination roll-out, as this will engage health systems in a vaccination roll-out of unprecedented scale, whilst progressively removing the obstacles to re-engaging with care. We expect there will be a need for public information campaigns to encourage people to come forward for diagnosis and treatment of non-acute conditions which may simply have been tolerated during the pandemic.
The focus is likely to be on people who may have chronic, primary care treatable conditions, such as hypertension, dyslipidaemia, or early type II diabetes. There are also clear concerns, and some hard evidence, that mental health conditions have risen in number and existing conditions been exacerbated during the lockdown, most worryingly, among the healthcare professionals who are so vital to post-pandemic recovery.
In 2021, the pharmaceutical industry must play its role in supporting post-pandemic healthcare system recovery, creating specific plans against this issue, tailored to country and therapy area.
The post pandemic launch
A key commercial concern in the early days of the pandemic was the impact that it might have on innovative launch. Bringing the newest pharmacotherapies to market could be affected at multiple levels – the approvals of new products by regulators, the availability of products in the commercial supply chain, access to new medicines evaluated and granted by payers, and then finally, the uptake and use of the product to its full potential.
New product approvals do not seem to have been adversely affected by the pandemic – as at the time of writing, the FDA has approved 48 novel drugs in 2020, matching the 48 medicines defined in the same way in 2019. The latest 2020 approval was Orladeyo for hereditary angioedema on 4 December, so there is potential for 2020’s approvals to exceed those of 2019. The EMA’s new medicines evaluation process seems similarly unaffected in 2020. This is encouraging but not unexpected; products approved in 2020 completed their trials and submitted their marketing authorisation applications prior to the pandemic. The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent.
Actual availability of approved medicines, as measured by IQVIA’s MIDAS data, is similarly unaffected in the US. In Europe the picture is more mixed- despite the single source of approvals from the EMA (including for the UK as 2020 is a transitional year). Actual availability of new medicines varies by country and falls below historical averages to August in Spain, and to a lesser extent the UK.
In Europe, health technology assessment (HTA) and payers granting access to products pose an additional barrier to launch uptake – so far IQVIA analysis of HTA concludes that whilst the pandemic had some impact on the volume of HTA activity, it has not yet changed the proportion of assessments that are positive or negative.
Ultimately, the real question is whether pandemic and post pandemic launches will fulfil their clinical and commercial potential. Global data on 2020 launch sales so far shows a challenging picture: a small number of launches have done well, solely because of their US sales. These strong launches include three with MIDAS sales of over $100m to August 2020, Ubrelvy and Nurtec, oral migraine agents both launched in February 2020 so prior to the first infection wave in the US, and Tepezza, the first and only approved treatment for the serious and rare condition, Thyroid Eye Disease (TED). The only other launch with significant global sales (again, from US sales) is a triple negative breast cancer treatment, Trodelvy. This and the remainder of the top 10 products by sales to August 2020 have made an average of $15m in global sales, as opposed to $33m for products of the same ranking in 2019.
2021 will therefore be a crunch year for post pandemic launch potential – focus will be on whether 2020 launches can accelerate sales and reach their expected pre-pandemic potential, and whether 2021 launches will experience the same challenges as those in 2020, given the environment will not be “pre pandemic” normal.
Price and value battleground
One key factor affecting innovative launch performance in 2021 will be the economic environment and healthcare system funding. Country GDPs fell an unprecedented amount in 2020, and whilst bounce back is inevitable in 2021 as lockdowns ease, the sums spent on managing the pandemic are huge, and economies are being re-shaped with unemployment sharply on the rise.
Healthcare and pharmaceutical industries generally weather economic downturns well, but there are features of this downturn which suggest particular challenge. The first is the combination of economic challenge with direct healthcare system challenge- stretched resources and the backlog of non COVID-19 patients. The second is the significantly reduced ability of healthcare systems to realise savings from existing pharmaceutical products going off patent. In 2009, $183m of global market value was due to go off patent in the next five years, in 2019, it was $200m. Similar gross figures, but the 2009 figure accounted for 30% of global market value, and 89% of the patent loss was small molecules. In 2019, the share of the market about to lose exclusivity has dropped to 19%, of which 44% is biologics.
From 2021 onwards, healthcare systems are going to be under considerably enhanced pressure to realise greater savings from biosimilars than ever before. Even if they do, however, their savings will be lower. They will need to control medicines spend elsewhere, and that means raising the bar for market access for innovation. We have already seen that the small number of pharmaceutical launches that did well in 2020 did so in the US market and represented either greater convenience and patient self-administration, or because they were unequivocally major steps forward for high unmet need patients.
Is it likely that in the price and value battleground, the distinction between winners and losers becomes much sharper in 2021, with evidence of clear, distinctive benefit more important than ever before. It is also possible that 2021 will see Europe start to fall back as the second market block for early launch return for innovative products, after the US.
Although separate to COVID-19, the UK’s departure from the EU takes it out of the EMA approval regime to become a clearly separate entity to the EU block. The market access lever is more heavily applied in Europe than the US. China and Japan, on the other hand, have come through the pandemic less heavily affected, and China is now approving innovative agents at historically unprecedented levels. Whilst the US will remain paramount for innovative launch, the East is on the rise.
Home healthcare and digital patients
While the technologies (and indeed the logic for) more home healthcare delivery and greater digital engagement existing prior to the pandemic, adoption has most certainly been accelerated vastly by it. 2021 will be the year where we understand where the new equilibrium will establish.
For example, in the US, weekly telehealth medical claims were up +800%, pre-pandemic vs Nov 2020, and building on its Mar 2020 capacity-increasing responses to COVID-19, in November the US CMS introduced the “Acute Hospital Care at Home” programme. However, on the other hand, some US private insurers have begun to roll back exemptions from out-of-pocket costs for non-COVID-19 related telehealth in response to high demand.
Self-administration & novel dosing regimes which free patient from clinic visits were definitely in the news in 2020. Merck, Sharpe and Dohme gained approval to halve its cancer immunotherapy (Keytruda) regimen to once per six weeks, reducing clinical visits by half with novel dosing, for example. Again, 2020 may have represented an acceleration of a pre-pandemic trend; IQVIA MIDAS data suggests spending CAGR 2015-20 for therapies suitable for self-administration was 13%, vs 7% for therapies which require hospital administration.
It’s not, of course, just self-administered pharmaceuticals which enable home healthcare – digital technologies enable home healthcare by allowing diagnosis, monitoring and patient engagement to happen at home. For example, UCB-Medisafe’s epilepsy portfolio digital companion will support patient engagement, and another US innovation, FDA approved platform including biosensor wearables and AI analytics powers Biofourmis’ [email protected] platform which has been rolled out nationally to help facilitate CMS’ “Acute Hospital Care at Home” program.
In the second article of “nine for 2021” we will look at the issues in 2021 which will directly impact pharma, including the permanent changes in pharma’s customer engagement model, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.
About the author
Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.
The pandemic has shed light on inefficiencies in healthcare systems, and provided an opportunity to adjust how we manage care in the future. Jennifer Haas, executive vice president of Noteworth, shares her 2021 predictions surrounding the future of telehealth and big data.
Healthcare providers are grappling with the task of scaling digital care delivery operations for ambulatory patients in response to the cost dynamics of effectively treating large populations with limited resources, especially in a post-COVID-19 world. At the heart of this challenge is how to secure, aggregate, analyse, and action the data necessary to make proactive patient care decisions and diagnoses.
In the coming year, there will be a renewed focus on healthcare providers needing to shift their business models to highlight the new need to make healthcare accessible and effective, regardless of geography, location, and mobility.
This will need to be done while also engaging and empowering patients in their own wellness. A recent report highlighted that over 40% of US adults had delayed seeing a doctor during the pandemic. Powering digital medicine platforms with big data and IoT devices ensures clinicians receive access to the entire scope of a patient’s health information while reducing the need for in-person visits and improving patient outcomes.
The ability to use big data in healthcare through digital medicine will prove to be invaluable for healthcare organisations as they work through the pandemic and the new world it has created. Having access to relevant data through digital medicine is helpful because it provides more opportunities for proactive intervention and a more accurate view of the patients’ health with consolidated real-time information.
“Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health”
When it comes to digital medicine, big data can improve communication and strengthen relationships between patients and their various healthcare providers. This is largely because the use of digital medicine platforms feel much more comfortable and personalised for many patients. It not only allows them to take a more active approach in their own healthcare, but gives them access to their clinicians more freely and frequently. It also allows the care team to be much more connected to the patients’ day to day progress and highlights potential intervention needs before they become critical. Risk modeling and stratification will continue to evolve, allowing clinicians to collaborate with AI and Big Data to make more accurate predictions of where a patient’s health is trending.
One of the focuses of digital medicine is remote patient monitoring. This technology is especially helpful during the current pandemic as it gives providers the information needed in order to track the patient’s health statuses and react quickly when a patient has an urgent need for proactive care. Remote patient monitoring can alert patients and their healthcare teams when intervention, including seeking in-person medical attention on a scheduled or emergency basis, is needed. Having this data is vital to the future of how patients and their healthcare providers work together. By combining the power of big data within healthcare, digital medicine platforms can help reduce the number of unnecessary visits patients take to the doctor or hospital and alert providers, caregivers, and patients when their status requires in-person care.
Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health. As we see within numerous apps or smartphones, they allow users to track health factors such as physical activity, heart rate, breathing rate, and diet. These data points can be transmitted directly to a doctor and be factored into any treatment decisions. Being able to bring this data together creates more insight into a patient’s preventive and personalised care.
The benefits of big data analytics range across the board in healthcare. Most, if not all, healthcare sectors stand to benefit from the implementation of big data analytics within digital medicine. The providers (hospitals or private practices) will be able to provide better care to their patients to make more accurate data-driven decisions more efficiently. The biggest winner will be the patients themselves who can utilise telemedicine and remote patient monitoring to their advantage in order to enjoy more flexible and convenient access to care which in turn helps them to live healthier lives.
The COVID-19 pandemic has pushed the once-niche telemedicine industry into the mainstream, creating a lasting shift in care delivery. In 2021 and beyond, we will see the healthcare industry shift even more towards digital medicine, specifically AI and risk stratification modeling.
If 2020 has taught the healthcare industry anything, it is that patients want choices and control over their own healthcare. Healthcare providers and insurers need to listen. Leveraging digital medicine platforms allows providers the ability to draw on the desire for personalized, proactive care by utilising actionable data to proactively monitor a patient’s health status between visits while driving down care costs and improving patient outcomes.
About the author
Jennifer Haas is executive vice president of sales for Noteworth, where she leads sales, channel partnerships, business development, marketing and social media including profit and loss management.
Reviewing 2019’s key digital health stories last year I suggested that, while big strides continued to be made, any definitive ‘coming of age’ moment for the sector was unlikely.
But that was before the first reports emerged of a highly contagious coronavirus and 2020 will be forever associated with COVID-19 and the global devastation and disruption it has wrought.
Now, after a year that feels like it had many more than the usual 12 months, ‘digital’ has most certainly come of age across all aspects of our lives, including communication, commerce, working life and, yes, health.
So, what were the standout changes for digital health, and digital pharma for that matter, in this most unusual of years?
I suppose I could just answer ‘COVID’ and be done with it.
In fact, preparing for our year in review articles, we decided in our editorial meeting to have at least one look at medical progress away from COVID.
Nevertheless, the pandemic was clearly the biggest change-agent for digital health and digital pharma in 2020.
1. Digital transformation moved front and centre
COVID-19 brought rapid, deep and likely lasting changes to healthcare and the pharmaceutical sector, as both scrambled to respond to unprecedented demands.
Consequently, what might previously have looked upon as a 3, 5 or even 10 year plan suddenly required progress within just days or weeks.
As I noted earlier this year, healthcare companies went from being lost in a ‘digitalisation jungle’ in 2019, to this year making huge progress thanks to the ‘digital accelerant’ of COVID, with many channels being used for the first time as a result of the pandemic.
2. Telehealth reached a tipping point
The rapid digitalisation of life during COVID-19’s acute phase also had a huge impact on healthcare delivery.
If you, or someone you know, has had to see a doctor since March, the chances are the health service tried to avoid an in-person visit to limit the spread of the coronavirus. Here in the UK, as elsewhere, directives from the top made adopting telehealth a vital part of the pandemic response.
Questions certainly remain about how far the use of telemedicine will return to pre-COVID times, but the sustained focus on changing healthcare models this year looks to have put in place a lasting transformation.
3. AI made historical progress
Moving away from COVID, up to a point, and artificial intelligence (AI) in pharma and healthcare looked to be everywhere this year, having already made significant moves towards centre stage in 2019.
Google’s AI company DeepMind grabbed many headlines in November when it solved the 50-year-‘protein folding problem’, but there was less theoretical progress made too with the announcement in Nature Medicine of new standards for clinical trials that involve AI.
The CONSORT-AI reporting guideline should help determine the difference between hype and useful data when AI is used in medical studies – a small, but growing area.
Meanwhile, just one of the big pharma companies expanding its focus on AI was GlaxoSmithKline, which opened a new AI hub in London in September and hopes to end 2020 with a nearly 100-strong AI team.
4. The FDA took a strategic approach to digital health
Although a few years in the making, the new centre should accelerate the FDA’s responses to new mobile health devices, software as a medical device, wearables and a range of other types of health tech, particularly when coupled with the September update to its digital health pre-certification programme.
It wasn’t the only major body taking steps to advance digital health this year, with the WHO publishing in February its draft global strategy on digital health for the next five years, in which it noted:
“Digital technologies are an essential component and an enabler of sustainable health systems and universal health coverage. To realise their potential, digital health initiatives must be part of the wider health needs and the digital health ecosystem and guided by a robust strategy that integrates leadership, financial, organisational, human and technological resources.”
5. Record-breaking digital health investments
Investor interest in digital health has been running high for some time but, with all of the above going on this year, 2020 is looking like being a banner year for deals.
With fragmentation still an issue in the sector, further consolidation is expected if the current lack of scale among some companies is to be overcome, and well-placed observers see large amounts of private equity waiting in the wings to support this.
Looking back on this year, we can see digital health increasingly becoming a necessity for ensuring patients have the best outcomes.
Consequently, the advances seen in 2020 should provide solid foundations for pharma companies – and others in the digital health ecosystem – to continue to make further progress in the new year, and beyond.
About the author
Dominic Tyer is a journalist and editor specialising in the pharmaceutical and healthcare industries. He is currently pharmaphorum’s interim managing editor and is also creative and editorial director at the company’s specialist healthcare content consultancy pharmaphorum connect.
The trials and tribulations of 2020 have brought the vital role of research, pharma, and biotech into sharp focus. But how has the push to develop treatments and vaccines for SARS-CoV-2 affected the industry’s commitment to patient centricity?
This time last year, researchers and industry players were working hard to embed patient centricity and engagement into their everyday work.
Then COVID-19 hit, and organisations big and small were forced to pivot operations to tackle the real and present danger of the pandemic. Since then, we have seen some mind-boggling scientific achievements, with innovations in vaccine development being just such one example.
But how has this global push for SARS-CoV-2 vaccines and treatments affected the research community’s commitment to patient centricity? We take a look back over the last 12 months to find out.
Green shoots of engagement
At the start of the year, the industry was busy incorporating the patient voice into trials in a bid to overcome the recruitment and retention problem – the figures showed that fewer than 5% of all those eligible to take part in research signed up, and the global average dropout rate was around 30%.
“The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight.”
While the research community was aware of the benefits of patient centric trials, however, they were still unclear on how to put that into practice, said patient engagement agency, Couch, back in February.
Said the team: “In the Annual Patient Centricity Benchmark Survey, when asked about training or preparing people to behave in patient-focused ways, over half of employees from biopharmaceutical and medical device companies said: ‘We are actively looking at how to teach this to our people’.
“Only 22% selected: ‘We know exactly what and how to teach this to our people’.”
That said, the community was going in the right direction. In March, we reported on how researchers were increasingly using methods such as patient-reported outcomes, remote reporting, and lay summaries to boost engagement.
But then the pandemic piqued people’s interest in medical research at previously unimaginable scale.
The RECOVERY Trial, a multi-arm RCT studying the efficacy of several repurposed treatments in COVID-19, recruited a staggering 2,000-plus people across 16 NHS sites in little more than three weeks. At the same time, thousands more signed up to report their health status to the King’s College London COVID Symptom tracker app every day.
Speaking to pharmaphorum in May, Dr Sheuli Porkess, Executive Director of Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI) said, if harnessed correctly, such changes could benefit research efforts for years to come.
“The studies are being covered on the news and that’s great for letting people know how they can get involved in research right now. What’s more, that ongoing exposure to discussions around trials and what people do when they are in a trial will, in the future, help people to say ‘yes, I want to be involved’. I think we really need to look into what it was that enabled people to sign up so quickly.”
The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight. In doing so, it proved it could provide robust data at the same time as reducing participant burden.
Casualty of speed?
But while the pandemic certainly created a collaborative discovery atmosphere, it also introduced an element of intense urgency – and this has, arguably, had a detrimental effect on engagement in research.
In November, pharmaphorum reported from the Pioneering Partnerships conference, organised by the ABPI, the National Institute for Health Research (NIHR), and the Association of Medical Research Charities (AMRC). We asked if rapid progress and patient engagement were mutually exclusive.
NIHR director, Jeremy Taylor, said: “One of the consequences of the system commissioning lots of urgent COVID-19 research was that, to a certain extent, patient and public involvement got bypassed. For various reasons it was too difficult or too time consuming to do when everybody was in a frightful rush.
“Patient and public involvement turned out to be less embedded than we thought, so I think COVID has been a bit of a shock to the system. It’s made us think that maybe we have been a little too complacent.”
Lessons to learn
The last 12 months have been something of a whirlwind for everyone, but the healthcare and research community have been in the eye of the storm.
In 2021, the research community can build on the widescale adoption of remote monitoring and huge increases in study recruitment rates, but it must also put what it has learned about “doing” engagement at speed and at scale into practice.
Want to read more about how COVID-19 has impacted in patient centricity? Check out the latest edition of pharmaphorum’s Deep Dive magazine, which is dedicated to the topic.
Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines.
A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings.
But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.
Compared with many of the established names in pharma these companies are young upstarts but they have managed to achieve what other big names in the industry have failed to do and harness the power of mRNA to make medicine.
Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.
As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.
In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.
The body produces antibodies against the protein, which neutralise the virus in the event of an infection.
It’s a revolutionary approach that allowed the vaccine to be made within a few days of the SARS-CoV-2 genetic code becoming available – what’s taken months are the rigorous clinical trials that proved the vaccines were safe and effective.
There has been considerable anxiety over whether using such an untried technology would be the best approach against COVID-19.
What the companies have now proved is that the technology can be used to make safe and effective vaccines in record time.
The companies are based on opposite sides of the Atlantic – Moderna was founded in Massachusetts in 2010 under the name ModeRNA Therapeutics by a team of investors two years after BioNTech began operating from a small lab in Mainz, Germany.
But both drew on the mRNA technology developed by Katalin Kariko from the University of Pennsylvania and her collaborator Drew Weissman, an immunologist from Boston University.
Together the pair had managed to find a way to get the human body to accept strands of mRNA without an immune reaction, by tinkering with the chemical make-up of the molecule.
It was a landmark discovery that meant a technology once derided as being a pipe dream could have applications in the real world as a medicinal therapy.
Moderna’s founders were led by Derrick Rossi, a post doctorate fellow from Stanford University who championed the technology to a team from Flagship Ventures, a Massachusetts firm founded and run by Noubar Afeyan.
CEO Stephane Bancel was hired the following year from France’s bioMerieux and Moderna went on to raise more than $2.6 billion in a series of private funding rounds, while fiercely guarding any details about the technology it was developing.
This changed in 2018 when Moderna went public with what was at that time the largest IPO in biotech history.
The launch raised $500m from investors using what is arguably the slickest stock market ticker out there – MRNA.
Its portfolio of products was broad – including a drug being developed with AstraZeneca for cardiovascular diseases, a cancer immunotherapy and a potential Zika vaccine.
“I was intrigued by the personalities of the founders. They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”
While Moderna blazed its investment trail and tried to find ways to make sure its mRNA vaccines did not produce dangerous immune reactions, a small biotech called BioNTech had licensed in the technology from Kariko and Weissman.
Run by husband-and-wife team Ugur Sahin and his wife Ozlem Tureci, BioNTech wanted to use the technology to create individualised cancer therapies.
Matthias Kromayer, a general partner at the German investment fund MIG that helped found BioNTech in 2008, said he first met the pair 15 years ago and was immediately intrigued.
He told pharmaphorum: “They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”
The company began to strike several deals with big pharma companies to develop cancer drugs and in 2013 hired Kariko, who had spent years working on mRNA at Penn, to oversee the mRNA work as senior vice president.
Fast-forward to the beginning of 2020 and the companies realised that they would have to quickly change their research priorities to vaccine development as the coronavirus pandemic began to emerge in China.
Kromayer said the risks and opportunities to take on the coronavirus vaccine challenge were huge for BioNTech, which only went public on the Nasdaq at the end of 2019.
He said: “It was a risk – if (the vaccine) had failed it would have shed negative light on mRNA tech. But it was a once in a lifetime opportunity.”
But according to Kromayer the BioNTech team were confident that mRNA was the solution to the coronavirus problem, as mRNA sequences can be generated in such a short amount of time.
“You can manufacture mRNA vaccine overnight and still it is stable,” said Kromayer.
The rest is history – Pfizer stepped in and licensed the technology, choosing the most promising of four potential mRNA vaccines from BioNTech.
Both Moderna and Pfizer’s shots aced the quickly convened clinical trials and became the first vaccines to make it to market less than a year after the pandemic began.
Thanks to the innovation there are hopes that peoples’ lives may return to normal as 2021 progresses but according to Kromayer this is just the tip of the iceberg for mRNA therapeutics.
The founders of both Moderna and BioNTech realised early on that this is far more than just a vaccine and could be used to tackle diseases that have proved impossible to tackle with the previous generations of medical technology.
Rossi, who left Moderna in 2014 had initially thought it could be used to reprogramme cells to act like stem cells but realised its potential after a bruising encounter with Robert Langer, the legendary MIT scientist and entrepreneur.
According to Kromayer potential uses include pre-emptive vaccines for diseases such as Parkinson’s as well as to create personalised cancer therapies.
Kromayer concluded: “The message is that mRNA based medicines are not just here to serve as vaccines it is much, much, more. This will revolutionise medicine over the next 10-15 years in areas we do not even imagine.”
That said, there were still some interesting moves indicating new directions of travel for big pharma players – with most deals focused on specific drugs from biotechs, particularly in cancer (though we did get rumours of an AstraZeneca-Gilead merger, which would have been the biggest pharma M&A deal of all time).
Here we take a look at the biggest mergers and acquisitions of 2020 and what they might mean for the companies involved.
Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and with the purchase, AZ will bolster its immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.
It marks something of a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.
Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.
The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.
While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.
In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.
Meanwhile, AZ will also pick up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.
Gilead & Immunomedics
The AZ-Alexion deal is likely to be the only big pharma merger this year, but Gilead’s purchase of US biotech Immunomedics and its potential cancer blockbuster Trodelvy isn’t far off it in terms of value, with the deal totalling $21 billion.
California-based Gilead announced its strong intentions in oncology in 2017 with its $11.9 billion buy of Kite Pharma and followed that earlier this year by acquiring immuno-oncology firm Forty Seven for $4.9 billion (see below). Shoring up its assets in a wider range of disease areas will help the company weather the storm as the pool of patients eligible to receive its hepatitis C drugs such as Sovaldi shrinks.
Trodelvy (sacituzumab govitecan) is a first-in-class TROP2 antibody-drug conjugate drug that was granted accelerated approval by the FDA in April for adults with metastatic triple-negative breast cancer (TNBC), who have received at least two previous therapies for metastatic disease.
Data from trials of the drug wowed ESMO in September – Trodelvy was shown to significantly extend overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared with standard chemotherapy in TNBC patients with brain metastases treated with at least two therapies.
The 500-plus patients in ASCENT had received a median of four previous anticancer treatments, but Trodelvy significantly improved OS with a median of 12.1 months, compared with 6.7 months in patients treated with chemotherapy.
Johnson and Johnson & Momenta
This $6.5 billion deal means that J&J has added potential inflammatory disease blockbuster nipocalimab to the pipeline at its Janssen pharmaceuticals unit.
J&J thinks that Momenta’s lead drug nipocalimab could be a kind of Swiss army knife drug that could be used across a range of inflammatory diseases including maternal-foetal disorders, neuro-inflammatory disorders, rheumatology, and autoimmune haematology.
The success of AbbVie’s Humira (adalimumab), which peaked at almost $20 billion in sales in 2018, demonstrates the potential of inflammatory diseases drugs to make mega-bucks.
Johnson & Johnson’s own Remicade (infliximab) was also a blockbuster several times over thanks to approvals in a range of inflammatory diseases including Crohn’s, rheumatoid arthritis and psoriasis.
But like the rest of this first generation of antibody-based drugs, Remicade has been hit by cheaper competition from biosimilars and the hunt is on for newer drugs that outperform standard therapy in terms of safety and efficacy.
Whether nipocalimab achieves the astronomical figures seen from Humira and Remicade remains to be seen – but the price J&J has paid shows the big pharma thinks it has considerable potential.
Momenta is best known for producing a generic version of Teva’s multiple sclerosis drug Copaxone (glatiramer), but nipocalimab is the company’s lead pipeline asset and the main rationale behind the acquisition.
“The first wave had disproportionate health, economic and social impacts on people in lower socioeconomic groups and those with black, Asian and minority ethnic backgrounds”
Gilead & Forty Seven
Further cementing Gilead’s ambitions in cancer, this $4.9 billion deal adds an antibody targeting several blood cancers to the company’s research pipeline.
Forty Seven is based in Menlo Park, a short drive away from Gilead’s base in Foster City, and is developing magrolimab, which is targeting myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML), and diffuse large B-cell lymphoma (DLBCL).
A potential first-in-class therapy, magrolimab targets CD47, which produces a “do not eat me” signal that allows cancer cells to avoid destruction (an area AbbVie has almost invested significantly in).
By targeting CD47 it’s hoped that magrolimab will allow the patient’s own innate system to engulf and eradicate cancer cells.
The company presented promising results from a phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology meeting in December.
Sanofi & Principia Biopharma
Sanofi added a potential multiple sclerosis drug to its pipeline when it bought Principia Biopharma for up to $3.68 billion in August.
The French pharma paid $100 per share in cash for San Francisco-based Principia, which specialises in Bruton’s kinase (BTK) inhibitor drugs, after the deal was unanimously agreed by both boards of directors.
Sanofi’s acquisition builds on a partnership to develop central nervous system drugs that began in late 2017.
In a statement Sanofi said that the acquisition will give it full control of the brain-penetrant BTK inhibitor SAR442168, making marketing more efficient and eliminating any royalty payments due under the 2017 agreement.
The drug known for short as ‘168 reduced multiple sclerosis brain lesions by 85% compared with placebo in a phase 2b trial.
Phase 3 development has begun and will comprise four pivotal trials across the MS disease spectrum.
Another of Principia’s BTK inhibitors, rilzabrutinib, is being tested in phase 3 for patients with moderate to severe pemphigus, a rare and debilitating autoimmune disease that causes blistering of the skin and mucous membranes.
Principia also has a topical BTK inhibitor, PRN473, which is in phase 1 development for immune diseases that could benefit from local application to the skin.
The deal follows Sanofi’s announcement late last year that it is rethinking its R&D operations, turning its back on diabetes and focusing on badly needed “transformative” therapies and maximising the potential of its asthma and eczema drug Dupixent.
CEO Paul Hudson, who was appointed to the role in June last year, has already acquired the oncology firm Synthorx and signed a potential $2 billion collaboration with Kymera Therapeutics to develop immune-inflammatory drugs.
Nicole Farmer, general manager, UK & Ireland at Sanofi Genzyme, tells us how the company aimed for agile adaptation during COVID-19, and how these lessons are driving patient centricity going forward.
2020 has been a watershed year for every company in the industry – and for Nicole Farmer, general manager for the UK & Ireland at Sanofi Genzyme, that meant moving into a pharma leadership role at a time when things couldn’t be more uncertain.
Nevertheless, Farmer – who was appointed in May at the height of COVID-19 – says that her main goals when coming into the company hadn’t changed due to the pandemic.
These goals were: creating an environment where people have the courage to be proactive and not wait to be told what to do; pushing beyond current limitations; and keeping customers and patients at the heart of why Sanofi does what it does.
COVID-19 has laid the UK’s health inequalities bare and created an imperative for the NHS to develop a step-change in how it cares for diverse and marginalised communities.
Health inequality is the “greatest societal challenge of our time”, according to a briefing document calling for a system-wide solution.
The report was published by the Association of the British Pharmaceutical Industry (ABPI) and the NHS Confederation as part of the NHS Reset project, which has been working to set a post-pandemic roadmap for health and social care.
Said the authors: “The pandemic has thrown into sharp focus the issue of health inequalities in the UK and exposed the consequences of a long-standing failure to tackle this deep-rooted and multi-faceted problem.
“The first wave had disproportionate health, economic and social impacts on people in lower socioeconomic groups and those with black, Asian and minority ethnic backgrounds.”
It highlights the need for a clear strategy, pointing to a recent survey that found nine out of ten NHS Confederation members agreed that “the time to act is now”. Just 41%, however, said they had the tools, knowledge, and support to deliver the necessary change.
In November, the two organisations held a roundtable with more than 20 NHS and industry leaders, who discussed “tangible approaches” to tackling “the greatest societal challenge of our age”.
Working under Chatham House rules, they agreed that reducing avoidable and unfair differences in health outcomes would require action in four key areas: data quality, community engagement, access to services, and risk identification and stratification.
“Participants heard that the health system is capturing patient ethnicity data around 65 per cent of the time. More complete – and more comprehensive – data is needed to obtain a full picture of how ethnicity affects health outcomes,” said the report.
The meeting agreed primary care had the biggest potential to rapidly increase the volume of captured ethnicity data, using opportunities such as vaccination programmes and changes to practice registration details.
It also discussed the need to involve and listen to local communities, and the possibility of funding community champions employed through voluntary and community sector organisations.
Much has been published on the increase of digital health during the pandemic, but, as the report stresses, digital exclusion and digital poverty can compound health inequalities.
According to NHS England, people from excluded groups or living in deprived areas often lack the skills, ability and means to get online. This can block access to initiatives such as virtual consultations, which have been soaring in popularity.
Restoring services in the aftermath of the pandemic was also felt to pose particular challenges relating to equity of access.
“Concerns were raised that providers simply working through waiting lists using standard processes, without viewing them through the lens of inequalities, could actively exacerbate the problem.
“A possible way to resolve this unintended outcome would be to use a clinical prioritisation process to identify who will benefit most from intervention,” said the authors.
“The first wave had disproportionate health, economic and social impacts on people in lower socioeconomic groups and those with black, Asian and minority ethnic backgrounds”
Wider determinants of health
Healthcare systems need to be able to proactively identify populations at high risk by virtue of their socioeconomic status and ethnicity, as well as their clinical and co-morbidity data.
The impact of poverty in particular was discussed as a factor requiring much more consideration in terms of risk stratification.
“For example, in some areas, people continued to work during lockdown despite being in high-risk COVID-19 localities, due to intense financial pressures and economic insecurity.”
As set out in the Long-Term Plan, integrated care systems (ICS), which bring health, social care, the voluntary sector, and local authorities together, are playing an increasing role in the NHS.
“ICS and their constituent place-based partnerships were viewed as potentially playing a role by convening organisations outside healthcare, such as housing associations, to ensure they are enabled to play a role in discussions about the wider determinants of health.”
The authors agreed that this approach presented a “particular opportunity to make system-wide improvements to determinants that have traditionally been out of scope for the NHS, such as air quality”.
However, it was also felt that this should be complemented by neighbourhood-level cross-sector multidisciplinary teams, able to provide health and care interventions, as well as connecting individuals to the wider community.
Call to action
Building these recommendations into the fabric of society, even with cross-sector involvement, will certainly be a challenge.
But, said the report, the NHS Confederation and the ABPI are “committed to a long-term partnership to help build the right tools, techniques, and capabilities to meaningfully address health inequalities”.
That includes developing a suite of datasets and methodologies to improve risk stratification, as well as recommendations on how to improve diversity, inclusion, and patient experience in research.
“Both organisations are eager for as many NHS and industry colleagues as possible to become part of this process, contributing expertise to co-create solutions to the greatest societal challenge of our age,” the authors concluded.
OPEN Health’s Richard Jones and Sumira Riaz assess the pandemic’s implications for understanding patients’ experiences and how the pharma industry can support them
It’s impossible not to view healthcare in 2020 through the lens of the current global pandemic and COVID-19 is certainly set to cast a long shadow over patient needs and engagement.
Even when the virus is tamed, and recent advances with vaccines are grounds for much optimism, the huge societal and healthcare changes that we’ve seen take place this year will undoubtedly have left their mark in all sorts of altered, and new, approaches.
The way in which patients make their way through the healthcare system has shifted enormously, bringing disruption to the patient experience. COVID-19 has driven massive uptake of different types of digital support and interventions, most notably with telehealth.
Episode four of Kantar Health’s Health Heroes podcast tackles pharma’s rare disease challenges, the role of patient registries and hears a moving story about the rare genetic disorder Tay-Sachs disease.
Joining me for this instalment of Health Heroes are Geneviève Bonnélye-Fesnien, global head of real-world evidence, research and consulting at Kantar Health, and Dan Lewi, co-founder of The Cure & Action for Tay-Sachs (or CATS) Foundation.
Dan’s eldest daughter Amelie was diagnosed with Tay-Sachs in 2011 at 15 months of age and he shares the emotional story of caring for her and how that led to setting up The CATS Foundation.
This episode of the podcast also looks at how the GM2 Disease Registry, managed by The CATS Foundation with support from Kantar Health, and it will help both patients and the pharma companies working on treatments for them.
The podcast finishes up with an overview from Geneviève on the current outlook for rare diseases.
The Health Heroes podcast series aims to inform and educate life sciences companies on ways for getting closer to patients to help drive improved health outcomes.
Experts from Healthware Group explore how companies can rebuild their approach to digital from the ground up for the benefit of patients.
Digital is not just a nice-to-have for pharma companies – it’s a necessity for ensuring that patients have the best possible outcomes in modern healthcare systems.
With digital tools and techniques being able to improve almost every aspect of a pharma company’s business, from R&D to sales, there’s no excuse for not implementing digital transformation at every level – and that’s not even mentioning new opportunities for life science firms to produce digital products that can complement or even replace traditional medicines.
Roberto Ascione, founder and CEO of Healthware, says that this landscape means that companies like his need to expand to be “communicators, connectors and builders” all at once – and this is a philosophy he has built up within Healthware over the last two and a half decades.
Graeme Duncan from ADVANZ PHARMA explores how successful cross-industry collaboration between pharma and generics companies has helped support supply challenges during the pandemic.
While the world has had to come together to fight COVID-19, so too has the pharmaceutical industry in ensuring that essential medicines reach patients in need. Surges in demand have created challenges throughout the supply chain, from production line capacity to managing the shipment of products from one country to another. During this time, the role and responsibility of generics suppliers and manufacturers has been brought into stark perspective as one of the leading contributors in this industry-wide effort.
A synergistic relationship
There is a long-established synergistic relationship between larger, “innovation-driven” pharmaceutical companies and the generics industry in ensuring supply of established, but nevertheless essential, medicines. Despite this, the role of generics can often be overlooked, however its performance during this crisis has demonstrated its crucial importance and ability to respond to a series of considerable challenges.
Over the past year, we have witnessed first-hand how older, “less innovative” molecules have been integral for emergency treatment in hospitals, and also how they have been central to clinical trial research in identifying existing medicines that can be used to treat COVID-19. This demonstrates the need to keep specialised medicines available for patients, while also highlighting the potential of established treatments, which can be repositioned for use in new therapeutic areas based on their mode of action, therefore providing much-needed cost savings to healthcare systems.
“Now more than ever, it is our responsibility as a sector to ensure affordable access to healthcare and enable the future longevity of medicine development and supply.”
The pandemic has further highlighted how research is not strictly limited to large, “innovator” pharmaceutical companies. The generics medicines sector can, too, play a substantial part in discovering new areas for licensed products to be used in. Value-added versions of traditional medicines are one such way of innovating around existing molecules and, crucially, providing a better experience for patients through exploring new indications, changes to dosage or an improved formulation.
The role of the generics sector has also been able to complement the outputs from innovator companies in the development of COVID-19 vaccines and shows the crucial significance of working together to provide joint solutions to this exceptional global emergency. The industry is undoubtedly a competitive one, but such challenges cannot be tackled in isolation. Now is a time for togetherness and partnership in our duty to serve patients around the world.
Delivery of essential medicines
Many generic medicines are used in intensive care units globally, while others are used to treat chronic illnesses that do not go away irrespective of the pandemic. Ensuring continued supply of these medicines has been a primary aim and only been possible through connectivity with cross-industry partner networks and the adaptability and resilience of global teams.
From dialogue with production lines, through to manufacturing and shipping, there have been countless moving parts in a unified operation to ensure supply continuity. When we look back and reflect on these exceptional times, I am sure, as an industry, we will be extremely proud of the role each organisation and institution has played in the discovery of a vaccine and the delivery of essential medicines to those that need them most.
Ensuring healthcare sustainability
Now more than ever, it is our responsibility as a sector to ensure affordable access to healthcare and enable the future longevity of medicine development and supply. Value-added generic medicines provide an opportunity for society to address several healthcare inefficiencies, delivering improved health to patients, while essentially contributing to the sustainability of healthcare systems.
Whereas large pharmaceutical companies invest their resource and scientific knowledge to develop blockbuster treatments for patient communities with huge unmet needs, generics companies can centre efforts on everyday needs. All of which contribute to an intricate healthcare ecosystem, whereby patients can have access to effective treatments, regardless of their disease or condition. It’s vital that we continue to work together efficiently as an industry to ensure that every day medicines can pave the way for healthcare systems, including the NHS, to afford the latest innovations in diseases such as cancer.
Brexit and the “second wave”
As we continue to navigate and understand the potential repercussions of the second wave of the pandemic, it’s imperative that we do not overlook its concurrence with Brexit in January 2021 and recognise the transition period we are continuing to work through. In our industry, it is vital that we have multifaceted supply models in place and include a number of contingency measures, such as ensuring the holding of safety supplies of medicines and creating a ‘buffer’ for stockholding.
Investment in dual sourcing is one such way companies can mitigate risks in order to safeguard supply and ensure demand can be met. We know that Brexit will inevitably bring change and we have to be familiar and aware of the effects it will have, but at the same time, as an industry we should feel well-prepared and confident that we will continue to maintain supply medicines during this pivotal period, and beyond.
Despite a large number of unknowns and uncertainty throughout the year, it’s been hugely inspiring to see the way the industry, and particularly the generics sector, has not only sustained its strength but also enhanced its dynamic support networks. The pandemic has undoubtedly acted as a catalyst to instigate new ways of working and has compelled us all to push the boundaries of what we thought possible, both at the business level and on a personal level. It’s crucial that we hold onto the fervid team spirit that we have established together, so that we can continue to find combined solutions as we move forward into a currently unknown landscape.
As we look ahead to 2021, the goal for patients and healthcare providers remains the same, however, this will now be viewed with a new, adjusted lens following our perspectives of, and lessons from this year.
New ways of working in this “new normal” era is something we are all still coming to terms with, but one thing that has been fiercely reignited is a commitment to collaboration and pulling together in times of need. 2021 sees new and exciting launches for generics companies as they look to expand across Europe and bring more complex medicines to patients and healthcare systems.
About the author
Graeme Duncan has been the Chief Executive Officer of ADVANZ PHARMA since the summer of 2018. Prior to this Graeme led the international segment of the business covering its global operations. Graeme has 25 years of healthcare and life science experience across innovative, branded generics, generics and services organisations. He has held senior management and executive roles in organisations including GSK, IVAX, Healthcare at Home and AMCo.
As this issue’s title suggests, patient centricity is about more than just talking points and marketing strategies – it requires companies to truly listen to, engage with and partner with the patients they serve, and in putting this month’s Deep Dive together it’s been great to see that so many pharma firms are now taking this to heart.
Not only that, but we are seeing patient insights being considered at every stage of a product’s lifecycle, from product design to clinical trials and even post-marketing patient services. In this issue you can read expert viewpoints from across the industry on how pharma can optimise its patient engagement at all these stages.
Finding agility in unprecedented times
Nicole Farmer, general manager, UK & Ireland at Sanofi Genzyme, tells us how the company aimed for agile adaptation during COVID, and how these lessons are driving patient centricity going forward
How patient insights are changing trial solutions
Patients have been asking for patient-centric trial solutions for years – the industry just hasn’t been listening. Medidata’s Anthony Costello tells us what insights pharma has been missing out on and how they can be harnessed to build better solutions
Boosting the impact of patient services
New research from Accenture has revealed that adoption of patient support services hasn’t improved since 2015 despite increasing pharma investment. Jennifer Spada tells us how companies can boost awareness of their programmes to improve outcomes
Patient journeys in the era of COVID-19
OPEN Health’s Richard Jones and Sumira Riaz assess the pandemic’s implications for understanding patients’ experiences and how the pharma industry can support them
pharmaphorum’s digital magazine Deep Dive provides objective, issue-driven views, analysis, high-level interviews and unique research for pharmaceutical companies, biotech firms and the wider healthcare sector.
In 2020 Deep Dive will have special focuses on disruptive technologies in pharma, R&D innovation, market access and commercialisation, oncology, sales & marketing innovation, digital health and patient engagement. Subscribe to future issues of Deep Dive.
In today’s fast-paced world how do you make sure your brand messages resonate with your customers and, if they do, how can your brand become even more remarkable?
These questions have always been relevant for healthcare communications, but the new world in which we all find ourselves have made them particularly pertinent as our customers’ behaviour and needs changed.
Furthermore, the COVID-19 pandemic ensures an ongoing state of evolution. Many of the big changes created by the global pandemic have yet to be fully assessed, or even settled into their final shape, and those may still not happen soon.
As communicators, many areas of our business need to be rethought – starting with conferences, education and promotional activities.
In fact, branding itself will need to be revitalised, with new processes and techniques put in place to reframe our conversations and ensure that the messages we create are relevant and useful to our customers.
How healthy is your brand?
It all starts with a check-up. Brands too can get sick and lose their vitality, but there are various diseases to watch out for, and here are two of the most prominent.
“The best treatment for brand diseases is ‘action copywriting’. It’s a validated neuromarketing approach that helps you choose the right words to activate the emotional engines of human behaviours”
The first is brand confusion, a typical disease whereby brands no longer have a remarkable image or are able to be distinguished from their competitors. This was seen during the first COVID-19 lockdowns: when people started talking about ‘social distancing’, too many brands responded by removing graphical elements of their logos to symbolise that distancing.
But look at the three logos below. Which one catches your eye the most? Which is more remarkable?
None of them stand out, and what is true for logos is also true for claims.
During the first wave of COVID-19, many companies started exploiting the same hashtags and their communications seemed like a line-up of the most popular online keywords.
Brand confusion, whether related to the visuals or the copy used, always has the same result: a weakening of the specificity, recognisability and memorability of the brand.
A second disease to watch out for is logorrhoea, better known in English slang as ‘verbal diarrhoea’. As in the case of dysentery, brand logorrhoea causes dehydration, cramps and general weakening, with the brand ending up withered as it moves slowly and clumsily across the media landscape.
The prime symptom of brand logorrhoea is an inability to describe oneself in a sentence.
Try it: if you are unable to describe in one sentence what your brand wants to do both in the market and in the world, you may have contracted logorrhoea.
Nursing brands back to health
The best treatment for these, and other common brand diseases, is what we would term ‘action copywriting’. It’s a validated neuromarketing approach that helps you choose the right words to activate the emotional engines of human behaviours.
It starts with identifying the brand action that we want our audience to take. What do we want our audience to do with us? Neither giving their money nor giving their likes on Facebook are of any use, because those actions express a superficial usefulness and make no real difference, here and now, to the brand or its customers.
Let’s consider the example of the New York Public Library, whose director of digital media Richard Schnorr described in a single sentence his mission: to inspire people hooked on social media to read more.
In managing to describe his brand in a single sentence he avoided logorrhoea and laid the foundations for the InstaNovel, an innovative use of Instagram Stories of famous books. The action that the brand has extended to its public made a difference, here and now, for both the brand and its audience in a symmetrical way, expressing a profound usefulness that has activated an emotional and communicative pact between brands and people.
Confusion and logorrhoea are just two examples of brand sickness. There are many others and, like all pathologies, they are diagnosed and cured by starting with their symptoms.
This is how a brand’s health is maintained and enhanced and there are five fundamental reasons for taking its temperature:
To achieve the brand’s full emotional potential
To give value to the values of the brand
To be noticed and remembered (like Seth Godin’s Purple Cow)
To attract those customers that are closest to you
So customers understand and appreciate your value – instead of being afraid of your price.
Having a healthy brand means all of this. So, have you taken your brand’s temperature recently? Why not schedule a brand check-up now.
About the authors
Elena Pirofalo is head of experience at Healthware International, curating the creation of transformational experiences for the healthcare industry. Since the beginning of her career in 2001, Elena has partnered with various stakeholders, such as patients, healthcare professionals and life-science companies, to create impact for modern marketing activities. She can be contacted via [email protected]
Paolo Guglielmoni is action copywriter and nerdist philosopher at RADS (Responsive Ads), a responsive network of talents that focuses on maximising brands’ creative and business performance. He also serves as contract professor of circular advertising at IULM in Milan and professor of fashion advertising at Milan’s Ferrari Fashion School. He can be contacted via [email protected]
Embedding diversity into clinical research does not start and end at trial recruitment – the community needs processes and institutions that reflect society and provide representation.
Greater representation among study designers, research teams, and funding committees would lead to greater diversity among research participants and help to tackle health inequalities.
Speakers at the virtual National Institute for Health Research (NIHR) Academy Members’ Conference said the inclusivity conversation had moved from “why” to “how”, and that it was time to look at wider structures.
Professor Sandra Eldridge, equality, diversity, and inclusion lead for Bart’s and the London School of Medicine and Dentistry, said: “I would suggest that the reasons our trials are not as inclusive as researchers would like are related to wider societal issues.
“Clinical trials are part of research, and research is part of society. While we may be able to improve things through trial design, we certainly can’t solve all the issues just by doing that.”
The barriers are multiple, she went on, citing a lack of trust in experts, institutions, and authority among some groups, which can be seen in current concerns over COVID-19 vaccines, and in the research process as a whole.
“The literature shows that people who feel this lack of trust acutely use words like ‘discrimination’, ‘deception’, and ‘exploitation’. They also talk about the idea of researchers being parachuted in to do research, without really involving or getting to know the group,” said Prof Eldridge, adding that there were a number of reasons for this mistrust.
“Clinical trials are part of research, and research is part of society. While we may be able to improve things through trial design, we certainly can’t solve all the issues just by doing that.”
“The first is historic racism in research, such as the infamous Tuskegee experiments, and the racism that people experience within the health service and wider society.
“Also, I think there is a lack of knowledge about research processes and safeguards among the general population and, coupled with that, a suspicion of large rich organisations such as drug companies.” Importantly, she went on, there is a “lack of visible role models within established research”.
Equality versus equity
Representation among research teams and funding committees is crucial to building processes, institutions, and interventions that work for the whole of society.
Achieving this means actively seeking out people in previously marginalised groups and making sure their voices are heard, said Professor Lucy Chappell, NIHR research professor in obstetrics at King’s College London.
Prof Chappell said: “We talk a lot about equality and that’s important. But perhaps even more important is equity – how are we genuinely ensuring everyone has an equitable opportunity to apply for research, lead research, and be on decision making bodies?
“If we put out adverts for funding committee members, for example, and are surprised when we don’t get a balanced representation of applicants, we need to ask ourselves what we are doing within that process that systematically prevents or discourages certain groups from applying.”
Gender and ethnicity are not the only considerations, she went on, adding that cognitive diversity, or the meeting of multiple – even conflicting – representative perspectives, was also crucially important.
“If I have a lot of intelligent people together in a room but they all have the same view, I’m not going to get diversity. It’s not about having clones or a tick box exercise, it’s about having diversity in the way people approach problems.”
In the same vein, research institutions should be looking for passion, ahead of the usual accomplishments and awards in their staff, said Prof Jill Manthorpe, director of the NIHR Health and Social Care Workforce Research Unit.
“Passion is the prod that makes people say: ‘but what about patient views, what about the views of the people we’re not hearing?’ Passion enables people, and spurs them to go the extra mile,” she said, using examples of community work and volunteering.
“It’s about long-term relationships, not just parachuting in for a project. It’s about what we as researchers can bring to communities, and how enriching that is for us over the years.”
Policies and tools to help organisations build ethnic diversity into processes, such as Trial Forge’s INCLUDE Ethnicity Framework, have been launched in recent years. What is less easy to pin down, though, is socioeconomic background, said Prof Manthorpe.
She pointed to the “7% problem”, referring to the 7% of people attending fee-paying schools who also hold most of the UK’s top jobs.
“How do we find and encourage people who didn’t have those educational opportunities? How do we differentiate between people who have had a very privileged education, from those who haven’t had the ability to build up robust networks early on in life?”
Older methods of establishing background, such as the age at which someone left school or whether they had an outdoor toilet growing up, are increasingly outdated and irrelevant, she said.
“We don’t know the answer as to how do you work out people’s socioeconomic status in a respectful and easily accomplished way.
“But I hope that we will get more people engaging with this, helping to answer some of those questions on how we reach people who are perhaps the hardest to hear,” she said, adding that all researchers wanted to “extend the ladder” to those who follow them.
There is lots of discussion about making research more diverse, and various initiatives have sought to alleviate the problem that can lead to devastating health inequalities in recent years.
But by making processes and infrastructure more inclusive, researchers will no longer need to worry about reaching underserved communities to make sure their interests are represented – because they will be part of them.
About the author
Amanda Barrell is a health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.
A new network of patient recruitment centres is set to shape the future of commercial clinical trials in the UK by offering new approaches to conduct late-phase, large-scale research projects. In a recent pharmaphorum webinar leaders from the NIHR’s five National Patient Recruitment Centres (NPRCs) outlined how they could bring cutting-edge therapies to greater numbers of UK patients.
The NPRCs are one of the Sector Deal 2 commitments from the government’s Life Sciences Industrial Strategy and are the first centres to be funded by the NIHR that are 100% dedicated to delivering commercial research.
The regional centres have been distributed across the country to provide opportunities for patients in areas of England who may not previously have been able to take part in the latest clinical studies.
They have also been designed to improve the speed and consistency through which commercial research is delivered in the NHS.
The goal is to attract life sciences R&D projects by making it easier and quicker to deliver commercial research, in turn improving the UK’s competitiveness in the global market.
pharmaphorum’s webinar, held in association with the NIHR, featured contributions from the directors of the NPRCs, the medical leaders who are leading the programme.
Dr William van’t Hoff, chief executive officer of the NIHR’s Clinical Research Network, began proceedings by highlighting some of the successes that have already been achieved.
“Our aim is to establish a relationship and build trust with our local community, to develop understanding, reduce the fear of research and increase engagement in that way” Yan Yiannakou
These include the delivery of COVID-19 vaccine trials and one of the UK’s first fully virtual interventional commercial clinical trials.
These studies have been made possible by the franchise-like operating model underpinning the network, which allows them to work in a harmonised manner, he said.
Franchise like operating model and collaborative working
The NIHR has provided £1.3 million in funding to each centre over three years to support their activities. Their collaborative model means the NPRCs will operate in an identical manner, offering a number of advantages to study sponsors.
As pointed out by Dr van’t Hoff, there will be a consistency of approach that could boost the UK’s competitiveness in a global market for late-stage clinical trial research.
The centres will benefit from shared standard operating procedures and will collaborate with each other as they host trials, the webinar heard.
Van’t Hoff said: “Each centre will provide a dedicated space and facilities for commercial clinical research, guaranteed access to NHS services to support research delivery, access to NHS clinicians to work as investigators, and a team of dedicated and highly-skilled research delivery staff to conduct the trials.”
Helen Quinn, director of the Joint Office for Clinical Research (University of Exeter and Royal Devon and Exeter NHS Foundation Trust), added that the centre in Exeter has been able to work with others across the country, costing and contracting for commercial research studies in a swift way.
“We can set trials up quickly for our patients, which is the most important consideration for us,” she said.
Speed, ease and volume
Using a franchise like operating model with standard operating procedures can speed up patient recruitment because of improved efficiency.
This was demonstrated by the swift set-up of a phase 3 COVID-19 vaccine study, which took just two weeks to set up and launch with over 1,900 patients recruited across the three NPRCs involved when it closed.
Dr Gavin Galasko is a consultant interventional cardiologist and director of research, development and innovation at Blackpool Teaching Hospitals NHS Foundation Trust, home to the Blackpool Patient Recruitment Centre.
He said: “We were the first in the world to recruit to this phase 3 study. We want to be there for pharma to show that the UK is a place to offer these latest state of the art late phase commercial studies that we can get to the patients quickly, efficiently, and in high numbers.”
Dinesh Saralaya, director of the NIHR Patient Recruitment Centre in Bradford, added that another factor that can allow trials to be quickly set up is the unified approach to costing across all the centres.
Each centre is also supported by research nurses, pharmacists and other research support staff who are dedicated resources available to the commercial trials run at the sites.
NPRCs are entirely focused on commercial research, further reducing the time to set up trials, the webinar heard.
The ‘recruitment engine’
Each centre is also driven by a ‘recruitment engine’ that uses several proactive strategies to reach out into the local community to empower patients to take part in, and to volunteer for, research.
As well as being linked to large hospitals, each centre will also collaborate with other healthcare organisations across primary, community and social care.
They can interact with primary care networks and integrated care partnerships (ICPs) for example to recruit from the local population.
This can help them find trial participants who are not hospitalised but who live with common chronic conditions and are not presenting in secondary care.
At the same time they benefit from links to large hospitals and their experience and expertise.
The centres can easily link with a wide network of GP surgeries and other local healthcare organisations, using linked NHS data sets to help identify patients to take part in research.
Yan Yiannakou, clinical director of the Newcastle NPRC, said that rather than going to a single GP surgery with 5,000 patients on its books, the centre works with federations of surgeries with 250,000 patients.
He said: “By working with a single point of contact in that federation and by working with the core federations around Newcastle, we can cover a population of 650,000 with a single search.”
Other innovative strategies employed at the NPRCs include virtual consultations, something that many other organisations have tried to implement but not succeeded.
Recruitment is further aided by digital consent, data capture and online eligibility checks, with the model already leading to a ground-breaking virtual trial, possibly the first in Europe.
Yiannakou said that the model has already been used to conduct a virtual trial in irritable bowel syndrome with diarrhoea (Relieve IBS-D).
The trial is currently recruiting 10 patients a week, which is twice as many as was being recruited by 28 sites before the study went virtual.
It’s just one of several innovative approaches to patient recruitment that are being explored at the NPRCs.
Yiannakou said: “Our aim is to establish a relationship with our local community, to build trust with the local community, to develop understanding, reduce the fear of research and just increase engagement in that way.”
Other approaches to recruitment will be explored, aiming to put patients and their needs at the centre of the process.
Melanie Davies, professor of diabetes medicine at the University of Leicester and director of the NPRC in Leicester, said: “This is all about bringing research closer to patients across the patch, across the NHS, but to provide it in a way that is attractive and accessible to patients.”
The cutting-edge of global life sciences research
A theme running all the way through the webinar was the sense of collaboration that each centre will bring to research projects.
The NPRC clinical directors all highlighted the centres’ ability to work together and with the wider healthcare ecosystem, such as primary, community and social care to enable access to a wider cohort of patients.
Yiannakou said: “The key is a willingness to develop and a willingness to change, and we have both the drivers and the substrates for that. The drivers are the fact that we are a novel concept centre, that we specialise in a particular area.
“We want to be the best in that area, we are focused in that area, and we have a remit and an intent to refine process and improve recruitment.”
According to Saralaya, the centres are sending a “strong message” to industry about the UK’s intent to be at the cutting edge of global life sciences research.
He said that the work already under way at the five centres shows they can deliver trials at speed, with quality and with very unified costing.
He concluded: “What better advocate can it be for a sponsor wanting to come to the UK?”
About the interviewees
Helen Quinn is the director of the Joint Office for Clinical Research, a collaboration between the University of Exeter and the Royal Devon and Exeter NHS Foundation Trust.
Dinesh Saralaya is a consultant respiratory physician and honorary senior lecturer at Bradford Teaching Hospitals NHS Foundation Trust. He has served as Director of the National NIHR Patient Recruitment Centre, Bradford since June 2020.
Yan Yiannakou is a consultant gastroenterologist and Clinical Director of the NIHR Patient Recruitment Centre (Newcastle).
Melanie J Davies is Professor of Diabetes Medicine at the University of Leicester and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust.
Dr Gavin Galasko is a consultant interventional cardiologist and the director of research, development and innovation at Blackpool Teaching Hospitals NHS Foundation Trust.
COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support.
The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.
To understand what healthcare professionals (HCPs) felt about this topic, CREATION.co investigated public social media, in collaboration with Sermo’s HCP survey platform, Sermo RealTime, which provides real time access to physician insights.
We looked at conversations that HCPs were having online to provide a full picture of their concerns and needs. By designing fast surveys based on insights from the online conversation we were able to get a powerful depth of insight. For the survey we recruited oncologists from the United States, United Kingdom and Spain.
HCPs concern for decreased cancer diagnosis
During the COVID-19 pandemic, delayed or decreased cancer diagnosis was highlighted by HCPs as a key concern. Prominent industry figures, such as oncologist and ex-director of the WHO Cancer Programme Professor Karol Sikora, shared news articles and utilised their networks to raise awareness of decreased cancer diagnosis.
In a usual April, we would normally see around 30,000 people diagnosed with cancer. I would be surprised if that number reaches 5,000 this month.
We are sleepwalking into a massive crisis and cancer patients will die unnecessarily if we don’t act now.https://t.co/mcy4Da1RrN
However, only a fraction of HCPs explained why they experienced a decrease. Knowing the “why” can help to address the specific challenges that hospitals are facing to ensure patients are receiving the care they need.
Using Sermo RealTime, we asked physicians to rank why they believe there has been a decrease in diagnosis at their hospital or practice. We discovered that cancellation of appointments by hospitals was perceived to have caused the most impact. The reason ranked as the next factor, was hospital staff being diverted to COVID-19 efforts. Understanding these reasons could help with resource allocation and impact assessments.
On social media, HCPs chose to encourage their peers to continue supporting their oncology patients during the pandemic. Again, key online influencers, such as Dr Tatiana Prowell – a well-known medical oncologist specialising in breast cancer, led a call to prioritise patients and raise awareness of decreased diagnoses. We have seen many HCPs supporting their peers online throughout the pandemic.
A significant part of the HCP conversation online discussed treatment of oncology patients. Physicians shared their concerns about delaying or changing treatment approaches and the impact this would have in the long term. When surveying physicians using Sermo RealTime, 79% of HCPs shared that they had delayed their patients’ treatment, while 52% of HCPs opted to change their patients’ treatment approach either by switching the drug their patient is on, or changing the administration timing or dose.
For the pharmaceutical industry, this knowledge could help teams in their communication plans to support HCPs with updated information or guidelines about treatments.
We regularly see HCPs share treatment guidelines on social media to provide support when there is confusion around new or existing treatment approaches, often creating their own guidelines when none exist.
ASCO Coronavirus Resources – FAQs @ASCO ‘Patients with diagnosed COVID-19 on active anti-cancer treatment, follow standard clinical management plans for delay or modification of cancer treatment in a patient with active infection’ https://t.co/AQUzNqJ1Be
And in our survey of physicians, 58% of respondents shared that regulatory guidelines have been their go-to source for information and advice for treatment during the COVID-19 pandemic, alongside consulting their peers. However, even HCPs’ go-to source did not always provide as much support as they would have liked, with some HCPs sharing that they are still unsure of the correct treatment for patients during the COVID-19 pandemic or for cancer patients that have COVID-19.
After surveying HCPs about how confident they were about the information and advice they have received about continuing treatment for their COVID-19 positive or negative cancer patients, 70% of physicians shared that they were “somewhat confident but consulted with their peers”, showing how important peer support is during this time.
HCPs look to the future
As COVID-19 continues to affect countries around the world, HCPs are concerned about the short-term and long-term implications the pandemic will have on patient diagnosis and care. Despite having to respond reactively day-to-day, and the focus on the here and now, the future is still on HCPs’ minds.
Dr Stephanie Graff, a breast cancer oncologist, shared her concerns about “what this might mean long term—stage at diagnosis for example”, and how to bring patients safely back to care.
I am worried about what this might mean long term—stage at diagnosis for example. I also worry about the way forward to bring everyone safely back to care. #COVID19#bcsmhttps://t.co/vJiQAOKD0n
When physicians in our survey were asked what some of the key concerns are for them going forward, they shared the backlog of patient cases that will need manual review and further investigations, switching to less effective or immunosuppressive treatments, and patients’ hesitancy or distress preventing them getting treatment. Others also shared the same concern as Dr Graff, that cancer patients present at a later stage because of backlogs and hesitancy to come to hospitals having a much larger impact on the treatment approach for these patients.
Across both open and closed online networks HCPs are concerned about the future of patient care.
The online HCP conversation continues at a steady rate each day with oncologists, nurses and specialists continuing to share their concerns and needs online with peers. Throughout the year, HCPs continue to seek the answers they are looking for and share resources online.
These concerns all present opportunities for pharmaceutical companies, hospitals, advocacy groups and medical organisations to support HCPs in very specific areas. Listening to the voices of HCPs online, especially as they are more active during this time, can help uncover key areas for engagement and support.
About the author
At CREATION.co, Lara supports clients in scoping and delivering projects. Her pharmaceutical experience includes laboratory research, as well as in marketing and strategy and she recently completed an MSc in Global Management from the London School of Economics. Working with CREATION.co she leads a team of insight analysts compiling reports.
Amanda Barrell speaks to Alfred Samuels on his experience of prostate cancer and diversifying clinical trials to include the Black, Asian and minority ethnic (BAME) community.
Alfred Samuels’ stage 4 metastatic prostate cancer brought his 30-year career, which had seen him travel the world with the likes of Beyoncé, Oasis, and Bob Dylan, to a shuddering halt.
Now, through his books and advocacy work, he is determined to help others prepare themselves for the “horrendous” cancer journey and help level the healthcare playing field for the BAME community.
In 2011, Alfred was a fit and healthy 54-year-old providing security for music’s A-listers on global tours. But then he started experiencing an excruciating pain which radiated from his lower back and into his leg.
“It’s really important for men, their partners and families to understand that there is much more to this disease than you think”
At A&E, he was told it was “probably sciatica”, but was advised to ask his GP to refer him for an MRI scan just in case.
“They messed me around for three months before agreeing to a scan. Then, two weeks after the MRI, the diagnosis came in. It was stage 4 metastatic prostate cancer and it had spread to six locations in my body,” said Alfred.
“I went for some tests and the prognosis came back – I was given six months.”
While he was fortunate enough to secure a place on the STAMPEDE clinical trial, during which he received abiraterone and hormone injections, the side effects were “not pleasant”.
“I was hospitalised on a couple of occasions because the pain was horrendous, and they hadn’t got the pain relief medications sorted out properly. I collapsed due to compression of the lower back. I had brain fog and fatigue. I went from someone who was able to run and sprint quite easily to being like a 90-year-old man. It was not a pleasant journey.
“It was untimely, unwanted, and as far as I’m concerned, undeserved,” he said. “My career was over, you’ve got all these mental issues, and then there’s the financial toxicity of it all.”
At the time of presentation, Alfred’s prostate-specific antigen (PSA) was more than 500 ng/ml, compared to the “normal” level for his age at the time, between 2 ng/ml and 4 ng/ml.
However, within months his PSA had dropped to less than 0.01 ng/ml, so Alfred stuck with the punishing protocol.
“One year became two years, two years became three years, and it’s probably then that I started to believe in myself, believe that I could beat it,” said Alfred.
Publishing the journey
Since then, he has published two books based on his experiences and the diaries he has kept of his journey. Invincibility in the Face of Prostate Cancer: Coming Out the Other Side charts his time in the clinical trial, and Motivated to Inspire focuses on the post-treatment period.
“I think it’s really important for men, their partners and families to understand that there is much more to this disease than you think. You really have to work as a team to get through it,” said Alfred, adding that his wife, Grace, had been invaluable support throughout his journey.
“Interacting with the medical fraternity needs to be explained to people so they get a better understanding of what they’re going to go through. It’s a journey full of pitfalls and pain, and you’ve got to be able to condition yourself for that.”
Focus on inclusivity
Alfred is an ambassador for Cancer Research UK, which funded the STAMPEDE trial, and works with groups including The Urology Foundation and Orchid. He also sits on a patient consultation panel for pharmaceutical company Parexel.
Much of the work he does centres around raising awareness of the patient experience, and the issues of diversity and inclusion are always top of his mind.
“Black people are not getting the best deal when it comes to healthcare, and where prostate cancer is concerned, black men are disproportionately affected,” said Alfred, explaining that Caucasian males had a one in eight chance of developing the condition, while the figure is one in four among black men.
A big part of the problem, he went on, was a lack of BAME representation in clinical trials, and he urged anyone from underserved communities to take part in research if they could.
“There are medications that are just not being tested on people from the BAME community. We will react differently to Caucasian people, so without more people from BAME backgrounds getting involved, we can never be sure that the information we are getting is correct,” he said.
Asked how the industry could be more inclusive, he said it was about trust and understanding.
“If you don’t take the patient’s voice into consideration, you have no understanding of what’s going on for them out there and you end up in a sticky situation.
“I think pharmaceutical companies are cottoning on to that now, but there’s still a lot of mistrust. It is about building relationships and getting to know the communities you are working with.
“Are you speaking in a language that they understand? Are the concepts broken down so that they are digestible?
“It’s not rocket science,” said Alfred, adding that the industry is now starting to understand the importance of such issues, and put plans in place to address them.
Patient Insights is a monthly series that appears in partnership with Inspire, a company with an online support community of more than 2 million patients and caregivers worldwide.
Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.
Having worked all around the world to supply medicines to developing markets, Dr Zulf Masters understands the biggest barrier for a pharma company entering these regions is a lack of understanding of their complexities.
His company, UK-based Masters Speciality Pharma, partners with big pharma, SME and biotech companies to bring their products to patients in developing markets. Although Latin America is a vast and varied region, it is one that, generally, presents difficulties for the industry as access to treatments is limited.
“There are a number of companies that, even in the last decade, have left the Latin American market completely because they just couldn’t handle the local nuances, such as devaluation of currencies, economic problems, political issues, the bureaucracy and, dare I say, quite a lot of corruption,” Dr Masters says.
Political issues in some countries are among the most conspicuous challenges in the region, and Dr Masters says they continue to “create havoc”.
“Sometimes this havoc can cause a huge swing in economic issues and lead to significant losses if you’re not careful.
“For example, during the impeachment time of Dilma Rousseff in Brazil, business with public healthcare completely dried up. We had to be nimble and move very quickly to start working with HMOs and the private sector to remain profitable.”
Thankfully, many governments are working towards emulating systems from other countries to make their healthcare systems more robust. For example, price regulations are becoming more common in Latin America, often being based on models such as NICE’s.
“Companies from North America and Europe tend to be used to thinking in fairly logical systems – but in Latin America, bureaucracy is not always logical”
“Several countries have brought in regional harmonisations and regulations, and the regulatory environment is becoming increasingly sophisticated and complex,” says Dr Masters. “Our medical and regulatory team have started teaching partners all over Latin America to embrace developing world regulatory and pharmacovigilance tactics and programmes.”
However, increased regulation can be a double-edged sword – they increase safety and efficacy but can also make access to medicines more difficult in many markets.
“National budgets are squeezed because drugs like new biologics are very, very expensive,” says Dr Masters. “National budgets are not used to spending $84,000 per patient per year for just one person who has hepatitis C. They are becoming very, very selective in what they can import.”
As a result, Latin American countries often end up importing products from cheaper but less-regulated markets like India and China, leading to some counterfeit medicines being introduced into the supply chain.
“It’s a big task for people like us in the industry to educate these systems and explain what they’re doing wrong,” Dr Masters says.
These regulations have also resulted in many essential COVD-19 products becoming unavailable in Latin American countries.
Colombia’s recent price regulations, for example, resulted in a lack of products like Midazolam, an anesthesia for people on ventilation.
“Because the price regulations are so drastic, many companies who had registered products like Midazolam had left the country by the time COVID came,” Dr Masters explains.
He adds that the pandemic has brought to light the fragility of healthcare systems in the region.
“Governments and individuals have found out that pandemic strategies are not easy to handle when you have very draconian bureaucracies in place. Locking down ports and airports added additional problems because most of these companies, even those who manufacture locally, have to depend on APIs coming in from China and India. The entire supply chain was disrupted, and the cost of logistics often increased tenfold.”
But like in other regions, healthcare systems are finding innovative ways to get around the unique problems posed by COVID.
“In countries like Brazil, where many people live in poor areas far away from centres of excellence or clinics, telemedicine and remote consultations have become very important. That trend is likely to accelerate.”
Dr Masters says that many of these issues can best be sidestepped by industry and government working together.
“It has to be an almost symbiotic relationship where we’re helping each other out and showing governments the right way to do things. We need to encourage them not to take paths that will lead to more counterfeit medicines entering their markets, because they will never come back from that.”
Dr Masters believes that having a local presence and employing local people can help companies better understand the cultures and economies of these regions.
“Companies from North America, Europe and other developed areas tend to be used to thinking in fairly logical systems,” he says. “In Latin America, bureaucracy is not always logical. It’s important to be well-informed, adapt yourself and find the right partnerships.”
He uses the example of sickle cell disease product Siklos, which Masters was attempting to bring into Brazil.
“The product was already registered by the FDA, but the Brazilian regulators decided they were above the FDA and started asking questions that were often irrelevant.
“Sickle cell disease patients in the Northeast of Brazil are generally poor and in desperate need of this medication, but the country will drag its feet and put up roadblocks.
“Health authorities and governments will have to rethink their strategies and reduce the barriers to entry if this situation is to improve.”
Similarly, Latin America is not part of many smaller biotech companies’ business models when they are first starting out, but partnering with companies local to the region that are organised according to EU/US laws can derisk the venture and help expand access beyond what they would normally be able to achieve.
“At Masters, for example, we do a lot of market research into disease areas and disease prevalence, and even do some local clinical trials if needed. Then we feed this information back to the company, and when the product is registered by the FDA we will look at licensing it into our markets and registering them locally.”
But Dr Masters says he is confident that the market will change.
“There are many emerging markets in Latin America who are always looking to North America and Europe as being the standard-bearers of drug regulation, and they are changing the way they think based on what they’re seeing there. They’re talking to those people to see how they can regulate their prices properly and equitably.”
The industry has an important role to play in helping these governments in this transition.
“Helping facilitate these discussions and connections, providing education and conducting local trials are all steps the industry can take to help open up these markets even further for other companies.”
About the interviewee
Zulf Masters, CEO of Masters Speciality Pharma, started his career back in 1980 working at Beecham as a medical rep, moving into international sales and marketing for certain emerging markets. This gave him the idea of founding Masters in 1984 to address the unmet patient need in emerging markets. The company began by serving the Caribbean from a single location from where, as Founder and CEO, Zulf has led Masters into becoming a truly international business. Masters Speciality Pharma is today a global pharmaceutical company, headquartered in the UK, with a 35-year successful track record in supplying medicines to hospitals, clinics, and government organisations in more than 75 countries.
Delayed diagnosis, misdiagnosis, and no cure or disease modifying treatments – children living with mitochondrial disease face all the issues often associated with rare diseases. It’s a problem that Michelle Bamber, whose two little girls both have the life-limiting condition, knows only too well.
Lily was a happy, contented baby, and her parents had no cause for concern until she went for her two-year check and was put on a pathway to diagnosis.
She is now 11, “healthily unhealthy”, and has just started secondary school. On the surface things are going well, but it has been a difficult journey for the family.
“Lily was a normal baby, and she met all the normal milestones,” says Michelle. “It was only when she was coming up to two that that we started to see issues that we weren’t really happy with.
“There was a delay in getting her two-year check, but when we did, she was referred to the Child Development Centre.”
Initially, they were told Lily probably had cerebral palsy, but as she continued to develop her healthcare team decided she needed further assessment. What followed was a litany of tests and invasive procedures as doctors tried to get to the bottom of her symptoms.
Michelle said: “She was walking, then she had a CT scan, and stopped walking. That obviously rung alarm bells. She had a lumbar puncture, a muscle biopsy, various scans. She had three general anaesthetics in the space of seven weeks.
“The internet told us some very disturbing things: that my child wouldn’t live past the age of five or that children don’t really live longer than two years after diagnosis”
“In August 2011, they said it was a form of mitochondrial disease, but didn’t know what one at that point. They just said it was a neurodegenerative, progressive disease, very similar to Parkinson’s.”
Lily was kept in hospital for a week where she was treated with IV vitamins, then the family were discharged with no further information.
“It was a total shock. We were just sent away from the hospital; we did not know anyone else who had it and we were very much in the dark about what was going to happen. We were on our own,” says Michelle.
“Where do you turn apart from Google? The internet told us some very disturbing things: that my child wouldn’t live past the age of five or that children don’t really live longer than two years after diagnosis.”
It was at this point that Michelle discovered Lily’s Foundation, a patient advocacy group established by Liz Curtis in memory of her own Lily, who died from mitochondrial disease at just eight months old.
Through the foundation, which Michelle actively fundraises for, the Bambers have met other families who are affected by mitochondrial diseases and have been able to access evidence-based information and support.
Mitochondrial disease, or ‘mito’, is an umbrella term for a group of medical disorders caused by mutations in the mitochondria, or the cell “powerhouses”, she explained.
The genetic condition affects different people in different ways, and the symptoms might include seizures, fatigue, vision and hearing loss, cognitive disabilities, respiratory problems, and poor growth. It can affect any of the body’s organs and systems, including the brain, heart, lungs, gut, liver, and skin. Crucially, there is no cure, and while work is ongoing to develop pioneering genetic therapies, the current standard of care relies heavily on symptom management.
That’s what makes the support provided by Lily’s Foundation invaluable, says Michelle, who explained that Willow, who was born in 2013, had been diagnosed at just four months in part due to the family’s new-found awareness of the signs.
“Usually, the foundation put on family weekends so all the families can come together. The kids go off and have fun with the volunteers at the kids’ clubs.
“The parents have lectures from the mitochondrial specialists and get all the latest advice and news on what’s happening in the medical world.”
While the charity has not been able to host such events during the COVID-19 pandemic, it has been able to offer support to many more families thanks to a sudden uptick in awareness.
Back in May, the son of long-standing Coronation Street characters Leanne Battersby and Steve McDonald, Oliver, was diagnosed with mito after suffering seizures.
“That’s, obviously, creating a good bit of awareness and phone calls to the Lily Foundation have really increased. More people have been welcomed into the Lily family and are not living on their own with whatever their child’s going through anymore,” says Michelle.
She also hopes the storyline, which the charity and specialist doctors were consulted on, will help to address a lack of awareness among healthcare professionals that can often result in delayed or incorrect diagnosis.
“A lot of people report that they are having seizures and are diagnosed with having epilepsy, for example. Sometimes it can take a long time to get to that bigger picture and see that a patient has this, this, and this and that it is all because of mitochondrial issues,” Michelle explains.
Asked what parents who suspect their child has a rare disease like mito should do in this situation, Michelle said they should “trust their gut”.
“If you think there’s an issue, then keep talking to the doctors. Unfortunately, a lot of people find that they’re not listened to – they have to keep going back and keep insisting that things aren’t right,” she says.
For more information about the Lily Foundation, click here.
Exploring Rare Diseases is produced in partnership with Cambridge Rare Disease Network (CRDN). CRDN is building a vibrant network of patients and stakeholders to share knowledge and foster innovation that leads to better diagnosis, treatment and support for those living with a rare disease.
TV viewing habits are changing dramatically, and these trends have only been accelerated by COVID-19 – but Intouch’s Justin Chase says that pharma is still stuck in a traditional advertising mindset. Drawing on research from a recent whitepaper, he tells us how the industry can optimize its TV advertising for an age of hyper-targeted media and modern marketing methodology.
Pharma companies are still spending billions of dollars a year on TV advertising in the US – but many of the industry’s media strategies are based on assumptions from traditional, linear TV, despite TV consumption becoming increasingly fragmented across platforms and devices.
“With the increasing availability of on-demand video content, we’re moving away from the concept of a standard primetime TV slot,” says Justin Chase, Intouch’s EVP of media & innovation. “People don’t live their lives like that anymore. Instead, to steal a concept from Google you have this very interesting dynamic of ‘personal primetime’, meaning primetime becomes a nuanced and personal experience. Primetime for a student might be watching their favorite new show on the bus or the subway. For a mom it might be waiting to pick the kids up outside of school. The thought that we all are going to sit down to appointment viewing on a Friday night with our friends and families to watch TGIF is as out of date as those shows.
“Now, with myriad content choices across a variety of platforms, it is incredibly difficult to nail down an audience, i.e. what are they watching, where are they watching it and when? You can’t get this type of multiplatform information from linear TV data.
“It is incumbent upon advertisers to take advantage of new technologies, especially as more than three quarter of US households have connected TV (meaning TV that is connected to the internet).”
Despite the fact that the landscape is becoming increasingly fragmented, it doesn’t mean there isn’t a better solution. Marketers can do what they always do – adapt. Both connected TV and automatic content recognition (ACR) allow advertisers to overcome the highly nuanced and personal viewing habits, by serving highly targeted ads at scale.
ACR data for example, is collected via a chip that is installed in the TV during the manufacturing process. The technology zeroes in on the unique audio or visual fingerprints attached to each piece of content and then matches snippets against an ever-growing reference library. This allows for a much more granular understanding of who is watching what and on what platform.
“There are around 120 million households that have TV in the US. Right now, we can track or target three-quarters of them with ACR. I believe that all media is going to be bought and sold programmatically in the next five years”
But pharma companies, by and large, have not updated their media plans to align with the changing viewing behaviors of their target audiences. The vast majority of plans have all the eggs going into the broadcast bucket and worse, they are using antiquated metrics, like Nielsen panel data which uses 50,000 households as a proxy for 120 million. Nielsen, to their credit, is heavily investing in ACR with Gracenote, but pharma hasn’t really taken advantage of this yet.
All of this is the subject of Intouch’s recent whitepaper, Future State: The New Media Landscape, which looks at the most prevalent trends in TV advertising and gives pharma recommendations for how to adapt.
“Pharma companies need to change everything,” says Chase. “They need to look at different ways to reach their targets, hit their goals, track their KPI scorecards – and it’s not via traditional media plans. The whole media landscape is shifting, and pharma needs to pivot accordingly.”
The Holy Grail
Chase says that the COVID-19 pandemic has only accelerated these trends.
“No analysts could have predicted just how much COVID would impact TV consumption. We knew that linear TV was waning but we had no idea that during COVID people were going to develop such strong affinities for their video-on-demand platforms, while losing interest in their linear TV subscriptions.”
This is also happening at a time when consumers are more attuned to healthcare than ever before, and as a result are more keen to hear from pharma companies.
Chase says that this offers a huge opportunity for the industry to take advantage of highly targeted audiences by using ACR and CTV to reach out with messages that feel “authentic”.
“A great way to inform a TV campaign is to do extensive social research to understand how patients or HCPs are talking about their condition in the real world, and then reflect their own language back to them.
“One of the things that we know after 21 years of digging through terabytes of social data, is that each patient population has a highly nuanced, and sometimes even idiosyncratic, vernacular. The messages that work best are those that incorporate that vernacular.
“For example, some companies have done an amazing job of taking the language that men use to describe erectile dysfunction and incorporate it into their advertising. That stops these ads feeling like a pharma company telling people what to do.”
The power of such messaging is only enhanced when it can be targeted to more specific populations.
“Many pharma companies are not currently making a distinction between CTV and linear TV in their plans, and might consider the same creative for both,” says Chase. “That’s really missing the point. CTV and addressable TV allow us to serve ads programmatically to specific segments in sequential fashion – allowing us, for example, to target patients who are treatment-naïve with different language and creatives than we’d use with patients who are treatment-mature.”
“Then you can layer in ACR to understand who’s seen what creative and through which channel. This allows you to serve different ads across those channels to the same person, effectively progressing them along their treatment journey.
“You can even go so far as to understand what actions the person took post-exposure – i.e. did they go see a doctor and fill your script after they saw your ads?”
While linear TV certainly still has its place in a brand strategy, Chase says that its influence is diminishing every year, and the pharma industry needs to start harnessing other approaches now before it finds itself completely out of touch with modern audiences.
“Most pharma brands I talk to believe they still need linear TV to get their message out and hit their goals – but that’s simply not the case anymore,” he says. “Almost all the key industry players we spoke to for this whitepaper said that addressable TV has the same, if not greater, potential reach. The reality is that pharma brands are comfortable with linear TV buying – they know the metrics, they know the KPIs, and we as brand marketers and media people need to help them understand that there are incredibly promising alternatives that can provide the same reach with greater targeting and ultimately better performance.
“There are around 120 million households that have TV in the US. Right now, we can track or target three-quarters of them with ACR. I believe that all media, not just TV, is going to be bought and sold programmatically in the next five years. The liquidity that programmatic offers is just too great to pass up. It allows you to segment, target and optimise your audiences in seconds, rather than the months it would take with a traditional media buy.”
Chase adds that companies can easily start with a linear base and transition to CTV if they are not yet comfortable with these new models.
“Once you’ve reached your initial base through linear TV you can layer in CTV in order to suppress ads to those people who saw that ad already via linear. This means that with each new ad dollar spent you are effectively reaching someone new.
“This dynamic is called de-duplicated incremental reach, and it’s the Holy Grail of TV advertising right now – making sure you’re always reaching new people rather than targeting the same groups again and again.”
Justin Chase is EVP, head of innovation & media at Intouch Group. Justin oversees Intouch Media and is responsible for orchestrating an innovation-centric dynamic at Intouch, taking the sensibilities of the patient, provider, payer and rep, then applying the lens of innovation, machine learning, and neural network development to solve problems and evolve the way the pharmaceutical industry thinks about marketing and media. Justin is also a frequent speaker, panelist and podcaster on some of the nation’s top networks.
About Intouch Group
Intouch Group is a privately held full-service agency network, providing creative and media services, enterprise solutions and data analytics globally through seven affiliates in eight offices, including Intouch Solutions, Intouch Proto, Intouch Seven, Intouch International, Intouch Media, Intouch B2D and Intouch Analytics. Collectively, Intouch Group employs more than 1,000 people. With a dedication to the life sciences, Intouch Group operates with the belief that there is no challenge too big to cure. Contact Intouch Group at [email protected] or visit them on the web at intouchg.com.
Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest drugmakers in the world.
Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and Charles Erhart. Both in their mid-twenties, the two men set up what was initially a fine chemicals business in a Brooklyn factory, using a loan from Pfizer’s father as capital. The company’s first product, a palatable anti-parasitic drug, made to taste like toffee, united Pfizer’s skills as a chemist with Erhart’s training as a confectioner. It was a success, and set the pattern for the company’s future development.
Pfizer’s Tokyo building
The convulsion of the American Civil War, which broke out soon after in 1862, had as much of an impact on the nascent pharmaceutical industry as on American society in general. The “first industrial war” involved drug producers as much as weapons manufacturers. Like their competitor Squibb, the sudden need for enormous quantities of painkillers and antiseptics for the Union armies provided a great scope to expand production. By 1868, Pfizer’s revenues had doubled since the start of the war, and their product lines had expanded greatly.
After the war, Pfizer continued to focus on industrial chemicals as much as medicines, producing the citric acid needed for the emerging soft drinks industry, fuelling brands like Coca Cola and Dr Pepper’s expansion in the 1880s. This became their mainstay for many years, laying the basis for their continued growth. Also, when supply of tartaric acid was disrupted due to the civil war and increased tariffs, Pfizer developed its production to become the leading supplier of chemicals in the US.
“The ‘first industrial war’ involved drug producers as much as weapons manufacturers”
Erhart died in 1891, and Pfizer in 1906, leaving a company of around 200 employees in the hands of Emil Pfizer, who served as president until the 1940s, the last member of the Pfizer family to be involved in managing the company. Under his stewardship, Pfizer’s expertise in scientific production methods developed greatly. In 1919 their scientists pioneered mould fermentation production of citric acid from molasses, freeing their citric acid business from European citrus fruit supplies, which had been disrupted by the First World War. They developed a deep tank fermentation process, the principles of which would later be applied to the production of penicillin. As a consequence of Pfizer’s innovation, the price of citric acid tumbled over the succeeding decades, with the value of the chemical falling by 5/6ths in 20 years. In 1936 the company discovered a fermentation free method of producing vitamin C, which they rapidly expanded into vitamins B2 and B12 amongst others, rapidly becoming a leading vitamin producer – chemicals that were very novel at the time.
This expertise in fermentation and large-scale pharmaceutical production put Pfizer in good stead when in 1941 the US government appealed to the pharma industry for support in producing penicillin for the war effort. In an unprecedented collaboration, Pfizer worked with government scientists, the researchers such as Frederick Banting who had been working on the drug before the war, and a plethora of other players in the industry to markedly improve the efficiency of drug production, as they proudly state “most of the penicillin that [went] ashore with Allied force on D-Day [was] made by Pfizer”.
Antibiotics marked the transition to the modern Pfizer. Their follow-up to penicillin, Terramycin, first marketed in 1950, was both their first proprietary drug, and the first for which the company used sales reps, their soon to be formidable force of salesmen starting with just eight members.
Pfizer initiated its first major internationalisation at this stage, moving into nine new countries in 1951. It was at this time they set their site at Sandwich in the UK, initially just to finish processing compounds imported from America, but due to tariffs on imported products the company rapidly expanded the plant to accommodate producing medicines from scratch. Pfizer’s international expansion put great trust in their local staff compared to other organisations, recruiting nationals and giving them a great deal of autonomy.
“Lipitor…became the biggest-selling prescription medicine ever, earning Pfizer $12 billion a year in 2007, one quarter of its total sales”
The areas that Pfizer directed its research into expanded in these years as well. In 1952, it established its Agricultural Division, beginning its foray into animal health, and in 1953 acquired Roerig, a nutritional supplement specialist, which became incorporated as a division in its own right. By the 1960s, Pfizer were at their “most diversified point in [its] history” – in its own words, its interests “stretched from pills to perfume, and petrochemicals to pet products”.
Throughout the 60s and 70s the company continued to bring out new drugs, such as the broad spectrum antibiotic Vibramycin, and broadening its research base, reorganising its R&D operations in 1971 into a Central Research Division, and increasing spend on this area of the company from 5% to 15% of revenue. This attention to innovation began to pay off in the 1980s, with a series of blockbusters, the first of which, the COX inhibitor Feldene, arrived in 1980 rapidly becoming one of the biggest-selling anti-inflammatories in the world. Others rapidly followed, including Glucotrol, aimed at diabetics, and Procardia, an anti-hypertensive. The 1990s and 2000s would soon take this blockbuster-based success to new levels.
The statin Lipitor, approved in 1997 for Warner-Lambert before their merger with Pfizer, became the biggest-selling prescription medicine ever, earning Pfizer $12 billion a year in 2007, one quarter of its total sales. It almost hadn’t made it through clinical development, facing problems with ineffective chiral isomers and limited efficacy in animal testing, but showed such impact in human trials that it blew the competition away.
But Pfizer’s almost Hollywood-level blockbuster of the 1990s was the little blue pill of Viagrar. Formulated initially at the Sandwich site in the UK as an anti-hypertensive, it was found have “unexpected” side effects that made the company rapidly change the indication to erectile dysfunction. But despite the cultural ubiquity, Viagra has recently faced the inevitable threat from competition and generics, dropping from 92% of the ED market in 2000 to around 50% in 2007, with vigorous competition from drugs such as Cialis and Levitra.
“Pfizer is the 6th largest lobbier in Washington, and spent $25 million on lobbying during the passing of Obama’s healthcare reform legislation alone”
Ups and downs
Like most pharma companies of its size, Pfizer has faced its fair share of controversy as one of the most well-known drugmakers in the world.
In 2009, Pfizer faced more than $2 billion in legal settlement payments over marketing practices for drugs, and around the same time announced it would close a large number of manufacturing and R&D sites worldwide, including its Sandwich facility, which at the time employed 2,400 people (though it ended up maintaining a reduced presence at the site).
In the late 2000s/early 2010s, Pfizer, like many other big pharma companies, was experiencing pipeline difficulties too, with drugs accounting for 40% of its sales coming off patent, and a series of high-profile failures of drugs in development, such as the anti-cholesterol drug torcetrapib that caused a marked increase in deaths compared with the control group in clinical trials. The news of this disastrous result came days after CEO Jeff Kindler had hailed the drug as potentially “one of the most important compounds of our generation”. Likewise, tanezumab, an anti-osteoarthritic, failed in trials.
However, these challenges in the core mission of drug discovery led Pfizer to focus on other means of keeping up its dominant position. One thing that highlighted this changed focus was the appointment of Kindler as CEO in 2006. Kindler was trained as a lawyer, and was a relatively new employee when he was given the top job in preference to others of much longer standing with scientific experience, highlighting the increasing importance of legal and marketing issues over traditional R&D. He was succeeded by Ian Read and later Albert Bourla.
Perhaps unsurprisingly for the biggest company in one of the biggest industries in the world, Pfizer has also been proficient in exerting its considerable political influence to preserve its interests, coming in as the 6th largest lobbier in Washington, and spending $US 25 million on lobbying during the passing of Obama’s healthcare reform legislation alone. It has been key in pushing counterfeit drugs up the political agenda, in part due to its ownership of that most counterfeited of drugs, Viagra. It has also been highly critical of parallel trade, and has been one of those militating for a pharmaceutical repackaging ban in the EU.
Despite this political clout, the company also tried to belay its image as a pharma monster, like many others in the industry, by spending generously on charity, donating AIDS drugs both to poor communities in the US, and to developing countries.
The era of mega-mergers
Since the turn of the millennium, Pfizer has embarked on a series of mega-mergers, gobbling up Warner-Lambert in 2000, Pharmacia and Upjohn in 2002, Wyeth in 2009, and Medivation in 2016.
In 2015 the company also paid $17 billion to acquire Hospira, a firm specialising in injectable drugs and biosimilars, at a time when copycat biologics were starting to make real waves in the market. The deal seemed to be a precursor to Pfizer’s plans to separate its patent-protected medicines business from its off-patent portfolio.
These plans were soon abandoned and Hospira has remained a key part of the core Pfizer organisation – but that didn’t put the idea of separate business units to rest completely.
In 2017/2018 Pfizer attempted to sell its consumer health unit, but buyers including Proctor & Gamble and GSK pulled out of negotiations.
This caused Pfizer to change its tactics, and instead the company ended up signing a deal with GSK to combine the two companies’ consumer health businesses and form a joint venture with combined annual sales of $12.7 billion.
Pfizer and GSK plan to divest the business completely in the long term and reap the rewards, while merging the two businesses is also expected to create cost savings for both partners.
Similarly, in 2019 Pfizer announced a deal to merge its Upjohn generics business with Mylan, creating a combined company called Viatris. The $12 billion deal was cleared in November 2020, creating a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word.
This era, though, was also marked by two major failed acquisitions, which both courted controversy due to Pfizer’s intention to exploit tax loopholes.
In 2014 the company made an offer of around $100 billion to acquire UK firm AstraZeneca (which at the time was going through a rough patch).
AZ seemed to have little interest in the idea, and the deal was instantly controversial in both Europe and the US. The merger would have created the biggest pharmaceutical company in the world – and would have given Pfizer a way to avoid paying costly US taxes on foreign earnings (a stance that president Barack Obama criticised heavily).
Indeed, critics feared this redomiciling was the main aim of the merger, and that Pfizer wouldn’t sustain investment in UK R&D in the long term.
Unusually, the UK parliament ended up getting involved, perhaps underlining the importance of AZ to the country’s life sciences sector, with both AZ and Pfizer asked to argue for the future of the company in parliamentary hearings. Pfizer seemed unable to allay the concerns of prime minister David Cameron and business secretary Vince Cable.
After numerous “friendly bids” and just as many rejections, Pfizer eventually made a final offer of £69.3 billion ($118 billion) – which was also turned down by AZ, with the company saying it was “inadequate”.
Leif Johansson, AZ’s chairman, did not mince his words, saying: “Pfizer’s approach throughout its pursuit of AstraZeneca appears to have been fundamentally driven by the corporate financial benefits to its shareholders of cost savings and tax minimisation.
“From our first meeting in January to our latest discussion yesterday, and in the numerous phone calls in between, Pfizer has failed to make a compelling strategic, business or value case. The Board is firm in its conviction as to the appropriate terms to recommend to shareholders.”
This did not stymie Pfizer’s desire to move its HQ out of the US, though. The next year it also attempted a ‘reverse takeover’ of Irish Pharma firm Allergan – where, technically, Allergan would acquire the US company and rename itself as Pfizer, allowing Pfizer to have its tax base in Ireland.
At the time $160 billion deal was the biggest ever seen in the pharma sector.
But soon the Obama administration came down hard on such ‘tax inversion’ deals, changing laws such that the deal was no longer attractive to Pfizer.
No signs of slowing down
Despite some setbacks, Pfizer remains one of the biggest pharma companies in the world today. The sheer size of the organisation is mindboggling, totalling well over 100,000 employees. One commentator compared the company’s 38,000 sales reps to “three army divisions”, a sales team that has been immortalised in a Hollywood rom-com of all things – Love and Other Drugs, starring Jake Gyllenhaal and Anne Hathaway.
And with the company becoming one of the first in the world to get a COVID-19 vaccine approved – via its collaboration with BioNTech – it feels like we’re only on the cusp of seeing where the company could head in the future.
Pfizer’s sheer diversity and economies of scale likely mean it will have the power to shape the pharmaceutical industry well into the 21st century. With fingers in every pie, ranging from small molecules to biologics in every clinical area, to stem cells and consumer goods, Pfizer will surely celebrate its 200th anniversary in as strong a position as it spent the last 160 years.
Not too long ago virtual reality (VR) tech might have seemed like a dream, but now it’s being harnessed by the healthcare industry for a wide variety of purposes, and during COVID-19 has helped educate physicians when real-world training isn’t feasible
Commercial VR is still a relatively fresh prospect, but already the pharma and healthcare industries have caught onto the hype and are exploring the myriad ways this tech could be used to improve patient outcomes.
That’s not to say VR is widespread in the sector – far from it – but the readiness to adopt such a new technology from even big pharma firms is somewhat surprising considering how conservative the industry has been in the past.
Novartis, for example, has used the tech to help researchers improve the molecular makeup of a drug, by allowing them to view these structures at a larger size and in a more “natural” 3D view. Similarly, Pfizer is using the technology to allow researchers to visualise and virtually explore the human body at a molecular level. One recent study even explored how VR could be used to analyse drug candidates that target the main protease of the SARS-CoV-2 virus behind COVID-19.
For so long the US healthcare system was built around the provider, with appointments and services set by the provider (along with insurance reimbursement systems). This structure relies on in-person visits of patients to operate and become profitable. But when the industry suddenly shifted due to COVID-19, so too did the power dynamics of the patient-provider relationship. Omri Shor, CEO of Medisafe, explores how.
Now operating under virtual formats, patients can demand healthcare access on their schedule, creating a pivot point for the industry where pharma and providers must meet the demands of the patient – not the healthcare system. And it’s no longer a pipe dream to think of a system that puts the patient first, treats them individually, and employs a network of patient technology to meet the health needs of each person.
Burden on the patient
Thinking back through my experiences in the healthcare system, a recent quote has stuck with me that sums up the burden placed on patients: “I left [the doctor’s office] with more directions on how to pay my bill than to care for my health.”
In many ways, treatment for patients has focused on addressing a condition or illness, not caring for the individual. And while that approach may have led to successful outcomes for most, it doesn’t incorporate a patient’s lifestyle, unique factors, individual challenges or barriers to successful treatment. This extends to pharma where medicine addresses a condition, but patient care, guidance, and support have often been an afterthought.
In many ways, the current system still places the burden on the patient, creating hardships and hurdles to navigate. And for the majority of patients who are managing chronic conditions, it means not only managing their health but also the complexities of the system. But the convergence of health and technology is helping to give patients more power in caring for their health, and demand for transparency, accountability, and control over their health and lives. As patients gain more choice in the marketplace, pharma and providers alike are starting to recognise the value in patient satisfaction and are quickly adopting new ways to respect the patient voice.
While new satisfaction measures and competition are helping to shift the model to connect with patients, the biggest advancements in the patient experience have come through tech advancements. The onset of the pandemic forced nearly all elements of the healthcare ecosystem to pivot to new formats to stay connected to patients. This also shifted the demand and scheduling to operate around patient’s schedules, instead of the other way around.
This shift comes at a time when patients were already embracing digital health apps, medication companions, and wearable technology. Suddenly digital health has put patient choice in the palm of their hands. In a world where everything is on-demand, streaming, and delivered next-day, users have come to expect a similar experience from medication management and pharma support.
Thanks to the convergence of tech and health, the future of healthcare places the patient directly in the driver seat, able to track their health stats, monitor and manage conditions, engage with providers and connect with pharmacies all within a digital platform. This new level of interoperability means improved transparency, greater connectivity, and more insight to treat the person, not just the patient.
Clinician adoption and integration
Healthcare remains one of the most personal experiences, and the influence of technology can improve the experience and outcomes, but it cannot replace human interaction altogether. Leaders in the health IT space know that tech alone isn’t the answer – it’s how to blend technology with personalisation to create a better ecosystem. In the most recent HLTH conference, companies such as Amazon, Google, and IBM explored ways to incorporate live interactions through tech devices to enhance segments of healthcare.
“I envision a future where technology helps to close gaps and connect patients more closely with physicians and their healthcare coverage”
Pharma is examining ways to reach the patient population through a combined effort of both personal and digital. One new partnership is through Pleio. This network of connected care coordinators works with patients upon receiving medications, walks the patient through their first 15 days on a new medication and then helps move them to a digital companion that tracks their usage, engagement, and delivers customised support via a connected app.
This hand-holding model from personal to digital has shown to improve medication adherence by up to 50%. Another way pharma is blending this model is through virtual clinical trial studies. By creating a disparate model in clinical trials, critical information is still being captured while using virtual technology and AI to remain engaged with patients remotely. This new structure is enabling pharma to engage with a larger pool of candidates, while also offering more flexibility to the lives of patients.
Patients still want personal care and are finding greater satisfaction through tech involvement in helping to manage follow-up interaction, medication management, financial support, and digital encouragement. As one physician put it, patients want “human support for the big stuff and digital access and guidance for smaller daily stuff.”
Future of integrated care
As we look to the future, amidst a pandemic that has changed everything about how health systems operate, it’s clear that digital has taken hold. I envision a future where technology helps to close gaps and connect patients more closely with physicians and their healthcare coverage. We are already seeing a glimpse of that as COVID-19 vaccine makers and pharma companies begin eyeing digital health platforms to help connect patients with safety resources. Tracking of vaccine doses will be essential to ending the pandemic and pharma companies are already in talks with leaders at Google, Apple, and Medisafe on ways to deploy such platforms.
The patient home has also become the new centre for care, further helping to put power back into patients’ hands. AI applications and digital integration in the home will soon be able to inform patients when a medication has shipped, if there is a flu outbreak in their area, or if they want to speak with a physician via FaceTime. In a similar move, Amazon is launching an at-home pharmacy delivery service, making medication management as easy as Prime membership for maintenance medications.
But healthcare that no longer leaves out the patient is truly about simplification. Patients want a healthcare experience that first recognises them as people, as individuals, and takes a comprehensive approach to care, not simply fixing a broken issue. The future of care is more personal, more connected, and more complete. With digital platforms that encompass a user’s whole health, including medications, vitals, nutrition, exercise, environment, behavioural and financial health. It’s care that addresses a person’s complete environment, with medication and support to improve their lives, not just their condition.
About the author
Omri Shor is the CEO of Medisafe. He is an expert in digital medicine applications and works closely with major pharma companies in developing and guiding direct connection to patients via innovative platforms to support improved health and treatment, with customisation and guided treatment.
Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies.
Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.
In serious cases, higher levels of pre-existing NAbs can even cause a dangerous immune reaction when such therapies are administered.
This is particularly pertinent in rare diseases, as a number of gene therapy products use viral delivery methods to deliver the transgene to target organs.
“NAbs are antibodies that are part of the humoral response of the adaptive immune system,” explains Rich Horgan, founder and president of Cure Rare Disease (CRD), a nonprofit biotech developing CRISPR therapeutics for Duchenne muscular dystrophy (DMD). “They defend against foreign pathogens or infectious particles, and are specific to the targeted antigen, neutralising its effect and rendering it no longer pathogenic by binding to it.
“The goal is to not have the body neutralise the therapeutic, and therein lies the issue with NAbs. For gene therapy treatments using viral delivery methods such as AAV, NAbs are an issue that we must all contend with for both initial patient dosing as well as subsequent redosing.
“Our belief is that patients should understand the challenges associated with drug development and how those challenges impact them personally… It is emotionally challenging for patients who must put their faith in the hands of pharma companies”
“Regardless of route of administration, the virus can be identified as a foreign pathogen causing the adaptive immune system to try and eliminate it through NAbs or other means.”
A further issue is that patients can, and do, develop NAbs from environmental exposure. For example, since AAV is derived from a common virus, patients can develop NAbs against AAV from common colds or other infections – and ultimately, even low levels of antibodies can prevent successful transduction of a viral-based therapeutic.
Clinical trials will screen potential patients for NAbs against the delivery vector to understand the level of NAbs present in the patient (known as the titer level) before dosing them with the experimental drug – but there is currently no standardisation for measuring NAb titer levels in a patient, and each pharma company develops their own assay for testing.
“Moreover, there is not a generally agreed upon threshold for a dose/no-dose decision,” says Horgan. “Ultimately, titer levels are related to safety, as dosing a patient who has a higher titer level (however that may be defined) is more likely to trigger an immune response to the treatment, an extreme example being the infamous case of Jesse Gelsinger.
“As additional gene therapy trials advance, it is important that bodies like the FDA begin to standardise NAb measurement assays and acceptable titer levels for inclusion in clinical trials.”
But although companies are able to screen patients in an attempt to avoid complications, only those already in line for clinical studies qualify, even though for many patients it’s critical to know this information in advance as they consider potential trials.
“To date, there hasn’t been a widely available mechanism for patients and patient families to get insight into whether or not they have a significant level of NAb activity other than through enrollment in a clinical trial,” says Horgan.
Because of this, Horgan believes there needs to be more conversations surrounding this issue, and much more education of patient communities regarding the issue of NAbs and the challenges they create towards participation in a gene therapy study.
“Our belief is that patients should understand the broad challenges associated with drug development and how those challenges may impact them personally. While drug development is technically challenging, it is even more emotionally challenging for patients and patient families who must put their faith in the hands of pharma companies to develop effective treatments for their disease.
“Given the rise of many gene therapies, especially those in the rare disease space, neutralising antibodies stand as a significant challenge to the patient community and it is critical that patients understand that a) these neutralising antibodies exist and can potentially prevent patients from participating in a gene therapy clinical trial and b) collaborative development efforts are needed to ensure that patients can get access to life-saving gene therapies if they possess a significant level of NAbs.”
As such, CRD has rolled out a new system to allow patients to get an understanding of where their neutralising antibody levels stand – knowing that these levels may change over time and that medical decisions should not be based on these results.
The system offers community access to preclinical neutralising antibodies screening. CRD enrolls patients into their research study, then sends a patient kit for local blood collection through a lab. Patients are then informed of the research results several weeks later, and are provided genetic counselling to understand and emotionally handle the results.
“We’ve gone to great lengths to provide a high level of counselling as we know, from personal experience, the results are more than data points – they are the hopes and dreams of a family counting on a potentially life-saving gene therapy,” says Horgan.
“Ultimately, we believe that patients should have knowledge of the impact of neutralising antibodies and must advocate for the advancement of technologies so that all patients may be eligible for viral-based therapeutics. Time and access are of the essence.”
Horgan says that the long-term benefits for families who choose to get screened comes from this generated knowledge.
“Knowledge is power. While the information provided does not change the reality of the situation, we hope that it encourages families to ask more questions and to advocate for the development of technologies to enable dosing with a viral-based therapeutic.
“While non-viral gene therapies will someday be possible, leading researchers believe it will be a number of years before this is realistically feasible.
“Moreover, we want to help patients avoid the immense emotional disappointment of a situation where the patient is found to be ineligible for a gene therapy study due to NAbs even though they never knew that NAbs were an issue to begin with.
“By rallying together a community, we can catalyse the development of technologies to enable dosing (and re-dosing) of advanced therapeutics so that all have access.”
About the interviewee
Rich Horgan is the founder and president of Cure Rare Disease. He has a deep passion for Duchenne muscular dystrophy (DMD) and other rare diseases. With a younger brother impacted by DMD, Rich has a strong interest in accelerating promising treatments for the disease. He has formed a collaboration with world-class researchers and clinicians to pioneer the rapid development of customised therapies for Duchenne and other rare diseases.
We speak to finalists from the Greater Manchester Future of Health accelerator to find out how digital start-ups can overcome the challenges small companies face in bringing their technologies into the NHS.
Right now the NHS is embracing digital to an extent no one could have foreseen a year ago – but that doesn’t mean it’s a smooth journey for digital health start-ups looking to gain traction in the health service.
“COVID has forced the NHS to change, but so far most of the implemented digital innovations have been low-hanging fruit such as video consultations,” says Rory Cameron, CEO and co-founder at diabetes risk management app Gendius. “Adoption of new tech is still a real challenge.”
He says that part of the problem is that standards of care are rapidly changing, and it is therefore difficult for companies to prove their concept.
Amanda Barrell explores how a perfect storm of changing economics, advances in technology, and the increasing volume of the patient voice is stoking change in the rare disease space.
New models of drug development are fuelling life-changing advantages in the rare disease space, previously an economic no-go area for pharma and biotech companies.
That was among the discussion points during Fighting Rare Diseases – The Science, Economics and the Patients, a webinar hosted by o2h Group.
Chairing the event, the company’s Prashant Shah, said: “Rare disease, by definition, means it affects a fairly small number of patients. But the economics are beginning to change, the return on investment is changing, and there is a lot more interest now.
“There are more organisations coming into play and patient groups and charity groups are becoming ever more active. I think there’s more hope for those suffering from rare disease than ever before.”
The interplay between technological advances, new models of drug development, and an increase in patient centricity, has created fertile ground for progress, the panel said.
“Partnering with patient groups has really been our superpower from the beginning, because they are the experts”
Michael Binks, vice president of Rare Disease Research at Pfizer, said: “There’s been a growing awareness of the magnitude of the unmet need, that there are 7,000 identified diseases…and very few therapies available for the majority of them.
“Key factors have been the emergence of communities around some of these diseases that have driven major legislative change and ensured that regulators are more flexible.”
This shift in the regulatory environment has made developing medications for the 300-500m people affected by rare disease globally more economically feasible, said Binks, whose company is focusing on gene therapies in the rare disease space.
There’s never been a better time for rare disease patients, said Tim Guilliams, CEO of AI-powered biotech company, Healx, who believes that technology such as machine learning (ML) is enabling researchers to take a new view on drug development
His company’s approach is to work with patient groups to understand unmet needs, then use ML to identify existing drugs that could tackle that need and bring them to trial.
“Drug discovery is really hard, and ML is not a magic wand. It’s really just bringing that component to the table to try to move as quickly as you can to get treatments into the clinic,” he said, adding that the method also needed the input of “amazing” pharmacologists, clinical experts, and patient advocates.
“Partnering with patient groups has really been our superpower from the beginning, because they are the experts,” he said.
Return on investment
Shah asked Binks and Guilliams if this paradigm shift in terms of patient involvement was contributing to higher returns on investment in clinical trials.
“It’s hard to put an absolute number on, because each disease has different endpoints, different number of patients that you can enrol, etc. but yes, we believe we can get the cost of clinical trials down significantly because of our model,” said Guilliams.
Binks said that working with patients early on could cut overall costs by reducing the likelihood of study failure.
“Running high-quality clinical trials is expensive. It is sometimes made more expensive by the frequency of failure because we don’t have an adequate understanding of the patient population or the disease.
“Bringing the patients and their families into the conversation early does help to define the clinical development path.”
Nicola Miller, editor-in-chief at Rare Revolution Magazine and co-founder and trustee of the Teddington Trust for those affected by Xeroderma Pigmentosum, said it made perfect business sense to involve patients in drug development early on.
For a start, she said, there is an assumption within the research community that everyone with a rare disease is seeking a curative treatment, yet many people accept their condition as part of who they are.
“We have all heard stories of where scientists have gone down a particular route, but they haven’t actually thought of engaging with the population as to what is the most debilitating part of their condition,” said Nicola.
“They could be developing something for photo sensitivity for a particular condition, for example, but generally people can cope with that, what they don’t want is a neurological decline which is going to impact their life.”
While some organisations were working well with patient groups, others appeared to be involved in more of a “box ticking operation” which doesn’t benefit anyone, she went on.
“There are huge sums of money and huge amounts of technology being ploughed into this area at the moment, so let’s make sure it’s going into the most beneficial point for the patients,” she said.
All three panellists agreed that there was an abundance of hope on the horizon for people living with rare diseases – so long as the whole community continues to work together to overcome the challenge.
“So many things are moving in the right direction: diagnosis, possible treatments, technology, and empowerment. It’s really incredible what is happening in this space now because that just wasn’t the case 20 years ago,” said Guilliams.
Trio Health’s Neil McGregor-Paterson asks whether the healthcare industry has paid enough attention to the patient voice during COVID-19 and looks at the many ways pharma can improve the patient experience across the sector going forward.
Never has the health and care voluntary sector (HCVS) played such a critical role in supporting our nation´s health and wellbeing. Since the start of the COVID-19 pandemic, the sector has stepped up – and in – to deliver support and services where the NHS and social services were unable to. All with a speed and agility that could never be replicated by providers.
Even now, the sector continues to plug services while NHS and social care retains its focus on COVID-19. But this level of involvement cannot and will not last. And, as the sector plans for a precarious and challenging future, there are several established and emerging themes that can help inform pharma on approaches to support it.
The importance of the long-term and sustainability
A recent report from National Voices, The Neurological Alliance and the Arthritis and Musculoskeletal Alliance showed that while there had been a significant increase in demand for HCVS services supporting those with long-term conditions, the pandemic has had a devastating effect on the sector’s finances. Of the 40 organisations that participated in their research, almost a third predicted a 40% drop in fundraising income in the period June 2020 to June 2021, and a further third a 25% drop.
Commenting on the current and future funding challenges facing the HCVS, Colin McGregor-Paterson, CEO for Oasis Partnership, a charity providing social and psychological support services to improve health and wellbeing, said, “The crisis in funding has significantly impacted on many organisation’s capacity and capability to deliver in the here and now, while challenging the sustainability of many. Collaboration with industry has never been more important, and this needs a commitment to the longer-term if the UK’s vibrant advocacy sector is to be sustained.”
This is a sentiment backed up by Annabel Cowper, director of corporate affairs at Biogen: “As we move beyond the acute COVID-19 crisis, it’s important that our industry understands the significant pressure the patient advocacy sector is under. Our support for the sector has never been more critical, but in a funding constrained environment, this support needs to be carefully targeted if we are to maximise patient gain.”
“Considering this is the greatest crisis this country has faced since the second world war, the voice of the patient and their advocates appears to have been noticeably absent in national COVID-19 planning”
Keeping the patient voice centre stage
Health and social care policy makers and providers are committed to ensuring that the voice of those with lived experience, and those organisations that advocate for them have a place around the planning table. Yet, considering the greatest crisis this country has faced since the second world war, the voice of the patient and their advocates appears to have been noticeably absent in national COVID-19 planning.
Who knows if things might have been different had policy makers and their advisors listened to the voice of patients? Maybe peoples’ fear of using NHS services during the pandemic would have been predicted and mitigated from the outset, possibly preventing thousands of avoidable deaths.
For industry, this should serve as a salutary reminder of the importance of listening to the voice of patients and their advocates as plans are being developed and signed-off for 2021 and beyond.
Addressing health inequalities
Even before COVID-19, in the UK there was a persistent 20-year gap in the number of years lived in good health between those living in the most and least affluent areas. And, for the first time in a decade, life expectancy has stalled for many, and declined for the poorest 10% of women.
COVID-19 has exacerbated health inequalities, while exposing the fact that underlying health inequalities, while not new, have been overlooked for a long time. This has resulted in an increased focus on addressing these among policy makers, providers and importantly the HCVS.
While pharma has a great track record in supporting equity of access to medicines and services, the need for improved data, measurements, reporting, and comparisons, coupled to the complexity of addressing health inequalities means that ex-US, pharma has traditionally steered clear of bespoke health inequalities initiatives beyond health literacy type projects and/or funding for third party organisations. However, times have changed, and just as the HCVS is increasingly stepping up to help address health inequalities, so companies focused on those conditions that disproportionately affect poorer and disadvantaged communities must also step up and collaborate with them.
“The pharmaceutical industry could become an important voluntary sector partner in addressing health inequalities if it is prepared to go beyond patient advocacy and get behind whole communities that are taking action that increases resilience and creates health,” said Merron Simpson, chief executive of New NHS Alliance, a national cross sector movement addressing health inequalities through Health Creation. “On a practical level there are several roles they could play such as supporting digital literacy or helping communities get access to and interpret local datasets. The most important thing is to listen to the priorities of local people.”
Community up vs. national down
The people and community response to COVID-19 has been phenomenal. Beyond the NHS Volunteer Responders programme, three million people collaborated with local organisations outside the system. They came together with speed to self-organise and meet the specific needs of their communities. From streel-level WhatsApp groups to locality-wide delivery of medicines, the benefits of community resilience have been recognised at the highest levels of government, while its link to digital health and power shifting to communities has been made.
In his report to the Prime Minister, entitled Levelling up our communities: proposals for a new social covenant, Danny Kruger MP, recognises that: “The experience of the recent crisis – the willingness of local people to step forward and collaborate, the flexibility shown by public services and the social commitment of businesses – shows what is possible. Add the extraordinary new dynamics of data and digital innovation, and a wholly new paradigm is possible in which community power replaces the dominance of remote public and private sector bureaucracies.”
“Digital is just another means of providing patients with choice, and it must not become the default position”
Commenting on the implication of Kruger’s report on UK pharma, Paul Naish, director of UK policy at AstraZeneca said: “The Kruger report flags the importance of digital – where our industry is already highly active – but also issues that should be a clarion call for pharma to advance community collaboration within, and alongside our deep commitment to established patient organisations. This way we can support people to be healthy in addition to supporting patients to be well.”
Creating health alongside prevention and treatment
COVID-19 has demonstrated the value of resilient and connected communities, while reinforcing that creating health within communities must sit alongside prevention of ill health and treating illness through medicines and services. Creating health is not new, but it is effective, and it is cost effective. It is also an area that pharma should be actively involved in.
Commenting on the potential role of pharma in creating health, Lord Nigel Crisp, former chief executive of NHS England, and author of the recently launched, Health in made at home, hospitals are for repairs, said, “The NHS can’t by itself deal with many of today’s major health problems such as loneliness, stress, obesity, diseases of poverty and addictions. It can only react, doing the repairs but not dealing with the underlying causes.
“The pharmaceutical industry has a great track record in working with the NHS in treating and preventing illness through medicines, vaccines and support for services. But, since healthcare provided by the NHS accounts for only 10-20 percent of a population’s health, the industry needs to think about collaborating more widely with the health and care voluntary sector to support the creation of health in schools, homes, communities and the workplace. This will have the added benefit of reducing the burden on the NHS.”
The value of digital as a connector and enabler
COVID-19 has had a super booster effect on the adoption of digital technology to support patients. It has also led to a shift in attitude in the healthcare setting, with providers wanting patients to take greater responsibility for their own health and wellbeing with technology. This is turn is matched by a stepping-up of the use of technology by the HCVS in terms of better connecting people and communities, reaching out to communities, taking services and support online, and launching new services such as Zoom exercise classes. In addition, the sector has been actively breaking down barriers to digital exclusion through training, supporting funding of technology and targeted outreach to vulnerable, disadvantaged, and isolated communities who would otherwise not be engaged in digital and digital health.
Commenting on the role of pharma in further supporting advocacy in this digital space, Mindy Daeschner, chief executive of Daeschner Consulting and author of What’s next in digital healthcare transformation post COVID-19, said, “We know that industry has made a significant contribution to digital health and to supporting organisations up their digital capacity and capabilities. However, digital is just another means of providing patients with choice, and it must not become the default position. COVID-19 has made it clear that digital exclusion is and will remain a challenge for some, while for many patient’s people interaction is critical. Supporting digital initiatives that enhance choice and people interaction must be a key consideration.”
Building Better Together
As countries focus on Building Back Better, New NHS Alliance has been quick to point out that this means Building Better Together. There is a great opportunity for pharma to revisit and refocus advocacy programmes to support the HCVS to continue building connectivity within communities.
COVID-19 has radically changed the environment within which the VHCS sector operates and this must be understood and reflected by industry. At the heart of this is listening to the voice of organisations, but in today’s word, industry must take this one step further and listen to the voice of people and the communities the VSCS represent.
About the author
Neil McGregor-Paterson is director of connections and collaboration for Trio Health.
Former chief digital officer for the NHS, Juliet Bauer, is now applying her experience to the private sector through video consultation firm Livi. She shares her thoughts on how well the NHS is integrating digital health and what the public and private sectors can do to further boost adoption.
Bauer’s path to working in the NHS began when she spent many months in the care of the health service with a highly risky pregnancy and an extremely premature baby in NICU.
“I was hugely grateful for the brilliant care I received whilst in hospital – but I could also see the huge potential for digital to improve patient access and efficiencies across the NHS,” she says.
Bauer wanted to utilise her first-hand patient perspective and experience in digital transformation to drive positive, long-term change.
Pharmaceutical marketing budgets are going through a period of readjustment as companies explore and exploit a myriad of different digital channels to deliver content to, and engage with, their doctors and other audiences.
The average allocation to digital channels with marketing budgets has doubled since 2016, up to 34% for 2020 according to Indegene research, and over a third of companies expect digital budget allocations to increase by more than 50% over the next three years.
But making effective use of these resources to reach doctors around the world increasingly remains a challenge for pharma companies.
M3’s new Engaging Doctors Around the Globe whitepaper explores the most pressing challenges that pharma will encounter when planning and delivering a global digital marketing campaign.
It features insights from industry experts, and M3’s head of commercial excellence Katy McPherson and executive vice president Tim Russell.
They explore the need for local knowledge, how to establish and then utilise trusted relationships with HCPs, and why the time is right for a global-to-local approach.
The publication also provides advice on:
Producing credible, engaging and relevant content
Meeting regulatory requirements
Delivering impactful campaigns
Defining and proving return on investment
Tailoring content to different markets
Addressing the needs of global customers
At a time when embedding a digital strategy as a prominent component of a pharmaceutical marketing campaign is becoming ever more important, when many digital capabilities are overstretched and fail to make a cohesiveness of resources.
To guard against that a clear strategy and senior level support is needed so that pharma companies can acquire the appropriate talent and form effective partnerships that are needed to effectively engage with doctors around the world.
You can view the Engaging Doctors Around the Globe whitepaper here or by clicking on the button above or below.
IQVIA’s Sarah Rickwood explores how pharma can help healthcare systems address treatment backlogs caused by the COVID-19 pandemic.
As lockdowns started in the West during March 2020, there was, inevitably, much punditry on exit scenarios – for economies, populations, and healthcare systems. Considerable time was devoted to the discussion of V- , U- and L-shaped recoveries.
As we cope with second waves of COVID-19 infections, it is probably fair to say most early pundits were over-optimistic on the length of time the crisis would take to resolve. The pandemic’s aftermath is looking to stretch into the first half of the 2020s. One of the most far reaching impacts will be from the backlog of non-COVID-19 patients who have seen diagnosis and treatment delayed, slowed or even missed and cancelled. For many patients the consequences will be devastating.
With the first wave of lockdowns, treatment backlogs were inevitable due to physical distancing requirements and a pivot to focus on COVID-19. The most immediate impact was cancellation of elective surgeries and other procedures, and the movement of healthcare professional/patient consultations to virtual platforms.
A study in the British Journal of Surgery estimated that globally, 28 million procedures would be cancelled or postponed during the peak 12 weeks of COVID-19 disruption. The same study also made an important prediction: even if all countries increased their normal surgical volume by 20% after the pandemic, it would take a median of 45 weeks to clear the backlog of operations resulting from the 12 weeks of the first wave of disruption.
It is pretty clear that healthcare systems are unlikely to be currently at 120% of their pre-COVID-19 capacity for elective surgeries. In all likelihood, as Europe and the US are in the throes of a second wave of COVID-19 infection, the specific backlog of elective surgery will take longer than predicted to address. Even past the second wave, as vaccines become available, healthcare systems will not return rapidly to pre-pandemic capacities, let alone deliver more than that capacity. The conclusion is that backlog clearance will extend into 2021.
“It is pretty clear that healthcare systems are unlikely to be currently at 120% of their pre-COVID-19 capacity for elective surgeries. In all likelihood, as Europe and the US are in the throes of a second wave of COVID-19 infection, the specific backlog of elective surgery will take longer than predicted to address”
Elective surgery, is, of course at one end of the spectrum of medical conditions with respect to disruptability by the pandemic – by definition they are optional (although if surgeries are postponed, they may become less optional over time), and necessitating visits to a health facility, which may not be possible if there is an infection risk, or that facility has been repurposed for COVID patients. Patients with other conditions, especially cancers, cannot wait.
It is clear that delay in referrals, diagnosis and treatment can mean the difference between treating a cancer that is early stage and therefore often curable to one that is late stage and could result in early death. In an August 2020 paper in the Lancet Oncology, the authors noted that referrals via the 2-week-wait urgent pathway for suspected cancer in England were reported to have decreased by 84%.
The authors used data on cancer patients treated in the English NHS to model the impacts of lockdown induced delays in diagnosis and treatment, and concluded, “Delays in presentation via the 2-week-wait pathway over a 3-month lockdown period (with an average presentational delay of 2 months per patient) would result in 181 additional lives and 3,316 life-years lost as a result of a backlog of referrals of 25%, 361 additional lives and 6,632 life-years lost for a 50% backlog of referrals, and 542 additional lives and 9,948 life-years lost for a 75% backlog in referrals.” The 2-week-wait pathway refers to the request from a General Practitioner in England for an urgent referral to a specialist of a patient exhibiting symptoms which could be cancer.
IQVIA has been conducting a survey of oncologists and haematologists on their experience of treating their cancer patients before and during the pandemic. So far, the study has undertaken three waves of research, covering hundreds of oncologists/haematologists across the five major European countries.
The cancer specialists interviewed reported that, on average, they were seeing 77 patients a week prior to the pandemic. This fell to 41 patients a week at the height of the first wave of the pandemic. The June period, which coincided with lows of infection numbers in these countries, was little improved, at 50 patients/week, and as countries faced the second wave of infection in October, the number of patients reported seen per week had fallen back again, to 45. This pattern was seen across the five countries.
Because of the lockdown, it is not surprising, but very worrying, that cancer specialists reported delays in diagnoses, surgeries and chemotherapy during each of the three waves of interviews. Graphic 2 details the average percentage of specialists reporting each type of delay across the five countries. It is notable that the percentage of specialist reporting delays, which had dropped during the June infection low, rose once again when the second wave was being faced during October.
In summary, we have evidence that cancer specialists are reporting delays to patient diagnosis and treatment for cancers across the major five European countries, delays that are continuing past the first waves of the pandemic and into the second, and there are models which suggest that significant increases in mortality and years of life lost will be a consequence of such delays. Treatment backlogs caused by the pandemic are real, will have serious consequences for patients, and will take significant time to resolve.
I’ve picked for discussion two areas, elective surgery and cancer treatment, where patients need to visit health facilities, and in the case of cancers, treatment delays have serious consequences. Not all diseases or conditions are so far along these axes – many chronic conditions can be managed to a very large extent remotely, and for some conditions delays to treatment, even quite lengthy ones, may not have an immediate adverse effect.
Many chronic conditions, such as diabetes, hypertension, dyslipidaemia are also highly prevalent. The impacts of the pandemic backlog on treatment outcomes for these diseases will be played out over years to come, and IQVIA’s longitudinal patient data is already showing decreases in treatment changes (new and switch prescriptions) in relation to key chronic conditions such as diabetes.
“Pharmaceutical companies will undoubtedly place more emphasis on developing treatments that can be home administered and self-administered in the future, and payers and health technology assessors may well value those attributes more highly”
The treatment backlog caused by the COVID-19 pandemic matters – to individual patients, to public health systems, and to the pharmaceutical companies developing treatments which patients may now not be receiving as and when they should for optimal treatment. Pharmaceutical companies cannot address this challenge alone. But they can help, and we are starting to see how.
The first step to addressing the backlog is through raising awareness, with health policy makers and with patients. For patients highlighting the importance of seeking treatment, but without generating unnecessary anxiety and health system pressure, is a sensitive task to be done in close collaboration with health systems. Companies need to acknowledge the pressures that healthcare professionals are under and identify where and how they can alleviate pressures and help doctors to help their patients.
Second, as health systems emerge from the pandemic and vaccines are rolled out (and mass vaccinations will also place pressure on health system and some individual doctor’s time), they will need better data and insight on patient journey bottlenecks, on healthcare system capacity stresses and on the services required to remove barriers to effective treatment.
Finally, pharmaceutical companies should play their role in seizing the opportunity to learn and future-proof healthcare delivery against future pandemics. The pandemic highlighted the value of treatments which patients can self-administer, and in many cases there’s been big swings to treatments which can be taken at home – a movement from warfarin, which requires clinic visits, to Direct Oral Anticoagulants (DOACs or NOACs), which do not, for example, in anti-thrombotic treatment. Pharmaceutical companies will undoubtedly place more emphasis on developing treatments that can be home administered and self-administered in the future, and payers and health technology assessors may well value those attributes more highly.
The pharmaceutical industry has risen magnificently to the challenge of COVID-19, in terms of treatment and vaccine development. As the virus is defeated and infection rates fall during 2021, pharma’s next challenge will become increasingly apparent – to help address the other public health crisis of the treatment backlog precipitated by the pandemic. The solutions that pharmaceutical companies can bring to address this, and the relationships that they can forge consequently, will shape the pharmaceutical industry’s role in healthcare systems for the remainder of the 2020s.
About the Author
Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.
Janssen’s Daniel de Schryver tells us why it’s time to give patients a permanent seat at the table and improve health outcomes through patient-pharma dialogue.
I’m struck by just how much we thrive when we share a common purpose; when – as a society, a group or a family unit – we work together to achieve the same goal. It’s no different in healthcare. Pharma companies, healthcare providers and governments share a well-established common purpose: the desire to make disease a thing of the past. But healthcare is often a system of silos, and what can get lost in the gaps is the input of patients themselves. Which rather begs the question: how well are we caring for patients, if we can’t always hear their voices?
I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies. Patient-centricity has, I fear, turned into a buzzword. We must remind ourselves to focus on systematic changes – from the early R&D phases, all the way through to reimbursement discussions – that enable us to develop optimal solutions together with patients. In short, to ensure they have a seat at the table at every stage of the process.
To get back on track and embed a comprehensive collaboration between patients and industry, I believe we need to consider the following three areas:
“To ensure we are making a difference, we need robust KPIs, both short and long-term, to measure patient-industry collaborations. We must understand the value over time of these solutions”
1. Open conversations lead to better patient-industry collaborations
Pharma needs to convey a clear picture of who we are and what we’re trying to achieve. When the public sees patients working directly with us, it can still arouse suspicions, as if there’s some form of collusion going on. Transparency is crucial, therefore, so that any outcomes from our collaborations with patients are shared and accepted.
We have been adapting our processes at Janssen to put patients at the heart of everything we do. It’s a work-in-progress, because this means streamlining the way we work to include the patient voice within acceptable timelines, while still meeting compliance requirements. But the aim is for every function in our value chain to demonstrate how they have involved the patient in their decision-making.
A good example of a productive, open collaboration we’ve experienced with patients, clinicians and regulators is the one that resulted in the Psoriasis Symptoms and Signs Diary (PSSD). Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most.
A major insight revealed once the tool was in use was to not just focus on the percentage of the body covered by psoriasis – a patient with smaller areas of their face or hands affected, for example, may find it more difficult to cope compared to patients with larger areas affected on their backs.
Projects like these are time intensive, of course; this collaboration with psoriasis patients took five years to co-develop. But the important thing was that it worked, and that it has provided a great model of patient interaction for us to replicate.
2. Pharma must support patient empowerment
Patient empowerment is not a catchphrase; it is a genuine drive to enable patients to take ownership of their health. We need more people to see themselves as experts in their own treatment, so they feel able to provide input into key debates and initiatives. It should be our duty, as pharma, to help more people achieve this.
The European Patients’ Academy on Therapeutic Innovation (EUPATI) is a good example of this in action. EUPATI is a public-private partnership run by a multi-stakeholder consortium. It brings together patients, pharma, academia, regulators, non-profit organisations, and health technology assessment bodies, and it allows trained patient experts to input into the R&D process, regulatory deliberations, and other initiatives.
In the UK, my colleagues have created a Patient Advisory Committee, two of whom mentor several members of the UK management committee, helping them to further embed the patient voice in their decisions. A more empowered patient helps improve solutions that are beneficial to their own health and the health of many other patients besides, thereby contributing to a healthier future for all.
3. Measure the success of patient-industry collaborations
To ensure we are making a difference, we need robust KPIs, both short and long-term, to measure patient-industry collaborations. It is rewarding to see the immediate impact these projects can have, but we must also understand the value over time of the solutions we are co-developing with patients.
Patients Active in Research and Dialogues for an Improved Generation of Medicines (PARADIGM) is a public-private partnership paid for by the European Commission and the pharma industry, and co-led by the European Patients’ Forum and The European Federation of Pharmaceutical Industries and Associations (EFPIA).
PARADIGM provides a framework for innovative patient engagement approaches and is able to demonstrate the benefits of these approaches to all stakeholders. Through this partnership, we have been able to support the development of solutions designed to not only improve an individual patient’s experience of care, but also the overall health of populations, and which, ultimately, should reduce the per capita costs of care.
Putting patients at the heart of the process
It’s essential to listen to what patients have to say, to identify solutions that are beneficial individually and collectively, and to provide feedback on how patients’ insights have helped shape better outcomes for all. If we can listen and listen well, and if we can show we genuinely care about patients’ views, then their contributions can make a real difference.
As I said at the start, we thrive when we are united behind one common purpose. We must be united with patients, and that common purpose must be their purpose.
So, to any patients reading this, I urge you to join a patient advisory group and multiply your impact, to study with EUPATI and become an expert, and – put simply – to get involved and be heard. And to everyone with whom we work across the industry, let’s follow the process: ask the patient, include them from the onset, and ensure their insights are at the core of everything we do. Let their voice be the driving force in our shared goal of making disease a thing of the past.
About the author
Daniel De Schryver is patient engagement & advocacy lead, Europe, Middle-East and Africa, at Janssen. He joined Johnson & Johnson in 2001 as Director Corporate Communications. In that function, he initially worked in the field of oncology. In 2006 he joined the Janssen teams working in Infectious Diseases where he helped to maintain and enhance the company’s relationships with the HIV Patient Community. Later, he built the external relationships in the field of Hepatitis C, before becoming the Global Therapeutic Area Communications Leader Infectious Diseases and Vaccines.
COVID-19 has turned the world on its head and healthcare systems have had to respond rapidly to match the sudden changes created by lockdown. Digital health had already been building a presence before the pandemic, but the tools it offers have been essential to counter the disruption caused by the coronavirus, reports Richard Staines.
COVID-19 isn’t going away any time soon but when, and if, this crisis subsides the healthcare systems that are left behind will have changed radically.
While the pandemic has been a global tragedy it has also forced health systems to rethink the way they operate in order to minimise risks to both patients and healthcare staff.
With face-to-face contact posing a risk of virus transmission, the emphasis has been on remote appointments where possible, backed systems that triage patients remotely to manage the pressure on the system.
COVID-19 has left us more reliant on media than ever – both the pharma industry and society as a whole. Havas Lynx Group’s 2020 white paper provides a blueprint for pharma brands to inject meaning into their media.
“Meaningful media experiences are made by connecting with the right people, in the contexts they spend their time, with content that drives impact. If a campaign does this, it will position a brand as trusting, engaging and influential, and deliver measurable performance”
Like so many others, the job of the pharma sales rep has been dramatically affected by the outbreak of COVID-19. A role built on interpersonal relations had its foremost tool – face-to-face meetings – rendered impossible in an instant. Sales forces have been admirably quick to adapt, but the situation accentuates an issue that many in the industry will already be aware of. A sales force cannot do it all – a successful pharma brand needs a clear purpose, strategy, central creative idea, and an effective media plan. The latter is the subject of our 2020 white paper, Media Means Business.
What do we mean by ‘media’?
‘Media’ is a very broad term and is applied differently from industry to industry. For the pharmaceutical marketing industry, it is the management of every channel and opportunity with which we deliver our marketing. From telephone calls to tweets, real-time programmatic display advertising to the ever-important representative. Getting media to work for you means getting it all to work together.
And what does media mean to us?
Looking at the bigger, societal picture for a moment, media is woven into the very fabric of our daily lives, no more so than in these recent and unprecedented times. Whatever you do and wherever you are, we’ve come to rely on it. This is as true for healthcare professionals as anybody else. When a doctor is explaining a treatment programme with a patient, or video-conferencing their wider team to discuss new protocols, or even just catching up on the news whilst grabbing a coffee, they’re constantly in touch with a myriad of channels. This means that media offers a huge opportunity for pharma to connect with healthcare professionals (HCPs).
Preconceptions about the cost, effectiveness and safety of media investment have held back many in pharma from seriously exploring the potential of media. In this white paper, we will look to dispel these preconceptions and provide a roadmap to developing an effective media strategy that builds a meaningful connection with HCPs.
Meaningful media experiences are made:
By connecting with the right people
This means establishing who your key targets are and really getting under the skin of the HCPs within this audience, white coats on, white coats off; from their motivations and pressures in their job, to whether they unwind by running marathons or marathoning Netflix series. Our digital lifestyles offer a bounty of insight into understanding who our audience are, how they spend their time, and what makes them tick.
In the contexts they spend their time
Pharma tends to lean on owned channels such as brand websites. However, by combining traditional staples with shared, earned, and paid media can reach audiences. From shaping the tone and timing of campaigns to reflect the national mood to placing patient information about overactive bladder on the back of public lavatory doors, where and when a campaign is seen has a huge influence on how and if it’s received.
With content that drives impact
We live in a world of content overload. The average person sees up to 3,000 advertising messages every day. So how do you stand out? In developing content, brands need to go beyond selling the product and explore how they can tangibly improve people’s lives, collectively and individually.
Giving you campaigns that deliver great effect
If a campaign does all of the above, it will position a brand as trusting, engaging and influential, and deliver measurable performance. And measurement is crucial. Outcomes from specific marketing strategies need to be assessed in order to join the dots between tactical performance and business performance.
Research Partnership’s Vicki Newlove explores research into digital change during COVID-19 to find out what business questions pharma needs to address to succeed with innovations.
Pharma companies are facing a confusing and uncertain future, and no one can say how the industry might look in a year’s time, or what the balance of digital and physical working might be. Even those companies that responded well to the pandemic and quickly embraced digital can’t know how long restrictions will last, and many are still revising their strategies and figuring out how best to position their digital offerings.
The companies that will thrive are those who gather insights into how COVID is impacting the patient journey and physicians’ behaviour and adapt accordingly. This will allow them to put robust, long-term strategies into place.
As the world continues to grapple with the ongoing impact of coronavirus, the healthcare industry has taken centre-stage, working tirelessly and more collaboratively than ever to tackle challenges thrown up by the pandemic.
Amid the turmoil and the race to not only find a vaccine but also help to care for those who are battling the long-term effects of COVID-19, healthcare organisations need to sharpen their communication skills.
Against a backdrop of multiple challenges, now may not feel like the right time to overhaul communication strategies, but in the race for relevance the choice is clear: adapt now or risk being left behind.
By adopting a design-led, solutions-based approach to communications, companies can help healthcare professionals (HCPs) to better meet the needs of their patients through their comms, taking a scientific approach to creating clear, rational processes built on discovery, definition, development, and delivery in every aspect of healthcare.
Good, empathetic design allows the science to shine. Scientists can use this as a basis for clearer communications, helping to share their expertise with patients and healthcare companies effectively. Creating a more informed patient can improve outcomes and ultimately, quality of life.
This goes hand in hand with a change already taking place – one that has been building for some time but has been accelerated in present day conditions – and that is for pharma medical affairs teams to become actively involved in their companies’ communications strategy.
When this starts earlier in the development process, it proves to be hugely beneficial in demonstrating the tangible value to the patient of the drug or treatment, the support structure surrounding it. Healthcare companies can do well to adopt the best practices of other industries’ marketing playbooks; those that have long considered the end user – the shopper, the enthusiast, the audience – at the outset of any product or service development.
“Better communication rooted in a design mindset does not mean dumbing down the scientific endeavour, rather it makes it possible to get the very best out of the science and for it to land in the most effective way”
In this merging of med affairs and communications, healthcare companies come close to emulating the tools used by marketing professions in other industries – the focus on the end user. From a shopper, to an online audience, marketing best practice gives significant consideration to the ultimate user throughout the development of any offering or communications.
Better communication rooted in a design mindset does not mean dumbing down the scientific endeavour, rather it makes it possible to get the very best out of the science and for it to land in the most effective way. By forming a thorough and insightful communications strategy based on patient needs, any advancements in efficacy can be matched by improved compliance and concordance.
Healthcare companies that take this approach can improve their processes before commercialisation by breaking down internal silos. This makes a thorough and insightful communications strategy based on patient need more likely. And subsequently, this can help improve efficacy, compliance and concordance with treatments.
The shift in the way companies bring their products to market needs to reflect how patients are taking a greater role in their healthcare decisions as they seek medical information outside their doctors’ surgeries. This means that presenting information in a form that patients can easily access and understand will become more prevalent.
It takes imagination to engage an audience, knowing how to appeal to people’s instincts, to meet their needs and address behaviours – this is a science in itself. Through design, better patient experiences and more relevant and compelling content. There are universal benefits to creating more imaginative and relevant content. Everyone gains – HCPs can do their job better, patient compliance improves, and healthcare companies achieve improved business results.
The role of medical affairs teams is vital in this process. McKinsey highlighted the new media opportunities when medical affairs teams work with all healthcare stakeholders to understand patients’ needs. These range from being an advocate and voice for patients, to embracing new technologies, ensuring health outcomes are the key focus for companies, and engaging with a range of stakeholders in the healthcare process. For HCPs looking to improve compliance, this helps to reassure them that drug manufacturers have incorporated patient insight into development.
With a blended approach, combining the intelligence and skillsets within a pharma company with the creativity and insight from an agency, the work of the R&D scientist, medical affairs, medical sales liaisons (MSLs), marketing and branding teams can come together.
Medical affairs teams have always been involved in patient engagement activities, but the fast-evolving environment and increased expectations of patients mean that their role has never been so important.
But it can take time to instigate these practices and truly embed them within a company. However, Covid-19 has offered an opportunity – healthcare companies have seen their traditional ways of communicating with HCPs curtailed. HCPs have had to find their information given sales reps and MSLs are no longer on the road.
Aside from better meeting patients’ needs, this change has been prompted by the expansion of digital environments. Digital in the broadest sense – be it AI, electronic patient records or access to real-time health tracking data – has allowed clinicians’ work to be streamlined, for systems to be optimised, human error to be reduced and costs to be lowered, all helping improve patient outcomes through better concordance and experiences.
This digital ecosystem can do so much to help HCPs – and subsequently patients – but it necessitates a clear digital strategy, so it aids the process, rather than creates information rabbit holes and disconnected systems.
This again calls for imaginative design practice. Designing intuitive, accessible, relevant and clear digital environments for the HCPs is one-way communications specialists can bring the world of science to life, through better design. By working with MSLs, medical affairs and science-based teams earlier in the lifecycle of the pharmaceutical and medical device companies, we can help join the dots.
Understanding the patient
Exactly how this manifests itself depends on therapy and treatment type. We usually start a project by adopting a broader perspective – to understand fully the environment we’re working in. Building patient dialogue invariably starts by researching how those patients feel about their illness or condition: gaining an understanding and insight into the challenges they face is the first step to seeing the patient, rather than the condition.
Truly understanding how patients talk about living with a condition may be best done through a social listening exercise or an ethnographic study. This helps build the picture of the here and now, the springboard from which the company can start preparing the market.
This should then be paired with deep understanding of the current environment for the disease area. Is it underdiagnosed or badly treated, does it fall between disciplines clinically, are there psychological as well as physiological impact? These factors determine the impact of a new drug coming to market, which HCPs to educate and how best to reach them.
HCP surveys and interviews might help identify the knowledge gap and collate findings to derive insights – there may be a lack of education around the condition, it may be misunderstood even though it’s a recognised condition, there may not be a clear protocol or pathway. The insight can, for example, be used to help build an educational programme that works in part as a pre-commercialisation process; develop a disease awareness campaign to highlight the real issues of living with a chronic condition.
Tackling issues around unmet need head on at the beginning of the process helps to build a strategy that puts the patient and HCP perspective at the heart of the communication and enables identification of how best to deliver it to make a difference – an app, video snippets, first-person perspectives, further evidence, different modes of communicating the science.
This comes from thinking about the HCPs’ information journey, what they need to know and when, accessing clinical information, being able to drill down in the areas where more explanation or background evidence is required, in a time-efficient and trusted way.
McKinsey identified three major changes to the healthcare landscape:
How value is defined – it will be much broader and will expand as healthcare stakeholders demand to see how value can increase. There will be an increased focus on evidence and proving product value.
Interactions between pharmaceutical companies and various medical stakeholders will continue to evolve as new decision-makers emerge and there is greater public scrutiny of these relationships. The role of patients will fundamentally change as consumerism in healthcare increases.
The proliferation of data and demands for transparency will accelerate. The number and types of users of medical data and information will continue to expand rapidly.
By embracing these changes, and creating innovative communication platforms, there is huge scope to add value for healthcare companies as they offer contextualised information to HCPs across all areas of medicine.
With empathetic design we can channel scientific endeavour, providing a springboard to communicate the benefits and treatments of medicines to all healthcare stakeholders, for the improved health of everyone.
About the author
Clare Bates is content director and a partner at Page & Page and Partners. She is a trained journalist with experience of developing content for B2B and B2C audiences.
COVID-19 has reminded the world how critical infectious disease is, from both a societal and economic standpoint. Cancer is rightly seen as one of the most pressing challenges of our time: but it has not yet caused a multi-trillion hole in the world’s finances.
For the first time in my career developing antimicrobials, I’m hearing more investors enthused by the prospect of investing in companies developing solutions to infectious diseases. We all know COVID-19 has shifted our perspective on a range of things, and in economic terms three developments have underpinned this shift.
First, there is now a wealth of innovation, perhaps more than ever, in antimicrobial design and development (almost all of it being generated by SME businesses). Second, push incentives from government and NGO bodies, particularly the AMR Action Fund, providing $1 billion of investment, are now substantial enough to really fuel that innovation. And third, pull incentives are now in place which are beginning to make an effective commercial case for antimicrobial development.
The NHS/NICE antibiotic subscription model announced earlier this year is potentially the most significant of these developments. The US PASTEUR Act, if enacted, would also pave the way for providing prepaid subscription contracts for antimicrobials in the US, collectively making antimicrobials viable again. Similar subscription models and other market entry reward proposals are being floated in Sweden and elsewhere.
After years of lobbying by the industry, policymakers now accept the need for “pull” models that de-link sales (by volume) from reward; reward being for developing and launching these drugs for when they are needed, not for promoting use. Antimicrobial stewardship is now clearly linked with economic success.
We’ve all heard the bear cases for antibiotics: the bankruptcy of Achaogen, fire sale of Tetraphase and other high-profile problems at antibiotic developers have highlighted the fact that even with the best possible support in the development phase, generating profitable versions of the ‘traditional’ antibiotic classes remains challenging. The decision by Cipla to withdraw Zemdri (plazomicin) from European marketing authorisation, is a sobering reminder that even highly effective antibiotics with proven efficacy are often not considered economically viable.
“We need to keep up the momentum. Although welcome, the pull incentives are the first small steps to creating the economic climate required for very successful commercialisation of antimicrobials.”
But now, just as a communicable disease poses the biggest economic challenge the world has faced in a decade, there are signs that new reimbursement models, alongside a new generation of innovation in development, have changed the rules of engagement.
Innovative and commercial savvy companies are creating platform technologies and diversified portfolios, focusing not only on antibiotics but desperately needed antifungals and antivirals as well.
NovaBiotics is proud to be developing antifungal and antiviral therapies alongside antibacterials, all of which mitigate resistance as they are based on platforms engineered from innate immune effector molecules – harnessing the way the body fights disease versus ‘synthetic’ approaches that introduce new resistance pressure to microbes. We are not alone in developing drugs which are designed to avoid creating antimicrobial resistance.
There’s every reason to believe that by the time these new drugs reach the marketing approval and launch, the reimbursement and commercial landscape will allow for a good economic runway.
We need to keep up the momentum. Although welcome, the pull incentives are the first small steps to creating the economic climate required for very successful commercialisation of antimicrobials. The forthcoming EU Pharmaceutical Strategy can perhaps create conditions to address market failure in antimicrobials and reinvigorate innovation, by taking the right actions. These include support for the SME companies which generate the lion’s share of innovation, better alignment between health systems and drug developers, the targeted use of diagnostics and a regulatory framework based around non-inferiority trials, to name a few.
The UK government, which has already played a leading role in creating a significant pull incentive for developers, is talking about creating an equivalent to DARPA. The UK has some of the world’s most innovative antimicrobial developers so there’s a clear incentive to do this.
This year may be the great awakening of the value of anti-infectives from a social perspective. 2021 could be the year that they demonstrate their economic case. Let’s use Antimicrobial Awareness Week to get that message out.
The healthcare system is running at its limits in many countries worldwide. One reason is the growing demand for healthcare, largely driven by the rise of chronic diseases. COVID-19 has further underscored just how stretched the system is today. Is there any solution to the twin challenge of managing costs while extending capacity?
We believe that digital technologies are an important part of the answer. Although still in early stages, it is poised for broader adoption thanks to recent technological advances. While digital won’t help solve all the problems in our healthcare system, it will significantly contribute to easing the cost and capacity burden.
One particularly promising area in this context is digital therapeutics. Based on the analysis of individual patient data, patients receive personalised medical recommendations – through an app or a digital platform – without the need for physician intervention. Digital therapeutics can help patients stick to treatment plans and/or better understand what triggers critical situations. Digital therapeutics are already available for different indications including diabetes or asthma and are being developed in many other areas as well.
As regional vice president for Northern Europe & Australia, Simon Lem led the digital launch of Vertex Pharma’s novel cystic fibrosis drug Kaftrio. He tells pharmaphorum about embracing digital change and the need for innovative reimbursement solutions.
For Vertex, COVID-19 accelerated a digital transformation much needed for the patients they serve.
As the leading developer of novel drugs to treat cystic fibrosis (CF) the Boston-based company has always taken a very focused approach.
“For CF, you have a proportion of the population predominantly quite young and tech-savvy. They do not want to be coming into the hospital,” Lem tells pharmaphorum. “There was already a direction of the clinical community to be having these interactions or helping patients manage their disease virtually. COVID-19 sped up all of that.”
With COVID-19 posing an added risk to people with CF, Vertex was “even more motivated” to secure its supply chain and access to drugs. In June 2020, NHS England swiftly approved a reimbursement deal for Vertex’s fourth CF drug Kaftrio meaning the medicine would be accessible for doctors and eligible patients in England from the day (in August 2020) it received licensing from the European Commission, with the medicine being accessible by eligible patients in Scotland, Wales and Northern Ireland soon after. The drug has since launched digitally.
“I never thought that in my career, I would see a launch of a significant product without having a face to face interaction with a customer, but it has worked. Early results are positive, it hasn’t changed the mission,” says Lem.
Like other pharmaceutical companies, Vertex still faces challenges with reimbursement and market access. The agreement for Kaftrio followed a long battle with NHS England to make the company’s three other cystic fibrosis medicines available.
“It’s one thing if you can develop an innovative medicine, but then you’ve got to get it to patients for it to be useful… that is challenging for many healthcare systems.”
“The challenge we face is universal to any biotech company. You are operating in multiple different countries with multiple different healthcare systems, multiple different cultures and all the different ways they approach, reimbursement, or engagement,” explains Lem.
“It’s one thing if you can develop an innovative medicine, but then you’ve got to get it to patients for it to be very useful and I think that is challenging for many healthcare systems, particularly ex-US where you have finite and limited budgets. You also have very well-established long-term health technology, appraisal systems.”
The speedy nature of Kaftrio’s approval is encouraging for how reimbursement could look in the future, says Lem. Working flexibly with NHS England and NICE, Vertex managed to ensure patients got access to the drug on the day of licensing.
“I don’t know of many examples where that’s happened before if any, but primarily it was about taking a step back and asking what we had learned from our ongoing discussions and how we could bring those forward into the next step of the negotiations.”
Engaging with the health system as early as possible and working flexibly was key to the success, he adds. “It has to be more collaborative. Especially if you move into things like gene therapies.”
UK’s opportunity for change
The UK government also has an opportunity now to speed up the process, Lem says. “I think sometimes other healthcare systems have looked at the UK as the ones that are playing catch up, and there is a less flexibility to change, but I think the UK could lead the way with this. We saw with our CF medicines; they can do it if all parties are motivated to do it.”
A more flexible approval process would also benefit patients within the UK. “Sometimes patients in the UK only get access to medicines much later than other European countries. I think there needs to be innovation, flexibility, and open communication with all parties involved in in the process including the HTA system and the health authorities.”
A bigger challenge for healthcare systems in future will be deciding reimbursement for curative medicines. “We’re at a very embryonic stage across the pharmaceutical industry. There’s going to have to be even more collaboration, even more flexibility and even more talking at a far earlier stage than we’ve done previously.”
Starting his pharma career as a sales rep, Lem has worked across the industry in management and marketing roles. He notes how business practice has changed significantly over the years. “Now we are far more focused on individual patients and individual prescribers and that has changed how you go about doing the businesses. It is far more personalised, and that’s down from a key account manager’s perspective to even reimbursement.”
Vertex’s focus for now is on being less of “a one-franchise organisation” and diversifying its portfolio. The company is investigating new medicines for serious diseases with key unmet needs.
“We want to treat the underlying cause of the disease,” says Lem. “It will be interesting seeing how that pipeline pans out and the impact that that will have on the business.”
Expanding into new diseases areas will require a different approach from the organisation, says Lem, but presents an exciting new challenge. Having worked at Vertex for nine years, he says that no day is the same as the day before.
“I can tell you what I am doing today is not the same as what I was doing this time last year. I think it’s a really exciting journey because we’re doing stuff so rapidly and having such a big impact that and we go into new disease areas.”
However, the goal to find a cure for CF remains core to the company.
“People say to me, ‘Are you happy? Patients have got the medicines. It’s over and done with.’ I say, no, it is not – there is still a lot of work to do for CF. We brought four medicines to the market. Yet there’s still work to be done.
“We’ve got medicines with the potential to treat up to 90% of people with CF, but the other 10% still don’t have a medicine. Until that 10% have got a medicine, the game’s not over.”
A new post-hoc analysis from Novo Nordisk of their SUSTAIN 6 and PIONEER 6 studies into semaglutide is looking to help ‘individualise’ treatment for diabetes patients by better predicting their cardiovascular lifetime risk. We spoke to lead study investigator, Utrecht University’s Dr Jan Westerink, to find out how he sees the results being used in daily practice.
The heightened risk of cardiovascular disease remains a pressing concern for type-2 diabetes patients, and one that many healthcare systems have not quite got a handle on yet.
Dr Jan Westerink, assistant professor of internal medicine, University Medical Center, Utrecht, believes that one issue is that the guidelines for addressing cardiovascular risk are too rigid, and don’t take into account each patient’s individual circumstance.
“People always say that patients and doctors should share decision making and discuss treatments with one another, but in reality, most of us just follow the guidelines.
“The problem is, if you have a high risk of cardiovascular disease, the guidelines might suggest that you are given statins and told to take them for the next 50 years, with no discussion at all.”
But Dr Westerink believes there needs to be more room for nuance and an understanding of lifetime risk.
“If you start taking a diabetes treatment with cardiovascular benefits whilst you’re relatively young, you will benefit more than a person who started taking it in their 70s.
“It’s like starting a savings account; if you start young then the benefits will be a lot greater than if you started at a higher age.”
“By using the results of the analysis on individual patient cases, we can show that with the use of semaglutide added to standard of care, some patients will have less than one year’s worth of benefits, and some patients will have more than two years. The mean benefit there would be 1.7 years, but it’s very different for each individual patient.”
But current guidelines do not always take into account this type of reasoning.
Applying a new model
To help understand the lifetime risk of developing CVD and how diabetes drugs like semaglutide can affect this for individual patients, Novo Nordisk conducted a post-hoc analysis by applying the Diabetes Lifetime-perspective prediction (DIAL) of cardiovascular risk model to data from two of Novo Nordisk’s phase 3 trials into semaglutide – SUSTAIN 6 and PIONEER 6.
This model was specifically developed for use in people with type 2 diabetes for lifetime risk prediction of cardiovascular events as well as the years free from cardiovascular disease gained from an intervention.
It was based on data from 389,366 people with type 2 diabetes in the Swedish National Diabetes Registry and externally validated across multiple geographical regions.
Prediction models like this are recommended to help prediction and prevention of cardiovascular disease by leading cardiology associations, including the European Society of Cardiology (ESC).
“As a lifetime risk model, it estimates your life expectancy without cardiovascular disease, whilst also taking into account that you have a risk of dying from other causes,” Westerink, who was lead investigator of the analysis, says.
The two studies included 6,480 people with type 2 diabetes with high cardiovascular risk aged between 50-90 years.
The analysis showed that the addition of semaglutide to standard of care may extend life without a cardiovascular event, such as heart attack or stroke, in people with type 2 diabetes and high cardiovascular risk for up to 3 years, with the average being 18 months.
The results also showed a 20% risk reduction in ten-year risk of experiencing cardiovascular events for participants receiving semaglutide compared to standard of care alone.
With semaglutide, the average number of years during which participants did not experience a cardiovascular event was extended by 7-35 months across all age groups (50 – 90 years), with the greatest benefit seen in people aged between 50 -65 years and with high cardiovascular risk.
The team then took the MACE hazard ratio from the trial cohort – 0.76 – and applied it to patient-level lifetime risk of cardiovascular disease events derived from the DIAL model. From that, they were able to calculate the return on investment from lifetime use of semaglutide for individual patients.
For example, for a specific patient, a 61-year old man with type 2 diabetes and a history of cardiovascular disease, the DIAL model showed that adding semaglutide to standard of care reduced the 10-year risk of having a cardiovascular event by 21% and provided almost two-and-a-half years (29 months) free of cardiovascular events.
“What we found is that, as expected, if you have a large population and you calculate absolute benefits in all those individual patients and you make a histogram, you can see that they have a very wide distribution,” says Dr Westerink.
“Although there’s an average hazard ratio of 0.76 and a 20% risk reduction when looking at every patient, not everybody’s got to benefit to the same extent.”
“By using the results of the analysis on individual patient cases, we can show that with the use of semaglutide added to standard of care, some patients will have less than one year’s worth of benefits, and some patients will have more than two years. The mean benefit there would be 1.7 years, but it’s very different for each individual patient.”
Dr Westerink hopes that insights like this could lead to recommendations for diabetes treatment becoming more personalised, based on each individual patient’s lifetime risk.
He adds that the most important aspect of this approach is its simplicity and logic.
“I’ve never met anybody who doesn’t understand the concept when they hear it,” he says. “The only problem at the moment is that it’s not what doctors are taught to do. Everybody feels that they shouldn’t give older patients certain kinds of drugs, or that they shouldn’t just tell young people to improve their lifestyle and not medicate them at all. In reality, we know that’s not really how it’s supposed to work, and that’s what makes this approach so logical.”
Dr Westerink hopes that eventually this approach will be included in international guidelines, although he acknowledges that changing practice will take “a different way of thinking” from doctors. For example, they might be required to do more in-depth interviews with patients to be able to accurately predict risk.
Westerink adds that individualising treatment in this way could ultimately lead to higher adherence.
“It lets the patient take the lead in their own treatment and lets them know exactly why they are taking a drug,” he says.
About the interviewee
Jan Westerink studied medicine at Utrecht University (1997-2003). During his training as an internist-vascular physician, he carried out three years of doctoral research and obtained his doctorate in 2012 as a result of research focused on the harmful effects of belly fat and the postprandial phase. Since 2013 he has been working as an internist-vascular physician at UMC Utrecht. There is a special interest in vascular diseases in patients with type 2 diabetes mellitus in both care and research.
Janette Curlis is a Multiple Sclerosis Nurse Advisor (MSNA) at Biogen, helping to support the company’s Multiple Sclerosis (MS) field teams and developing patient and Healthcare Professional (HCP) materials.
We spoke to her about being a bridge between pharma and the NHS and the challenges that are facing Multiple Sclerosis Nurses (MSNs) and patients today.
Janette, what does your day-to-day work involve as a MSNA?
I work within the medical department at Biogen covering the UK and Ireland where my role is wide and multifaceted. As well as supporting our field teams, I develop nurse and patient materials, education and projects.
As a MSNA, my role has naturally evolved to accommodate how I support the nurses that I work with. I listen to and identify the gaps in their education and work cross functionally to develop training and education that will support their needs – at the same time being mindful not to increase their workload.
“As the demands of the job have changed, perhaps it is time to review the role and skill mix needed within MS teams. MS support nurses and MS admin coordinators would free the MSNs to concentrate on more complex needs of their patients”
The Disease Modifying Therapy (DMT) landscape alone requires education, information and planning to ensure the patient has the right treatment at the right time and the best experience.
The role of an MSN has changed over the years and has become more complex – what would you say are the main challenges MSNs face today and what are some of the wider challenges in MS care now?
The role is multipurpose, challenging and ever changing along with the National Health Service (NHS) in the UK and the Health Service Executive (HSE) in Ireland.
MSNs are time-poor. As the role has developed there are several new challenges they face. With around 14 disease modifying therapies now available, the MSNs of today require a different skill set to previous years.
There is a lack of consistency when it comes to provision of dedicated admin support to the MSNs. The increasing workload has put pressure onto nurses to fit everything into their working week, whilst maintaining quality time with their patients.
As the demands of the job have changed, perhaps it is time to review the role and skill mix needed within the teams. MS support nurses and MS admin coordinators would free the MSN to concentrate on more complex needs of their patients.
Looking at the wider challenges, it’s difficult to separate them out individually. They are wide ranging, and, not unlike the NHS, a lack of investment in developing services that reflect the change in delivery that’s needed today and for the future is a major factor.
What I find is that there are inefficiencies in the systems causing delays and duplication of work, and with no time to address these issues we see delays on areas such as time to treat and referrals.
How is the NHS addressing these challenges, and how does Biogen support that work?
With limited resource around service improvement in the NHS, Biogen have a team of Neurology Business Managers who work with MS services across the UK and can identify where improvements can be made. I can then support the nurses by assisting where appropriate.
How do you support Biogen in helping to address these challenges?
Moving forward we are building on the programme we delivered in 2019; the nurse advisor team ran numerous bespoke events and individual teaching sessions.
We continue to support the MS Trust Mental Health Campaign and I am working with the team to look at how we can support both MSNs and people with MS.
What are the key areas you’re looking to focus on to help improve value and engagement in MS?
All new MSNs appreciate onboarding is difficult. I have a specific half-day training programme to enable the nurses to have a firm grounding in MS. I also hold follow up sessions for MSNs which include immunology, DMTs, and MRI.
Nurses often ask why I left my hospital position of MSN, and whether I miss the patients. My reply is always that I never left MS nursing; I still work on behalf of the patients, just in a different way!
About the interviewee
Janette Curlis is a MSNA working at Biogen. She has worked in Neurology since 1991 and specifically as an MSN since 1997. Janette was one of the few MSNs pre risk sharing scheme recruitment. She worked in clinical research in MS studies as well as her role as MSN up until leaving the NHS in 2011. She worked with almost all of the now licensed therapies in trial phase. Janette moved to the pharmaceutical industry to take up a new role as nurse advisor for Novartis in 2011 and joined Biogen in 2014.
Since Covid-19 hit, many industries have shifted a heavier weighting of their business into the online world, relying on e-commerce and digital engagement to counterbalance the reduced ability for physical interactions.
The pharma world is no exception, and this year both small and large players have made the transition – partly out of necessity – from a world that relied predominantly on the face-to-face side of doing business, into a new digital world.
By no means has this been an easy task, and even now some pharma businesses are still struggling to embrace this much needed digital transformation. As with every other sector, pharma has come to recognise that there has never been a better time to have an online presence when it comes to future business growth.
This year as a nation – and globally – we are more aware of our health than ever before. Coupled with national and regional lockdowns, consumers want to minimise face-to-face contact as much as possible. Offering medicines and healthcare products in a digital capacity through online purchasing and delivery, or via a click-and-collect service, is the perfect solution. And for those pharma businesses that can get it right, digital adoption is certainly the way forward.
For pharmaceutical giant GlaxoSmithKline (GSK), the move to digital was fuelled through a desire to evolve and happened way ahead of others within the industry. The first step was changing their business model with a focus on building trust and creating transparency. Part of this strategy saw the launch of new digital platforms, including e-commerce. As one of the biggest pharmaceutical companies in the world, GSK is known for its innovation and is at the forefront when it comes to digital transformation.
“Pharma businesses need to ensure that they market themselves accordingly to both B2B and B2C. Targeted advertising is crucial to ensure the messaging is tailored to the right audience – healthcare and medical professionals or customers and consumers”
The challenge of compliance
One of the main concerns the pharma industry faces is around the issue of compliance and what products they can and can’t advertise. The good news is Pharma businesses have the opportunity to use a multitude of digital marketing channels to advertise on such as LinkedIn, YouTube, Google and Twitter.
Being registered with the General Pharmaceutical Council & approved by Medicines and Healthcare Products Regulatory Agency;
No promotion of prescription or specific drugs within adverts or landing pages; and
Where a marketing company might own and manage a domain on behalf of a pharma brand, written proof from the brand is needed to confirm collaboration with the marketing company.
Providing these conditions are adhered to, there should be no reason for pharma businesses not to use online advertising, which is positive news especially in a world where more and more people are online.
How to maximise your digital marketing strategy
Pharma businesses need to ensure that they market themselves accordingly to both B2B and B2C. Targeted advertising is crucial to ensure the messaging is tailored to the right audience – healthcare and medical professionals or customers and consumers. Ensure keywords used are relevant for your audience – medical terminology for professionals and informational keywords providing solutions to ailments for consumers. Also, it is vital that all adverts and landing pages add value and are easily digestible.
Remarketing allows brands to stay at the forefront of customer’s minds, even after they have visited your website, through display advertising across platforms such as Google Ads and LinkedIn. Both platforms allow specific audience targeting and offer tracking of ROI to ensure the method is working effectively.
For independent pharmaceutical businesses, who do not have the same budget as some of the larger players in the industry, justifying advertising spend can be difficult. Therefore, it is crucial to trial and test digital marketing methods to work out which ones will deliver the best results, and to track all touchpoints to fully understand the customer journey.
One way to test is through split testing of adverts – giving each advert a separate UTM (Urchin Tracking Module) code which can be used to track performance and give insight on where traffic is coming from. If this is done correctly then it will provide understanding of which audiences and targeting are generating the highest ROI. By adopting this method, it will also ensure you are always improving your advert quality.
Using Twitter for campaigns to raise brand awareness, and to encourage healthcare practitioners to sign up for relevant webinars or download content about your brand, is another effective marketing method. Twitter’s advertising policy covers the promotion of clinical trial data, so care must be taken to avoid using keywords which make any health claims surrounding diagnosis, prevention and cures. As with Google, use target keywords relevant to your audience.
How to make the move from physical to digital
Transitioning commerce from a traditional bricks-and-mortar store to online means pharma businesses need to ensure they offer a seamless customer experience. Online customers behave differently to how they would in a physical store.
If you think of how pharmacies have traditionally been used – the customer tells the pharmacist their ailment and the pharmacist talks them through a range of medicines that may help them, guiding them through the decision making process – a process that cannot be replicated online.
The customer journey needs to be clear – the features and benefits of the products they are looking to purchase should be easy to understand – consumers do not want to be met with medical jargon.
Purchasing should be simple – preferably via an e-commerce function on their own website. Selling through other retailers, or through a direct to consumer (DTC) marketplace such as Amazon, will not be as profitable in the long run. However, Amazon can typically offer high conversion rates and it is possible to get instant traffic through sponsored product adverts on their website. So it should certainly be considered as part of your marketing strategy.
Case Study: UK leading emergency contraceptive pill
In January 2020, one of the UK’s leading emergency contraceptive pill brands which is available online and in pharmacies worldwide, chose to invest in its paid and organic digital marketing activity; with an emphasis on optimising the customer journey.
To ensure all the activity adhered to the strict compliance guidelines, the campaign worked with medical professionals and regulators to make sure its activity was validated and performed optimally on search engines.
To date, the business value to the brand includes:
An 118% rise in consumer engagement meaning more people are now aware of the brand and its product,
155% uplift on clicks from the campaign to their independent sales site or other major retailers who stock their product such as Boots and Lloyds Pharmacies, and
An impressive reduction in the cost-per-click of 60%, meaning budgets have been used effectively. The reduction also means budget is being saved which can therefore be allocated for other activities.
Customers are spending more time online than ever before, and this transition is set to stay, and continue to grow. Whilst not all pharma businesses will follow in the steps of GSK when it comes to embracing the digital world, they should certainly learn from them and incorporate elements of their business strategies into their own. The move to digital should be a permanent requirement, not just a temporary solution to the pandemic.
About the author
Rachel Murray is head of partnerships and a strategist for Fountain Partnership.
It’s day two of digital health innovation conference Frontiers Health, which will be mainly held online because of the COVID-19 pandemic.
This year Frontiers will be a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition will be hybrid combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, the USA and more
It will be dedicated to digital health innovation, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation and ecosystem development.
The programme starts at 2.00pm CET with plenary sessions (talks and panels) and parallel break-out sessions (masterclass, workshop, deep-dive formats) in the unique Frontiers style.
The iconic Start-up Discovery sessions have also moved online opening more opportunities to connect with both earlier stage and more established digital health start-ups.
Paul Tunnah, chief content officer and managing director UK at Healthware Group will open day two of the conference, followed by an opening keynote from Healthware CEO Roberto Ascione.
This will be followed by keynote addresses by David Klein, CEO of Click Therapeutics and Kuldeep Singh Rajput, CEO and Founder of Biofourmis.
They will respectively discuss removing barriers to healthcare access with digital therapeutics and adoption at scale of digital biomarkers.
View the live coverage of day two at Frontiers Health on this exclusive blog from the pharmaphorum team, who will also be posting updates on twitter.
View the live coverage from day two at Frontiers Health 2020 from 13 November below, revisit coverage of day one (The live blog may take a moment to load.)
2020 might go down as the year digital health truly began to boom – but to continue thriving, health tech start-ups will need a strong support network and an environment that fosters innovation.
With advanced tech becoming ubiquitous, healthcare stakeholders finally embracing digital, and patients rapidly shifting their preferences, there has arguably never been a better time to be a digital health start-up.
Dr Kath Mackay, managing director of Bruntwood SciTech’s Alderley Park – the UK’s largest single-site life science campus – says there are many positive signs for the sector.
“There’s a lot of investment in life science and digital health. Private and public stakeholders are keen to fund these companies, and many firms are growing. People are embracing digital technologies like never before, and awareness has never been so high.”
Digital health innovation conference Frontiers Health kicks off its 2020 edition this week, although the majority of the conference will be held online because of the COVID-19 pandemic.
This year, Frontiers will be a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition will be hybrid, combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, the USA and more.
It will be dedicated to digital health innovation in the context of the “new normal”, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation and ecosystem development.
This year’s programme will start at 2.00pm CET on both days with plenary sessions (talks and panels) and parallel break-out sessions (masterclass, workshop, deep-dive formats) in the unique Frontiers style.
The iconic Start-up Discovery sessions have also moved online opening more opportunities to connect with both earlier stage and more established digital health start-ups.
Highlights of day one include a welcome performance by musician Korinami, with visuals by designer Joe Ferrari.
Healthware Group CEO Roberto Ascione will open the conference with Frontiers Conferences CEO Matteo Penzo.
This will be followed by a keynote speech on digital health during Germany’s EU Council Presidency by Dr Gottfried Ludewig, director general digitalisation and innovation at the Federal Ministry of Health, Germany.
View the live coverage from day one at Frontiers Health 2020 from 14:00pm CET on 12 November below and we will also have live coverage from day two from 13 November (The live blog may take a moment to load.)
In the first episode of our Health Innovators series, Paul Tunnah speaks to David Van Sickle, CEO of Propeller Health about how digital technologies are revolutionising the field of respiratory medicine.
Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment.
With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare.
“We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation, Intouch Group, tells pharmaphorum. “We can put AI use cases in three buckets – healthcare and hospital systems, pharmaceutical companies and patient and caregivers.”
For healthcare systems, AI implementation will bring faster, more efficient diagnosis for medical imaging. Other promising benefits include administrative automation and population health risk analysis. AI technology may also aid in health crisis prediction and augmented reality, with AI implemented for medical education and surgical assistance.
For pharmaceutical companies, artificial intelligence can help spur drug discovery through finding complex relationships within genomics data. “Patients and caregivers will also benefit from real-time health monitoring, adherence support and patient self-service through intelligent bots,” says Rahman. “AI can play an important role to help support physicians though automation, predictive analytics and recommendation. In the US especially, doctors spend much of their time doing administrative tasks that can be automated to save time and reduce errors.
“We are already seeing pilots for treatment and diagnosis recommendations and automatic note taking through speech-to-text within EHR systems. AI based diagnostic image analysis is showing a lot of promise. In some cases, they are shown to be accurate and can find minute anomalies in images better than humans. These types of implementations will save time for the physicians and allow them to spend more quality time with the patients.”
Rahman says the primary challenges for artificial intelligence implementation occur in three key areas. The first is around data and technology. “Lack of interoperability across various healthcare systems is still an issue,” he explains. “It’s not always possible to access the data sources in an automated way. There is also legitimate concern with having the relevant opt-ins and waivers to ensure data is accessed and managed in a compliant manner. The quality of data can also be a concern.”
Bias in the data and lack of transparency can also show up during the AI training and deployment processes. “It is important to be careful about all the different ways bias in artificial intelligence can impact the outcome of the implementation. It is also important to show the reasons behind AI recommendations so that the physicians and patients can have a complete and transparent view.”
Organisational changes are also required as AI implementation often requires retraining and can change certain aspects of a job. “Change of any kind can generate some resistance. It is important to appropriately plan an AI implementation. Proper AI implementation requires people with the appropriate cross-domain knowledge. Cooperation across multiple teams is vital and not always easy to achieve.”
But as COVID-19 pushes every industry to use technology to solve challenges, pharmaceutical companies are being forced to change how they communicate with healthcare professionals and patients. New strategies around drug launches, use of telehealth, virtual patient events and virtual HCP conferences are all in place due to COVID-19 and Rahman believes the trend will continue.
“Pharma now more than ever before is ready to use AI to provide engagement, efficiency and customer support. The pandemic has also helped generate massive amounts of data from online events, blogs, forums etc,” he says.
“We are implementing AI based self-service and personalised solutions for both HCPs and patients. We have also seen computer vision-based AI technology become more popular to engage users. We are working on providing virtual bots within conferences so that HCPs can get the right information at their fingertips.”
About the author
Abid Rahman is the vice president of innovation, Intouch Group. He will be leading a virtual masterclass on Artificial Intelligence implementation at Frontiers Health on 12th November. The session will help educate on the benefits of using and implementing effective, reliable AI systems to tackle and solve healthcare challenges.
Abid has over 18 years of experience in software engineering and 15+ years in pharmaceutical marketing and technology. As an innovation leader, Abid’s primary role involves making technology relevant in healthcare by designing and collaborating on solutions for patients, caregivers and healthcare providers. His technology expertise is in architecture and design of enterprise solutions with emphasis on artificial intelligence.
When Chris Cooper of EPG Health launched his ‘European Prescriber Guide’ software twenty years ago, he was among a select few taking digital in pharma seriously. Since then he has seen the industry slowly come to embrace every aspect of digital. He tells pharmaphorum how pharma can learn from the past to enter an innovative future.
“I always knew pharma was notoriously slow to adopt change,” Cooper says when asked about the unexpected digital changes he has seen in the industry over his career, “but I never thought 20 years ago that change would take this long in digital!”
Luckily, he says, the industry has now got to a stage where it is starting to think beyond just clicks and impressions and is treating doctors as consumers of valuable and relevant information – and there has been no better time for pharma to harness this to make their content more impactful than ever.
This is a path Cooper has been on for some time, though, and he was somewhat ahead of the curve when, in 2000, he founded the European Prescriber Guide, which aimed to give up-to-date prescribing information to HCPs via a software application.
As part of our series looking at how pharma companies have adapted to the pandemic, Shannon Rush, leader of Eli Lilly & Co’s diabetes business unit in Northern Europe, tells pharmaphorum how the company is working to support diabetes care in the UK amid the pandemic.
As COVID-19 turned the world on its head, healthcare services for people living with long-term conditions like diabetes, came under a huge strain.
With the NHS advising that the virus could have a worse effect on people with diabetes, Eli Lilly & Co knew it needed to help physicians keep services running.
“From a business unit standpoint, the first thing we did was to connect with clinicians and ask how we could help,” Shannon Rush told pharmaphorum. “I needed to get a pulse of how we could add value.”
The company decided to develop a series of virtual webinars to support physicians with COVID-19. The first part focused on how healthcare systems could triage patients with diabetes and COVID-19.
“We looked at how will you need to assess them? How does it affect the medications they are on? What things would you do differently?” she said.
The next part tackled how to virtually assess patients and initiate different medications. “We really just flipped everything on its head. We had to adapt to what our customers need from us right now and that is helping them handle a co-morbidity illness during an acute healthcare crisis.”
Offering the webinars from across the organisation only two weeks after conceiving the idea was a proud moment, says Rush. “We are still offering it as obviously this is our new reality – we won’t be going back to the days of clinicians seeing as many people face-to-face.”
“I think the innovation of how we live, how we’re able to interact from a healthcare setting, I think it’s something that will live beyond COVID-19. For me, it is just the sheer impact of how we all adapted, not just the healthcare system, in general, to really respond”
While the pandemic accelerated plans, digital education is something Eli Lilly had always planned to do. Ensuring compliance across the company was also a challenge.
“That is our North Star, we want to make sure we’re doing things in a compliant way. Again, it was another cross-functional effort across our entire organisation to make sure that we were able to interact virtually in the right way,” says Rush.
“It seems like it’s common sense, but as we see, there are more challenges to it, sometimes, than not. We had a general upskilling, as well, in diabetes to helps advance the treatment during this, as well.”
Population health tools
Eli & Lilly diabetes also worked with the NHS, to create a population health management tool. The tool PARM (ProActive Register Management) Diabetes allows for clinical commissioning groups (CCGs) to stratify the risk and opportunities to treat specific populations and review analytics on different cohorts living with illnesses. The tool organises practice-level patient data to show how well patients are managing their condition, identify any potential issues as well as those who need critical or urgent attention, and can predict who may need input from a diabetes specialist in the future.
“That’s another way we’ve been able to help beyond the day-to-day patient care. The data stays within the CCG but it helps them to look at their organisation and the ones they serve.”
For Eli Lilly, it opens partnership opportunities for different resources that could help CCGs once their population needs are assessed. This support across the healthcare value is important for the company, Rush says.
“Obviously right now we do not have direct opportunities for direct patient feedback, but via clinicians the main thing we kept hearing is they wanted stability. Patients wanted the reassurance that even while COVID-19 was in this acute phase they could still manage their health effectively.”
PARM Diabetes aims to provide this stability. “For some there is comfort in knowing that, obviously, everybody was doing the right thing to manage COVID-19 but not forgetting there were opportunities for those living with diabetes and other illnesses to continue to manage as they would.”
Despite the severity and devastation of COVID-19, Rush believes there has been some “shining lights” coming out of it.
“I think the innovation of how we live, how we’re able to interact from a healthcare setting, I think it’s something that will live beyond COVID-19. For me, it is just the sheer impact of how we all adapted, not just the healthcare system, in general, to really respond.”
Digital therapeutics are gaining momentum worldwide and offer developers, including pharma, both a huge opportunity and a stimulating market access challenge, say Olaf Schoeman and Emanuele Arcà.
The last 12 months have shone a spotlight on digital transformation in Europe’s healthcare systems, with all the signs pointing to digital therapeutics (DTx) moving ever more into the healthcare mainstream.
Germany is spearheading these advances, particularly with its 2019 changes on national digital health reimbursement. The country will provide further momentum during its presidency of the Council of the European Union (EU), which runs from July until December 2020 and will see it work closely with the succeeding presidencies of Portugal and Slovenia. The countries have agreed a ‘trio programme’ to identify issues that would benefit from a fluid transition from one EU member state’s presidency to the next to form an 18-month agenda, with progress in digital health one of the highlights of their plans.
While we would not expect digital therapeutics to replace pharmaceuticals themselves, they could bring huge complementary benefits to patients and prescribers and, in doing so, could bring pharmaceutical companies perhaps as much value as the medicines they traditionally produce.
COVID-19 has sparked a flurry of research and discoveries are being made at an unprecedented rate – but patient participation cannot and should not be left behind in the rush, say leading voices.
SARS-CoV-2 has demonstrated both the strengths and the weaknesses of the life sciences ecosystem, and it is now up to the sector to learn and to lead.
While trials of COVID-19 vaccines and treatments have accelerated at a hitherto unimaginable rate, work in other conditions has been halted and paused, both of which could hinder future progress, said Aisling Burnand, chief executive of the Association of Medical Research Charities (AMRC).
“In a race of frantic, unprecedented change with challenges none of us have faced before, patient and public involvement has felt pushed aside.”
“Research has stopped, and what has gone ahead has felt rushed, with little listening,” she said during the first session of this year’s Pioneering Partnerships conference, organised by the Association of the British Pharmaceutical Industry (ABPI), the National Institute for Health Research (NIHR), and the AMRC.
As we turn the research tap back on, the sector must do everything it can ensure the patient voice gains rather than loses importance, said the speakers.
“One of the consequences of the system commissioning lots of urgent COVID-19 research was that, to a certain extent, patient and public involvement got bypassed. For various reasons it was too difficult or time consuming to do when everybody was in a frightful rush”
In April, 73% of clinical trials were stopped, and, as of early October, more than 40% were still on hold.
Aisling said we were “unlikely” to reach pre-COVID levels of non-SARS-CoV-2 clinical research before August 2021, even without the looming second wave. It means that without a cross-sector plan to get trials back up a running, a decade of research could be lost to the COVID-19 crisis.
Baroness Nicola Blackwood, Conservative MP and chair of Genomics England, agreed, and said that unlocking what we have learned from research during the pandemic so far would help move the NHS from a “sick care service to a healthcare service”.
“COVID-19 has transformed the way clinical trials are run. Our research ecosystem responded to the crisis with a pace and effectiveness that few other nations were able to match,” said Baroness Blackwood.
“UK researchers sourced streamlined regulatory processes, had better communication with patients and clinicians, and we saw some much more sensible approaches to risk. This sped up the development of new COVID treatments, without sacrificing safety.”
But the crisis also brought some of the system’s weaknesses into sharp focus, said NIHR director Jeremy Taylor.
“One of the consequences of the system commissioning lots of urgent COVID-19 research was that, to a certain extent, patient and public involvement got bypassed. For various reasons it was too difficult or time consuming to do when everybody was in a frightful rush,” he said.
“Patient and public involvement turned out to be less embedded than we thought, so I think COVID has been a bit of a shock to the system. It’s made us think that maybe we have been a little bit too complacent.”
The virus, which has disproportionally affected people from Black, Asian and minatory ethic (BAME) communities had also highlighted a lack of diverse voices, and the urgent need to address clinical trial representation and health inequalities, he said.
“We need more BAME voices around the table. We need younger people, and we need people from excluded communities.”
Regardless of what the health system is faced with, Dr Richard Torbett, chief executive of the ABPI, said that “we can’t ignore our collective responsibility to make sure we conduct ethical research”.
“We need to continue advocating the importance of having the patient voice right at the heart of everything that we do.”
Building on the positives
Aisling said we needed to build upon the positives, pointing to the increased public awareness around the process, language, and importance of clinical research.
More people have volunteered for trials than ever before and thousands are monitoring their health on a daily basis.
The sector must seize this opportunity to build back better and stronger, the speakers agreed.
Said Baroness Blackwood: “We need to look honestly at the areas where the crisis has brought sharp relief, and what needs to be improved.
“If we don’t take this chance, we risk losing what is a golden moment to make our clinical research landscape fit for the next generation.”
It was a sentiment echoed by Dr Torbett, who said the UK government needed to take “urgent action” to develop a sustainable, safe, restart plan for non-COVID clinical research.
“It is incredibly important to ensure all patients have the opportunity to be involved and engaged with research. That needs to be a principle that carries right the way through this,” he said.
“I really feel that we’ve got a head of steam right now with multiple stakeholders, particularly in this country, who really understand the value of medical research. We have a genuine opportunity to lead here.”
In response to the COVID-19 pandemic, the ABPI has published a summary of its advice to the pharmaceutical industry on working with patients and the public. Click here for more information.
It’s time for pharma to take a 360-degree view of its clinical trial data and step into the future with near real-time trial management.
The pharmaceutical industry faces an important inflection point in its approach to clinical trials and it’s one that COVID-19 has thrown into even sharper relief.
The last great change for studies was the advent in the early 2000s of electronic data capture (EDC). At the time there was a significant amount of resistance to EDC, but now it’s rare to hear about the collection of trial results using paper in all but the occasional single site investigator study.
Now, the major advance that’s available to pharmaceutical companies is in the amount and range of data they have access to and how it can be applied to the risk-based monitoring and remote monitoring of studies.
COVID-19 has been a shock to the system for every industry, not least pharma, but the sector is already looking at new ways to build resilience for the future.
Kevin Nikitczuk, INTIENT Network lead at Accenture, notes that collaboration and innovation are two of the key aspects that allow pharma to be ready for (hopefully unlikely) future situations akin to the pandemic.
“With COVID-19, the industry has realised that they need to accelerate and expedite everything they do – from identifying new targets to executing clinical studies to getting drugs onto the market.”
The sharing of knowledge has already been critical in the industry’s collaborative efforts to expedite a COVID-19 vaccine, and Nikitczuk believes that this open approach should extend beyond research into the software and data tools pharma uses every day.
A current problem, he notes, is that each of the many steps on this path requires different software tools – and most companies are using myriad different platforms within their organisation.
Part of this is an issue with unproductive competition – which can sometimes be a road blocker for innovation, particularly when proprietary technology is custom-built by niche players or developed in-house.
But it’s also true that over recent years – and especially during the course of the pandemic – the pace of technological growth in pharma has exploded, meaning there are more possible solutions available than ever, including more patient-facing technology such as telemedicine.
“We have some partners providing very similar tools to each other, and that’s okay, because we want to provide clients with options… I think that helps foster collaboration and encourages a little bit of healthy competition – which is always good for science”
This fragmented landscape creates issues for pharma.
“If, for example, regulations change or new standards for processing data come out, companies are going to face difficulties if they don’t have the proper infrastructure to quickly pivot out their software with new tools,” Nikitczuk says.
“Because of that, they may miss out on getting their products to patients in time.”
Nikitczuk believes that open, cross-company collaboration will be key to building flexibility and, ultimately, resilience against these difficulties.
Accenture, for example, decided to take its previously siloed platform products in areas as diverse as research, clinical studies and patient support and bring them under one umbrella.
The resulting INTIENT Platform brings together multiple third-party tools to allow continuity and flow of data across software and companies, whilst also facilitating insights delivered by artificial intelligence.
Rahul Kabra, INTIENT’s Europe lead, says he hopes the platform will streamline and accelerate collaboration across an entire product life cycle.
“We have partners providing patient facing capabilities in the form of medical devices or tools to enhance adherence. We also have partners providing the backend technology to secure personal data or manage workflows.
“Pharma and external partners can now use all these tools under one, end-to-end platform.”
In fact, Nikitczuk notes that clients themselves had a large role to play in pushing for a joined-up approach – showing that the spirit of collaboration in the industry is putting to rest any concerns that competition will continue to be a barrier.
“Our clients started pointing out that even though they were subscribed to several of our platforms, these tools weren’t talking to each other, and everything was still siloed.
“We took their advice and worked with them to bring these platforms together onto one end-to-end solution. Then we started working on bringing third-party vendors in. It’s been really great to see the collaborations blossom.”
To further this, Accenture is encouraging clients to develop their own software tools or bring their existing niche partners into the ecosystem and strengthen its capabilities.
It is also further encouraging open collaboration by keeping the platform solution-agnostic.
“We have some partners providing very similar tools to each other, and that’s okay, because some clients have a preference for certain vendors, and we want to be able to showcase that and provide clients with options.
“I think that helps foster collaboration and encourages a little bit of healthy competition – which is always good for science.”
Another reason for this approach is the fact that, traditionally, trying to get a software solution into a pharma company has been quite an endeavour.
“First you have to navigate procurement, which can be inhibitive for smaller start-ups. Even well-established firms struggle to get new products installed in large companies or even single departments which can be a time- and resource-intensive activity. We want to make this process incredibly fast.”
Nikitczuk adds that the more this partnership ecosystem and infrastructure is built up, the easier it will be to get future solutions onto the platform and into pharma companies.
Kabra adds that, as with pharma companies sharing knowledge to develop COVID-19 vaccines, he hopes that open collaborations like this in software will allow life science companies to take advantage of the collective intelligence of independent vendors who have poured all their time, energy, and passion into developing solutions – which, in turn, will enable the industry to push boundaries and accelerate innovation.
“By being more open, the industry can allow companies the flexibility to test and implement new, potentially game-changing technologies,” Kabra says.
“We might even see the days of laborious, expensive, and inefficient procurement and implementation processes become a thing of the past.”
This is part of the draw of true open collaboration – when different companies are aligned to the same goals, processes that once took months to do can be done in days, or even less.
“As the biopharma landscape grows and evolves, we must continue to uncover new insights and innovative uses for data,” says Kabra. “By doing so, we develop new opportunities to raise the standard and personalisation of patient care and accelerate treatments to market.”
Luckily, it seems that the industry is more than ready to be truly collaborative and drive this collective mission forward.
To learn more about how Accenture is bringing companies together, click here.
About the interviewees
Kevin Nikitczuk is a senior principal within Accenture’s Life Sciences, leading the network partnerships for the INTIENT platform. Kevin has an in-depth working knowledge of life science R&D after years of laboratory and corporate experience within the pharmaceutical, biotechnology, and medical devices fields. Kevin earned a PhD in Immuno-Oncology from Rutgers University and has published peer-reviewed articles on his work and holds several patents.
Rahul has over 25 years’ experience in technology strategy, innovation, global partnerships and solution development. He has previously held positions as a Strategy Lead for Accenture’s Products Group, and as the Ecosystem and Ventures Lead for Accenture Technology. Rahul holds a degree in Computing from City University London, and an MBA from Henley Business School.
Ahead of Frontiers Health 2020, steering committee members Roberto Ascione and Paul Tunnah from Healthware give us their thoughts on the trends driving the bright future of digital health.
It might be easy to think of pharma and healthcare as conservative industries, but the reality is that digital health is now far further along than we predicted it would have been 10 years ago – or even one year ago.
Much of this is, of course, down to COVID-19 – but it’s clear that digital health was already on the up and up long before the pandemic hit.
When the industry first started talking about digital health, we were really talking about ‘beyond the pill’ strategies, which mostly included things like apps to boost adherence and patient support programmes.
After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use.
The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the patient voice is “in the room” when pharma companies make decisions.
“My journey is a bit complicated, because I am a three-time cancer survivor,” said Robert, 60, who lives just outside of Philadelphia in the United States.
“First, it was testicular cancer, back in 1991, then I was diagnosed with liposarcoma in 2010, and pancreatic cancer in 2014.”
His first two cancers were discovered early, and, while he did experience treatment side effects, things were “manageable”, he said.
“My broad ambition is to get medicines and medical solutions that are more accessible, more affordable, and available in a more timely, more patient friendly way.”
“I don’t want to minimise cancer in any way, shape or form, but the testicular cancer was caught early, and the treatment success rate was well over 90%. It was more of an inconvenience. It was like entering a tunnel, but you could already see the light at the end.
“The liposarcoma was a little but different, but it was still caught pretty early and there was a high survival rate. Neither of the cancers significantly disrupted work.”
The pancreatic cancer, however, was a “completely different ball game”.
“At that time, the five-year survival rate was in the order of 7%. So, when I entered that tunnel, it was pretty dark.”
Robert decided to enrol on a clinical trial of chemotherapy plus high dose vitamin D at the University of Pennsylvania. Afterwards, he had to fight for the proton beam radiation therapy his doctor recommended as his insurance company considered it to be experimental.
“I was told my policy didn’t cover it. Even though my entire medical team was saying ‘we can’t do normal radiation because it’s too much exposure and his system as a whole won’t be able to handle it’.
“I am not a passive patient, so I kept calling and calling and finally they said there was a review panel,” said Robert, adding that he was shocked to find the panel did not include a radiation oncologist. “Even the voice of my doctor, who is probably one of the top three in his field worldwide, was being totally muted.”
After a number of reviews and appeals and countless phone calls, the treatment was finally approved but it had taken six weeks and many headaches.
Being in the room
His experiences have made him realise the importance of the patient voice being front and centre of healthcare decisions.
“I want to be in the room where it happens, where the decisions are made, so that it’s not just me, a passive patient sitting in the chemo suite,” he said.
“That means working with pharma companies to influence early decisions around R&D, and providing patient insights throughout the process.”
We also need to think about how other stakeholders – insurance companies, doctors, and hospitals, for example – fit into that, said Robert.
“My broad ambition is to get medicines and medical solutions that are more accessible, more affordable, and available in a more timely, more patient friendly way.”
Explaining why patients were an essential part of that mission, he said: “Everyone is driven by different goals and different stakeholders will have different drivers of what’s important.”
Robert, who works with several pharma companies on a variety of projects, believes that the industry is going in the right direction, but that there is still some way to go.
He described three levels of patient engagement, saying most organisations were currently “between one and two”.
“The first one is engaging the patient. That might call a patient or group of patients in to review a consent form or a trial protocol. They will ask them if it seems reasonable, feasible, or overly burdensome, then take those comments and say: ‘see you later’.”
The second level is more like a patient partnership, he said, using his position as member of one company’s Oncology Patient Council as an example.
“We meet once a month throughout the development cycle to provide feedback. We engage with them on challenges they might be facing, or on specific topics such as patient diversity. It’s a continuous process – a feedback loop – not a one-off interaction,” said Robert.
The next step is true patient centricity, which Robert described as “putting the patient at the centre of the wheel”.
“What that looks like in practice is ongoing involvement and engagement with the patient throughout,” he said, adding that it included making sure interventions were as easy to access geographically, logistically, and physically, as possible.
“It all goes back to this idea of being in the room. Of course, not all patients can be there, but if I can share the insights I have gained from my own journey, under the caveat that all patients are different, then at least they have heard what I have to say,” Robert concluded.
Patient Insights is a monthly series that appears in partnership with Inspire, a company with an online support community of more than 2 million patients and caregivers worldwide.
Ring Chromosome 20 Syndrome, or (R)20, is an ultra-rare form of epilepsy with a devastating impact – yet despite huge leaps forward in gene sequencing in recent years, diagnoses are going down instead of up. We spoke to Allison Watson, co-founder of Ring 20 Research and Support, about raising awareness, building the evidence base, and the importance of helping people through a pandemic despite limited funding.
Allison’s son David was just six when he started displaying the symptoms of (R)20, a genetic condition that can cause multiple, uncontrollable seizures, declines in cognition and mobility, and terrifying hallucinations.
As with many cases of (R)20, often called ring 20, David’s seizures appeared to come out of the blue.
“Unlike with many similar conditions, a child will develop normally until the seizures start to kick in,” said Allison.
“The child will often go backwards and lose abilities that they previously had. They may lose the ability to process properly or to speak. They might lose mobility and need a wheelchair. Others need help feeding.”
Ring 20 is a chromosome anomaly. Instead of being a pair that looks like two sticks, one or both arms of the 20th chromosome are joined at the ends, making them look like a ring under the microscope.
“A lack of awareness of the condition, which is known to affect at least 150 people worldwide, contributes to a diagnostic delay, said Allison, adding that children often experienced nocturnal, hallucinogenic seizures that healthcare professionals were simply not familiar with.”
The resulting seizures vary – in length, type, and severity – from person to person, but even mild forms of the disease have a huge impact on quality of life.
Typically, people have impaired awareness seizures that can last anywhere between 20 and 40 minutes. For some, this can go on for days, leaving them in hospital or even in an induced coma.
“My son, who is now 23, will have four to six non-convulsive events every day – that’s just normal.
“It’s like the lights are on but no one is home, so you have to be really careful. They could be doing something like cooking or having a bath. It really impedes their independence,” said Allison.
Non-existent treatments and diagnostic challenges
Despite the huge unmet need, ring 20 diagnosis is slow, and treatments are practically non-existent.
“Ring 20 doesn’t respond to any treatments: nothing seems to work. There are no clinical practice guidelines, meaning doctors treat on a case-by-case basis. They are effectively working blind,” said Allison, who co-founded the charity in 2014.
“Families just have to learn to live with these regular seizures and the associated comorbidities.”
A lack of awareness of the condition, which is known to affect at least 150 people worldwide, contributes to a diagnostic delay, said Allison, adding that children often experienced nocturnal, hallucinogenic seizures that healthcare professionals were simply not familiar with.
“A child may appear to awake from sleep. They may shake or shout out and can have a stiffness in their bodies or their arms. They may have a frightened expression on their face, and some describe horrific events. They see sharks swimming around their head, or fire in the room, or big black holes jumping up in front of them.
“This is often misdiagnosed and disregarded as night terrors, so this obviously denies diagnosis.”
Another, apparently contradictory, point is that the number of ring 20 diagnoses have actually declined with advances in genome sequencing, which cannot detect the presence of ring chromosomes.
Allison explained: “Human genome sequencing, exome sequencing, and even CGH array all look for additions, duplications, or something missing from the DNA. But in the majority of ring 20 cases, there is no misspelling in the chromosome.
“The way to diagnose it is to go back to the old-fashioned carrier type, to physically look at the cells under a microscope to see the rings.”
Additionally, doctors looking for a chromosome abnormality would typically send 30 cells for analysis. But the misshaped chromosomes that characterise ring 20 are only present in a certain proportion of the person’s cells.
Said Allison: “They need to be sending about 100 cells for analysis, otherwise they could miss the ring.
“We suspect that this particular disease is very underdiagnosed in people with genetic epilepsies or an undiagnosed cause for epilepsy, and we also suspect that people that do have a diagnosis may be potentially misdiagnosed.”
Raising awareness, offering support
That’s why Allison is so keen to build the evidence base and raise awareness of the condition.
As co-chair for EpiCARE, the European Reference Network for rare and complex epilepsies, she is working on projects ranging from a patient pathway map to e-learning modules for healthcare professionals.
And members of Ring 20 Research and Support have raised enough money to embark on a two-year natural history and biomarker study, as well as establish a patient registry.
“This is a fundamental building block to future research opportunities so we’re very proud of our families for getting us to this point,” she said, adding that the registry “would have been up and running by now if it wasn’t for COVID”.
The pandemic caused both a surge in demand and a drop-in financial support – a problem that has been seen across the patient support sector.
But with it being more important than ever to ensure people with ring 20 and their families get the support they need, so COVID or no-COVID, Allison and her team have no intention of scaling back their plans. In fact, they have even extended their offering to include online peer networking.
“Because our families are so disparately located, some may never get to meet another family with ring 20 at all. So, we have been having fortnightly Zoom calls. We’re connecting families from the US and Australia, the UK and Europe, even South Africa,” said Allison.
“We’re based in the UK, but we support families worldwide. We’re the only organization doing this,” said Allison.
Exploring Rare Diseases is produced in partnership with Cambridge Rare Disease Network (CRDN). CRDN is building a vibrant network of patients and stakeholders to share knowledge and foster innovation that leads to better diagnosis, treatment and support for those living with a rare disease
The pharmaceutical industry has sometimes been a laggard in terms of digital maturity, but the COVID-19 crisis has provided companies the impetus to rapidly implement the most cutting-edge technologies. At the heart of most of these digital advancements is AI and machine learning.
With a collective sense of uncertainty, many are pinning their hopes on a vaccine and treatment, and sophisticated technology could help speed up the process of finding an effective medicine.
In January, Google DeepMind debuted AlphaFold, a deep-learning system that predicts the structure of several under-studied proteins, including those associated with COVID-19. Predicting protein structures would typically be a time-consuming process, but now scientists can use technology to better analyse viruses, thus helping in the search for a vaccine that can trigger an immune response.
Scientists are using AI to sift through existing literature on a disease and study its disease’s structure. This knowledge is critical in understanding how effective certain drugs might be in treating the virus. It has helped determine the availability of current drugs on the market that could be repurposed to treat COVID-19.
AI is also being used to track the spread of diseases and detect anomalies. Canadian artificial intelligence platform BlueDot was able to detect a cluster of unusual pneumonia cases in Wuhan before the world even knew about COVID-19. In countries like China, AI is integrated with track and trace mobile apps to aggregate and analyse data on the spread of the virus.
“A recent study by Kearney revealed 68% of global industry leaders in the healthcare sector see AI and advanced analytics as major value drivers, indicating most companies are aware of their combined potential”
COVID-19 may have led to an uptick in companies using AI to clear the path for breakthroughs, but firms have already been adopting these sophisticated technologies across all areas of healthcare.
A recent study by Kearney revealed that 68% of global industry leaders in the healthcare sector see AI and advanced analytics as major value drivers, indicating most companies are aware of their combined potential.
One example is Novartis. With the combined efforts of CDO Bertrand Bodson, head of drug development John Tsai and key members of the team like Bruno Villetelle, the drug manufacturer has amassed a database of a decade’s worth of clinical trials, forming the core of an AI-powered central command centre. Scientists and technicians at Novartis have been able to analyse all its global clinical trials to predict trial schedules and quality outcomes across the organisation.
The company has also employed AI to facilitate its drug development process, compiling 20 years of data from 2 million patients and using this information to design pioneering new drugs.
Critically, they are not doing it alone but reaching out into the tech ecosystem through their innovation centre in Silicon Valley, which partners with AI and machine learning start-ups in biopharma. The case of Novartis demonstrates how important it is for companies to adapt their working methods and invest shrewdly to successfully implement an AI transformation.
Similarly, the medical device company Medtronic has created alliances with both tech giants and promising start-ups to develop innovative AI-supported products. The medtech giant recently acquired technology from Nutrino, a nutrition insights platform with a predictive glycemic response algorithm. They have partnered with IBM Watson to create a glucose monitoring tool that predicts whether a patient with diabetes will have low glucose within a one-to four-hour period.
Disease management tools are likely to witness a proliferation of valuable applications in the aftermath of the coronavirus pandemic as the long-term impacts of the virus are still poorly understood.
Another negative side effect of the pandemic has been a wholesale delay and sometimes suspension of treatment for people with chronic conditions. This will create a backlog requiring urgent attention as the pandemic recedes. AI tools will be critical to managing this backlog effectively, and companies will likely need to implement these technologies to rejuvenate their business methods.
The barriers to adoption
AI is incredibly useful but has limitations. These drawbacks have caused resistance to its adoption by some companies and healthcare providers. First and foremost, data is not infallible and bias within data sets can lead to biases being inherently built into algorithms.
Privacy and cybersecurity risks are also at the forefront of chief data officers’ minds, as well as the significant infrastructure investment required to integrate data sets and create data lakes that the organisation can tap into for research and commercial insights.
Despite these concerns, artificial intelligence might be the productivity multiplier that the pharmaceutical company needs more than ever right now.
What’s on the horizon?
There are exciting developments happening for AI in healthcare – from drug discovery to diagnostics and care delivery. As well as ongoing patient monitoring.
In areas like pain management, we are now on the brink of being able to blend artificial intelligence and virtual reality to create simulations that cocoon patients from their pain or the pangs of withdrawal. This might help with the dependence that many patients experience on powerful painkillers.
Companies like Helpsy are also developing chatbots to help with patient care. These chatbots can nurse and triage patients. In the future we could see virtual nursing assistants become commonplace to support care.
We are also likely to see surgeries conducted with robotic assistance. AI-assisted robotics can analyse previous surgical data to guide the surgeon’s hands. Research found an AI-assisted robotic technique created by Mazor Robotics demonstrated a five-fold decrease in surgical complications compared with surgeons operating unaided.
The pharmaceutical industry has been scrutinised in recent years over R&D productivity, pricing and obsolete engagement models, and AI and machine learning could be the game changing technology that transforms the sector.
With COVID-19 dominating people’s concerns, more sophisticated tech could lead us towards a vaccine or cure. What is more, with delays for other illnesses being neglected, the industry will have to be capable at dealing with a backlog of patients. AI might just be the key to achieving a successful resolution.
About the author
Paula Bellostas Muguerza is a principal at Kearney.
Most of the digital health experts we spoke to for this issue of Deep Dive made one thing clear – no one can really say what the future holds for digital tech in the pharma and healthcare industries.
But this isn’t necessarily a bad thing – our interviewees also stressed that if companies can remain adaptable and innovative, there are myriad opportunities to thrive during and after COVID-19. In this issue we hone in on some of the tech that is set to change healthcare forever – including VR, AI and digital therapeutics – and look at how pharma can best harness themWe also examine how the pandemic is affecting digital sales, patient support programmes and HCP consultations, and speak to some exciting digital start-ups that are bringing new ways of managing health into systems like the NHS.
A “pivotal moment” for digital health adoption
Former chief digital officer for the NHS, Juliet Bauer, is now applying her experience to the private sector through video consultation firm Livi. She shares her thoughts on how well the NHS is integrating digital health and what the public and private sectors can do to further boost adoption
Navigating the NHS as a digital start-up
We speak to finalists from the Greater Manchester Future of Health accelerator to find out how digital start-ups can overcome the challenges small companies face in bringing their technologies into the NHS
pharmaphorum’s digital magazine Deep Dive provides objective, issue-driven views, analysis, high-level interviews and unique research for pharmaceutical companies, biotech firms and the wider healthcare sector.
In 2020 Deep Dive will have special focuses on disruptive technologies in pharma, R&D innovation, market access and commercialisation, oncology, sales & marketing innovation, digital health and patient engagement. Subscribe to future issues of Deep Dive.
GlaxoSmithKline’s Nucala (mepolizumab) last month became the first and only biologic treatment approved in the US for Hypereosinophilic Syndrome (HES).
It’s part of the company’s focus on eosinophil-driven diseases, and ahead of that regulatory milestone I spoke with Tiffany Robinson-Smith, global medical affairs lead for biologics at GSK, about eosinophils and why they’re an important element of her company’s research programmes.
We also spoke in this episode of the podcast about some of the research challenges GSK faces with eosinophils and where they fit into the pharma company’s current product portfolio.
Since entering the pharmaceutical industry as a graduate trainee in the late 1990s, Asad Mohsin Ali’s career has taken him across the business from Novartis, MSD and Tesaro, before joining global biopharma Ipsen. He tells us how the company has responded to COVID and how he’d like to see the UK industry grow in the future.
As managing director, Ipsen UK & Ireland, Ali heads up one of Ipsen’s three global hubs, as well as chairing a UK & Ireland Site Steering Committee overseeing 900 people.
“My primary goal on joining Ipsen UK&I was to incorporate and elevate the talents of our Specialty Care organisation, but also the 900 colleagues in the UK and Ireland, to ensure we bring maximum value to patients and healthcare systems,” Ali tells pharmaphorum.
Ipsen UK&I’s culture is based on the principle, “One Ipsen” he says.
“Being “One Ipsen” means acting together on what matters most to our patients, customers and our employees.”
As COVID-19 disrupted the world, the pharmaceutical industry was urged to respond quickly – primarily by ensuring continuity of medicines for patients.
“The level of response required by industry, the impact to business and the duration of the crisis have surpassed the extent of a lot of business contingency plans,” Ali says. “Government responses and restrictions put in place to contain COVID-19 have changed over time. So, businesses like Ipsen UK&I have had to stay agile, adapt and re-group to deal with the changes, whilst ensuring a strong crisis management team is in place, and the right subject matter experts advising on our approach.”
“Changes in treatment patterns and patient journeys – companies need to understand how some of the changes will be long-term; not just about how patients can be safely re-introduced to the healthcare system, remote consultation and treatment will be more widely used.”
Ipsen UK&I recognised early on there would be no “one size fits all” way of working, says Ali. “For our manufacturing site in Wrexham, which is classified as critical workers, not much has changed except for the need to have less people on site with more PPE. But for our field-based team, the transition to fully home-based working with limited external interactions it has been a complete change that required a lot more adaptation.”
The company also focused on providing wellbeing resources to employees such as virtual yoga, an online wellbeing hub, a network of Mental Health and Wellbeing Ambassadors and an Employee Assistance Programme.
“We implemented a COVID-19 volunteering policy, which enabled our employees to go back into the NHS or carry out volunteer work for local community groups for one day per week fully paid,” Ali says.
With COVID-19 anticipated to change how pharmaceutical companies engage with healthcare professionals, Ipsen UK&I is preparing for a more remote and virtual healthcare system. Prior to the pandemic, 95% of all the company’s UK customer facing teams’ interactions took place in person at NHS hospitals.
“Overnight this became unfeasible so we invested a significant amount of time on how we could optimise remote interactions. This took many forms, from instant messaging to full video-based interactions with interactive e-materials. We have learned that the way our customers interact with their patients has shifted significantly and maybe permanently, so this in turn will drive how they want to interact with us.”
Indeed, more virtual patient engagement across the board means that services and products allowing remote engagement will thrive.
“Changes in treatment patterns and patient journeys – companies need to understand how some of the changes will be long-term; not just about how patients can be safely re-introduced to the healthcare system, remote consultation and treatment will be more widely used.”
The pharmaceutical industry can also expect to face challenges with innovation and funding, Ali says.
“While the pressure on healthcare systems is at an all-time high, industry innovation is keeping apace, with industry pipelines indicating over 7,000 medicines are currently in development. Products launched by companies will enter a very different launch environment in the mid-term. This will impact on all aspects of launch preparation.
“For HCPs, innovations or technologies that reduce the number of patients that come into hospital for treatment are key; and for patients, innovations (remote consultation, self-care devices or therapies) that empower them to manage their treatment independently are just as important.”
UK industry potential
The UK represents 3% of the global pharmaceutical business, but Ali believes its importance is underplayed.
“With some of the best talent, academic institutions, scientific infrastructure and of course the one-of-a-kind NHS, the UK could play an even greater leadership role than it does currently. Given the UK is home to a large proportion of biotech start-ups across Europe, it has great potential to lead the way in innovation and medicine development with the right investment and recognition.
“What I’d like to see is a clear recognition of what value the pharma industry brings to the UK economy and an understanding of the very high standards we operate with. Without this our public reputation will continue to be mediocre as it has been for the last few decades.”
For Ipsen UK&I it will be focusing efforts on several underserved disease areas across Oncology, Neuroscience and Rare Disease.
“My ambition is to unlock this potential and lead the way in adding value in these areas to our customers and their patients,”Ali says.
About the interviewee
Asad Mohsin Ali joined Ipsen in September 2018 as managing director, UK & Ireland, bringing more than 20 years of experience in the pharmaceutical industry. Since entering the industry as a graduate trainee in the late 1990s Asad has worked in big pharma (with Novartis and MSD) and biotech (with Tesaro), and now mid-sized biopharma with Ipsen UK&I. Over 22 years he has held a range of positions – in sales, marketing, portfolio management, strategy, value and access, and latterly in general management
With exclusive data from Freedom of Information (FOI) requests sent to the National Institute for Health and are Excellence (NICE), Leela Barham takes a look at the trend in early engagement with the UK’s HTA body.
In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early scientific advice, at a cost. The fees range from £20,000 to £75,000 per project. They are based on cost-recovery.
The idea behind this service is help companies understand the agency’s point of view on evidence; the gaps and how to fill them before the appraisal. Ultimately the idea is to help companies achieve patient access.
The NICE scientific advice service includes a standard approach (taking around 18 weeks) and an express scientific advice service (taking around 12 weeks). The standard approach offers the most in-depth option. Companies ask questions through the service, often on:
Clinical trials, design and analysis
Quality of life data
Economic analyses (modelling, extrapolation, resource use and costs)
The service is popular; over the eleven years it’s been used on average almost 18 times each year although take-up has varied over time (see figure 1).
“Getting advice with NICE as part of the dialogue with others has proven to be more popular than talking to the agency alone. It’s not clear how far advice from NICE alone is a substitute for getting advice as part of a bigger conversation”
Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20
Source: Data from NICE FOI responses. Note the light service has been incorporated into the standard service. Light was previously aimed at small and medium sized enterprises.
Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA). OMA can offer a safe harbour for discussions with NICE, NHS commissioners and other stakeholders. This has proven popular too and has seen a steady increase in safe harbour meetings held over time (figure 2).
Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20
Source: Data from NICE FOI responses.
By 2017, NICE added the Preliminary Independent Model Advice (PRIMA) service. PRIMA is a way to get the agency to check health economic models, taking either 12 weeks for the standard service, or eight weeks for an express service. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE.
There are good reasons to want to engage PRIMA. Researchers analysed single technology appraisals completed in 2017 by NICE, looking specifically at technical errors and validation processes reported on the economic models submitted by companies. Only two STAs (5%) had no reported errors. Four STAs had more than ten errors (10%). That prompted Jeanette Kusel, director at NICE Scientific Advice, to highlight on LinkedIn the importance of the PRIMA service for checking models prior to submission.
Engaging with NICE, regulators and other HTA agencies
There are also other services that NICE can be part of in providing early advice. The agency has been a popular choice as part of the EUnetHTA early dialogue offer and has also been one of the HTA agencies taking part in EMA-multi-HTA early dialogues. With Brexit though, NICE has set up a concurrent scientific advice service for when companies want advice from EMA and the UK body at the same time. The latest option is with NICE and the Canadian Agency for Drugs and Technology in Health (CADTH) together. The NICE-CADTH service was launched in 2019. It’s not had long enough to really get a track record, even more so when COVID-19 saw CADTH temporarily suspend the service.
Getting advice with NICE as part of the dialogue with others has proven to be more popular than talking to the agency alone (see figure 3). It’s not clear how far advice from NICE alone is a substitute for getting advice as part of a bigger conversation with others. It’s likely though that hearing from NICE on their own will give a depth of advice that might not be possible in the limits of a meeting held with several other voices in the conversation.
Figure 3:NICE early scientific advice projects alone and with others, 2009/10 to 2019/20
Source: Data from NICE FOI responses. Note: EMA-HTA includes NICE concurrent services delivered in parallel to EMA-multi-HTA dialogue.
What is the impact?
It is clear that the services to secure NICE advice are popular. The agency has a few testimonials on their website to support that. For example, for their scientific advice service, it quotes from a project feedback questionnaire:
“I truly value this Scientific Advice service… It creates fantastic opportunities for global drug development teams to better understand reimbursement hurdles and evidence requirements for timely market access. Great job!”
For PRIMA, the agency quotes Peter Wheatley-Price, market access and pricing director at Takeda UK, who said: “The Takeda team highly regarded the quality of the PRIMA reports and model review documentation. We appreciated the PRIMA team’s engaging and flexible approach at this pivotal stage in development and look forward to using the service as part of our model development efforts going forward.”
Yet it’s hard to know what difference they are making in terms of evidence strategies –what evidence will now be generated, and importantly for efficiency, what evidence won’t be generated because it won’t be valuable to the agency and payers in the UK – and ultimately, NICE recommendations. The services aren’t staffed by those who make the decisions later and it isn’t clear if Appraisal Committee members know if a company has sought advice, what that advice was, and whether it was acted upon by the company. There is a question over pull, through.
NICE has, so far, kept the details of which companies and which products have sought advice close to their chest. The various services offered are confidential and aren’t legally binding on both sides. Yet that doesn’t seem to explain why they can’t routinely release statistics about take-up of their services – it would be a real indicator of value if companies go back repeatedly for different products across their portfolios – nor why they can’t release details in the final guidance on whether advice was sought.
EMA does put into the public domain if a company has sought scientific advice and when. EMA keeps the details of the discussion out of the public domain. There is clear evidence that EMA scientific advice improves the chances of marketing authorisation.
Whilst companies who have sought advice from NICE will know the difference it has made or not, those companies who have yet to engage with the agency could be more likely to, if they know it can make a difference.
About the author
Leela Barham is researcher and writer who has worked with all stakeholders across the health care system, both in the UK and internationally, on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).
Claus Møldrup explores research showing that patients want their voice to be heard more by pharma, and asks what a truly effective feedback loop for medicines might look like.
The democratisation of data opens up improvements to virtually every product and service across virtually every sector — bar one. Pharma remains stubbornly closed to feedback, with potentially damaging consequences for the industry, healthcare systems and patients.
The most obvious iteration of democratisation is the rise of online experience sharing platforms. From highly specific sites such as Trip Advisor to all-encompassing platforms such as Trustpilot, the modern consumer’s voice carries weight. While negative reviews can sink a business, forward-thinking organisations see this accountability as a driver for continuous improvement.
The omission of medicines from the feedback revolution is curious and potentially damaging. Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. Identifying, recruiting, retaining and monitoring patients during this part of the cycle is estimated to cost pharma US$19 billion a year as companies seek to harvest patient experiences.
Once a drug is licensed and launched, however, there is a deafening silence. Millions of patients are prescribed often complex drugs and are expected to follow equally complicated regimens. While clinical outcomes are of course monitored through healthcare systems, the patient’s experiences, such as the reality of their drug administration and day-to-day effects, are ignored by the very companies that developed — and continue to develop — them.
“As most other sectors have long recognised, if a business isn’t taking part in the conversation then others will fill the void to tell their story instead. That narrative, for many patients, is that pharma companies just don’t care”
Pharma is swimming against the tide and can’t pretend that the democratisation of medicines data doesn’t exist — because it’s already here. As most other sectors have long recognised, if a business isn’t taking part in the conversation then others will fill the void to tell their story instead. It means pharma has lost control of its own narrative – and that narrative, for many patients, is that pharma companies just don’t care.
Research supports this conclusion, showing an alarming lack of patient trust. A 2020 survey from DrugsDisclosed.com of 3,346 users of prescription and over the counter (OTC) medicines from the UK and the Nordics revealed that:
more than three-quarters of patients do not trust advice from pharmaceutical companies about their medication;
81% feel the pharmaceutical industry influences prescription decisions; and
72% do not feel listened to by pharmaceutical companies.
These are startling statistics, and this overwhelmingly negative perception must be of concern. Pharma is an industry that should have a hugely positive story to tell as it develops the medicines and treatments that bring benefits to billions of people around the world. Yet it is widely mistrusted.
If pharma companies listened more, they would hear that the users of their medicines often feel confused and alone. In direct opposition to the emerging era of personalised healthcare, medicine information leaflets are one-size-fits-all documents that fail to reflect a patient’s individual circumstances and experiences, and are obligated to list every possible side-effect (which can make them virtually meaningless). In addition, patients have no opportunity whatsoever to feed back or pose questions to the company or — as critically — other users.
As one Crohn’s Disease patient describes in a DrugsDisclosed user case study, “It can be difficult getting useful and reliable information on your medication, and leaflets that come with them can be scary. They have to list all of the possible side effects, even the rarest. It is reassuring to read about other people’s real-life experience… It is important because it is by the people that actually take the medications. It makes me feel less alone.”
Shared experience — the power to improve
There is a better way. Healthcare (as distinct from pharma) has evolved with society and its technologies. Go back just a few decades and patients were passive bystanders to their own healthcare. Medicine took a patrician approach: it knew best and patients should lie still whilst they were poked, prodded and prescribed until they (hopefully) got better. This has changed — and changed for good.
Many healthcare systems are well advanced in listening to patients. In the UK, for example, every NHS hospital has a ‘patient panel’ made up of service users. These panels provide real-time feedback on experiences, from food to hygiene to clinical care, and members often sit on the main hospital Board to ensure that actions are informed by patient insight. This isn’t a PR exercise — it improves hospital environments, focuses decision-making and ultimately benefits clinical outcomes.
We are now seeing this evolve further as a new and distinct discipline emerges, known as Public Engagement (PE). PE isn’t traditional ‘communications’ where organisations talk to try and change patient behaviours, rather it’s about listening to patients to change corporate behaviours.
This evolution is particularly prevalent in emerging medicines, with organisations such as Genomics England and The Wellcome Trust supported by Understanding Patient Data recognising the huge and largely untapped value of patient experience — and that the success of new forms of medicine depends on public understanding, acceptance and consented participation.
The way back
Some of these issues fall out of well-intentioned codes and regulations to protect patients, but this can no longer be cited as an excuse for pharma’s continuing lack of engagement with its ultimate end users.
Technologies — specifically a sophisticated form of ‘Trustpilot for medicines’ — exist to bridge the gap between pharma and patients responsibly. Using this kind of technology will see significant improvements to healthcare generally and medicines specifically.
Research again backs up this conclusion, with a study that reviewed patients who had used an anonymised — regulatory compliant — medicines feedback app. After two months:
79% experienced an improvement in remembering to take their medications;
three quarters experienced an improvement in taking their medications as prescribed;
close to half felt they better understood their medications;
69% felt more motivated to take their medications; while
more than a third felt the effect of their medication actually improved.
In calling for further research, another study concluded that use of these apps improved clinically relevant indicators of adherence and impact and benefits were related to level of app usage.
Asking patients how they feel about medications can also benefit wider healthcare systems. In the UK, for example, more than half the public expressed an unwillingness to take a vaccine unless it had been tested for at least a year. Further, close to three quarters would be unwilling to allow their children to receive such a vaccine. This is priceless public insight during a pandemic as pharma races to find a COVID-19 vaccine — allowing the industry to better support governments as they prepare populations should a vaccine become available.
Beyond improvements to patient well-being, health outcomes and pandemic response, listening to patients can also improve pharma’s business operations. Understanding, for example, the factors that heighten the risk of poor adherence to medication regimens can lead to solutions designed to mitigate them — and reduce patient drop out. Further, with insight direct from users, pharma companies can optimise their Patient Support Programmes and patient support materials, while they also have access to a continuous, near real-time market research resource made up of hundreds of thousands of highly engaged patients willing to share experiences.
From bad medicine to good
The democratisation of data is here, and it’s here to stay. Pharma’s longstanding reluctance to join the conversation simply isn’t sustainable. The choice is whether the industry engages quickly and willingly or continues to resist and is dragged into the 21st century under duress. The former will go a long way to restore patient trust, while the latter will further undermine it.
Pharma needs to capture deep patient insight into its medications, which it can apply from product development to marketing to patient support. At the same time, this will allow users to feel empowered in helping to shape a medicine environment that reflects, recognises and responds to their daily experiences.
The tragedy is that a continuing failure to join the conversation hurts pharma companies, health systems and millions of medicines users around the world. Now is the time for pharma to join the feedback revolution and turn bad medicine to good.
About the author
Claus Møldrup is co-founder of DrugsDisclosed.com and CEO of DrugStars.
Analysing real-world health data could help overcome the bias towards men in traditional medical research, says Sensyne Health’s Dr Lucy Mackillop.
Collecting and analysing anonymised patient data has the potential to generate valuable insights that can catalyse research, lead to improved patient care, and power the development of new treatments.
Being able to analyse large data sets can provide a better understanding of how some patients will respond to a treatment or predict who may develop a disease based on data collected during clinical care.
Medical research has often focused on men, meaning that the insights gained have not always been reflective of how women would react to a treatment or disease. Women are likely to have different symptoms to men for the same illness and do not necessarily have the same reactions to certain drugs or respond to the same doses as a male counterpart.
Therefore, it is important to increase the collection and analysis of women’s health data so better insights can be gained for supporting their care.
“The effect of failing to include women proportionately in clinical trials may have consequences for the quality of medical care women receive, with therapies, doses and risk assessment tools being tailored to the male population”
The impact of underrepresenting women
Research from the Allen Institute for Artificial Intelligence found that over the past 25 years, although women have made up nearly half (49%) of participants across drug trials, for many types of disease the proportion of female participants did not match the gender breakdown of real-world patients. In trials for cardiovascular, HIV, kidney disease and digestive diseases, women have especially been underrepresented.
The effect of failing to include women proportionately in clinical trials may have consequences for the quality of medical care women receive, with therapies, doses and risk assessment tools being tailored to the male population. The use of real-world medical data from women may change this – and more broadly, ensure that representative samples of data are used for the disease or issue.
What we can learn during pregnancy
As well as collecting more representative samples of data from women for conditions like cardiovascular disease, accurate data collected during pregnancy could offer a valuable information.
This is because typically, ‘real-world’ medical data is collected from patients who are ill. However, pregnancy is a unique time when large quantities of data are collected in otherwise ‘healthy’ women.
Pregnancy can also act as a cardiometabolic stress test for women and reveal underlying susceptibilities to conditions such as diabetes or hypertension.
Therefore, by analysing the data collected during a woman’s pregnancy, clinicians can view a window into future health risks and understand who is most at risk. This helps develop better preventative strategies and also prioritises care.
Research has found that the environment in which a baby grows has a significant impact on its health throughout its life. This means that being able to improve the way we care for pregnant women through collecting and analysing data can also significantly influence the health of their offspring.
While collecting data from patients is important in development of new treatments, clinical research, and patient care, there must be a greater focus on ensuring that women are well represented in trials.
For pregnant women in particular, the information that their medical records can offer must be recognised, and databases that can be used to support the improvement of care and outcomes has the potential to provide important insights.
About the author
Dr Lucy Mackillop is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust; honorary senior clinical lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford; and chief medical officer at Sensyne Health.
Preventive care programmes are key to better health outcomes, but several factors are limiting their uptake. A new analysis looks at these barriers and asks how they could be overcome.
Over the past decade, many healthcare systems have worked to expand their focus on health maintenance and disease prevention as several studies have indicated that preventive care services can play a significant role in improving general health while helping reduce long term healthcare costs.
Strategies include different options focused on health maintenance, such as vaccination programmes, smoking cessation services, support for physical activity, and access to technologies that support early detection of diseases. In addition to representing more efficient and cost-effective options in healthcare coverage, these measures offer the prospect of positive health outcomes and quality of life for patients.
While the benefits of preventive measures are established, integration of many options can be limited when payers do not agree on what are considered adequate or optimal levels of preventive care.
This is especially true when preventive care involves a direct cost to payers. CRA’s Life Sciences Practice recently conducted an analysis of the barriers that currently limit reimbursement for many preventive care services and how the evolution of healthcare systems and preventive care offerings could change the demand and uptake of preventive care by 2030.
Understanding payer views of preventive care
The analysis found that a range of factors including significant upfront costs, limited allocation of healthcare budgets to cover preventive care, and the focus on short-term or quarterly cost savings, rather than longer term strategies in managing care, are limiting adoption of preventive care programmes among payers.
From both a business and a societal perspective, in many cases payers consider preventive care as sub-optimal because it is positioned to deliver clinical and economic benefits over a longer timeframe – often years or decades.
Many other industry stakeholders, including medical organisations and government agencies, consider preventive care to be a good investment. They cite preventive care programmes as critical for improving the general health of a population and addressing many major global health issues effectively. These stakeholders also are in position to benefit from strategies that will deliver net reductions in healthcare costs over the long term.
For example, according to the US Centers for Disease Control and Prevention (CDC), “chronic diseases that are avoidable through preventive care services account for 75% of the nation’s healthcare spending and lower economic output in the US by $260 billion a year. If everyone in the country received recommended clinical care, then the healthcare system could save over 100,000 lives a year.”
CRA’s findings also show that if decisions on the adoption of preventive care services are left to individual stakeholders such as payers who focus mainly on short-term cost effectiveness, use of these measures may be limited.
This limitation is also reflected in the fact that, on average, countries that are part of the Organisation for Economic Co-operation and Development (OECD) did not increase the percentage of their healthcare budgets allocated to preventive care between 2010 and 2017 (2.8%), despite the need for many of these countries to adopt measures to control healthcare spending (Figure 1).
Figure 1: OECD average of public spending on health (Source: OECD)
Independent global advisors are advocating that the preventive healthcare model must operate beyond the limitations of short-term cost assessments favored by many political and healthcare decision-makers.
The reason is based on both economic and societal benefits. If preventive measures that can deliver cost benefits and improved health over the longer term are not implemented, healthcare systems risk a continued escalation in demand for care which, in turn, may be more costly than implementation of preventive measures in a timely manner.
The fact that payers must allocate resources based on limited annual budgets is another factor leading them to deprioritise many preventive care measures, especially those that require significant upfront investment. Preventive care typically targets large patient populations and has a considerable impact on budgets, even though the cost per patient will often be relatively low. Payers also often have difficulties forecasting the cost-effectiveness of preventive care and thus can be uncertain about the true budget impact.
Even in cases where payers allocate resources to preventive care services, research shows that many may not be allocating those funds as effectively as possible. Misallocation of funding is often the result of payers trying to meet patients’ expectations on services that will be covered rather than focusing on the most efficient approach. On average, nearly half of all preventive care spending is allocated to patient monitoring (e.g. health or dental check-ups), rather than to support immunisation and early disease detection, which have been shown to be more effective.
There are also unique challenges in adoption of many preventive care services in multi-payer systems. As patients move across payers, the economic benefits from an investment in preventive care will likely be realised by a different payer than the one who originally funded the preventive service or programme.
To address any gaps in healthcare funding, some payers are prioritising preventive care measures that deliver nearer-term cost savings rather than cost effectiveness. For example, offering the seasonal influenza vaccine to healthy working-age adults is a cost-saving preventive measure (generating net savings of $68.96 per person in the US) and is widely adopted.
In contrast, vascular disease health checks are a cost-effective preventive measure for the broad population, but access is often limited to only high-risk patients.
“Payers may better recognise the value of preventive care as services become more targeted. With the increased availability of new technologies, including wearable devices, health apps, and genetic testing, preventive care is rapidly improving”
How could payer views change by 2030?
By 2030, there will likely be more data available demonstrating the longer-term benefits of preventive care, suggesting that payers may have fewer concerns over cost effectiveness. Some payers may also come under increased societal and governmental pressure to allocate more funding to preventive care services. For example, government advisors are proposing that Nordic countries should allocate equal amounts to sick care and preventive care (5% of GDP to each) by 2030.
Currently, 3% of global healthcare budgets are allocated to preventive services but a recent analysis projects that this will increase to 9% by 2030 (Figure 2).
This shift in fund allocation is also supported by the fact that integration of preventive care measures could be considered the more cost-effective option as more innovative, targeted (and potentially curative) treatments are developed and become commercially available. As a result, healthcare decision-makers, including payers, are expected to push for broader adoption of preventive care programmes that could delay or eliminate the onset of disease and the associated need for treatment among high-risk patients.
Figure 2: How the allocation of healthcare budgets is expected to change by 2030
Payers may also better recognise the value of preventive care over time as services become more targeted. With the increased availability of new technologies, including wearable devices, health apps, and genetic testing, preventive care is rapidly improving.
In one example, genetic testing would allow patients with a high risk of developing some diseases to receive more targeted preventive care including routine screening and biomarker checks. This is currently the case for women with a variant of the breast cancer (BRCA) gene, which greatly increases their chance of developing breast and ovarian cancers and is readily identifiable through testing.
With the development of more targeted and effective preventive solutions, increasing payer willingness to cover them, and growing demand for these services among patients, many healthcare stakeholders expect that both access and uptake will expand and evolve significantly in future. This shift toward broader adoption of preventive care services can support improved sustainability of healthcare budgets and presents many new and more effective opportunities to improve the health and outcomes of patients around the world.
About the authors
Michele Pistollato is an associate principal and Elaine Damato is a consulting associate in the Life Sciences Practice at CRA, based in the London office. Rajini Jayasuriya is a senior associate in the Life Sciences Practice at CRA, based in the Washington, DC office. Views expressed herein are the authors’ and not those of CRA or any of the organisations with which the authors are affiliated. The authors wish to acknowledge the contributions of Lev Gerlovin and Neil Turner to this article.
Given the recent rise in digital engagement and the drastic increase in digital content, it’s now essential that pharmaceutical companies have a comprehensive content strategy.
A foundational step in this process is to implement an integrated solution for digital asset management (DAM) and medical, legal and regulatory (MLR) review.
This enables pharma companies to simplify management of digital assets and speed up the creation, and review of new promotional materials. This also helps teams reduce agency spending, improve content reuse and ensure full ownership of all source files.
Check out this new eBook to learn how one specialty pharma successfully launched and scaled a single system for DAM and MLR review.
“Our goal was to have a single solution for both MLR review and DAM. Now our submissions are higher quality, workflow isn’t held up, and the review process is quicker,” said the company’s director of marketing services, adding: “I can’t imagine using two systems for MLR review and DAM—one solution for both is incomparable.”
By following the tips in this ebook, companies can lay a foundation for success in their commercial content strategy. The ebook includes advice on how to influence change management and drive adoption, how to structure priorities and launch plans, and how to manage day-to-day operations and quality control.
Is a century-old vaccine a ‘game-changer’ for COVID-19? Anita de Waard from Elsevier and Radoslav Kirkov from Estafet tells us how a hackathon is harnessing data science to look beyond the hype and seek definitive clinical evidence.
Today, the notion of ‘data science’ has permeated almost every area of society. Words like machine learning, artificial intelligence and deep learning have entered the everyday business lexicon. From government agencies to online retailers, a ‘big data strategy’ is a must-have. This year, as the COVID-19 pandemic has spread, there has been increased talk of statistics, modelling, predictive analytics, and using data to solve the serious issues we face.
But often, what purports to be data science is actually just a random correlation between different data sets. The phrase ‘data science’ is often used to represent any form of data analysis, however rudimentary, and regardless of whether it is based on scientific understanding. Given the amount of faith we increasingly put in algorithms to make decisions on our behalf, whether in our hospitals, our courts, or our education system, we need a much deeper understanding of how these correlations are drawn, and what they are based on, in order to apply data science for good.
This is especially true in the search for effective therapies to fight COVID-19, and a vaccine. Speed is truly of the essence, but at the same time, the integrity of the science underpinning any clinical recommendations must be maintained. With so many research projects, collaborations and clinical trials taking place in an attempt to limit and prevent the virus, we have to be clear on how decisions are being made and what the data behind an apparent breakthrough is really telling us.
“In a worst-case scenario, misplaced hype could lead to a sudden rush to buy doses of the BCG vaccine. In nations where TB is widespread, this could put many lives at stake”
Understanding the link between COVID-19 and the BCG vaccine
A good example of this phenomenon is the sudden hype around the Bacillus Calmette–Guérin (BCG) vaccine, which is primarily used against tuberculosis (TB). This century-old vaccine came to prominence recently, when a number of early ecological studies (those which study population factors in epidemiology) seemed to show a strong correlation between receiving the vaccine and having immunity against COVID-19.
Some studies suggested the link was a “game-changer” and a “silver bullet”. The studies claimed to show a strong correlation between the BCG vaccination and protection against COVID-19, but closer examination revealed a tenuous correlation, from which clear conclusions can’t be drawn. Indeed, the World Health Organization said that, “Such ecological studies are prone to significant bias from many confounders, including differences in national demographics and disease burden, testing rates for COVID-19 virus infections, and the stage of the pandemic in each country.”
The world-leading TB researcher Prof. Madhukar Pai was also quick to warn of the serious limitations with this approach and the need to be cognizant of confounding variables. In a worst-case scenario, misplaced hype could lead to a sudden rush to buy doses of the BCG vaccine. For developed nations with low TB rates, this would have little impact. But in nations where TB is more widespread, such as India, the potential implications of a sudden shortage of BCG vaccine could put many lives at stake.
The aim now must be on providing stronger clinical trial evidence of the link between the BCG vaccination and incidence of COVID-19, to enable data-led decisions to be made. There are clear shortcomings with current ecological studies, which take aggregated data and look to make inferences at an individual level. If the data are not representative or confounders are not taken into account, the results will be inaccurate.
Establishing an evidence-backed link
The only way to truly understand the correlation between COVID-19 and the BCG vaccine is to conduct randomised trials combined with deep analysis of existing data. To that end, Estafet and Elsevier have initiated a two-stage hackathon. The groups are working together with the BCG World Atlas team, which is led by an infectious disease specialist at the University of Ottawa, Dr Alice Zwerling. The BCG Atlas is an open-source database of global BCG vaccination policies and practices, founded in 2011.
Many of the aforementioned ecological studies were based on data from the BCG Atlas, so the first stage of the hackathon aimed to augment and improve the Atlas; with additional data and health records available on BCG vaccinations. These have been found through natural language processing (NLP) methods. With thirty volunteers globally, including judges, organisers, and data gatherers, prizes were awarded to those deemed to have extended the data most. The winner was Dimitrina Zlatkova of Sofia University, who contributed 57 additional data points, followed by developer Marouane Benmeida of Morocco who added 33 additional data points.
The hackathon now moves to stage two, where the volunteers will seek to answer a series of questions, such as whether the BCG vaccination is causally related to reduced COVID‐19 mortality, or if other factors like lockdowns and average age of the population are responsible for the different mortality rates. If the BCG vaccination does reduce COVID-19 mortality, what are the key factors. For example. how long does the immunity from BCG last after that vaccination? Does the strain of BCG vaccination impact immunity? The team is now looking for more volunteers to get involved as the hackathon progresses. Once complete this most valuable insights from the task will be shared with the ongoing BCG COVID-19 clinical trials.
Data science for good
When it comes to COVID-19, data science will certainly be critical – but it is the blend of scientific understanding and technical acumen through data science that is vital.
It is a job for all of us engaged in data science projects – whether in academia or commercial or government research – to stem the hype. It is important to assess the veracity of a claim before accepting any conclusions, and empower the public to do the same. This habit of mind is important not only in the development of treatments and vaccinations, but paramount to establishing a broad public trust in data-led decision making.
About the authors
Anita de Waard is VP research collaborations at Elsevier and Radoslav Kirkov is technology director at Estafet.
Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase.
No one gets through cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with.
Megan-Claire Chase, a fierce patient advocate who has been blogging about her experiences since she was diagnosed with breast cancer in 2015, said the disease never went away.
“Sometimes, people feel that once you finish your treatment, you are done, and you should stop talking about it. But really, it has only just begun. It is a lifelong journey.
“We’re going to need to have scans forever and we’ve been traumatised by the whole experience, so it’s hurtful when your family members and your friends think you should just move past it.”
Megan-Claire underwent 16 rounds of chemotherapy, nine operations, and 33 radiation treatments after developing invasive lobular breast cancer in her 30s.
As a result of the treatment, she is infertile, has chemo-induced fibromyalgia and neuropathy in her hands and feet. She goes to the cancer center for a diagnostic mammogram and rotates between getting an MRI and ultrasound every six months for 10 years.
“You know that people have good intentions and they are coming from a good place, but when your family and friends just want to see you smiling all the time, it can feel like you’re putting on an act”
Quality of life after cancer
There are a lot of quality of life issues, many of which were not understood outside of the cancer community, says Megan-Claire.
She says: “Sometimes I have to walk with a cane. Because of the neuropathy on my feet, I can’t walk very long distances because the numbness goes up my leg and I fall over and hurt myself.
“That’s what I want people to understand. Some people are on active treatment forever. For others, that treatment has a stopping point, but even then, there are all these other issues that can stem from the poison that goes into your body.”
News stories about cancer survivors going on to achieve great feats of endurance do nothing to help the public perception of what it means to live with the long-term effects of the disease and its treatments.
“Some people are able to climb mountains and do walks and all of that physical stuff. But for others that ability was taken away and it feels like yet another loss,” says Megan-Claire:
“We’re constantly grieving – grieving the loss of the body parts that are missing, the physical abilities we had, and, for many of us, grieving the jobs we used to have before we had to stop working.
“We also have to grieve the friends we have made and lost along the way. We’re constantly reminded of our mortality and have to live with the fear that it could come back at any time.”
Releasing the negative
Through her blog, Life on the Cancer Train, and her advocacy work, Megan-Claire meets many young people in a similar position to her. She believes it helps to give them the space to own their feelings and share their experiences with others who truly understand the nuances of life after cancer.
“When I write, I write what is on my mind, but I always find that resonates with people. A lot of people are hurting, and I think it helps that I post about the elephants in the room: the mental health issues, the anger, the post-traumatic stress disorder,” says Megan-Claire. “People need a place to release all that.”
‘Toxic positivity’ is another issue people who have been through cancer treatment commonly face and dealing with it head on can be extremely difficult, Megan-Claire explains.
“It’s impossible to be this tower of strength all the time. A lot of us get annoyed when we are told: ‘Oh, you’re so brave’, or ‘I don’t know how you do it’. When that happens, all I’m thinking is ‘Do I want to live or do I want to die. It’s not a fair choice.’
“You know that people have good intentions and they are coming from a good place, but when your family and friends just want to see you smiling all the time, it can feel like you’re putting on an act.”
What people need, she went on, was a place where they could “take off the mask and just be vulnerable”. And that’s where peer support comes in.
“Cancer support groups are a safe place where people can meet and talk about their experiences with no judgement.“” says Megan-Claire, who belongs to several young adult cancer groups online.
“My advice to people is always: if you’re angry, be angry. If you’re sad, be sad. Just don’t wallow in it forever. We need to feel these emotions so we can move through them and then do what it is we need to do to move forward with our lives.”
To read Megan-Claire’s blog, click here. See our last interview with Megan-Claire here.
Patient Insights is a monthly series that appears in partnership with Inspire, a company with an online support community of more than 1.5 million patients and caregivers worldwide.
In our latest article in the What HCPs Think series, CREATION.co’s Jamie Doggett analyses the social media activity of doctors to determine their views on how schools should operate during COVID-19.
When and how schools should return was a big question for the UK during summer, and one that is continuing to go on.
A modelling study released in the Lancet, concluded that the best strategy for schools to prevent a second wave required the “large-scale, population-wide testing of symptomatic individuals and effective tracing of their contacts, followed by isolation of diagnosed individuals”.
The use of social media has increased for healthcare professionals (HCPs) during the pandemic as they seek to learn, give opinions and share resources and guidelines. By analysing the unprompted conversations of HCPs on public social media, it can give us a clearer understanding on their views about schools reopening.
Differentiating common cold symptoms
When publishing a social media post, many HCPs add links to stories they wish to share or discuss. The most shared link by HCPs related to the reopening of schools was a resource from The Royal College of Paediatrics and Child Health website. The page provided a summary of current policy and other guidance. 134 healthcare professionals shared this summary comparing and contrasting common cold and COVID-19 symptoms. HCPs were seeking to show their peers and the public the advice on when children should get tested.
A key voice of influence in the UK HCP conversation was Devi Lalita Sridhar, a Professor and Chair of Global Public Health at the University of Edinburgh. Her Twitter account was highly retweeted by HCP peers, on topics linked to school openings. In one post she added her thoughts on the importance of testing as she called for a high bar in availability and turnaround time for testing in order for school returns to be viable.
Lesson for all countries –> build your testing esp. as schools return. And don’t open everything at the same time, but rather step-changes bc if tests are not accessible or results take too long (longer than 24 hours), the entire test/trace/isolate system can’t function. https://t.co/IHhmalXrzP
Being sure that the UK’s testing infrastructure was prepared for the return to school was a common point in HCP conversation. Other concerns emerged leading up to the first day back.
HCPs discussed various emotions relating to school returns, from general worries to panic – but there was also hope. Dr Matthew Snape, writing for the Guardian, published an article broadcasting this hope entitled “There is now clear data on Covid-19 and children: it should be safe to reopen English schools”.
HCPs weigh up the pros and cons of reopening schools
Following Dr Snape’s piece supporting the reopening of schools, Professor Chris Whitty, on behalf of the government, said “missing school is worse for children than the virus”. The BBC article with a video of Whitty’s advice was the most shared news story (40 shares) by UK HCPs relating to the schools. The idea that missing lessons “damages children in the long run” being a bigger factor than the “incredibly small… chances of children dying from COVID-19” was met with mixed feelings from HCPs.
Sarah Jane Kipps, a London-based nurse, emphasised the role school nurses will play during the reopening and was extremely positive about starting her specialist community public health nursing course.
School Nurses are around to support our schools when they reopen. I can’t wait to start my SCHPN course this September. Even better I’m doing it with my first team@HarrowNursing BBC News – Coronavirus: Missing school is worse than virus for childrenhttps://t.co/Jl0M2DY2e9
A little more caution was demonstrated by Chris Roseveare, a consultant physician in Hampshire, who, while not doubting Witty’s statement speculated on the possibility of a spike of infections and warned hospitals should prepare for such an eventuality.
I’m sure Prof Whitty is correct, but having worked in acute Medicine for over 20 years, we commonly see a spike in adult respiratory admissions around the 3rd wk of September, after schools go back; hospitals should plan and prepare for this https://t.co/4oAjfrWm1h
HCPs have discussed many benefits that opening schools, colleges and universities will bring but have also raised concerns, especially connected to safety. The two safety aspects that were most actively discussed were the wearing of masks and how social distancing would be maintained.
The most active UK HCP was Sharon White, the CEO of the School & Public Health Nurses Association. She often looked to use her online influence to share resources including infographics, webinars and advice from organisations. Sharing resources to help prepare the general public, especially parents and carers, was a common behaviour among HCPs.
Another key resource that resonated with HCPs (shared 44 times) was the Going back to school guide published on the Children’s Commissioner website. This guide was designed for children to inform them about the possible changes when going back to school and gave advice for those who are worried or nervous.
Most pupils return to school
Initial figures indicated that 88% of pupils returned for the start of term – lower than previous years. However, the evidence is not conclusive as to whether this was due to COVID-19 outbreaks or fears. As children and teachers return to school there has been an increase in demand for tests, COVID-19 cases and the R number. HCPs continue to share their best advice using public social media, playing an important part in supporting the public, and their peers, to see an eventual end to the disease.
About the author
As head of insight with CREATION.co, Jamie Doggett leads a team that discovers what healthcare professionals think by analysing their online social media conversations. Jamie has collaborated with healthcare professionals, marketers and communicators to leverage data for health strategy, and has pioneered new research methodologies using CREATION.co’s global dataset. Research produced by Jamie and his team has informed academic articles, health policy, and product launches all over the world.
Sarah Rickwood delves into IQVIA data to find out exactly how pharma’s HCP engagement has changed over COVID-19, and what the channel mix might look like after the pandemic.
The pandemic has triggered a change in how pharmaceutical companies are engaging with healthcare professionals.
With in-person visits drastically reduced, pharma has been challenged to find ways to continue engaging effectively with HCPs via remote channels.
When IQVIA polled non COVID-19 treating Italian HCPs in March when the crisis was at its worst, it asked HCPs if they still welcomed pharmaceutical company engagement during the crisis.
The answer was yes.
“Italy is a high touch, relationship driven promotional environment, with, pre-pandemic, the highest volume of face-to-face engagement activity of all of the major European countries”
In Italy, 80% of healthcare professionals, from general practitioners to specialists, said maintaining engagement with pharmaceutical companies was important.
Italy is a high touch, relationship driven promotional environment, and pre-pandemic, had the highest volume of face-to-face engagement activity of all major European countries, so the desire to maintain relationships throughout the crisis was expected.
When IQVIA conducted a similar survey in the UK during April, the majority consensus was the same: most HCPs believed that continued engagement with pharmaceutical companies is important, during and after the pandemic.
This was interesting as pre-COVID-19, the UK’s promotional environment had the lowest face-to-face engagement of all major European countries.
These conclusions are reassuring for industry, but still pose the problem of how pharma can “meaningfully” engage with customers.
Meaningful engagement may seem a vague term, however research shows that healthcare professionals have different preferences, in terms of channels, types and formats of information and relationships. As the term omnichannel implies, it is usually not one single channel, but a combination of channels in the optimal mix and sequence that is most effective. Especially for launches, an interactive discussion with an HCP, most often one-to-one and most often face-to-face, was regarded as the core of meaningful engagement for product adoption.
“The UK is different to the other major European countries in that face-to-face detailing, always low even pre-pandemic, has remained a tiny fraction of its pre-pandemic level, and remote detailing has risen and continues at close to peak levels”
As Graphic 1 shows, during the height of the pandemic, March-May 2020, face to face discussions between pharmaceutical companies and HCPs reduced to close to zero in all major countries. While remote communication with HCPs rose in all countries in the same time period, not all remote engagement was the type likely to be described as meaningful – much of the volume was in emails, with WhatsApp, and other remote messaging, also important during the peak infection period.
Such remote channels are important to provide rapid, basic, necessary information, and maintain relationships, but lack the interactivity and scope for learning that a meaningful interaction will have. This interactivity is important when HCPs are learning about new treatments, or making new decisions about innovative approaches.
Remote rep contacts, which will replicate most closely the interactivity of a face to face call, rose in all countries during the lockdown, although as the y axis shows, not to the levels of pre-pandemic face to face engagement.
Spain and the UK saw the highest levels of remote rep contacts as a percentage of pre-pandemic face-to-face rep contacts. In the UK, remote rep contacts were at 55% of pre-pandemic face to face rep contacts by August, and in Spain they were at 39%. The figure in Spain was especially high in May, at 80% of pre-pandemic face-to-face contacts, although that was immediately after the first wave of the pandemic.
The UK is different to the other four major European countries in that face-to-face detailing, always low even pre-pandemic, has remained a tiny fraction of its pre-pandemic level, whereas in other countries face to face has recovered a substantial percentage of pre-pandemic activity. The UK is also unique compared to other countries as remote detailing has risen and continues at close to peak levels.
Graphic 1: Face to face rep activity is starting to show recovery, but not to pre-pandemic levels
Documenting the change in pharma’s engagement of HCPs is one thing – predicting where channel mix goes in the future, the most important question, is quite another. Crucially, HCP’s preferred channels of engagement with pharmaceutical companies could, of course, have been impacted by the enforced changes at the height of the pandemic as well as HCP expectations of how they will need to operate in the more remote post-pandemic healthcare environment.
IQVIA’s ChannelDynamics panel has run a survey of HCP channel preference since 2017 across 30 countries and many different HCP types, both general practitioners and specialists. The findings of this channel preference survey are unique, as they provide a multi-year baseline of pre-pandemic channel preference.
As Graphic 2 shows, 2020 has indeed brought some trend-breaking changes in HCP channel preference. There are also distinct differences in terms of what has changed between the top five European countries, and the US.
In both regions there has been a trend away from preferring individual interactions (one to one interactions, which could be either face to face or remote). Traditionally this type of interaction has been viewed as the most meaningful and impactful.
In the US, the trend had already started pre-COVID-19. In Europe, channel preferences were pretty stable 2017-2019, but now have undergone a significant shift, with a six point drop in preference for one to one engagement, and an 11 point rise in preference for online resources. In all countries/regions the dominant preference shift is away from individual interaction, and towards online resources. Preference shifts for the other two groupings, meetings events and seminars (in person or remote) and published medical content, see some, but much more minor, shifts.
Graphic 2: Historic Channel Preference and shifts during the pandemic, US and Europe
Even if preference is reducing for this channel as the primary source of engagement, interactions with reps are still a key part of engagement with HCPs. While the pandemic moved those interactions from face-to-face to remote through force of circumstance, HCP preference may keep many of these interactions remote in the future. The ChannelDynamics Channel Preference survey asked HCPs whether videoconference interaction with reps would be partially or wholly sufficient for their needs in the future or not. In the US, it is now the case that a majority (54%) would agree that remote interaction with reps is either partially or wholly sufficient. In Europe, its still a minority – 44% – but a substantial one. The “virtual core” of HCPs who deem virtual interactions with reps entirely sufficient for their needs is now one in five HCPs in Europe, and one in four in the US.
Graphic 3: Preference for remote interactions with reps
There is enough evidence accumulating to predict that the commercial model of the 2020s will not be a return to 2019, with COVID-19 a “blip”. Substantial changes in actual channel mix have been made, and HCP channel preferences have seen significant shifts.
As Graphic 4 outlines, this needs to be done from a starting point of the country’s pre-pandemic promotional “culture”. European countries with high levels of face to face rep engagement are seeing a return of this engagement, just not to the levels seen pre-pandemic.
Others, like the UK, where face-to-face engagement was already markedly low, may not see a return to 2019 levels. However, this shift does not imply reps are no longer needed. Indeed, remote or face-to-face reps generate the meaningful interaction with HCPs necessary to new and switch prescriptions, and therefore establish launch products and build growth products.
However, whatever a country’s promotional culture, changes in HCP preferences in terms of engagement must be researched. The IQVIA ChannelDynamics Channel Preference survey findings show at an aggregate level that every company should be directly researching the preferences of their healthcare professional audience as they are now, and feeding that insight into their customer engagement strategy.
That customer engagement strategy is likely to be a hybrid model in the future, with reps engaging with HCPs both face to face and remotely, informed by circumstance and HCP channel preference, and with the rep engagement embedded in a channel mix designed to have an impact greater than the sum of its parts. Other commercial and customer facing individuals, such as key account managers, will also find they will need to adopt this hybrid approach when engaging with institutional stakeholders.
Graphic 4: Planning the commercial model in a post pandemic world
Changing the channel can be daunting, and pharmaceutical companies have overall taken an incremental approach to developing commercial models. IQVIA’s full year ChannelDynamics review covering promotional activity to the end of 2019 shows that face-to-face selling remained the globally preferred channel, with just over 60% of measured marketing expenditure placed on reps – a level that has remained constant for several years.
While 9 of the 10 leading companies did pull back in terms of estimated sales force activity in 2019, total rep equivalent (FTE) volume was down only slightly (1.3%) worldwide for the year.
Likewise, other “traditional” channels continued to command a large share of the marketing mix budget through 2019. On site meetings & events, samples and DTC featured heavily, accounting for over 30% of the mix. Meanwhile, investment in digital channels, as measured by ChannelDynamics, was up 19% worldwide in 2019. Once again, this represented a double-digit increase on the previous year but only brought the share of spend on that channel to 6% of the channel spending mix.
Prior to the pandemic, the possibilities of multichannel marketing were only just starting to be tested. COVID has now disrupted a commercial model that was slow to change – and as with all disruption there will be innovative and creative new ways of engaging with HCPs in the coming months and years.
One final, encouraging point is research published by IQVIA in a white paper analysing the promotional mix of the most commercially successful recent innovative launches in the US, top 5 Europe, and Japan.
When this issue was first researched in 2018, looking at a cohort of launches that came to market between 2012 and 2016, it was found that the average first year volume share of promotional activity that was digital was, on average, nine points higher for the most successful launches than the rest, and was higher in every single one of the countries.
In updated work, looking at pre-pandemic launches, but up to 2018 (then followed for a year to the end of 2019) it was found that higher digital volume share for the first year promotion of the most successful launches replicated, whether those launches were specialty launches or primary care (see graphic 5).
Digital here includes channels such as email which are more enablers for other meaningful interactions. Yet interactive e-details and other meaningful contacts are also within the digital mix. Even before the pandemic forced a more remote environment for engagements, and changed HCP channel preferences, the seeds of the commercial model revolution were already sown.
Graphic 5: Digital promotion in pre- and post-COVID worlds
About the Author
Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.
As part of our series of opinion pieces from leaders at Janssen, the company’s Maria Raad looks at how we can embrace tech and data science to overcome increasing pressures on healthcare systems.
For the next generation born in the western world, living to be the age of 100 will be the norm. While this seems like a desirable aspiration for our grandchildren, it adds new pressures on our healthcare systems. The number of people living with chronic illnesses will rise year-on-year, and the ongoing management of illnesses like diabetes and cardiovascular disease will require ever increasing resources.
This is nothing new. Healthcare expenditure is growing faster than GDP the world over, a trend that has been amplified by the COVID-19 pandemic. Together, these forces have accelerated technological transformation, acceptance, and adoption across our industry, reinforcing my belief in the ‘triple aim’.
The triple aim considers how we balance the needs of the individual with pressures on our health systems and, in a phrase coined by Berwick, Nola and Whittington in 2008, it is defined as:
Improving an individual’s experience of care
Improving the health of populations
Reducing the per capita costs of care
Changes to any one of these goals can affect the other two, negatively or positively. In order to succeed, we must shift the paradigm of healthcare and drive towards more objective measurements of value and improved experiences for everyone, to create a truly patient-centric system of care.
In the past, our collective adoption of, and trust in, digital technology has been incremental and often reluctant. All too often approached with a narrow mindset, such technologies have been regarded as simply tools to reduce costs or lessen the need for human interaction, when they have the potential to do so much more.
As the scientific evidence behind digital solutions has grown alongside our accelerated need for changes, we’re starting to see the full potential that data science might offer – a potential to create more efficient disease management solutions, reduce the economic burden of healthcare and, most importantly, empower patients to be integral decision-makers in their own care.
Real-time digital solutions for real-world evidence
Two billion people have access to mobile health data, but simply having access is not enough. It is how we use health data that will drive us forward. The emergence of big data, smartphone adoption and cloud storage technologies means that information can be captured in real-time, and then aggregated and analysed to develop new insights.
Collaborations such as HONEUR (Haematology Outcomes Network in Europe), which brings together a partnership of universities, hospitals and institutions across Europe, can help with this by bringing together multiple stakeholders to analyse real-world data (RWD), quickly and at scale, from as many sources as possible. By answering research questions in real time, partners can extract real-world evidence (RWE) that informs their conclusions and accelerates their work.
While acceptance varies between countries, we believe RWE is a key component in moving towards a more value-based healthcare model, as it is one of the few under-utilised resources left in our field.
Healthcare companies are now working with tech companies to put innovative, data-capturing tools directly in the hands of the individual. Wearable tech and mobile health apps can provide patients with information, allow them to manage medication, and help them to become experts in their own condition. This personal depth of knowledge can complement the quantitative data on which we currently rely, so we must ensure it’s integrated into treatment pathways going forward.
Combining digital therapeutics with pharmaceutical innovations
The pandemic has prompted a significant uptake in the use of data technologies. Clinicians, patients and payers are utilising the potential of these platforms, and many are doing so for the first time. We will, however, need to embed such changes across all parts of our healthcare systems, and I believe there are four foundational elements to this:
Evolving from sick-care to well-care: healthcare systems are struggling to provide care via traditional models, which are largely based on treating illness rather than preventing it. This means moving on from just products and treatments, to platforms and solutions focused on prevention and real-time, outcomes-based care. Digital technology will be a major contributor to this transformational shift from diagnosis and treatment to prediction and prevention.
Data science: harnessing data networks, artificial intelligence and real-world evidence, and the interdependence between all three, can help move us towards agreeing an objective measure of value for any given therapy. That’s essential if we are to build a new healthcare ecosystem, and if we get it right, everyone will benefit.
Long life care: ageing populations are growing in size and increasing the pressure on healthcare systems. Without digital technology, the amount of resources required to manage long-term, non-communicable diseases will be unsustainable.
Personalised care: digital therapeutics, when certified as medical devices, can enable clinicians to prescribe a treatment system that goes beyond the pill. They can also engage patients more effectively in their own care, through real-time symptom monitoring, for example, or by providing physiological support for those dealing with the burden of disease.
These are not short-term solutions. The ultimate goal is healthcare that’s thriving, sustainable and accessible to all. And we can drive towards that goal by harnessing and sharing the benefits of the ever-evolving technologies within our reach. But it’s a team sport – the days of any individual, organisation, government or industry attempting to change the world on their own are gone.
Data science actually has the potential to make healthcare more human. And, as we look to the next 100 years, with all this technology available to us, perhaps there’s reason to hope that we will yet see a world where fewer people get sick and more people live longer, healthier, happier lives.
About the author
Maria Raad is vice president, customer & digital strategy, EMEA at Janssen. In this capacity, Maria is responsible for the functions of business intelligence, advanced analytics, digital acceleration, and patient healthcare solutions. She has held various positions, since joining Janssen in 2006 – prior to her current role, Maria was Global VP & Chief Information Officer of Actelion, and a member of the Actelion leadership team based in Basel, Switzerland.
In the age of artificial intelligence, no trial data should be going to waste. Findacure’s Rick Thompson looks at how these technologies could bring us closer to treatments for underserved rare diseases.
The repurposing of drugs is becoming more common, especially in the field of rare diseases. In the past, repurposing has mostly been driven by academics looking for new possibilities in generics. Now, as part of lifecycle management, pharmaceutical companies are looking more closely at drugs they have on their shelves. These might be licensed drugs that could hold potential for a patent extension, or drugs which failed efficacy trials for an intended indication.
In the quest to repurpose a drug for a rare condition, there is a need to look at any and all available data. The wealth of published scientific literature forms one crucial source of data, with the ever-expanding pool of ‘omic data forming another.
A third pool of clinical evidence is formed by trial data, which will probably only be considered through the published literature. By definition, however, trial master files represent a much richer and more detailed source of data on a drug and how it performs. Published literature tends to catalogue successful clinical trials, but value can also lie in a trial that did not lead to a positive and viable outcome: the data it produced could still provide evidence for repurposing. For instance, provided a drug has not failed a trial on safety, the side effects it caused in one population could constitute on-target effects in another.
With large datasets crucial to gaining an understanding of rare diseases and opening the door to drug development, digital technology is proving transformative. It enables careful collation and organisation of information, but the innovations of artificial intelligence (AI) are now taking things further, facilitating the effective analysis and interrogation of big data to create new treatment hypotheses.
“Patient associations are working to develop registries (some using wearable technologies or apps) and natural history studies, which means that ever-greater volumes of data are being produced”
These techniques make the production of and access to high-quality data on rare diseases the gateway to treatment identification, and so are proving more crucial than ever for organisations in pharma.
Digitised, rigorously controlled data lends itself to techniques of processing and analysis which characterise both drug discovery and drug repurposing.
Raw text can be analysed by Natural Language Processing (NLP) techniques which form connections between studies that could otherwise take thousands of hours of human time to identify.
When combined with analyses of ‘omic approaches, and an appropriate level of disease-specific knowledge from patient groups, you can create a powerful resource for the identification of new treatment hypotheses for rare diseases – and an opportunity to address severe unmet needs.
Findacure is a charity that works directly with rare disease patient groups to help them grow and professionalise. Over the last five years we have focused on the power of drug repurposing for rare genetic diseases. It is estimated that, worldwide, just 400 treatments are licensed for 7000 known rare conditions, which tend to be determined by a very specific genetic factor.
As a consequence, most patients are being left with no hope of a treatment in their lifetime. Luckily, patient associations are working to fill the void by uniting patients and driving research forward for their conditions. Many are working to develop registries (some using wearable technologies or apps) and natural history studies, which means that ever-greater volumes of data are being produced.
This drive to generate data on and interest in their condition – along with the collated knowledge of their community’s lived experience of rare disease – can prove transformative to the treatment landscape. We are now seeing patient associations involved in several collaborative efforts that are identifying drugs which, as candidates for repurposing, stand to deliver treatments to rare disease patients more quickly and cheaply.
In 2020, the pharmaceutical industry has not by any means proved immune to the disruption caused by COVID-19. But, as in other industries, the pandemic has accelerated the process of digital transformation that was already underway.
A recent survey of more than 200 life sciences professionals, conducted on behalf of digital archiving specialists Arkivum, found 70% of respondents saying that COVID-19 has triggered a change in the way clinical trials will be conducted. There can be no doubt that digital technology will play a key role in that change. The survey reports that over 90% of sponsors and CROs have already adopted an eClinical application to improve study execution and data collection in live trials.
When a trial is completed, the valuable and extensive data it has produced must be archived – an exercise crucial both to regulatory compliance and to any future efforts at repurposing. 70% of sponsors reported that they use a digital archive rather than the traditional paper-based option, and 45% of respondents cited the role that clinical trial data plays in finding new indications and formulations. Yet at the same time, 38% of sponsor organisations described their ability to access archived clinical data and records as ‘extremely or very inadequate’.
This percentage rose to 65% amongst QA, compliance, legal and regulatory professionals. Moreover, just 31% of life sciences organisations seem to run a digital archive of sufficient sophistication to ensure that data can be managed in accordance with the FAIR data principles.
These were established to further scientific study through keeping data Findable, Accessible, Interoperable and Re-usable – all key attributes when it comes to exploring the new potential of an existing drug.
In the search to repurpose drugs, readier, more reliable access to archived trial data – including trials that produced negative results – can clearly prove highly beneficial.
If data has been well stewarded before and after it reaches the archive, and if its integrity has been maintained through careful curation, it facilitates the application of AI techniques. Natural language processing can be used in conjunction with, say, analysis of ‘omic-level data and patient group insights in order to work through the problems and side effects encountered in the full spectrum of trials. This can open the way to repurposing for different populations, and to new approaches to the design of clinical trials.
The success of these endeavours will also be favoured by the availability of comprehensive rare disease registries which collate patient-level data on disease natural history while also bringing together a pool of patients who could participate in trials.
Meanwhile at the pre-competitive stage of drug development, researchers are adopting a more open, collaborative approach to data. Now is the time to enable further collaboration by increasing access to historical data and releasing its full value. Success in finding treatments for rare disease is above all the product of collaboration, as technological innovation complements and amplifies a compassionate, patient-centred approach.
In all this, it is worth remembering that the people who participate in clinical trials – especially in the field of rare disease, where recruitment of patients is a particular challenge – would appreciate knowing that their participation will have a lasting value, whatever the outcome of the trial.
Trial participants take on a burden by putting in time, effort, hope and commitment. They also put themselves at some degree of risk whenever they take an experimental drug. In the field of rare diseases, trial participants are hoping to help the next generation of patients even more than themselves.It is crucial to maximise the potential value of data they are helping the professionals to collect.
With repurposing on the table, and improved access to all trial data, we can better unlock this potential.
About the authors
Dr Rick Thompson is CEO of Findacure, a UK charity dedicated to building the rare disease community to drive research and develop treatments.
Tom Lynam is head of Marketing at Arkivum, specialists in digital preservation of valuable data in life sciences and global scientific institutions.
The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with new ways of working.
The coronavirus pandemic has forced a traditionally risk-averse industry tied to legacy systems for regulation and compliance to fully embrace digital solutions in commercial and marketing functions.
While the majority of executives understand the value and business potential of digital, keeping up this new tempo of rapid digital implementation and asset approval is increasingly challenging while simultaneously maintaining compliance footing.
New digital channels have changed the way patients engage with the medical world around them, while driving expectations on how the pharma industry must respond and deliver their communications during the pandemic.
Every digital initiative, from content creation to review, approval, and distribution, comes with the potential for delays during medical/legal/regulatory review, regulatory impediments, or unexpected factors. And, as the digital world demands fast-tracked timelines, many pharma companies are still held back by inefficient processes and outdated manual systems that limit visibility, collaboration, and sharing across the digital supply chain.
Traditionally, many pharma companies have taken a centralised approach to content management and legal approval in which entire assets, such as a brochure or an article, are created and approved centrally, and then distributed on a local level to every country.
While this traditionally meets the need for brand consistency and compliance, the pandemic has unleashed a greater variance of digital formats that need to be approved at a greater speed.
“The challenge requires transformation and change management on an organisational level and needs to be supported by senior leadership… Embedding the new processes and ways of working is a huge cross functional project that needs good coordination, communication and capability building” Bhupinder McJennett, AbbVie
Indeed, research by Veeva Systems research shows that 83% of pharma companies are creating more content now to support digital engagement than six months before.
The sheer volume of content required across multiple formats threatens to overwhelm traditional, centralised strategies.
Bhupinder McJennett, global digital lead, eyecare, at AbbVie International articulates this problem: “The pandemic has created a marked shift towards digital content creation and the need to approve this content in different formats and at speed. I can only see this workload increasing, driving a need for more efficient, agile approval processes.”
Many commenters have observed that this challenge is about a reallocation of resources and people management. Rick O’Neil, digital consultant to pharma and founder of LTF Agency, says: “As the need and workload of digital assets increases we will clearly require a parallel investment in more headcount on the reviewing and approval side.”
Meanwhile, AbbVie’s McJennett believes that a digital strategy from management is required to address this issue: “The challenge is not confined to digital content creation. It requires transformation and change management on an organisational level and needs to be supported, if not mandated, by senior leadership to facilitate this shift.
“Embedding the new processes and ways of working is a huge cross functional project that needs good coordination, communication and capability building.” Another solution to removing bottlenecks and allowing information to flow from a single source is the use of digital asset approval technology to speed up the approval process.
Such technology could allow for better compliance and faster availability with accelerated creation, approval, and distribution of commercial content across the digital supply chain.
Replacing a mix of systems and processes with a single, seamless digital asset management solution could also reduce complexity and save costs and time.
In practice this means that content could be bulk published, updated, or withdrawn wherever it appears. This approach reduces the need for expensive reworking of minor details, removing bureaucracy and enabling teams to focus on content rather than administration.
Rick O’Neil agrees that enterprise technology will play a key contribution to digital asset approval in the future: “Digital Pharma also needs to consider an efficient process for adapting central content into localising content assets. This is where I see a potential opportunity for a quality enterprise technology to solve this problem”
As the pharma industry responds to the increasing requirements of the pandemic, in-house marketers must use this opportunity to break down the silos between marketing and regulatory teams and address the bottlenecks to initiate more efficient data-driven processes.
This is not easy to do given the current demands of the pandemic but senior management must recognise that this it is vital to enable an efficient digital asset approval process to flourish and scale About the author
David Reilly is the founder of Let’s Learn Digital; delivering quality training in digital and emerging technology for the UK pharma industry.
Delayed diagnosis, lack of awareness, and a limited evidence base – Aarskog syndrome faces all the challenges of rare diseases everywhere. But a new study hopes to kick start a revolution in understanding.
For five years, Michelle Erskine faced a succession of closed doors and disbelief as she struggled to convince someone that all was not well with her son.
Eventually, after undergoing five operations in as many years, he was seen by a Consultant Ophthalmologist with knowledge of the condition and was placed on the road to an Aarskog syndrome diagnosis.
“When I saw it in black and white, I just burst into tears,” says Michelle, founder of the Aarskog Foundation, which recently marked Aarskog Awareness Week from 29 September to 4 October.
“Up until then, I was unable to convince anyone that something was wrong. We kept going to the nurse and the GP, but we were never referred to a paediatrician. No one would listen.”
The rare, X-linked genetic condition is characterised by short stature and facial, limb and genital abnormalities and was first described in 1970.
Michelle, who had recognised similarities between her son and two of her brothers, who had never been diagnosed, set up the Facebook page that eventually evolved into the foundation 12 years ago.
“I wanted to start a conversation and give people a space where they would be listened to. But from that, I wanted to formalise things – if all we do is talk as a group then nothing will ever get done”
Together with two fellow ‘Aarskog mums’ who had started social media pages around the same time, she had soon made contact with around 100 people from four countries around the world.
“I just wanted to start a conversation and give people a space where they would be listened to, so that no other mother would feel alone again. We were talking about the characteristics of the condition, advising people on how to speak to a GP, when to get a referral, etc.,” says Michelle.
“But from that, I wanted to formalise things – if all we do is talk as a group then nothing will ever get done. As my mum used to say: ‘if you do what you’ve always done, you’ll get what you’ve always got’.”
The Aarskog Foundation was established in 2017 and was given charitable status the following year. The objective, Michelle says, was to ensure families like hers received the support they needed.
“I wanted to change the dynamic, I wanted to raise awareness of the condition, and I wanted to help people to get a diagnosis,” says Michelle, who has published a six-step care plan pathway, which includes when to ask for a referral to a geneticist, on the foundation’s website.
As with many rare diseases, part of the problem families come up against when seeking care is a lack of solid evidence.
It is thought that around one in 25,000 people live with the condition, but the characteristics vary from person to person.
Most experience some form of cognitive difficulty, and some develop psychosocial problems related to short stature and feelings of social isolation.
The physical impact of Aarskog is extremely wide ranging. Michelle’s son, who is now 22, needed operations for undescended testicles and a bilateral hernia before his fifth birthday, for example.
“The challenge we have with Aarskog syndrome is that the medical literature hasn’t extensively addressed the natural history and the spectrum of symptoms,” she says. “Although the advancements in sequencing technologies have enabled the genetic confirmation of this disease, an effort to understand the genetic basis of this multitude of symptoms is still due.”
“For instance, all our children are on the autistic spectrum in one form or another. Still, there is a considerable lack of literature discussing the variability and etiopathogenesis of the autism spectrum disorder in Aarskog syndrome.”
Because Aarskog is an X-linked genetic condition affecting predominantly males, women have traditionally been considered asymptomatic carriers. However, Michelle believes that around 80% of the mothers she speaks to have an inflammatory disease such as rheumatoid arthritis or ankylosing spondylitis that should be evaluated for any association with this syndrome.
“Women have traditionally been considered asymptomatic carriers – but Michelle believes that 80% of the mothers she speaks to have an inflammatory disease such that should be evaluated for any association with Aarskog syndrome”
“We are not aware of so many aspects of this disease because they have not been researched adequately,” she says.
“Because this disease is so rare and there is no cure yet, it is not seen as important by researchers and physicians. This is what I want to change. I want people to have a system that they can rely on and be supportive”
Natural history study
To this end, Michelle’s foundation has just started working with two medical geneticists to identify and delineate the syndrome’s novel characteristics. This human history study project will use data from the foundation’s patient registry.
“This study will primarily use the data to understand the natural history of the disease phenotype so that we can help the patients and families with better care of their ailments.
“At the moment, there is information about this disease, but it’s neither concise nor comprehensive in nature.”
The human history study, which is being funded by the foundation and its supporters, will feed into gene reviews, an international point-of-source for inherited disorders. The team hopes that this study’s scope will also shed light on the gene’s impact on the women who carry it in addition to an elaborative genotype-phenotype correlation.
The two research projects, Michelle says, will start to build the evidence base.
“This condition causes so much pain for families. I hope the research encourages clinicians to look into this further so that they can better inform people about the condition and put people on better management pathways,” she concludes.
To contribute to the cost of the studies, click here
Exploring Rare Diseases is produced in partnership with Cambridge Rare Disease Network (CRDN). CRDN is building a vibrant network of patients and stakeholders to share knowledge and foster innovation that leads to better diagnosis, treatment and support for those living with a rare disease
A few months into the pandemic, the world is now moving beyond managing the crisis, with more focus on addressing the collateral damages and shaping the future. As part of a new series looking at how pharma has responded to the pandemic, Neale Belson, SVP UK & Ireland and general manager for the UK at GSK, tells us that it is “absolutely critical” to do this with the pace and out-of-the box thinking of the past months.
Belson became GSK’s general manager in the UK in March, just before lockdown came into effect, and because of this he says he has now got to know himself and his colleagues better than he could have anticipated.
“Working remotely has given me greater appreciation and understanding of their home life, personal priorities and challenges. I have also seen how my colleagues handled the pressures of the pandemic to find solutions to brand new challenges, motivated by their passion for protecting patients and improving the way they live their lives.”
Belson says that the obvious place for GSK to start in its response to the pandemic was to leverage its experience in vaccine discovery.
“This specific vaccine effort, however, is like no other in its sense of urgency and scale of need,” he says. “With COVID, even the approach to vaccine discovery is transforming.
“The key word from the beginning has been ‘collaboration’,” he adds.“We are working in partnership with companies and research groups across the world to help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19.”
“This specific vaccine effort, however, is like no other in its sense of urgency and scale of need. With COVID, even the approach to vaccine discovery is transforming”
He highlights GSK’s “unprecedented” partnership with Sanofi, where the two companies are combining their science and technologies to develop an adjuvanted COVID-19 vaccine, which entered clinical trials in September 2020.
But he stresses again that this collaborative effort needs to extend beyond the research and discovery phase.
“We are already thinking of how we will make a potentially successful vaccine candidate available and affordable globally, and in the UK we have already agreed with the government to supply up to 60 million doses of a COVID-19 vaccine.”
Beyond the urgent need for treatments and vaccines, the pandemic has also challenged the NHS to adapt quickly to establish new ways to keep patients, especially those most vulnerable to the virus, away from hospitals and clinics and remain in the safety of their own homes.
“We’ve also had to ask ourselves how we can support the NHS to meet those demands, working as a partner to protect the public,” says Belson. “This will only become more vital as we enter the latter months of the year and support the NHS as they attend to the backlog of patients that await non-COVID related examination and treatment and as they prepare for winter, which will bring additional pressures to the system, with the flu season upon us.”
One approach GSK has taken is to leverage its experience through a series of webinars that aim to support HCPs to build their skills and confidence as they take consultations online.
“This not only protects vulnerable patients but also our vital NHS workforce, reducing their exposure to the coronavirus and maintaining their ability to remain at work,” says Belson.
GSK has also started to pool knowledge into an accessible online resource hub, with the aim of creating a “one-stop shop” of guidance and support for respiratory HCPs across the NHS.
This provides free advice and training to support HCPs as they adjust to new tools and ways of working, and to guide respiratory patients through the journey with them.
The company is also contributing to the NHS’ ‘Your Covid Recovery’ online tool as patients return home to recover from the coronavirus.
“Severe asthma, lupus and cancer patients have been able to follow government guidance to reduce their exposure to COVID-19 by receiving care and testing in their homes,” says Belson. ”We’ve brought forward formulations for self-administration by working closely with regulatory bodies, as well as doubling homecare offerings and launching a patient app.
“These initiatives share an underlying factor: the use of innovation to improve people’s lives in these new circumstances and beyond.”
Patients aren’t just vulnerable during a pandemic, and Belson says that much of the novel approaches companies have tried in the past months will continue to be present and further evolved in the future.
“The NHS has provided an incredible level of care and support during this time, demonstrating the solutions our unique healthcare system can offer patients and HCPs.
“By giving severe asthma patients the independence to access their treatment from their sofa, we are freeing up time that HCPs can spend seeing and treating new patients on waiting lists in clinics. By those with respiratory and autoimmune diseases being able to see their GP on a screen and not through a waiting room, we are protecting them from unnecessary exposure to disease and complications. These are the types of solutions we will try to explore and support as the pandemic continues, working as a trusted partner alongside the NHS and patients.”
Belson says that the pandemic has emphasised the importance of asking ‘how’ care is administered as well as ‘what’ care is administered.
“We now need to continue working with our partners to benefit patients long-term.”
OPEN Health’s Beth Lesher and Annemarie Clegg examine what the convergence of medical communications and market access means for pharmaceutical companies.
Value in healthcare is a continually changing concept. As the needs of different stakeholders evolve and gain in prominence, pharmaceutical companies must be prepared to address value from various viewpoints using a variety of different metrics.
The evolution of value in healthcare is a trend that has important implications for communications, particularly because ‘value’ is very much in the eye of the beholder. For a physician, value may centre around safety and efficacy whereas healthcare decision makers and regulators may place more emphasis on cost. Patients may place more value on cost when dealing with a chronic disease and quality of life when dealing with an end of life illness.
As patients play a more active part in their own care, physicians grapple with the ever-changing nature of medical science and payers are continually pushed by budgetary constraints, it’s important to understand that how you communicate value to the industry’s various audiences needs to be different.
Better management of customer data could help pharmaceutical companies’ digital transformation, according to Veeva’s Rebecca Silver. pharmaphorum’s Richard Staines spoke to her about how the use of customer reference data can transform pharma companies, increase competitiveness, and benefit the bottom line during these challenging times.
Precision medicine is emerging as a key approach for disease treatment and prevention, which makes it even more critical to get the right medicine to the right patients. But according to OpenData’s general manager Rebecca Silver, the industry is often challenged with having accurate data on the doctors and the organisations they work for.
Times are changing, though, and with the advent of COVID-19 the use of digital technology has increased considerably. One of the noticeable effects of this has been a massive uptake of remote working across the industry, which has accentuated difficulties in conducting remote sales engagements due to poor customer data quality.
The changing pharma environment during COVID-19
According to Silver, the coronavirus pandemic changed the pharma industry’s priorities overnight, and several other factors are transforming the way that pharma companies are interacting with doctors.
Speed to market is all-important in accelerating innovation, she notes, adding that using customer data well is crucial to get the kind of targeted approach needed when interacting with healthcare professionals.
“Personalised medicine is driving the need to get more information to more physicians. It’s targeting the right medicine to the right patients, so giving very specific information to physicians is really important”
“Personalised medicine is driving the need to get more information to more physicians. It’s targeting the right medicine to the right patients, so giving very specific information to physicians is really important.”
But Silver identified some challenges that must be overcome to allow pharma companies to make the most of their customer reference data. For example, data is often siloed in different parts of the company, instead of a centralised database that allows company-wide access.
Quality of data is another issue identified by Silver as being detrimental to a coordinated approach to customer relations management. She pointed to the Veeva European Customer Reference Data Survey that showed 41% of companies are not satisfied with the quality of their third-party legacy providers of customer data.
“Complexity comes in when data’s in silos and fragmented. If the data is in silos within a pharmaceutical company, you’ll find multiple people that are buying the same data assets and storing them and managing them in various systems completely disconnected from each other.
“It’s almost impossible to get a single, comprehensive view and an actionable view of their customer. It makes it really difficult to derive insights from that data because they’re not getting the full picture of their customers.”
Ensuring that customer data is accurate and up to date is a priority, no matter what size a company is.
One way of making sure that the data is also useful to reps is having technology that allows customer data to be updated in real-time, whether they are looking to engage with healthcare professionals directly or via remote detailing, according to Silver.
Good data governance will help to get the information accurate and up to date – but making a case for improving it isn’t always an easy task.
But Silver said it’s possible to make the case for strong data governance by outlining the productivity benefits it can bring by taking steps to identify who owns the data and ensuring a single department is responsible for curating it.
“People don’t like the term ‘governance,’ but it’s the reality of it, and there is a strong impact. If companies have data governance issues and undertake initiatives to improve data management, they’re more likely to be satisfied with the ability of their data to support their analytics.”
Properly curated customer data allows reps to make fast decisions, as they have confidence in the information available to them.
Silver said: “Customers want their reps in the field to be able to react with speed and they want to maximise the value out of their investment of those reps. So, it is important to empower the sales rep with the most accurate data updates while they’re standing in a hospital and can still effectively execute on a call, for example.”
C-suite taking notice
Despite these challenges Silver said pharma companies are more likely to overcome them now that the C-Suite is starting to notice the issue.
Companies are increasingly realising that their customer data is an important strategic asset that can have a real impact on the bottom line. Driving this is a realisation at executive level that getting customer data right is crucial to keeping a company competitive.
Pharma companies that don’t use data as an asset risk falling behind, whether they are competing in a tight market where there are many other therapeutic options available or whether they are launching a new product and under pressure to bring in sales.
Silver said: “All of that pressure and that stress has increased the awareness around data in the C-suite. So, what I’m seeing is many business leaders are re-examining their data organisations and searching for opportunities to reduce wasted time and effort, while at the same time increasing productivity.”
Data is ‘cool’
The digital revolution has moved far beyond fascinating gadgets and devices, and promises to profoundly change the way pharma companies operate.
Pharmaceutical companies are starting to adopt a business model with data as a foundation for the company’s strategy.
Customer data and helping reps on a day-to-day basis will be at the heart of this, but companies will also be guided during crucial projects such as launching new drugs, when pharma must maximise opportunities in the often-crucial initial window for sales.
According to Veeva, the COVID-19 pandemic is likely to fundamentally change the way pharma companies operate as they are forced, at least in the short term, to move away from conventional sales operations based on face-to-face meetings with doctors.
These will still have their place, but the future is expected to favour a hybrid approach as the importance of digital support for physician interactions grows, driven by innovations in multi-channel materials and remote detailing.
To guide this hybrid approach, pharma companies should look to the insights that can be found through a sophisticated analysis of CRM data – the advantages of which are increasingly being recognised by those at the very top of their organisations.
Silver concluded: “Customer data is the foundation of companies’ success; data is now cool.”
About the interviewee
As general manager, Veeva OpenData, Rebecca leads a dedicated team of product managers, data stewards, engineers, and services professionals to deliver a superior reference data experience for Veeva customers. Before leading the global OpenData team, Rebecca was vice president of Veeva OpenData North America, where she led the launch and growth of Veeva’s data offering. Earlier, as VP, professional services, North America, she directed successful implementations of Veeva’s suite of commercial products for many of the world’s most prominent pharmaceutical companies.
There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available to help speed up processes and increase data accuracy. But for many life sciences organisations, these tools are either not yet fully adopted or are not being put to good use within their regulatory functions.
Adopting intelligent automation could help organisations realise disruptive benefits that are above and beyond the tangible gains of cost, quality and productivity improvements. By applying intelligent automation, companies could realistically expect to enable: the seamless distribution of product information in a variety of multimedia channels to all internal and external stakeholders; rapid and accelerated implementation of product advances that could propel continuous improvement; and advanced prediction of risks to mitigate against resource capacity constraints – which have been highlighted during COVID-19.
For many companies, it could be realistic to automate as much as half of the manual maintenance tasks currently performed, resulting in significantly different future operating models where blended roles will prevail with strategic product oversight.
“One of the most common mistakes companies make is to allow business units to carry automation initiatives in silos”
But where to begin?
Where do you begin this transformation? Start with the data. Companies need to change the way people collect, curate, interpret and apply data for regulatory submissions and improve confidence in that data. According to Accenture research, most organisations are still struggling to understand the basic ‘truth’ of the data they use and exchange with others. The Accenture Technology Vision survey found just one-third of 103 life sciences executives have high confidence in their data and validate it extensively. To improve data confidence regulatory executives should take a four-step approach to change how they:
Collect Data: Life sciences organisations should utilise cloud-based solutions with global access that facilitates one repository with a single source of truth and eliminates the use of local file sharing and servers. By integrating applications across the end-to-end value chain, they eradicate data entry duplication.
Curate Data: Regulatory specialists need to apply data standardisation and master data management to define the right granular level of data for storage. This needs to be done up front. By implementing robust data governance and management, they can maintain data quality and integrity. By ensuring traceability of data evolution, as well as end-to-end transparency of submission status and its components, they help promote confidence in the data itself.
Interpret Data: Executives need to make more use of readily available data to drive business decisions and optimise operations. They should be applying analytics to past submission data to recommend future submission content plans and pre-empt and mitigate health authority (HA) questions.
Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data. Making real-time data accessible to the consumers of the information when and where it’s needed increases the likelihood of buy-in to the system’s value-add. In this way, manufacturing scheduling can be optimised, and batch release decisions more informed. This, in turn, enables healthcare practitioners to get the most up-to-date product information at their fingertips.
Focusing on the business outcomes of how data can be interpreted and applied, through implementation of analytics, RPA and AI, will help strengthen your data vision, enhance your data stewardship culture and provide financial justification for investing in improved data management. This is crucial because all signs point to a future world order of increasing volumes and complexity of new products coming to market, and digital support is a must have – not a nice to have – to handle this workload.
What intelligent automation to consider?
As companies make the move into the realms of intelligent automation, there are 3 key considerations that need to be considered from the offset.
Set the North Star vision: Discuss the company strategy and pipeline considerations for the next 3-5 years and what the business objectives to achieve this strategy are. Is the driver for intelligent automation waste reduction and cost saving, or the speed at which innovative products are being brought to patients? Define the priority focus areas for your intelligent automation roadmap and evaluate the balance of ‘quick wins’ versus longer term strategy initiatives.
Create the Operational Blueprint: Outline what the future processes look like with the inclusion of intelligent automation. What activities remain and from where should they be performed? Consider how job descriptions and roles will evolve to account for the transformed future working environment.
Prototype, automate, evaluate, repeat: Establish the infrastructure to prototype at speed and fail fast. Consider how to implement in an agile, modular manner that gradually combines into an end-to-end solution. Carefully evaluate benefits realised.
“Lack of communication on how the workforce will be re-purposed post automation implementation can lead to internal unrest and possible attrition”
Here are some example use cases showing how Intelligent Automation is changing the game:
Regulatory Requirements & Content Plans
Business Challenge: Maintaining data on submission requirements is a constant challenge. As a result, market requirements gathering is often repeated for each submission, generating longer lead-times. Additionally, insights gained from HA feedback are not incorporated into submissions, reducing first time submission approval accuracy.
Solution: Analytics can compare new submission properties against past submissions to suggest a content plan based on the closest match, and most recent, approved submission.
Health Authority Correspondence Processing
Business Challenge: Timely recording of submission approval dates or tracking of HA questions can be challenging when information received by affiliates needs deciphering and translating before being entered into regulatory systems.
Solution: AI tools can translate and decipher letters without the need for local affiliate intervention and automatically enter information in Regulatory Information Management systems for stakeholders to act upon.
Label Authoring and Tracking
Business Challenge: Managing and providing traceability of the roll out of global label updates is onerous based on language nuances, implementation considerations and replicated data terms across multiple documents which can lead to a high risk of product label inconsistencies.
Solution: AI tools can take the complexity out of mapping global-to-local terms and automatically suggest what updates are needed where, as well as provide end-to-end traceability of the update progress.
As companies make the move to adopt intelligent automation, they need to make sure their projects are: business-outcome oriented (rather than simply automating a task or function); human-centred (so they don’t just eliminate repetitive tasks but rather free up people to focus on higher-value analysis, decision making and innovation); and technology rich (i.e. integrated into the broader architecture of data sources and applications).
How do you ensure success?
And there are pitfalls to avoid. One of the most common mistakes companies (across all industries) make is to allow business units to carry automation initiatives in silos. You should drive home the notion of ‘one company’ and keep an eagle-eye out for cowboys building their own rogue programmes. Similarly, make sure everyone is on the same page – if there is a disconnect between IT and the business, what’s built may not serve what’s needed. And make sure your HR, training and communications teams are looped in, informed and armed with the right information and tools to encourage and support adoption.
Lack of communication on how the workforce will be re-purposed post automation implementation can lead to internal unrest and possible attrition. There will need to be training and change control in place, and that takes planning and management. Finally, from the onset and throughout there needs to be a team tasked with ensuring responsible automation is in place. This needs to be owned by the C-Suite and at every turn communicated to employees, so it is part of the DNA of the transformation: consider the ethical and legal implications when data is handled, and tasks are automated. Know who is accountable and responsible for outcomes and ensure those teams own that responsibility.
The process of adopting intelligent automation isn’t easy but it’s also unavoidable. Adoption of processes and procedures to handle complex data is essential in this day and age – the companies that fail to build a platform that is adaptable to change are at risk of being left behind; those that do adopt new solutions are not only poised to succeed – they are the industry leaders of the future.
About the author
Kim Brownrigg is a senior principal at Accenture and leads the Regulatory Domain in Europe. Her responsibilities include interlinking Consulting, Technology and Operations services to optimise client value and defining next generation service offerings. Kim is currently leading Accenture’s Regulatory digital transformation programme; helping clients define their digital strategy and roadmap within Regulatory, designing applied intelligence solutions and prototypes and delivering pilots and scaled implementation to transform and streamline the industry.
Better patient care pathways and models of care can be leveraged from the use of data, and the ability to collate and assess this information will drive more sustainable models of care, whilst unlocking the value of ‘longitudinal, real-world data’ as a resource for healthcare organisations, research and academia, policy advisors and pharma.
There is a societal shift that is required though, to educate patients on the value of this data and how it can be used to improve the outcome of patients globally. Samir Dhalla, head of THIN and Richard Ballerand, co-chair of THIN’s Patient Advisory Committee, explore how ‘good data’ can power this.
The benefits for public health
Data has been essential in the fight against COVID-19, with records used to identify and notify 2.2 million individuals who were at significant risk from the virus, and to advise them to shield. Ongoing tracking and data analysis of the virus has also allowed for data profiles to be built up around the types of conditions that result in COVID-19 posing a greater threat, for instance Type 2 diabetes. The NHS has proven the value of public health data in this way, and globally it has been a powerful tool to assess risks and treatments.
It’s also helped to drive research – for example the European Health Data & Evidence Network’s (EHDEN) took part in the OHDSI COVID-19 Virtual Study-a-thon which rallied 330 researchers with very different backgrounds and from thirty different countries. It also launched its COVID-19 Rapid Collaboration Call in a bid to plug the gaps in fragmented, siloed and poorly interoperable real-world health data in order to characterise patients, manage their care and assess treatment safety.
“The public are generally comfortable with anonymised data from medical records being used for improving health, care and services. However, there is still worry around this health data being accessed by commercial organisations”
These forms of national and international collaboration have shown the power of data in managing the pandemic, as the importance of population health data in identifying and containing the virus has not been overstated. The NHS has created its own COVID-19 Data Store for instance, and on top of this, analysis of 16.2 million anonymised longitudinal patient records revealed a significant increase in the proportion of lower respiratory tract infections diagnosed by late 2019 compared to previous flu seasons, raising the odds of UK COVID-19 cases having appeared earlier than previously thought.
By harnessing the information in electronic health records, such findings clearly open the path to near real-time tracking of large-scale population health events that can support public health bodies to detect, investigate, and respond timely and effectively to them.
Patients are becoming more content for their data to be used in this way, however it must be anonymised to tackle privacy and trust concerns. The public have reported they are generally comfortable with anonymised data from medical records being used for improving health, care and services, for example through research. However, there is still worry around this health data being accessed by commercial organisations, and so the privacy and broader benefits of patient data must be emphasised.
For instance, data can be used to improve diagnosis speeds and anonymous data can be overlaid onto NICE guidance, as well as within local and national patient pathways to provide better insight into the types of treatments that might work more effectively for certain patients. ‘Cohorts’ of patients can be created as well as effective treatment profiles based on these individual characteristics, to ensure the most effective treatment pathway is selected and faster. These can be based on existing health conditions, for example diabetes, and co-morbidities. Information such as age, weight, sex, faith, ethnicity and lifestyle choices can also be included to help specialists get closer to the best treatment the first time around to improve patient outcomes.
A prime example of the value of this type of data is in the case of pancreatic cancer, a disease that is often diagnosed late and progresses exceptionally quickly. It’s the deadliest common cancer, and by the time a diagnosis is achieved, many individuals are at stage three or stage four, with 75% not surviving a year after diagnosis. Symptoms are vague and often confused with other conditions such as pancreatitis, gallstones, irritable bowel syndrome (IBS) or hepatitis.
For both GPs and patients, embedding detailed symptom information within clinical systems would be hugely beneficial, enabling far earlier diagnosis and hospital referral. The GP would spend far less of the budget on one specific patient and it would ensure that the patient receives the best treatment possible for that diagnosis and faster referral to the right clinician.
Data analytics can also be used to better understand patient responses to specific treatment types and surgeries, by using predictive modelling to map out likely outcomes – enabling pharma to work closely with healthcare professionals and services to get closer to ‘the right medicine, to the right patient, first time’.
Modelling based on real-world data allows for tailoring and marketing specific medicines to specific groups of patients with specific predispositions or health conditions, and it reduces the ‘trial and error’ process that clinicians sometimes have to follow to find the appropriate treatment.
For example, analysis of cardiac surgery patients has evaluated the risks for certain types of heart surgery as well as post-surgery, taking into consideration a number of factors, including age and ethnicity to improve recovery. This can be extended to provide individual patients with information about their health conditions and risks to empower and encourage them to make changes to lifestyle or behaviours. This Predictive, Preventive and Personalised Medicine (PPPM) explores a complex mix of personal and population health data to avoid future health deterioration or detect problems before they arise.
Ultimately, PPPM will help patients to take control of their own health issues. Retaining individuals within primary care will both save money by reducing the pressure on secondary care and release investment in other areas of high demand healthcare. On a broader level, this detailed predictive model will allow the healthcare system to potentially predict population health issues over the next three to four years, helping to allocate resources to the correct specialties at the right time.
The key to this process is early identification of potential health issues, which requires proactive collection of patient health data – from weight to cholesterol and blood pressure readings. Understanding the trajectory of these readings over the past year, combined with predictive modelling as to the potential outcome if no preventative measures are taken, will help clinicians to present personalised patient advice.
The other important factor is the volume of the datasets used in analysis. The pool of reliable patient data must be detailed and vast in order to provide a complete picture and inform decisions. Globally it’s known that there is significant value to be had, but many researchers are still relying on synthetic datasets which mirror real-world data. This data simply fails to deliver the depth of insight delivered by real-world patient data.
It’s clear that the analysis and use of global health data can drive better patient diagnosis, treatments and ultimately outcomes. There has been a societal shift around the use of personal health data in recent months, as the value of it has been shown in the fight against COVID-19, and this change can continue to leverage benefits.
Primacy Care data is being utilised to inform patient pathways across a range of disease areas and enable better understanding of local health economies, while GPs have a chance to inform life-changing medical research, supporting research crucial to gaining insights and developing policies, and helping to highlight trends in clinical effectiveness