Bomb scare sparks evacuation of plant making AZ COVID-19 vaccine

A plant in Wales manufacturing the AstraZeneca COVID-19 vaccine was evacuated on the advice of the authorities today after it was sent a suspicious package.

Bomb disposal experts were called in to investigate the parcel at the fill and finish facility in Wrexham, operated by Wockhardt UK, which has the capacity to produce around 300 million doses of the vaccine per year.

North Wales Police have asked people to stay away from the area of Wrexham Industrial Estate, where the plant is located, and have set up cordons. There are no reports of any injuries and as yet no word whether the package was dangerous.

The plant was visited by Prime Minister Boris Johnson last month along with Wrexham’s conservative MP Sarah Atherton, shortly after the UK government reserved one fill and finish production line at the unit for its exclusive use for 18 months. The contract covers production of 100 million doses of the AZ vaccine.

At the time, Johnson said the agreement was “a significant milestone for the British life science industry and will help produce the vaccines this country needs.”

Welsh First Minister Mark Drakeford said that the devolved government is “working with local police and the military to find out more about this incident”.

He added: “Thank you to the security personnel who are on-site to protect lives and ensure the safety of our vaccine supply. This highlights the vital role they play in keeping us all safe.”

There’s no indication yet what the motivation for such an act could be, although there have been cases of individuals seeking to disrupt the roll-out of COVID-19 vaccines.

Yesterday, a hospital pharmacist from Wisconsin in the US pleaded guilty to two charges that he tampered with supplies of the Moderna vaccine in an attempt to render them inactive.

Steven Brandenburg (46) deliberately left vials containing 500 doses of the vaccine – which has to be kept at very low temperatures – at room temperature overnight to allow them to spoil. He then returned them to the freezer, and 57 patients were subsequently given the shots.

According to law enforcement, Brandenburg said he was “sceptical of vaccines in general and the Moderna vaccine specifically”.

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What does the future hold for Medical Affairs?

“A new medical affairs communication model is emerging that provides greater collaboration and stakeholder engagement”

I am a clinical pharmacist by training, but my interest lies in drug information. I found out about medical communications when working in the Drug Information Center at the Medical College of Virginia Hospitals. A colleague of mine offered to share some of her freelance medical writing work. After that, I was hooked and bided my time until the first medical communications company I wanted to work for had enough business to hire a medical writer. That was 20+ years ago and I’m still hooked. I love being on the cutting edge of the pharmaceutical industry’s innovations and working alongside people who are just as interested in communicating complex science as I am.

The Medical Affairs function in the pharmaceutical industry has grown in importance in recent years, having a greater voice internally and becoming significant budget holders. It’s fair to say it is now a key third leadership pillar in pharma alongside commercial and R&D.

Medical Affairs teams are collaborating with other departments more than ever – partly because of expiring corporate integrity agreements, partly due to the rich datasets and insights generated by medical affairs, but also partly because of a trend toward collaboration-centric and cross-functional ways of working. Combine these factors with the age of digital transformation and it’s a recipe for a whole new suite of communication strategies and tools in medical affairs.

These trends give us more opportunities to partner with our clients to strategize and help them navigate the changing market dynamics, bringing insights together from multiple stakeholders. Even traditional publication work has experienced new life by embracing digital innovation, with publication enhancements such as animated figures, e-posters, and author videos.

“Combine these factors with the age of digital transformation and it’s a recipe for a whole new suite of communication strategies and tools in medical affairs”

As the Medical Affairs function has become more connected, we have honed our integrated approach to support pharmaceutical teams across the full product lifecycle and the associated customer journeys. Opportunities range from consulting on research and development, the pipeline and product development to working on publications and medical affairs strategy and implementation, all the way to commercial support. It is not uncommon for us to begin working with medical affairs clients and expand to internal clients interested in our market access, internal training, multichannel, and media support capabilities.

One of the biggest challenges our clients will face is extracting strategy-changing insight from the rich array of data they can access and creating clear communications. However, like the world in general, the pharmaceutical industry is beginning to experience data overload. Organizations are inundated by easily accessible information, but how do they navigate insight and find a story that resonates?

As we know, and to quote the author Simon Sinek, stories are much more engaging when the audience understands the “why.” Scientific communicators, such as ourselves, are well-placed to help navigate the data and insight, defining the clear story for communication of the “so what” for our clients and their audiences.

The appetite for data, and healthcare data specifically, is ravenous. At the same time, many of our clients have undergone digital transformations. The way we visualize data now – in infographic formats and animated illustrations – has made data even more interesting and engaging.

“Organizations are inundated by easily accessible information, but how do they navigate insight and find a story that resonates?”

New strategies, technologies, and tools, driven by artificial intelligence and the ethos of personalization, will come into play to shape communications that achieve greater reach and impact than ever before. However, Medical Affairs teams will need deeper insight to determine what tools and channels will work best in communicating scientific data and messages with patients and healthcare providers on their interconnected journeys.

With all this in mind, a new medical affairs communication model is emerging that provides greater collaboration and stakeholder engagement, based on the tailored application of deeper insights. As a result, scientific engagement is becoming much more sophisticated, which places a strong emphasis on greater internal collaborations between medical affairs, other departments, partnerships between patients and healthcare professionals, and, of course, agencies like us! I’m looking forward to seeing all this come together in new and interesting ways, so it’s certainly an exciting time to be part of a company such as ours.

To find out more about our work in Medical Affairs and how we can help you solve your challenges, contact [email protected]

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UK agency Aurora promotes Chris Bath to managing director

Independent UK comms agency Aurora has promoted Chris Bath to managing director.

In a statement the London-based agency said Bath joined in 2015 and achieved rapid promotion to the agency’s management team.

As well as providing senior counsel to clients and agency teams, he led the development of the agency’s digital insights capability and recently launched its measurement practice, Acumen, which helps clients prove the impact of their communications.

Aurora was founded in 2005 by Claire Eldridge and Neil Crump and has recently launched a sister consultancy, Atlas.

This supports clients to connect with patients and advance products and services through strategy, co-design and organisational change services.

Despite the pandemic, Aurora said it has been able to continue to hire and promote, to build its team of 28 communications experts.

Aurora is the sole UK agency and European hub for GLOBALHealthPR, the largest independent health and science communications agency partnership worldwide.

CEO Claire Eldridge said: “Chris is the ideal person to lead this charge, both from a cultural and capability perspective.

“He provides excellent counsel, champions evaluation, and lives our company values every day. In doing so, he enables our healthcare clients to communicate effectively and so achieve better patient outcomes – which is what Aurora is all about.”

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Plugging modular content into pharma’s omnichannel strategies

86% of respondents to a recent Veeva survey of pharma and biotech professionals said they are creating a greater volume of content now, compared to six months ago.  Yet while many pharma companies are creating more content than ever before, they also face increased pressure to quickly deliver highly personalised – and compliant – content to HCPs.

The proliferation of digital channels – and the COVID-promoted shift to remote working – have focused attention on speed and quality, so further work is needed to make the content creation process more efficient and less prone to error.

At a time when pharma marketing materials are often recreated and reapproved multiple times, and when regional teams can struggle to reuse assets across different regions, a dramatic shift in how to draft, review and distribute assets is needed. Modular content can provide a new foundation for creating relevant commercial content faster and at scale.

To assist executives in life sciences with scaling marketing assets in a virtual world Veeva has published a new eBook, Powering Omnichannel Strategies with Modular Content.

Acknowledging that life science companies are on a continuing journey with their use of modular marketing content, the eBook looks at how speed, personalisation and compliance will define the future of the content ecosystem – from creation all the way through to omnichannel delivery.

The publication provides:

  • A clear process for creating pharma modular content
  • A roadmap for bringing modular content to life
  • The key questions sales and marketing executives should ask of their content
  • An outline of the metrics for success that can be applied
  • A way to approach change management in modular content

Download Powering Omnichannel Strategies with Modular Content.

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ARK promotes King to client services director, hires Rodriguez as art director

London-based comms agency ARK has promoted Nicky King to client services director, with Martina Germinario Rodriguez joining as art director from Langland.

King joined ARK, which describes itself as “the data-driven agency”, in 2018 as co-founder and account director and helped grow two of the biggest accounts in the group.

After working with a variety of healthcare clients she grew her team in 2020 with three new recruits and oversaw a global pharmaceutical brand launch.

Zsofia Kopetka, co-founder and managing director, described King as “one of the hardest workers and most positive people in the industry”.

Meanwhile, Rodriguez joins the creative team at ARK as art director and will be reporting to Dom Marchant, founder and chief creative officer. She joins from Langland and previously worked at Publicis LifeBrands.

Marchant said of the appointment: “We are delighted to welcome Martina into the ARK family as she has demonstrated great skills in various disciplines and across media in her work.”

“She has developed a great portfolio and considerable experience in a relatively short time. Having looked at many, many candidates for this role, we knew that we had struck gold after the first interview and we are excited to see Martina augment the agency’s creative output over the coming years.”

ARK’s pharma clients include AstraZeneca, Bayer and Kyowa Kirin.

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Pharma digital transformation: customer data expected to play a pivotal role

A new survey highlights the importance of customer reference data to digital transformation and analyses ways pharma companies can improve the quality of their datasets.

In a remote world, customer data is more foundational than ever, and Veeva’s 2020 European Customer Reference Data Survey found 91% of organisations view customer data as a global strategic asset, while 88% said it’s essential for new product launches or sales models.

However, the research suggests more work is needed – 41% of respondents said they are not satisfied with the quality and service they receive from their legacy customer data provider.

Furthermore, only 57% of respondents believe their organisation has the right customer data foundation to fully support digital transformation, a figure that drops to 43% when they don’t believe their data governance is efficient.

Commenting on the results, Boehringer Ingelheim’s global head of data excellence Philippe Houben noted that “without strong data governance across the organisation, life sciences cannot have the right foundation to support digital engagement initiatives”.

More pharma companies are moving in this direction, and 78% of respondents said they are undertaking, or planning, a customer data enhancement initiative.

Rebecca Silver, general manager, Veeva OpenData, said: “Having a complete, full picture of the customer is key to getting the right insights and accelerating digital engagement.”

Insights from the 2020 European Customer Reference Data Survey can help translate this ambition into better customer data across organisations. In particular new report analyses:

  • The role of customer data in digital transformation
  • The impact of good data on product launches and sales models
  • How to develop analytics and reports
  • Challenges and solutions for customer data integration

Where in the past there were often gaps between intentions and investment when it came to customer reference data, now is the perfect time to build a strong data foundation to drive true digital transformation.

Download: 2020 European Customer Reference Data Survey

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GSK’s Neale Belson on building trust with employees and society

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.

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Nine for 2021: Addressing the pandemic legacy

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.

Environment divergence

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 accelerate

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 RickwoodSarah 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.

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Tivicay approved in Europe in new dispersible tablet for children with HIV

ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV.

The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation.

These tablets are used in combination with other antiretroviral agents for treatment of human immunodeficiency virus type-1 infection in paediatric patients.

To be eligible, children must be at least four weeks of old, weighing at least 3kg and must not have been treated with an integrase inhibitor, although it doesn’t matter whether they have been treated with other drugs classes.

This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

Approval is based on data from the ongoing P1093 and ODYSSEY studies, which are being conducted in collaboration with international paediatric research networks.

P1093 is a a safety, tolerability and dose finding registrational study in paediatric patients aged four weeks to 18 years being conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania.

ViiV Healthcare, the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) are collaborating in this trial.

ODYSSEY is a randomised control efficacy trial in first and second- line treatment, in paediatric patients aged four weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa.

Originally designed to support World Health Organization (WHO) guideline recommendations by WHO weight bands, this study will now also provide data to support revised dosing and continue to 96 weeks.

ViiV Healthcare, the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY are collaborating in this trial.

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Amgen’s Enbrel heads ICER list of unjustified US price rises

US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence.

The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for all but one the list price increase was at least double the US rate of inflation in that year.

Amgen’s venerable TNF inhibitor Enbrel (etanercept) for arthritis and other inflammatory conditions topped the list of offenders in terms of the added cost to the healthcare system, which ICER – the Institute for Clinical and Economic Review – estimated to be $403 million.

Enbrel’s list price rose 5.4%, but the net price was up almost 9% once adjusted for other factors, which could include rebates, wholesale fees and other variables like patient assistance programmes.

Second place was Johnson & Johnson’s schizophrenia treatment Invega Sustenna/Invega Trinza (paliperidone), with a 6.8% increase in the list price – and 10.7% net – which added $203 million to US drug spending.

The biggest price increases were seen with Salix’ irritable bowel syndrome therapy Xifaxan (rifaximin) – up 8.4% and 13.3% respectively – which added $173 million to the national spend.

The rest of the seven were: Bristol-Myers Squibb’s arthritis drug Orencia (abatacept) at a cost of $145 million; Biogen’s multiple sclerosis therapy Tecfidera (dimethyl fumarate) at $118 million; AbbVie’s TNF drug Humira (adalimumab) at $66 million; and UCB’s Vimpat (lacosamide) for epilepsy which swelled spending by $58 million.

“Several of these treatments have been on the market for many years, with scant evidence that they are any more effective than we understood them to be years ago,” said ICER’s chief medical officer David Rind.

The increases came against a backdrop of relatively modest price increases overall in 2019, a time when the US administration had recently published a series of proposals to tackle high prescription drug prices, although many of those failed to come to fruition.

It’s worth noting that the scale of the increase identified in the latest report is considerably lower than was seen in ICER’s last edition in 2019. That also identified seven hefty price hikes for products – including Humira and Tecfidera – but cumulatively they all added a massive $4.8 billion to the US drugs bill.

According to a 2019 report by the OECD group of industrialised nations, the US spends roughly twice the average amount spent by other member countries on pharmaceuticals per head.

Three drugs also saw sizeable price increases, but ICER says those may have been justified by new clinical evidence – although the organisation notes it hasn’t run a full cost-effectiveness analysis.

The three were Novartis’ heart failure therapy Entresto (sacubitril/valsartan), Takeda’s Entyvio (vedolizumab) for ulcerative colitis and Astellas’ prostate cancer therapy Xtandi (enzalutamide).

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Are face-to-face medical meetings a thing of the past?

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.

International reach

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.”

Re-creating face-to-face

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.

Industry adaptations

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.

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AmerisourceBergen buys Walgreens Boots Alliance wholesaling business for $6.5bn

US wholesale giant AmerisourceBergen is to buy the majority of Walgreens Boots Alliance’s wholesaling business for around $6.5 billion in a cash and shares deal.

AmerisourceBergen will pay $6.275 billion in cash and around 2 million shares of its common stock for Alliance Healthcare in a deal to support its global distribution business.

Alliance will be able to increase the expansion of its core retail pharmacy business as a result of the transaction, which involves a business that generated revenues of $19 billion in full year 2020.

The acquisition applies to the global healthcare business, including the UK market, with the exception of China, Italy and Germany.

The deal is expected to close by the end of AmerisourceBergen’s fiscal year on 30th September according to a joint statement from the two companies.

This latest deal builds on a partnership dating back to 2013, leading to Walgreens Boots Alliance becoming the largest shareholder in AmerisourceBergen, with a nearly 30% stake in the company.

The two companies have agreed to strengthen their strategic partnership by extending and expanding their commercial agreements.

A US distribution agreement will be extended by three years until 2029 and the partnership is being expanded to include a commitment to pursue new opportunities in sourcing and distribution.

Alliance Healthcare UK will remain the distribution partner of Boots until 2031 and the companies said these agreements are expected to create incremental growth, synergies and efficiencies.

The savings from the acquisition for AmerisourceBergen will increase to an annual run-rate of $75 million in the fourth year.

The combined business is forecast to see its cash flow increase by 125% compared with AmerisourceBergen’s estimates of its stand-alone business.

The companies said that the agreement will expand distribution networks for specialty medicines such as cell and gene therapies.

AmerisourceBergen said the acquisition is not expected to have an impact on its dividend policy.

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COVID-19 and the digital pharma marketing revolution

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.

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2021 Outlook: The future for life sciences customer experience

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.

Check out the full report: COVID-19: Accelerating Digital Transformation in Life Sciences

Download the executive summary: COVID-19: A Pulse of the Life Sciences Industry

About Omnipresence

Omnipresence Logo

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.

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Health strategy consultancy CREATION.co makes two senior hires

Health strategy consultancy CREATION.co has made two senior appointments, with former government analyst Tom Bourne and former TV marketer Victoria Donougher getting on board.

Bourne has joined as associate director, analytics overseeing a team of 36 analysts, data scientists and language specialists at the company’s global offices.

His brief will be to lead the team providing strategic insight to CREATION.co clients.

Bourne has previously held analytical roles at both local and national government level. Most recently at Kent County Council as the public health intelligence manager, he oversaw a team of specialist public health analysts which supported local government’s tracking of the spread of COVID-19 cases.

Earlier in his career, Bourne spent five years working as senior analyst at the UK’s National Audit Office, where he strategically led and undertook various elements of health value-for-money audits of government spending on behalf of Parliament.

Donougher has joined as associate director of marketing and communications, where she will lead a team focused on sales and marketing.

Previously, Donougher ran her own marketing consultancy business specialising in strategic and digital marketing for SMEs and start-ups.

Prior to running her own business, Donougher held marketing roles at a number of television and publishing companies, including Disney and BBC.

CREATION.co provides insights and consulting to inform health strategy, communications and policymaking among some of the world’s largest healthcare companies, government organisations and NGOs.

 

 

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Pfizer drops the blue pill, kicks off 2021 with new DNA logo

Pharma companies are always talking about moving ‘beyond the pill’, and Pfizer’s new brand identity embodies that – it’s decades old pill-like logo has been replaced with a DNA double helix that it says reflects its commitment to breakthrough science.

The logo – which retains the company’s traditional blue colour scheme – has been more than 18 months in the making and according to the company it is “unlocking the pill to reveal Pfizer’s DNA: the power of science.”

It’s likely no coincidence that Pfizer’s flagship project in 2020 while the design of the logo was being finalised was unquestionably its high-profile alliance with BioNTech on the RNA-based coronavirus vaccine Comirnaty, which provided further evidence of the potential of harnessing genetic toolkits to tackle health issues.

In fact, one wag on Twitter compared the time taken to come up with logo to the mere seven months Pfizer and BioNtech needed to bring their COVID-19 vaccine through clinical testing:

Another took issue with the orientation of the helix part of the logo, claiming it overlooks some basic scientific principles.

Pfizer has also been changing a lot in the last few years, moving away from being a diversified healthcare company covering branded human and animal medicines, generics and consumer health products to one focused on novel therapies.

Last year, it exited generics – which had been a drain on profit – after combining its Upjohn unit with Mylan to form Viatris. It’s also in the process of offloading consumer health into a joint venture with GlaxoSmithKline and several years ago spun out its animal health assets into standalone company Zoetis, so as to concentrate on higher-margin, innovative drugs.

The logo also “signals [a] shift from commerce to science”, according to an explanation on Pfizer’s website, but retains the same tagline as its predecessor: “Breakthroughs that change patients’ lives.”

A Wall Street Journal article notes that Pfizer surveyed more than 4,000 patients and 2,000 doctors across multiple countries, and held 12 internal focus groups, before deciding on the new design.

“Our new identity reflects the dignity of Pfizer’s history and captures the innovative spirit and science focus alive in the company today,” said Sally Susman, Pfizer’s executive vice president and chief corporate affairs officer.

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Ex-Resolute co-founder Blackburn starts hybrid agency Certain Health

Former joint founder and owner of Resolute Communications and Real Science Paul Blackburn has launched a new hybrid agency, Certain Health.

Blackburn made the move after Resolute and Real Science were absorbed into Publicis Langland.

The company said its hybrid model has the benefits of both the traditional and virtual agency models, with expertise in health PR, medical education and the creative space.

Former joint founder and owner of Resolute Communications and Real Science Paul Blackburn has launched a new hybrid agency, Certain Health.

Paul Blackburn

Prior to founding Resolute and Real Science, Paul Blackburn was a former MD of Fleishman Hillard UK, founder and MD of Ketchum UK’s healthcare practice, head of healthcare at Edelman UK and a former pharmaceutical marketeer.

The company aims to serve companies from biotech, pharma, devices, consumer tech, health and nutrition sectors.

It launches with a small number of clients, which have not been disclosed, including in the UK and Europe.

Blackburn said: “I started reaching out to a handful of potential clients in the middle of the year to see what interest there would be in a new hybrid consultancy model working on projects and programmes, local and global, and have been very pleased by the feedback.

“For years I’ve felt that a more flexible and integrated structure could bring huge benefits for clients and colleagues – now starting with a small team I’m making that a reality.

“For clients, this hybrid structure optimises resources, enables creativity and even greater collaboration, but most importantly allows many of the outstanding people in our industry who could work with us, to improve their work-life balance and so continue to develop their careers in the optimal way.”

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UK parliament backs EU trade deal, as industry sifts through detail

The post-Brexit trade deal agreed on Christmas Eve has been overwhelmingly backed by the UK parliament, providing some degree of stability – but also plenty of disruption – for the coming months and years.

The UK is leaving the EU’s single market and customs union, but the deal means tariffs on goods won’t be imposed when the transition period ends at 23:00 GMT tonight.

In a marked divergence from the wrangling and acrimony that surrounded votes on the withdrawal agreement a couple of years ago, the EU (Future Relationship) Bill was backed by 521 votes to 73 last night.

Prime Minister Boris Johnson said the deal – which comes four-and-a-half years after the UK voted to leave the EU in a referendum – will “fulfil the sovereign wish of the British people to live under their own laws, made by their own elected Parliament.”

The new regime has been welcomed by pharma organisations on both sides of the English channel, although there are still a lot of unanswered questions about what it will mean in practice for the regulation and trade in medicinal products.

With the text of the 1,200-page document now available, it has been confirmed that there will be mutual recognition between the two parties, which means that inspections and certification of good manufacturing practice (GMP) facilities by the UK regulatory authority will be recognised by the EU, and vice versa.

What appears to be missing at first glance from the document however is mutual recognition of safety and quality testing, which might mean some duplicate tests are needed.

The appendix on medicines does however refer to “the exchange and acceptance of official GMP documents between the parties,” and includes an article covering “regulatory cooperation” on changes to technical regulations or inspection procedures.

To make that easier, a Working Group on Medicinal Products will be set up to monitor the impact of the deal on medicines in the UK and EU, for example to respond if there is a threat to medicines supply or public health, and organise future cooperation in areas like scientific or technical guidelines.

BioIndustry Association (BIA) chief executive Steve Bates said after the deal was agreed that it provides “much desired certainty for our sector” after four years of negotiation, although the trade body is still working through the details of the text.

BIA said that traders can self-certify the origin of goods sold and enjoy “full cumulation”, making it easier to comply with requirements and obtain zero-tariff access, adding that there will be specific facilitation arrangements for pharmaceuticals and chemicals.

The appendix on medicinal products is far from detailed – in fact, Labour Leader Keir Starmer has described the entire document as “thin”, whilst also instructing his party to back it in the parliamentary vote to prevent no deal.

There are other encouraging points for the life sciences, according to the BIA, including the UK continuing to have access to the Horizon Europe Research and Innovation programme as a paying third country.

“We look forward to working with the UK government on this positive agenda, mindful of the fact that our sector seeks, and benefits from, innovative global standards and regulatory collaboration and co-operation,” said Bates.

A joint statement released by the Association of the British Pharmaceutical Industry (ABPI) and European Federation of Pharmaceutical Industries and Associations (EFPIA) – representing the UK and EUK pharma industries – also said it would take time to examine the details of the agreement.

“We have always said that a deal is in the best interest of patients in the UK and the EU,” they said, adding: “regardless…the end of the transition means there will be a significant change in how border and customs arrangements work come Jan 1st and companies have been working on contingency plans to mitigate any disruption.”

Flurry of MHRA guidance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has already started publishing guidance on how things will change from Friday.

This week, for example, it confirmed it will set a 150-day assessment timeline for new medicines, whilst also providing details of its equivalent to the EMA’s “rolling review” designed process to speed up access to novel medicines.

It has also provided updates on the processes needed to submit changes to marketing dossiers for medicinal products, as well as for amendments to clinical trials.

Image by DANIEL DIAZ from Pixabay

 

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The top 5 pharma M&A deals of 2020

2020’s M&A activity hasn’t quite reached the heights of last year’s, where two pharma mega-mergers – BMS’ buyout of Celegne and AbbVie’s acquisition of Allergan – accounted for almost 40% of total M&A deal values.

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.

AstraZeneca & Alexion

By far the biggest pharma deal of the year is AstraZeneca’s late-breaking offer to buy Alexion for $39 billion.

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.

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Have you checked your brand’s temperature?

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?

3 logos

 

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

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]

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Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table

Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.

The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s 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.

The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.

Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.

Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.

It marks something 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.

Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.

Meanwhile, AZ will also picks 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.

AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.

Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.

Along with  new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.

That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).

“Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.

“This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”

The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.

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Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table

Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.

The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s 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.

The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.

Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.

Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.

It marks something 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.

Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.

Meanwhile, AZ will also picks 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.

AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.

Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.

Along with  new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.

That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).

“Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.

“This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”

The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.

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OVID Health appoints high-profile leaders as senior counsel

Independent communications agency OVID Health has appointed Niall Dickson, professor David Salisbury and Athena Lamnisos as senior counsel, providing strategic advice and thought leadership across several projects involving healthcare and pharma clients.

In addition to these appointments, Grace Holland has joined the team as account manager.

For more than thirty years Niall Dickson has been at the centre of health policy and regulation and most recently was CEO of the NHS Confederation, representing UK health service organisations.

He was formerly CEO and registrar of the General Medical Council and is a well-respected leader in health policy and communications. His previous roles include CEO of the King’s Fund, the BBC’s social affairs editor and health correspondent, as well as editor of Nursing Times. He was awarded a CBE for patient safety in 2017.

Prof Salisbury was director of immunisation at the Department of Health until the end of 2013. He was responsible for the national immunisation programme and led the introduction of many new vaccines.

He is the chair of the Global Certification Commission and Chatham House’s Global Health Programme Associate Fellow. He previously chaired the WHO’s Strategic Advisory Group of Experts on Immunization, the WHO committee that sets global immunisation policy. He was made a Companion of the Order of the Bath in 2001.

Athena Lamnisos is a senior third sector leader and is currently CEO of leading women’s cancer research charity, The Eve Appeal. Athena is experienced at forging partnerships between private, public and not for profit sectors. She has a track record of directing successful change programmes in the arena of public health and oncology and is passionate about making service user voices central to strategy.

Grace Holland joins OVID from specialist life science PR agency Zyme Communications, where she managed client accounts in the respiratory, oncology, digital, diagnostics and AI sectors, helping to build corporate value and generate interest with scientific and investor audiences. Grace’s academic background is in biology specialising in genetics.

OVID was founded in 2018 by ex-Lib Dem health adviser and agency leader Jenny Ousbey. In recent weeks the agency has won and been highly commended as New Agency of the Year (PR Moment and PR Week Awards 2020).

In the past year the agency has achieved six-figure growth and launched the Patient Partnership Index, an initiative that aims to help create better partnerships between the pharma industry and patient communities.

 

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UK, EU agree Northern Ireland medicines, food border controls

The UK and EU have reached an agreement on border checks for Northern Ireland that should guarantee that trade in medicines and food continues without disruption after 1 January – regardless of whether eleventh-hour negotiations result in a trade deal.

The agreement means that the UK government will not press ahead with plans to override parts of the Withdrawal Agreement in order to prevent a border down the Irish Sea, which would have broken international law.

The agreement is separate to the post-Brexit trade deal talks, which appear to be at an impasse at the moment, but remove one complication and could build goodwill between the negotiating teams.

Details of the agreement have yet to be released, but in a statement the two sides said it covers issues including the supply of medicines, border checks on animal and plant products, and deliveries of chilled meats and other food products to supermarkets. There was also “clarification” on the application of rules on state subsidies.

As a result, the UK has said it will withdraw clauses of the UK internal market bill, and will not introduce any similar provisions in a forthcoming taxation bill, that would have rewritten the Withdrawal Agreement to protect trade between Great Britain and Northern Ireland.

The EU has previously threatened to take legal action if those earlier proposed changes had been implemented.

The agreement follows talks in Brussels between Cabinet Office Minister Michael Gove and EU commissioner Maroš Šefčovič as part of the EU-UK Joint Committee, but with details currently scant, some NI politicians have said they are worried about the potential for the EU to have continued influence in their jurisdiction.

As part of the agreement there will be an EU presence in Northern Ireland to monitor implementation of the protocol at the border, which has been slammed by the Democratic Unionist Party (DUP).

The government said today that 98% of GB businesses exported to NI will not face any tariffs, and items shiped into the EU via NI will also largely be expempot from levies.

Efforts to reach an accord on a broader trade deal to come into effect on 1 January when the Brexit transition period comes to an end remain deadlocked over fishing rights, business competition rules and how any trade deal would be enforced in future.

UK Prime Minster Boris Johnson is scheduled to meet with EU Commission President Ursula von der Leyen this evening to try to make a breakthrough in the talks.

Gove told ITV News that businesses in Northern Ireland “have the opportunity to enjoy the best of both worlds; access to the European single market… and at the same time unfettered access to the rest of the UK market.”

When it comes to the regulation of medicines, several weeks ago the UK and EU agreed a phased process for implementing medicines regulation in Northern Ireland for an additional year, i.e. up to 31 December 2021, to avoid an abrupt change in the rules.

Under the terms of that earlier agreement, the EU pharmaceutical regulatory framework will continue to apply in Northern Ireland from 1 January, but would be enforced by the UK Medical and Healthcare products Regulatory Agency (MHRA).

Great Britain – which is the supply route for 80% of medicines used in Northern Ireland – will no longer have to comply with EU regulations if no trade agreement is forthcoming.

The 12-month period will provide additional time needed for businesses to prepare for changes to batch testing, importation, and the need to scan a unique identifier on medicine packs at the point of dispensing to protect patients from falsified, expired or recalled drugs – part of the EU Falsified Medicines Directive.

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Are pharma’s TV ad strategies out of date?

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.”

For more information read the full whitepaper.

About the interviewee

Justin ChaseJustin 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.

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A history of Pfizer

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.

For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.

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Online Live Team Pharma Forecasting Training Now Available

Working remotely can have its challenges, why not get together for a fun and rewarding learning experience and refresh your forecasting skills?

Following the success of J+D Forecasting’s face to face training, the content has been redesigned to make it suitable for live, online audiences.  There are two types of courses, type one is tailored to your objectives and delivered by experienced forecasting professionals via a sharing platform. Your team is interviewed prior to the training and the focus of the training is agreed in advance with you and your colleagues.

The second type of training allows you to choose from a selection of pre-set courses that are completed when you choose. The most popular independent courses are the Fundamentals of Forecasting and Oncology Forecasting courses.

The training is suitable for anyone involved in pharmaceutical forecasting who wishes to refresh or learn new skills. It is particularly useful for Forecasters, Marketeers, Analysts and Market Researchers.

In addition, trainees gain access to FC+ software, case studies and quizzes, plus reminder cards.
For further information get in touch: [email protected] or visit jdforecasting.com

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Langland appoints Angela Rochelle to clinical trial diversity role

Langland has announced the appointment of Angela Rochelle as account director, head of diversity initiatives in clinical trials.

Rochelle will be the agency’s leading advocate for diversifying patient representation in Clinical Trial Experience (CTE).

She will collaborate with Langland’s established clinical trial inclusivity taskforce—a team committed to designing and deploying clinical trial communications that proactively address common barriers experienced by underrepresented communities, and advising on best practices throughout the agency’s US, UK, and Australia offices.

Rochelle’s appointment comes as the agency reaffirms its commitment to equity and fair representation in clinical trials, and in the broader healthcare communications industry.

Prior to joining Langland, Rochelle spent time at some of the country’s leading multicultural advertising agencies working with high-profile clients such as Unilever, General Motors, Walmart, and Proctor & Gamble.

Her more than two decades of industry experience has also involved successful roles in healthcare advertising account management, including recent clinical research and patient advocacy work with clients including Bristol Myers Squibb.

Rochelle now brings her considerable expertise to Langland’s established legacy of excellence in clinical trial recruitment and experience.

Recognising that equitable representation should be a goal across the industry, Langland has also increased its focus on practices that build a more diverse and inclusive workplace.

Across all of its locations, these practices include anonymised resumé submissions, mandatory unconscious bias training, career programs, and school relationships for people from mixed socio-economic backgrounds, as well as internal support communities for women, LGBTQ+ (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning, and Related Communities), and BIPOC (Black, Indigenous and People of Color) employees and their allies.

In Langland’s US office, as more staff have been brought on to support expanding CTE business, 80% of new hires self-identify as BIPOC; overall, 40% of total US staff—including 40% of agency leadership at the account director level and above—self-identify as BIPOC.

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VMLY&R creates global healthcare agency for innovative pharma companies

Marketing agency VMLY&R has launched a new global healthcare agency, VMLY&Rx, to service specialty prescription pharmaceutical companies developing innovative breakthrough therapies.

The global VMLY&Rx offering has been created by aligning teams from within WPP Health Practice — including the specialist talent from Sudler in France, UK, Germany, Italy, Switzerland, Spain, China, and Japan — with VMLY&R, an agency with deep roots in creativity, technology, and customer experience.

This new agency will be led by Claire Gillis, international CEO of WPP Health Practice. VMLY&Rx will expand the healthcare offering of VMLY&R outside the US by providing global solutions with specialty prescription pharmaceutical expertise for client partners.

The new entity has been developed to service expansion within the prescription medicines market, the trend towards specialist and personalised therapies, and the surge in innovative health technologies.

The Sudler brand will be officially retired at an international level.

VMLY&Rx will also help its clients address the growing fragmentation in the management of disease, enabling connected support across a broad range of multidisciplinary stakeholders throughout the health ecosystem.

This followed an announcement in September where WPP Health Practice announced its partnership with The European Society for Person Centered Healthcare (ESPCH).

This is the first partnership between a healthcare communications company and an academic society dedicated to patient centricity.

Announced at a critical moment for patients, the partnership will bridge critical gaps in understanding and result in the development of a proprietary theoretical framework for analysing person-centred healthcare for agencies, health systems, health care providers, clients and societies.

On a day-to-day basis, it will enhance the development of patient-centric client services and creative communications through multi-stakeholder engagement such as development of frameworks around person centred healthcare for specific diseases.

Following the pandemic, the partnership will provide evidence-based learnings to further understand and highlight patients’ continued challenges and needs.

 

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The calm after the storm: How COVID-19 is making pharma more resilient

COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 will serve the industry well for years to come. As part of our EU Leader series, Christian Pawlu, head of strategy, portfolio and BD&L at Sandoz, told us about how securing supply in a time of crisis will ensure future access, build resilience, and transform relationships.

Since the start of the year, pharmaceutical companies have been riding a rollercoaster of challenges. Pawlu describes a “perfect storm” as the various strands came together to threaten supply chains.

“First, we saw a doubling or tripling of usual demand for a lot of our products. At the same point, there were big worries about supply chains in China.

“Then, as we went further into the crisis, there were some almost protectionist moves in some countries, as they placed or considered export bans on active pharmaceutical ingredients (API).”

Navigating this rapidly evolving landscape presented a challenge, but not an insurmountable one, Pawlu says.

“The industry, and our company in particular, always has business continuity plans in the drawer. But never in recent history have we had to pull out strategies for so many of our products and subsidiaries at the same time and put them into place.”

Daily calls with supply chain colleagues, activating second sources and alternative supply chains, along with strategic API and finished product stockpiling, all contributed to an absence of any major disruptions.

“For us, the crisis was also a reminder of our purpose as a company: to provide and pioneer access to the patient. We were the first company to commit to keeping prices stable for drugs seen as essential treatments for COVID-related symptoms.

“As an industry, we will have to be more honest with ourselves. We’ll be much better able to see where we have a really deliverable message and when we elicit a response, rather than measuring it by the time people spend with the customer”

“We made a commitment early on that we would not want to benefit from any shortages. In addition, we have made a commitment to provide 15 drugs to low-income countries at cost.”

Remote pharma

COVID-19 has fundamentally changed the way all sectors work on a day to day basis, but pharma did not have the luxury of time in allowing these changes to bed in.

Within a week, all 100,000 employees at Sandoz and parent company Novartis had transitioned from office to remote working, a process Pawlu describes as relatively “frictionless”.

“The biggest challenge was the interaction with our customers, because we weren’t able to see healthcare providers physically anymore. But, in the end, that turned out to be an opportunity.”

Before the pandemic, Sandoz was able to reach around 15% of its customers digitally, but that has now increased to around 70%.

As people adjusted to connecting digitally, through Zoom, Microsoft Teams, and other video-based software, in their private lives, this expanded into their professional lives, says Pawlu.

“Traditionally, the way we interact with our customers has been a big barrier to conveying messages, particularly in off-patent pharma.”

While using digital channels will not necessarily be easier, it will make companies think differently about how best to interact with healthcare professionals, Pawlu believes.

He says: “The key question we need to ask ourselves is, if we have more access to physicians, how do we want to use it? More reach? More efficiency?

“We are working through this as we speak and are thinking how we complement or even replace the traditional channels, and how we can reach customers we haven’t reached so far. It’s exciting.”

As the industry moves from a face-to-face to digital communication model, it needs a change of mindset, he adds.

“A physical person showing up in a physical office is the old normal.

“As an industry, we will have to be a bit more honest with ourselves. We’ll be much better able to see where we get access, where we have a really deliverable message, and when we elicit a response or an active request for follow up, rather than measuring it by the time people spend with the customer.”

Resilient future

Another change Pawlu hopes is here to stay is the increased communication and collaboration between industry and policy makers.

This is, in part, thanks to a greater appreciation of the importance of resilient supply chains, he says.

“Over the last 30 years, the volume of products produced in Europe versus Asia has flipped. The majority of APIs and an increasing share of FDF is currently being manufactured in Asia,” explains Pawlu, adding that this was driven, particularly in generics, by price.

“I think the balance we need to keep in mind is cost, quality, and resilient supply. You can optimise all three, but you can only maximise two at the same time.

“If you can go for the highest quality and resilient supply, you will have to pay a higher cost, or you do it the other way around – of course we never want to compromise on quality.”

Supply chain issues during the pandemic have brought this argument into sharp focus, and it is now “on the radar” at an international level.

“Sandoz has been in contact with heads of governments across Europe, and I’m extremely happy that this topic has gained so much attention,” he says, adding that the European Commission has committed to developing a continent-wide pharma strategy.

Back in July, Sandoz announced that it had entered a partnership with the Austrian government to keep production of penicillin at the company’s Kundl facility – the last remaining integrated production chain for antibiotics in the western world.

“Austria is something that’s been very visible, but we’re having similar discussions on other product areas with other governments,” Pawlu says.

Ultimately, 2020 has been a challenging time for pharma, but it has also presented a myriad of opportunities to learn and evolve.

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives.

About the interviewee

Christian PawluChristian Pawlu is the global head, strategy, portfolio and BD&L for Sandoz and a member of the global Sandoz Executive Committee. Christian studied medicine in Germany, Canada and France and is a licenced physician. Before he joined Sandoz, Christian was a start-up entrepreneur.  He was a partner at McKinsey & Company where he specialised in pharmaceuticals and medical products with a focus on generic drug manufacturers. Prior to joining McKinsey, Christian was a neuroscience researcher at the university of Freiburg, Germany. Christian is married to a professor of medicine and they have three children.

About the author

Paul TunnahDr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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Alliance and Boots donate dexamethasone to NHS

The UK’s largest medical wholesaler and pharmacy have donated half a million dexamethasone tablets to support the effort against COVID-19.

Alliance Healthcare and Boots, both part of Walgreens Boots Alliance, donated the 2mg Almus Dexamethasone tablets to the NHS to support it during the pandemic.

The decision followed the findings of the RECOVERY trial, which showed the low-dose steroid treatment can reduce fatalities by up to a third in hospitalised patients with severe respiratory complications of COVID-19.

Alliance’s UK managing director Julian Mount and Boots’ managing director for UK and Ireland Seb James, wrote letters to NHS chief executive officer Sir Simon Stevens and health secretary Matt Hancock offering to donate the lifesaving medicine to the NHS.

Alliance has completed the delivery of the dexamethasone tablets to Public Health England, which is holding stockpiles of medicines to be distributed to NHS hospitals across the UK as they are needed.

The findings of the large scale RECOVERY trial were hailed as a “major breakthrough” after showing that after 28 days of treatment, dexamethasone cut mortality by a third in patients who needed mechanical ventilation. In a control group, 41% of patients had died.

For patients who required oxygen support, 25% of patients in a control group had died after 28 days, while dexamethasone reduced that rate by 20%.

The drug did not have an effect in patients who did not require oxygen or ventilation.

Results also showed what didn’t work: the anti-malarial drug hydroxychloroquine, which was stockpiled on the orders of the Trump administration in the US, did not produce a significant effect.

John Southall, senior pharmacy purchasing technician at Mid and South Essex University Hospital NHS Foundation Trust, said: “It was evident from early COVID-19 trials that dexamethasone was very important in the treatment of severely ill patients as it was shown to improve symptoms very quickly in some patients, consequently preventing many patients progressing on to requiring costly mechanical ventilation and long term hospital care.”

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Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’

The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.

Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.

Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).

That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford’s AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.

AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”

At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.

The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.

Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.

“Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said.

Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.

Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.

Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.

So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn’t yet been approved by the EMA.

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FDA approves Roche’s Xofluza to prevent flu spreading in families

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person.

Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

With this third indication, Xofluza has become the first single-dose medicine approved for this new use also known as post-exposure prophylaxis.

This provides a more convenient alternative to older drugs such as Roche’s own Tamiflu (oseltamivir), which is taken once daily for 10 days in this indication.

Approval was based on the phase 3 BLOCKSTONE study, recently published in the New England Journal of Medicines, which compared Xofluxa with placebo as a preventive treatment for household members who were living with someone with flu.

Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact.

The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified.

The most frequently reported adverse events occurring in at least 1% of adult and adolescent influenza patients treated with Xofluza included diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

It’s hoped that the new indication could take the pressure of health systems that are struggling to cope with the extra workload caused by the COVID-19 pandemic.

Serese Marotta, chief operating officer at Families Fighting Flu, said: “The flu is a serious illness that burdens households and sickens millions across the U.S. every year.

“As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.”

Genentech is in talks with the FDA to develop Xofluza for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.

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Media means business

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.

Mx = C x C x C = E diagram

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.

Download the Media Means Business white paper today at https://www.havaslynx.com/thought-leadership/media-means-business/.

About the author

Sarah Price is the director of media and performance at Havas Lynx Group, heading up the company’s specialist media department, AMP.

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Prescient Announces Recent Appointments to its Senior Team

Prescient hires three new senior members to expand its expertise and keep pace with the company’s growth

LONDON, November 3, 2020 – Prescient, a biopharma product and portfolio strategy partner, announces the recent appointment of three new senior members: Gordon Gochenauer, Dr. Priya Kar and Dr. Cameron Mackenzie. They join the existing leadership team, which shapes the competitive strategies of Prescient’s clients through dynamic decision support.

Gordon joins Prescient with more than 15 years of dedicated oncology experience in market research and competitive intelligence. He has an MBA in market and strategy from Carnegie Mellon University and a BA in biochemistry from the University of Pennsylvania. Prior to joining Prescient, he led teams and projects at Kantar Health, AlphaImpactRx (now part of IQVIA) and Psyma International across the development timeline, including competitive intelligence, licensing and BD assessments, market landscapes, tracking studies, pricing and market access studies, and strategic workshops. At Prescient, Gordon is responsible for expanding our company’s presence in the Philadelphia and New Jersey areas and for supporting team professional development.

Priya joins Prescient with more than 15 years of healthcare experience, particularly in the realm of commercial and clinical insights and strategy development. She earned her PhD in molecular biology from the New Jersey Medical School and her MBA in pharmaceutical management and marketing from Rutgers Business School. Prior to joining Prescient, she served as a subject matter expert and trusted client advisor. Priya has co-authored several peer-reviewed scientific articles and industry-relevant white papers. At Prescient, Priya is responsible for driving growth within our Intelligence & Insight business, managing key business accounts and providing strategic leadership.

Cameron joins Prescient with 15 years of experience in the pharma and biotech industries. He spent his early career working in R&D and manufacturing at established companies before joining a start-up to lead the development, launch and global sales of a novel product. He holds a PhD in biophysical chemistry from the University of Glasgow, an MSc in chemistry from the University of Strathclyde and an MBA from Strathclyde Business School. At Prescient, Cameron is responsible for leading high-quality engagements with new and existing clients and applying his knowledge and experience to answer their strategic business questions.

“Clients partner with Prescient to understand the situation analysis, which impacts critical success factors underpinning their clinical and commercialization strategies, thus ensuring the product’s value proposition is differentiated and resonates with key market stakeholders,” says Dr. Rakesh Verma, Prescient’s President. “Gordon, Priya and Cameron bring extensive experience and deep-rooted expertise to support pharma cross-functional teams throughout the product life cycle in their decision making at critical inflection points.”

Biographies and contact information for the Prescient senior team can be found on www.PrescientHG.com.

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GCI London bolsters leadership with David Berkovitch hire

GCI Health’s London office has bolstered its senior leadership team with the hire of David Berkovitch, who joins after a four-year stint at 3 Monkeys Zeno and previous roles at Edelman and Fleishman Hillard Fishburn.

Kath Kerry, MD at GCI Health commented, “We are thrilled to have Dave join the GCI Health family. He and I worked together years ago, and I knew he would be a great hire for us.

“His skills and expertise coupled with his drive and passion, will further enhance what we can deliver for our clients. Dave also brings significant experience in leading a successful business, and we are looking forward to his contributions to realising our vision for GCI Health.”

David Berkovitch

David Berkovitch

In addition GCI Health has also appointed three new account directors to support the team: Kayleigh Moore, senior account director, previously at Syneos; Fenya Lazar, account director, previously at Syneos; and Harriet Mooney, account director, previously at Evoke KYNE.

The agency has also hired an additional five junior team members to support across various accounts.

GCI said its management team has put a lot of emphasis on and effort into making sure new starters can still benefit from its culture, despite the virtual working environment in place because of the pandemic.

Deputy managing director Kim Walker said: “We have stepped up to the challenge of ensuring we keep the whole team connected, motivated and most importantly, happy, while we work remotely.

“We are dedicated to looking after our GCI Health family and maintaining morale – from guest speakers, to plant growing challenges, to our first virtual GCI-festival – we’re thinking differently to keep our spirits high.”

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Pharma needs to adapt its communications or be left behind

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.

Patient focus

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.

Embracing digital

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 BatesClare 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.

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Envision acquires commercial solutions firm Two Labs

Scientific communications company Envision Pharma has bought Two Labs, a firm specialising in commercial solutions for the pharma and biotech sector, for an undisclosed sum.

The combined company will bring together complementary clients, services, and technologies, extending Envision’s scientific footprint to new clients in the “product pre-launch setting” – while opening up new business avenues and geographies for Two Lab’s launch planning services.

Excellere Partners, a US-based private equity firm focused on partnering with entrepreneurs and management teams in emerging growth companies, will exit its investment in Two Labs following a four-year partnership.

Two Labs, founded in 2003 and headquartered in Powell, Ohio, has offices and operations across the US and UK, and is an established strategic consulting and marketing provider to the biopharma industry.

Two Labs helps pharmaceutical companies develop and execute customised launch strategies for products.

Envision’s acquisition of Two Labs follows the recent announcement of GHO Capital’s increased investment in the company and the backing of management for its continued global expansion.

Since being founded in 2001, Envision has delivered strong year-on-year organic growth and established leadership in medical affairs strategy, medical communications, and enterprise-wide Envision technology.

The acquisition followed an investment in Envision by specialist European fund Global Healthcare Opportunities (GHO) earlier this month.

The transaction sees GHO lead a consortium of its investors headed by Mubadala Investment Company, and including HarbourVest Partners and Northwestern Mutual to drive a new phase of growth, while Ardian exits its investment following a four-year partnership with Envision and GHO.

 

 

 

 

 

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Fresh doubts over BMS’ merger payout as FDA delays key drug review

Holders of a risky “bet” on three Bristol-Myers Squibb drugs are looking increasingly unlikely to get their pay-out after the company said COVID-19 travel restrictions are delaying a key regulatory review.

Shareholders in Celgene received a contingent value right (CVR) at the time of the company’s $74 billion merger with BMS last year, which pay out $9 each if the FDA approves three medicines before certain deadlines.

There were already concerns at the beginning of the month when BMS said in its Q3 results that the FDA had not yet inspected a manufacturing facility for the B-cell lymphoma CAR-T therapy lisocabtagene maraleucel (liso-cel), one of the three drugs.

BMS has confirmed the worst, saying in a statement that the FDA has delayed a decision on liso-cel until it can visit the facility – something that is proving difficult because of COVID-19 travel restrictions. Liso-cel has to be approved by the end of the year for the CVR to pay out.

The FDA was due to make a regulatory decision on liso-cel next week, and with the deadline laid out in the CVR looming there are now serious concerns about whether holders of the publicly traded instrument will receive their cash.

The announcement sent the value of the CVR down sharply in pre-market trading as there are also concerns about whether the third drug in the “bet” will be approved on time as well.

Multiple myeloma CAR-T idecabtagene vicleucel (ide-cel) – has to be approved by 31 March next year, just four days after the FDA’s action date.

The first of the three CVR medicines, Celgene’s multiple sclerosis drug Zeposia (ozanimod) was approved in March.

While CVR holders are feeling the pressure, there are no such worries for BMS, which has seen its revenues rocket thanks to the merger.

BMS revenues rose 75% in Q3 to $10.5 billion thanks to the addition of Celgene, but were up 6% on a pro forma basis

BMS said that it is “committed to working with the FDA to progress both applications to achieve the remaining regulatory milestones required by the CVR.”

But if the CVR does not pay out, it won’t be the first time that investors have been burnt by such a deal.

Last year Sanofi settled a long-running dispute with shareholders in the biotech Genzyme, who claimed the French pharma held back development of a multiple sclerosis drug to avoid CVR payments after a takeover in 2011.

Sanofi said it had agreed to pay Genzyme investors $315 million to settle the lawsuit.

As part of Sanofi’s $20 billion takeover of Genzyme, the French drugmaker promised shareholders in the US biotech payouts under a CVR that was due when MS drug Lemtrada (alemtuzumab) achieved certain regulatory and sales milestones.

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Pharma brands must ‘up the ante’ in their digital presence

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.

Each country has different regulations in regard to the online advertising of prescription drugs and over-the-counter medicines. In the UK, Google allows the promotion of online pharmacies providing they follow Google’s procedures and are registered with the relevant pharmaceutical authorities in the countries their ad campaign targets. These procedures include:

  • 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 MurrayRachel Murray is head of partnerships and a strategist for Fountain Partnership.

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Divided Congress paves way for drug price reforms on Biden’s watch

Unless president Donald Trump is successful with legal challenges, Democratic rival Joe Biden looks to have won the White House in last week’s election but faces the challenges of a divided Congress when it comes to implementing important health policies.

Making healthcare affordable is one of Biden’s goals as many Americans struggle to pay for healthcare, including those who have lost their jobs in the pandemic and with it their health insurance schemes.

High drug prices was a touchstone issue in the 2016 elections and Biden has also made this a priority in his campaigning.

Brian Bewley, partner in the life sciences and healthcare practice at corporate law firm Goodwin, said: “President-elect Biden has consistently prioritised affordable healthcare for all.  This includes reducing drug costs to consumers in the United States.

“In order to accomplish this, Biden has proposed allowing US Government agencies to negotiate directly with pharmaceutical manufacturers on drug pricing, enacting legislation to effectively limit or cap drug prices (brands and generics), and allowing consumers to purchase drugs from foreign countries.

“If any of these are successful, it could materially impact profit margins for the drug manufacturers.”

The Senate elections have not been decided and at the time of writing the House of Representatives is set to remain under control of the Democrats by the slimmest of margins.

This means that Biden will have to use all his charm and persuasion to bring legislators in line in a Congress that is reflective of the rifts in US society, although he may have support for drug price reform, according to Goodwin.

He said: “Right now, the Senate majority hangs in the balance with Democrats and Republicans holding at 48 seats each, with four seats outstanding.  That said, it appears that if Republicans have a majority, it will be by a slim margin.

“When it comes to President-elect Biden’s agenda on reducing drugs costs, he may have bi-partisan support – especially when you consider that the current administration under President Trump also tried to address drug pricing and transparency.”

According to Goodwin many states have been more aggressive than the Federal government on drug pricing and at least 15 have passed prescription drug price transparency laws, requiring manufacturers to report price increases exceeding a certain threshold.

These laws are meant to help states identify generics for their own prescription drug development programmes.

“I don’t see states being a major obstacle or impediment to President-elect Biden’s agenda on drug pricing as the states have, in many ways, outpaced their federal government counterpart,” said Goodwin.

Obamacare and COVID-19

Biden is an architect of the Affordable Care Act  and helped to implement the legislation as vice president of the Obama administration.

He will attempt to expand this legislation, nicknamed “Obamacare”, after Trump’s Republicans unsuccessfully tried to unpick it with their withdrawn American Health Care Act.

A likely addition to the legislation is a new “public option” to cover uninsured Americans and expansions of Medicare and Medicaid cover to older people and those on lower incomes respectively.

In the shorter term the COVID-19 pandemic will be a major focus as the country gears up to put together a mass vaccination programme.

Biden is an advocate of mask wearing, saying that doing so could save almost 70,000 lives.

But whether governors of Republican-leaning states will stand by his proposal to make mask-wearing mandatory outside their household is another matter.

The Trump administration became increasingly resistant to measures such as mask-wearing and social distancing played a part in the election, with Trump advising his supporters to attend polling stations in person and Biden urging his voters to use postal ballots instead.

Biden has set out proposals to improve testing and tracing, with the federal government taking responsibility for personal protective equipment (PPE) for healthcare workers.

Other measures include allowing the Centers for Disease Control to take the lead on how to control the disease with social distancing measures.

His seven-point pandemic plan also outlines proposals to protect higher-risk groups such as older people and these from certain ethnic minority groups.

He also plans to rebuild links with the World Health Organization, which Trump famously defunded after blaming it for failing to effectively control the COVID-19 pandemic.

As the world digested the news that Pfizer/BioNTech’s vaccine could be more than 90% effective Biden said he will make distributing a vaccine a priority.

With the rising cases every day, it’s the part of Biden’s plan that’s less likely to face political pushback, although there is distrust among the public about vaccines.

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Could an FDA inspection scupper CVR deadline for BMS’ liso-cel?

Bristol-Myers Squibb posted a solid set of financial results for the third quarter, but shares slid on investor fears that a payout tied new product approvals was in jeopardy.

BMS’ stock fell a little over 2%, but the big casualty was a contingent value right (CVR) due to former shareholders in Celgene, which BMS acquired for $74 billion a year ago. Celgene investors accepted a $9 CVR to sweeten the deal, tied to FDA approval of three late-stage medicines.

The CVR lost around three quarters of its value after BMS revealed on its third-quarter results call that the FDA still hasn’t carried out an inspection of a manufacturing facility that will be used to produce B-cell lymphoma CAR-T therapy lisocabtagene maraleucel (liso-cel), one of the three drugs.

Liso-cel has to be approved by the FDA before the end of the year to satisfy the requirements of the CVR. One manufacturing facility in Bothell, Washington has been inspected by the US regulator, but another operated by Lonza in Texas has not.

As both facilities need to be inspection before approval, that has led to speculation that the agency may not be able to complete its review of liso-cel by its 16 November deadline.

FDA inspectors “are doing what they can to ensure that…staff are kept safe in this COVID pandemic,” said Samit Hirawat, BMS’ chief medical officer. “And because of the travel restrictions, we have to obviously honour their desire as to where they go and when they go.”

Some analysts appealed for calm, noting that the FDA would likely have notified the company already if an inspection would not be happening in time and a delay to the review would be needed.

The first of the three CVR-tied medicines – Celgene’s multiple sclerosis drug Zeposia (ozanimod) – was approved in March. The final one – multiple myeloma CAR-T idecabtagene vicleucel (ide-cel) – has to be approved by 31 March next year, just four days after the FDA’s action date.

Liso-cel is already due for an FDA verdict three months later than anticipated after the regulator delayed its review by three months in May.

Worries about the liso-cel deadline drove the value of the CVR to penny share territory, down from almost $1.90 a year ago, and also cast a shadow over BMS’ third-quarter results.

BMS revenues rocketed 75% to $10.5 billion thanks to the addition of Celgene, but were up 6% on a prof forma basis. The numbers came in around $200 million ahead of expectations, which BMS put down to a good performance by anticoagulant blockbuster Eliquis (apixaban) which grew 9% to $2.1 billion.

Blood cancer therapy Revlimid (lenalidomide) also grew 10% to $3 billion, but cancer immunotherapy Opdivo (nivolumab) slipped 2% to $1.8 billion. BMS said it expects its flagship PD-1 inhibitor to return to growth next year.

The results came a couple of days after BMS presented impressive data with its psoriasis candidate deucravacitinib, which outperformed Amgen’s rival Otezla (apremilast) in a head-to-head trial.

CEO Giovanni Caforio said: “Our financial strength and flexibility combined with our robust inline businesses, multiple launches and progress in our deep pipeline, including the promising results from the deucravacitinib trial, strongly position the company to deliver our mission and help more patients.”

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Lundbeck tops Q3 expectations following strong sales of mental health drugs

Denmark’s Lundbeck has beat its expectations in third quarter results, following a strong performance from its portfolio of mental health drugs, although its newly-launched migraine drug seems to have got off to a slow start.

Lundbeck posted quarterly sales of 4.46 billion Danish kroner ($693.39 million), which Reuters noted beat expectations of around 4.39 billion kroner expected by analysts in a poll compiled by Refinitiv.

The performance was thanks to increased sales of its mental health drug Abilify Maintena, which increased 19% in the first nine months of the year compared with the same period last year to 1.729 billion Danish kroner ($270 million).

Sales of its depression drug Trintellix increased 14% to 2.3 billion kroner ($360 million) over nine months.

Another of the company’s mental health drugs, Rexulti (brexipiprazole) for maintenance treatment of schizophrenia saw sales increased by 24% to just over 2 million Danish kroner ($310 million).

The company also has high hopes for its Vyepti migraine drug, although this has only produced sales of 42 million Danish kroner ($6.5 million) since its launch in the US in March.

Lundbeck added Vyepti to its portfolio following its acquisition of Alder in a deal worth up $1.95 billion in September last year.

The last in a gang of four calcitonin gene-related peptide (CGRP) drugs to be approved, Alder decided to develop Vyepti as an intravenous drug that is administered in hospital instead of using pens where patients administer doses themselves.

While the self-administered rivals from Amgen/Novartis, Eli Lilly and Teva that were already on the market at the time of approval may have an advantage in terms of convenience, Lundbeck hopes its IV drug will be more popular with payers.

CEO Deborah Dunsire said that patient feedback about Vyepti had been “strongly positive” and noted its fast onset may also give it the edge over rivals.

Lundbeck upwardly revised full-year earnings before interest and tax (EBIT) to come in between 2 billion crowns and 2.2 billion Danish kroner, up from a previous estimate of 1.8 billion kroner to 2 billion kroner.

 

 

 

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FTC clears Mylan merger with Pfizer’s Upjohn – with conditions

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products.

The Federal Trade Commission (FTC) has ruled that the combined company – to be called Viatris – could have an anticompetitive position in the US market for seven generic drugs used for high blood pressure, heart failure, epilepsy, bacterial infections and uterine bleeding if the divestments don’t go ahead.

The FTC’s ruling means that Pfizer and Mylan have now obtained all the antitrust approvals needed for the merger to go ahead. Upjohn is now due to be spun off from Pfizer on 13 November, with the merger concluding three days later – around 16 months after first being announced. It was backed by the European Commission in mid-September.

Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word. Mylan shareholders will hold approximately 43% of the new venture, with Pfizer investors taking 57%.

The deal is structured in a similar way to Pfizer’s joint venture with GlaxoSmithKline in consumer health, allowing the company to shed off lower-margin products whilst retaining an interest and generating cashflow to invest in its new product pipeline.

Mylan meanwhile will benefit from Upjohn’s greater global reach, allowing its generics to grow more quickly, according to the companies.

The generics that have to be divested include medroxyprogesterone, amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin, and eplerenone products, according to the FTC.

Upjohn’s amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin and medroxyprogesterone products must be divested to Prasco, and Mylan’s eplerenone product must also be shed.

The FTC was also concerned about three other drugs – sucralfate to treat and prevent ulcers in the small intestines, levothyroxine for hypothyroidism, and varenicline, the active ingredient in Pfizer’s smoking cessation brand Chantix.

The approval conditions also require a green light from the FTC before Pfizer, Mylan or Viatris may “gain an interest in, or exercise control over, any third party’s rights” to levothyroxine, sucralfate and varenicline tablets.

The divested products should continue to be manufactured by Upjohn and Mylan’s current suppliers in order to avoid any shortages in the market, and in some cases Pfizer will act as a contract manufacturer to Prasco.

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Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 billion in deposits for the shot.

The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call on which he also highlighted a new agreement to supply 50 million doses of mRNA-1273 to Japan in the first half of next year with the help of Takeda.

The Japanese deal adds to a 100 million-dose agreement with the US governments agreed in August, worth some $1.5 billion, as well as a 20 million order from Canada and others including a recent agreement with Qatar.

Bancel reiterated Moderna’s expectation of an initial data readout from the pivotal COVE trial of mRNA-1273 in early November, with the critical two-month safety follow-up on half the 30,000 enrolled subjects later towards the end of that month.

That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. In the meantime, rolling reviews are also underway in the UK and Canada and planned in the EU.

The $1.1 billion cash injection has been booked as deferred revenue by Moderna, and helped the company generate positive cash flow for the first time in its 10-year history.

The vaccine also sets up 2021 to be the “most important inflection year in Moderna’s history”, according to Bancel – not least because it has emerged as the test bed for the biotech’s entire drug development platform.

“We intend to reinvest the returns from the sales of the vaccine into our pipeline development and hope to bring more medicines to the market,” he said. “I believe that the long-term strategic implication are large.”

Moderna’s chief medical officer Tal Zaks said on the call that clinical results with mRNA-1273 to date indicate the shot is generally safe and well-tolerated – with flu-like symptoms and injection site reactions the most common side effect reported with the two-dose regimen.

He also stressed that neutralising antibodies rise quickly after a second dose, and are seen consistently in patients regardless of age – a positive result because the immune system tends to weaken with age and older people are those most at risk of dying from the coronavirus.

Last month, Moderna said it was slowing enrolment in COVE to make sure that older patients, younger people with chronic diseases, and subjects of African American, Hispanic/Latin and Asian descent were included in the trial population.

Hitting the data readout timeline depends on 53 cases of COVID-19 being diagnosed for the interim analysis, and with rates of infection climbing around the world that should be easier to achieve. Further analysis of the data will also be triggered COVID-19 cases reach 106 and then 151, the final threshold.

Moderna said it expects to produce around 20 million doses of mRNA-1273 ready to ship in the US this year, which is a reduction on earlier estimates. It says it could be able to make 500 million to a billion doses next year.

The biotech has retained full control of its vaccine rather than partnering with a larger company, and has agreed to supply it to the US at a cost of $25 per dose.

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Gilead Q3 revenue rise bolstered by $873m Veklury sales

Gilead Sciences is the first and so far only company to claim FDA approval for a COVID-19 treatment with its Veklury antiviral, and its latest financial results reveal the benefit of that achievement.

The US drugmaker sold $873 million-worth of Veklury (remdesivir) in the three months to the end of September, helping it to a 17% rise in product revenues to $6.6 billion at a time when most other pharma companies have seen sales growth pegged back by restricted access to healthcare during pandemic lockdowns.

The bulk of the Veklury sales ($785 million) were in the US, with Europe accounting for a sizeable chunk of the remainder.

Chief executive Daniel O’Day told analysts on a conference call that Gilead is now in a position to meet global demand for the drug “because of the work we’ve done since January to ramp up our supply.”

Gilead also defended the efficacy of the drug in light of recently-published data from the World Health organisation (WHO) led Solidarity study which found that it had little or no effect on length of hospital stay or 28-day mortality in 11,000-patients hospitalised with severe COVID-19.

The company’s chief medical officer Merdad Parsey said the results “don’t alter the demonstration of efficacy observed with remdesivir” in prior studies, adding that Gilead is waiting to see the peer-reviewed data from the study.

He also suggested there might be some shortcomings in the design, for example a lack of confirmation of COVID-19 infection at enrolment and a failure to distinguish between patients with carrying severity of symptoms, based on supplemental oxygen requirements.

Veklury worked better in patients requiring lower levels of oxygen in the ACTT-1 trial that demonstrated a five-day reduction in hospital stays with Veklury, but no significant impact on mortality.

However, Parsey said that in less ill patients requiring low levels of oxygen – around 40% of the ACTT-1 study population – those who received Veklury had a 72% reduction in mortality at day 15 and a 70% reduction in mortality at day 29.

“These results are what we would have expected and hoped for with an antiviral therapy that should have the most impact when given earlier in the course of the disease before the inflammatory cascade leads to critical illness,” he said on the call.

“As you get sicker, inflammation, such as [acute respiratory distress syndrome] or fibrosis, potentially things like vascular blood clots and bacterial pneumonias could kick in,” added Parsey. “An antiviral doesn’t clear inflammation or blood clots once they’re formed, so this makes sense.”

Gilead said that predicting the future demand for Veklury continues to be challenging, but with incidence rates and hospitalisations rising amid a second wave of infections and the approaching winter, it looks likely that it will rise sharply in the fourth quarter.

The company also said it doesn’t expect vaccinations for COVID-19 to become widely available until late in 2021.

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Vaccine sales recover at GSK in Q3, but lockdown fears weigh on shares

GlaxoSmithKline saw a recovery in its vaccine sales in the third quarter after a big hit in the second as a result of the COVID-19 pandemic, putting it back on course to meet the lower end of earnings guidance for the year.

The bounce-back wasn’t enough to ease investor worries however – with fresh lockdowns reported to be looming in various countries including France and Germany – and shares in the UK drugmaker were tracking down after the announcement.

Overall, group sales slipped 3% to £8.6 billion ($11.2 billion), mainly hit by falling vaccination rates, with pharmaceuticals down by the same margin to £4.2 billion, buoyed by respiratory and its two-drug HIV products.

Highlights included asthma drugs Trelegy (fluticasone furoate/umeclidinium/vilanterol) and Nucala (mepolizumab), which grew 26% and 29% respectively, injecting further upward momentum to GSK’s respiratory franchise.

Despite the recovery, vaccine sales still fell 12% compared to the previous year’s quarter to £2 billion. There were declines for shingles jab Shingrix and Bexsero to prevent invasive meningococcal disease offset by a rise in flu vaccine sales. Shingrix, which has been driving growth at the company of late, fell 30% to £374 million.

Governments have been trying to ramp up flu immunisation to reduce the burden of the disease on hospital admissions with a second COVID-19 wave building.

“GSK has responded well to a challenging operating environment this year with disciplined cost control and strong commercial momentum in key growth products,” said CEO Emma Walmsley.

GSK is working with Sanofi on a potential vaccine for the SARS-CoV-2 coronavirus, and Walmsley confirmed the company is on track to deliver on its pledge to produce a billion doses of the adjuvanted, recombinant protein-based shot by the end of 2021, assuming it gets the regulatory approvals it is hoping for in the first half of next year.

Ahead of the results announcement, GSK and Sanofi confirmed that 200 million doses of their COVID-19 vaccine had been committed to COVAX, a World Health Organisation (WHO) backed effort aimed at distributing COVID-19 vaccines fairly around the world.

“Since we started working on the development of COVID-19 vaccines, GSK has pledged to make them available to people around the world,” said Roger Connor, president of GSK Vaccines.

“ We are proud to be working with Sanofi to make this…vaccine available to the countries signed up to the COVAX facility as soon as possible – this has the potential to be a significant contribution to the global fight against COVID-19.”

COVAX is aiming to make 2 billion doses of vaccine available by the end of next year. Sanofi and GSK initiated a 440-patient phase 1/2 study of their vaccine in September and expect initial results in early December. They hope to start a phase 3 study before the end of the year.

The two parts have already taken advance orders for 60 million doses of the vaccine with the UK government, and 100 million doses with the US in a deal valued at $2.1 billion.

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10 Tips for Digital Asset Management Success

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.

Download: ‘10 Tips for Digital Asset Management Success’ eBook

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Purdue to pay $8.3bn after admitting criminal charges in opioid case

After years of legal wrangling, Purdue Pharma has agreed a deal to resolve litigation about its role in the US opioid epidemic that will cost it up to $8.3 billion.

As part of the criminal and civil settlement, the manufacturer of opioid painkiller OxyContin (oxycodone) pleaded guilty to a three-count felony, including two counts of violating anti-kickback laws and one of conspiracy to defraud the US government.

Purdue faces a criminal fine of $3.54 billion, $2 billion in forfeited assets, and $2.8 billion in civil damages to states affected by the opioid crisis, which the Department of Justice said was the largest penalties ever levied against a pharmaceutical manufacturer.

In a related settlement, the billionaire Sackler family that own the company agreed to pay $225 million to resolve civil claims.

There was however opposition to the plea deal even before it was formally announced. Late last week, 38 Democrat lawmakers delivered a letter to US Attorney General William Barr saying it wasn’t right that  the criminal liabilities would be resolved “without a single person serving a day in prison.”

“If the only practical consequence of your Department’s investigation is that a handful of billionaires are made slightly less rich, we fear that the American people will lose faith in the ability of the Department to provide accountability and equal justice under the law,” they wrote.

The DoJ insists the deals don’t release any executives or employees of Purdue or members of the Sackler family from any future criminal liability.

Meanwhile, they are still facing thousands of lawsuits brought by local governments across the US claiming that aggressive marketing of OxyContin fuelled an epidemic in addiction that has claimed hundreds of thousands of lives.

Purdue filed for bankruptcy last year, after it proposed a separate $10 to $12 billion settlement package to resolve those lawsuits.

The DoJ resolution still has to be approved by the bankruptcy court, and one stipulation is that Purdue will stop operating in its current form and emerge from the procedure as a public health organisation functioning “entirely in the public interest,” according to prosecutors.

Another condition is that the Sackler family give up control of Purdue, which is intended to re-emerge after the bankruptcy process with a focus on developing drugs to treat opioid addiction and reverse overdoses that would be provided at very low cost.

In a statement, the drugmaker said the latest agreement brings it closer to the goal of “delivering more than $10 billion in value to address the opioid crisis,” adding that the “overwhelming majority” of the pay-out will be directed to state, local and tribal governments that have been left to deal with the consequences of the epidemic.

Abuse of opioid drugs “remains a significant public health challenge that impacts the lives of men and women across the country,” said Gary Cantrell, deputy inspector general for investigations at the Department of Health and Human Services (DHHS) Office of Inspector General.

“Unfortunately, Purdue’s reckless actions and violation of the law senselessly risked patients’ health and well-being,” he added.

Purdue’s admission of criminal activity centres on its insistence to the US government that it was operating an anti-diversion programme for opioids, when in reality it was continuing to sell them to doctors who were clearly over-prescribing and diverting the drugs between May 2007 and March 2017.

It admitted to bribing two doctors to write more prescriptions of OxyContin as well as other drugs between June 2009 and March 2017.

The Sackler family also released a statement after the news emerged, claiming that the “proposed resolution includes relinquishing our ownership of Purdue and has been valued at $10-$12 billion – more than double all Purdue profits the Sackler family retained since the introduction of OxyContin.”

The family says it will contribute $3 billion to the proposed settlement offered to state, local and tribal governments as well as handing over Purdue itself, but there still seems to be considerable opposition to the package.

Image by Gerd Altmann from Pixabay

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Time to change the channel? The future for customer engagement models

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 RickwoodSarah 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.

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FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies.

The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results.

But accelerated approval is only a temporary measure and manufacturers must provide confirmatory survival and safety data from large trials so drugs can remain on the market in the long term.

The FDA’s approval covers use of Venclexta (venetoclax) in combination with azacytidine, or decitabine, or low-dose cytarabine (LDAC) for newly diagnosed AML in adults 75 years or older, or who have comorbidities preventing intensive induction chemotherapy.

The drug’s US label also covers certain patients with chronic lymphocytic leukaemia, including a chemotherapy-free regimen for previously untreated patients.

Approval of the combination therapies is based on the results of two phase 3 studies, VIALE-A and VIALE-C.

Overall survival from the 431-patient VIALE-A trial showed Venclexta plus azacitidine significantly reduce risk of death by 34% compared with azacytidine alone, with a median overall survival of 14.7 months compared with 9.6 months in the control group.

Those treated with Venclexta had significantly higher rates of complete remission with 37% achieving this compared with 18% in those treated with azacitidine alone.

Results of the trial have led to the combination being included in guidelines for treatment of AML by the US National Comprehensive Cancer Network.

The most frequent serious adverse reactions reported in 83% of people treated with Venclexta plus azacitidine, were low white blood cell count with fever (30%), pneumonia (22%), blood infection (excluding fungal; 19%) and bleeding (6%).

The Venclexta and LDAC combination was approved based on the 211-patient VIALE-C study which showed 27% of people treated receiving Venclexta plus LDAC achieving a completed remission compared with 7.4% receiving LDAC alone.

Overall survival results were not statistically significant, with the median OS in the Venclexta plus LDAC group being 7.2 months compared with 4.1 months for those treated with LDAC alone.

The most frequent serious adverse reactions reported in 65% of people treated with Venclexta plus LDAC, were pneumonia (17%), low white blood cell count with fever (16%), and blood infection (excluding fungal; 12%).

Venclexta is being developed by AbbVie and Roche’s Genentech unit and is jointly marketed by the companies in the US, and by AbbVie outside of the US.

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COVID-19 tests prop up Roche as US biosimilars bite in Q3

Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes.

Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US.

Avastin was down 30% compared with the same quarter last year, generating revenues of just under 1.2 billion Swiss francs ($1.3 billion)

There was a similar story with MabThera/Rituxan, which was down 33% to just over CHF 1 billion ($1.1 billion) for the quarter, and Herceptin’s sales dipped 38% to CHF 879 million ($947 million).

In the past three years Roche has enjoyed one of the most successful drug launches of all time with MS drug Ocrevus, but this has not been enough to offset the falling sales from these cancer drugs which at their peak generated yearly sales in excess of $20 billion.

All three are facing competition from several different biosimilars in the US, which have come to market over the last couple of years and after the cut price competitors hit the European market.

Biosimilars are near-copies of complex biologic drugs that are shown to be as safe and effective as the originator with a series of rigorous trials and tests.

They are not sold at the rock-bottom prices seen with generics of small molecules but can save health systems billions by undercutting the price of the expensive biologics.

Sales for the pharma division slipped 4% to just over CHF 11.1 billion ($11.95 billion) for the quarter.

Surging sales from the company’s diagnostics division, which has been busy because of demand for tests during the COVID-19 pandemic, meant that sales for the group were broadly flat in the quarter.

The diagnostics division saw an 18% increase in revenues to just under CHF 3.6 billion ($3.9 billion), meaning that at constant exchange rates the company’s sales were up 1$ to CHF 14.7 billion ($15.8 billion).

Overall the company saw strong sales in the first quarter followed by a COVID-19 related decline in Q2, with sales stabilising in Q3 thanks to stronger sales of new medicines and demand for coronavirus tests.

Confirming the company’s 2020 outlook, CEO Severin Schwan noted the FDA approvals for three new medicines: Enspryng and Evrysdi for rare diseases and the cancer medicine Gavreto.

Roche is also working with Regeneron on the REGN-COV2 antibody cocktail, which the FDA is reviewing for an Emergency Use Authorization for COVID-19.

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Accelerating the digital approval process

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.

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Harmony’s sleep disorder drug Wakix gets US label extension

Harmony Biosciences has scored an expanded use for its Wakix narcolepsy drug to include cataplexy – a symptom of the sleep disorder that can cause total body collapse.

Wakix (pitolisant) was first approved in August 2019 for treatment of excessive sleepiness in adults with narcolepsy.

It is the only FDA-approved drug to treat cataplexy associated with narcolepsy not scheduled as a controlled substance by the US Drug Enforcement Administration.

Cataplexy is a temporary loss of muscle tone and often triggered by strong emotions such as excitement or laughter. Effects can be severe and cause knee buckling or the body to collapse.

Last year, the FDA rejected Wakix for the additional use.

After receiving the Complete Response Letter rejecting Wakix for cataplexy, Harmony met with the FDA who agreed to review a new analysis of the HARMONY1 trial.

Following review of the data, the agency acknowledged it showed a statistically significant reduction in the rate of cataplexy for Wakix compared with placebo.

The new indication adds to Wakix’ use in a market dominated by older drugs such as modafinil for improving wakefulness, and others treating cataplexy attacks such as sodium oxybate and venlafaxine.

Last year, Jazz Pharmaceuticals’ Sunosi (solriamfetol) was approved to improve wakefulness in adults with narcolepsy or obstructive sleep apnoea.

The company added another alternative, Xywav (calcium, magnesium, potassium, and sodium oxybates) earlier this year although these drugs lack the cataplexy use on their label.

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Pharma’s response to COVID: GSK

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.”

This series is supported by the Association of the British Pharmaceutical Industry (ABPI)

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Pharma’s digital transformation journey and the role of customer reference data

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.”

Real-time updates

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

Rebecca SilverAs 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.

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J&J settles 1,000 talc lawsuits for $100m+; report

Johnson & Johnson has agreed to pay more than $100 million to settle over 1,000 lawsuits that allege the company’s Baby Powder talc products caused cancer, according to Bloomberg.

Citing people close to the matter, the news agency said the settlement marks the first time that J&J has opted to settle litigation in bulk, rather than individually.

All told, there are estimated to be more than 19,000 lawsuits claiming injury caused by J&J’s talc products, so the settlement – if confirmed – represents a fraction of the potential liability facing the company.

The Bloomberg report suggests that the hiatus on courtroom proceedings caused by the coronavirus pandemic in the last few months allowed settlement talks to gather pace.

Many of the lawsuits claim that users of Baby Powder developed ovarian cancer or mesothelioma as a result of exposure to minute levels of asbestos in talc, and plaintiffs insist the company knew of the product’s cancer risks by the early 1970s and failed to warn consumers.

J&J refutes that assertion, and insists there is no asbestos in its talc, although it has been at odds on the latter issue with the FDA.

Earlier this year the company said it was planning to phase out its talc-based Baby Powder range in North America, leaving some corn starch-based products on sale, but insisted that decision was taken as a result of declining demand for Baby Powder products.

The drop in sales came from changing consumer habits, misinformation about talc’s safety, and “a constant barrage of litigation advertising”, it said at the time. Liability law specialists said the phase-out was a key step in resolving the talc litigation as it sets a cut-off point for future lawsuits.

J&J hasn’t commented on the Bloomberg article other than to say that “in certain circumstances, we do choose to settle lawsuits, which is done without an admission of liability and in no way changes our position regarding the safety of our products.”

The company has been fighting litigation over talc for years, with wins and losses, but the standout result was a $4.7 billion damages award to plaintiffs in a Missouri lawsuit a couple of years ago, that was reduced to $2.1 billion on appeal and is still in play.

Before COVID-19 lockdowns, a jury in a New Jersey trial awarded $750 million in punitive damages against J&J, although that was immediately slashed to $187 million by the judge as that was the maximum penalty allowed under state law.

In its latest quarterly report J&J said it had spent $600 million on litigation in the first half of 2020, primarily associated with talc lawsuits. A fresh trial involving a factory worker who claims his mesothelioma was caused by J&J’s talc products is due to start in California later this month.

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W2O acquires health policy consulting firm Discern Health

W2O has bought US health economics and outcomes research company Discern Health, marking its sixth acquisition in less than a year.

The move will give Discern Health access to healthcare communications agency W2O’s proprietary data models and tools, as well as its 1,400-person-strong multidisciplinary team – including data analysts, scientific strategists, branding experts, communications specialists and creatives.

Rita Glaze, practice leader of commercial strategy and market access at W2O, said: “Our clients need ongoing evidence-generation strategies that mirror the market dynamics they are facing, along with up-to-the-minute insights and counsel.

“With Discern Health as part of our organisation, we will continue to raise the quality and depth of our data and analytics offering, to ensure it stands up to the scrutiny of peer and government review. We will truly be #BetterTogether.”

Founded in 2004, Baltimore-headquartered Discern Health provides strategic direction and policy solutions to life sciences companies, government and non-profit agencies, and health insurers. The firm works with organisations to strengthen and quantify clinical and real-world evidence strategies that inform ongoing market access and commercialisation initiatives.

Discern Health’s founder Guy D’Andrea said: “Value-based care is a key driver of health system change. To be successful, health care companies need to integrate value-based strategy into each level of their organization and each stage of product development.”

Tom Valuck, partner at the firm, added: “We’ve been working with W2O over the past year and have gotten to know each other well.

“Being part of the W2O team means that we can supercharge our capabilities and incorporate world-class analytics and insights into our work, bringing even greater resources to our clients and, ultimately, improving patient outcomes.”

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Teva charged in US price-fixing investigation

The US Department of Justice has charged Teva with conspiring with other pharma companies to fix prices for generic drugs.

According to an indictment filed on Tuesday, the company participated in three counts of conspiracy from at least May 2013 until around December 2015, which could have resulted in customers being overcharged by at least $350 million.

The Department alleges that Teva conspired with companies including Sandoz, Glenmark Pharmaceuticals, Apotex and Taro USA to increase prices, rig bids, and allocate customers for generic drugs including medicines for arthritis, brain cancer, cystic fibrosis, seizures, pain, skin conditions, and blood clots, as well as the cholesterol medicine pravastatin.

Sandoz, Apotex and Taro USA have admitted to their roles in these conspiracies and agreed to pay fines. Glenmark is awaiting trial.

Four pharma company executives have also been charged, three of whom have entered guilty pleas. The fourth, Apotex’s former executive Ara Aprahamian, is awaiting trial.

Each of the charged offenses carry a statutory maximum penalty of $100 million for companies, but the maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by the victims if either amount is greater than $100 million.

“Today’s charge reaffirms that no company is too big to be prosecuted for its role in conspiracies that led to substantially higher prices for generic drugs relied on by millions of Americans,” said assistant attorney general Makan Delrahim of the Department of Justice’s Antitrust Division.

“The division will continue to work closely with our law enforcement partners to ensure that companies that blatantly cheat consumers of the benefits of free markets are prosecuted to the full extent of the law.”

In a statement Teva said it was “deeply disappointed” that the government had chosen to proceed with this prosecution.

“The Company has been investigating this matter for over four years and has concluded that Teva did not participate in price fixing,” it said. “Based on our internal review, Teva firmly rejects the allegations and will vigorously defend the Company in court.

“Teva has fully cooperated throughout the course of the Department of Justice (DOJ) investigation and has attempted to reach a resolution in the best interest of the Company, its stakeholders and the patients the company serves. The DOJ has shown an unwillingness to consider alternatives that would not deeply impact Teva and the stakeholders who depend on the Company, including the patients who benefit from our medicines.”

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Behind the scenes of the new ABPI Code of Practice

For over 60 years the ABPI Code of Practice has been key to the UK industry’s self-regulation, and now, as pharma is experiencing its most intense period of change in decades, a new update seeks to bring the Code in line with the modern sector. With the new Code now in its consultation stage, we spoke to ABPI president Haseeb Ahmad to find out more about the key changes.


What would you say are the most important changes to the Code in this new update?

It’s impossible to go through all the changes, but the most notable difference is in the structure.

The new Code is going to look and feel very different. It’s going to appear more modern, it’s going to be easier to use and it’s going to be more accessible – for example through the use of colour-coded sections.

That’s one of the main things our members have been requesting – there are probably thousands of people who reference the Code every day, so we want to make it easier for them to use in their day-to-day jobs.

Another key change is a new proposal for ‘collaborative working’ alongside those for ‘joint working’.

Whilst joint working involves pharma working together with the NHS to improve patient outcomes, we also recognise that the NHS is under pressure in other areas, and collaborative working is when the industry works with the system to relieve that and provide other benefits to the health service.

For example, post-COVID there will be a real drive to support the management of patients at home. It is absolutely in the interests of the NHS and the industry to work together on programmes where you can deliver a continued high quality of care in a more efficient setting, which can improve capacity for the NHS to then treat patients with other diseases.

We’re also making changes in the area of transparency. Companies will now need to disclose payments not just to HCPs but also to members of the public and journalists who write for them. That really demonstrates that transparency is a key imperative for us as an industry.

How does the scale of the changes compare to previous updates of the Code?

You can look at it through different lenses, but in terms of how many clauses have changed it’s more of an evolution than a revolution. What I do think is revolutionary is the new format. The new Code will look and feel very different, and we hope that will help with engagement.

How aware of the Code are the general public and HCPs? Was there a conscious effort to appeal to them more with this update?

It obviously varies somewhat, but we do see complaints raised under the Code from HCPs, and the Code is also referenced within NHS conflict of interest guidance. We do also see some members of the public making complaints under the Code.

It has always been the ABPI’s role to continue to improve the level of awareness of the Code. We see this current consultation as a great opportunity to help do that.

“The new Code is going to look and feel very different. It’s going to appear more modern, it’s going to be easier to use and it’s going to be more accessible”

How well do you think industry self-regulation works at the moment? Are there any deficiencies that the new Code is trying to address?

Self-regulation has stood the test of time very well. The Code has been working effectively for more than 60 years now, and self-regulation has great support from the government.

We carried out opinion research on the Code in 2018, and found that the interviewees associated positive changes in industry practice with developments in the Code. That has contributed to improving the perception of the industry and of HCPs.

Anyone in the UK who has any concerns about the activities of any pharmaceutical company can raise them with the PMCPA and be confident that it will be investigated under the auspices of a memorandum of understanding with the MHRA, backed up by UK law. That’s something we should be very proud of – the UK has been a frontrunner globally in terms of self-regulation. It has worked very well for over half a century, and I believe it will continue to work well going forward.

Do you see an active role for the Code in helping to improve the reputation of the Industry?

I think an improved reputation is a by-product of the Code, but it’s not its reason for being. The reason we have the Code is to benefit patients and ensure that our members act with integrity and operate in the interests of the public. If that leads to a better reputation, then that’s great.

In general, though, I think the industry is doing a much better job these days of stepping up and demonstrating that we are a force for good.

How does the new Code align with other codes of conduct, such as EFPIA’s?

We’ve made sure to align with the EFPIA Code as much as possible, for the sake of consistency for companies that operate throughout Europe and the rest of the world. EFPIA recently updated three of their Codes into one, and most of what led to that has been incorporated into the new ABPI Code.

Many of those companies also have their own codes of conduct, so they have to adhere to those guidelines as well as the ABPI Code, while the ABPI Code has to reflect the EFPIA Code and the International Federation of the Pharmaceutical Manufacturers Association (IFPMA) Code as well as UK law. Through alignment we can make these processes more seamless.

Although you have that alignment, how much of the Code needs to be unique to deal with the particularities of the UK industry?

There are far, far more similarities than differences between the Codes. Obviously, we ensure that we are aligned with UK law – and in many cases go beyond it. We’re specifically looking for feedback on activities in the UK as part of the consultation process. We want to ensure that what comes out at the end is a Code that is fit for local purposes.

“I think the industry is doing a much better job these days of stepping up and demonstrating that we are a force for good.”

Are there any other particular areas of feedback you’re interested in hearing about during the consultation?

We do have a list of questions that we’d like feedback on, but really it’s a fully open consultation process. People can comment, question or challenge any aspect of the Code.

Do you hope that more people will take part in the consultation stage than has been the case for previous Codes?

Absolutely. The participation levels during the consultation are a barometer of engagement.

We have also built time for training and familiarisation into this process. The PMCPA is hosting a series of events that will help companies understand and discuss proposals during the consultation process and once the final Code is published.

Is there any way in which COVID has affected this process, or indeed the content of the Code itself?

I’m pleased to say that it hasn’t affected our ability to start the consultation process. We’re continuing the preparatory work with the PMCPA events, and we haven’t missed any deadlines. Looking at whether COVID will help or hinder that, it’s clear that more people will be in front of the computer, and will therefore have the opportunity to participate.

It also hasn’t affected the development and the proposals for a new Code – many of the new focus areas, like collaborative working, were already emerging as important trends before the pandemic, and we had already started working them into the update. Many of them have actually become more important during the pandemic, as the industry seeks to help the NHS cope with the crisis.

To take part in the consultation process for the new Code, visit https://abpi.citizenspace.com/code/consultation/

About the interviewee

Haseeb Ahmad is president of the Association of the British Pharmaceutical Industry (ABPI) as well as being global head of value & access and commercial development and country president UK of Novartis Pharmaceuticals. His twenty-year career in industry has included senior in-country appointments, including managing director, UK, Ireland & Nordics of Novartis, managing director for MSD in Greece during the economic crisis, and above-country roles in strategy, operations, sales and marketing. Haseeb has also previously led the American Chamber of Commerce Pharma Group, is a member of the ABPI board and Novartis European Executive Committee.

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Takeda agrees $2.3bn sale of Japanese consumer health unit

Takeda has joined the ranks of big pharma companies jettisoning consumer health businesses in order to concentrate on higher-margin prescription drugs.

The drugmaker is divesting Takeda Consumer Healthcare, which operates mainly in Japan, to private equity group Blackstone for 242 billion yen ($2.3 billion), with the deal expected to close in March of next year.

Takeda Consumer Healthcare sells OTC medicines and other health products with sales of 60 billion yen ($567 million) in fiscal 2019. Its top-selling products are Alinamin – a vitamin B1 preparation used to relieve eye fatigue and muscle pain that has been a staple for Japanese households for more than 60 years – and cold remedy Benza Block.

Takeda’s chief executive Christophe Weber

The deal adds to a drive at Takeda to pay down the sizeable debt it absorbed after taking over Shire in a $59 billion deal that closed in early 2019. It also comes after chief executive Christophe Weber said the sale of the consumer health unit was “unlikely” last year.

Since the mega-merger, Takeda has been steadily selling off over-the-counter (OTC) and mature prescription medicines on a piecemeal basis. Earlier this year it divested products with annual sales in Europe of around $230 million, plus two manufacturing plants in Denmark and Poland, to Danish drugmaker Orifarm in a $670 million deal.

That came after a $660 million divestment of OTC and prescription drugs – sold mainly in Russia and Commonwealth of Independent States (CIS) countries – to Germany’s Stada last year, and a similar $200 million sell-off to Acino in Near East, Middle East and Africa (NEMEA) countries.

The latest deal takes Takeda a big step closer to its strategic goal of divesting $10 billion in non-core assets, and Weber said it will allow the company to zero in on developing and selling medicines for its five key therapeutic areas – gastroenterology, rare diseases, plasma-derived therapies, oncology and neuroscience.

Weber added that Takeda Consumer Healthcare would benefit from the move as it deals with “an increasingly competitive consumer health care market in Japan.”

It’s the second transaction for New York-based Blackstone in Japan’s healthcare sector, coming after the private equity giant acquired specialty medicine and biosimilar company Ayumi Pharma last year for around $1 billion.

Atsuhiko Sakamoto, head of private equity for Blackstone Japan, said Takeda Consumer Healthcare is “well-positioned to grow its established brands in Japan and launch new and expanded product offerings,” adding: “we see tremendous potential for [the company] in Japan and throughout Asia.”

Other companies that have been exiting the consumer health business in recent years include Novartis, Merck KGaA, and Bristol-Myers Squibb as well as Pfizer and GlaxoSmithKline which have agreed to combine their respective business units into a joint venture intended for a future spin-off.

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Merck makes communications leadership change

German pharmaceutical company Merck has appointed Thomas Möller as its new head of group communications.

Most recently responsible for corporate communications, Möller has worked at Merck since 2017, when he joined as head of external communications.

Prior to that he served as head of media relations at BASF and held various corporate communications positions in Germany, the US and Switzerland.

In his new role Möller takes over from Constantin Birnstiel, who is leaving Merck, will like his predecessor Möller will report directly to chairman of the executive board and CEO Stefan Oschmann.

Oschmann said: “I cordially thank Constantin Birnstiel for his engagement and the results achieved in positioning Merck as a science and technology company, as well as in purposefully advancing our communications activities.

“Thomas Möller is an experienced communications professional with excellent knowledge of Merck. I am really looking forward to collaborating with him further.”

Merck Constantin BirnstielBirnstiel (pictured left) had headed Merck’s group communications since 2017 having joined the company after working for Siemens, Osram, E.ON and Uniper.

While with the pharmaceutical company he was responsible for building Merck’s brand identity in China and, together with Möller, established Merck’s global newsroom, which was launched in 2020.

The two also worked together to drive the digitalisation of group communications over the past several years.

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UK doctors call for tighter rules on coronavirus antibody tests

Doctors have called for rules to be tightened on coronavirus antibody tests in the UK amid fears that false readings could put the public at risk.

It’s not even known for sure that having antibodies against the SARS-CoV-2 coronavirus confers immunity.

But with many other diseases the presence of specific antibodies indicates that the body can quickly fight off an infection in healthy individuals.

No antibody test has been officially approved for at-home use in the UK, but many different kits are available.

The BBC reported that the Royal College of Pathologists has written to UK health secretary Matt Hancock calling for tougher rules on the tests, saying they could “mislead the public and put individuals at risk”.

The doctors said the tests should not be used without professional support, must give accurate results and be “properly readable”.

The Medicines and Healthcare products Regulatory Agency told the BBC it had “worked collaboratively with cross government agencies at pace to prevent non-compliant antibody test kits being placed into the UK market.”

But Royal College of Pathologists president Jo Martin said: “Currently, if you buy a test on the internet or you buy it in certain boutiques or shops, we can’t guarantee that the quality of that is of an appropriate standard.

“We can’t guarantee that the result will be easy to interpret or that it will not be misleading.”

An analysis seen by the BBC’s Newsnight programme found that in 41 tests sold to the public in the UK, almost a third provided incomplete and inaccurate information.

While a number claimed to offer “peace of mind” just 10% had documents available to support their claims according to academics from the universities of Birmingham and Warwick.

Lead researcher Jon Deeks, professor of biostatistics at the University of Birmingham, said the antibody tests should be subject to the same level of regulatory screening as medical devices and drugs.

He said: “If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.”

A Department of Health spokesperson said tough action is being taken against those who market bogus antibody tests, with “a number” of arrests and 47,000 tests seized.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Creative agency woolley pau regains independence after buyout

Healthcare marketing agency woolley pau has gone back to its independent roots following a management buyout by three of its senior team.

Ed Shorthose, managing director, said the move “felt right on every level”.

Shorthose, Christian Dawson and Dean Woolley bought out the agency, which was had previously been acquired by healthcare communications company gyro in 2007 and then in 2016 by digital marketing company Dentsu Aegis Network.

Woolley, head of creative for woolley pau, said of its new leadership team: “We have different skills that dovetail perfectly to make us a formidable, problem-solving team for our clients.”

Dawson, head of strategy, added: “We’re gaining the benefits of independence, with all the buzz and energy of a start-up, while still being able to call on the resources of a global network of world-leading data and digital experts.”

The London-based agency was co-founded in 1993 by Woolley and Louisa Pau, who left in 2013, and works on pharmaceutical and medical device brands for pan-European and global clients.

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Teva shares slide as it faces illegal kickback charges from US government

Shares in Teva were down sharply this week after the US Department of Justice filed a complaint that the company paid illegal kickbacks to patient groups to boost sales of its multiple sclerosis drug Copaxone (glatiramer).

The allegation is that Teva’s subsidiaries Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. illegally paid Medicare co-payment costs through purportedly independent charities while at the same time jacking up the price of Copaxone, which had no generic rival at the time.

The US government alleges that the payments occurred from 2007 until the end of 2015, to charities called The Assistance Fund (TAF) and Chronic Disease Fund (CDF).

During that period Teva raised the price from around $17,000 per year to over $73,000 per year, the DoJ alleges.

Teva mainly administered the scheme through its specialty pharmacy, Advanced Care Scripts (ACS) with payments amounting to around $300 million during the period, according to the complaint.

Teva referred virtually all Copaxone patients who faced Medicare co-pays to ACS, which liaised with the foundations to calculate how much money was needed to cover the co-payments.

ACS also referred newly-prescribed patients to TAF and CDF in batches, according to the DoJ, which alleges the scheme violates the US False Claims Act.

The DoJ alleges that Teva’s scheme is an attempt to dodge the co-pay provision in Medicare Part D, which aims to put a check on drug prices and overall costs to the healthcare system by making patients pay a proportion of the price.

Andrew E. Lelling, United States Attorney for the District of Massachusetts, said: “Teva’s alleged kickbacks undermined the Medicare programme’s co-pay structure, which Congress created as a safeguard against inflated drug prices.”

Teva said in a statement:  “The company’s legacy multiple sclerosis patient assistance charity program was designed to support patients who needed important treatment options by appropriately providing charitable contributions to independent charitable foundations that helped patients obtain access to medicines, as prescribed by their physician.

“This case brought by the Department of Justice regarding these charitable contributions only seeks to further restrict patients’ access to important medicines and healthcare. The company will vigorously defend itself against these allegations.”

This is the latest in a string of legal troubles for the Israel-based pharma in the US, where it already faces lawsuits that it improperly marketed an opioid painkiller, and colluded with other pharma companies to fix the price of generic drugs.

Only this week the state of New York accused Teva and Allergan of insurance fraud for downplaying the risks of their opioid painkillers to patients and doctors.

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Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved.

Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, but has admitted that it won’t be able to meet the expected demand for the drug on its own.

The agreement with Roche will “substantially” increase the number of doses available if the drug works in clinical trials.

REGN-COV2 was the first therapeutic to be backed under the Trump administration’s Operation Warp Speed, which previously had focused only on coronavirus vaccines.

It is being tested in phase 2/3 trials both as a treatment for coronavirus infections as well as prophylaxis against infection in people exposed to SARS-CoV-2, with initial results expected before the end of September.

The US deal envisaged 70,000 to 300,000 therapeutic doses of the drug being made available by September, equivalent to 420,000 to 1.3 million prevention doses.

Under the terms of the agreement, each company has committed to dedicate a portion of its production capacity to REGN-COV2 each year.

The two partners think that by working together they could increase capacity to provide up to 2 million therapeutic or 8 million prophylactic courses a year.

Meanwhile, in addition to chipping in for its production, Roche also gets distribution rights to the antibody cocktail outside the US, in return for jointly funding and carrying out the phase 3 stage of the prevention trial as well as phase 1 healthy volunteer safety studies outside the US.

The Swiss drugmaker will also take responsibility for filing REGN-COV2 outside the US and carrying out any trials needed in those countries. Profits from the drug will be split, with Regeneron’s share expected to be in the 50% to 60% range.

REGN-COV2 was developed by Regeneron based on tests in mice genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.

The cocktail targets two components in the spike protein on SARS-CoV-2, the virus that causes COVID-19, with the aim of preventing attachment of the virus to host cells and interrupting infection.

The same approach has been used in the development of Regeneron’s Ebola candidate REGN-EB3, which is under review at the FDA with a verdict due in October.

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Pharma improves HCP engagement during COVID-19 – report

Pharma companies have improved how they engage with healthcare providers as a result of COVID-19, according to a new survey of HCPs.

This has resulted in pharma companies being more relevant and providing more value in closing the care gap, the report says.

The Accenture survey of 720 general practitioners, oncologists, cardiologists and immunologists globally found that this is in turn helping HCPs better serve patients.

For example, most HCPs said pharma companies are increasingly providing education on how to better treat patients remotely and help them manage their conditions in light of COVID-19. Nearly one in five HCPs (19%) said they expected that asking patients to self-administer more may be a permanent change after the pandemic, and the survey notes that 36% of patients have asked to have treatment remotely during COVID-19.

Companies are also helping patients understand where they can access labs, infusion centres or imaging centres, and are offering solutions to HCPs and their practices so they can more easily afford and keep stock of therapies.

HCPs in the US said that information on affordability programmes that pharmaceutical companies offer has been particularly helpful.

“57% of HCPs said they felt reps are failing to understand the true impact of COVID-19 on them, and 58% said they have been spammed by a pharma company”

The survey, which was conducted in May and June across China, France, Germany, Japan, the UK and the US, indicates that many patients and HCPs believe these changes are here to stay.

“Pharma companies are smart to be offering these new services but there’s more they can do to support HCPs and patients who want more self-directed and virtual interactions,” said Brad Michel, Accenture North America life sciences lead.

“Consider how 65% of all HCPs we surveyed said they value self-administration methods for patients, such as auto-injectors or on-body devices, more than they did pre-pandemic. And 62% said they value tools for remote monitoring of their patients at home more now than they did prior to COVID-19.

“This feedback, in combination with patients saying that they want to go into HCP offices less frequently even after the pandemic ends, suggests an increasing opportunity for pharma companies to be even more relevant to HCPs and patients’ changing needs.”

Luckily there does seem to be a growing trend towards pharma companies diversifying their communication beyond product information, while HCPs are finding more value in additional support services – 82% of HCPs in the survey said they have seen pharma companies change what they communicate about, to include support that meets their most pressing needs.

The impact on launch

Before COVID-19, 64% of meetings with pharma sales reps were held in person. During the pandemic, this shifted to 65% of meetings held virtually. Many of the HCPs reported that they expect restrictions in access to healthcare facilities will continue for some time – perhaps even permanently – and 97% of HCPs want either all virtual or a mix of virtual and in-person meetings even after the pandemic ends.

Indeed, 43% of HCPs said they are currently restricting who can enter the office for professional reasons (i.e. no pharmaceutical reps). Twenty-eight percent of those with restrictions said they believe it is something they may implement permanently and another 44% said they would keep the restrictions “for the foreseeable future”.

But HCPs also said they still want to learn about new treatments and interact with pharma sales reps – they just want to do so in different ways.

Eighty-eight percent of the HCPs surveyed said they want to hear about new treatments despite being amidst the pandemic. Four in ten HCPs said the likelihood of starting a patient on a new treatment has increased, as they have a greater ability to monitor patient response, more access to information on new treatments and more time to learn about them.

In fact, 61% said they are interacting with pharma sales reps more during COVID-19 than they did before. But they want pharma sales reps to have a better understanding of their needs and the needs of their patients. For example, 57% said they felt reps are failing to understand the true impact of COVID-19 on HCPs (with 51% saying pharma was failing to understand the impact on patients), and 58% said they have been spammed by a pharmaceutical company – receiving high volumes of digital content that misses the mark.

“We are at a critical juncture because HCPs want to communicate with pharma sales reps and learn about new treatments, but they need more value-added interactions and outreach that show a greater understanding of their situation and that of their patients,” said Ray Pressburger, Accenture’s global life sciences marketing, sales and access lead.

“To add value pharma companies should consider how they can capitalise on sales reps’ unique customer insights and re-channel their time once spent onsite and on the road into designing more personalised, and newly relevant HCP engagement strategies.”

The full report can be accessed here.

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Roche takes on Alexion as FDA approves satralizumab in NMOSD

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng.

Roche is taking on Alexion’s blockbuster Soliris (eculizumab), which was approved in NMOSD last year and in June Viela Bio, a spinoff from AstraZeneca, also won approval for another rival, Uplinza (inebilizumab).

The big Swiss pharma had been hoping for approval in patients regardless of whether they have anti-aquaporin-4 (AQP4) antibodies.

But so far Roche has not produced enough data in the broader patient group and the FDA has instead approved Enspryng in patients producing the AQP4 antibodies.

However Roche is claiming an advantage over Soliris with a more patient-friendly administration regimen: Enspryng can be self-administered by a patient or a caregiver every four weeks.

Patients taking Soliris have to visit a clinic to get an injection via a drip every week for five weeks, then every fortnight.

Uplinza offers another easier option as it is infused every six months after two starter doses two weeks apart.

Roche has yet to release any information on Enspryng’s price, but has plenty of room to manoeuvre given Soliris’ list price of around $500,000 per year.

Enspryng has a different mechanism of action from Soliris too: Roche’s drug inhibits the IL-6 receptor that is believed to play a key role in inflammation associated with NMOSD while Soliris targets the complement system.

It was designed by Chugai, part of the Roche group, using antibody technology allowing for longer circulation and subcutaneous dosing every four weeks.

NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve and spinal cord, causing blindness, muscle weakness and paralysis.

Roche said that NMOSD will be launched in two weeks.

This approval is supported by results from two randomised controlled phase 3 trials, the SAkuraStar and SAkuraSky studies.

In those studies Enspryng showed robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody positive NMOSD.

Results were sustained for 96 weeks, significantly reducing the risk of relapse compared with placebo as a monotherapy and when used concurrently with baseline immunosuppressant therapy (IST), which has commonly been used to manage NMOSD symptoms associated with relapses.

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Cello Health acquired for £182m by private equity firm

Cello Health has been acquired by Arsenal Capital Partners, a private equity firm investing in healthcare and industrials companies.

Arsenal said the £181.8 million deal would give it the foundation for a new enterprise to enable its healthcare and biopharmaceutical clients to maximise the value of their products.

Jon Williams, CEO of Arsenal’s new planned enterprise, said: “We are creating an enterprise that supports better strategic decisions, generates robust data and evidence, undertakes advanced analytics to draw out critical insights, and supports communication with a range of critical stakeholders.

“We look forward to working with our new colleagues as we embark on the next important phase of our journey.”

UK-headquartered Cello Health currently works with 24 of the top 25 global pharmaceutical companies, as well as a wide range of biotech, diagnostics, devices firms and other key non-healthcare clients. The firm assists clients to commercialise, differentiate their assets, and drive brand success in global markets.

Mark Scott, CEO of Cello Health, said: “Today’s announcement marks an exciting moment for Cello Health. We have a shared belief with Arsenal that clients need a partner that combines industry expertise, commercial experience, scientific depth, and cutting-edge technology and data.

“We’re confident that we can accelerate growth by expanding support for our clients, investing in innovation, and continuing our ambition to become a world-class, truly global company.”

Arsenal’s deal with Cello Health follows its acquisition of Sheffield, UK-based health economic and outcomes research consultancy BresMed in February.

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What can pharma marketing learn from other regulated industries?

The financial world, like the pharmaceutical industry, must operate within a tightly-defined regulatory environment, and in doing so has proved adept at connecting with its customers. No one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content.

In this article Joanna Carlish, managing director of financial services at Tag Americas, and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry.

Virtual connections

This is an area where only ‘approved emails’ from pharma sales reps to HCPs have historically approached standard practice, with virtual e-detailing or eRep activities more likely to be still in the pilot stage than in regular use. Nevertheless, the advent of COVID-19 is forcing pharma, and many other sectors, to make some radical changes.

Joanna: “This is a really interesting time and what we’re seeing is that financial agents and the retail banking environment are embracing the challenge and the opportunity to connect with people in their homes.

“It allows them to establish a different relationship, with a higher level of trust, because they’re engaging people within their comfort zone, be that in their living room, their home office or even the garden. Although it has been challenging for some, the types of relationships being built are evolving. The key is adapting existing legacy and traditional printed material for the digital environment.”

Robb: “In pharma the approaches are varied, partly because our clients have any number of customers, including – but not limited to – healthcare practitioners, payers and insurance companies. Clearly, over the last few months, sales reps have had limited in-person access to HCPs, which has presented a challenge.

“A lot of printed materials have been migrated to digital so that patients can opt-in to receive digital communications or HCPs can receive digital product or disease state information in the form of rep-triggered emails and microsites. Interactions between sales reps and HCPs has shifted to more digital forms of communication as a result of the lack of face-to-face interaction.

“This presents a big opportunity for unbranded social content, medical education, patient and caregiver engagement, social activity and community management-type efforts aimed at starting online conversations. At the moment, it’s really all about earning and maintaining patient and HCP trust when it comes to pharma marketing.”

Engagement channels

When examining how companies are engaging with their customers and other stakeholders, pharma has not lagged behind. In terms of its use of social and online channels, pharma has even – on occasion – moved quicker than some of the major consumer brands in starting to use channels like Twitter. However, the challenge the industry has faced is around making greater, and more meaningful, use of the digital channels that are available, which is where it could learn from other sectors.

“Hyper-personalisation is one of the marketing trends for 2020 I’m most excited about… It’s about making sure the communication is personally addressed to the audience, and hitting the customer at the point they are most active in their buying journey”
Joanna Carlish

Joanna: “We have a client who has transformed an existing platform for distributing email marketing into something that can help support sales discussions. Sales calls that now have to start with a phone call are supported by digital and social content straightaway. Before, there would have been 12 people in a meeting room with a notepad.

“We’re seeing a vast amount of video being embraced – now the transition from print to digital has genuinely happened, and the conversations about video are evolving, ‘what can we do now with video or social to make that more interactive?’ In the online learning space, one of our clients had an uptake of about 70% of their engagement with their customers by developing online tutorials. In that instance, the idea of modular-based video is key, especially for regional audiences that need some level of local adaptation in order to create messaging within content that resonates.

“There is a strong emphasis on regulated industries having a voice and being ethical, and social is a great way to be able to deliver those messages – partly because you can reach your audience at whatever point they are in their decision-making funnel.”

Robb: “We’re seeing a surge in social activity, a lot of podcasts and community management-type efforts to start an online conversation and earn trust that way. As a result there is a huge demand for trustworthy content. Moving imagery continues to be an essential part of the mix, for example Key Opinion Leader videos serve to share these professionals’ expertise and create trusted medical and promotional content to grow engagement and encourage patient-HCP dialogue. Utilising 3D animation, motion graphics, illustration and data visualisation, Mechanism of Action videos are created to visually explain drug or device impact. These two examples have been traditional pharma marketing tactics, but they are being ramped up even more as the need for content has increased with the proliferation of digital platforms and telemedicine.

“As people increasingly have live, digital interactions with healthcare professionals or providers, there’s opportunity to inject some motion graphics and video into the process that will get messages out to either patients directly or to HCPs and payers. Pharma companies can also play a large role in the creation of ‘communities of care’, which allow them to share knowledge and build up trust through digital channels.”

Content consistency

The proliferation of multi-channel activity demands a really strong focus on consistency of content across the different channels companies use. It’s a challenge that pharma and any industry working across multiple geographies, with a multitude of local agency partners, will know all too well.

Joanna: “Within the financial services sector ensuring consistency of content across different channels is happening at different scales. We often find that we’re able to, especially on the global scale, help assess and research that level of consistency on behalf of our clients to present to them with a view as to what’s happening at a regional level. When you expand globally it becomes an even bigger challenge, especially when you start to build in language and cultural variations. That’s obviously a challenge that’s relevant to all industries.

“As institutions think about what content and messages they’re putting out, it’s a great opportunity to assess where things are. Do they have the right tone? Is there legacy branding? How can we help consolidate all of that material? It has to evolve to focus on the quality, rather than quantity, of content and that can only be defined by the data and ROI. Financial institutions have been assessing how much they’re producing and what’s really resonating with the market right now.”

Robb: “The companies that are doing it well are creating libraries of pre-approved imagery, claims, references and other marketing components that help speed-to-market, consistency in message and branding and also minimise risk. Within this, the progressive pharma companies are utilising modular content to increase brand standards.

“There’s quite a way to go when it comes to automation and it’s a real opportunity for pharma to serve up a unique experience to a user, which is a completely different approach to a more generalised method based on demographic information that is either public domain or has been opted-in by a user. The combination of wearable technology,  opted-in point-of-care data collection and telemedicine presents some very legitimate, less risky and more controlled opportunities for pharma companies.”

Personalising marketing content

The pharma industry, and healthcare in general, faces huge issues with how individuals’ data is used to further their health and provide them with more relevant healthcare content that cuts to the heart of debates about privacy and public health. At the same time, consumer expectations are for experiences that are tailored to their specific needs. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

Joanna: “I love hyper-personalisation, it’s one of the financial sector’s marketing trends for 2020 that I’ve been really excited about. The idea is about really tapping into where the customer is in their journey. It’s about not only making sure that the look and the feel of a communication is personally addressed to the audience, but going beyond that to really make sure that it’s hitting the potential customer at the point at which they are most active in that part of their buying journey.

“To me, that’s really exciting because there are so many ways to do that. I think that’s what helps level-up the success of a financial institution’s engagement and level of trust with their customers when they get that right. It just means so much to the customer when their trusted financial resources are  talking to them at that particular time when it’s most needed.”

Robb: “Some of the ways folks are utilising digital channels to take more control of their own health, has made them a little more willing to give up some of that personal information that can then be used to serve up more personalised experiences. Whether that’s in the form of ads or content, it can help create awareness and/or influence behaviour – by either driving people to an HCP to discuss something or to flat out purchase their product if it’s available over-the-counter.

“As digital becomes more and more the norm, in terms of how people interact with their HCPs, it’s another opportunity for more data collection. Should the patient opt-in, they can then be served up more personalised content that can ultimately change behaviour and impact positive patient outcomes.”

Regulated industry learnings

There’s clearly already a lot that pharmaceutical marketing gets right, but the way the financial services industry has taken learnings from the retail sector and adopted them for the highly regulated way in which it must work provides some pointers to the future.

The sector has been able to strike a more approachable tone with its stakeholders, supporting it with libraries of pre-approved content that increase message consistency and minimise risk.

As the public becomes increasingly comfortable with exchanging a measure of personal data for more personalised communications, financial companies have been able to build trust and engage potential customers at key decision-making points in their journey with content that really resonates with them.

Whether pharmaceutical companies can convert old ways of approaching a topic into something that their audiences would happily read on a Saturday morning, having a cup of coffee, remains to be seen. Nevertheless, taking a more personalised approach to content that is adaptable while remaining consistent could help messages resonate with the pharmaceutical industry’s diverse stakeholders.

About the authors

Joanna Carlish, managing director, financial services, Tag Americas

Joanna CarlishJoanna leads Tag’s Financial Services division in the Americas, working with top tier banking, retirement, investment and insurance organisations. She is an expert in improving internal process and enhancing existing resources to transform traditional marketing operations. Her primary focus areas include; service delivery; enhancing creative; delivering innovation and thought leadership content; continuous improvement; operational excellence; and business transformation initiatives. Joanna began her career at Tag as an Account Manager with Banco Santander in London. She went on to support Sony Group, before relocating to Chicago in 2012 to lead an on-site creative studio, dedicated to producing global campaign adaptations and local marketing materials for Zurich’s North American business. Since 2016, Joanna has led Tag’s client partnerships in the Financial Services sector in the US, providing dedicated creative production and strategic sourcing/print management services.

 

Robb DeFilippis, managing director, life sciences, Tag

Robb DRobb DeFilippis is an accomplished marketing operations executive with 25 years of experience leading organisations and clients to more efficient, profitable and innovative creative production, sourcing and business process excellence. Robb has held leadership positions at major ad agency networks including Omnicom, WPP, Publicis and IPG, across sectors such as CPG, health and beauty, finance, automotive and fashion. He has dedicated the last 10 years of his career to servicing the life sciences sector and continues to serve this industry. For Tag, Robb’s emphasis is building highly functioning, client-centric, creative delivery teams who execute across all media and regulatory tactics including digital, print, outdoor, video, social, broadcast, MLR submissions and packaging – serving audiences comprised of HCPs, patients, sales and point-of-care.

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EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million.

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials.

Those deals cover 200 million doses of J&J’s Ad26.COV2.S – with an option on another 200 million – and 300 million doses of the Sanofi/GSK candidate. Meanwhile, the EC is also talking to Pfizer/BioNTech, Moderna and CureVac about access to their COVID-19 shots.

There are concerns that the scale of the deals – which comes after a series of similar big orders from the US and other national governments – could make accessing supplies more difficult for organisations such the WHO and GAVI, which are aiming to supply less affluent countries.

Reuters says that the Commission has “urged EU states to shun the WHO-led initiative because it sees it as too expensive and slow.”

The EU is now suggesting that it could use a portion of its vaccine orders to supply countries elsewhere in the world, which could be viewed as stepping on the toes of these non-governmental organisation (NGO) initiatives.

“We will continue to work tirelessly to bring more candidates into a broad EU vaccines portfolio,” said Stella Kyriakides, EU Commissioner for Health and Food Safety, adding that a vaccine “remains the surest exit strategy to protect our citizens and the rest of the world from the coronavirus.”

The advance order will be financed using the EU’s Emergency Support Instrument, a €2 billion fund set aside to cover purchases of vaccines, drugs and other goods needed to fight the coronavirus epidemic.

The fund has already been deployed to order Gilead’s antiviral drug Veklury (remdesivir) and apheresis equipment to collect antibodies from the blood of patients who have recovered from COVID-19.

Last month, interim results from a phase 1/2 trial of ChAdOx1  were published in The Lancet and showed the jab was tolerated and generated immune responses against the SARS-CoV-2 virus in all vaccinated participants.

It is based on an adenoviral vector formed on a weakened version of the adenovirus that causes a common cold-line illness in chimpanzees, containing the genetic material of SARS-CoV-2 spike protein.

AZ said that it has now signed supply deals for around 3 billion doses of the vaccine, with Russia, South Korea, Japan, China, Latin America and Brazil also placing orders.

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Emotional empathy is driving brand equity

How the COVID-19 pandemic is forging pharmaceutical brands into better shape.

Day by day it becomes clearer that some brands are coming through the pandemic in better shape than ever.  These are the brands that have clearly demonstrated emotional intelligence, that have shown emotional empathy to their target audience. They understand the current, heightened emotional state of their customers and respond to it in ways that show they give a damn. Sometimes it is just about style and tone: like a mother’s soothing words to a crying child that create immediate comfort and calm. Sometimes they go further, and like that same mother applying a soothing balm to a grazed knee, show by their action that they care.

The emotional wave of the moment is all about reliability, the calm in the storm, the trusted friend. Think of the sourdough craze or the social media frenzy around banana bread: in these times of unprecedented uncertainty in relation to life’s fundamentals – health and livelihood – we are reaching out for the warmth of a well-worn comfort blanket.

Simple kindness is one such comfort blanket. Something we want to receive and something we want to give. Each of us is touched by the countless acts of community kindness being shown to the vulnerable. We see the dedication of healthcare workers – or of the shelf-filler in our local store – and we are moved to thank them and to make our own contribution.

Non-pharma brands leading by example

Something was broken before COVID-19 came along. The 2019 Edelman Global Trust Barometer showed levels of mistrust in business to be stratospheric, at their highest point ever. Government and the media didn’t fare any better. Of these three societal pillars, it is, perhaps surprisingly, business that has stepped up to the plate most assuredly in 2020 – led by some of the world’s strongest brands.

“Pfizer has shown remarkable emotional intelligence at a corporate brand level”

Brands are contributing in myriad different, relevant and engaging ways. T-Mobile went into partnership with Verizon, AT&T, and iHeartMedia to give 40,000 phone chargers to hospitals, putting frightened, isolated patients back in touch with loved ones. Verizon also donated $2.5 million to small businesses to support the Local Initiatives Support Corporation and has offered special prices for nurses and teachers. These are acts of kindness appropriate to both the brands and the situation.

Kindness starts with colleagues. Starbucks extended its mental health benefits for members of the team. In partnership with Lyra Health, Starbucks offer personalised, confidential mental health care, free in-person or video sessions, and access to a provider network of mental health therapists and coaches. Microsoft keeps on paying support staff who earn an hourly wage even when there’s nothing much for them to do.

The pandemic is global, so let’s take a quick peek at some beautiful examples from around the globe.

  • In the Philippines, Coca-Cola handed over its precious advertising spaceto support the COVID-19 relief and response efforts of local communities.
  • Bacardi switched production from its famous rum to ethanol so that hand sanitiser could be manufactured in bulk. Louis Vuitton did much the same thing in France.
  • PepsiCo and partners have provided one million meals a week to rural children in need across the US and Puerto Rico.
  • LinkedIn threw open many of its learning courses for free.
  • Nickelodeon launched a free site to keep kids out of their parents’ hair.
  • In Britain, the venerable BBC launched BBC Bitesize to help parents home-school children. They even launched virtual church services, presumably so those parents could pray for the schools to reopen!
  • New York Magazine, the New York Timesand The Economist amongst many other news organisations knocked down their paywalls for COVID-19-related coverage to keep readers informed in a rapidly changing and often confusing environment.
  • At Delta Airlines, the CEO ripped up his pay-check for the year to try and diminish layoffs.
  • Bank of America halted foreclosure sales, evictions and repossessions.
  • CVS facilitated COVID-19 testing in secure areas of parking lots at select stores. Individuals tested haven’t had to leave their car or step into the store.

Big pharma surprises itself

The pharmaceutical industry, often depicted as public enemy number one, has (with a gargantuan leap into the future), seemed to catch the public mood and respond appropriately. There is a scale difference in this transformation.

In 2017 Pfizer was one of the top ten US donors of charitable aid, to the tune of a staggering $210million (or 1.7% or profits) according to the Chronicle of Philanthropy, yet still, the organisation doesn’t even appear on the 2019 Axios Harris poll of top 100 reputation ranking. In 2018 the research firm Reputation Institute ranked Pfizer’s reputation at rock bottom on a list of 22 pharma companies – and none of them ranked highly against other sectors!

The data isn’t public yet but today Pfizer holds its head up high and talks about reputation openly and assuredly: clearly confident that there has been a change and that there is more to come. How did that happen? Pfizer has shown remarkable emotional intelligence at a corporate brand level.

“For the moment, the successful brands are the ones that understand the universal emotional tide of the moment. In the future, these brands will need to strive for a differentiating emotional connection”

The change is local and global. To take one local example, in the UK Pfizer is working with the National Schools Partnership to make its Superbugs and Vaccines education program suitable for home learning. Over at corporate HQ, the ambition is as big as it gets, of the moon-shot order in fact, when it comes to defeating COVID-19. Pfizer has four different mRNA platform vaccines in play against one-another: a radical new approach for them. Their chief, Albert Bourla, quoted in Forbes magazine in May, made the new way of thinking and working crystal clear to his team:

“Think in different terms…Think you have an open cheque book…Think that we will do things in parallel, not sequential. Think you need to build manufacturing of a vaccine before you know what’s working. If it doesn’t, let me worry about it and we will write it off and throw it out.”

He was clearly impressed with the way his team responded to the challenge, saying:

“How fast we moved is not something you could expect from big, powerful pharma. This is speed that you would envy in an entrepreneurial founder-based biotech.”

Sharing is caring

From the beginning, Bourla openly authorised having discussions and sharing proprietary information with rival firms. A brave move in the often closeted, secretive world of big pharma. Bourla made Pfizer’s manufacturing capabilities available to small biotech concerns and is in talks to make large quantities of other companies’ COVID-19 drug candidates.

One Pfizer brand getting plenty of attention is Xeljanz, their blockbuster anti-JAK rheumatoid arthritis pill that could damp down the massive immune response that overwhelms some COVID-19 patients. Pfizer is supporting a Xeljanz trial in Italian COVID-19 patients, as well as a US trial that will test a different arthritis medicine, an experimental drug that targets the Irak-4 protein, against the virus.

It is not just Pfizer though: we’ve simply highlighted them because of the low levels of trust the wider community has had in their brand, and because they’re now a great example of what the industry is doing to rebuild brand trust. There are many other mega pharmaceutical companies in the kill-COVID game: Johnson & Johnson, Sanofi, AstraZeneca, GSK and Roche included.

Here’s a mini roundup:

  • Speed of development and partnership are characteristic of many players, ahead of the race is Moderna (working with the National Institute of Allergy and Infectious Diseases) with a trial under the aptly titled ‘Operation Warp Speed’ now in Phase 3.
  • AstraZeneca has joined forces with GSK and Sanofi to play a socially responsible role in the search for a vaccine and its rapid production. More quietly, AZ has donated nine million face masks to struggling nations.
  • GSK is scouring its portfolio of brands for ones that might impact COVID-19 patient treatment. They’re also investing heavily in trials of the best candidates.
  • Eli Lilly is supporting diabetes patients who are encouraged to call the Lilly Diabetes Solution Center, where they can talk through their options with advisers (including switching to generics).
  • In our own small way, at THE PLANNING SHOP, we are supporting the Hemophilia TalkShop online community as they support one-another in these unprecedented times. The RAM (Rare Advocacy Movement) Living with Rare Disease online community is another heart-warming example where patients are turning out to be a great comfort and source of solace to each other.

There is one final example that convincingly tells us that trust has become immensely important to pharma companies: Chinese clinicians are using an AbbVie HIV treatment to address coronavirus-related pneumonia. Kaletra (also known as Aluvia) contains anti-viral components that block virus replication. Although not yet approved as a treatment for coronavirus, Kaletra has shown efficacy across multiple trial cases.

AbbVie has donated $1.5 million worth of Kaletra to China for use as an experimental treatment option.

Kaletra is vital to AbbVie’s commercial success, yet the company has given up some of the brand’s commercial potential by announcing in April that it wouldn’t defend patent rights to Kaletra. In the event that Kaletra does prove effective against COVID-19, the move would allow competitors to create additional supply to satisfy demand that AbbVie alone can’t meet. That is an astonishing move of generosity that can only inspire admiration and trust.

There are emotions other than comfort and trust

The pandemic has given brands, including pharmaceutical brands, the opportunity to demonstrate emotional empathy by responding to the need for confidence and trust with clear demonstrations of caring. The power of emotional connection has never been clearer. For the moment, the successful brands are the ones that understand the universal emotional tide of the moment. In the future, these brands will need to strive for a differentiating emotional connection.

This is a big ask. There are very few pharma brands not built with an emotional component, but that component rarely has foundations anywhere near as deep as the functional core claim. The generic nature and lack of ownability of the emotional component is clear, if you recognise these four emotional foundations, then you know the problem:

  • Confidence
  • Reassurance
  • Satisfaction
  • Empowerment

To capitalise on the opportunity, pharma brands will need to embrace the growing evidence base of human science behind understanding emotion, and they will have to invest in growing their knowledge.

Acclaimed academics such as Professor Lisa Feldman-Barrett are seeing their work on emotion as a learnt, not innate, trait, become more widely understood, and this is something we’ve been fascinated by at THE PLANNING SHOP. So much so, that we’ve built our new brand creation Thought Model to help our clients build brands with equally strong functional and emotional foundations.

The importance of understanding emotion is creating an exciting new world. The growing ability to understand emotions and to better empathise with customers is revealing new opportunities for brands. There is a growing realisation of the role a brand should play in shaping emotions and impacting deeper with audiences. Perhaps for the first time ever, pharma is well ahead of other sectors in this understanding. THE PLANNING SHOP is daily growing our knowledge and evidence base on how to build an Emotional Brand.

Some brands are coming through the pandemic in better shape than ever because they are showing themselves to be in tune with the times. The next generation of emotionally intelligent brands need to learn from this and start to write the tunes of the future.

About the author

Michael Dumigan is global brand consultant at THE PLANNING SHOP. If you’d like to talk to Michael about this article, please get in touch!

About THE PLANNING SHOP

THE PLANNING SHOP is an insight-led brand and communications consultancy of choice for the healthcare industry, with offices in the US and UK.

We dig deeper, go further and challenge perceptions to generate the insight-led business solutions pharmaceutical companies need to grow successful healthcare brands.

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Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine

The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 billion –around $15 per dose or $30 per course.

That’s a steep discount on the $32 to $37 price per dose in its earlier smaller deals, revealing that purchasing power will be a big factor as supplies of COVID-19 vaccines become available – and also that countries with deep pockets will be at the front of the queue.

Nevertheless, consumer advocacy group Public Citizen has slammed the amount Moderna is charging the US for the mRNA-1273 vaccine, saying that as taxpayer money had funded 100% of the work done to bring it to market the US is “paying twice” for the shot.

“When the president bragged on the campaign trail about his deal-making prowess, this isn’t what people had in mind,” said the organisation.

“It is absurd that Trump and [Health and Human Services Secretary Alex Azar] are touting $30 per course as a good deal for the American people, in light of the consistent and ongoing support from the US government towards mRNA-1273 research, development and manufacturing.”

The $1.525 billion order includes $300 million in incentive payments for swift delivery, in other words if the vaccine is approved for marketing or gets an emergency-use green light on or before 31 January next year.

It takes the total amount allocated to the vaccine by the US government to $2.48 billion, including $955 million previously awarded to Moderna to fund clinical development and manufacturing of mRNA-1273.

The shot is in a phase 3 trial called COVE which started last month with the help of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Moderna has previously said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021, thanks to a manufacturing collaboration with Lonza.

The company also has a large-scale fill and finish contract with Catalent’s biologics facility in Indiana, following $1.3 billion in funding from investors in a public equity offering in May.

Shares in Moderna spiked up around 5% on the announcement, but fell back just as quickly to end the day only fractionally up.

Analysts said the US deal could lead to others being signed quickly as other countries try to snap up available stocks, once again raising fears of “vaccine nationalism” that will leave lower-income countries at the back of the queue when it comes to access.

The US government previously signed deals – all for 100 million doses – of a vaccine from Pfizer/BioNTech at a cost of $39 per course, $21 per dose for a Sanofi/GlaxoSmithKline shot, and $10 per dose for a Johnson & Johnson candidate.

It also has deals in place to supply vaccines from Novavax and AstraZeneca/University of Oxford for 100 million doses at $16 and 300 million doses at $4, respectively.

“The Trump Administration is increasing the likelihood that the US will have at least one safe, effective vaccine by 2021,” said Azar in a statement.

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Intouch Group hires Susan Perlbachs as chief creative officer

Intouch Group has announced the hire of Susan Perlbachs as its chief creative officer (CCO). As CCO, Perlbachs will be responsible for creative leadership across all Intouch Group affiliates, locations and clients. She will be based in Intouch’s New York office.

“I’m looking forward to being part of this award-winning organisation that I’ve admired for quite some time,” said Perlbachs. “I’m thrilled to work with the incredibly talented executive creative directors who have made the Intouch creative team what it is today, and to partner with them to elevate the organisation and its reputation to even greater heights.”

Perlbachs brings nearly 20 years of experience with other renowned healthcare agencies, including high-level positions at GSW and Grey Healthcare, driving major campaigns for US and global brands for professional and consumer audiences, including over-the-counter, oncology, nephrology and neurology.

Most recently, she served as EVP, Group Creative Director at FCB Health. Honours and accolades include being named one of PharmaVoice’s Top 100 Most Inspiring People, speaking at Cannes Lions Health and serving as a Clio judge. She also was named an HBA Rising Star.

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Novo Nordisk: Prevention, digital tools and collaboration to define the future of diabetes

In our latest UK Leaders article Pinder Sahota, UK general manager at Novo Nordisk, tells us how he hopes to bring the NHS and pharma together to improve outcomes in diabetes and other long-term conditions.

Though Novo Nordisk is perhaps not as much of a household name as other pharma companies in the UK, it has a huge presence in diabetes, with a bigger market cap than the likes of GSK and AstraZeneca – and UK GM Pinder Sahota is keen to shout about the organisation that he describes as a “sleeping giant”.

“Danish culture is very humble, but there’s a lot going for the company in terms of the culture, the way staff are treated, the profile of the company and the sense of purpose, so I’d love for more people to hear about us.

“Novo Nordisk is actually the only company I’ve worked at that regularly audits its culture. Every couple of years we’ll look at where we want it to be and whether we are achieving that.”

In particular, when coming into the company two and a half years ago, Sahota sought to build a culture that “liberates talented people to be able to work together to do great work”.

“There are more and more instances where pharma workers need to be multidisciplinary – so we want to enable fantastic teamwork as a core competency.

“We can use the NHS as an example – look at the multidisciplinary nature of surgical procedures, for instance; the way they have to work, the way they communicate, the way they get feedback, the way they audit their results. That’s what we want to inject into Novo Nordisk.”

“We’d like to get to a point where our treatment and prevention offering can be packaged together for the NHS – because both go hand in hand, alongside digital tools”

Collaborating to prevent diabetes

Sahota says that these kinds of multidisciplinary teams are vital in order to propel projects forward and achieve the changes they want to see happen – which is particularly pertinent when diabetes and related conditions continue to have huge, unsustainable impacts on healthcare systems.

“These are massive societal burdens on countries,” says Sahota. “Whilst our treatments will help manage symptoms – and maybe one day offer a cure – we also recognise that these are unsustainable chronic conditions for society. If you want to be a sustainable company – not necessarily in terms of the environment, but in terms of what you do for your communities – then you need to focus on prevention as much as treatment.”

Sahota says that Novo Nordisk wants to take a “holistic view” on prevention.

“The solution to obesity isn’t just ‘exercise more’. There are various triggers for why obesity happens, and more and more factors are starting to be understood. Some of it is lifestyle, some of it is emotional, some of it is genetic – which is why last January, the Royal College of Physicians recognised obesity as a disease.

“We need to understand those factors and de-stigmatise obesity, making sure we provide the right support to individuals who need it.”

The company is helming various prevention programmes, such as Cities Changing Diabetes – a global initiative where Novo Nordisk helps cities tackle the condition.

“We’ve got two such projects in the UK, in Leicester and Manchester,” says Sahota. “We bring together people from different parts of the city – everyone from the mayor to faith communities and sports clubs – to have a conversation around how we can stop the rise of diabetes in the city. How can they make people aware of the issue, access the right kind of facilities, eat the right kind of food? How can we get that message into communities? Those conversations weren’t being had before.”

Sahota hopes that the company will be able to do more with these initiatives over time, as well as collaborating more with the NHS on obesity.

“We’d like to get to a point where our treatment and prevention offering can be packaged together – because both go hand in hand, alongside digital tools.”

Sahota sits on the ABPI board and leads one of the Association’s workstreams on engaging with the NHS on collaborations.

He says the UK industry is keen to foster large scale collaboration with the health system and overcome the barriers to partnership that some NHS customers face.

“If we can do this, then we can successfully improve outcomes for patients, and it’s a win-win all around. We’re pushing that agenda, but I still think it’s not going at the pace that we would like within the NHS.”

Sahota says that there are several approaches the industry can take to improve this.

“One is engaging at the highest level within the NHS to extoll the value of collaborating. We also believe it will help if we can put in place frameworks for how we can collaborate. In addition, it’s important that we tap into groups like the Academic Health Science Networks.”

He adds that the industry needs to think more “through the NHS’ eyes”.

“For example, in the NHS Long Term Plan, chronic conditions are called out because aging populations tend to suffer from diseases that have co-morbidities. This is where the burden for the healthcare system is going to be as people grow older and live longer.

“The NHS has identified those issues, and if we look at it through their eyes we can focus and figure out how best to ease that burden. Then you can come up with optimal solutions – whether it’s highly effective treatments, digital solutions, or prevention programmes.”

Sahota adds that the NHS’ willingness to engage with pharma is also improving.

“It’s a lot better than it was 10 years ago,” he says. “Some of these collaborations have resulted in significant improvements for patients, and the NHS’ challenge has always been scaling that to bigger regional or national impact. For me, that pace of change isn’t fast enough, but luckily through the ABPI I can have dialogue with NHS leaders about how we accelerate that.”

Digital tools

Sahota is also optimistic that the COVID-19 pandemic will ultimately boost adoption of the digital technologies that can be vital to improving outcomes in diabetes, saying that the crisis has “removed a lot of the cynicism and pre-conceived barriers” around such devices.

“The pandemic has shown everyone how we can work very differently. In the NHS, we are seeing more investment in telehealth. Six months ago, people would have said that telehealth had limited value and wasn’t going to take off, that you need to be able to physically see patients to really understand their conditions.

“The view now is that even post-COVID-19, the majority of consultations will probably be done remotely. Our industry needs to consider what we need to do to make our products, and our services, fit that type of consultation.”

This will also mean the industry needs to think about how HCPs will want to interact with pharma companies.

“If they’re more comfortable doing virtual consultations with their patients, then maybe this is something our commercial teams need to be engaging in as well.

“That will fundamentally change the way we set up our commercial models, the role of our commercial teams, and the skills that they need to acquire – which is something that Novo Nordisk is working hard on.”

Sahota adds that if pharma is able to more easily connect with patients remotely, this would help improve remote diabetes management – which is becoming an increasingly important part of diabetes care for many patients.

“There are several examples of continuous glucose monitors that a patient wears – the most famous example being the FreeStyle Libre device that Theresa May uses. They sit on the skin, monitor glucose levels, and give the patient constant readings on their phone. And in some cases, HCPs could see those readings as well, if they have permission.”

Novo Nordisk is itself investing in such technology, and is aiming to introduce more  connected devices, such as digital insulin pens, in the future.

“When the patient takes an insulin shot with this pen, the information gets downloaded to an app on the phone, which tells the patient when they took the dose, and what dose they took.

“There’s no need to fill out paper diaries, which are easy to forget about. Now the physician can view all of that remotely, then guide patients over the phone on what they’re doing right or wrong.”

The other side to this, Sahota says, is thinking about how companies can provide more support so that patients can self-care at home as well.

“As aging populations, long-term conditions, and co-morbidities place a burden on the healthcare system, governments and health departments have to figure out how patients can self-care and manage at home. Digital tools and technology can support that.”

Again, the spectre of this burden is the main factor driving the NHS, Novo Nordisk and other pharma companies to innovate with a holistic, multi-disciplinary approach to treatment and prevention.

“As the NHS gets squeezed so will the healthcare industry,” Sahota says, “and that’s where companies will have to work hard to show the value our treatments can offer – as well as what we are prepared to do in terms of collaborations to improve patient outcomes, NHS productivity, and prevention of long-term diseases.”

About the interviewee

Pinder SahotaPinder Sahota has been general manager and corporate vice president, United Kingdom, at Novo Nordisk since March 2018 with responsibility for all operations. Pinder is also a member of the European management team. Pinder brings extensive business, commercial and leadership experience to Novo Nordisk from a variety of senior UK and European roles. He was responsible for developing the commercial & market development strategy for key brands across Europe in his role as senior vice president of market and commercial development for Europe at Smith & Nephew based in Baar, Switzerland.

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Bad behaviour: why understanding human behaviour can improve outcomes

Why did I do that? A common question I often ask myself after opening the biscuit packet for the third time in an hour. Only ten minutes before I had a mental argument with myself, which I thought I had won, promising not to eat another one until tomorrow. The process that goes on inside our heads, affecting the good and bad choices we make regarding our health every day, is the focus of health psychology and the growing interest around behavioural change.

Research on the social determinants of health indicates that our behaviour accounts for up to 38% of our health status and that we should be looking to broader aspects of health as medical care represents only 11%. This research also shows the complex system that drives our health outcomes, including the environment, our genetics and our social circumstances.

Our behaviour patterns shape the conscious and unconscious decisions we make about our health and are often an indicator of future health outcomes. Therefore, understanding why we exhibit bad health behaviour is an essential part of planning healthcare interventions, and this is especially true for chronic or long-term diseases.

Human behaviour underpins our actions towards medication adherence, physical activity, tobacco and drug use. It affects our sleep patterns, shopping behaviour, hand washing and the way we monitor ourselves for changes in health or disease indicators.

Outside of direct effects on our health behaviour, it also affects health through other people’s decisions. For health workers, choices change the way we interpret new clinical information and the speed at which we adopt new clinical standards. The behaviour of care workers and their decisions also affects individual care. As the social determinants of health help visualise, behaviours should be viewed as part of a system, and therefore when we attempt to change behaviour our interventions need to address the interplay of factors that underpin current actions.

“Great leaps have been made in patient outcomes – but further growth will require us to use a deeper understanding of behaviour to make these gains more sustainable”

Great leaps have been made in the improvement of patient outcomes – but there’s a growing realisation that further growth will require us to use a deeper understanding of behaviour and how to change it to make these outcome gains more sustainable.

The most recent health strategies aim to build an approach to health based on the Four P’s of disease:

  • Prevention: preventing a disease or reversing illness before it has an irreversible effect on health
  • Prediction: knowing when a disease will have an impact on health and providing interventions beforehand
  • Precision: moving to interventions that target diseases specifically instead of broadly
  • Personalisation: creating interventions based on individuals knowing their genetics, biology and psychology as well as their social and geographical environment.

While great progress has been made in diseases like diabetes, where HbA1c can be controlled for the majority of patients, we can still improve health outcomes further by providing better monitoring of disease and through more personalised drug delivery.

Advances in digital tools and medical devices have also enabled better outcomes through better decisions. More recently, work on understanding the drivers of positive health determinants like food choice, smoking cessation, and increased physical activity have started to add to overall health improvements for diabetic patients. Our understanding of the basis of behaviour and the choices we make are moving us away from the reliance on information and education as the prime intervention. More systematic approaches to understanding behaviour and the interventions that support change appear in the literature. In part, this change is fueled by recent research but also from advances in digital tools and the ability to access people’s actions through devices like smartphones.

In a previous article I argued that behavioural science capabilities are a new skill that pharma needs to master. This is not the first time that pharma has tried to go ‘Beyond the Pill’. Ten years ago, a wave of digital health departments started focusing on the capabilities of new digital media. mHealth followed, with the advent of connected systems and the rise of the Internet of Medical Things (IoMT). Recently a more considered approach to digital medicine and digital therapeutics has taken over. Prescription Digital Therapeutics (PDTs) are appearing as both a companion and a replacement to some drugs. Companies like Pear, Omada, Wealthy, Noom, Lovingo and Welldoc all provide solutions to help patients improve health outcomes, most of them having a component of behavioural change.

There are many models of health behaviour that attempt to both explain the origin of current behaviour and plan for interventions to support change in behaviour. A review of the literature shows common approaches include the Trans Theoretical Model, the Theory of Planned Behaviour and COM-B. Each of these and the other theories have their place in helping health providers plan for change.

COM-B is an accessible approach to behaviour change developed by Michie et al. at the Centre for Behavioural Change, UCL in London. It draws from 93 other models to create a unified approach to understanding and changing behaviour. COM-B is an acronym for the drivers of behaviour, with people needing the (C) capability to perform the desired behaviours as well as the (O) opportunity and the (M) motivation. This approach has had successful implementation in many settings, such as smoking cessation, hand washing, medication adherence and others.

Remembering that behaviours occur in systems helps us use tools like COM-B to create health interventions that are more holistic and consider the underlying cause of behaviours that may need to be changed to improve the target outcome. COM-B asks if the person has the capability of performing the behaviour. Enablers of this are both physical and psychological. For example, in physical activity, there may be a physical limitation, through skill, strength or stamina. Psychologically there may be a need to inform or educate to enable the behaviour.

Going back to the physical activity example, we may need to explain to patients what we mean by physical activity to ensure they can execute the behaviour. COM-B provides a validated taxonomy of interventions that may support patients’ capability to perform the behaviour more frequently.

Beyond capability, patients also need the opportunity to perform the planned behaviour. Patients’ opportunity can be viewed as having the right resources and environment to perform the behaviour. There are also social opportunities that arise from those around us that influence our thinking and actions, as well as the cultural norms that affect the way we think.

Finally, we must also understand patients’ motivation to perform the desired behaviour. For example, what motivates patients to check blood glucose or to take medication? Our motivation systems are complex, and there is much research in this area. In terms of COM-B, we can think of reflective motivation, which encompasses the plans we make and how we evaluate our choices. How much do we value the task of performing the behaviour? The second system of motivation is our automatic motivation with processes involving emotional reactions, desires (wants and needs), impulses, inhibitions, drive states and reflex responses.

Behavioural change frameworks help teams in pharma, medical device, and digital therapeutic companies create programmes to improve health outcomes. These frameworks create intervention plans that support pharmacotherapy and device use. They are also useful tools for looking at brand plans to understand if the planned tactics can support the type of behavioural change intended.

For many diseases, the next level of health innovation will require advanced chemistry, formulation or delivery (in other words, what pharma companies are good at today) along with insights into behaviour and how to change it, as well as how to deliver behavioural change at scale. Not all our behaviours or choices are bad, but there is room for improvement for all of us, and we need all the behavioural support we can get.

About the author

Mark Lightowler is the CEO of Phorix, a behavioural change design agency. They work with patients, physicians and pharmaceutical companies to improve health outcomes through behaviour change design and are based in Basel and London.

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Pharma’s rep soars on back of COVID-19, says FutureBrand

The perception of pharma and medical product companies has surged forward since the start of the COVID-19 pandemic, but they still lie mostly outside the top-rated firms in the FutureBrand Index.

Roche, AstraZeneca, Novo Nordisk, and Sanofi all shot up the rankings in the first edition of the report since the start of the coronavirus crisis, but the big loser was Gilead Sciences, falling 71 places to 74 in the list since the last edition in 2018.

The FutureBrand Index surveys public perception of the top 100 companies identified by global professional services firm PwC

Roche was the highest healthcare climber – up 49 places to 28 – which the report suggests could be in part due to its work on coronavirus diagnostics and experimental treatments for the infection, as well as a pledge to share the data as quickly as possible.

Gilead’s plummet down the rankings comes despite – or perhaps because of – its work on COVID-19 therapy remdesivir.

While it is one of the few to have data pointing to efficacy, the drug generated some bad headlines during lockdown, including an unpopular decision to sell all early stocks to the US government, and reports suggesting Gilead had ramped up its price.

The top-rated healthcare companies weren’t from the pharma sector, however. Highest are medical device companies Danaher – a new entrant in the list at number 16 – and Medtronic at 20.

While these are the only two healthcare companies in the top 20, FutureBrand suggests this “masks the real story: both firms are world leaders in medical technology and their rankings are bolstered by many other healthcare companies that have also seen a rise.”

Raised awareness and concern over health during the pandemic looks likely to be a key factor behind the sectors upward trajectory. Meanwhile, FutureBrand suggests that healthcare companies are doing what tech companies were once famous for – innovating for the good of mankind

“Tech-inspired innovation is paying dividends for healthcare brands, literally and figuratively,” says the report. “Whereas before drug research tended to hog the limelight in the health sector, now it’s new medical technologies.”

The highest-ranked companies in the list have in common that they have “all shown a highly individual response to Covid-19 as well as other significant market and societal shifts,” says Jon Tipple, global chief strategy officer at FutureBrand.

Among the pharma contingent AbbVie claimed the highest position at 22 followed by Amgen at 26 and Johnson & Johnson at 27, just ahead of Roche. AbbVie’s fall of 17 places on its 2018 place is worth a mention, as it is the first time it has fallen outside the top 20 since 2014.

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Bayer slides on €9.5bn loss caused by litigation, COVID-19 impact

Bayer counted the cost of its expensive Roundup weedkiller settlement in the second quarter with a €9.5 billion net loss made worse by lower sales in its pharma and consumer health divisions.

Group sales were down 2.5% to just over €10 billion, with pharma falling 8.8% to just under €4 billion, “weighed down” by COVID-19 and China’s new volume-based procurement policy for healthcare products.

Shares in Bayer were on the slide in mid-morning trading after the figures were announced, down a little over 3%.

In common with many of its peers, Bayer saw an uptick in pharma sales in the first quarter in part due to stockpiling of medicines as the coronavirus pandemic gathered momentum.

Like others it has also been hit by the effects of lockdowns on prescribing rates in the second quarter – with women’s health, ophthalmology and radiology products hit the hardest as consultation rates plummeted – but says it saw glimmers of a recovery at the end of the period.

There was a sizable fall for Eylea (aflibercept) for age-related macular degeneration (AMD), Bayer’s second-biggest product which declined 6% to €568 million, but the contraceptive franchise was hit hardest, down more than €110 million on the same period last year to €185 million.

Gains for top-seller Xarelto (rivaroxaban), Bayer’s oral anticoagulant, and cancer drug Stivarga (regorafenib) offset the declines, aided by the earlier return to some degree of normality in China in the second quarter as the pandemic eased.

Consumer health sales also dipped 1.9%, falling back after a strong first quarter driven by consumer purchasing over-the-counter medications amid the COVID019 crisis.  

The headline news for the German company however was the near $11 billion deal agreed in June to settle claims, inherited after its $66 billion takeover of agricultural products company Monsanto, that its Roundup herbicide causes cancer.

The settlement covered around three quarters of all current lawsuits – estimated to number around 125,000 – and also includes a capped amount for any that emerge in the future.

Taking out the settlement charge, Bayer says it would have posted a 5.6% increase in earnings to nearly €2.9 billion.

Essure litigation still lingering

While the Roundup litigation should be in its rear-view mirror, Bayer had to include a provision in its second-quarter accounts for litigation relating to birth control device Essure.

The company took a charge of more than €1.5 billion in the period “that mainly comprised expenses in connection with the Essure litigation,” with 32,000 lawsuits ongoing alleging injury from the device as of 24 July.

Plaintiffs claim birth control with Essure led to side effects including hysterectomy, pain, bleeding, weight gain, depression and unwanted pregnancies.

Looking to the full-year, Bayer says the financial impact of the COVID-19 pandemic “remains difficult to predict.”

It expects a recovery in pharma and consumer health, but doesn’t think they will bounce back to earlier forecast growth, and is trimming its group sales forecasts for the year by €1 billion to €43-€44 billion.

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Preparing for an influx of cell and gene therapy approvals

Cell and gene therapies offer some of the most groundbreaking advancements in patient care the pharma industry has ever seen. However, to fully realise the potential of these innovative therapies, integration across the supply chain is critical – particularly with reimbursement and logistics.

As of the end of 2019, there were 17 cell and gene therapy products approved by the FDA. Now, there is more momentum than ever to bring these innovative medicines to market, and the FDA anticipates that it will approve 10 to 20 cell and gene therapy products a year within the next five years.

These therapies can offer new opportunities to patients with conditions where there are few treatment options and no cures. But the potential these products offer could remain largely unrealised if manufacturers and their partners are not prepared. Cell and gene therapy innovators and other stakeholders across the supply chain need to set themselves up for the greatest chance of success by addressing three key challenges: access barriers; logistics; and the need for stakeholder education.

Addressing access barriers through innovative payment models

While cell and gene therapies offer novel treatment to patients who have limited options, the cost associated with each product – anywhere between $375,000 and $2 million – can create significant access barriers. This challenge is compounded compared to traditional treatments that typically require multiple doses, as many cell and gene therapies are one-time treatments.

This situation increases the risk for payers covering the cell and gene therapy, given that the long-term magnitude and durability of the product is not known at the time of first regulatory approval and patients switch insurance carriers throughout their lifetimes.

“Stakeholders across the industry have recognised the increasing need to consider alternatives to the standard payment system if cell and gene therapies are to become widely available”

Stakeholders across the industry, such as manufacturers and payers, have recognised the increasing need to consider alternatives to the standard payment system if cell and gene therapies are to become widely available. As a result, a variety of payment models have been discussed:

  • Value-based model: The payer pays only a portion of the full price upfront. If the therapy achieves prespecified outcomes, the payer remits the remainder in full. This model spreads the financial risk, therefore, between the payer and manufacturer, and has been the most commonly employed method to date.
  • Pay-over-time model: The payer agrees to a fixed price for the therapy but pays in regular installments, like with an annuity, spreading the cost over time.
  • Subscription-based model: This model offers the payer a flat rate for coverage of various cell and gene therapy products, which provides predictability and helps them offset the potentially high upfront costs of these therapies and realise longer-term cost-savings.

We have already begun to see payers and manufacturers of cell and gene therapies attempt to adopt alternative payment models for their products, and more should continue to do so as additional therapies come through the approval pipeline. With a range of interdependencies that affect the success of cell and gene therapies, manufacturers need to develop their reimbursement strategy early in the commercialisation process. It’s critical for manufacturers to consider various payment models for cell and gene therapies ahead of approvals so that they can maximise patient access for their products.

Ensuring therapies reach their patients

Manufacturers have noted that the delivery of critical shipments is one of the biggest challenges facing the advanced therapy industry, as if you cannot connect cell and gene therapies with patients their efficacy is irrelevant. The inclusion of patients into the cell and gene therapy supply chain, the potentially life-altering impact of the therapies and their high cost leaves no room for failure.

These therapies require timely delivery and maintaining precise temperature control is integral for the patient and the product. It calls for near-perfect execution ranging from mapping the best transportation route and planning for multiple contingencies (such as closed international borders), to how the packaging itself is evaluated, validated and used to maintain product integrity in all conditions.

Successful execution of these processes requires both manufacturers and other supply chain partners to maintain a robust logistics platform. Currently, many manufacturers are developing different logistics plans for each of the stages of a clinical trial, only to find out these processes don’t scale when it is time to commercialise. Developing a plan early that can scale will position a product for success as more therapies are reviewed and approved. Manufacturers need to work with their 3PL and distribution partners to ensure control and oversight throughout the product journey to the patient – failure to do so will put patient outcomes and commercial success at risk.

Promoting stakeholder education

Many stakeholders – spanning payers, providers and patients – do not understand the full clinical, logistical, operational, financial or reimbursement components associated with cell and gene therapies. Manufacturers can leverage the preliminary data they’ve gathered throughout their initial commercialisation journey to support education and awareness efforts with these key stakeholders.

As payers conduct product reviews earlier and earlier in the development lifecycle, their demand for pre-approval information continues to grow. However, recent research shows that a gap still exists between the evidence sought by healthcare decision makers and what is being shared by manufacturers. COVID-19 has also caused delays in providing information in a timely and relevant manner, causing even more challenges for stakeholders.

The use of Pre-approval Information Exchange (PIE) is one way to combat these challenges. PIE allows manufacturers to communicate ahead of approval to partners with accurate, and unbiased information on products or indications, and share information early that may result in a “place saved at the table” for their product. This information equips stakeholders with the education needed to understand a product’s value story and positioning. Partners embedded in the industry – particularly those with a patient-centric focus – can also offer manufacturers the information they need to showcase the value of these products to patients.

The cell and gene therapy space is continuing to evolve. Through analysing payment models, working with partners to navigate logistical challenges and leveraging data, patients will have more opportunities than ever to access the next generation of medicines. Overall, the collaboration between stakeholders across the supply chain will facilitate a world in which we see 10 to 20 cell and gene therapies not only approved each year but out in the market directly impacting patients.

About the authors

Alex Guite is vice president services and alliances at World Courier. As strategy and services lead, Alex is responsible for developing and executing key strategic initiatives.Before joining World Courier in 2013 as head of pricing, Alex spent nearly 3 years with Oliver Wyman as a consultant in the Health and Life Sciences practice.

Ana Stojanovska is vice president, reimbursement & policy insights at Xcenda. She has extensive practical knowledge in working with key stakeholders to motivate local coverage of new products by both public and private payers and providing strategic compendia analyses and ongoing coding support. Prior to Xcenda, Ana worked for a bipartisan, non-profit health policy organization in Washington DC, where she helped lead research, health policy analysis, media outreach, and fundraising.

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Novartis, company culture and COVID-19: the pharmaphorum podcast

Novartis’ Steven Baert joined the pharmaphorum podcast for episode 22 to discuss how COVID-19 will change the face of company culture, now and in the future.

We also looked at how Novartis’ own operations had to change in response to the coronavirus pandemic and the considerable challenges that presented him as its chief people and organisation officer.

It’s a role that sees him responsible for the physical and mental wellbeing of 130,000 employees around the world, huge numbers of which had to rapidly transition to new ways of remote working.

Steven also talked about how his company’s culture has already changed in response to COVID-19 and what he thinks the virus means for pharma’s future working practices.

You can listen to episode 22 of the pharmaphorum podcast here, download the episode to your computer or find it – and subscribe to the rest of the series in iTunes, Spotify, acast and Stitcher.

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Next wave: how pharma analytics can be improved with new technologies

Pharmaceutical companies have always had access to a steady stream of data to look at what has happened in the past and to try to predict future prescribing trends.

Business intelligence (BI) departments have supported this throughout with timely and effective reporting, within an environment that has seen in recent years a bit of an ‘arms race’ with BI tools adding an increasing array of chart types and functionalities.

To date this has been typified by the visual approach of the ‘fish tank’ chart. But now technology – specifically artificial intelligence (AI) and machine learning – is poised to offer new ways of analysing and processing data, allowing the pharmaceutical industry’s use of analytics to step up a gear.

Business intelligence analytics today

BI provides key metrics for pharma companies to track sales performance over time, whether through market share, contact rates or other endpoints.

You absolutely do need to know what worked in the past when you’re making your future plans, but the various retrospective figures that have been available to pharma to date can only show occurrences that have been and gone.

Different metrics have come into fashion and then departed, with some even coming back around again. However, they only look at the traditional questions companies ask of their sales teams: Are we doing well? Are we hitting our targets? Are we growing? How do we compare with the competition?

Meanwhile, recent years have seen some major changes in the types of information that is available to those in pharma who assess sales and marketing performance.

Traditional NHS prescribing data has been augmented by information on biosimilar uptake across the health service, real-world data and other sources, while the data sets available to pharma have also increased in size. The advent of this big data means the typical pharma sales rep might now receive up to 4,000 data points a month, depending on the size of their territory and the number of competitor products or packs in their markets.

But there are limits to the insights that such large data sets, on their own, can bring to the industry – not least because diving fully into all of the data that is available would be a full-time job in itself.

Why we need to improve current BI tools

To make the most of modern-day analytics requires a new approach. The users of these data sets fall into a number of different types, all of whom must be catered for, but typically they’re all non-analysts. Our core users come from pharma sales and marketing, and it’s important we give them as much value from the data in the time they can spare from their regular duties.

In this way we can help up everyone’s game so that they can in turn have a bigger impact on business performance. What we’re trying to do as a consultancy is shift that curve a little bit, so that everyday users – as much as super users – benefit from these tools.

Timeliness is another area where improvements are needed. The worth of current business intelligence tools has long been proved, but they’ve had to focus on what has happened in the past and, within this, deal with time lags with the data.

Even the most up to date mainstream sales and market data will only arrive at the end of the following month, which in practice means a one to two-month lag on the period it covers. It’s great to learn from the past, and an important part of how analytics should be used, but it’s also a side of business intelligence that can be further enhanced.

New BI technology for pharma

To date, technology has been a limiting factor for development. Business intelligence has always been haunted by this to some extent, but tech’s continual advances mean that it will get better. As it does pharma should be looking for improvements to come from the insights it can uncover from the data, and particularly by combining large datasets.

With the ever-increasing size and number of datasets that are available, new technology can provide a hugely valuable ‘noise cancelling for BI’ role, allowing those in pharma to cut through the white noise to get to the relevant information. It’s here that machine learning can come into its own, doing some of the heavy lifting that your data requires; if the thousands and thousands of data points it offers are to be made sense of.

At the same, applying AI to the data can start to reveal the hidden patterns from the data sets in a way that just isn’t possible when an individual has to click through 100 bricks or 200 practices and look at every pack or product prescribed to try and decide if something has happened that’s interesting. There are a wealth of different hidden patterns in the data that the human eye won’t know are there, while the machine won’t rest until they are found.

“Further value might be found as we start to assess what the post-COVID future might look like, and combining AI and advanced analytics will allow pharma companies to measure, monitor and predict this”

 

Advancing analytics to provide future value

Looking for patterns in the data, and at what might happen in the future, is all about helping pharma to ‘find the interesting’ in the data, and the technology that facilitates this can also free up users’ time by providing them with quicker answers.

Among those answers might be directions to redirect the marketing strategy based on the data, or to institute a wider adjustment in sales and marketing team behaviour to drive tactical change on the ground.

Further value might be found as we start to assess what the post-COVID future might look like, and combining AI and advanced analytics will allow pharma companies to measure, monitor and predict this. Certainly no AI predicted COVID-19 and the devastation it would cause, but it could assess the virus’ impact on different diseases, therapies and NHS locations.

However, as with any use of new technology, it’s vital that pharma benefit from it and, with so much talked about in AI, there is a real need to avoid ‘AI atrophy’ when solutions are built and implemented before any assessment has been conducted of where they will add value.

Answering pharma’s big questions with tech-enabled BI

How will COVID-19 change prescribing patterns, what impact will a new formulary have on physician decision-making and how will market dynamics change when a new product is launched? These are some of the big questions that a tech-enabled approach to BI analytics might answer.

At the centre of this process will be the use of machines to guide and power-up human decision-making so that pharmaceutical sales and marketing teams can look to the future, as well as the past, processing more data, more quickly than ever before.

Technology is going to do a lot of the heavy lifting for BI professionals in the future and they will also be able to give it more lifting to do as they seek to solve specific problems for their organisation. As this happens it will also provide a welcome dose of ‘de-risking’, removing elements of human error that can sometimes creep into the data.

The future of pharma analytics is about getting people to answers – and questions – quicker, so the time they spend using the next wave of BI tools can have a positive impact on the future performance of their organisation.

About the interviewee

Lee Ronan is commercial director at CSL. Lee has worked in healthcare business intelligence since 2002, beginning as an analyst and CRM admin before spending time in an SFE role as well as working on secondment as a medical rep.

He has a passion for helping clients use data and visualisations to make informed decisions – Lee’s experience in the field gives him a unique insight into the challenges and opportunities offered by the healthcare sector.

Having previously served on the British Healthcare Business Intelligence Association (BHBIA) board, Lee is now a member of the Best of Business Intelligence (BOBI) committee with a focus on organising the BHBIA Analyst of the Year competition, as well as the Newcomer awards.

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After final $600M opioid settlement, Indivior looks to the future

UK drugmaker Indivior looks finally to have put years of uncertainty over its exposure to opioid litigation in the US behind it, after agreeing a $600 million settlement.

The deal resolves criminal and civil liabilities faced by the company related to charges it engaged in an illicit nationwide scheme to increase prescriptions of opioid addiction drug Suboxone Film (buprenorphine/naloxone).

It follows a guilty plea by former chief executive Shaun Thaxter last month, and a $1.4 billion settlement agreed with its former parent company Reckitt Benckiser last year.

There had been speculation after the indictment in the case in April 2019 that it could bankrupt the company, wiping three quarters of the value off its share price, but the stock has firmed since and rocketed 38% after the settlement was announced, with further gains today.

Under the terms of the agreement, the Department of Justice will move to dismiss all charges returned by the jury in the lawsuit, according to Indivior.

“We believe the agreement provides greater certainty for all Indivior stakeholders, including the patients around the world who are prescribed our medicines,” said new CEO Mark Crossley and interim chair Daniel Tassé in a statement.

An Indivior subsidiary – Indivior Solutions – pleaded guilty on Friday to one felony count in connection with making false statements to promote the Suboxone Film to the Massachusetts Medicaid programme, namely that the product had a lower risk of children taking the drug by accident.

As a result, MassHealth agreed to provide access to Suboxone Film for patients with children under the age of six.

The settlement includes a $100 million payment as soon as it gets the go-ahead from a judge, plus six annual payments of $50 million between 2022 and 2027. The final balance will be due in December 2027.

Indivior also has to disband its Suboxone sales force and remove medical providers from its promotional programmes who pose a high risk of inappropriate prescribing.

The actions “hold accountable entities and individuals that unlawfully marketed opioid-addiction products,” said principal deputy associate attorney general Claire Murray.

“When a drug manufacturer claims to be part of a solution for opioid addicts, we expect honesty and candour to government officials, as well as to the physicians and patients making important treatment decisions based on those representations,” she added.

The settlement comes after a difficult couple of years for Indivior in which it also suffered a major defeat in the US courts over patent protection for Suboxone Film, opening the door to early generic competition for the drug – which accounts for most of its sales.

It is trying to compensate with the launch of new products such as long-acting schizophrenia therapy Perseris (risperidone), but sales of that product have been modest so far at just $3 million in the first three months of 2020.

It also sells another buprenorphine-based opioid withdrawal product called Sublocade in the US, and recently claimed approval for the drug as Subutex in Sweden, its first European market.

“The incident to which the agreement relates occurred well in the past and does not reflect the values Indivior has strived to demonstrate and uphold during our long history of partnering with healthcare providers, policymakers, and communities to fight the opioid crisis,” said Crossley.

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Country focus: Iraq’s pharma industry sees upward trajectory

After decades of turmoil, Iraq’s healthcare sector is growing fast – but the country still holds some unique challenges for companies looking to enter its market. We spoke to Ali Mosawi, founder of Al Hayat Scientific Office, to get his view on the past, present and future of healthcare in Iraq, and find out what it’s like to operate a pharma company in the region.

Today, Iraq’s pharmaceutical market is worth between $3.5-$4 billion, and is expanding rapidly – driven by an ambitious, well-educated population, a growing roster of international brands and high investment in clinical training. According to the latest figures, over 3,000 pharmacists graduate in Iraq each year.

But Ali Mosawi, founder of Iraqi pharma firm Al Hayat, notes that this is not often the view of observers from outside the country.

“Most people’s preconceptions have been shaped by decades of news reporting focused exclusively on unrest, war, and instability. Over the years, a damaging and misleading picture of Iraq’s business landscape has emerged, which masks both its opportunities and progress. It’s only recently that more international investors and pharma companies have begun to fully understand the true nature of the sector.”

“People are often surprised to learn that, in 1989, Iraq had the largest healthcare budget in the Middle East and was the region’s leading pharmaceutical market”

Mosawi founded Al Hayat to ensure that people in Iraq had access to life-saving medical products – after seeing first-hand the difficulties in bringing medicines to the country in the aftermath of the First Gulf War. Now he hopes to help guide Iraq’s industry into a more regulated, compliant future, even as the country still struggles with issues of corruption and smuggling.

“People are often surprised to learn that, in 1989, Iraq had the largest healthcare budget in the Middle East and was the region’s leading pharmaceutical market, larger even than Saudi Arabia, Turkey and Egypt,” he says.

“Since then, Iraq has experienced a series of tragedies – from the occupation of ISIS and the Iraq War to the oil crash in 2014 – and the healthcare sector has not been insulated from these events. The market has fluctuated accordingly but in this period of recovery and relative stability, it is on the path to recovering its former strength.”

A pivotal moment came in 2003 when the Iraq market was opened to the private sector, allowing companies like Mosawi’s to grow their operations and bring new pharmaceutical products to market – and this is where Al Hayat has focused most of its efforts in recent years.

“The private sector is still young and continues to experience rapid expansion as it matures and welcomes growing international investment,” Mosawi says. “There are certainly clear opportunities for investment in a market which is not yet saturated with branded products and looking to increase product availability.

“Meanwhile, an emerging brand-aware middle class has heightened demand for quality products and there is significant scope for international companies to capitalise on this.”

Starting a pharma company in times of conflict

Al Hayat’s story, though, began in a time when healthcare in Iraq was suffering in the midst of conflict and instability.

After winning a scholarship to study in the UK in the 1960s, Mosawi returned to Iraq to work in IT, becoming a director at the Iraq Atomic Energy Commission in 1971. In 1974, however, he was forced to flee Iraq for the UK as a result of the Hussein regime.

In London, he worked as an IT consultant and later became a director at the Abu Dhabi National Oil Company from 1978 to 1983, when he left to start his own IT company, operating across the Middle East until the First Gulf War forced it to cease operations.

While visiting family in Baghdad after the war, Mosawi visited the offices of the Iraqi Red Crescent and learned of the urgent need for medical supplies in the aftermath of the conflict.

“I began to make small donations of medicines and, following conversations with the Ministry of Health, approached international pharma companies for contributions,” he explains.

“My first involvement with the pharma sector grew out of these donations and I became a consultant to SmithKline Beecham and the newly-formed Zeneca.”

The situation in the country deteriorated, however, between 1992 and 1996 when the Hussein regime refused to implement the UN Oil for Food programme, and Iraq suffered a chronic shortage of vaccines and essential medicines.

“International pharma companies were unable to contribute because the government owed them significant unpaid debts,” says Mosawi. “To rectify this, I worked with the Bank of England, DTI and Iraq’s Ministry of Health to settle the unpaid debt by releasing part of the £1 billion of frozen Iraqi assets in London. The debts were paid and enabled a significant set of vaccine donations.”

He says that founding Al Hayat was the natural progression from there – and when Iraq accepted the Oil for Food resolution in 1996, he set up the company to promote the medicines of Zeneca and SmithKline Beecham in the country. When Astra and Zeneca merged, Al Hayat became their exclusive agent and distributor in Iraq, a relationship which continues to this day.

At founding the company’s central goal was to provide medicine and vaccines to ensure the people of Iraq had access to life-saving products. Since then Al Hayat’s objectives have expanded to include helping international partners – like AstraZeneca, Pfizer and MSD – to share their experience with Iraqi medical institutions, bolster training and improve the standard of care, especially in chronic health issues.

Mosawi adds that a core focus now is on providing only the highest-quality medication.

“By this I do not only mean bringing premium products from international brands to market, but also for us to develop a reputation for leading on quality assurance, product safety and governance,” says Mosawi. “We remain the only pharmaceutical agent in Iraq to have a special label placed on our products to signify this commitment, enabling pharmacies and hospitals to have confidence that the medicine they receive has been stored and distributed in accordance with the highest international standards.”

A unique market

Much progress has been made, but Iraq still remains a challenging country for a pharma company to operate in – decades of damage to infrastructure, an inhospitable climate, and the recent outbreak of protests across the country have made for a difficult environment.

“High levels of investment in both insurance and modern smart technology have proven crucial in addressing these challenges,” says Mosawi. “Temperature sensors and advanced GPS tracking for all products, combined with a thorough understanding of the risk landscape, have allowed us to tackle these logistical issues, even in times of considerable instability.

“That said, it can be challenging to guarantee distribution and preserve supply when an area has been severely affected by unrest. Our solution to this has been to establish multiple storage and distribution hubs across Iraq, dividing our operations between Baghdad, Erbil and Basra.”

Meanwhile, the country’s legal system and the strict product registration process can be intimidating and difficult to navigate for companies coming into the market from outside Iraq.

“Those companies who place staff in the country and work with local agents fare better than those who manage their operations in Iraq at arm’s length from a different geography. Our experience is that external pharma companies who work with local agents are better able to capitalise on the sector’s opportunities, and do so in a compliant, efficient manner.”

Mosawi adds that the wider business environment in Iraq has traditionally been plagued with “unscrupulous actors” engaging in poor governance and corrupt practices, including smuggling medicines in from other countries – a situation Al Hayat is keen to see changed.

“Recent developments are encouraging – corruption is being scrutinised as never before and the pharmaceutical sector has benefited from increasingly strict compliance requirements. While issues with counterfeit medicine and smuggling present significant challenges to the market, we have found success working with large international partners, adopting their uncompromising standards, and benefiting from their expertise.

“It is only by holding ourselves to the same regulatory requirements as our partners that we have been able to navigate the market effectively and compliantly.”

But despite the challenges, Mosawi says he is optimistic about the future of Iraq’s healthcare sector.

“In 2019, the Iraqi healthcare sector grew by 30-35%, and we expect this trend to continue in the coming years. The Ministry of Health has been diligent and proactive in developing the sector’s regulatory framework, facilitating increased international investment and stronger governance practices.”

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BCW promotes Catherine Keddie and Tamsin Tierney

BCW (Burson Cohn & Wolfe) has bolstered its healthcare leadership team, promoting Catherine Keddie and Tamsin Tierney to new roles.

Keddie (pictured above left) becomes group managing director for healthcare and head of culture, UK at the healthcare communications agency, with responsibility for overseeing the continued growth of BCW’s UK Healthcare business.

She’s been with BCW for six years, having previously served as director, health at Edelman and in senior roles at Ketchum and Hill & Knowlton.

Her former role of managing director of BCW’s UK Healthcare practice will be filled by Tierney (pictured above right), who will report to Keddie and will sit on the agency’s UK board.

Tierney joined BCW as deputy managing director of the agency’s Healthcare business in 2017, prior to which she held senior med comms roles at Cohn & Wolfe, Tonic Life Communications and Just::Health PR.

BCW’s UK CEO Rebecca Grant said: “Our plan for BCW in London is to become a creative business for sustained growth and innovation, with a clear purpose of solving complex problems by moving people. This trajectory has been most exemplified by our healthcare practice over recent years under Catherine’s leadership so it’s no accident that she has taken on this cultural role that is so critical for our future success.

“Given her experience and contribution to the agency thus far, we’re confident that in her new role, Tamsin will further evolve and drive forward the success of our healthcare practice as we continue to meet the dynamic demands placed on our clients as we emerge from the pandemic.”

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UK pharma resilient in 2Q, despite pandemic fallout

UK manufacturing exports fell sharply during the second quarter as the COVID-19 pandemic gathered pace, but pharma and healthcare products were much less affected, says a Lloyds Bank report.

The latest quarterly UK International Trade Index reveals that the Chemicals and Plastics sector – which covers pharma and healthcare – was particularly resilient in the initial stages of the crisis as customers stockpiled produc