Category: digital

One in 11 adults aged over 65 have reported a lack of willingness to receive a COVID-19 vaccine, according to a US-based survey.

The findings are concerning given that adults in this group are at highest risk for complications from the disease.

Findings from part of the Heartline clinical study, sponsored by Johnson & Johnson and Apple, have been published online on a preprint server and have yet to be peer-reviewed.

Recruitment to the study began in February last year and it was initially set up to test whether wearable and custom-built mobile apps could enable earlier detection and better treatment of atrial fibrillation in patients aged 65 and older.

Willingness to vaccinate against COVID-19 was assessed through an optional survey through the Johnson & Johnson app between 6th and 20th November last year,

The assessment included questions on beliefs about vaccines in general, beliefs about COVID-19 and the COVID-19 vaccine, and opinions on vaccine dosing and potential side effects.

Shortly after the survey was offered, Pfizer announced first interim analysis results showing the vaccine it developed with BioNTech had an efficacy of around 90% and authors compared answers before and after this event to gauge its impact on opinions.

Of the 7,402 people who responded, 63.6% of participants reported they were very willing to receive a COVID-19 vaccine, 27.8% were somewhat willing, 6.0% were not very willing, and 2.6% were not at all willing.

Overall, authors said that 91.3% were “willing” to be immunised and 8.7% were “unwilling”.

Analysing different demographic groups, the study found participants identifying as Black or African American were least likely to want to take COVID-19 vaccines.

A total of 26.8% of Black or African American participants noted they were not very willing or not at all willing to vaccinate, compared with 8.0% of white participants.

Study author Janeta Nikolovski, director of the World Without Disease Accelerator at Johnson & Johnson’s Janssen pharma unit, told pharmaphorum in an emailed interview that she not surprised about vaccine hesitancy in older age groups.

“Several prior published studies have shown those trends as well,” said Nikolovski, who said further work is being done to understand why older people are more likely to be sceptical about vaccines.

She added: “Among those who said they were unwilling to get vaccinated, the majority stated that they would discuss their decision with their healthcare provider, providing an important opportunity for education.”

Further work is also needed to identify why different demographic groups have differing attitudes to the vaccine.

She added: “We agree that further study is needed and a one-size-fits all approach in communication will not be ideal to address specific concerns.”

Nikolovski is hopeful that as vaccine campaigns are rolled out, attitudes to vaccines could change for the better.

“Given that we found vaccine safety and efficacy to be a strong predictor of willingness to vaccinate, I think as people get vaccinated and share their experience with others, trust will grow.

“We saw an increased vaccine willingness after the trial results were released, suggesting that public willingness to vaccinate may continue to rise as additional positive data are released.”

Conversely, negative news stories about vaccines, including reports about adverse events, may have a negative impact.

“In general however, I believe transparency with research results is important, whatever the results, as it is important to realistically manage expectations, “ she concluded.

Janssen is working on a single shot COVID-19 vaccine, which has shown promise in early trials with phase 3 data possibly due by the end of the month.

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Digital cancer care platform Careology has joined forces with RedArc, which provides long-term support for people with serious illnesses.

RedArc has a team of registered nurses that provide support and expert advice by phone to people after referral from insurers, trade unions and groups such as trade unions.

The new partnership provides RedArc nurses with digital tools that will help them care for cancer patients.

Using leading Bluetooth wearable and connected technology, the Careology platform allows RedArc nurses to quickly view real-time health and wellbeing data, including a patient’s temperature, heart rate, mood, journal entries and activity levels.

Access to this information can help provide consistent and effective practical advice and emotional support to patients remotely.

No financial details were disclosed about this latest deal.

In October, Careology linked with doctors at the private London General Practice, a private GP group with around 50,000 people on its books.

This allowed the doctors to remotely monitor patients.

Careology launched its remote monitoring service for cancer patients in the UK last summer, with Macmillan Cancer Support among early adopters of the tool.

The company points out that it offers a way to remotely manage or proactively support patients going through gruelling and often extremely toxic treatment regimes.

Patients themselves have to reach out if they have severe symptoms or side-effects at home.

It’s also a challenge for them to recall how they felt on particular days and assessing the impact and complications of treatment can be unreliable as results.

The system produces red flags and alerts in markers such as vital signs, systemic anti-cancer toxicities and medication adherence.

This allows early and proactive interventions to support the patient, with the potential of saving lives.

The company has its own dedicated NHS division headed by Dr Henry Carleton who has already established two software businesses that serve the health service.

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ViiV Healthcare and London’s Westminster Hospital NHS Foundation Trust have launched a digital triage service for HIV patients supported by a mobile app.

ViiV, a joint venture majority owned by GlaxoSmithKline, with Pfizer and Shionogi as minority shareholders, has been working with Chelsea and Westminster Hospital NHS Foundation Trust on the service.

The new service is being gradually launched to patients at the hospital’s Kobler Outpatient Clinic, one of the largest centres of HIV care in Europe.

It is then planned to expand to larger patient populations across multiple sites at the trust in the coming months.

The organisations have already run a pilot scheme through a joint working agreement, which were presented at last year’s British HIV Association Annual Congress, showing high levels of patient satisfaction and quality of care.

The service known as Klick has also been designed to respond to the current demands on HIV healthcare services brought by the COVID-19 pandemic allowing outpatient clinics to rapidly evaluate clinical needs, provide access to care remotely and communicate effectively with patients.

Design and implementation have been led by a project team comprising individuals from ViiV Healthcare’s innovation team, along with clinical and non-clinical staff from the Kobler Clinic.

The service has been designed with a focus on ensuring digital solutions can integrate with and enhance the service model, whilst delivering a positive experience for patients.

Dr David Asboe, Clinical Director for HIV at Chelsea and Westminster Hospital NHS Foundation Trust, said: “We have made significant advances in the care of people living with HIV, but this work is not finished.

“In many regards, it has just begun. Our combined efforts have shifted HIV from an acute to a predominantly long-term condition.

“It is our duty to understand the emerging needs of our patient cohort, to design care that is responsive to these needs, and to provide care in a sustainable fashion.

“We must achieve these things with a backdrop of the challenges we now also face with COVID-19.

“The collaboration between the Trust and ViiV Healthcare has provided an opportunity to produce an evidence-based and practical service concept that provides a strong platform on which we can build.”

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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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Karina Malhotra from Acumentice explores how digital tech and data could help address the NHS elective care backlog in 2021 and beyond.

The repercussions of the COVID-19 pandemic are going to take a considerable time to repair and nowhere is this more pertinent than in NHS elective care.

The impact on elective care has been considerable. Reports have shown that the number of people waiting more than a year for an operation has reached its highest level since 2008. According to NHS figures, in September 2020 139,545 patients in England had been waiting more than 12 months for surgery such as a hip and knee replacement or cataract removals. These waits have worsened with the winter period and some hospitals are already cancelling planned operations. Under the NHS constitution, everyone needing non-urgent treatment should get it within 18 weeks. This has posed two challenges – clearing the existing and growing backlog and instigating better systems and processes in doing so to prevent the same problem repeating in the future.

Problems pre-pandemic

While extended waiting times have sometimes been pitched as a problem created by COVID, but that is only partially true. Even before the pandemic, there were around 4.4m people on the NHS waiting list and although the majority – around 80% – of patients were treated within the 18 week constitution, it had been falling short of the 92% target set by the government for some time.

There are many factors at play driving this. We’ve seen extreme seasonal cycles of weather for several years now, which has upped demand for all services like ambulance, A&E and mental health care. Services used, in some regard, by pretty much every societal section. This has been compounded with the looming spectre of Brexit, which has meant the NHS lost some of its valuable workforce from overseas. Fast forward to March 2020 and the vast majority of elective activity was suspended due to COVID, massively adding to an existing backlog.

While the pandemic exacerbated historical issues, it also underlined that NHS can respond to a crisis and isn’t static, as is the widely-held perception. In moving into Phase III, it was asked to reach 80% of previous activity levels by the end of September, and in some areas they exceeded those targets.

The bluntness of targets

The answer to the capacity issue has, historically, been to increase efficiency and throughput – more people, smaller space, shorter time. Of course, in a world of social distancing and infection prevention and control, we’re now doing exactly the opposite. This, combined with the fact that existing metrics and processes for monitoring elective care performance may no longer be fit for purpose means a new approach is required.

Reverting to type is not an option and both clinicians and healthcare providers must find ways of treating those patients at most risk of harm in sufficient numbers to make a difference without simply working down a checklist to hit a target. It’s something the Royal College of Surgeons has called for – to not look at targets but look at the patients and what they need as individuals. As an example, Professor Catherine Urch has taken this approach and enhanced it at Imperial NHS Trust to include a measure for retrospective and prospective harm that may arise as a result of awaiting time to guide the decision further.

The key principle being that there’s huge variation between patients that need to be seen very quickly versus those that can wait and that the healthcare sector as a whole has to be mature and realistic about managing the huge numbers of diagnostics interventions, outpatients and treatments. The culmination of which is a very different lens to look at the clinical picture. It would mean not trying to meet a generic population within a given time period but instead, match the individual patient need against a population-driven set of priorities.

Critical to the success of this approach will be to engage clinicians in what is traditionally perceived to be an administrative function. We must enable them to bring their expertise and knowledge of their patient to the table, and allow them greater jurisdiction over the movement of patients rather than a next-cab-off-the-rank scenario. We have to be focusing on using our limited resources for the maximum value for those individual patients and a more clinically driven approach to doing that can only be a good thing.

Dealing in data quality

Thankfully, the NHS has proven itself to be an incredible innovator. We’ve seen more collaboration and adoption of new tools and technologies than ever before. That said, one area that remains ripe for disruption isn’t the waiting list process itself, but the quality of data on it. These lists contain thousands of names and if some of those are inaccurate or no longer required, it places much greater significance on the coveted appointment slots for the patients that genuinely need them.

However, unlike sweeping changes to attitudes and the core process of prioritising patients, improving data quality by using digital tools such that the manual work is reduced is something of a no-brainer. There are many examples where this is happening already. For instance, our partners at Imperial are using a ‘smart’ software (Qubit) to automate data quality correction and validation saving 35,000 manual hours of work annually. It is also worth noting that the clinical prioritisation and review process that we’ve supported implementation of at Imperial has seen an improvement in clinical engagement, which has resulted in improved data quality on waiting lists. Clinicians can decide what’s important for their patients, and how long they should wait whilst addressing any inaccurate waiting list entries of patients not requiring treatment, leading to a 10% to 15% improvement in waiting list data quality.

All of these innovations are key because losing patients in the system or increasing the number of incorrect entries on the waiting list are the worst thing that could happen at this time. The balancing item is ensuring we have full-scale engagement with the patients – the people who ultimately pay for and are the beneficiaries of the services that we provide.

Capitalising on the rest opportunity

There is no doubt COVID has brought major challenges to the NHS but it has simultaneously exposed valuable learnings and it is critical we use the reset opportunity that has been given to us. It is clear that change is needed and we have to do things more efficiently, more effectively and more innovatively because even if we combine capacity in the NHS and independent sector, we still don’t have the capacity to achieve the current targets.

The last 12 months have highlighted that we’ve got to have transparent and honest relationships with the people that we are actually here to serve. This has to be the bedrock of a future where lengthy elective care waiting lists are a thing of the past.

About the author

Acumentice founder Karina Malhotra is a former NHS director and senior leader, with extensive experience and subject matter expertise in all aspects of elective care management.  She has provided expert advisory support to executive teams at some of the UK’s largest Trusts. Karina founded Acumentice in 2014, with a view to share this expertise through the development of clear and sustainable methodologies and frameworks.

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Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new FDA guidance is adopted.

Pandemic emergency provisions were put in place in March last year to allow certain medical devices to be launched for use by patients without having to go through the FDA’s usual premarket notification requirements – also known as the 510(k) process.

That included some low-risk (Class IIa) digital health apps under the software as a medical device (SaMD) category, which can be used to minimise direct contact between patients and healthcare professionals at a time when non-essential visits are best avoided.

Now, the FDA is seeking comment on plans to make that emergency regulatory flexibility permanent, by doing away with the premarket review requirements altogether  “for some or all of [these] devices”, according to a Federal Register notice (0991–ZA52).

The document is likely to be one of the last signed by Health and Human Services (HHS) Secretary Alex Azar, who has resigned from the role as preparations continue for the start of the new administration under President-elect Joe Biden on Wednesday.

Last April, the FDA temporary waiver covered digital health tools used specifically for psychiatric disorders, along with low-risk general wellness and digital health products for mental health or psychiatric conditions. The discretion also covered digital pathology tools and other medical devices like thermometers and ventilators.

Pandemic lockdowns mean patients with mental illness are less able to maintain contact with healthcare and support workers, placing them under added strain, and when it announced the measure the FDA said remote tools could help them cope until some degree of normal life can be restored.

The waiver meant that a number of apps were launched earlier than expected in the US, including Pear Therapeutics’ smartphone-based Pear-004 for people living with schizophrenia and Akili Therapeutics’ attention deficit hyperactivity disorder (ADHD) app Endeavor (AKL-T01), as well as computerised cognitive assessment aids.

The experience so far seems to have been a success, given the FDA is considering making the exemption permanent for 91 devices and SaMD tools out of 221 Class I and Class II medical device types covered by the waiver categories.

“The exemptions provided for and proposed under this notice for these 91 device classes could eliminate anywhere from $9.1 to $364 million in startup costs if there were one new entrant into each device market,” says the guidance.

“At the same time, should these waivers go into effect as proposed, patients stand to gain more immediate access to new products that would otherwise be required to obtain a 510(k) clearance prior to marketing.”

The proposal would also spare FDA’s “scarce review resources” as a result of the pandemic and allow it to redeploy these elsewhere, including devices intended for use in managing CPOVID-19 patients.

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Belgian drugmaker UCB has been steadily building its digital health expertise for several years, and that includes nurturing new projects. One of those is now being launched as a new company – Nile AI – that aims to improve the care of people with epilepsy.

UCB is bankrolling Los Angeles-based Nile with €25 million (around $29 million) in startup cash and will be a majority shareholder, with a presence on the company’s board as well as options on acquiring “data and insights” from its platform.

Nile is being formed to develop a digital health platform – consisting of a patient app that links to a portal for healthcare professionals – that can use data from patients’ past epileptic seizures to try to predict future attacks.

The patient app connects individuals with their care team, and provides information about their treatment and progress, while the portal shows the status of patients, maintains support between consultations, and allows data-driven decisions on treatment and care, according to UCB.

The digital tools are being piloted at Massachusetts General Hospital and Michigan State University Healthcare, and the aim is to have it ready for a commercial launch before the end of this year.

“We know that patients suffering from epilepsy struggle with the unpredictable nature of their lives,” said Dr Leo Petrossian, Nile AI’s CEO.

“Every single day they awake uncertain of what they can expect. At Nile, we believe that all of the data to predict the path of an epilepsy patient exists, though it is fragmented and disconnected.”

Nile’s software operates as a care management system, and cam be used to address this uncertainty, he continued, with the ultimate goal of shortening the time it takes for people with epilepsy to be on the best care available.

It’s a mission that dovetails with UCB’s position as a well-established player in the epilepsy category. Medicines like Vimpat (lacosamide), Keppra (levetiracetam), Briviact (brivaracetam) and recent launch Nayzilam (midazolam) nasal spray collectively make upwards of €2.3 billion a year and account for almost half of its net sales.

UCB added to its range last June with the $270 million acquisition of Engage Therapeutics and its Staccato Alprazolam product for the rapid termination of seizures.

“UCB has a deep understanding of epilepsy and the challenges that people living with the disease face every day, including how patients communicate with their healthcare providers,” said the Belgian firm’s head of neurology Charl Van Zyl.

“We think Nile’s platform can provide valuable insights and foster a better care management experience for people living with epilepsy.”

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Healthcare technology firm Seqster has introduced a new version of its service that aims to help pharma companies work with patients’ data while on virtual clinical trials.

Seqster announced the new version of its platform had been launched on the Microsoft Azure cloud at the annual JP Morgan Healthcare Conference.

The new Seqster 7.1 service will allow secure access to real-world data from electronic health records (EHRs), DNA analysis and fitness wearables.

However, the company’s head of strategic business development Parsi Parsinejad said that the system is differentiated from competitors by its focus on putting patients in control of their data.

By making pharma companies sign data use agreements directly with the patient, Seqster says it has been able to create a platform that allows patients to create a one-point login they can control many forms of US health data.

This can range from health records to ancestry data, allowing patients to track their data in a similar way that the Mint budget tracker allows people to control their expenditure.

The platform is FDA 21 CFR Part 11 compliant enabling secure delivery of EHR documents directly to regulated clinical trial management systems and allowing eConsent-based visualisation of participants’ data.

Parsinejad told pharmaphorum in an interview: “You have been seeing a proliferation of cloud services. They are introducing a cloud-based service and industry specific applications.

“What Seqster does for pharma clinical trials is it brings together in real time a health record for participants. Patients can bring together their data wherever it resides.”

He added the tool could be used to help run virtual trials, which have become increasingly common due to the shift towards electronic technology in healthcare because of the pandemic.

The data gathered can be used as the basis for filings with the FDA, although for now the system works only with data gathered by US-based services.

The company adds that it has split data into two silos to prevent hackers from using it in the unlikely event of a breach.

Parsinejad said: “It’s highly secure, 256 bit encryption the same as Azure. Patient identified data is in a separate container from health data. If there is a breach they would not be able to make sense of the data.”

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W20 has begun 2021 by buying data technology firms Swoop and IPM.ai, adding to its rapidly growing list of acquisitions.

Representing the ninth acquisition for W2O in just over a year, the company said the acquisitions show its commitment to technology and the role it will play in the future of healthcare.

As part of the announcement, W20 has established a new health tech division that combines W2O’s data and analytics software with the Symplur, Swoop and IPM.ai tech and data assets.

W2O said it has evolved its business and made big bets on tech-enablement over the past few years adding that this is another milestone in its transformation to a healthcare innovation company.

In a statement, W20 said Swoop and IPM.ai are pioneers in using machine learning, artificial intelligence, and real-world data to solve big challenges in healthcare.

Swoop creates precise patient audiences, improving targeting of healthcare engagement and empowering patients to become active participants in their treatment journey.

IPM.ai uncovers the ideal patient, enabling accelerated research, development, and marketing of life-saving therapies in under-defined patient populations.

W20 has been on the acquisition trail since it announced a partnership with New Mountain Capital in 2019.

The company achieved revenues of more than $350 million in 2020, an increase of 50% from the previous year.

W20 was founded in 2001 by Jim Weiss and now employs 1,500 people, using analytics and technology to build insights for clients in the life sciences industry.

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Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update.

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.

Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

In its latest statement, the EMA said that the investigation “revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties have been leaked on the internet.”

The EMA added that “necessary action is being taken by the law enforcement authorities.”

It gave no further details about where the documents were posted, adding that further information will be provided “in due course” as the investigation continues.

The EMA said its regulatory framework remains fully functional and timelines relating to review and approval of COVID-19 medicines and vaccines are not affected.

Just days before the EMA hack emerged in mid-December, analysts from IBM warned that a phishing campaign had targeted organisations involved with the cold chain needed to keep vaccine supplies moving.

The operation began in September and spanned six countries and looked like the work of an unnamed “nation-state”, the analysts said in a blog post.

While individual cyber criminals would be unlikely to profit from the information they argued that “advanced insight into the purchase and movement of a vaccine that can impact life and the global economy is likely a high-value and high-priority nation-state target.”

Sam Curry, chief security officer at Cybereason, said that the actions were “diabolical” but added that bringing the perpetrators to justice would be “more fantasy than reality.”

Curry added that hackers see COVID-19 data as a “valuable asset” and will continue to do so for the “foreseeable future.”

He added: “Kudos to the pharma and research companies for working with law enforcement agencies to face these threats head on with advanced cyber tools and improved security hygiene.

The hackers “are well funded and are looking to reap both financial and political fame,” Curry added.

“As the protection surface expands to mobile, the cloud and other potential attack vectors, those companies that can detect a breach quickly and understand as much as possible about the hacking operation itself, will be able to stop the threat and minimise or eliminate the risk all together.”

Feature image copyright BioNTech SE 2020, all rights reserved

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Israeli company Itamar Medical has agreed to acquire Spry Health, aiming to use the US company’s wearable technology to develop a watch-like remote monitor for sleep apnoea, a potentially life-threatening condition.

Itamar already markets a sensing device called WatchPAT that attaches to the finger during sleep, measuring vital signs like heart and breathing rate, oxygen levels in the blood, and changes the volume of blood pumped during a heartbeat – known as peripheral arterial tone (PAT).

That is only suitable for a single night’s measurement, however, and Itamar hopes that by adding Spry’s wearable technology it will be able to develop a device that would be suitable for continuous monitoring of sleep apnoea over weeks or even months.

That could provide a clearer picture of the seriousness of the condition, and the accumulated burden of sleep apnoea on a patient’s heart and vascular system.

Sleep apnoea is caused when relaxation of the muscles in the throat cause the airway to narrow, reducing the amount of air taken in and out with each breath. Sometimes the airway can be shut off completely, and if that lasts for 10 seconds or more it is classed as obstructive sleep apnoea.

In severe cases, apnoea episodes can occur hundreds of times a night, each causing a brief period of wakefulness or shallower sleep.

Symptoms are snoring and feeling sleepy during the daytime, but the underlying effects can be damaging and can lead to other health problems, including high blood pressure, heart attack, stroke and diabetes. The condition affects around 54 million people in the US alone.

Spry’s Loop System wearable has already been approved by the FDA for the collection of physiological data like oxygen levels, respiration and heart rate in patients with chronic obstructive pulmonary disease (COPD) and other chronic health conditions.

It does so by emitting electromagnetic waves through the skin. It then measures the reflection of light frequencies to define the concentration of specific molecules in the blood.

Repurposing for sleep apnoea should be fairly swift – Itamar reckons it could have approval for the apnoea indication in 2022. There are other advantages as well, including the fact that the device already has the necessary codes for reimbursement in the US healthcare system.

Itamar’s chief executive Gilad Glick said the Loop System is a “perfect fit” with its aim of developing a continuous wearable monitor for sleep apnoea.

“While finger-based monitoring yields the highest accuracy, it is currently not suitable for longer-term wear,” he added. “A device that is designed for the wrist, while potentially less accurate for precise disease diagnostics, is more suitable for monitoring the continuous accumulated burden of sleep apnoea and its potential impact on other diseases.”

The technology also gives Itamar an opportunity to extend its focus into other diseases areas like COPD, addressing a larger slice of the remote patient monitoring (RPM) market that is predicted to reach a value of $2 billion worldwide in 2027.

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European telehealth firm HealthHero has bought MyClinic.ie, a rival based in the Republic of Ireland.

Already a major telehealth player in Europe, HealthHero’s services cover 20 million people and 1,000 businesses across Europe.

The acquisition means HealthHero has a direct-to-consumer offer in Ireland, where it was previously providing services through insurance companies and through businesses to their employees.

It follows HealthHero’s acquisition of Doctorlink in December, one of 11 suppliers selected by the UK’s NHS to provide video consultations for primary care during the pandemic.

Founded in Dublin by doctors Daniel Clear, James Ryan, and Terry Deeney, MyClinic’s services include online repeat prescriptions, mental health, physiotherapy and wellbeing products, as well as video consultations with healthcare professionals ranging from GPs, therapists, midwives, physiotherapists, and fertility specialists.

Services include remote access to experienced doctors and expert clinicians directly to patients, insurance-policy holders and employees.

HealthHero only launched in August last year with aspirations to become the biggest company of its kind under the leadership of founder, the entrepreneur and investor Ranjan Singh.

It announced its launch with the acquisition of Berlin-based telemedicine company Fernarzt, which was set up in 2017 and is already offering thousands of online consultations each month in Germany.

Since the onset of COVID-19 HealthHero has seen demand for its UK and Republic of Ireland services increase by over 300%, and MyClinic has reported a similar surge, making it very timely that HealthHero add a direct-to-consumer offering to its services.

No financial details of the deal were disclosed.

Singh is also managing director of digital health for London based investment house MARCOL, which bankrolled the Fernarzt acquisition.

Singh serves as CEO of the group alongside his role as chairman of Medical Consultations, a 20-year-old telemedicine company based in the UK that is at the heart of the HealthHero group. He was named CEO of the UK company in February.

Singh said: “Since the onset of Covid-19 HealthHero saw demand for its UK and Republic of Ireland services increase by over 300%, and MyClinic has reported a similar surge in demand. It’s an exciting time for HealthHero to add a direct-to-consumer offering to our services.”

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2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay.

I think it is fair to say that 2020 will not be particularly missed by anyone. Many started the year with big plans, whether for overseas trips, weddings, or industry events, and then the unthinkable happened. While the world first heard of the novel coronavirus in late 2019, it was not until 11 March 2020 that it was declared a global pandemic and it finally sank in just how serious of a threat it was. But how will the world continue to change in 2021?

Major global events

COVID-19 has amplified many of the issues that society was already facing. Although the pandemic has largely taken the media’s focus away from the climate crisis, it has given us a preview of what is to come if we do not stop exploiting the planet and our wildlife. Indeed, 2020 brought new record forest fires and extreme weather events.

In addition, 2020 was the year where social justice (not least in the form of Black Lives Matter protests) was brought into focus. Racial discrimination and bias were also uncovered in healthcare, with stark differences in COVID-19 rates and mortality between different ethnicities in many countries.

COVID-19 has widened the already large class divides seen between white-collar and service workers, with the former typically having the option of working from home and taking the recommended social distancing precautions. Conversely, the latter group is largely being forced to carry on with their work with little protection and low compensation, if they even have a job to go to after many smaller businesses closed their doors.

Public health has been politicised

Somehow, in 2020, wearing a mask to prevent the spread of a highly contagious disease became a controversial and political issue. People were asked to stay home, watch Netflix, and bake sourdough bread to protect those who are vulnerable, yet photos of packed bars and sports stadiums soon emerged and anti-masking protests were held across the world.

Epidemiologists, researchers, and clinicians are now household names, with people like Dr Anthony Fauci and Sweden’s Anders Tegnell drawing their fair share of both praise and criticism domestically and internationally. Countries’ strategies to contain the spread of the virus have been debated and criticised, and it will likely be years before we will be able to say which approaches were “right” and “wrong”.

“On the upside, the pandemic has brought enhanced focus to mental health issues and innovative approaches on how to best address these. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma around mental health can be lifted and better treatment strategies can emerge”

Mental health focus

The secondary effects on mental health during the pandemic are vast. We are already seeing increased rates of depression and anxiety because of the pandemic, and there are no signs of this slowing down. Women are especially impacted, disproportionately having to take on childcare or home-schooling compared to their male counterparts.

On the upside, the pandemic has brought enhanced focus to these issues and innovative approaches on how to best address mental health. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma can be lifted and better treatment strategies can emerge.

United global research

Another positive note is that the pandemic has accelerated laboratory and clinical trial collaboration far beyond what has ever been seen before. From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centres or countries. It has also shown that the time it takes to get a drug to market can be substantially reduced when there is enough funding and political will. How this will affect clinical trials and regulatory approvals in the future remains to be seen, but there is reason to be optimistic.

Healthcare goes virtual

Before 2020, telehealth appointments were few and far between, with many clinics not set up for these services. Since then, the growth of telemedicine has been exponential. Another aspect of healthcare that has had to adapt is the way we monitor chronic conditions. Older patients or those with co-morbidities are at higher risk of severe COVID-19, so frequent clinic visits for routine blood pressure measurements are not always feasible. As a result, we have seen a dramatic increase in the interest and uptake of remote monitoring devices such as wearables and mobile health apps. I predict that this is just the beginning of healthcare’s virtualisation and am excited to see what the new year has in store.

Remote work is the future

Another major change in 2020 was of course the sudden move to remote work. For many, it was a 180-degree shift from business as usual. Interestingly, in a Canadian survey, the majority of respondents (55%) expected at least some of the workforce to remain remote in a substantial way after the pandemic is over, while only 17% expected all staff to be onsite five days a week. Further, major companies like Twitter have announced that employees will be able to work from home permanently, signalling a clear change in the way that we do work. While not without challenges, I see remote work becoming a mainstay due to its greater flexibility and convenience for workers.

Virtual events are rapidly improving

Finally, the ways that pharmaceutical and scientific communities attend meetings and events completely changed in 2020. Virtual meetings such as advisory boards and steering committees were already popular before this year but were often accompanied by in-person meetings. We have now seen without a doubt that it is possible to meet the same objectives virtually, often more effectively and at a lower cost.

The biggest change, however, is the way we now attend larger events such as conferences, congresses, and medical education events. There is no shortage of online conference solutions available, but there is still much to improve on. For example, some aspects of in-person events are not always there or are poor substitutes for the real thing.

Ideally, virtual event platforms should be comprehensive so that everything you need is in the same place. The layout, branding, and inclusions should be completely customisable to your needs, and it should come with all aspects of in-person events such as networking, breakout workshops, exhibitor booths, and poster sessions. The good news is that these types of platforms are getting better by the day, and so are the virtual events that they host.

What have we learned from the last year?

The past 12 months have shown that firstly, we live in a highly polarised world where science and public health are up for debate. Secondly, crisis leads to innovation and finally digital health technologies are the future with remote work and virtual meetings here to stay.

Wishing you all a safe, happy, and healthy 2021.

About the author

Natalie Yeadon is the CEO and co-founder of Impetus Digital, where she helps life science clients virtualise their meetings and events and create authentic relationships with their customers.

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With the ink barely dry on its last merger agreement, clinical trial and imaging specialist Bioclinica is on an expansive drive once again, buying digital clinical trial specialist Saliency.

Silicon Valley-based Saliency adds an artificial intelligence (AI) powered software platform that speeds up analysis of medical images and is used to support trials of pharmaceuticals and medical devices.

Just before the New Year, Bioclinica announced its merger with ERT, ramping up the digitisation of its clinical imaging platform with ERT’s expertise in electronic clinical outcome assessment, cardiac safety, respiratory and wearables.

That deal was directed squarely at improving endpoint data collection in clinical trials, and adding Saliency to the platform takes that effort up a gear.

According to Bioclinica, the AI technology will “dramatically accelerate [its] image processing and quality control capabilities to support a wide range of therapeutic areas”.

The last few years has already seen a big increase in the use of digital technologies to improve subject recruitment retention and access, boost engagement, harvest data and improve the blinding of controlled trials. That trend came even more to the fore in 2020, as the coronavirus pandemic hit face-to-face clinical work.

Digital promises to improve the efficiency of trials, getting results more quickly whilst also reducing costs and – in theory at least – speeding up the time it takes to get new medicinal products approved and onto the market.

Saliency’s platform uses proprietary algorithms to build and train AI models from a small number of de-identified images. The models can be used to screen, redact, or interpret medical images and will be embedded in Bioclinica’s imaging tools.

“Clients rely on us for time-sensitive expert-level image interpretation for their clinical trials so they can focus on outcomes,” said Dan Gebow, chief innovation officer at Princeton, New Jersey-based Bioclinica.

“We evaluated a variety of medical imaging AI platforms and know the Saliency platform is head and shoulders above others in the market in its ability to deliver value for our clients.”

Saliency’s co-founders, Stanford researchers Kevin Thomas and Łukasz Kidziński, will join Bioclinica’s image science team.

The shift towards virtual clinical trials accelerated by the pandemic has also stimulated a flurry of M&A activity amongst technology providers in the last few months.

Last November, for example, digital trial specialist VirTrial was acquired by Signant Health, which provides clinical trial management systems (CTMS), while in the prior month clinical trial data company Medidata snapped up sensor maker MC10’s digital biomarker and wearables business.

ERT meanwhile bought wearable specialist APDM ahead of the merger with Bioclinica, while private equity firm GI Partners took a majority stake in Clinical Ink, which offers a platform for capturing and integrating electronic data from clinical sites.

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Six months after rebranding from BHE, Panalgo has won a contract to supply the European Medicines Agency (EMA) with its IHD data analytics platform, pledging to streamline its public health efforts.

IHD – or Instant Health Data – will be used by the EMA to carry out data analyses and examine medicinal product utilisation, answer questions about safety and efficacy, and understand how treatments perform in real-world settings, said the Boston, US-based company.

The use of real-world evidence (RWE) has grown rapidly in pharma over the last few years, as healthcare payers and regulatory agencies have tried to get a deeper understanding of the impact medicinal products have in actual practice, rather than just within clinical trial settings.

“Our company is strongly aligned with the EMA’s public health goals, for which timely evidence-based insights are of particular importance, especially during this COVID-19 pandemic,” commented the US company’s CEO Joseph Menzin.

Panalgo is also opening an office in Amsterdam, the home of the EMA, in order to provide close support for the roll-out and management of the new software at the regulator.

Panalgo says IHD’s library of healthcare-specific algorithms does away with the need for complex programming and allows users to “focus on what matters most: turning data into insights”, using sources like electronic health records and patient registries.

There has been a spike in the use of data analytics by healthcare organisations during the coronavirus pandemic to try to guide the public health response to the crisis, for example to make effective, real-time use of resources.

The new agreement with the EMA adds a new dimension to Panalgo’s data analytics business, as most of its clients have so far been life science companies and research organisations.

The company says IHD passed a rigorous assessment by the EMA – in competition with software from other providers – and will support decision-making at the population level, including therapy risk/benefit and life cycle analyses that can be used in public health planning.

“Most of Panalgo’s life sciences clients already rely on IHD to perform rapid analyses that support regulatory initiatives,” said Menzin.

“The IHD platform will be a valuable tool to allow collaboration between drug manufacturers and regulatory agencies, such as the EMA,” he added.

Image by Ceescamel – Own work, via Wikimedia, CC BY-SA 4.0

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ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries.

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients.

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

The latest deal builds on that arrangement in 2019 and while the financial deals are not disclosed, chief executive officer Ian Wilson told pharmaphorum it involves an up-front fee plus payments each time the treatment is manufactured for use.

The company argues that its technology, based on specially engineered antibody fragments, can give an accurate map of T-cell activity, giving a more representative picture of how the tumour is responding to an immunotherapy.

Information of this kind can make or break a cancer trial, giving guidance about whether a tumour is growing or has become swollen because of an incursion by T-cells.

Big pharma is catching on to the idea as companies try to find ways to determine whether immunotherapies are working and avoid expensive trial failures.

“They are looking for effective tools that allow them to read out quicker and faster and better than current methodologies,” said Wilson, who said trials have failed or been delayed because of issues with conventional invasive biopsies.

“(The technology) allows them to make decisions quicker and allows them to triage their drugs more quickly in the clinical phase.”

Equally important to the company is the safety data gathered as the technology is used as the pharma companies use it to guide development of cancer immunotherapies.

This could lead to an approval in the coming years by regulators such as the FDA, where the technology could be used as a guide by doctors to indicate whether a course of immunotherapy is working, or if another option should be used.

Wilson counts US biotech CellSight as its only direct competitor with equivalent technology, although this seems to be considerably further away from commercial use by big pharma.

“From a health economic payer point of view (our technology) allows everyone to rationalise and improve patient care,” said Wilson.

 

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The UK government agency NHS Digital has awarded an £8m digital system that processes coronavirus test results to healthcare software specialist X-Lab without competition.

According to a tender document, the “extreme urgency brought about by the COVID-19 pandemic situation” justified the decision not to open up the contract to competition.

The document added that the technical demands for the project mean that X-Labs is the only provider capable of fulfilling the contract.

Specialist tech website The Register reported that the contract will be to “deliver the digital service” supporting coronavirus service.

It will require a messaging service allowing pathology labs to communicate so all test results and requests can be processed digitally.

The system will underpin the NHS COVID-19 Test and Trace system known as “pillar 2”, which is based on swab testing for the wider population.

It will also help “pillar 3” testing, which shows whether people have antibodies against COVID-19 after contracting it.

Based in Leeds, X-Lab is a private software company that already has experience with the NHS after building the National Pathology Exchange (NPEx), which ensures coronavirus test results are matched to patient records.

This system links laboratories including private facilities with the NHS Business Services Authority, which informs patients of their test results.

In England, the NPEx links to GP records, using details from NHS Digital or Public Health England.

The IT infrastructure underpinning the UK’s testing system has proved controversial in recent months.

Early in October it emerged that data from “pillar 2” private testing labs had been stored on an Excel spreadsheet.

But limitations on the size of the spreadsheet caused thousands of positive results from the labs hired to provide extra capacity to be omitted from the UK’s official records.

This caused official records to show that numbers of infections were stable or falling when in fact around 16,000 positive results were missing from public records.

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Private medical insurance company Further Group has ramped up its presence in digital healthcare by merging with Trustedoctor, a startup that puts patients in contact with medical professionals.

Further – which was rebranded from BDU International last year – specialises in providing cross-border health insurance to people across Europe, the Middle East, Africa and Asia, and according to CEO Frank Ahedo aims to provide people with access to healthcare “no matter what the location or cost.”

Adding Trustedoctor to the business bolsters its digital health capabilities with online consultations, second opinions and other tools to help patients take control of their illnesses and access the care they want, without geographical restrictions.

“Together, we will continue to remove financial and logistical hurdles faced by consumers that want to access the very best treatment when faced with a serious illness,” said Ahedo.

First launched in 2016, Trustedoctor was born from the experiences of founder and CEO Greg Jarzabek whilst trying to get the best care for his mother, who died of pancreatic cancer in 2011.

Using the platform, patients can seek out a doctor based on factors such as location, tumour and treatment type, and request a consultation with their chosen choice.

The tool means the doctor can review necessary information like medical records, scans, and diagnostic results in a digital file, and decided whether to accept the consultation, or refer to anther specialist. The consultation and referral both take place within the Trustedoctor platform.

Trustedoctor started out focusing on oncology, but is expanding into other medical areas and is now being used to connect patients with doctors in more than a dozen countries across Europe, the US and Asia.

It was already offering critical insurance and employee benefits services to corporate clients before the merger with Further. The company will have business in over 30 countries and partnerships with over 300 insurers and employers.

Jarząbek said the merger will create “a new market-leader in borderless, complete healthcare solution and provide a unique opportunity for us to collectively grow our network of doctors and hospitals.

“This will ultimately mean that more patients see the benefits of world-leading medical expertise.”

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Haven, the healthcare venture launched by Amazon, Berkshire Hathaway and JP Morgan Chase is to cease trading next month after failing to achieve its goal of pushing down health insurance costs for US workers.

The joint venture had been billed by many as Amazon’s big move into healthcare when it was launched three years ago with great fanfare.

But since then there has been little news from the secretive venture sparked by an idea from JPMorgan CEO Jamie Dillion, with support from Amazon’s Jeff Bezos and Berkshire’s Warren Buffet.

The venture had sought to “transform healthcare” while also cutting costs for hundreds of thousands of workers.

But the Wall Street Journal reported that these ambitions proved too difficult to achieve, citing sources close to the company that had kept out of the public eye since its high-profile launch.

The company simply did not have the clout to effect a change in the US healthcare system, where insurance payments are often linked to employment status, according to the report.

Resolving differences between the three companies’ healthcare arrangements was another major factor that caused the project to fail.

Each employer’s healthcare arrangements required different fixes and as a result they opted to close down Haven instead.

Writer and surgeon Atul Gawande, who was appointed in June 2018 as CEO, stepped down in May saying that he wanted to focus on the pandemic while staying on as executive chairman.

The WSJ sources said that Gawande decided to move away from managing the company and other executives left as it struggled to make headway, including chief technology officer Serkan Kutan and chief operating officer Jack Stoddard.

Haven did manage to pilot projects involving flat rates for healthcare services in all three founding companies.

One of them involved around 30,000 JPMorgan employees in Ohio and Arizona and Haven also looked at ways to cut prescription drug costs.

Haven employs around 57 people, who are likely to be split between the three founding companies, according to press reports.

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The pandemic has shed light on inefficiencies in healthcare systems, and provided an opportunity to adjust how we manage care in the future. Jennifer Haas, executive vice president of Noteworth, shares her 2021 predictions surrounding the future of telehealth and big data. 

Healthcare providers are grappling with the task of scaling digital care delivery operations for ambulatory patients in response to the cost dynamics of effectively treating large populations with limited resources, especially in a post-COVID-19 world. At the heart of this challenge is how to secure, aggregate, analyse, and action the data necessary to make proactive patient care decisions and diagnoses.

In the coming year, there will be a renewed focus on healthcare providers needing to shift their business models to highlight the new need to make healthcare accessible and effective, regardless of geography, location, and mobility.

This will need to be done while also engaging and empowering patients in their own wellness. A recent report highlighted that over 40% of US adults had delayed seeing a doctor during the pandemic. Powering digital medicine platforms with big data and IoT devices ensures clinicians receive access to the entire scope of a patient’s health information while reducing the need for in-person visits and improving patient outcomes.

The ability to use big data in healthcare through digital medicine will prove to be invaluable for healthcare organisations as they work through the pandemic and the new world it has created. Having access to relevant data through digital medicine is helpful because it provides more opportunities for proactive intervention and a more accurate view of the patients’ health with consolidated real-time information.

When it comes to digital medicine, big data can improve communication and strengthen relationships between patients and their various healthcare providers.  This is largely because the use of digital medicine platforms feel much more comfortable and personalised for many patients. It not only allows them to take a more active approach in their own healthcare, but gives them access to their clinicians more freely and frequently.  It also allows the care team to be much more connected to the patients’ day to day progress and highlights potential intervention needs before they become critical.  Risk modeling and stratification will continue to evolve, allowing clinicians to collaborate with AI and Big Data to make more accurate predictions of where a patient’s health is trending.

One of the focuses of digital medicine is remote patient monitoring. This technology is especially helpful during the current pandemic as it gives providers the information needed in order to track the patient’s health statuses and react quickly when a patient has an urgent need for proactive care. Remote patient monitoring can alert patients and their healthcare teams when intervention, including seeking in-person medical attention on a scheduled or emergency basis, is needed. Having this data is vital to the future of how patients and their healthcare providers work together. By combining the power of big data within healthcare, digital medicine platforms can help reduce the number of unnecessary visits patients take to the doctor or hospital and alert providers, caregivers, and patients when their status requires in-person care.

Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health. As we see within numerous apps or smartphones, they allow users to track health factors such as physical activity, heart rate, breathing rate, and diet. These data points can be transmitted directly to a doctor and be factored into any treatment decisions. Being able to bring this data together creates more insight into a patient’s preventive and personalised care.

The benefits of big data analytics range across the board in healthcare. Most, if not all, healthcare sectors stand to benefit from the implementation of big data analytics within digital medicine. The providers (hospitals or private practices) will be able to provide better care to their patients to make more accurate data-driven decisions more efficiently.  The biggest winner will be the patients themselves who can utilise telemedicine and remote patient monitoring to their advantage in order to enjoy more flexible and convenient access to care which in turn helps them to live healthier lives.

The COVID-19 pandemic has pushed the once-niche telemedicine industry into the mainstream, creating a lasting shift in care delivery. In 2021 and beyond, we will see the healthcare industry shift even more towards digital medicine, specifically AI and risk stratification modeling.

If 2020 has taught the healthcare industry anything, it is that patients want choices and control over their own healthcare.  Healthcare providers and insurers need to listen. Leveraging digital medicine platforms allows providers the ability to draw on the desire for personalized, proactive care by utilising actionable data to proactively monitor a patient’s health status between visits while driving down care costs and improving patient outcomes.

About the author 

Jennifer Haas is executive vice president of sales for Noteworth, where she leads sales, channel partnerships, business development, marketing and social media including profit and loss management.

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There are hopes that a new app based on blockchain technology will allow safe international travel via Singapore’s Changi Airport, which verifies passengers’ COVID-19 status before boarding planes.

Developed by health and security provider International SOS and AOKPass, the app was first used to provide a digitally verifiable COVID-19 heath certificate for entrance to Singapore on 21st December.

The companies said that the ability to authenticate health records before border points of entry will allow safe and efficient resumption of international travel during the global pandemic.

A Singapore citizen returning from Japan on Singapore Airlines flight SQ637 successfully used the ICC AOKpass for the first time, to officially present a negative COVID-19 polymerase chain reaction (PCR) digital test result for arrival verification at Changi Airport’s immigration counters.

According to the companies this was the first time an immigration authority has used a blockchain based, digitally verifiable health certificate.

Shinagawa East Medical Clinic, issued the digital certificate on ICC AOKpass, which was scanned by Affinidi’s Universal Verifier solution at Changi Airport.

Following the successful pilot programme, all travellers, starting with Malaysia and Indonesia will now be able to use ICC AOKpass to digitally authenticate their COVID-19 test results, as well as any other necessary health credentials during immigration at Changi Airport.

The companies said that the digital system is a step forward from the paper certificated that have been previously used for border crossings.

There are now dedicated immigration lanes at Changi where passengers can digitally verify their credentials using the app.

Before departure to Singapore, passengers will need to check the Singapore Safe Travel website for requirements and book a PCR test before departure at a healthcare provider that issue credentials using the app.

Travellers will each receive their test result with a unique QR code in their ICC AOKpass app, which authenticates and securely stores their negative COVID-19 test results.

Upon arrival at Changi Airport, they can use the dedicated immigration counters to swiftly verify their health credentials by scanning the given QR code in their ICC AOKpass app.

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A serotonin sensor designed using Artificial Intelligence (AI) could help scientists study sleep and mental health and potentially find new neurology drugs.

The US National Institutes of Health said that the research it had co-funded used AI to transform a bacterial protein into a new research tool.

It is hoped that the protein, which “catches” serotonin molecules and allows them to be tracked, could detect subtle, real-time changes in serotonin levels during sleep, fear and social interactions.

The technique could also be used to test the effectiveness of new psychoactive drugs, according to the US-government funded NIH.

This study in mice was funded by the NIH’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) initiative, which aims to revolutionise understanding of the brain under healthy and disease conditions.

It was led by researchers in the lab of Dr Lin Tian, principal investigator at the University of California Davis School of Medicine.

In the study, researchers transformed a nutrient-grabbing Venus-flytrap shaped bacterial protein into a highly sensitive fluorescent sensor that lights up when it captures serotonin.

Tian’s lab builds on the work of scientists in the lab of Dr Loren Looger, Howard Hughes Medical Institute Janelia Research Campus, Ashburn, Virginia, who used traditional genetic engineering techniques to convert the bacterial protein into a sensor of the neurotransmitter acetylcholine.

Tian worked with Looger’s team and used artificial intelligence to completely redesign the protein known as OpuBC to catch serotonin instead.

The researchers used machine learning algorithms to help a computer ‘think up’ 250,000 new designs. After three rounds of testing, the scientists settled on one.

Experiments in mouse brain slices showed the sensor responded to serotonin signals sent between neurons at synaptic communications points.

Further experiments on cells in petri dishes suggested that the sensor could effectively monitor changes in these signals caused by drugs, including cocaine, MDMA and several commonly used antidepressants.

Mouse studies showed the sensor monitored an expected rise in serotonin levels when mice were awake and a fall as mice fell asleep.

They also spotted a greater drop when the mice eventually entered the deeper, REM sleep states.

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Reviewing 2019’s key digital health stories last year I suggested that, while big strides continued to be made, any definitive ‘coming of age’ moment for the sector was unlikely.

But that was before the first reports emerged of a highly contagious coronavirus and 2020 will be forever associated with COVID-19 and the global devastation and disruption it has wrought.

Now, after a year that feels like it had many more than the usual 12 months, ‘digital’ has most certainly come of age across all aspects of our lives, including communication, commerce, working life and, yes, health.

So, what were the standout changes for digital health, and digital pharma for that matter, in this most unusual of years?

I suppose I could just answer ‘COVID’ and be done with it.

In fact, preparing for our year in review articles, we decided in our editorial meeting to have at least one look at medical progress away from COVID.

Nevertheless, the pandemic was clearly the biggest change-agent for digital health and digital pharma in 2020.

1. Digital transformation moved front and centre

COVID-19 brought rapid, deep and likely lasting changes to healthcare and the pharmaceutical sector, as both scrambled to respond to unprecedented demands.

Consequently, what might previously have looked upon as a 3, 5 or even 10 year plan suddenly required progress within just days or weeks.

As I noted earlier this year, healthcare companies went from being lost in a ‘digitalisation jungle’ in 2019, to this year making huge progress thanks to the ‘digital accelerant’ of COVID, with many channels being used for the first time as a result of the pandemic.

2. Telehealth reached a tipping point

The rapid digitalisation of life during COVID-19’s acute phase also had a huge impact on healthcare delivery.

If you, or someone you know, has had to see a doctor since March, the chances are the health service tried to avoid an in-person visit to limit the spread of the coronavirus. Here in the UK, as elsewhere, directives from the top made adopting telehealth a vital part of the pandemic response.

Questions certainly remain about how far the use of telemedicine will return to pre-COVID times, but the sustained focus on changing healthcare models this year looks to have put in place a lasting transformation.

3. AI made historical progress

Moving away from COVID, up to a point, and artificial intelligence (AI) in pharma and healthcare looked to be everywhere this year, having already made significant moves towards centre stage in 2019.

The year began with Exscientia moving the world’s first AI-created drug into clinical trials in January and there were also signs of the technology’s potential in drug pricing and spotting COVID-19 in chest x-rays.

Google’s AI company DeepMind grabbed many headlines in November when it solved the 50-year-‘protein folding problem’, but there was less theoretical progress made too with the announcement in Nature Medicine of new standards for clinical trials that involve AI.

The CONSORT-AI reporting guideline should help determine the difference between hype and useful data when AI is used in medical studies – a small, but growing area.

Meanwhile, just one of the big pharma companies expanding its focus on AI was GlaxoSmithKline, which opened a new AI hub in London in September and hopes to end 2020 with a nearly 100-strong AI team.

4. The FDA took a strategic approach to digital health

The creation of the FDA’s Digital Health Center for Excellence in September marked a major step forward for the US regulator’s approach to new technology.

Although a few years in the making, the new centre should accelerate the FDA’s responses to new mobile health devices, software as a medical device, wearables and a range of other types of health tech, particularly when coupled with the September update to its digital health pre-certification programme.

It wasn’t the only major body taking steps to advance digital health this year, with the WHO publishing in February its draft global strategy on digital health for the next five years, in which it noted:

“Digital technologies are an essential component and an enabler of sustainable health systems and universal health coverage. To realise their potential, digital health initiatives must be part of the wider health needs and the digital health ecosystem and guided by a robust strategy that integrates leadership, financial, organisational, human and technological resources.”

5. Record-breaking digital health investments

Investor interest in digital health has been running high for some time but, with all of the above going on this year, 2020 is looking like being a banner year for deals.

Indeed, the first six months of the year saw unprecedented digital health activity, with venture funding reaching $5.4 billion led by standout deals such as Teladoc Health’s $18.5 billion acquisition of Livongo.

With fragmentation still an issue in the sector, further consolidation is expected if the current lack of scale among some companies is to be overcome, and well-placed observers see large amounts of private equity waiting in the wings to support this.

Looking back on this year, we can see digital health increasingly becoming a necessity for ensuring patients have the best outcomes.

Consequently, the advances seen in 2020 should provide solid foundations for pharma companies – and others in the digital health ecosystem – to continue to make further progress in the new year, and beyond.

About the author

Dominic Tyer is a journalist and editor specialising in the pharmaceutical and healthcare industries. He is currently pharmaphorum’s interim managing editor and is also creative and editorial director at the company’s specialist healthcare content consultancy pharmaphorum connect.

Connect with Dominic on LinkedIn or Twitter

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Verily is planning “significant and focused growth” in 2021 after closing a $700 million funding round from investors including its parent company, and Google holding firm, Alphabet.

The capital injection will support wide-ranging plans for the new year that include several life sciences programmes in surgery, pathology and immunology, which would add to the digital ophthalmology joint venture it signed with Japan’s Santen in February.

Verily is also looking to accelerate a number of its key businesses, with the company calling out clinical research ecosystem Baseline, COVID-19 testing platform Healthy at Work and virtual clinic Onduo.

Another focus for the life sciences and health firm will be Coefficient, the commercial insurance venture it set up with Swiss Re in August to combine health tech with insurance and payment models.

Andrew Conrad, CEO and founder at Verily, said: “We’re humbled and excited about the opportunity to expand the scope and rapidly scale our products and services. With this new round of funding from our largest investors, they are strengthening their commitment to help expedite our original vision.

“2021 will be a year of significant and focused growth for Verily’s operations as we continue to drive innovation in our core programmes.”

It’s been a busy year for many of these programmes. Baseline was involved in screening and testing nearly two million people for COVID-19 across 351 sites and Healthy at Work was launched in June to help businesses and universities to reopen safely.

Meanwhile, the last 12 months have seen a refocusing at Onduo. Initially launched as a diabetes-focused joint venture with Sanofi in 2016, the French pharma company significantly scaled back its involvement in the firm last December, retaining just a small financial stake in it.

Nevertheless, Verily is bullish about the prospects for expanding Onduo’s virtual clinical model into new areas, and this year it added support for hypertension and general wellness.

In addition to Alphabet, supporters of Verily’s latest funding round also included Silver Lake, Temasek, and Ontario Teachers’ Pension Plan.

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The UK government is funding a network of three centres that will use digital technology to train the next generation of scientists specialising in advanced therapies.

The National Horizons Centre, RoslinCT and the University of Birmingham have been selected as preferred bidders to deliver high impact physical and digitally-delivered training courses as part of the growing Advanced Therapies Skills Training Network (ATSTN) programme.

With funding from the government-backed Cell and Gene Therapy Catapult, the centres bring with them complementing capabilities and a vast wealth of experience across manufacturing and bioprocessing.

Their expertise within virtual reality training will prove instrumental for driving the successful development of cell and gene therapy as well as vaccine manufacturing staff across the UK, through the delivery of these industry-leading training courses.

A core aim of the ATSTN is to develop National Training Centres to deliver specialist on-site courses, including innovative digital training utilising virtual reality, providing learners with the hands-on expertise and experience to succeed in the advanced therapies and vaccine manufacturing sector.

Based on the findings from the Cell and Gene Therapy Catapult’s (CGT Catapult) Skills Demand Survey 2019, 83% of advanced medicinal therapy products (ATMP) and vaccine manufacturing companies raised concerns that the recruitment and retention of skilled talent will be an important issue which slows down or delays their forecasted manufacturing expansions.

As such, a coherent national training offering for core manufacturing skills was requested by industry, in order to drive the required uptake of skilled talent at all levels and allow the UK sector to reach their full potential.

The ATSTN programme, which launched on 2nd December, is backed by £4.7m in funding from the Department for Business, Energy & Industrial Strategy (BEIS) alongside the UK’s innovation agency Innovate UK and is driven by industry and coordinated by the CGT Catapult.

Comment on behalf of partners in Scotland including Edinburgh Napier University, RoslinCT’s CEO Janet Downie said: “Not only does this fully align with the work we are doing with the Life Sciences Scotland Industry Leadership Group to develop a ATMP and Vaccines Growth Plan for Scotland, this fantastic initiative by Cell and Gene Therapy Catapult will enable us to play our part in developing a skilled talent pool and enable the tremendous growth in vaccines and ATMP manufacturing across the UK.”

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More than 1,000 NHS patients have booked flu vaccinations using a virtual assistant as part of a pilot project in the south east of England.

The pilot project, run in collaboration with GP practices in Buckinghamshire, Brent, and Greenwich, involved patients using the Ask NHS app, which is already used by more than 375,000 patients.

Patients in the pilot used the app developed by Sensely to self-check eligibility and quickly make appointments for flu jabs.

Launched in 2017, the free-to-use Ask NHS app lets users easily check symptoms, book clinician appointments, access self-care resources, and connect with live video consultations.

The app uses Natural Language Processing (NLP) and speech recognition technologies make the conversational interface easy to use, while freeing up doctors and nurses’ time.

Citing post-usage survey data, Sensely claims the app can reduce per-patient costs by as much as 14.4%.

Adding vaccination information, a self-service eligibility check, and booking functionality to Ask NHS lets patients, protect themselves and loved ones, quickly get the information they need and make appointments without having to call their clinic.

Designed in partnership with NHS nurses, the tool also allows high-risk patients to be prioritised based on symptoms or underlying health issues, improving access to vaccinations for vulnerable patients while easing the strain on healthcare providers.

The project sets the stage for the more widespread use of virtual assistants as the UK begins to roll out COVID-19 vaccines.

Sensely is currently developing COVID-specific virtual tools and plans to begin supporting NHS coronavirus vaccination efforts with customised virtual assistant technologies in early 2021.

Sensely CEO Adam Odessky said: “During the pandemic, more people than ever are getting flu shots — but that places an enormous strain on clinics, and those challenges will only increase as we roll out COVID-19 vaccines.

“Our top priority, now and always, is to support the NHS and ensure patients get vaccinations quickly and easily. By using next-gen digital tools as part of an omnichannel strategy, we’re empowering patients to take ownership of their healthcare journey, and protect their families while easing the burden on hardworking doctors and nurses.”

The app is available on iOS and Android smartphones.

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Researchers in the UK have developed a chatbot-enabled website that can train people to detect and counter misinformation on COVID-19 and other topics, using techniques from some of philosophy’s greatest critical thinkers.

Earlier this year, the World Health organisation (WHO)  said the world was dealing with an “infodemic” that is accompanying the pandemic and it is hard for the general public to recognise the “grey area of” misinformation.

Do masks actually protect your from coronavirus? Is it similar to the flu in severity, and was it man-made and developed by governments to force mass vaccinations? The Fake News Immunity Chatbot won’t answer those questions directly, but aims to give people the skills to make up their own mind.

It takes the form of an interactive quiz, presented as a question and answer session between the user and other figures like Aristotle, Socrates and Gorgias, that encourages them to look into the facts beyond the headlines.

Using the exchanges, users can gauge whether they would fall for misinformation – what the researchers call semi-fake news – information that is misleading but not intentionally produced, unlike disinformation or fake news.

Semi-fake news can derive from misinterpretation of study findings, cherry picking of data points to suit someone’s bias, anecdotal stories, or hasty generalisations – which can all be hard to spot.

The chatbot has been designed by researchers at the Universities of Liverpool and Dundee to coach anyone with the skills needed to cut through the noise.

Users choose an identity and are then guided through a discourse with the three philosophers, as each teaches their rhetoric speciality: Aristotle explains the ten fallacies, Socrates encourages the need to question everything and Gorgias challenges mainstream opinions.

“Our chatbot is unique as it allows people to play and be trained by the greatest thinkers and become their own fact-checkers,” says Dr Elena Musi of Liverpool University’s department of communication and media, who is leading the project.

“You can play by yourself or encourage family, friends or colleagues to join in so you can quiz each other,” she adds. “Learning together and helping each other to understand how news is produced for different purposes provides the necessary skills needed to flag misleading content in our news feeds.”

The game has three levels – credulous, sceptic and agnostic – with users competing to pick up points shaped as gadflies.

Why gadflies? Plato described Socrates as a gadfly stinging people with questions to keep them on a virtuous path.

“We hope that with our chatbot, people will develop critical thinking that strengthens their digital literacy and helps them and their communities to become more resilient to information manipulation,” according to Musi.

“Acquiring critical digital literacy collectively, can help us build a healthier, stronger and smarter democracy.”

The chatbot was developed with the help of £200,000 in UK government funding.

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Tik Tok is unlikely to spring to mind as a source of reliable information about complex issues, but scientists are using it to fly the flag for COVID-19 vaccines and other health topics.

The social media platform, which allows users to share short and often frivolous video clips, has a growing number of experts using it to communicate important information to a broad audience, and particular teenagers and young adults.

One such scientist is Dr Anna Blakney (pictured above left), who is working on the COVID-19 vaccine project underway at Imperial College London in the UK and has attracted an impressive 205,000 followers.

She told the BBC that her approach on TikTok is “come for the entertainment, but stay for the science.” Her videos cover a host of topics from the science behind the immune system, side effects caused by the shots and vaccine hesitancy and the clinical and regulatory path to approval.

Another is Dr Austin Chiang, a gastroenterologist and the chief medical social media officer at Jefferson Health in Philadelphia, who said in an interview with the New York Times that covering vaccine-related topics on TikTok can be a minefield.

“When we talk about vaccines as health professionals, people who are vehemently anti-vaccine can take it out of context for their agenda. That makes me hold back sometimes,” said Chiang.

“The approach that I try to take is to leave room for the grey. If you say vaccines don’t cause any harm and are the best things in the world, it can alienate people who are vaccine hesitant. If we instead acknowledge that there are risks just like anything else in medicine and life, it’s a more effective message.”

TikTok itself meanwhile says it has taken steps to make sure its users have access to reliable information about the pandemic, which will be stepped up as immunisation programmes start in the UK, US and elsewhere.

Kevin Morgan, head of product and process, Europe, at the social media firm, notes in a blog post that in January it introduced an in-app notice so that when users searched for hashtags related to the pandemic, they would be provided with easy links to the World Health Organisation’s website and the British Red Cross.

The following month it rolled out an information hub in-app to provide the TikTok community with access to accurate information, which has been viewed 2 billion times since June and will be updated on 17 December with new information on vaccines

“Additionally, we will soon introduce a new vaccine tag to detect and tag all videos with words and hashtags related to the COVID-19 vaccine,” says Morgan.

“We will attach a banner to these videos with the message ‘Learn more about COVID-19 vaccines’,” which will redirect users to “verifiable, authoritative sources of information.”

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Experts from Healthware Group explore how companies can rebuild their approach to digital from the ground up for the benefit of patients.

Digital is not just a nice-to-have for pharma companies – it’s a necessity for ensuring that patients have the best possible outcomes in modern healthcare systems.

With digital tools and techniques being able to improve almost every aspect of a pharma company’s business, from R&D to sales, there’s no excuse for not implementing digital transformation at every level – and that’s not even mentioning new opportunities for life science firms to produce digital products that can complement or even replace traditional medicines.

Roberto Ascione, founder and CEO of Healthware, says that this landscape means that companies like his need to expand to be “communicators, connectors and builders” all at once – and this is a philosophy he has built up within Healthware over the last two and a half decades.

 

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Apps that patients can use to report symptoms and seek advice on treatment are highly variable in their accuracy, but some come close to matching GPs, says a new study.

The peer-reviewed study – published in the journal BMJ Open – compared eight of the most popular symptom assessment apps to a control group of seven GPs against a series of 200 primary care scenarios or “vignettes” designed to mimic real-world patient experiences and gleaned from the NHS 111 telephone triage service.

The apps – Ada, Babylon, Buoy, K Health, Mediktor, Symptomate, WebMD, and Your.MD – were put through their paces against three criteria, namely the breadth of content covered, and the accuracy and safety of advice given compared to a GP consultation.

The researchers from Brown University in the US and German digital health company Ada Health – which developed the Ada app – suggests there are wide differences between the apps on all these measures which raise questions about whether some are fit for purpose in clinical settings.

The paper found that coverage of the conditions in the vignettes ranged from 51.5% with Babylon to 99% with Ada, with an average overall of 69.5%, while GPs provided 100% coverage.

Those at the bottom of the coverage list were not able to suggest conditions for significant numbers of cases, including scenarios involving children, patients with a mental health condition, or pregnancy, according to the German company.

Ada was also rated as the most accurate for accuracy, suggesting the right condition in its top three suggestions 71% of the time while the average across all the other apps was just 38%, indicating that they didn’t identify the correct condition in the majority of cases. Once again, GPs were top with 82% accuracy.

On the final measure, most apps gave safe advice most of the time, but only three approached the 97% rating for doctors. Among these, Ada came top again at 97%, followed by Babylon at 95% and Buoy at 80%.

It’s worth pointing out that some of the apps that fared less well – including Buoy, K Health and WebMD – were designed for the US market, so may have been penalised by the use of NHS-derived vignettes.

Noting that symptom assessment apps are now used by tens of millions of patients annually in the US and UK alone, Dr Hamish Fraser of Brown’s Centre for Biomedical Informatic said the study is an important indicator of how valuable they are.

“Compared to a similar study from five years ago, this larger and more rigorous study shows improved performance with results closer to those of physicians,” according to Fraser. “It also demonstrates the importance of knowing when apps cannot handle certain conditions.”

The results could also be used to determine which of the apps are ready for clinical testing in observational studies and then randomised controlled trials, he added.

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The pharma industry has been making great strides forward in digital health, but one element of that – gamification – hasn’t yet made much headway in the sector. Armed with new data from a randomised clinical trial, one company is hoping to change that mindset.

The company is FriendsLearn – based in India and with an R&D office in San Francisco – which recently reported results from a trial showing that its fooya! app was able to induce healthy food and lifestyle habits among a group of 104 children aged 10 to 11.

FriendsLearn hopes that use of gaming apps like fooya! could help to curb rising levels of childhood obesity among children, using neuroscience, artificial intelligence and virtual reality to improve dietary choices, physical activity and health literacy.

The company’s founder and chief executive Bhargav Sri Prakash told pharmaphorum that the clinical study, published in the journal JMIR mHealth and uHealth, showed that just 20 minutes of gaming time a week had a strong positive impact on children’s food choices when polled immediately following the game.

“Our methods of gamified neuro-cognitive training have been designed and built to stimulate the brain of children in specific ways, through patterns of messaging and exposure to visual, auditory, and tactile stimuli,” he said.

“This trial validates effective transference of our neuro-modulation methods to behavioural outcomes, while validating the appropriate level of dose exposure.”

In fooya!, an avatar fights against robots that represent unhealthy/bad foods, with the aim of maintaining a good body shape for the avatar and earning enough coins to win the level and unlock the next stage. Avatars perform better if they eat healthy foods and move a lot, and are slower and heavier as they consume more calories.

Sri Prakash describes FriendsLearn’s approach as administering a “digital vaccine” that along with changing habits could induce an immune response through biological pathways of the gut-brain axis – a two-way communication channel linking emotional and cognitive centres of the brain with peripheral intestinal functions.

The company is continuing to evaluate fooya! to generate real world evidence about its effects, as well as to monitor for any side effects, with the help of collaborators at Carnegie Mellon, Johns Hopkins Bloomberg School of Public Health, and Stanford University in the US, as well as the National University of Singapore.

Meanwhile, its turning its attention to other apps, notably fooya!D aimed at people living with diabetes, which is undergoing clinical testing in the US and India.

“fooya!D is designed to cater to paediatric diabetes populations, to assist them with self-care through better adherence to clinically prescribed diet and lifestyle, as well as in regulating their glycaemic levels through the appropriate use of insulin,” said Sri Prakash.

Also in the pipeline is a pair of apps – dubbed FYA-003 and FYA-004, respectively – that are intended to help people prevent infection with SARS-CoV-2 and influenza viruses, for example by encouraging hand washing, disinfecting surfaces, social distancing, etc.

While the data is starting to emerge on gaming apps for health, there is still a disconnect between the two sectors that is preventing more widespread adoption, according to Sri Prakash.

“There has not been visible precedent for commercially successful companies that have defended the viability of this space at the intersection of these disparate industries,” he said.

He warned that pharma risks being left behind in the area of gamification, allowing itself to be superseded by other players through a reluctance to back the approach with any deep conviction.

A high level of commitment would be required to take on the high standards for consumer-level engagement  that is being set by big-budget productions by studio, as well as “deep skills in design and analytics-based iteration.”

At the same time, healthcare companies meanwhile have a whole different set of issues to contend with – clinical trials, patient data, regulatory pathways, physician buy-in, and reimbursement models – which are alien to the gaming sector. And added to that, sources of risk capital to fuel innovation have also existed in silos of expertise.

“While the opportunity to build evidence-based healthcare solutions with game-like engagement and sophistication, is abundantly clear, the cost of this multidimensional innovation is high,” said Sri Prakash.

“The opportunity is vast and investors that have the appetite for category creation are beginning to see the potential, especially given the momentum for digital health.”

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The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed.

In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.

Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

Responding to fears that the review could be delayed, the company said it had been assured by the EMA that the timeline should not be affected. The agency has indicated it should complete its review by 29 December.

BNT-162b is already approved in the UK and Canada, and the first UK patients started to receive the shot on Tuesday this week. The EMA is also reviewing another vaccine from Moderna, but at the moment it’s not clear if data from that programme has also been compromised.

“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed,” said BioNTech in a statement on its website.

It added that it had publicised the breach “given the critical public health considerations and the importance of transparency”.

The cyberattack came just days after international enforcement agency Interpol warned that organised criminals may try to target COVID-19 vaccine supply chains, for example by falsification, theft and illegal advertising of unlicensed shots.

Europol meanwhile warned earlier this year that criminal networks are exploiting the COVID-19 pandemic with a surge in cybercrime, targeted thefts and counterfeiting, including attempts to target organisations through business email compromise (BEC), which can be used to harvest sensitive data, siphon off funds or damage its reputation.

There’s no indication yet who was behind the EMA hack, but a volunteer group set up to tackle cybercrime related to COVID-19 – CTI League – has suggested that one motivation could be to uncover details about the supply and distribution of vaccines.

The group’s found Marc Rogers told Reuters that information “potentially significantly increases the attack surface for the vaccine”.

IBM recently said an email phishing campaign had targeted organisations linked to the Cold Chain Equipment Optimisation Platform (CCEOP) of Gavi, the international vaccine alliance, suggesting that the sophistication of the assault pointed to a nation state being the culprit.

“Without a clear path to a cash-out, cyber-criminals are unlikely to devote the time and resources required to execute such a calculated operation,” according to the tech giant’s Security X-Force.

There has also been reports that hackers linked to North Korea, South Korea, Iran, Vietnam, China and Russia have tried to steal information about vaccines, targeting pharma companies and other organisations involved in COVID-19 medicine R&D, according to the news agency.

In October, Indian pharma company Dr Reddy’s Laboratories, which is helping to conduct late-stage testing of Russia’s Sputnik V COVID-19 vaccine, said it had been hit by a cyberattack that disrupted its production facilities.

Sam Curry, chief security officer at Cybereason, is convinced that a nation state is behind the EMA attack, saying: “Cyberattacks on the global COVID-19 vaccine distribution network from nation-states China, Russia and North Korea are diabolical in nature and acts of war.”

While acknowledging the average person “might be asking themselves why nation-state actors…are deliberately sowing doubt and confusion around the world at the worst possible time,” Curry says there is tremendous value in interfering with the distribution of COVID-19 vaccines.

“A COVID-19 vaccine is a strategically valuable asset to nation-states; whoever gets a vaccine distributed first has an economic advantage. It is the ultimate IP with immediate value. It is like having an oil rush, a data advantage or territorial gain in older real political terms.”

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UK digital health firm Sensyne has secured access to millions more anonymised patent records via an alliance with US clinical trial data specialist Phesi.

The new agreement comes after a string of access deals with NHS trusts for patient data, and coincides with a bid by Sensyne to raise £27.5 million (around $37 million) through a 90 pence per share placing.

The proceeds of that round – and possibly a second £2.5 million open offer that is also planned – will go towards “industrialising” its big data analytics and clinical artificial intelligence (AI) platform, with £10 million going towards buying a 10% equity stake in Phesi.

Oxford-based Sensyne uses patient data to improve drug development, disease understanding and clinical trial design, as well as to discover new drug targets, and also develops digital health software applications powered by AI such as GDm-Health for diabetes and CVm-Health for COVID-19.

Another £10 million from the fundraising will go towards building Sensight – a real-world, pharmaceutical R&D platform intended to analyse data more rapidly and cost effectively – while £6.5 million is earmarked for development of its Sense clinical AI engine for healthcare providers and payers.

“Currently, responding to questions about available categories of Sensyne’s data can take several weeks with clinical AI answers taking months to produce,” says the company’s fundraising prospectus.

“Investments into industrialising this process are expected to dramatically reduce these timescales to seconds and weeks,” it goes on.

It already has access to around 6.1 million UK patient health records – equivalent to around 10% of the country’s total population – and the new agreement with Phesi will add around 13.5 million international patient records from 320,000 clinical trials dating back to 2007.

Phesi provides Sensyne with the benefit of a different type of data set, according to Sensyne, namely anonymised clinical trials data and clinical investigator site information.

Once the transactions go through, Sensyne and Phesi will work together to offer “synthetic” clinical trial arms and clinical decision support tools combining trial and real world data, for an initial period of five years.

Sensyne’s approach has already resulted in several agreements with major pharmaceutical and biotechnology companies including Bayer, Roche, Alexion and Bristol-Myers Squibb, while Phesi also has “a strong list of clients having worked with multiple blue-chip pharmaceutical and biotechnology companies.”

Peel Hunt and Liberum Capital Limited are acting as joint bookrunners for the placing.

The post Sensyne launches fundraising, agrees patient data deal with Phesi appeared first on .

UK digital health firm Sensyne has secured access to millions more anonymised patent records via an alliance with US clinical trial data specialist Phesi.

The new agreement comes after a string of access deals with NHS trusts for patient data, and coincides with a bid by Sensyne to raise £27.5 million (around $37 million) through a 90 pence per share placing.

The proceeds of that round – and possibly a second £2.5 million open offer that is also planned – will go towards “industrialising” its big data analytics and clinical artificial intelligence (AI) platform, with £10 million going towards buying a 10% equity stake in Phesi.

Oxford-based Sensyne uses patient data to improve drug development, disease understanding and clinical trial design, as well as to discover new drug targets, and also develops digital health software applications powered by AI such as GDm-Health for diabetes and CVm-Health for COVID-19.

Another £10 million from the fundraising will go towards building Sensight – a real-world, pharmaceutical R&D platform intended to analyse data more rapidly and cost effectively – while £6.5 million is earmarked for development of its Sense clinical AI engine for healthcare providers and payers.

“Currently, responding to questions about available categories of Sensyne’s data can take several weeks with clinical AI answers taking months to produce,” says the company’s fundraising prospectus.

“Investments into industrialising this process are expected to dramatically reduce these timescales to seconds and weeks,” it goes on.

It already has access to around 6.1 million UK patient health records – equivalent to around 10% of the country’s total population – and the new agreement with Phesi will add around 13.5 million international patient records from 320,000 clinical trials dating back to 2007.

Phesi provides Sensyne with the benefit of a different type of data set, according to Sensyne, namely anonymised clinical trials data and clinical investigator site information.

Once the transactions go through, Sensyne and Phesi will work together to offer “synthetic” clinical trial arms and clinical decision support tools combining trial and real world data, for an initial period of five years.

Sensyne’s approach has already resulted in several agreements with major pharmaceutical and biotechnology companies including Bayer, Roche, Alexion and Bristol-Myers Squibb, while Phesi also has “a strong list of clients having worked with multiple blue-chip pharmaceutical and biotechnology companies.”

Peel Hunt and Liberum Capital Limited are acting as joint bookrunners for the placing.

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Addenbrooke’s Hospital in Cambridge will be the first in the world to use an artificial intelligence tool developed by Microsoft that promises to cut the time it takes to analyse computed tomography (CT) scans, and allow treatment to start sooner.

The Project InnerEye tool was developed just down the road from Addenbrooke’s at Microsoft’s Cambridge research labs, and uses AI to highlight tumours and healthy tissue on patient scans, guiding an individual treatment plan.

The AI has been shown to speed up clinicians’ ability to perform radiotherapy planning for head and neck as well as prostate cancers 13 times quicker than manual methods, without compromising accuracy, according to a JAMA Network Open research paper.

Microsoft is making the tool freely available as opensource software to speed up its use by hospitals, though of course clinical use of machine learning models is subject to regulatory approval.

Up to half of the population in the UK will be diagnosed with cancer at some point in their lives, and of these, half will be treated with radiotherapy, with delivery guided by a CT scan to reveal where the radiation beams should be directed to minimise damage to other tissues.

Stacks of 2D images generated during a CT scan have to be reviewed by a radiation oncologist, a time-consuming process, but using Project InnerEye the time to complete that process can be cut by 90%, according to studies.

The AI’s conclusions will be checked and confirmed by a clinical oncologist before the patient receives treatment.

With charity Cancer Research UK estimating that as many as three million people in the UK have missed out on cancer screening tests during the pandemic, the AI could help reduce a “mounting cancer treatment backlog” according to Microsoft.

Lightening the workload of oncologists could also help prevent clinician burnout, which Microsoft says is happening across the NHS as a result of COVID-19. The hope is that quicker treatment could also help improve survival rates for some cancers, although there’s no hard evidence for that yet.

Yvonne Rimmer, consultant clinical oncologist at Addenbrooke’s, said: “There is no doubt that InnerEye is saving me time. It’s very good at understanding where the prostate gland is and healthy organs surrounding it, such as the bladder. It’s speeding up the process so I can concentrate on looking at a patient’s diagnostic images and tailoring treatment to them.

“But it’s important for patients to know that the AI is helping me in my professional role; it’s not replacing me in the process. I double check everything the AI does and can change it if I need to. The key thing is that most of the time, I don’t need to change anything.”

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Novartis has signed a multi-year agreement with RetinAI, which will see the companies work together to use artificial intelligence (AI) tools to support ophthalmology and digital health projects.

Both companies have already worked on pilot projects in this area.

The first project under a new master agreement will involve a multi-centre international clinical study involving patients with neovascular age-related macular degeneration (nAMD).

The study is designed to investigate the influence of optical coherence tomography image solutions, while using AI to assess disease activity.

The study will be conducted in several clinical centres in several European countries and Canada, involving more than 500 patients.

RetinAI will provide its CE-marked web-based platform, RetinAI Discovery, a data management platform that processes data at scale across imaging platforms and devices.

The technology is already used by professionals to navigate imaging data, compute imaging biomarkers and track changes over time for common eye diseases.

It also allows diagnostic analyses and clinical workflows as well as patient monitoring and adherence to treatment.

Dirk Sauer, global development head of the ophthalmology franchise at Novartis, said he saw RetinAI as a strategic partner for advancing eye care through digital innovation.

He said: “With previous projects, RetinAI’s services have enabled us to enhance and more efficiently structure retina scans and data collected from our clinical studies.

“Together with RetinAI, we are working on end-to-end solutions to generate swift and comprehensive disease insights to better treat patients and improve patient outcomes.”

Since Vas Narasimhan was appointed CEO more than two years ago, the company has made adoption of digital technology one of its priorities.

The idea is to use digital technology to enhance the company’s portfolio of pharmaceutical products.

One of Narasimhan’s first decisions when he took charge was to appoint chief digital officer Bertrand Bodson, who joined the company’s executive committee shortly after he joined.

 

 

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AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibody drug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering.

The Vancouver, Canada-headquartered biotech – which has been bankrolled in part by billionaire entrepreneur and venture capitalist Peter Thiel – plans to offer 23 million shares at a price of between $14 and 17%, which could raise $380 to $390 million.

If that target is hit it will be record for a Canadian biotech, overtaking the $253 million raised by Repare Therapeutics in the summer, and could value the company at up to $4.5 billion.

The company says in its IPO prospectus that it plans to list its shares on the Nasdaq Global Market under the ABCL ticker.

AbCellera is a specialist in applying artificial intelligence to drug discovery, specifically to sift through immune system data to find antibodies that can be developed as drugs. Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development.

That has resulted in 26 partnerships, but the poster child of AbCellera’s portfolio is its alliance with Lilly for bamlanivimab (LY-CoV555), which was approved by the FDA and Canadian regulator for emergency use as treatment for mild-to-moderate COVID-19 patients last month.

The antibody can be given to adults and children who are at high risk of progressing to severe COVID-19 and/or hospitalisation, according to the FDA approval.

Starting from a single blood sample obtained from a recovered COVID-19 patient, AbCellera and Lilly identified the drug candidate within three weeks, and started clinical testing just 90 days after starting the programme.

Bamlanivimab is directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

In testing, bamlanivimab achieved a 72% reduction in hospitalisation risk compared to placebo in the BLAZE-1 study involving 465 COVID-19 patients. The drug is also being tested in other trials, including a phase 3 study looking at its role in prevention of SARS-CoV-2 infection.

Its Celium platform uses software, AI and visualisation tools to crunch through the massive amount of data generated during an antibody discovery campaign, reducing the time it takes to come up with a lead candidate.

AbCellera was founded in 2012 and posted $28 million in revenue for the 12 months ending 30 September.

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Israel’s specialist venture capital firm, Olive Tree Ventures (OTV) has closed a fund worth $170 million, with plans to expand its portfolio of digital health firms.

OTV is the only VC in Israel whose main focus is digital health, specialising in supporting portfolio companies reaching maturity.

This includes help with regulatory hurdles and marketing of any validated products.

Over the past five years the OTV has added several high-profile digital health firms to its portfolio, including TytoCare, Lemonaid Health, Emedgene, Scopio, and Donisi Health.

OTV was founded in 2015 by general partners Mayer Gniwisch, Amir Lahat and Alejandro Weinstein. Together with partner Manor Zemer, the OTV leadership team is comprised of investors with a wide range of backgrounds, encompassing healthcare, technology, private equity and financial services, and with experience in the US, Latin American, Israeli and Asian markets.

Alejandro Weinstein, general partner at OTV, said: “OTV’s goal for the upcoming period is to harness our expertise in facilitating the growth of digital health companies, and, with laser sharp focus, identify the market leaders of tomorrow.

“Digital health technology is increasingly important for strained healthcare systems seeking to provide accessible and affordable treatment, especially to traditionally under-served populations. The COVID-19 pandemic elucidated the importance of digital products to the global healthcare ecosystem, but industry pain points predated the current crisis and clear solutions will be needed in the years to come.”

OTV also announced the appointment of Jose Antonio Urrutia Rivas as head of Asia Pacific, who joins after working at LarrainVial as Asian market developer.

Israel has been identified as one of the hottest areas for investment in digital health, with three cities identified in the top 10 busiest places for deals in the sector.

Tel Aviv, Jerusalem and Haifa all made the top ten list of the most active cities for digital health investment, according to a quarterly report from Startup Health.

2020 is already looking like the busiest ever for investment in digital health, with a record $16 billion flowing into the sector during the first nine months alone, according to the report.

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Why do some computer gamers invert their Y axis controller, so up means down? Answering that question may provide insights into visual perception and cognition with broad ramifications, including in medicine, according to researchers.

In the virtual word of gaming, most players push their controller joystick or mouse upwards to look up, and vice versa. However, a sizeable minority will set the controller to do the opposite – and both camps vehemently insist theirs is the logical, intuitive way to play.

A new project to tease out the reasons for that difference in perception has been launched by UK researchers at Brunel University London, who say in The Guardian that the research could have broad implications, particularly as we spend more of our lives in digital and virtual spaces.

Using remote behavioural and psychophysical experiments, they will compare inverters and non-inverters to see “how fast and accurately people are able to mentally rotate shapes and the extent to which they rely on different body and contextual cues when making spatial judgments,” said Dr Jennifer Corbett, one of the lead investigators, in an interview with the newspaper.

“Understanding these sorts of individual differences can help us better predict where to place important information and where to double-check for easily missed information in everything from VR gaming to safety-critical tasks like detecting weapons in baggage scans or tumours in X-rays,” she said.

Some gamers think that inversion is habitual, stemming from early exposure to flight simulator-type games, but the academics think it isn’t that simple and may stem from how people visualise the connection between themselves and the onscreen action.

In some cases people switch between the modes depending on the game, for example, and that may depend on whether they are playing from their own perspective, or the perspective of an object in space relative to the virtual world around it.

Corbett and co-investigator Dr Jaap Munneke will compare measures like average reaction time and average accuracy with information from a questionnaire on gaming habit in the hope of understanding how visual perception can affect how an individual interacts with real and virtual environments.

“It may be the case that the extent to which a person relies on visual versus bodily context has a huge influence on whether or not they choose to invert the Y axis on their gaming consoles,” according to Corbett.

Image by Jan Vašek from Pixabay

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A heart monitor developed by iRhythm has become the first product to be endorsed by NICE in a pilot project covering digital health technologies.

In new guidance, the health technology assessment (HTA) agency has recommended iRhythm’s Zio XT service for detecting abnormal heart rhythms – provided NHS organisations that deploy it collect evidence of its benefits.

The wearable electrocardiogram (ECG) patch and associated software has been tested for its ability to detect atrial fibrillation (AF) in high-risk patients, with investigators reporting higher rates of diagnosis and more use of potentially life-saving anticoagulant therapy among users, but also increased demand on healthcare resources.

Zio XT has been recommended by NICE as an option for people with suspected cardiac arrhythmias who would benefit from ECG monitoring for longer than 24 hours, as a lighter, discreet alternative to Holter monitoring, which requires patients to wear several electrodes as well as a bulky monitor.

iRhythm’s device is waterproof, so can even be taken into the shower – an important consideration as it is used for up to two weeks, day and night.

NHS patients will have access to Zio XT for three years while more data is collected to address “evidence gaps about its benefit”, according to NICE. After that period, NICE will look at the new evidence before making a final recommendation.

Assuming NHS trusts take up the tech, it could be available for more than 150,000 people in the UK, according to the HTA. As it stands, there are more than 1.2 million people with diagnosed AF in the country, and another 500,000 are thought to be undiagnosed.

People with AF are more likely to suffer a stroke, and the risk is much higher in people who are unaware they have the heart rhythm disorder.

Monitoring patients for up to 14 days means that more data from each patient will be available to review, potentially improving its ability to spot arrhythmias.

At the end of the monitoring period, users remove the patch and send it via freepost for analysis using artificial intelligence algorithms, with the findings forwarded to their clinician.

Currently 12 hospital trusts across England are evaluating the Zio XT service, which costs £265 per patient, according to NICE, which says it is likely that Zio XT will be cost saving – or at least similar in cost – to Holter monitoring.

“Throughout the COVID-19 pandemic we have seen a number of cardiac patients avoiding hospitals and suffering in silence, even when experiencing serious conditions such as strokes,” said iRhythm’s EMEA vice president Justin Hall.

“This has led to a backlog of patients requiring care, putting additional pressure on medical staff and services,” he added. “Services like Zio can help ease this backlog, offering clinically-validated services remotely.”

Earlier this year, iRhythm won a UK government AI in Health and Care Award for Zio XT, securing funding to trial the service in selected sites across the country over the next three years.

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French tech company Kayentis has raised €7 million in private funding that will be invested in its digital platform for clinical trials.

The Grenoble-based company operates in the electronic Clinical Outcome Assessment (eCOA) market, which covers areas like patient and clinician reported outcomes, automatic remote testing, and patient diaries through a combination of web and mobile tools.

The worldwide eCOA market is expected to more than triple in value worth to around $2.6 billion in 2027, according to market research firm Data Bridge, and is one of the fastest growing digital patient engagement tools used in clinical studies today with annual increases of more than 15% predicted.

The adoption of eCOA is being driven by a desire to engage more closely with patients by the pharma industry, as well as greater use of decentralised and virtual trials that don’t require patients to visit clinical sites. It can also increase the quality of study data and help meet regulatory requirements.

The latest financing – equivalent to around $8.3 million – was led by Kayentis’ existing investors Extens and LBO France, with French national investment bank Bpifrance also contributing.

Kayentis chief executive Guillaume Juge said the cash injection will help boost “innovation and operational capacity” for its Clin’form3 eCOA platform, but also fund an expansion into new areas such as online consultations, electronic consent forms, and the use of wearable devices.

The drive will “support the trend towards virtual, decentralised and remote trials, where patient-facing digital technologies are increasingly playing an important role”, he added.

Clin’form3 will have new functions added to support post-COVID ‘new normal’ and decentralised clinical trials, according to Kayentis. It also plans to boost its presence in the US market with new hires at its Boston office, and expand in Asia where it currently has a unit in Japan.

The platform has already shown its value this year in helping biopharma companies, investigator sites and patients mitigate the disruptions of the pandemic on clinical trials, according to the company.

“We are reinvesting today so that the company attains the top ranks in this global market through an enlarged product offering and a strengthened commercial presence across Asia and the Americas,” commented Cédric Berger, partner at Extens, which has invested in the company since 2015.

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Not too long ago virtual reality (VR) tech might have seemed like a dream, but now it’s being harnessed by the healthcare industry for a wide variety of purposes, and during COVID-19 has helped educate physicians when real-world training isn’t feasible

Commercial VR is still a relatively fresh prospect, but already the pharma and healthcare industries have caught onto the hype and are exploring the myriad ways this tech could be used to improve patient outcomes.

That’s not to say VR is widespread in the sector – far from it – but the readiness to adopt such a new technology from even big pharma firms is somewhat surprising considering how conservative the industry has been in the past.

Novartis, for example, has used the tech to help researchers improve the molecular makeup of a drug, by allowing them to view these structures at a larger size and in a more “natural” 3D view. Similarly, Pfizer is using the technology to allow researchers to visualise and virtually explore the human body at a molecular level. One recent study even explored how VR could be used to analyse drug candidates that target the main protease of the SARS-CoV-2 virus behind COVID-19.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Healthcare agency, consultancy and digital health group Healthware Group has acquired Finland-based digital service development and creative agency Make Helsinki.

The acquisition builds on prior collaborations between the two organisations, including in best-in-class full-service agency offerings, digital transformation, technology/enterprise solutions and corporate venturing.

The move will see Make Helsinki’s CEO and co-founder Petteri Kolehmainen assume the role of managing director Finland at Healthware Group.

He said: “We have been cooperating together for several years, and have found that we strongly share similar focuses, cultures and targets. As part of Healthware Group we can serve our existing and new customers better, faster and with wider expertise than ever before.”

Make Helsinki was founded in 2015 and offers services such as virtual reality (VR), customer experience, design, augmented reality (AR) and recruitment for virtual trials, as well as having strong knowledge of the Nordic market.

The deal will see Make Helsinki rebrand to Healthware and function as a regional hub for the group, continuing to offer its services in addition to the entire Healthware Group offering. Existing employees in the region will report into the new organisation.

Healthware CEO Roberto Ascione said the acquisition will allow the group to focus on the Nordics and Baltics region and become part of the burgeoning Finnish tech ecosystem.

Ascione said: “We are excited about this new acquisition, which extends our global footprint with a Nordics and Baltics presence and reinforces our expertise in key disciplines that are increasingly important to the future of health.”

Founded in 1997, Healthware has seen rapid growth in the past few years. It became privately-owned once again after spinning out of a healthcare communications conglomerate in 2015 and saw €10 million investment in early 2019 led by FITEC, one of the main European VC funds focusing on technology. This latest deal follows the group’s acquisition of pharmaphorum earlier this year.

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For so long the US healthcare system was built around the provider, with appointments and services set by the provider (along with insurance reimbursement systems). This structure relies on in-person visits of patients to operate and become profitable. But when the industry suddenly shifted due to COVID-19, so too did the power dynamics of the patient-provider relationship. Omri Shor, CEO of Medisafe, explores how.

Now operating under virtual formats, patients can demand healthcare access on their schedule, creating a pivot point for the industry where pharma and providers must meet the demands of the patient – not the healthcare system. And it’s no longer a pipe dream to think of a system that puts the patient first, treats them individually, and employs a network of patient technology to meet the health needs of each person.

Burden on the patient

Thinking back through my experiences in the healthcare system, a recent quote has stuck with me that sums up the burden placed on patients:  “I left [the doctor’s office] with more directions on how to pay my bill than to care for my health.”

In many ways, treatment for patients has focused on addressing a condition or illness, not caring for the individual. And while that approach may have led to successful outcomes for most, it doesn’t incorporate a patient’s lifestyle, unique factors, individual challenges or barriers to successful treatment. This extends to pharma where medicine addresses a condition, but patient care, guidance, and support have often been an afterthought.

In many ways, the current system still places the burden on the patient, creating hardships and hurdles to navigate. And for the majority of patients who are managing chronic conditions, it means not only managing their health but also the complexities of the system. But the convergence of health and technology is helping to give patients more power in caring for their health, and demand for transparency, accountability, and control over their health and lives. As patients gain more choice in the marketplace, pharma and providers alike are starting to recognise the value in patient satisfaction and are quickly adopting new ways to respect the patient voice.

Tech shift

While new satisfaction measures and competition are helping to shift the model to connect with patients, the biggest advancements in the patient experience have come through tech advancements. The onset of the pandemic forced nearly all elements of the healthcare ecosystem to pivot to new formats to stay connected to patients. This also shifted the demand and scheduling to operate around patient’s schedules, instead of the other way around.

This shift comes at a time when patients were already embracing digital health apps, medication companions, and wearable technology. Suddenly digital health has put patient choice in the palm of their hands. In a world where everything is on-demand, streaming, and delivered next-day, users have come to expect a similar experience from medication management and pharma support.

Thanks to the convergence of tech and health, the future of healthcare places the patient directly in the driver seat, able to track their health stats, monitor and manage conditions, engage with providers and connect with pharmacies all within a digital platform. This new level of interoperability means improved transparency, greater connectivity, and more insight to treat the person, not just the patient.

Clinician adoption and integration

Healthcare remains one of the most personal experiences, and the influence of technology can improve the experience and outcomes, but it cannot replace human interaction altogether. Leaders in the health IT space know that tech alone isn’t the answer – it’s how to blend technology with personalisation to create a better ecosystem. In the most recent HLTH conference, companies such as Amazon, Google, and IBM explored ways to incorporate live interactions through tech devices to enhance segments of healthcare.

Pharma is examining ways to reach the patient population through a combined effort of both personal and digital. One new partnership is through Pleio. This network of connected care coordinators works with patients upon receiving medications, walks the patient through their first 15 days on a new medication and then helps move them to a digital companion that tracks their usage, engagement, and delivers customised support via a connected app.

This hand-holding model from personal to digital has shown to improve medication adherence by up to 50%.  Another way pharma is blending this model is through virtual clinical trial studies. By creating a disparate model in clinical trials, critical information is still being captured while using virtual technology and AI to remain engaged with patients remotely. This new structure is enabling pharma to engage with a larger pool of candidates, while also offering more flexibility to the lives of patients.

Patients still want personal care and are finding greater satisfaction through tech involvement in helping to manage follow-up interaction, medication management, financial support, and digital encouragement. As one physician put it, patients want “human support for the big stuff and digital access and guidance for smaller daily stuff.”

Future of integrated care

As we look to the future, amidst a pandemic that has changed everything about how health systems operate, it’s clear that digital has taken hold. I envision a future where technology helps to close gaps and connect patients more closely with physicians and their healthcare coverage. We are already seeing a glimpse of that as COVID-19 vaccine makers and pharma companies begin eyeing digital health platforms to help connect patients with safety resources. Tracking of vaccine doses will be essential to ending the pandemic and pharma companies are already in talks with leaders at Google, Apple, and Medisafe on ways to deploy such platforms.

The patient home has also become the new centre for care, further helping to put power back into patients’ hands. AI applications and digital integration in the home will soon be able to inform patients when a medication has shipped, if there is a flu outbreak in their area, or if they want to speak with a physician via FaceTime. In a similar move, Amazon is launching an at-home pharmacy delivery service, making medication management as easy as Prime membership for maintenance medications.

But healthcare that no longer leaves out the patient is truly about simplification. Patients want a healthcare experience that first recognises them as people, as individuals, and takes a comprehensive approach to care, not simply fixing a broken issue. The future of care is more personal, more connected, and more complete. With digital platforms that encompass a user’s whole health, including medications, vitals, nutrition, exercise, environment, behavioural and financial health. It’s care that addresses a person’s complete environment, with medication and support to improve their lives, not just their condition.

About the author

Omri Shor is the CEO of Medisafe. He is an expert in digital medicine applications and works closely with major pharma companies in developing and guiding direct connection to patients via innovative platforms to support improved health and treatment, with customisation and guided treatment.

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We speak to finalists from the Greater Manchester Future of Health accelerator to find out how digital start-ups can overcome the challenges small companies face in bringing their technologies into the NHS.

Right now the NHS is embracing digital to an extent no one could have foreseen a year ago – but that doesn’t mean it’s a smooth journey for digital health start-ups looking to gain traction in the health service.

“COVID has forced the NHS to change, but so far most of the implemented digital innovations have been low-hanging fruit such as video consultations,” says Rory Cameron, CEO and co-founder at diabetes risk management app Gendius. “Adoption of new tech is still a real challenge.”

He says that part of the problem is that standards of care are rapidly changing, and it is therefore difficult for companies to prove their concept.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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UK artificial intelligence startup Okra Technologies has launched a new software platform that it claims can take the guesswork out of the price that can be charged for new drugs, years ahead of launch.

The AI system – called ValueScope – can predict the price  as well as the likely outcome of negotiations with health technology assessment agencies like NICE in the UK and IQWiG in Germany with more than 90% accuracy, claims the company.

The platform uses AI to “dramatically free up the time spent on crunching datasets, modelling scenarios and building price predictions,” says Okra, a Cambridge-based company led by Dr Loubna Bouarfa, a machine learning scientist who was formerly a member of the European Commission’s high-level group on AI.

Bouarfa has also been named as an Innovator Under 35 for 2017 by MIT and as one of Forbes’ Top 50 Women in Technology.

“ValueScope provides intelligence that pharma executives require when critical decisions about future investments and patient access are made,” said Bouarfa, adding: “We use data to bring clarity and transparency to the table.”

At the moment pricing and reimbursement modelling requires many hours building evidence from clinical trial data, real-world evidence, historic drug submissions, pricing data and HTA appraisals, according to the startup.

ValueScope avoids this by injecting AI directly into the workflow of every pricing professional, performing in minutes what could take months with traditional approaches, it claims.

The AI was built using data from more than 1,700 drugs that have been launched in Europe, creating a virtual model for HTA negotiations. It was put through its paces in Germany, and hit the 90% accuracy threshold when predicting the outcome of appraisals and the negotiated price of phase 3 treatments.

The system enables market access and commercial teams to perform assessments of early drug candidates faster and more efficiently than before, without the need for extensive pricing research and repetitive data crunching.

Okra has also developed AI platforms to make sales reps’ workflows more efficient, predict sales volumes for products, and improve communications between medical scientific liaisons (MSLs) and healthcare practitioners.

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The US government has introduced a scheme to allow hospitals to reduce the number of inpatients they see through a telehealth platform that would helps deliver acute care at home.

The move comes as the number of new cases of COVID-19 have been climbing to around 180,000 a day, with deaths since the start of the pandemic now rising above 260,000, and concerns that some hospitals could become overwhelmed over the winter months.

The Centres for Medicare & Medicaid Services (CMS) announced the plans as part of  broad plan to free up hospital capacity amid the COVID-19 surge, although it stressed patients won’t have to use the service unless they want to, and the first assessment by a physician must take place in person.

It said that treatment for more than 60 different acute conditions, including asthma, heart failure, pneumonia and chronic obstructive pulmonary disease (COPD), can be carried out “appropriately and safely in home settings with proper monitoring and treatment protocols.”

The new telehealth scheme applies to patients with conditions that require at least daily visits by a physician and ongoing medical team monitoring.

Six health systems across the country have already been approved to participate in the programme, getting the necessary Medicare waivers to allow them to treat patients at home.

They are Brigham and Women’s Hospital in Massachusetts, Massachusetts General Hospital, Huntsman Cancer Institute in Utah, Mount Sinai Health System in New York City, Presbyterian Healthcare Services in New Mexico, and Iowa’s UnityPoint Health.

Participating hospitals must have screening protocols in place before care at home begins, to assess that patients have access to working utilities, ensure there are no other physical barriers to care, and rule out welfare concerns such as a risk of domestic violence.

The US healthcare system has rapidly adopted telehealth and remote patient monitoring during the response to the coronavirus pandemic, with some suggesting it will transform the future of health care delivery, although there are dissenting voices.

In March 13, President Trump made an emergency declaration that empowered the CMS to issue waivers to Medicare programme requirements to support healthcare providers and patients during the crisis.

Since then, the CMS has added dozens of services to the list of telehealth services it will reimburse during the public health emergency, including emergency department visits, initial nursing facility and discharge consultations, home visits, and physical, occupational and speech therapy services.

Some of the changes have found their way into the proposed 2021 Physician Fee Schedule, which will make reimbursement for some telehealth and digital services permanent.

“We’re at a new level of crisis response with COVID-19 and CMS is leveraging the latest innovations and technology to help healthcare systems that are facing significant challenges to increase their capacity to make sure patients get the care they need,” said CMS Administrator Seema Verma.

“With new areas across the country experiencing significant challenges to the capacity of their health care systems, our job is to make sure that CMS regulations are not standing in the way of patient care for COVID-19 and beyond,” she added.

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BioNTech may be deeply ensconced in the latter stages of its bid to bring a COVID-19 vaccine to market, but it’s still pushing forward on other fronts, including a partnership with InstaDeep to deploy artificial intelligence and machine learning across its business.

The two companies have been working together in this area since 2019, but BioNTech has opted to double down on the alliance with a revised agreement focusing on new immunotherapies for cancer and infectious diseases.

The headline news in the new agreement is the formation of a joint AI Innovation Lab – split between InstaDeep’s headquarters in London in the UK and BioNTech’s site in Mainz Germany – that will focus on drug discovery and design, protein engineering, manufacturing and supply chain.

One of the main research areas for the new lab will be the development of new vaccines and biologic drugs for the treatment of cancer and prevention and treatment of infectious diseases, including COVID-19.

InstaDeep – which was founded in Tunisia – has built its business across a range of sectors, mainly helping small- and mid-sized companies to develop bespoke apps harnessing computer vision, predictive analytics, 3D imaging, augmented and virtual reality, and deep learning. It was recently nominated by CB Insights as one of the 100 most promising AI start-ups in the world

With BioNTech, the company will focus on three main areas. The duo will apply InstaDeep’s protein design platform – called DeepChain – to engineer new mRNA sequences against protein targets, and also collaborate on sifting through anonymised patient data to identify new drug targets and biomarkers.

They will also use AI and machine learning to find ways to make manufacturing and supply chain processes more efficient, tapping into technologies like robotics and autonomous decision-making algorithms.

“Pairing BioNTech’s deep knowledge of the human immune system and scientific data-driven development approach with our AI platform could transform the way we discover and develop new drug classes for patients all over the world,” said Karim Beguir, InstaDeep’s chief executive.

A recent study by Kearney revealed that 68% of global industry leaders in the healthcare sector see AI and advanced analytics as major value drivers.

All attention at the moment is on BioNTech’s Pfizer-partnered coronavirus vaccine BNT162b, but it has a packed pipeline of earlier-stage projects, including a Roche-partnered mRNA-based drug for melanoma in phase 2 and several other cancer therapies in phase 1.

“We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” said BioNTech chief executive Ugur Sahin. “This collaboration will expand our digital capabilities and optimise our operations across the value chain.”

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Former chief digital officer for the NHS, Juliet Bauer, is now applying her experience to the private sector through video consultation firm Livi. She shares her thoughts on how well the NHS is integrating digital health and what the public and private sectors can do to further boost adoption.

Bauer’s path to working in the NHS began when she spent many months in the care of the health service with a highly risky pregnancy and an extremely premature baby in NICU.

“I was hugely grateful for the brilliant care I received whilst in hospital – but I could also see the huge potential for digital to improve patient access and efficiencies across the NHS,” she says.

Bauer wanted to utilise her first-hand patient perspective and experience in digital transformation to drive positive, long-term change.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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An artificial intelligence tool developed by GE Healthcare twinned with a mobile X-ray device can help the placement of endotracheal tubes (ETTs), a necessary step for COVID-19 patients who require ventilation.

The new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation and make sure ETTs are positioned correctly which should reduce complications.

It also includes algorithms that help radiologists triage and prioritise critical cases, and automates processes to help cut average review times for X-rays, which can currently take up to eight hours even when flagged as urgent.

The company says up to a quarter of patients who are intubated outside of the operating room have misplaced ETTs on chest X-rays, which can lead to hyperinflation of the lungs, collapsed lung (pneumothorax), cardiac arrest and death.

GE Healthcare says the new tool is of particular value at the moment as the world is battling the coronavirus pandemic, as this has massively increased the demand for intubation and ventilation.

Overall, around 45% of all patients admitted to intensive care need to be intubated, and it is estimated that between 5% and 15% of COVID-19 cases require intensive care surveillance and intubation for ventilatory support.

Using the AI suite, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been place correctly. It will also quickly detect complications like pneumothorax, and can automatically send an alert to a radiologist along with the x-ray images for review.

“Seconds and minutes matter when dealing with a collapsed lung or assessing endotracheal tube positioning in a critically ill patient,” said Dr Amit Gupta, director of diagnostic radiography at University Hospital Cleveland Medical Centre in the US.

The algorithm has already shown its worth in COVID-19 cases, identifying cases of pneumothorax as well as barotrauma – tissue injury caused by a pressure-related change in body compartment gas volume, he added.

“Today, clinicians are overwhelmed, experiencing mounting pressure as a result of an ever-increasing number of patients,” said Jan Makela, president and CEO, Imaging, at GE Healthcare.

“The pandemic has proven what we already knew – that data, AI and connectivity are central to helping those on the front lines deliver intelligently efficient care.”

Critical Care Suite 2.0 and its five quality algorithms were developed using GE Healthcare’s Edison platform and are deployed on its AMX 240 mobile X-ray system.

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A merger involving two US digital health specialists and a blank cheque company has created a telemedicine player, called UpHealth, that is valued at more than $1.3 billion.

The three-way deal combines UpHealth – which provides patient care management, telemedicine and digital pharmacy services and gives its name to the new group – with CloudBreak, which provides a video consultation platform for doctors and patients.

The blank cheque company or ‘special purpose acquisition company’ (SPAC) that provides funding is GigCapital2, which raised $150 million in its public offering in June 2019.

The merger is expected to be completed in the first quarter of 2021, subject to the usual closing conditions. Once completed, UpHealth will continue to be listed on the NYSE but with a new ticker symbol (UPH).

The combined company will cover a broad swathe of the digital health landscape, bringing together population health software, telehealth services, digital pharmacy delivering compounded and manufactured medicines, and tech enabled behavioural health services for people with mental health and substance abuse issues.

It will have pro forma 2020 revenues of around $115 million, rising to $194 million next year, coming from established contracts with health providers, insurers and payors from all 50 states in the US as well as nine international markets, according to the prospectus for the merger.

The new UpHealth will have two co-chief executives – Al Gatmaitan and Ramesh Balakrishnan – with Chirinjeev Kathuria of UpHealth and Avi Katz of GigCapital2 serving as co-chairman.

The elements of its digital health portfolio included integrated care management unit Thrasys – whose SyntraNet health information exchange platform is used to organise patient health records and workflows.

Telehealth will be split into a US division – consisting mainly of CloudBreak – and an international division centred on Glocal Healthcare Systems that is operating in India, Southeast Asia, and Africa.

The digital pharmacy business will be provided by MedQuest, which is licensed in all 50 states and pre-packages and ships medicines direct to patients, serving a network of 13,000 providers.

Finally, behavioural health will be provided by two subsidiaries – TTC Healthcare and Behavioural Health Services – which provide both onsite and telehealth services.

The increased reliance on telemedicine services during the coronavirus pandemic has sparked a flurry of M&A and fundraising activity among providers trying to broaden and expand their businesses.

The largest by far was the $18.5 billion merger between Teladoc and Livongo to create a digital health giant with pro forma sales of $1.3 billion, which came shortly after Teladoc bought InTRouch Health for $600 million.

Other sizeable deals include Veritas Capital’s acquisition of the health and human services assets of DXC Technology for $5 billion, Align Technology’s buyout of digital dentistry specialist exocad for $417 million, and Google’s $100 million investment in telehealth player Amwell on the same day the Boston-based company announced its IPO.

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German digital health company smartpatient is adding a new section of its MyTherapy app providing information on wet age-related macular degeneration (AMD), a leading cause of blindness.

The Munich-based company is launching the educational See What’s Next app in collaboration with Novartis, which sells the wet AMD medicines Beovu (brolucizumab) and Lucentis (ranibizumab), and has also been a big proponent of digital health technologies.

Wet AMD affects more than 20 million people worldwide, and is the top cause of blindness in people aged over 65. It develops when abnormal blood vessels grow into the macula of the eye. These vessels leak blood or fluid which leads to scarring of the macula and rapid loss of central vision.

While injecting drugs like Beovu, Lucentis and Bayer/Regeneron’s rival Eylea (aflibercept) into the eye can slow down the progressive loss of vision associated with the disease – particularly if wet AMD is diagnosed early – careful adherence to therapy is critical for treatment to work effectively.

The new, free of charge section makes tailored information about wet AMD available to the approximately 20 million people worldwide with wet AMD along with tools to help them stay on track with treatment and in communication with their doctors.

“Non-adherence is a challenge in most health conditions, but in few are consequences as direct and severe as in wet AMD,” says Sebastian Gaede, smartpatient’s chief executive.

See What’s Next is available to patients through their ophthalmologists, according to smartpatient, which has co-created the wet AMD app with Novartis, and will roll out initially in Italy and Spain with additional markets planned in the coming months.

MyTherapy has already been downloaded by millions of people around with world, and has more than 80,000 ratings on Apple’s App Store and Google’s Play Store – which smartpatient claims makes it the world’s fastest-growing disease management app.

Novartis and Lucentis marketing partner Roche have been battling Bayer in the wet AMD market for years, but the company hopes to make headway with recent launch Beovu as patent protection for Lucentis is expiring this year in the US and in 2022 in Europe.

Novartis earned $2 billion from Lucentis last year, while Roche – which sells it in the US – made $1.8 billion from the drug. Eylea was the market leader with Regeneron recording US sales of $4.6 billion in 2019, while Bayer posted $2.5 billion.

Beovu hasn’t really taken off yet, with sales of just over $150 million in the first nine months of the year, impacted by the pandemic but also because there have been reported of patients experiencing retinal vasculitis after being treated with the drug following its launch in the US in 2019.

Market research company GlobalData still thinks Beovu will become a blockbuster with peak revenues of $3.6 billion in 2028, when it expects the total wet AMD market in eight top pharma markets – the US, France, Germany, Italy, Spain, UK, Japan, China, and Australia – to reach $18.7 billion.

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COVID-19 has turned the world on its head and healthcare systems have had to respond rapidly to match the sudden changes created by lockdown. Digital health had already been building a presence before the pandemic, but the tools it offers have been essential to counter the disruption caused by the coronavirus, reports Richard Staines.

COVID-19 isn’t going away any time soon but when, and if, this crisis subsides the healthcare systems that are left behind will have changed radically.

While the pandemic has been a global tragedy it has also forced health systems to rethink the way they operate in order to minimise risks to both patients and healthcare staff.

With face-to-face contact posing a risk of virus transmission, the emphasis has been on remote appointments where possible, backed systems that triage patients remotely to manage the pressure on the system.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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A Greek health insurance firm has released a new platform to encourage members to adopt a healthier lifestyle.

Generali Hellas is the sixth largest insurance company in Greece and has had a presence there since 1886.

With its new platform, My Health IQ, the company aims to improve the wellbeing of customers by encouraging their active involvement in the adoption of a healthier lifestyle.

The company said it will use a combination of motivational techniques from behavioural science, gamification and social networking, plus artificial intelligence and automated coaching to achieve these goals.

Generali has joined with dacadoo, which is providing the technological support for the project, which allows customers to monitor and improve their physical and mental health based on a scientifically validated technology.

The app was released this month.

dacadoo licenses its technology, including its Health Score, to life and health insurance operators, supplying insurtech and health-tech solutions to over 35 of the top 100 life and health insurance operators globally.

Available in over 16 languages, dacadoo’s technology is provided as a fully branded, white label solution or it can be integrated into customers’ products through its API.

dacadoo also provides a risk engine, which calculates relative risk on mortality and morbidity in real-time.

Peter Ohnemus, President and CEO of dacadoo, says: “We are very pleased to work closely with Generali Hellas; it was a perfect match as we both strive for quality and innovation within our product offering.

Panos Dimitriou, CEO of Generali Hellas, said: “The use of digital technology and telematics in the insurance sector is an innovative and necessary step, as it effectively shifts the narrative from a risk-based approach to one focused on the premise of prevention and the promotion of good he”alth.

“The new health app is part of our recently launched Generali Health Ecosystem, where digital tools and services provide added value and an overall elevated customer experience.”

The post Greek health insurer partners with dacadoo to launch health app appeared first on .

Research Partnership’s Vicki Newlove explores research into digital change during COVID-19 to find out what business questions pharma needs to address to succeed with innovations.

Pharma companies are facing a confusing and uncertain future, and no one can say how the industry might look in a year’s time, or what the balance of digital and physical working might be. Even those companies that responded well to the pandemic and quickly embraced digital can’t know how long restrictions will last, and many are still revising their strategies and figuring out how best to position their digital offerings.

The companies that will thrive are those who gather insights into how COVID is impacting the patient journey and physicians’ behaviour and adapt accordingly. This will allow them to put robust, long-term strategies into place.

Our own research has shown marked shifts towards digitisation in the industry. For example, findings from our Therapy Watch report ‘Free thinking: The impact of COVID-19 on chronic disease management and the implications for pharma marketing’ show that 89% of physicians across the EU5 report replacing face-to-face consultations with virtual consultations during the pandemic.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Bayer has provided funding to five more digital health start-ups as part of its G4A partnering programme, which has already provided backing for more than 150 companies since 2013.

The latest crop of recipients in the G4A scheme were selected from more than 400 applications from companies in dozens of countries around the world and have apps covering women’s health, chronic conditions, genomic testing, disease management and telemedicine.

G4A (formerly Grants4Apps) was originally set up to fund mobile health apps, but has been expanded in recent years to include a broader range of digital health technologies, and has already resulted in 30 partnerships.

It has two partnership types, a ‘growth track’ which provides €100,000 in funding to help early-stage startups get off the ground, and an ‘advance track’ scheme for more mature companies that already have a platform on the market and are looking for commercial partnerships.

This year’s competition sought out digital health innovations in four key areas: cardiometabolic and renal disease, oncology, women’s health and pharmacovigilance.

The latest recipients include two growth track awards for Caria and Elly Health, and three advance track partnerships with Decipher Biosciences, Sweetch, and MyONCARE.

Caria from Chorus Health (previously called Clio) uses artificial intelligence (AI) to help women in menopause track symptoms and connect them with evidence-based treatments, as well as providing personalised health advice and access to a digital support community.

The Elly app is billed as a ‘smart companion’ for people with chronic conditions that aims to help them live healthier and happier lives. Along with audio messages intended to build motivation, it provides disease education, meditation and exercise videos, symptom management, and other support tools.

Decipher Biosciences picks up its advance track award for its GRID database project, which draws together data from its genomic testing programmes – focused on solid tumours – which are used by pharma companies to identify biomarkers of response to new therapies.

Another AI-harnessing platform – Sweetch – is a disease management behavioural coach that provides patients with personalised recommendations via their smartphone and other connected devices in the hope of improving their clinical outcomes.

Finally, MyONCARE is an app that assists healthcare professionals with the organisation of interactions with patients, so they always have data such as diagnoses, medication, vital signs, therapy and nursing plans to hand, as well as providing a direct telemedicine channel.

“Building new digital business models is a key element of Bayer’s business strategy, with the ambition to actively shape the future of healthcare,” said Jeanne Kehren, Bayer’s head of digital and commercial innovation.

“We are proud to support startups who share our vision of integrated healthcare solutions that put the patient in focus, not the disease,” she added.

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UK biotech Closed Loop Medicine (CLM) has started recruiting patients into a trial that will test whether a drug linked to a smartphone app can improve treatment for hypertension.

The new study is specifically designed to include patients shielding from COVID-19, to see how well they can manage their blood pressure in a home environment and explore whether having hypertension raises the risk of severe disease.

CLM’s programme – CLM-HT01 – combines new formulations of already-registered drugs for high blood pressure with a digital therapeutic app, and earlier this year was awarded a second grant from Innovate UK for a clinical study at Queen Mary University of London that was unfortunately delayed by the pandemic.

Lead investigator Dr David Collier and his team at Queen Mary have now re-designed the study so that no in-hospital visits are required, with all interactions between patients and clinical staff carried out remotely.

Called Personal COVID BP, the rejigged trial is much larger and will involve up to 1,000 patients, with an initial 200-subject group given drug therapy while using an app to monitor blood pressure, as well as any potential side effects.

The main aim of the study is the development of a combination product that will have the potential to save thousands of lives through fewer heart attacks and strokes, says the company. At the same time, the digital app will also monitor COVID-19 symptoms in a larger group of people with hypertension.

During the early stages of the pandemic, researchers suggested there may be a link between COVID-19 mortality and high blood pressure, and a Nature paper published in May that analysed 17 million electronic health records reinforced the connection.

That study also pointed to an elevated risk of COVID-19-related death for Black and South Asian people and those from deprived areas, as well as other factors such as obesity and diabetes.

“In lockdown the CLM development team worked tirelessly to enable COVID-19 symptom tracking in addition to the existing hypertension monitoring features of the app,” said Collier.

The main thrust of the trial will however be to put the drug + digital approach through its paces in a real-world setting and see if it can optimise treatment.

“Some of the drugs we use are great at preventing heart attacks and strokes, but frequently cause unwanted side-effects, something this trial sets out to address,” according to Collier.

“We hope that through this study we can not only demonstrate that one size does not fit all, but that by using technology in this combined way, we can personalise treatment for the individual at a population scale.”

Earlier this year, CLM also formed a partnership with clinical trial specialist Curebase to explore the relationship between high blood pressure and COVID-19 in the US.

Under the terms of that agreement, Curebase has set up a clinical trial platform – called CURE-19 – that is being used to run at-home COVID-19 studies, and the first results from that effort could be ready this year.

CLM is making its app available on the CURE-19 platform, and the symptoms, drug regimen and blood pressure data it harvests – once de-identified – will be placed in a database and used to look for relationships with disease severity.

The post CLM tests drug plus digital combo for high blood pressure appeared first on .

The healthcare system is running at its limits in many countries worldwide. One reason is the growing demand for healthcare, largely driven by the rise of chronic diseases. COVID-19 has further underscored just how stretched the system is today. Is there any solution to the twin challenge of managing costs while extending capacity?

We believe that digital technologies are an important part of the answer. Although still in early stages, it is poised for broader adoption thanks to recent technological advances. While digital won’t help solve all the problems in our healthcare system, it will significantly contribute to easing the cost and capacity burden.

One particularly promising area in this context is digital therapeutics. Based on the analysis of individual patient data, patients receive personalised medical recommendations – through an app or a digital platform – without the need for physician intervention. Digital therapeutics can help patients stick to treatment plans and/or better understand what triggers critical situations. Digital therapeutics are already available for different indications including diabetes or asthma and are being developed in many other areas as well.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Researchers at the Wellcome Sanger Institute in the UK are working on software to monitor the genome of SARS-CoV-2 coronavirus in the hope of spotting changes that could affect the fight against COVID-19.

Backed by £12.2 million in UK government funding, Wellcome Sanger and the COVID-19 Genomics UK (COG-UK) Consortium intend to develop a real-time nationwide surveillance system that could identify mutations in the virus.

Wellcome Sanger will use the funding to develop the software to capture genomic information digitally, and pair it up with data from the UK public health agencies and the NHS and Trace programme.

The hope is that monitoring will allow health authorities to quickly identify mutations that might allow the virus to sidestep diagnostics, vaccines and drug therapies, for example, and guide the development of counter measures.

It will also allow linking of viral sequencing patterns with host genomics, immunology, clinical outcomes and risk factors, according to the consortium.

With the second wave of COVID-19 infections now gathering pace, and vaccines on the brink of being made available, genomic data will be critical to determine whether the virus evolves to escape them.

Since the first whole-genome sequence of SARS-CoV-2 was shared online on 11 January, scientists around the world have been sequencing the virus to spot genomic changes that will allow outbreaks to be tracked and controlled.

The effort could also help local authorities respond to outbreaks more quickly, according to researchers, and could become particularly important in allowing international travel to return to some degree of normality.

Specific lineages of virus can be identified from around the world, and that makes it possible to detect lines of transmission by comparing the genetic sequences of virus samples.

Sequencing also allows scientists to monitor key viral characteristics like transmission and disease severity, according to COG-UK director Prof Sharon Peacock from the University of Cambridge.

Since March, COG-UK has published more than 100,000 SARS-CoV-2 genomes, making up over 45% of the global total, an effort that it says has not been achieved previously for any pathogen, anywhere in the world.

The genomic data already generated by the COG-UK network – which includes Wellcome Sanger – has already “provided important scientific insights into the spread and evolution of the virus, at local, regional, national and international scales,” says the consortium.

Earlier this year, Swiss medical data specialist Sophia Genetics launched data mining tools to help researchers examine how the genome of SARS-CoV-2 changes over time, and combine that data with patients’ clinical and genetic information.

Tech company NVIDIA has also made its Parabricks genome-sequencing software available at no charge to researchers sequencing the coronavirus and the genomes of those suffering from COVID-19.

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The US healthcare system’s focus on activity rather than value for money was behind the demise of Proteus Digital Health and its “digital pill”, which measured whether schizophrenia patients took their meds, according to the company’s former CEO.

At the Frontiers Health conference Andrew Thompson spoke to pharmaphorum’s web editor Catherine Longworth about lessons that can be learned from the company’s troubled attempt to market the technology.

Together with Japan’s Otsuka Pharmaceuticals, the company produced the ground-breaking smart pill Abilify Mycite (aripiprazole).

But the partnership ran into trouble after poor uptake by payers in the US and an ill-fated fundraiser.

After disappointing sales, Proteus filed for bankruptcy earlier this year and in September, Otsuka ended up buying what was left of Proteus for $20 million.

Although Novartis was reportedly also interested in the company’s technology, it was a huge fall from grace for Proteus Digital Health which was once valued at $1.5 billion.

Proteus’ pills contained a tiny ingestible transmitter that communicated with a bluetooth patch worn by the patient, which transmitted data to a smartphone.

This then allowed doctors and healthcare staff to monitor whether they have taken their meds.

According to Thompson, who is now focusing on his role as managing director of Spring Ridge Ventures after leaving Proteus earlier this year, the product failed to take off because of the way drugs are funded in the US, where the system effectively funds healthcare activity.

Abilify Mycite did the opposite of that, reducing healthcare costs but also reducing healthcare activity and income for hospitals.

“In the United States you get paid more for doing more. We do exactly the opposite of what a provider would do in the US, which is make more money.”

He called for reform to the funding system to reward innovators in the same way as the automotive industry.

At the moment Tesla gets money from other automotive manufacturers who can’t meet emissions requirements and uses this to fund its research into electric cars.

A similar incentive scheme should be set up to encourage more innovation in medicines, according to Thompson who criticised the system for its current focus on a limited range of health problems, chiefly cancer.

The drug industry has pivoted towards this because of the money available for cancer drugs that produce a limited return in terms of life expectancy increase, he argued.

Changing the way the system is funded would allow more patients to access innovative products, which could reduce healthcare expenditure, he added.

He told the conference, which was mainly held virtually: “What we proved is that digital solutions reduced heads in beds and reduced minutes in clinics.”

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Shots:

• Qiagen has initiated the commercialization of the portable digital QIAreach SARS-CoV-2 antigen test in the US that can be used by laboratories to detect active infections in 2-15mins.
• The test provides a higher throughput testing for SARS-CoV-2 antigen by processing up to 8 tests/ hub. The digital results do not need subjective interpretation and enable Ab tests to run simultaneously with Ag tests
• QIAreach SARS-CoV-2 Ag test is a fast, digital, and easy to use a test that utilizes sensitive nanoparticle technology and is developed in partnership with Ellume. The company anticipate receiving CE-IVD registration for the EU and other markets by the end of 2020

Click here­ to­ read full press release/ article | Ref: Qiagen | Image: Holland One

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US data analysis company Palantir Technologies could be drafted in to manage the UK government’s troubled COVID-19 Test and Trace programme, according to press reports.

Palantir has been linked with the project for several weeks and the Financial Times is the latest to suggest that the company could get involved with the troubled project.

Palantir was founded in 2003 by a team including paypal co-founder Peter Thiel and the company’s billionaire CEO Alex Karp.

Taking its name from the “seeing stones” in The Lord of the Rings, Palantir is known for counter-terrorism work and fraud investigation with agencies of the US federal government.

The company is reportedly being hired to fix the “technical error” that caused around 16,000 positive test results to go unreported.

There was widespread anger and derision when the issue turned out that the results had been stored on a Microsoft Excel document that had run out of storage space.

According to the FT, officials are in discussions with Palantir over licensing its software to the test and trace programme, with a long-term goal of finding deeper insights into how the virus is spreading.

The aim is to allow the government to respond more quickly to outbreaks, an issue that the government has been struggling with over the last few weeks.

Before the government called a month-long national lockdown, it struggled to keep on top of rising numbers of cases in the north of England with its targeted local approach.

Palantir is already working on another pandemic-related project, after it was drafted in to support work on the COVID-19 data store.

The company’s contract was extended for four months in July although a procurement process is open for a supplier to continue the work on the technology platform.

According to Digital Health News the contract could be worth £18m a year over five years.

Privacy campaign groups raised concerns about Palantir’s involvement in the pandemic when the company first got involved in April.

Privacy International, Big Brother Watch, medConfidential, Foxglove and Open Rights Group sent Palantir questions about its work with the NHS during the coronavirus crisis.

The questions published on the Privacy International website wanted to know whether Palantir would use the data analysis work with the NHS to strengthen its own systems, among other things.

The Department of Health Social Care has not publicly commented on the reported talks with Palantir, but said that Test and Trace is committed to the highest ethical and data governance standards.

Shares in Palantir began trading on the New York Stock Exchange through a direct public listing in September this year.

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It’s day two of digital health innovation conference Frontiers Health, which will be mainly held online because of the COVID-19 pandemic.

This year Frontiers will be a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition will be hybrid combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, the USA and more

It will be dedicated to digital health innovation, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation and ecosystem development.

The programme starts at 2.00pm CET with plenary sessions (talks and panels) and parallel break-out sessions (masterclass, workshop, deep-dive formats) in the unique Frontiers style.

The iconic Start-up Discovery sessions have also moved online opening more opportunities to connect with both earlier stage and more established digital health start-ups.

Paul Tunnah, chief content officer and managing director UK at Healthware Group will open day two of the conference, followed by an opening keynote from Healthware CEO Roberto Ascione.

This will be followed by keynote addresses by David Klein, CEO of Click Therapeutics and Kuldeep Singh Rajput, CEO and Founder of Biofourmis.

They will respectively discuss removing barriers to healthcare access with digital therapeutics and adoption at scale of digital biomarkers.

View the live coverage of day two at Frontiers Health on this exclusive blog from the pharmaphorum team, who will also be posting updates on twitter.

 

 

View the live coverage from day two at Frontiers Health 2020 from 13 November below, revisit coverage of day one (The live blog may take a moment to load.)

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Finnish startup Popit has joined with Spain’s Almirall to produce an app that tracks whether patients have taken their psoriasis medicine and sends them a reminder if they miss a dose.

Popit’s technology, which is available in the Netherlands, is clinically validated to reduce the number of missed doses and has been already used by several pharma companies.

The company cited a pilot study showing how the system increased adherence in birth control pill users.

The technology is based around an electronic device which is attached to the push-through pill packages that monitor whether a dose has been taken.

Results of the pilot study in 24 women showed that without the system, 46% of those taking part forgot to take one or more pills during the first one-month period.

When the on-demand reminder system was turned on in the second month, 8% (2 women) forgot one or more pills.

This translated into a statistically significant reduction in the number of missed doses. The companies hope to use the technology to ensure patients stick to their regimens of Almirall’s Skilarence (dimethyl fumarate), a systemic treatment taken orally for moderate to severe plaque psoriasis.

Medicines based on dimethyl fumarate – such as Biogen’s multiple sclerosis drug Tecfidera – are notorious for their gastrointestinal side-effects.

Biogen resorted to using a telephone support service to help patients get through the side-effects that often settle after a few weeks on treatment.

Popit does not provide medical advice but patients have access in the app patient information provided by Almirall, which includes gastric issues.

The companies have not disclosed whether the app is created to deal with the gastrointestinal issues, instead noting problems with patients forgetting to take their meds.

Popit’s CEO Teemu Piirainen said: “There is a great need to improve medication adherence and patient support in psoriasis care. Popit can really help in this by tackling some of the most common causes for why doses are missed, which include forgetting the daily doses and insufficient awareness of how missed doses impact treatment outcomes.

“Additionally, the patient might face quite practical challenges with their treatment, like up-titration or predetermined changes in product strength, which may not always be easy to master. Popit supports the patient with these challenges.”

The post Popit and Almirall’s new app tracks adherence to psoriasis med appeared first on .

Finnish startup Popit has joined with Spain’s Almirall to produce an app that tracks whether patients have taken their psoriasis medicine and sends them a reminder if they miss a dose.

Popit’s technology, which is available in the Netherlands, is clinically validated to reduce the number of missed doses and has been already used by several pharma companies.

The company cited a pilot study showing how the system increased adherence in birth control pill users.

The technology is based around an electronic device which is attached to the push-through pill packages that monitor whether a dose has been taken.

Results of the pilot study in 24 women showed that without the system, 46% of those taking part forgot to take one or more pills during the first one-month period.

When the on-demand reminder system was turned on in the second month, 8% (2 women) forgot one or more pills.

This translated into a statistically significant reduction in the number of missed doses. The companies hope to use the technology to ensure patients stick to their regimens of Almirall’s Skilarence (dimethyl fumarate), a systemic treatment taken orally for moderate to severe plaque psoriasis.

Medicines based on dimethyl fumarate – such as Biogen’s multiple sclerosis drug Tecfidera – are notorious for their gastrointestinal side-effects.

Biogen resorted to using a telephone support service to help patients get through the side-effects that often settle after a few weeks on treatment.

Popit does not provide medical advice but patients have access in the app patient information provided by Almirall, which includes gastric issues.

The companies have not disclosed whether the app is created to deal with the gastrointestinal issues, instead noting problems with patients forgetting to take their meds.

Popit’s CEO Teemu Piirainen said: “There is a great need to improve medication adherence and patient support in psoriasis care. Popit can really help in this by tackling some of the most common causes for why doses are missed, which include forgetting the daily doses and insufficient awareness of how missed doses impact treatment outcomes.

“Additionally, the patient might face quite practical challenges with their treatment, like up-titration or predetermined changes in product strength, which may not always be easy to master. Popit supports the patient with these challenges.”

The post Popit and Almirall’s new app tracks adherence to psoriasis med appeared first on .

2020 might go down as the year digital health truly began to boom – but to continue thriving, health tech start-ups will need a strong support network and an environment that fosters innovation.

With advanced tech becoming ubiquitous, healthcare stakeholders finally embracing digital, and patients rapidly shifting their preferences, there has arguably never been a better time to be a digital health start-up.

Dr Kath Mackay, managing director of Bruntwood SciTech’s Alderley Park – the UK’s largest single-site life science campus – says there are many positive signs for the sector.

“There’s a lot of investment in life science and digital health. Private and public stakeholders are keen to fund these companies, and many firms are growing. People are embracing digital technologies like never before, and awareness has never been so high.”

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Digital health innovation conference Frontiers Health kicks off its 2020 edition this week, although the majority of the conference will be held online because of the COVID-19 pandemic.

This year, Frontiers will be a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition will be hybrid, combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, the USA and more.

It will be dedicated to digital health innovation in the context of the “new normal”, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation and ecosystem development.

This year’s programme will start at 2.00pm CET on both days with plenary sessions (talks and panels) and parallel break-out sessions (masterclass, workshop, deep-dive formats) in the unique Frontiers style.

The iconic Start-up Discovery sessions have also moved online opening more opportunities to connect with both earlier stage and more established digital health start-ups.

Highlights of day one include a welcome performance by musician Korinami, with visuals by designer Joe Ferrari.

Healthware Group CEO Roberto Ascione will open the conference with Frontiers Conferences CEO Matteo Penzo.

This will be followed by a keynote speech on digital health during Germany’s EU Council Presidency by Dr Gottfried Ludewig, director general digitalisation and innovation at the Federal Ministry of Health, Germany.

 

View the live coverage from day one at Frontiers Health 2020 from 14:00pm CET on 12 November below and we will also have live coverage from day two from 13 November (The live blog may take a moment to load.)

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In the first episode of our Health Innovators series, Paul Tunnah speaks to David Van Sickle, CEO of Propeller Health about how digital technologies are revolutionising the field of respiratory medicine.

The post Health Innovators: David Van Sickle on digital innovation in respiratory medicine appeared first on .

Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment.

With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare.

“We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation, Intouch Group, tells pharmaphorum. “We can put AI use cases in three buckets – healthcare and hospital systems, pharmaceutical companies and patient and caregivers.”

For healthcare systems, AI implementation will bring faster, more efficient diagnosis for medical imaging. Other promising benefits include administrative automation and population health risk analysis. AI technology may also aid in health crisis prediction and augmented reality, with AI implemented for medical education and surgical assistance.

For pharmaceutical companies, artificial intelligence can help spur drug discovery through finding complex relationships within genomics data. “Patients and caregivers will also benefit from real-time health monitoring, adherence support and patient self-service through intelligent bots,” says Rahman. “AI can play an important role to help support physicians though automation, predictive analytics and recommendation. In the US especially, doctors spend much of their time doing administrative tasks that can be automated to save time and reduce errors.

“We are already seeing pilots for treatment and diagnosis recommendations and automatic note taking through speech-to-text within EHR systems. AI based diagnostic image analysis is showing a lot of promise. In some cases, they are shown to be accurate and can find minute anomalies in images better than humans. These types of implementations will save time for the physicians and allow them to spend more quality time with the patients.”

Key challenges

Rahman says the primary challenges for artificial intelligence implementation occur in three key areas. The first is around data and technology. “Lack of interoperability across various healthcare systems is still an issue,” he explains. “It’s not always possible to access the data sources in an automated way. There is also legitimate concern with having the relevant opt-ins and waivers to ensure data is accessed and managed in a compliant manner. The quality of data can also be a concern.”

Bias in the data and lack of transparency can also show up during the AI training and deployment processes. “It is important to be careful about all the different ways bias in artificial intelligence can impact the outcome of the implementation. It is also important to show the reasons behind AI recommendations so that the physicians and patients can have a complete and transparent view.”

Organisational changes are also required as AI implementation often requires retraining and can change certain aspects of a job. “Change of any kind can generate some resistance. It is important to appropriately plan an AI implementation. Proper AI implementation requires people with the appropriate cross-domain knowledge. Cooperation across multiple teams is vital and not always easy to achieve.”

But as COVID-19 pushes every industry to use technology to solve challenges, pharmaceutical companies are being forced to change how they communicate with healthcare professionals and patients. New strategies around drug launches, use of telehealth, virtual patient events and virtual HCP conferences are all in place due to COVID-19 and Rahman believes the trend will continue.

“Pharma now more than ever before is ready to use AI to provide engagement, efficiency and customer support. The pandemic has also helped generate massive amounts of data from online events, blogs, forums etc,” he says.

“We are implementing AI based self-service and personalised solutions for both HCPs and patients. We have also seen computer vision-based AI technology become more popular to engage users. We are working on providing virtual bots within conferences so that HCPs can get the right information at their fingertips.”

About the author

Abid Rahman is the vice president of innovation, Intouch Group. He will be leading a virtual masterclass on Artificial Intelligence implementation at Frontiers Health on 12th November. The session will help educate on the benefits of using and implementing effective, reliable AI systems to tackle and solve healthcare challenges.

Abid has over 18 years of experience in software engineering and 15+ years in pharmaceutical marketing and technology. As an innovation leader, Abid’s primary role involves making technology relevant in healthcare by designing and collaborating on solutions for patients, caregivers and healthcare providers. His technology expertise is in architecture and design of enterprise solutions with emphasis on artificial intelligence.

 

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When Chris Cooper of EPG Health launched his ‘European Prescriber Guide’ software twenty years ago, he was among a select few taking digital in pharma seriously. Since then he has seen the industry slowly come to embrace every aspect of digital. He tells pharmaphorum how pharma can learn from the past to enter an innovative future.

“I always knew pharma was notoriously slow to adopt change,” Cooper says when asked about the unexpected digital changes he has seen in the industry over his career, “but I never thought 20 years ago that change would take this long in digital!”

Luckily, he says, the industry has now got to a stage where it is starting to think beyond just clicks and impressions and is treating doctors as consumers of valuable and relevant information – and there has been no better time for pharma to harness this to make their content more impactful than ever.

This is a path Cooper has been on for some time, though, and he was somewhat ahead of the curve when, in 2000, he founded the European Prescriber Guide, which aimed to give up-to-date prescribing information to HCPs via a software application.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Drug discovery firm Exscientia has beefed up its leadership team with the appointment of former AstraZeneca scientist Dr Garry Pairaudeau as its chief technology officer.

Pairaudeau – who will report directly to Exscientia chief executive Prof Andrew Hopkins – has been at AZ for 25 years, most recently as head of hit discovery with a brief covering high-throughput screening and virtual screening, computational chemistry, machine learning, and DNA-encoded libraries.

He also served as chair of AZ’s Global Chemistry Leaders Network, with responsibility for implementing strategic initiatives and collaborations, and championed developments in artificial intelligence (AI), machine learning,  physics-based computation and automation.

Pairaudeau joins Exscientia at a fertile time for the UK biotech, which specialises in applying artificial intelligence to the drug discovery process and reckons its approach can carve up to 75% off the time it takes to find preclinical candidates.

The company hit the headlines earlier this year when it started clinical trials of the first drug molecule invented entirely using AI – a potential treatment for obsessive-compulsive disorder (OCD) partnered with Sumitomo Dainippon Pharma.

It then built on that success with a $60 million third-round financing in May – led by Novo Holdings – which is being used to build out its drug pipeline.

At Exscientia, Pairaudeau will be responsible for making sure Exscientia becomes “the most efficient drug discovery organisation in the world.”

Among his past achievements was the Malcolm Campbell award from the Royal Society of Chemistry (RSC), which he shared with other scientists for the discovery of Brilinta (ticagrelor), AZ’s blockbuster antiplatelet medication which is used with aspirin to lower a patient’s chance of having another heart attack, stroke or blood clot.

“Garry has forged a long-standing impressive career that has combined real-life drug hunting with cutting edge computational and AI techniques as well as robotics”, said Hopkins.

He added that the new CTO “has the rarest of talents of both a deep understanding of the problems of drug discovery and a drive to lead the development of new AI and automation approaches to solve those problems.”

Interest in using AI and machine learning to boost efficiency of drug discovery and development has been rising as the biopharma industry is facing declining returns on investment, and desperately needs more efficient R&D methods to boost productivity.

The global market for AI in healthcare was worth $2.1 billion in 2018, with exponential growth to $36 billion predicted by 2025, at a combined annual growth rate of 50.2%, according to a recent report by finnCap.

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Digital therapeutics are gaining momentum worldwide and offer developers, including pharma, both a huge opportunity and a stimulating market access challenge, say Olaf Schoeman and Emanuele Arcà.

The last 12 months have shone a spotlight on digital transformation in Europe’s healthcare systems, with all the signs pointing to digital therapeutics (DTx) moving ever more into the healthcare mainstream.

Germany is spearheading these advances, particularly with its 2019 changes on national digital health reimbursement. The country will provide further momentum during its presidency of the Council of the European Union (EU), which runs from July until December 2020 and will see it work closely with the succeeding presidencies of Portugal and Slovenia. The countries have agreed a ‘trio programme’ to identify issues that would benefit from a fluid transition from one EU member state’s presidency to the next to form an 18-month agenda, with progress in digital health one of the highlights of their plans.

While we would not expect digital therapeutics to replace pharmaceuticals themselves, they could bring huge complementary benefits to patients and prescribers and, in doing so, could bring pharmaceutical companies perhaps as much value as the medicines they traditionally produce.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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DigitalHealth.London has announced the latest 20 small and medium sized businesses selected for its digital accelerator programme.

The programme selects digital solutions or services with the highest potential to meet the city’s health and social care challenges.

This the fifth year the event has been running and the NHS delivered programme will see funding matched by the European Regional Development Fund.

This year’s digital projects include patient self-management tools, femtech, digitised NHS process, artificial intelligence (AI) and machine learning.

Organisers said this year’s entrants have the highest potential to meet London’s NHS and social care challenges.

A collaborative programme delivered by MedCity and London’s three Academic Health Science Networks – UCL Partners, Imperial College Health Partners and the Health Innovation Network.

The selected projects include ART Healthcare Software, which has developed software enabling efficient processing of patient referrals.

VUI Diagnostics has developed a plug and play retinal screening device and companion software for simple, affordable and accurate retinal screening.

Concentric Health has been selected with its consent app with remote functionality and Bleepa, which has a medical imaging tool enabling clinicians to view and discuss cases with the touch of a button.

Another selection is Peppy Health, an app providing support through life’s transitions, such as becoming a parent, going through the menopause, or going through a fertility journey.

Odin Vision and its AI-enabled applications for endoscopy is another successful entrant along with Phlo Digital Pharmacy, a rapid on-demand same-day pharmacy delivery service.

The accelerator team will work with the selected projects over the next year, giving bespoke support and advice.

They will also get to attend workshops and events allowing them to network with NHS organisations.

Tara Donnelly, chief digital officer at NHSX, said: “The DigitalHealth.London Accelerator is part of a digital revolution in the NHS that continues rapidly to develop, and we will continue to support innovative organisations delivering ground-breaking work.

“This programme has established itself as an important player in supporting the NHS and social care to make the most of the opportunities digital healthtech offers.”

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It’s time for pharma to take a 360-degree view of its clinical trial data and step into the future with near real-time trial management.

The pharmaceutical industry faces an important inflection point in its approach to clinical trials and it’s one that COVID-19 has thrown into even sharper relief.

The last great change for studies was the advent in the early 2000s of electronic data capture (EDC). At the time there was a significant amount of resistance to EDC, but now it’s rare to hear about the collection of trial results using paper in all but the occasional single site investigator study.

Now, the major advance that’s available to pharmaceutical companies is in the amount and range of data they have access to and how it can be applied to the risk-based monitoring and remote monitoring of studies.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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There isn’t enough evidence to suggest that digital therapies for people with opioid use disorder (OUD) can improve on standard interventions, according to the Institute for Clinical and Economic Review.

The US cost-effectiveness watchdog has concluded in an evidence report that none of three digital therapies under scrutiny – apps from Pear Therapeutics, Chess Health and DynamiCare Health – have data from a randomised clinical trial showing they can enhance long-term abstinence or retention rates.

Of the three, ICER was able to develop a cost-effectiveness model only for Pear’s reSET-O digital app, which was approved by the FDA two years ago and consists of a 12-week programme.

Chess’ Connections app and DynamiCare’s eponymous software – providing a seven-session programme and 36 classroom-based modules respectively – didn’t have enough clinical evidence available  for that to take place, it said.

However, for all three the data “has substantial limitations and can provide no firm estimate of net health benefit for patients with [OUD] versus usual care.”

ICER’s main criticism is that there’s very little data on retention in the digital therapeutic programmes – reducing the very high drop-out rates seen among patients in recovery programmes for opioid use – in the critical six-month to two-year timeframe.

That duration of retention is associated with “the outcomes that really matter to patients: employment, reduced financial stress, decreased hospitalisations and emergency room visits, and improved relationship,” according to the organisation.

The digital apps are generally based on cognitive behavioural therapy (CBT) and are intended to be used alongside standard treatment for OUD – including pharmacological therapy with drugs like buprenorphine – to reduce opioid use.

Features include keeping patients in contact with healthcare providers, encouraging appointment attendance, and providing small rewards for compliance with the programme.

“While these new digital therapeutics incorporate cognitive and behavioural interventions that may provide benefits to patients, there are no randomised trials demonstrating that patients benefit from any of these specific apps compared to medication assisted treatment alone,” according to ICER.

It said that there are  two uncontrolled studies suggesting possible benefits with reSET-O, but in both cases there was a high risk of bias.

“The impact of these interventions is modest at best and remains controversial, according to the report, although it notes use of the apps is unlikely to be harmful to patients and there may be “incremental benefits.”

There were 70,000 drug overdose-related deaths in the US in a 12-month period to mid-2017, 50,000 of which were due to opioids, and levels are thought to be on the rise in the last couple of years.

While medication assisted treatment (MAT) is the most effective intervention, more than half of all patients drop out within three to six months, says the ICER report. CBT has been shown to improve retention rates in some studies, but is resource-intensive, and digital therapies aim to provide the same benefits at reduced cost.

The report doesn’t cover a new OUD digital therapeutic – Orexo’s Modia – which is due to be launched later this year in the US under emergency legislation that has made it possible to secure reimbursement for certain digital products for psychiatric disorders during the COVID-19 pandemic.

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Ahead of Frontiers Health 2020, steering committee members Roberto Ascione and Paul Tunnah from Healthware give us their thoughts on the trends driving the bright future of digital health.

It might be easy to think of pharma and healthcare as conservative industries, but the reality is that digital health is now far further along than we predicted it would have been 10 years ago – or even one year ago.

Much of this is, of course, down to COVID-19 – but it’s clear that digital health was already on the up and up long before the pandemic hit.

When the industry first started talking about digital health, we were really talking about ‘beyond the pill’ strategies, which mostly included things like apps to boost adherence and patient support programmes.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Eli Lilly’s chief information and digital officer (CIDO) Aarti Shah is leaving the company next year after 27 years at the company.

Shah is retiring from a role that only became part of the drugmaker’s executive committee in 2017, reflecting the relatively late acknowledgement of the strategic value of information technology in the pharma industry. A search is now underway for her successor.

She has been CIDO at Lilly since 2016, charged with leading the “digital transformation” of the company and merging a diverse portfolio spanning IT, information security, digital health, and data analytics.

Shah’s appointment came at the beginning of a proliferation of senior pharma data specialists becoming elevated to the C-suite, and being able to influence company-wide strategy and make IT more central to corporate decision-making.

Even now, having a CIDO or chief digital officer on the board isn’t ubiquitous among big pharma companies, despite the encroachment of big tech firms like Amazon, Google and Apple into the healthcare space.

Lilly is one of a select but growing group of pharma companies – along with Pfizer, Bayer, GlaxoSmithKline, Novartis, Merck & Co, Sanofi and others – who have made CIDO/CDO appointments in the last few years.

Companies are looking to thread digital capabilities throughout their operations, from drug discovery to production and delivery to patients, in order to boost productivity and make processes more efficient.

At the same time, the industry is looking to develop digital medicines that improve patient outcomes.

Shah has been at Lilly since 1994, joining the company as a senior statistician, rising to become vice president for biometrics in 2009. That was followed by a stint in 2013 as global brand development leader in Lilly’s biomedicines business unit – leading up to the approval of Taltz (ixekizumab) for psoriasis – before making the step up to CIDO three years later.

“Aarti has been an invaluable member of our executive committee,” said Lilly’s chairman and CEO David Ricks.

“Her deep experience in drug development enabled her to connect our information technology organisation to all aspects of our business from drug discovery and development, to manufacturing, to our commercial capabilities,” he added.

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Talking Medicines has raised £1.1 million ($1.4 million) in funding that will be used to develop an artificial intelligence (AI) data platform that can be used by pharma companies to gain insights into how patients perceive them.

The Glasgow-based company – which is behind the MedSmart app that helps patients keep a digital records of their medicines and symptoms using barcodes – says it will use the cash injection to launch a new AI data platform which will “translate what patients are saying into actionable pharma grade intelligence.”

The platform could serve as an alternative to traditional patient focus groups, prescriber reports and clinical target patient profiles, and help drugmakers find out who is using their medicines, how they are finding the experience, and what they really think of brands.

The platform will mine information from social media and connected devices to regulated medicine information to capture and analyse the conversations and behaviours of medicine users and get a picture of “patient sentiment.”

The fundraising has been backed by Internet of Things (IoT) investment specialist Tern plc, along with The Scottish Investment Bank, Scottish Enterprise’s investment arm. To date Talking Medicines has raised £2.5 million, including £600,000 in grant funding from Scottish Enterprise last year.

Chief executive Jo Halliday (pictured centre) said the money would allow the company to hire an additional nine staff in its natural language processing (NLP) data tech team, which researches how machines can be made to understand human language accurately.

“Now more than ever we passionately believe that big pharma needs a systematic way to make data driven decisions through accessing high grade social intelligence driven from the patient,” said Halliday.

“This investment will scale our team and the development of…tools to translate what patients are saying into actionable pharma grade intelligence through our global patient confidence score by medicine.”

Tern chief executive Al Sisto is joining the board of the data specialist, and said Talking Medicines’ platform “is solving a critical problem for an industry that spends around $30 billion on marketing annually, whilst lacking systematic data tools that can structure patient sentiment from social channels.”

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An implantable neurostimulation migraine device from Salvia BioElectronics has gained Breakthrough Device Designation from the FDA.

Traditional neurostimulation systems are not designed to be compatible with the anatomy of the head, so Netherlands-based Salvia has developed flexible bioelectronic foils (pictured) that could be inserted below the skin in a minimally invasive procedure.

Breakthrough Device designation is reserved for potential products that could offer an improvement over existing therapies for a serious disease, in terms of safety and efficacy.

The designation allows Salvia to have more frequent interactions with FDA regulators when preparing filings, with the possibility of a faster review of trial data.

The decision from the FDA follows Salvia’s 26 million euro ($30 million) fundraiser in September to fund further development of the therapy.

Migraine is the first cause of disability in under 50s, affecting one out of seven people, predominantly women.

People with migraine experience episodes of throbbing, pulsating pain, sometimes accompanied by nausea, vomiting, and sensitivity to light, that can last anywhere from a few hours to a few days.

More than 5% of patients suffer from chronic migraine, where they experience migraines for an average of 22 days per month.

The Series A investment round was led by Panakès Partners, INKEF Capital and SHS Gesellschaft für Beteiligungsmanagement with participation from BOM Brabant Ventures, Thuja Capital and Dolby Family Ventures.

The total raised includes a 5m ($5.78 million) euro deferred risk-bearing Innovation Credit from the Netherlands Enterprise Agency (RVO, part of the Dutch ministry of Economic Affairs and Climate Policy).

A group of drugs known as calcitonin gene-related peptide (CGRP) inhibitors have recently been approved to prevent or reduce attacks.

However there has been limited progress to find new treatments for migraines for patients with chronic disease.

The most common treatments are antidepressants, beta blockers, anti-seizure medications, painkillers and even botulinum toxin.

 

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It could be possible to detect whether someone has COVID-19 or not, just from the sound of their coughing.

That’s the conclusion of testing of an artificial intelligence (AI) algorithm developed by the Massachusetts Institute of Technology (MIT), which was able to detect around 98% of cases of COVID-19 from a forced cough delivered down a cell phone – confirmed by coronavirus testing.

Almost unbelievably, the neural network was also 100% effective in correctly diagnosing COVID-19 in people with no symptoms but who had tested positive for the virus, according to the MIT researchers, although the trade-off was a false positive rate of around 17% in this group.

The MIT Open Voice algorithm was put through its paces in more than 5,300 patients, finding a 97.1% accuracy rate overall, with 98.5% sensitivity and 94.2% specificity.

The finding ties in with anecdotal reports that COVID-19 causes a very distinctive sounding cough, although it will have to be thoroughly tested in additional studies to see if it could be useful as a screening tool.

If its value is confirmed however, it could provide a way to reduce the logistical burden and expense on healthcare systems around the world of providing coronavirus testing, according to the scientists, who have published the work in the IEEE Open Journal of Engineering in Medicine and Biology.

“The effective implementation of this group diagnostic tool could diminish the spread of the pandemic if everyone uses it before going to a classroom, a factory, or a restaurant,” says co-author Brian Subirana, a research scientist in MIT’s Auto-ID Laboratory.

The tool was built up from databases of sounds generated by human vocal cords, starting with simple words and sounds, then adding in variations for different emotional states and neurological conditions like Alzheimer’s.

The final stage was to develop a database of cough sounds that could pick up changes in lung and respiratory performance. All the components were then layered together alongside an algorithm to detect muscular degradation by distinguishing strong coughs from weaker ones.

The tool was originally designed to diagnose early-stage Alzheimer’s, but Subirana and colleagues decided to see if it could be repurposed for COVID-19 as the pandemic started to gather pace earlier this year.

“The sounds of talking and coughing are both influenced by the vocal cords and surrounding organs. This means that when you talk, part of your talking is like coughing, and vice versa,” according to Subirana.

“It also means that things we easily derive from fluent speech, AI can pick up simply from coughs, including things like the person’s gender, mother tongue, or even emotional state.”

In future, the tool could be refined to different age groups and regions of the world to improve accuracy even further, according to the research team.

So far, the researchers have collected more than 70,000 cough recordings, including around 2,500 submitted by people confirmed to have COVID-19.

They are working with an undisclosed company to develop a free pre-screening app based on their AI model, and have agreements with hospitals around the world to collect further cough recordings, to train and strengthen the AI model’s accuracy.

Other groups at Cambridge University, Carnegie Mellon University and UK health start-up Novoic have been working on similar projects, according to a BBC report, although some of these are reported to be having teething troubles.

Image by mohamed Hassan from Pixabay

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More competition than ever before

The pharmaceutical industry has long relied on congresses to build relationships with customers and to showcase the latest data and information on new additions to the pipeline. However, COVID-19 has changed the congress experience significantly. Social distancing and travel restrictions have forced congress organizers to make a tough decision between canceling events or re-formatting for a remote audience.

As hard as congress organizers try, replicating the congress experience on a virtual platform is difficult. Rather than trying to replicate the in-person congress experience, the industry has a real opportunity to innovate, leverage the benefits of digital channels, and approach congresses in a completely different way.

More competition than ever before

Virtual congresses are different from physical congresses and bring with them a new set of challenges. Firstly, delegate behavior differs. When a healthcare professional attends a physical congress, they commit the entire day to the event. At a virtual congress, they can log on or off at a time that suits them, and they can become distracted by work or by their home life. So, you are competing with more than just your competitors for attendees’ time.

During the ASCO 2020 Annual Meeting, just 16% of respondents visited virtual booths or exhibits from pharmaceutical companies. Among those who did visit, more than half spent significantly less time visiting the stands than when attending an in-person congress. With no congress hall to walk around the delegates may not have felt inspired to visit the exhibits.

We have more patience in the physical world. Slow loading times, poor user experience, content that is too personalized and perceived as invasive, poorly written content, and content that is not personalized enough, all leads users to click away from a website without a second thought.

These challenges change the essence of the congress experience. However, virtual congresses also provide new ways of engaging customers and develop a captive digital audience. So, how can pharmaceutical companies create an impactful virtual congress experience?

Download the rest of the article here

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The pharmaceutical industry has sometimes been a laggard in terms of digital maturity, but the COVID-19 crisis has provided companies the impetus to rapidly implement the most cutting-edge technologies. At the heart of most of these digital advancements is AI and machine learning.

With a collective sense of uncertainty, many are pinning their hopes on a vaccine and treatment, and sophisticated technology could help speed up the process of finding an effective medicine.

In January, Google DeepMind debuted AlphaFold, a deep-learning system that predicts the structure of several under-studied proteins, including those associated with COVID-19. Predicting protein structures would typically be a time-consuming process, but now scientists can use technology to better analyse viruses, thus helping in the search for a vaccine that can trigger an immune response.

Scientists are using AI to sift through existing literature on a disease and study its disease’s structure. This knowledge is critical in understanding how effective certain drugs might be in treating the virus. It has helped determine the availability of current drugs on the market that could be repurposed to treat COVID-19.

AI is also being used to track the spread of diseases and detect anomalies. Canadian artificial intelligence platform BlueDot was able to detect a cluster of unusual pneumonia cases in Wuhan before the world even knew about COVID-19. In countries like China, AI is integrated with track and trace mobile apps to aggregate and analyse data on the spread of the virus.

Company transformations

COVID-19 may have led to an uptick in companies using AI to clear the path for breakthroughs, but firms have already been adopting these sophisticated technologies across all areas of healthcare.

A recent study by Kearney revealed that 68% of global industry leaders in the healthcare sector see AI and advanced analytics as major value drivers, indicating most companies are aware of their combined potential.

One example is Novartis. With the combined efforts of CDO Bertrand Bodson, head of drug development John Tsai and key members of the team like Bruno Villetelle, the drug manufacturer has amassed a database of a decade’s worth of clinical trials, forming the core of an AI-powered central command centre. Scientists and technicians at Novartis have been able to analyse all its global clinical trials to predict trial schedules and quality outcomes across the organisation.

The company has also employed AI to facilitate its drug development process, compiling 20 years of data from 2 million patients and using this information to design pioneering new drugs.

Critically, they are not doing it alone but reaching out into the tech ecosystem through their innovation centre in Silicon Valley, which partners with AI and machine learning start-ups in biopharma. The case of Novartis demonstrates how important it is for companies to adapt their working methods and invest shrewdly to successfully implement an AI transformation.

Similarly, the medical device company Medtronic has created alliances with both tech giants and promising start-ups to develop innovative AI-supported products. The medtech giant recently acquired technology from Nutrino, a nutrition insights platform with a predictive glycemic response algorithm. They have partnered with IBM Watson to create a glucose monitoring tool that predicts whether a patient with diabetes will have low glucose within a one-to four-hour period.

Disease management tools are likely to witness a proliferation of valuable applications in the aftermath of the coronavirus pandemic as the long-term impacts of the virus are still poorly understood.

Another negative side effect of the pandemic has been a wholesale delay and sometimes suspension of treatment for people with chronic conditions. This will create a backlog requiring urgent attention as the pandemic recedes. AI tools will be critical to managing this backlog effectively, and companies will likely need to implement these technologies to rejuvenate their business methods.

The barriers to adoption

AI is incredibly useful but has limitations. These drawbacks have caused resistance to its adoption by some companies and healthcare providers. First and foremost, data is not infallible and bias within data sets can lead to biases being inherently built into algorithms.

Privacy and cybersecurity risks are also at the forefront of chief data officers’ minds, as well as the significant infrastructure investment required to integrate data sets and create data lakes that the organisation can tap into for research and commercial insights.

Despite these concerns, artificial intelligence might be the productivity multiplier that the pharmaceutical company needs more than ever right now.

What’s on the horizon?

There are exciting developments happening for AI in healthcare – from drug discovery to diagnostics and care delivery. As well as ongoing patient monitoring.

In areas like pain management, we are now on the brink of being able to blend artificial intelligence and virtual reality to create simulations that cocoon patients from their pain or the pangs of withdrawal. This might help with the dependence that many patients experience on powerful painkillers.

Companies like Helpsy are also developing chatbots to help with patient care. These chatbots can nurse and triage patients. In the future we could see virtual nursing assistants become commonplace to support care.

We are also likely to see surgeries conducted with robotic assistance. AI-assisted robotics can analyse previous surgical data to guide the surgeon’s hands. Research found an AI-assisted robotic technique created by Mazor Robotics demonstrated a five-fold decrease in surgical complications compared with surgeons operating unaided.

The pharmaceutical industry has been scrutinised in recent years over R&D productivity, pricing and obsolete engagement models, and AI and machine learning could be the game changing technology that transforms the sector.

With COVID-19 dominating people’s concerns, more sophisticated tech could lead us towards a vaccine or cure. What is more, with delays for other illnesses being neglected, the industry will have to be capable at dealing with a backlog of patients. AI might just be the key to achieving a successful resolution.

About the author

Paula Bellostas Muguerza is a principal at Kearney.

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The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”

The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.

The company is a subsidiary of US group GenPact, which already offers an AI and machine learning based tool called Cora PharmacoVigilance that can be used to identify patterns in data to foresee potential side effects.

The contract from the Medicines and Healthcare products Regulatory Agency (MHRA) recognises that the timelines for the development of coronavirus vaccines has been accelerated so fast that a complete picture of their safety may not be available when they start to be used in widespread immunisation campaigns.

Former UK Prime Minister Tony Blair said this morning that the AstraZeneca/Oxford University adenovirus-based vaccine AZD1222 should be rolled as soon as possible – ideally in the month of November – as “it is essentially safe.”

He also called for experimental drugs being tested in the UK RECOVERY trial to be used in any hospitalised patients at risk of serious illness from COVID-19, in a foreword to a report on the pandemic published by the Tony Blair Institute for Global Change.

The MHRA told the Financial Times that based on historical vaccination data, it is expecting between 50,000 and 100,000 ADR reports for every 100 million doses delivered to patients over a six to 12 month period

The regulator also stressed that an ADR does not necessarily mean a true side effect has been observed, and AI would help spot any emerging safety signals.

The coronavirus vaccination programme would be larger than any adult campaign carried out to date, and the MHRA is concerned it could be derailed by “anti-vaccine social media activity and lobbying.”

The GenPact UK contract bypasses the usual “call for competition” tender process required by EU regulations, according to the MHRA, because if “reasons of extreme urgency”, and because it would not be feasible to “retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine.”

The agency also says in the contract announcement that its proposed SafetyConnect programme,  for pharmacovigilance and medical device safety monitoring would not be ready by the expected coronavirus vaccine launch.

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Most of the digital health experts we spoke to for this issue of Deep Dive made one thing clear – no one can really say what the future holds for digital tech in the pharma and healthcare industries.

But this isn’t necessarily a bad thing – our interviewees also stressed that if companies can remain adaptable and innovative, there are myriad opportunities to thrive during and after COVID-19. In this issue we hone in on some of the tech that is set to change healthcare forever – including VR, AI and digital therapeutics – and look at how pharma can best harness themWe also examine how the pandemic is affecting digital sales, patient support programmes and HCP consultations, and speak to some exciting digital start-ups that are bringing new ways of managing health into systems like the NHS.

The key elements driving the success of digital health
Ahead of Frontiers Health 2020, steering committee members Roberto Ascione and Paul Tunnah from Healthware give us their thoughts on the trends driving the bright future of digital health

A “pivotal moment” for digital health adoption
Former chief digital officer for the NHS, Juliet Bauer, is now applying her experience to the private sector through video consultation firm Livi. She shares her thoughts on how well the NHS is integrating digital health and what the public and private sectors can do to further boost adoption

What will the digital health ecosystem look like post-COVID?
Digital health had already been building a presence before the pandemic, but the tools it offers have been essential to counter the disruption caused by the coronavirus, reports Richard Staines

Germany’s digital health changes will boost digital therapeutics in Europe
Digital therapeutics are gaining momentum worldwide and offer developers, including pharma, both a huge opportunity and a stimulating market access challenge, say Olaf Schoeman and Emanuele Arcà

Digital therapeutics: Why human psychology is key to adoption
How can we boost low adherence rates for digital therapeutics? The psychology of the ‘therapeutic alliance’ might help

Navigating the NHS as a digital start-up
We speak to finalists from the Greater Manchester Future of Health accelerator to find out how digital start-ups can overcome the challenges small companies face in bringing their technologies into the NHS

Building the infrastructure for successful digital health start-ups
2020 might go down as the year digital health truly begun to boom – but to continue thriving, health tech start-ups will need a strong support network and an environment that fosters innovation.

Two decades of digital: the changing habits of pharma and HCPs
When Chris Cooper launched his ‘European Prescriber Guide’ software twenty years ago, he was among a select few taking digital in pharma seriously. He tells pharmaphorum how pharma can learn from the past to enter an innovative future

Thriving in COVID-19 with flexible marketing strategies
Pharma sales is set to change forever. To keep afloat in the current climate, teams need to embrace flexibility and remember that traditional content won’t work in new contexts, say experts from Syneos Health

VR, COVID and ensuring safety with cutting-edge tech
Not too long ago virtual reality (VR) tech might have seemed like a dream, but now it’s being harnessed by the healthcare industry for a wide variety of purposes

3 innovations booming during COVID and how to adopt them successfully
Research Partnership’s Vicki Newlove explores research into digital change during COVID-19 to find out what business questions pharma needs to address to succeed with innovations.

A new dawn for clinical trial management
It’s time for pharma to take a 360-degree view of its clinical trial data and step into the future with near real-time study management.

 

• Read the latest issue Deep Dive: Digital Health Innovation 2020 in full

pharmaphorum’s digital magazine Deep Dive provides objective, issue-driven views, analysis, high-level interviews and unique research for pharmaceutical companies, biotech firms and the wider healthcare sector.

In 2020 Deep Dive will have special focuses on disruptive technologies in pharma, R&D innovation, market access and commercialisation, oncology, sales & marketing innovation, digital health and patient engagement. Subscribe to future issues of Deep Dive.

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Takeda has partnered with patient data firm Seqster in a drive to improve care through better access and understanding of patient-level data.

The partnership follows Takeda’s investment in the US startup earlier this year. The pharma firm said it wants to leverage the company’s technology across its business

San Diego-based Seqster has developed a portal that gathers together a patient’s data – such as electronic health records (EHR), genetic information, fitness results from wearables etc – and keeps it in a secure format that gives control over its collection, ownership and sharing.

Takeda hopes Seqster can help expand its external data and digital collaboration ecosystem, with better access to real-world evidence, and generate powerful data and insights for research and patient services. 

The company says it wants to activate 12 distinct use cases across our business “in a matter of weeks”.

One use of Seqster’s decision support system and research platform is to reduce the time for consenting and onboarding patient data during clinical trials. The aim is to enhance patient engagement and compliance through a single-entry point for EHRs and integrates with partners enterprise data backbones.    

At the time of Takeda’s investment in Seqster, Bruce Meadows, head of investments at Takeda Digital Ventures, said it was “a cornerstone of our digital health strategy,” and that the key element is “interoperability” for health data sharing.

Seqster’s platform “addresses interoperability on not only a nationwide scale but also globally,” according to Meadows, who notes that interoperability “is one of the biggest barriers to applying precision medicine to clinical trials and patient engagement.”

It is also a key objective for the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) in the US.

The two agencies have a pair of proposed rules on interoperability and patient access to health information under review at the Office of Management and Budget (OMB) that could come into effect later this year.

A key part of those proposals is to allow patients easy, electronic access to their personal health information at no cost.

The Seqster Research Portal (SRP) can be used to speed up recruitment into clinical trials, as well as the consent process, and can work with a broad range of study types including patient registries used to generate real-world evidence, says its developer.

“Seqster provides clinical trial participants a secure platform to consent and share their data with investigators and study personnel in real-time,” according to the company’s chief executive Ardy Arianpour.

In turn, that creates “a longitudinal health record that facilitates patient clinical trial onboarding, monitoring and post-trial follow-ups,” he adds.

Seqster says the SRP platform currently connects users to more than 3,000 healthcare providers and over 100,000 hospitals and clinics across the US.

Listen to our podcast interview with Ardy Arianpour here.

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insitro has landed another big biopharma partnership, signing a five-year collaboration with Bristol Myers Sqibb to develop therapies for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). 

Neurodegenerative disorders such as ALS and FTD are considered a challenging therapeutic area, with no disease modifying treatments available today.

insitro uses machine-learning technology to discover novel drug targets and patient segments. Since its inception in 2018, the company has brought on several high-profile partners and investors.

Last year, the company signed its first major multi-million dollar research collaboration with Gilead Sciences to target liver disease, nonalcoholic steatohepatitis (NASH). insitro scored $15 million through the deal and could receive a further $1 billion.

Under the terms of the agreement with BMS, insitro will get $50 million in cash upfront but could be eligible for up to $2 billion if other milestones are reached.  insitro’s platform, the insitro Human (ISH) platform, will be used to create induced pluripotent stem cell (iPSC) derived disease models in ALS and FTD.

The platform applies machine learning, human genetics, and functional genomics to generate predictive in vitro models that provide insights into disease progression. BMS will have the option to select targets identified by insitro and then lead clinical development. BMS said it will be responsible for regulatory submissions and commercialisation activities.

“We believe that machine learning and data generated by novel experimental platforms offer the opportunity to rethink how we discover and design novel medicines,” said Richard Hargreaves, senior vice president, head of neuroscience TRC research and early development at BMS.

Insitro recently boosted its machine-learning portfolio, with the acquisition of rival company Haystack Sciences. The private, San-Francisco based company focuses on DNA sequencing technology. It synthesises, breeds and analyses large combinatorial chemicals that are encoded by DNA sequences called DNA-encoded libraries, or DEL’s. Financial terms of the deal were not disclosed.

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Gamified digital therapeutics firm Sidekick Health has raised $20 million in a Series A funding round, which it plans to use to develop its product offering.

Based in Iceland, Sidekick said the oversubscribed funding round was led by Wellington Partners and Asabys Partners through its SAHII fund, with existing investors Novator and Frumtak Ventures.

The funding will be used to grow operations in Europe and the US, Sidekick said in a statement.

Sidekick specialises in developing gamified digital therapeutic solutions and programs aimed at managing chronic diseases, as well as encouraging users to proactively stave off onset with healthier lifestyles.

Therapeutic areas range from diabetes to ulcerative colitis and smoking cessation.

Proceeds help validate products and expand the company’s reach into new therapeutic areas and further its efforts in patient engagement and retention.

Dr Regina Hodits, managing partner at Wellington, and Josep Sanfeliu, partner and co-founder of Asabys will join Sidekick’s board following the fundraiser.

Fundraising efforts were supported by the EIT Digital Accelerator and it went on to be selected by EIT Digital as one of Europe’s ten best deep technology scale-ups.

EIT Digital is an innovation and entrepreneurial organisation that has supported start-up and scale-up companies, which have collectively raised 900 million euros.

Sidekick was founded by two medical doctors – Dr Tryggvi Thorgeirsson and Dr Saemundur Oddsson – who had worked for years treating tens of thousands of patients with lifestyle-related illnesses.

The company combines an evidence-based clinical approach with behavioural economics and gamification and is already working with big pharma clients including Pfizer.

This year’s COVID-19 pandemic has seen an increase in investment in digital health technology.

A quarterly report on the sector from Rock Health showed digital health-focused venture capital firms reported $4 billion in US-based digital startup investments during Q3 alone.

This brings the fundraising total to $9.4 billion for the first nine months of the year, already well ahead of the previous annual record set in 2018 of $8.2 billion.

However according to Rock Health M&A activity in the sector is down by volume – there were 63 acquisitions in the first nine months of this year, while in 2019 there were 113 for the whole year.

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WebMD Health Corp. is acquiring coliquio, a digital medical information company for German-speaking health professionals. 

Coliquio is used by doctors to share educational content and will be added to WebMD’s flagship brand, Medscape.

WebMD Health Corp is one of the largest providers of online health information services, with Medscape and its affiliate network of platforms currently reaching over 5 million physicians worldwide. Over 4 million of these physicians are based outside the US.

The COVID-19 pandemic has caused an increased consumption of online medical content, with companies like coliquio experiencing a rise in membership.

coliquio said its telemedicine and doctor-patient offering medflex is not part of the acquisition and will remain independent, operated by Germany-based medflex GmbH.

The deal is expected to close by the end of the year, subject to regulatory approval. Financial terms were not disclosed.

Jeremy Schneider, senior vice president at WebMD Global said coliquio’s platform was an “excellent” addition to its global presence. “Together, we can leverage our combined strengths to extend our reach and engagement to healthcare professionals in Europe and increase our value to customers through our best-in-class digital channels.”

Earlier this year, WebMD bought employee wellbeing firm, The StayWell Company, a subsidiary of US-based Merck & Co. The company’s products include its core StayWell employee wellbeing platform and the Krames clinical patient education platform.

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Analysing real-world health data could help overcome the bias towards men in traditional medical research, says Sensyne Health’s Dr Lucy Mackillop.

Collecting and analysing anonymised patient data has the potential to generate valuable insights that can catalyse research, lead to improved patient care, and power the development of new treatments.

Being able to analyse large data sets can provide a better understanding of how some patients will respond to a treatment or predict who may develop a disease based on data collected during clinical care.

Medical research has often focused on men, meaning that the insights gained have not always been reflective of how women would react to a treatment or disease. Women are likely to have different symptoms to men for the same illness and do not necessarily have the same reactions to certain drugs or respond to the same doses as a male counterpart.

Therefore, it is important to increase the collection and analysis of women’s health data so better insights can be gained for supporting their care.

The impact of underrepresenting women

Research from the Allen Institute for Artificial Intelligence found that over the past 25 years, although women have made up nearly half (49%) of participants across drug trials, for many types of disease the proportion of female participants did not match the gender breakdown of real-world patients. In trials for cardiovascular, HIV, kidney disease and digestive diseases, women have especially been underrepresented.

The effect of failing to include women proportionately in clinical trials may have consequences for the quality of medical care women receive, with therapies, doses and risk assessment tools being tailored to the male population. The use of real-world medical data from women may change this – and more broadly, ensure that representative samples of data are used for the disease or issue.

What we can learn during pregnancy

As well as collecting more representative samples of data from women for conditions like cardiovascular disease, accurate data collected during pregnancy could offer a valuable information.

This is because typically, ‘real-world’ medical data is collected from patients who are ill. However, pregnancy is a unique time when large quantities of data are collected in otherwise ‘healthy’ women.

Pregnancy can also act as a cardiometabolic stress test for women and reveal underlying susceptibilities to conditions such as diabetes or hypertension.

Therefore, by analysing the data collected during a woman’s pregnancy, clinicians can view a window into future health risks and understand who is most at risk. This helps develop better preventative strategies and also prioritises care.

Last year it was estimated that 20% of pregnant women in the UK were affected by gestational diabetes, while each year, up to 15% of pregnancies are affected by hypertension. Developing therapeutic strategies and individual care pathways may allow for prevention or delay in these diseases, both for the mother and her offspring.

Improving health of future generations

Research has found that the environment in which a baby grows has a significant impact on its health throughout its life. This means that being able to improve the way we care for pregnant women through collecting and analysing data can also significantly influence the health of their offspring.

While collecting data from patients is important in development of new treatments, clinical research, and patient care, there must be a greater focus on ensuring that women are well represented in trials.

For pregnant women in particular, the information that their medical records can offer must be recognised, and databases that can be used to support the improvement of care and outcomes has the potential to provide important insights.

About the author

Dr Lucy Mackillop is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust; honorary senior clinical lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford; and chief medical officer at Sensyne Health.

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Sensyne Health has signed a five-year non-exclusive Strategic Research Agreement (SRA) with Milton Keynes University Hospital NHS Foundation Trust (MKUH).

The non-exclusive agreement will apply Sensyne’s artificial intelligence technology to anonymised patient data for research into new medicines.

MKUH is organised into four clinical divisions (medicine, surgery, women and children and core clinical) and a number of corporate directorates. The dataset covers 650,000 unique patient records.

Sensyne has already signed SRAs with Oxford University Hospitals NHS Foundation Trust, Chelsea & Westminster Hospitals NHS Foundation Trust, South Warwickshire NHS Foundation Trust, Wye Valley and George Eliot NHS Trusts.

MKUH will take an equity stake in Sensyne Health and receive 1,428,571 ordinary shares in the UK company, representing 1.1% of its existing issued share capital. MKUH will also get an investment of up to £250,000 per year over the 5-year term of the contract for information technology.

The agreement brings the total share ownership held by NHS Trusts in Sensyne to 10.86%.

MKUH will also receive a royalty on revenues generated by Sensyne from research undertaken under the SRA.  The hospital trust said any financial returns will be invested back into the NHS to fund patient care.

The news followed Sensyne’s announcement of a new research agreement with Bristol Myers Squibb (BMS).

BMS said it will use Sensyne’s technology for research into disease progression and patient stratification for patients with various diseases with Myeloproliferative Neoplasms (MPNs).

MPNs are a group of rare blood diseases characterised by the overproduction of one or more types of blood cells.

It is Sensyne Health’s fourth successive partnership with a major pharmaceutical company following collaborations signed with Bayer, Roche and Alexion. Financial terms of the deal were not disclosed.

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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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Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers.

The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019.

Canada is the latest country to join a global network of hubs opened by Novartis. The company has established centres in the US, UK, France and India.

The Canadian Biome has already struck a partnership with Canadian virtual care specialist company Insig Health to launch a digital health accelerator. Other companies joining the Biome network include ConversationHEALTH, which develops AI healthcare chatbots, and Amblyotech, a digital therapeutics company for treating amblyopia.

Novartis announced the news at the virtual XEFFERVESCENCE Digital and AI in the Healthcare Industry event, attended by government officials and members of the healthcare industry.

Canada is investing to position itself as a world-leading destination for AI innovation. In 2017, it was the first country to announce a national AI strategy, and the government has invested $125M in a five-year Pan-Canadian Artificial Intelligence Strategy.

The goals of the strategy include increasing the number of AI researchers and graduates, partnering with AI institutes and developing global thought leadership on the economic, ethical, policy and legal implications of advances in AI.

Christian Macher, country president at Novartis Pharmaceuticals Canada said Novartis was calling on start-ups to join the Biome.

“Our goal with the Biome is to become the leading health tech pharma company in Canada,” he said, “working in collaboration with health tech pioneers who will become our partners in creating better healthcare solutions that can help enhance and accelerate the patient journey from diagnosis through treatment.”

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Akili has new data from its childhood hyperactivity therapeutic video game EndeavorRx, as the company builds a case for the technology with longer-term trial data.

The company announced several new data readouts, including outcomes data from the STARS-Adjunct trial, a multi-site open-label study testing EndeavorRx on impairments in daily life in children with attention-deficit/hyperactivity disorder (ADHD).

EndeavorRx is a therapeutic video game approved in the US and Europe in June and has been developed by one of a group of companies founded by PureTech, which retains a 34% stake in the venture.

The game is used with other treatments such as clinician-directed therapy, medication and education to treat the common disorder.

The game is designed to target and activate neural systems, by presenting sensory stimuli and motor challenges to improve cognitive functioning.

Data was presented at the American Academy of Child and Adolescent Psychiatry annual meeting, which has gone virtual because of the COVID-19 pandemic.

Figures revealed two-thirds of parents reported real-world improvements in a child’s ADHD-related impairments following two months of treatment, both when used alone or alongside stimulants.

Improvements in the ADHD Impairment Rating Scale (IRS) were statistically significant compared to baseline and were similar in magnitude regardless of whether or not children were taking stimulant medication.

More than a third of children no longer showed attention impairment on at least one measure of objective attention following treatment.

Analyses across four studies in paediatric ADHD showed that overall 34.5% of children moved into the normative range on at least one measure of attention following four weeks of EndeavorRx treatment.

Early exploratory evidence showed children who improved in attention functioning following treatment also improved their maths and reading skills.

The STARS-ADHD Adjunct study was a three-month open-label, multi-site study of EndeavorRx in 206 paediatric participants aged 8-14 years with a diagnosis of ADHD, across two cohorts: 130 children who were taking ADHD stimulant medications and 76 children who were not taking ADHD medications for the duration of the study.

Children completed one month of treatment with EndeavorRx, formerly known as AKL-T01, followed by a one-month pause and then another month on treatment.

The primary outcome measure of the study was the change from baseline after one month in the Impairment Rating Scale (IRS) for each cohort.

Secondary outcome measures included the ADHD Rating Scale (ADHD-RS), Test of Variables of Attention (TOVA), Clinical Global Impression – Improvement Scale (CGI-I), as well as exploratory outcomes of academic performance measures (TOSREC, MFaCTS).

 

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Scientists say on-skin printing could be used to create on-body sensors to monitor physiological signals and devices to wirelessly transmit the data.

A team led by Huanyu Cheng from Penn State University, say the sensors are capable of precisely and continuously capturing temperature, humidity, blood oxygen levels and heart performance signals. The next stage on the project is to target specific application, for example to develop a sensor network that could monitor symptoms associated with COVID-19.

Crucially, the technique to print the circuits onto skin can be carried out at room temperature, as earlier efforts have been hampered by the need to use heated materials, or printing onto a carrier layer before attaching them to the body.

Writing in the journal ACS Applied Materials & Interfaces, Cheng and colleagues say they have developed a “universal fabrication scheme” for on-body printing that makes use of a polyvinyl alcohol (PVA) paste and additives to reduce the temperature needed by the printing process.

Known as sintering, this type of printing typically requires temperatures of around 300 degrees centigrade to bind the silver particles used to form the circuits together.

By adding “nanoadditives” to the mix the scientists reduced that temperature to about 100 C, which allowed printing of circuits on clothing and paper but was still way too hot for use on skin.

Using PVA as a carrier layer along with calcium carbonate and changing the printing material was the key to enabling room temperature sintering, according to Cheng.

The PVA reduces printing surface roughness and allows for an ultrathin layer of metal patterns that can bend and fold while maintaining electromechanical capabilities. When the sensor is printed, the researchers can use a simple cool air blower to remove the water that is used as a solvent in the ink.

Once applied the sensors will resist immersion in tepid water for a few days, allowing washing, but can be removed easily with a hot shower.

“It could be recycled, since removal doesn’t damage the device,” Cheng said. “And, importantly, removal doesn’t damage the skin, either. That’s especially important for people with sensitive skin, like the elderly and babies.”

He added: “The device can be useful without being an extra burden to the person using it or to the environment.”

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Huge demand for ventilators and patient monitors spurred third quarter sales for Royal Philips, the company announced.

The Dutch health technology group reported sales of €4.98bn, a 10% year-over-year growth. The connected care business, which includes patient monitors and ventilators saw the biggest rise, increasing by 42%.

Philips said it had ramped up production of the equipment to meet global demand.

CEO, Frans van Houten said he was pleased that under “challenging circumstances” the group had been able to return to growth and improve profitability.

Across the business, Philips diagnosis and treatment division still declined but showed signs of a slow recovery. Sales were down 3%, to €1.97bn compared to a 9% dip in Q2. The company said elective procedures were returning slower than expected but anticipated to recover further in Q4. Demand for telehealth solutions like tele-ICU, tele-radiology, tele-pathology, to help virtual working of care professionals also drove growth in Q3.

Philips said it expects a big boost for its home ventilation and sleep apnoea solutions next year. Both areas suffered a sales hit due to the pandemic and are expected to strongly recover as sleep tests are carried out again.

Frans van Houten also teased Philips’ financial 2021-2025 targets which will be released in full at its Capital Markets Day on 6 November. The five-year plan is mapping 5-6% average annual growth for all divisions, excluding connected care, which is expected to shrink in 2021 as ventilator demand declines and business patterns stabilise.

It’s also unclear whether widespread demand for ventilators in hospitals will continue during the pandemic after emerging evidence suggested that overuse of the machines may have increased mortality in the pandemic’s early stages, because it is a risky, invasive, procedure.

Dr Alison Pittard, dean of the Faculty of Intensive Care Medicine in London, told Sky News that a range of approaches are now being used to manage patients with serious infections and help them breathe, with mechanical ventilation used as a last resort.

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As part of our series of opinion pieces from leaders at Janssen, the company’s Maria Raad looks at how we can embrace tech and data science to overcome increasing pressures on healthcare systems.

For the next generation born in the western world, living to be the age of 100 will be the norm. While this seems like a desirable aspiration for our grandchildren, it adds new pressures on our healthcare systems. The number of people living with chronic illnesses will rise year-on-year, and the ongoing management of  illnesses like diabetes and cardiovascular disease will require ever increasing resources.

This is nothing new. Healthcare expenditure is growing faster than GDP the world over, a trend that has been amplified by the COVID-19 pandemic. Together, these forces have accelerated technological transformation, acceptance, and adoption across our industry, reinforcing my belief in the ‘triple aim’.

The triple aim considers how we balance the needs of the individual with pressures on our health systems and, in a phrase coined by Berwick, Nola and Whittington in 2008, it is defined as:

1. Improving an individual’s experience of care
2. Improving the health of populations
3. Reducing the per capita costs of care

Changes to any one of these goals can affect the other two, negatively or positively. In order to succeed, we must shift the paradigm of healthcare and drive towards more objective measurements of value and improved experiences for everyone, to create a truly patient-centric system of care. ​

In the past, our collective adoption of, and trust in, digital technology has been incremental and often reluctant. All too often approached with a narrow mindset, such technologies have been regarded as simply tools to reduce costs or lessen the need for human interaction, when they have the potential to do so much more.

As the scientific evidence behind digital solutions has grown alongside our accelerated need for changes, we’re starting to see the full potential that data science might offer – a potential to create more efficient disease management solutions, reduce the economic burden of healthcare and, most importantly, empower patients to be integral decision-makers in their own care.

Real-time digital solutions for real-world evidence

Two billion people have access to mobile health data, but simply having access is not enough. It is how we use health data that will drive us forward. The emergence of big data, smartphone adoption and cloud storage technologies means that information can be captured in real-time, and then aggregated and analysed to develop new insights.

Collaborations such as HONEUR (Haematology Outcomes Network in Europe), which brings together a partnership of universities, hospitals and institutions across Europe, can help with this by bringing together multiple stakeholders to analyse real-world data (RWD), quickly and at scale, from as many sources as possible. By answering research questions in real time, partners can extract real-world evidence (RWE) that informs their conclusions and accelerates their work.

While acceptance varies between countries, we believe RWE is a key component in moving towards a more value-based healthcare model, as it is one of the few under-utilised resources left in our field.

Healthcare companies are now working with tech companies to put innovative, data-capturing tools directly in the hands of the individual. Wearable tech and mobile health apps can provide patients with information, allow them to manage medication, and help them to become experts in their own condition. This personal depth of knowledge can complement the quantitative data on which we currently rely, so we must ensure it’s integrated into treatment pathways going forward.

Combining digital therapeutics with pharmaceutical innovations

The pandemic has prompted a significant uptake in the use of data technologies. Clinicians, patients and payers are utilising the potential of these platforms, and many are doing so for the first time. We will, however, need to embed such changes across all parts of our healthcare systems, and I believe there are four foundational elements to this:

• Evolving from sick-care to well-care: healthcare systems are struggling to provide care via traditional models, which are largely based on treating illness rather than preventing it. This means moving on from just products and treatments, to platforms and solutions focused on prevention and real-time, outcomes-based care. Digital technology will be a major contributor to this transformational shift from diagnosis and treatment to prediction and prevention.
• Data science: harnessing data networks, artificial intelligence and real-world evidence, and the interdependence between all three, can help move us towards agreeing an objective measure of value for any given therapy. That’s essential if we are to build a new healthcare ecosystem, and if we get it right, everyone will benefit.
• Long life care: ageing populations are growing in size and increasing the pressure on healthcare systems. Without digital technology, the amount of resources required to manage long-term, non-communicable diseases will be unsustainable.
• Personalised care: digital therapeutics, when certified as medical devices, can enable clinicians to prescribe a treatment system that goes beyond the pill. They can also engage patients more effectively in their own care, through real-time symptom monitoring, for example, or by providing physiological support for those dealing with the burden of disease.

These are not short-term solutions. The ultimate goal is healthcare that’s thriving, sustainable and accessible to all. And we can drive towards that goal by harnessing and sharing the benefits of the ever-evolving technologies within our reach. But it’s a team sport – the days of any individual, organisation, government or industry attempting to change the world on their own are gone.

Data science actually has the potential to make healthcare more human. And, as we look to the next 100 years, with all this technology available to us, perhaps there’s reason to hope that we will yet see a world where fewer people get sick and more people live longer, healthier, happier lives.

About the author

Maria Raad is vice president, customer & digital strategy, EMEA at Janssen. In this capacity, Maria is responsible for the functions of business intelligence, advanced analytics, digital acceleration, and patient healthcare solutions. She has held various positions, since joining Janssen in 2006 – prior to her current role, Maria was Global VP & Chief Information Officer of Actelion, and a member of the Actelion leadership team based in Basel, Switzerland.

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Regular fliers are used to long queues to clear security – but a rigorous COVID-19 testing regime could be added to pre-flight checks backed by a digital “health passport” to prove passengers are free from the coronavirus.

The UK is the latest country to test the scheme that allows passengers to demonstrate their coronavirus status as part of a global framework for COVID-safe air travel.

Backed by the World Economic Forum, the CommonPass system is being trialled with a small number of passengers flying from the UK to the US.

There are other initiatives to use digital technology to prevent the spread of coronavirus through air travel: Switzerland’s ender diagnostics is working with Swiss International Airlines, a subsidiary of Lufthansa, on a system providing rapid molecular tests for cabin crew.

But The Guardian noted that there are concerns over the sensitivity and specificity of the tests in some countries and fears over greater monitoring of people’s movements.

The digital pass was created by the Commons Project, which received startup funding by the Rockefeller Foundation two years ago.

The trial will apply for passengers flying from Heathrow to Newark on a United Airlines flight on Wednesday.

Tests from the private company Prenetics will be administered by travel and medical services firm Collinson, with testing facilities set up with Swissport.

A QR code that can be scanned by airlines staff and border officials is produced if the test comes out negative.

It’s unclear how passengers can secure a refund in the event of a positive test and airlines will pay CommonPass for the service.

The scheme has already been piloted on Cathay Pacific flights between Hong Kong and Singapore.

CommonPass CEO Paul Meyer told The Guardian that countries that have closed borders and imposed quarantines are looking to “thoughtfully reopen” their borders.

He noted that that certain countries require paper-based evidence of a yellow fever vaccination, and this would work in a similar way but based on digital technology.

Meyer said digital proof of a coronavirus vaccination could soon be required to travel for “the foreseeable future.”

But there are issues: the BMJ pointed out that the polymerase chain reaction (PCR) tests commonly used to identify whether the virus is present do not show whether someone is infectious.

Most arrivals to the UK have to quarantine for a fortnight, with only around 45 countries on the “travel corridor” list that does not require quarantine.

 

 

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In the age of artificial intelligence, no trial data should be going to waste. Findacure’s Rick Thompson looks at how these technologies could bring us closer to treatments for underserved rare diseases.

The repurposing of drugs is becoming more common, especially in the field of rare diseases.  In the past, repurposing has mostly been driven by academics looking for new possibilities in generics. Now, as part of lifecycle management, pharmaceutical companies are looking more closely at drugs they have on their shelves. These might be licensed drugs that could hold potential for a patent extension, or drugs which failed efficacy trials for an intended indication.

In the quest to repurpose a drug for a rare condition, there is a need to look at any and all available data. The wealth of published scientific literature forms one crucial source of data, with the ever-expanding pool of ‘omic data forming another.

A third pool of clinical evidence is formed by trial data, which will probably only be considered through the published literature. By definition, however, trial master files represent a much richer and more detailed source of data on a drug and how it performs. Published literature tends to catalogue successful clinical trials, but value can also lie in a trial that did not lead to a positive and viable outcome: the data it produced could still provide evidence for repurposing. For instance, provided a drug has not failed a trial on safety, the side effects it caused in one population could constitute on-target effects in another.

With large datasets crucial to gaining an understanding of rare diseases and opening the door to drug development, digital technology is proving transformative. It enables careful collation and organisation of information, but the innovations of artificial intelligence (AI) are now taking things further, facilitating the effective analysis and interrogation of big data to create new treatment hypotheses.

These techniques make the production of and access to high-quality data on rare diseases the gateway to treatment identification, and so are proving more crucial than ever for organisations in pharma.

Digitised, rigorously controlled data lends itself to techniques of processing and analysis which characterise both drug discovery and drug repurposing.

Raw text can be analysed by Natural Language Processing (NLP) techniques which form connections between studies that could otherwise take thousands of hours of human time to identify.

When combined with analyses of ‘omic approaches, and an appropriate level of disease-specific knowledge from patient groups, you can create a powerful resource for the identification of new treatment hypotheses for rare diseases – and an opportunity to address severe unmet needs.

Findacure is a charity that works directly with rare disease patient groups to help them grow and professionalise. Over the last five years we have focused on the power of drug repurposing for rare genetic diseases. It is estimated that, worldwide, just 400 treatments are licensed for 7000 known rare conditions, which tend to be determined by a very specific genetic factor.

As a consequence, most patients are being left with no hope of a treatment in their lifetime. Luckily, patient associations are working to fill the void by uniting patients and driving research forward for their conditions. Many are working to develop registries (some using wearable technologies or apps) and natural history studies, which means that ever-greater volumes of data are being produced.

This drive to generate data on and interest in their condition – along with the collated knowledge of their community’s lived experience of rare disease – can prove transformative to the treatment landscape. We are now seeing patient associations involved in several collaborative efforts that are identifying drugs which, as candidates for repurposing, stand to deliver treatments to rare disease patients more quickly and cheaply.

In 2020, the pharmaceutical industry has not by any means proved immune to the disruption caused by COVID-19. But, as in other industries, the pandemic has accelerated the process of digital transformation that was already underway.

A recent survey of more than 200 life sciences professionals, conducted on behalf of digital archiving specialists Arkivum, found 70% of respondents saying that COVID-19 has triggered a change in the way clinical trials will be conducted. There can be no doubt that digital technology will play a key role in that change. The survey reports that over 90% of sponsors and CROs have already adopted an eClinical application to improve study execution and data collection in live trials.

When a trial is completed, the valuable and extensive data it has produced must be archived – an exercise crucial both to regulatory compliance and to any future efforts at repurposing. 70% of sponsors reported that they use a digital archive rather than the traditional paper-based option, and 45% of respondents cited the role that clinical trial data plays in finding new indications and formulations. Yet at the same time, 38% of sponsor organisations described their ability to access archived clinical data and records as ‘extremely or very inadequate’.

This percentage rose to 65% amongst QA, compliance, legal and regulatory professionals. Moreover, just 31% of life sciences organisations seem to run a digital archive of sufficient sophistication to ensure that data can be managed in accordance with the FAIR data principles.

These were established to further scientific study through keeping data Findable, Accessible, Interoperable and Re-usable – all key attributes when it comes to exploring the new potential of an existing drug.

In the search to repurpose drugs, readier, more reliable access to archived trial data – including trials that produced negative results – can clearly prove highly beneficial.

If data has been well stewarded before and after it reaches the archive, and if its integrity has been maintained through careful curation, it facilitates the application of AI techniques. Natural language processing can be used in conjunction with, say, analysis of ‘omic-level data and patient group insights in order to work through the problems and side effects encountered in the full spectrum of trials. This can open the way to repurposing for different populations, and to new approaches to the design of clinical trials.

The success of these endeavours will also be favoured by the availability of comprehensive rare disease registries which collate patient-level data on disease natural history while also bringing together a pool of patients who could participate in trials.

Meanwhile at the pre-competitive stage of drug development, researchers are adopting a more open, collaborative approach to data. Now is the time to enable further collaboration by increasing access to historical data and releasing its full value. Success in finding treatments for rare disease is above all the product of collaboration, as technological innovation complements and amplifies a compassionate, patient-centred approach.

In all this, it is worth remembering that the people who participate in clinical trials – especially in the field of rare disease, where recruitment of patients is a particular challenge – would appreciate knowing that their participation will have a lasting value, whatever the outcome of the trial.

Trial participants take on a burden by putting in time, effort, hope and commitment. They also put themselves at some degree of risk whenever they take an experimental drug. In the field of rare diseases, trial participants are hoping to help the next generation of patients even more than themselves.It is crucial to maximise the potential value of data they are helping the professionals to collect.

With repurposing on the table, and improved access to all trial data, we can better unlock this potential.

About the authors

Dr Rick Thompson is CEO of Findacure, a UK charity dedicated to building the rare disease community to drive research and develop treatments.

Tom Lynam is head of Marketing at Arkivum, specialists in digital preservation of valuable data in life sciences and global scientific institutions.

 

 

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Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects.

The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.

The investigators hope the digital tools will encourage people with heart failure to make and adhere to changes in their lifestyle that will improve “patient outcomes, clinical efficiencies and…quality of life.”

If it works, the approach could have a significant impact on the care of people with heart failure, which is a massive problem worldwide. In the US alone there are six million people with failing hearts, leading to a million hospitalisations each year.

The 200-patient study will look at each of the three digital technologies separately, added to standard care for heart failure, and see how they perform compared to standard care alone over a six-month period.

The primary endpoint of the study is improvement in quality of life assessed by a scale known as the KCCQ survey, with secondary measures including the number of hospitalisations, treatment prescribing rates and mortality.

Crucially, given the ongoing pandemic, all the digital technologies can be used in the home, so there will be no need for anything more than the regular follow-ups in clinic for the enrolled subjects.

“Our digital health study…will move beyond evaluating if these tools work and establish if they actually help make patients’ lives better, which is how these technologies should be judged,” said Yale professor of medicine Perry Wilson, one of the study investigators.

“The health of heart failure patients can change quickly, and these tools can help healthcare providers intervene before serious complications lead to hospitalisations, alleviating our overburdened healthcare system,” he added.

Boehringer is already an investor in the smart scale – called Bodyport – as the pharma company led the start-up’s $11 million first-round financing in August. The device is designed to detect cardiac signals and biomarkers through a user’s feet, rather than relying on wearables.

The live coaching app, Noom, provides personalised diet and weight management advice and its developers have also previously partnered with Novo Nordisk on a programme designed to help people struggling with obesity.

Finally, the motivational tool – Conversa – is an automated conversational platform that its developers say uses artificial intelligence and behavioural science methodology to encourage patient engagement.

The tool is already being used by hundreds of hospitals in the US to help manage chronic care, acute discharge, perioperative, cancer treatment and COVID-19, according to the company.

“We launched this study with Yale to help identify how digital health technology may address some of the key pain points for adults with heart failure, like the need for more frequent communication with healthcare providers in between visits and coaching to help with the daily management of the condition,” said Christine Marsh, Boehringer’s senior vice president, market access.

Results from the study are due next year, according to the investigators.

Heart failure has become a hot topic for study of digital interventions, in part because of the slow progression of the condition also because adherence to treatment and lifestyle interventions is closely linked to how well patients fare.

Johnson & Johnson for example is deploying wearables and smartphone apps in the CHIEF-HF trial of its Invokana (canagliflozin) in heart failure patients.

Amgen meanwhile is sponsoring a study in the US to investigate whether wearables can help physicians monitor changes in heart failure patients’ conditions so they can get the optimal doses of medications.

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Astellas Pharma is to buy bioelectronic medical devices firm iota Biosciences in a deal worth up to $429m, building on a previous research partnership.

In August last year the companies began a joint research and development agreement based around iota’s bioelectronic devices in several indications.

Bioelectronics is a field that has been investigated by Google’s life sciences division Verily, which co-founded Galvani Bioelectronics with GlaxoSmithKline in 2016.

The partnership focused on harnessing the body’s electrical signals to treat chronic diseases such as asthma, arthritis and gastrointestinal diseases.

Companies including AliveCor and Apple use bioelectronics to measure the heart rate and predict atrial fibrillation.

iota’s technology uses ultrasound as a power source and means of communication. Together with Astellas the pair will develop technology based around tiny millimetre-sized implantable medical devices, the companies said.

Astellas will pay $127.5 million up front to buy the remainder of the iota shares that it does not already own – the Japan-based pharma already has a stake after a US subsidiary invested in iota’s Series A stock offering.

Shareholders in iota could also receive additional payments of up to $176.5 million if pre-determined milestones are met before certain deadlines.

Upon completion iota will become a wholly-owned subsidiary of Astellas, which said it is also committing to spend a total of $125 million over the next five years to fuel iota’s “aggressive expansion”.

iota is a start-up founded in 2017 by Michel Maharbiz and Jose Carmena, who are both experts in the field of bioelectronics.

The company’s technology uses ultrasound to power miniature devices and enable wireless communication, allowing ultra-small, battery-free, wireless implantable medical devices.

Conventional implantable medical devices require batteries for power supply and wires or large electronic circuits to enable communications.

This has made size reduction difficult and has often resulted in highly invasive implant procedures.

iota’s bioelectronic devices can be implanted through a less invasive operative procedure and promise improved effectiveness and reduced physical burden for the patients during and after surgery.

Since striking up the research partnership last year the companies have begun several projects, and clinical trials based on the technology are expected to begin in the next few years.

Astellas said it is still reviewing the financial impacts of the transaction for the fiscal year ending 31^st March 2021.

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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.

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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US startup Blue Oak Pharma has joined a lengthening list of companies turning to Exscientia of the UK for its expertise in applying artificial intelligence to drug discovery.

Waltham, Massachusetts-based Blue Oak –  led by neurobiologist and former Eli Lilly and Sunovion executive Tom Large – will work with Exscientia on new classes of neuropsychiatric drugs, with a focus on “bispecific” small molecules that can interact with two drug targets at once.

The UK company made headlines earlier this year when partner Sumitomo Pharma started clinical trials of a drug candidate for obsessive compulsive disorder, said to be the first medicine developed using AI to enter testing in humans.

Exscientia’s roster of partners – which also includes pharma heavyweights like Bayer, Bristol-Myers Squibb’s Celgene unit, Sanofi, GlaxoSmithKline, and Roche – have bought into the promise of its platform to accelerate drug discovery and improve drug development productivity.

The UK biotech reckons its use of AI and machine learning can trim years off the current 12- to 15-year cycle from early research to marketed product. Sumitomo’s OCD candidate, for example, went from discovery to clinical testing in just 12 months.

Blue Oak has been operating largely under the radar since it was set up in 2016, but has quietly started building alliances as it prepares to advance new drug classes for central nervous system disorders, including a partnership with early-stage drug discovery specialist PsychoGenics in 2017.

Over the years, Large’s research teams have generated 13 experimental drugs advancing through all stages of clinical development, including Sunovion’s SEP-363856, a drug for schizophrenia which also grew out of a PsychoGenics alliance. That candidate is in late-stage clinical testing and picked up an FDA breakthrough designation last year.

At Blue Oak, Large is spearheading the development of first-in-class drugs with new mechanisms-of-action for bipolar disorder, schizophrenia and treatment resistant depression, although at the moment all these projects are in the discovery phase.

In a statement, Exscientia said the timing of its partnership with Blue Oak is “prescient”, because after decades of stagnation researchers are starting to generate and validate new pharmacological targets for brain disorders.

“We’ve known the strengths of the Exscientia AI platform for some time, especially the ability to evolve very small molecules that can selectively interact with more than one target,” said Large.

“With Blue Oak’s deep knowledge of complex neuropsychiatric illness, we will be able to look at carefully chosen target combinations that can bring major benefit to psychiatric patients,” he added.

The global market for AI in healthcare was worth $2.1 billion in 2018, with exponential growth to $36.1 billion predicted by 2025, at a combined annual growth rate of 50.2%, according to a recent report by finnCap.

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Equity investor Gresham House has invested £5m into the NHS’s digital triage provider eConsult Health, allowing the service to expand to meet demand during the COVID-19 pandemic.

eConsult provides online consultation services to NHS primary care organisations and will use the investment to maintain its position as a provider in GP surgeries.

COVID-19 has showed the need for tools to relieve pressure on surgeries.

The company says it has seen exponential growth of its services over the past year and will use the new funds to continue with the rollout of its digital triage platform.

The £5m investment, made on behalf of the Baronsmead Venture Capitalist Trusts, is in addition to further investment from existing shareholders and will support the expansion of eConsult Health into the secondary care market.

Beyond maintaining its position as the leading digital triage services in GP surgeries, eConsult Health will continue the rollout of its Urgent and Emergency Care triage product, eTriage, and outpatient referral software, eSpecialist.

Digital triage allows patients to be dealt with more effectively and efficiently, moving from a world where 90% of patients have no option other than a face to face appointment to one where the majority of cases are appropriate for remote closing.

This allows healthcare practitioners to prioritise face to face consultations with those patients in greatest and most urgent need.

Earlier this year, eConsult was added to the NHS app, a project launched by NHS Digital in 2018 as part of its push into digital health.

It has features including ordering of repeat prescriptions, appointment management, symptom checking and allowing people to view medical records.

The app offers an alternative to the 24-hour NHS 111 non-emergency helpline, which at the height of the outbreak was struggling to keep up with the volume of information requests.

Before the COVID-19 crisis around 70% to 90% of consultations were face to face, but the company said that has been turned on its head, with roughly the same proportion now conducted through digital means.

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Relationships are built over time. However, with the inability to meet face-to-face, many life sciences commercial teams are left wondering what to do next. Unfortunately, we have been truly disrupted – not only in our work environment, but in what our customers, healthcare providers (HCPs) want. A recent research report by Accenture revealed that 65% […]

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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.”

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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UK-based RHYTHM AI is to go ahead with a larger clinical trial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication.

Antiarrhythmic drugs are standard therapy but they often only work for around 18 months, after which time a catheter ablation procedure is necessary to isolate the cause of the electrical abnormality that is the cause of the disease.

The ablation procedure works by using small burns to isolate the vein causing the irritation that is disrupting the electrical pathways in the heart.

RHYTHM AI’s STAR Mapping uses novel computer algorithms to identify the causes of atrial fibrillation, using 3D mapping equipment to inform the ablation procedure.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given the go-ahead for the company to proceed with its ‘ROCSTAR’ clinical trial to further test the system as a potential treatment for persistent AF.

The company said that in a single centre study published in May last year, 80% of patients treated in a single procedure using STAR Mapping were free of AF without use of anti-arrhythmia drugs at an average of 18.5 months follow up.

This compares with a study showing 48% of patients from AF at 18 months follow-up without use of anti-arrhythmic drugs using standard 3D mapping technology.

RHYTHM AI will expand the research, using a multi-centre clinical trial designed to be a ‘real-world’ evaluation of the STAR Mapping System as a potential treatment for patients undergoing cardiac ablation procedure for persistent AF.

The randomised trial will recruit 177 patients in up to 15 UK centres and follow the patients to evaluate freedom from AF at 12 months follow up.

A control group of 59 patients will receive the standard pulmonary vein isolation ablation procedure, while a study group of 118 patients will receive a pulmonary vein isolation procedure by guided further ablation using STAR Mapping.

The primary goals are freedom from AF without anti-arrhythmia drugs at 12 months and response to STAR guided ablation during the procedure – either a slowing or termination of AF.

Clinical development of the system got off the ground last year when the company announced the closure of a £2.15m financing round.

This was led by an affiliate of Rinkelberg Capital Ltd, a private wealth management firm based in London, as well as investment from founders.

Developed at the city’s St Bartholomew’s Hospital, the system was developed by a team including London-based cardiologist Richard Schilling.

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Japan’s Toppan Printing and MIT spin-off FIGUR8 have announced results of a pilot scheme testing a remote physical training guidance scheme that uses musculoskeletal sensors to collect data on movement.

The companies have been collaborating since February this year on services that use data on movement of individual users.

They said factors including the coronavirus pandemic have resulted in increased demand in the online fitness sector, as people across the world continue to have their personal freedom curtailed by lockdown measures.

Toppan and FIGUR8 said their system uses musculoskeletal sensors to collect accurate and objective data on body movement.

The system then gives exercises instructions based on the data, and results of the test have enabled both trainers and test subjects to be identified.

The economic impact and increase in medical costs associated with musculoskeletal complaints and conditions has garnered attention in recent years, the companies noted.

Common complaints include stiff backs, necks, and shoulders as well as sprains, pulled muscles, ligament and tendon damage and other sports injuries.

The designers hope that the system will allow trainers to give instructions on how to exercise safely, as exercise therapy works best when muscles are used flexibly and without strain.

Results of the test showed improvements in three KPIs: balance, stability, and flexibility. In the case of a 60-year-old male participant, functional improvements included the absence of discomfort in the lower back as well as the ability to squat and to put socks on while standing on one leg and to move flexibly without straining.

This enhanced motivation and provided reassurance for the test subject and the trainer, the companies said.

Trainers participating found that being able to give guidance based on the measured data made it possible to approach exercise in a logical fashion and offer more compelling training regimes.

They found progress is clearly visible to both clients who like to understand what they are achieving and those who find it difficult to stay motivated.

Shu Tanabe, manager of business creation in Toppan’s Business Development Division, said: “We plan to create a mechanism for compiling and leveraging data on movement analysis and hope to work with bodyworkers, trainers, physical therapists, orthopaedic specialists, athletes, and partner companies to expand sales of services for the fitness, sports, and rehabilitation sectors.”

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Japan’s Toppan Printing and MIT spin-off FIGUR8 have announced results of a pilot scheme testing a remote physical training guidance scheme that uses musculoskeletal sensors to collect data on movement.

The companies have been collaborating since February this year on services that use data on movement of individual users.

They said factors including the coronavirus pandemic have resulted in increased demand in the online fitness sector, as people across the world continue to have their personal freedom curtailed by lockdown measures.

Toppan and FIGUR8 said their system uses musculoskeletal sensors to collect accurate and objective data on body movement.

The system then gives exercises instructions based on the data, and results of the test have enabled both trainers and test subjects to be identified.

The economic impact and increase in medical costs associated with musculoskeletal complaints and conditions has garnered attention in recent years, the companies noted.

Common complaints include stiff backs, necks, and shoulders as well as sprains, pulled muscles, ligament and tendon damage and other sports injuries.

The designers hope that the system will allow trainers to give instructions on how to exercise safely, as exercise therapy works best when muscles are used flexibly and without strain.

Results of the test showed improvements in three KPIs: balance, stability, and flexibility. In the case of a 60-year-old male participant, functional improvements included the absence of discomfort in the lower back as well as the ability to squat and to put socks on while standing on one leg and to move flexibly without straining.

This enhanced motivation and provided reassurance for the test subject and the trainer, the companies said.

Trainers participating found that being able to give guidance based on the measured data made it possible to approach exercise in a logical fashion and offer more compelling training regimes.

They found progress is clearly visible to both clients who like to understand what they are achieving and those who find it difficult to stay motivated.

Shu Tanabe, manager of business creation in Toppan’s Business Development Division, said: “We plan to create a mechanism for compiling and leveraging data on movement analysis and hope to work with bodyworkers, trainers, physical therapists, orthopaedic specialists, athletes, and partner companies to expand sales of services for the fitness, sports, and rehabilitation sectors.”

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OPEN Health’s Beth Lesher and Annemarie Clegg examine what the convergence of medical communications and market access means for pharmaceutical companies.

Value in healthcare is a continually changing concept. As the needs of different stakeholders evolve and gain in prominence, pharmaceutical companies must be prepared to address value from various viewpoints using a variety of different metrics.

The evolution of value in healthcare is a trend that has important implications for communications, particularly because ‘value’ is very much in the eye of the beholder. For a physician, value may centre around safety and efficacy whereas healthcare decision makers and regulators may place more emphasis on cost. Patients may place more value on cost when dealing with a chronic disease and quality of life when dealing with an end of life illness.

As patients play a more active part in their own care, physicians grapple with the ever-changing nature of medical science and payers are continually pushed by budgetary constraints, it’s important to understand that how you communicate value to the industry’s various audiences needs to be different.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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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.”

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

As general manager, Veeva OpenData, Rebecca leads a dedicated team of product managers, data stewards, engineers, and services professionals to deliver a superior reference data experience for Veeva customers. Before leading the global OpenData team, Rebecca was vice president of Veeva OpenData North America, where she led the launch and growth of Veeva’s data offering. Earlier, as VP, professional services, North America, she directed successful implementations of Veeva’s suite of commercial products for many of the world’s most prominent pharmaceutical companies.

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An Excel spreadsheet was behind IT glitch that caused thousands of positive COVID-19 tests to be omitted from the UK’s official records, according to press reports.

The issue that left almost 16,000 positive results going unreported has been blamed on the way Public Health England tracks results from mainly private labs that have been hired to add extra testing capacity.

While established “Pillar 1” labs in hospitals around the country feed straight into a central PHE database, the mainly private “Pillar 2” labs feed results to the central database with data stored in a CSV file created using an Excel spreadsheet.

But Excel files created using the older version of the spreadsheet are limited to 65,536 rows, Sky News noted, which is why so many positive results were not included in the official figures.

The results were being missed off the bottom of the spreadsheet, meaning that while all other indicators suggested the number of cases in the UK were rising rapidly, the numbers displayed on the government’s COVID-19 dashboard seemed to be staying constant or even falling.

According to the reports the problem has now been solved by saving the data in several CSV different files.

Despite the temporary fix, the incident raises serious issues about how the government has been managing the outbreak.

Sky noted that the budget for the test and trace system is around £12 billion, almost more than any other government investment programme in recent history.

But the issue could have been solved with a £100 upgrade for Excel, or a more serious investment in the IT system at the heart of the test and trace system.

The delays to publishing thousands of results mean that although people were eventually notified if they tested positive, it is also possible that people were unnecessarily exposed to the virus.

The test and trace results also help to inform whether the government imposes local lockdowns to try and stop the virus from spreading.

Without a vaccine, good data is the only way the government can stop the virus from spreading and it’s less than reassuring that the system fell over because of such a simple oversight.

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There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available to help speed up processes and increase data accuracy. But for many life sciences organisations, these tools are either not yet fully adopted or are not being put to good use within their regulatory functions.

In Accenture’s Intelligent Life Sciences: Redefining Regulatory through Intelligent Automation report, we underscore how automation can help regulatory professionals in life science organisations bring products to patients faster.

Adopting intelligent automation could help organisations realise disruptive benefits that are above and beyond the tangible gains of cost, quality and productivity improvements. By applying intelligent automation, companies could realistically expect to enable: the seamless distribution of product information in a variety of multimedia channels to all internal and external stakeholders; rapid and accelerated implementation of product advances that could propel continuous improvement; and advanced prediction of risks to mitigate against resource capacity constraints – which have been highlighted during COVID-19.

For many companies, it could be realistic to automate as much as half of the manual maintenance tasks currently performed, resulting in significantly different future operating models where blended roles will prevail with strategic product oversight.

But where to begin?

Where do you begin this transformation? Start with the data. Companies need to change the way people collect, curate, interpret and apply data for regulatory submissions and improve confidence in that data. According to Accenture research, most organisations are still struggling to understand the basic ‘truth’ of the data they use and exchange with others. The Accenture Technology Vision survey found just one-third of 103 life sciences executives have high confidence in their data and validate it extensively. To improve data confidence regulatory executives should take a four-step approach to change how they:

1. Collect Data: Life sciences organisations should utilise cloud-based solutions with global access that facilitates one repository with a single source of truth and eliminates the use of local file sharing and servers. By integrating applications across the end-to-end value chain, they eradicate data entry duplication.
2. Curate Data: Regulatory specialists need to apply data standardisation and master data management to define the right granular level of data for storage. This needs to be done up front. By implementing robust data governance and management, they can maintain data quality and integrity. By ensuring traceability of data evolution, as well as end-to-end transparency of submission status and its components, they help promote confidence in the data itself.
3. Interpret Data: Executives need to make more use of readily available data to drive business decisions and optimise operations. They should be applying analytics to past submission data to recommend future submission content plans and pre-empt and mitigate health authority (HA) questions.
4. Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data. Making real-time data accessible to the consumers of the information when and where it’s needed increases the likelihood of buy-in to the system’s value-add. In this way, manufacturing scheduling can be optimised, and batch release decisions more informed. This, in turn, enables healthcare practitioners to get the most up-to-date product information at their fingertips.

Focusing on the business outcomes of how data can be interpreted and applied, through implementation of analytics, RPA and AI, will help strengthen your data vision, enhance your data stewardship culture and provide financial justification for investing in improved data management. This is crucial because all signs point to a future world order of increasing volumes and complexity of new products coming to market, and digital support is a must have – not a nice to have – to handle this workload.

What intelligent automation to consider?

As companies make the move into the realms of intelligent automation, there are 3 key considerations that need to be considered from the offset.

1. Set the North Star vision: Discuss the company strategy and pipeline considerations for the next 3-5 years and what the business objectives to achieve this strategy are. Is the driver for intelligent automation waste reduction and cost saving, or the speed at which innovative products are being brought to patients? Define the priority focus areas for your intelligent automation roadmap and evaluate the balance of ‘quick wins’ versus longer term strategy initiatives.
2. Create the Operational Blueprint: Outline what the future processes look like with the inclusion of intelligent automation. What activities remain and from where should they be performed? Consider how job descriptions and roles will evolve to account for the transformed future working environment.
3. Prototype, automate, evaluate, repeat: Establish the infrastructure to prototype at speed and fail fast. Consider how to implement in an agile, modular manner that gradually combines into an end-to-end solution. Carefully evaluate benefits realised.

Here are some example use cases showing how Intelligent Automation is changing the game:

Regulatory Requirements & Content Plans

• Business Challenge: Maintaining data on submission requirements is a constant challenge. As a result, market requirements gathering is often repeated for each submission, generating longer lead-times. Additionally, insights gained from HA feedback are not incorporated into submissions, reducing first time submission approval accuracy.
• Solution: Analytics can compare new submission properties against past submissions to suggest a content plan based on the closest match, and most recent, approved submission.

Health Authority Correspondence Processing

• Business Challenge: Timely recording of submission approval dates or tracking of HA questions can be challenging when information received by affiliates needs deciphering and translating before being entered into regulatory systems.
• Solution: AI tools can translate and decipher letters without the need for local affiliate intervention and automatically enter information in Regulatory Information Management systems for stakeholders to act upon.

Label Authoring and Tracking

• Business Challenge: Managing and providing traceability of the roll out of global label updates is onerous based on language nuances, implementation considerations and replicated data terms across multiple documents which can lead to a high risk of product label inconsistencies.
• Solution: AI tools can take the complexity out of mapping global-to-local terms and automatically suggest what updates are needed where, as well as provide end-to-end traceability of the update progress.

As companies make the move to adopt intelligent automation, they need to make sure their projects are: business-outcome oriented (rather than simply automating a task or function); human-centred (so they don’t just eliminate repetitive tasks but rather free up people to focus on higher-value analysis, decision making and innovation); and technology rich (i.e. integrated into the broader architecture of data sources and applications).

How do you ensure success?

And there are pitfalls to avoid. One of the most common mistakes companies (across all industries) make is to allow business units to carry automation initiatives in silos. You should drive home the notion of ‘one company’ and keep an eagle-eye out for cowboys building their own rogue programmes. Similarly, make sure everyone is on the same page – if there is a disconnect between IT and the business, what’s built may not serve what’s needed. And make sure your HR, training and communications teams are looped in, informed and armed with the right information and tools to encourage and support adoption.

Lack of communication on how the workforce will be re-purposed post automation implementation can lead to internal unrest and possible attrition. There will need to be training and change control in place, and that takes planning and management. Finally, from the onset and throughout there needs to be a team tasked with ensuring responsible automation is in place. This needs to be owned by the C-Suite and at every turn communicated to employees, so it is part of the DNA of the transformation: consider the ethical and legal implications when data is handled, and tasks are automated. Know who is accountable and responsible for outcomes and ensure those teams own that responsibility.

The process of adopting intelligent automation isn’t easy but it’s also unavoidable. Adoption of processes and procedures to handle complex data is essential in this day and age – the companies that fail to build a platform that is adaptable to change are at risk of being left behind; those that do adopt new solutions are not only poised to succeed – they are the industry leaders of the future.

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Better patient care pathways and models of care can be leveraged from the use of data, and the ability to collate and assess this information will drive more sustainable models of care, whilst unlocking the value of ‘longitudinal, real-world data’ as a resource for healthcare organisations, research and academia, policy advisors and pharma.

There is a societal shift that is required though, to educate patients on the value of this data and how it can be used to improve the outcome of patients globally. Samir Dhalla, head of THIN and Richard Ballerand, co-chair of THIN’s Patient Advisory Committee, explore how ‘good data’ can power this.

The benefits for public health

Data has been essential in the fight against COVID-19, with records used to identify and notify 2.2 million individuals who were at significant risk from the virus, and to advise them to shield. Ongoing tracking and data analysis of the virus has also allowed for data profiles to be built up around the types of conditions that result in COVID-19 posing a greater threat, for instance Type 2 diabetes. The NHS has proven the value of public health data in this way, and globally it has been a powerful tool to assess risks and treatments.

It’s also helped to drive research – for example the European Health Data & Evidence Network’s (EHDEN) took part in the OHDSI COVID-19 Virtual Study-a-thon which rallied 330 researchers with very different backgrounds and from thirty different countries. It also launched its COVID-19 Rapid Collaboration Call in a bid to plug the gaps in fragmented, siloed and poorly interoperable real-world health data in order to characterise patients, manage their care and assess treatment safety.

These forms of national and international collaboration have shown the power of data in managing the pandemic, as the importance of population health data in identifying and containing the virus has not been overstated. The NHS has created its own COVID-19 Data Store for instance, and on top of this, analysis of 16.2 million anonymised longitudinal patient records revealed a significant increase in the proportion of lower respiratory tract infections diagnosed by late 2019 compared to previous flu seasons, raising the odds of UK COVID-19 cases having appeared earlier than previously thought.

By harnessing the information in electronic health records, such findings clearly open the path to near real-time tracking of large-scale population health events that can support public health bodies to detect, investigate, and respond timely and effectively to them.

Anonymisation

Patients are becoming more content for their data to be used in this way, however it must be anonymised to tackle privacy and trust concerns. The public have reported they are generally comfortable with anonymised data from medical records being used for improving health, care and services, for example through research. However, there is still worry around this health data being accessed by commercial organisations, and so the privacy and broader benefits of patient data must be emphasised.

For instance, data can be used to improve diagnosis speeds and anonymous data can be overlaid onto NICE guidance, as well as within local and national patient pathways to provide better insight into the types of treatments that might work more effectively for certain patients. ‘Cohorts’ of patients can be created as well as effective treatment profiles based on these individual characteristics, to ensure the most effective treatment pathway is selected and faster. These can be based on existing health conditions, for example diabetes, and co-morbidities. Information such as age, weight, sex, faith, ethnicity and lifestyle choices can also be included to help specialists get closer to the best treatment the first time around to improve patient outcomes.

A prime example of the value of this type of data is in the case of pancreatic cancer, a disease that is often diagnosed late and progresses exceptionally quickly. It’s the deadliest common cancer, and by the time a diagnosis is achieved, many individuals are at stage three or stage four, with 75% not surviving a year after diagnosis. Symptoms are vague and often confused with other conditions such as pancreatitis, gallstones, irritable bowel syndrome (IBS) or hepatitis.

For both GPs and patients, embedding detailed symptom information within clinical systems would be hugely beneficial, enabling far earlier diagnosis and hospital referral. The GP would spend far less of the budget on one specific patient and it would ensure that the patient receives the best treatment possible for that diagnosis and faster referral to the right clinician.

Predictive modelling

Data analytics can also be used to better understand patient responses to specific treatment types and surgeries, by using predictive modelling to map out likely outcomes – enabling pharma to work closely with healthcare professionals and services to get closer to ‘the right medicine, to the right patient, first time’.

Modelling based on real-world data allows for tailoring and marketing specific medicines to specific groups of patients with specific predispositions or health conditions, and it reduces the ‘trial and error’ process that clinicians sometimes have to follow to find the appropriate treatment.

For example, analysis of cardiac surgery patients has evaluated the risks for certain types of heart surgery as well as post-surgery, taking into consideration a number of factors, including age and ethnicity to improve recovery. This can be extended to provide individual patients with information about their health conditions and risks to empower and encourage them to make changes to lifestyle or behaviours. This Predictive, Preventive and Personalised Medicine (PPPM) explores a complex mix of personal and population health data to avoid future health deterioration or detect problems before they arise.

Utilising datasets

Ultimately, PPPM will help patients to take control of their own health issues. Retaining individuals within primary care will both save money by reducing the pressure on secondary care and release investment in other areas of high demand healthcare. On a broader level, this detailed predictive model will allow the healthcare system to potentially predict population health issues over the next three to four years, helping to allocate resources to the correct specialties at the right time.

The key to this process is early identification of potential health issues, which requires proactive collection of patient health data – from weight to cholesterol and blood pressure readings. Understanding the trajectory of these readings over the past year, combined with predictive modelling as to the potential outcome if no preventative measures are taken, will help clinicians to present personalised patient advice.

The other important factor is the volume of the datasets used in analysis. The pool of reliable patient data must be detailed and vast in order to provide a complete picture and inform decisions. Globally it’s known that there is significant value to be had, but many researchers are still relying on synthetic datasets which mirror real-world data. This data simply fails to deliver the depth of insight delivered by real-world patient data.

It’s clear that the analysis and use of global health data can drive better patient diagnosis, treatments and ultimately outcomes. There has been a societal shift around the use of personal health data in recent months, as the value of it has been shown in the fight against COVID-19, and this change can continue to leverage benefits.

Primacy Care data is being utilised to inform patient pathways across a range of disease areas and enable better understanding of local health economies, while GPs have a chance to inform life-changing medical research, supporting research crucial to gaining insights and developing policies, and helping to highlight trends in clinical effectiveness within the NHS.

Patient data can achieve significant changes in preventative care and improve global health for the better; but it has to be the power of good data.

About the authors

Samir Dhalla is Head of THIN and Richard Ballerand is co-chair of THIN’s Patient Advisory Committee.

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Digital health firm Your.MD has secured $30 million in a Series A round investment led by the consumer health giant Reckitt Benckiser (RB).

Your.MD is the company behind the medical-grade, augmented intelligence self-care app Healthily, and will use the funding to accelerate the platform through a series of clinically-validated “health hubs”.

Following a seed funding round led by RB and existing shareholders, the now completed Series A funding round will allow the app to reach other markets including the UK, India and the US.

Healthily competes the likes of Headspace, Grateful, Happify and Shine, aiming to differentiate itself as the only such app to be classified as a Class 1 medical device.

The platform aims to provide clinical-grade information that people can use to manage their health before contacting a doctor.

The self-care app includes a chatbot that helps people to decide if they need to see a doctor after analysing the symptom information.

It also has a health library based on information from the UK’s National Health Service and the company’s own medical team.

There is a secure health journal and symptom tracker that will help people keep track of their health and store notes in complete privacy.

For those in need of medical help there is a vetted directory of healthcare products and services offered by other companies.

It also offers self-care hubs to manage and improve specific health areas or conditions and the first two hubs on sleep and general wellbeing are completely free.

Your.MD has also developed a COVID-19 Symptom Mapper, that helps people compare symptoms against global norms.

This has gathered data to help researchers from academic and public health organisations such as Imperial College and NHSx understand the virus.

The Symptom Mapper has had more than 4 million visits to date and won the CogX People’s Choice COVID-19 Best Innovation – Society Award.

The company has recruited a “power trio” of board members from tech giants Uber and PayPal to drive growth.

Three new senior hires are Geraldine Butler-Wright, who formerly worked at Imperial College and PayPal, chief digital officer David Gross, and Dan Kaziyev, previously of Uber, who takes the role of head of data and insights.

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Patient simulations have been a key tool for educating physicians in some form for hundreds of years – and now cutting-edge technologies are helping them become more realistic and informative than ever. Medscape’s Martin Warters tells us more.

Learning from a textbook can only take you so far, and when doctors need to put theory into practice in a safe environment, they often turn to patient simulations that use a case study approach to emulate real life clinical scenarios.

Modern day recognisable simulations have been used in medical education since the 18th century and have evolved into realistic and medically accurate physical and digital solutions designed to allow learners to simulate a scenario-based encounter with a patient in a safe environment.

This has ultimately led to the development of virtual patient simulations (VPS), which have become one of the most impactful ways clinicians can learn.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Sweden’s Orexo says its opioid use disorder (OUD) digital therapeutic – now christened Modia – is on course for a launch before the end of the year in the US.

Like its earlier digital therapies for alcohol misuse and depression, Modia’s earlier-than-expected rollout stems from legislation that has made it possible to secure reimbursement for certain digital products for psychiatric disorders during the COVID-19 pandemic.

It will still need to be tested from both a technical and clinical perspective before broad launch, which Orexo anticipates could take place sometime in the latter half of next year, but will start being made available for “a controlled group of patients” in the coming weeks, said Orexo on a business update call.

Modia is designed to tackle the lack of access to psychosocial support for people with OUD who are also receiving medication-assisted treatment (MAT) to help free them of their dependency.

A survey by the Substance Abuse and Mental Health Services Administration (SAMHSA) reported earlier this year found that 93% of healthcare providers think most patients receiving MAT would benefit from counselling, but only around a third (36%) said there was an adequate number of counsellors in their area.

Meanwhile, another recent study showed that 41% of patients treated with buprenorphine for OUD receiving no counselling at all.

“Modia is designed to close the gap as it relates to the access and receipt of quality, evidence-based therapeutic interventions and behavioural health services for individuals with OUD who participate in outpatient treatment with MAT,” said Michael Sumner, Orexo’s chief medical officer.

Orexo also sells drugs to combat opioid misuse, including Zubsolv (buprenorphine/naloxone), which accounts for the bulk of its revenues and is funding the development of the company’s digital therapeutics as well as a pipeline of specialty pharma products.

The epidemic of OUD in the US resulted in more than 67,000 overdose-related deaths in 2018, according to data from the Centers for Disease Control and Prevention (CDC).

All three of Orexo’s digital therapeutic products – originally developed by Germany digital health specialist GAIA – are based on cognitive behavioural therapy and other psychological approaches delivered using audio and video recordings, text, animations and illustrations to try to make treatment engaging.

Around 50% of individuals suffering from drug or alcohol addiction also report having a mental health illness, but only half receive treatment, so it makes sense to offer digital therapies across that spectrum of illnesses, said Nikolaj Sørensen, Orexo’s chief executive (pictured).

Orexo acquired US rights to Vorvida for alcohol misuse and Deprexis for depression and has been setting up a platform for distribution and reimbursement that it says will support the launch of Modia and other products in the pipeline.

The company has stepped up its involvement with Modia, claiming global rights to the brand, so will have full control over the rollout of that product if approved.

It anticipates that each of its three digital therapeutics has the potential to make between $120 million and $225 million in US net sales, said Sørensen on the call, whilst acknowledging that the market for digital therapeutics is still in its infancy.

There are still hurdles to overcome to allow those targets to be reached, he pointed out, including the best way to commercialise and price these products, and a lack of defined reimbursement and health insurance protocols for these emerging therapies.

For example, unlike medicines digital therapeutics don’t yet have a specific identifier number that can be used in the reimbursement process, despite being FDA approved.

Orexo is looking at traditional pharmaceutical reimbursement models similar to pharmaceuticals, as well as framework agreements with specific insurance companies, and for the last week or so is also offering patients the opportunity to pay for Vorvida out of pocket – a six-month subscription costs $750.

“There’s no established reimbursement and distribution process for digital therapeutics, including administration, and this is slowing down implementation,” added Dennis Urbaniak, head of digital therapeutics at the company.

Sørensen said several of the large insurance companies in the US are now hiring people to try to tackle these issues and develop pathways to handle DTX across the board, and he is hopeful that the first reimbursement agreements will take place before the end of the year, building further in 2021.

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In a world producing more content than ever before, getting information to time-poor HCPs can be incredibly difficult – even if they want to find it. Ian Daley and Jonathan Macdonald from EPG Health tell us how pharma can take cues from digital publishing and companies like Amazon to make sure their messages get heard.

We’re a long way from the times when doctors would get most of their medical information from print journals and medical meetings. Even before COVID-19, physicians were becoming more and more digitally savvy, especially as millennials entered the workforce.

But this has not necessarily made pharma’s life easier. The industry still often struggles to deliver their messages to HCPs and engage with them effectively.

“One phrase I’ve heard is that ‘information is available for those who want it, not those who need it’,” says Ian Daley, chief digital officer at EPG Health, which publishes the medical website Medthority. “If you’re hell bent on finding information, you probably will, but you’ve got to know where to look for it and invest time in reaching it, whereas people who are busy need information quickly and on a device that works for them, but have trouble finding it.”

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Swiss medical data specialist Sophia Genetics has raised $110 million in an oversubscribed funding round that will be used to boost its headcount and international presence and prepare to take its shares public.

Proceeds from the sixth-round of private fundraising will fund the growth in Asia and the US, where it already operates a subsidiary based in Boston, according to the company, which has raised $250 million since its launch in 2011. It will also be used to add to the capabilities of its data platform.

Sophia Genetics specialises in artificial intelligence-powered data mining tools that can sift through genomics data generated in DNA sequencing studies at academic institutions, and look for patterns that can be used to provide insights into diseases, guide treatment and signpost the development of new therapies.

In August, for instance, it launched a data-mining tool to try to unearth some of the many unknowns with the SARS-CoV-2 virus and predict how the COVID-19 pandemic will evolve in the coming months and years.

It is among a growing group of companies offering tools that help scientists to perform these complex genetic analyses, and its platform is already used by more than 1,000 healthcare institutions around the world, analysing 17,000 genomes a day.

“Since inception, we knew that leveraging a wide range of data modalities powered by cutting-edge technologies was key to sustainably deliver better outcomes to the global healthcare community,” said chief executive Jurgi Camblong.

“Now, with this new funding round, we can embark on the next stage of our development and take our collaborative approach further, delivering intelligent medicine together.”

Aside from hospitals and other healthcare groups, Sophia Genetics has started to attract biopharma partners, including ADC Therapeutics which tapped into its technology last year to identify genomic markers associated with clinical response to ADCT-402, a lymphoma drug.

Plans for a public listing are still in the rarely stages and Sophia Genetics says it will wait until its annual revenues top $100 million – expected in 2022 – before pressing ahead with an IPO on the Nasdaq.

The Series F round was led by aMoon, a health tech and life sciences venture fund based in Israel, with Hitachi Ventures, Credit Suisse, Pictet Group, Swisscom Ventures, Endeavour Vision, Generation Investment Management, Alychlo, Eurazeo Group, ACE & Company and Famille C Invest also named among the investors.

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Amazon has launched a fitness band, app and subscription service – called Halo – that promises to look after both your body and mind.

The e-commerce giant’s entry into the health wearables market combines monitoring of physical data such as activity levels, sleep patterns and body fat with artificial intelligence (AI) algorithms that listen for the emotion in a user’s voice.

It also claims that the voice analysis tool can help them “understand how they sound to others, helping improve their communication and relationships.”

Halo doesn’t feature a screen or notifications like trackers from Apple and Fitbit – currently awaiting approval for a $2.1 billion takeover by Google – and will be sold at $99.99 for the device and $3.99 per month for a subscription – a substantial discount to its rivals such as the new Fitbit Sense.

The Halo Band device includes an accelerometer, a temperature sensor, a heart-rate monitor and two microphones, with an LED indicator light. Amazon claims a battery life of seven days and charging in under 90 minutes, and will sell it for an introductory price of $64.99 including six months’ subscription.

“When we look at devices that track and measure our health, we’re hyper-focused on the physical elements like activity, weight, or sleep,” writes Amazon’s principal medical officer for the Halo project, Dr Maulik Majmudar, in a blog post.

“But while these are important, they don’t make up the full picture. The globally recognised definition of health includes mental and social well-being in addition to the physical,” he notes.

The Halo app suite includes Activity, Sleep and Body – the latter featuring a computer vision technology that Amazon claims can give an accurate body fat percentage measurement that is a better metric for health than body mass index (BMI).

The BFP measurement in Halo is as accurate as methods a doctor would use and nearly twice as accurate as leading at-home smart scales, according to Amazon.

The Tone app provides the voice analysis software that according to the company may reveal that a difficult work call leads to less positivity in communication with a customer’s family.

“I’ve seen team members use Tone to practice for big meetings or presentations, understand how they may sound over video conference calls, and make sure they’re conveying what they want during an important conversation,” says Majmudar.

The final app – called Labs – is a set of challenges, experiments, and workouts developed by Amazon and partner companies that Halo customers can use to build healthier habits, for example to check if having coffee in the afternoon affects sleep quality.

“Despite the rise in digital health services and devices over the last decade, we have not seen a corresponding improvement in population health in the US,” according to Majmudar.

“We are using Amazon’s deep expertise AI and machine learning to offer customers a new way to discover, adopt, and maintain personalised wellness habits.”

Halo is available on iOS and Android to customers in the US only for now. Without a subscription, the device can only be used for basic features such as measurements of steps, sleep time and heart rate.

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The world is awash with data, and while retailers and TV subscription services have perfected the art of collection and curation, public health has been trailing behind. But the advent of COVID-19 is proving to be something of a coming of age for digital epidemiology, which has been putting data from disparate sources to global use for the last 15 years.

Giving the Joseph Leiter lecture at this year’s virtual Medical Library Association (MLA) conference Harvard Medical School’s Professor John Brownstein spoke about embracing non-traditional data streams in public health.

Data inadequacies

Prof Brownstein, who is also chief innovation officer at Boston Children’s Hospital, said: “COVID-19 has put a real focus on the inadequacies of public health. At this moment, people recognise that monitoring infectious diseases, in the US or globally, is challenging because data takes time.

“People get sick, the data goes into health records, the laboratory confirmations end up in Centers for Disease Control (CDC) and the ministries of health, and eventually with world bodies. By the time you find out something is going on, it has taken weeks or months.”

Digital epidemiologists, he explained, think about how alternative, freely available data streams can “unwind the hierarchical information flow”.

“Many other industries have exploded because they’ve been able to access data,” he said. “If you’re consuming news, shopping or travelling, all the data about you and people like you is used to help you make better decisions. That exists in almost every domain except for healthcare.”

Traditional healthcare data was often fragmented, siloed, and highly localised, he added.

“Traditional sources of data really can’t cut it if you’re trying to do real time surveillance on a global scale.”

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The ongoing digital transformation of the healthcare and pharmaceutical industries has been greatly accelerated during the coronavirus pandemic. In The Medscape Professional Networks’ latest white paper, Healthcare’s New Normal: COVID Speeds Shift to Digital Communications, key opinion leaders and industry experts agree that in the post-pandemic world, even as lockdowns are lifted and restrictions relaxed, the emerging trends for an increase in digital communications will stay.

Medscape, the leading online destination for physicians worldwide, interviewed a series of respected physicians and healthcare professionals on how the pandemic has impacted the way they manage their practice and learn about new clinical advances and treatments. Dr. Kerr, professor of Cancer Medicine in Oxford, United Kingdom, emphasized that the COVID-19 pandemic has driven an enormous change in how he delivers cancer care: “there’s great momentum for our national health service to be able to embrace the new digital health technology. It has been a remarkable turnaround. And it’s here to stay.” Dr. Silverberg, a gastroenterologist in Toronto, sees this current moment as an “opportunity to embrace new technologies to make medicine and healthcare more efficient and more tech-friendly”.

The white paper also features exclusive insights from a recent Medscape survey about how the pandemic has changed the way global physicians interact with the pharmaceutical industry, including:

• 91% of physicians outside the US (OUS) report higher consumption of online medical content
• A shift to virtual interactions with pharma reps is expected, with 61% of OUS physicians anticipating a decrease in in-person meetings
• Virtual congress attendance has dramatically increased, with OUS physicians reporting a 67% increase
• 56% of OUS physicians say changes in how they use different information sources will last more than a year, if not be permanent

 

Read the full white paper, Healthcare’s New Normal: COVID Speeds Shift to Digital Communications, to discover more.

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Digital health startup Lyra Health has raised $110 million in fourth-round financing, raising its value above the $1 billion threshold for the first time since it was founded five years ago.

California-based Lyra provides mental health care services that employers can include in health care plans for their staff, and already features companies like eBay, Uber and Genentech on its customer roster.

Its platform connects employees to mental health professionals and supports them through treatment with coaching, medication management and self-care tools.

The $110 million Series D comes just a few months after a third-round fundraising that brought in $75 million, and brings the total amount raised by Lyra to $292 million.

Lyra says it is now pitching at revenues of around $100 million this year, boosted by what chief executive and cofounder David Ebersman describes as more interest than ever from employers looking to invest in better workforce mental health as the coronavirus pandemic rumbles on.

“In a normal year, companies generally wait until Jan. 1 to launch new health care benefits,” he writes in a blog post published this week which notes that the number of employers covered by its customers had doubled in the past year.  

“This year has been different. Many companies have decided their employees need better mental health services right now.”

Since the start of the COVID-19 crisis, Lyra has added 800,000 members, takings it tally to around 1.5 million.

The Series D was led by Addition and also included Adams Street Partners and existing investors, and the cash injection will be used to invest in new services such as Lyra Blended Care for conditions like depression and anxiety.

Ebersman describes the service as “teletherapy…that pairs video therapy sessions with personalised digital tools based on cognitive behavioural therapy (CBT).”

Blended Care was shown to reduce depression and anxiety symptoms in six weeks in a 385-subject study published in the Journal of Medical Internet Research last month.

“I believe we will look back on 2020 as a turning point in our collective recognition that the mental health status quo is not good enough,” says Ebersman, in a reference to data the company generated with the National Alliance of Healthcare Purchaser Coalitions in July which suggested that  83% of US employees are experiencing mental health issues.

“Too many people in need don’t have easy access to potentially life-changing treatment, “ he adds. The same National Alliance survey of 1,200 workers found that one in four said their employer does not support their mental health at all.

Image by Joakim Roubert from Pixabay

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Health insurer Humana has filed a lawsuit against telemedicine company QuivvyTech that it says resulted in fraudulent prescriptions worth millions of dollars being written for duped customers.

According to the complaint, QuivvyTech hired telemarketers to cold-call Humana members, whose details were obtained using “illegal means,” and encouraged them to talk about common ailments, claiming to be calling from Humana.

The script used by the telemarketers was designed to prompt members into describing medical conditions such as “pain and inflammation, acne breakouts, eczema or psoriasis episodes, cold sores, or conditions commonly treated with antifungal medications such as athlete’s foot,” it adds.

The company is accused of then passing on the call recordings and other information to physicians – some of whom are also named in the suit – who then prescribed medicines to the Humana patients without informing them “and never having met or spoken to them.”

“They designed pre-printed prescription forms with multiple options of pre-determined categories of medical conditions with the physician marking boxes for medications, often high-dollar cost topical creams and ointments,” claims Humana and its legal counsel.

The suit also mentions “co-conspirator pharmacies” which it claims were also in on the scam and billed, dispensed and shipped the medicines to patients, often numerous times via automatic refills.

The pharmacies aren’t named as defendants in the lawsuit because of “contractual arbitration provisions” between them and Humana, but are identified in the complaint.

Humana says it paid out between $590,000 and $2.3 million to reimburse drugs prescribed by the six doctors named in the lawsuit, for a total of almost $10 million.

The suit exposes the potential for fraud with telemedicine, which has come to the fore during the COVID-19 crisis at the same time as use of digital health approaches has skyrocketed, fuelled by increased reimbursement of virtual healthcare consultations though Medicaid and Medicare.

Some of the scams identified by a recent article in Fraud magazine include “fraudulent claims using false diagnoses, phantom patients, fake telemedicine appointments and insurance reimbursement for non-essential drugs and fictitious treatments.”

Needless to say, this type of activity undermines the benefits that can accrue from greater use of telehealth services, including reduced burden on healthcare practitioners and easier access to care for people living in remote areas or those who have mobility difficulties.

Image by Sabine van Erp from Pixabay

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It’s all go in the US telehealth sector, with Alphabet’s Google investing $100 million in Amwell on the same day the Boston-based firm unveiled plans for an initial public offering (IPO).

Google has also agreed a partnership with Amwell that makes the telehealth company its preferred partner, while Amwell in turn has agreed to switch some of its online service to Google Cloud from current provider Amazon Web Services.

The IPO aims to raise around $100 million, according to Renaissance Capital, but no pricing has been publicly disclosed yet.

Amwell is one of the larger players in the US market, providing telemedicine to more than 2,000 hospitals and 55 health plan partners with more than 36,000 employers, and recording $202 million in revenue in the 12 months ended June 30.

The coronavirus pandemic has resulted in a dramatic increase in the use of telehealth in the US and elsewhere, and in turn seems to have prompted companies to look at strategic deals to enhance their presence, and avoid falling behind the competition.

Earlier this month, Teladoc and Livongo announced an $18.5 billion merger that will create a digital health giant with pro forma sales of $1.3 billion from telehealth systems and health monitoring tools if it gets regulatory approval.

That is the largest deal ever signed in the telehealth sector, and according to analysts signals growing confidence in the continued growth of the market once the pandemic subsides. Frost & Sullivan has predicted sevenfold growth in telehealth by 2025, an annual growth rate of more than 38%.

According to data from the US Department of Health and Human Services, Medicare primary care visits delivered remotely grew from less than 1% in February of 2020 to more than 40% in April when the pandemic was starting to peak.

“The pandemic has resulted in historic telehealth utilisation, making it a priority and, in many cases, a preference for patients, providers, and health plans,” said Amwell in a statement.

“The partnership aims to make the healthcare experience much simpler and more continuously accessible to underserved populations” like seniors and patients with chronic illnesses, it added.

The partners say they plan to work together in areas such as automated waiting rooms and checkout, language translation services, and digital triage to reduce the burden on clinicians and streamline the reimbursement process.

Google Cloud’s global director of health care strategy Aashima Gupta said in a blog post that the aim is to create a future “in which your visit begins with a customised greeting and relevant information in a digital waiting room.”

A conversational chatbot would ask about symptoms and the reason for the consultation, sharing this information with a physician prior to a remote consultation. All the interactions would take place in the patient’s preferred setting with artificial intelligence (AI) providing live, translated captioning of the conversation.

Routine tasks such as filling out reimbursement forms would be automated during the visit, freeing up more time for the consultation, and the same technology could also be applied to ongoing monitoring of patients at home.

“We’ll work together to bring these solutions to market, helping expand access to virtual care among our mutual customers and the global healthcare industry,” said Gupta.

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Bayer has taken a further stake in New York-based One Drop to support its plans to become a digital health business by developing new integrated care services for patients.

The German pharmaceutical company will work with One Drop on digital health products that span multiple therapeutic areas, with Bayer citing oncology, cardiovascular diseases and women’s health as potential targets.

The agreement is worth up to $98 million and will see Bayer increase its equity stake in One Drop, as the lead investor in the company’s Series C financing, and comes a year after Bayer invested $20 million in One Drop’s Series B financing round.

This next stage of their collaboration will see the companies use One Drop’s existing platform and its data-driven predictive capabilities as the basis for ‘modular’ solutions for patients with multiple chronic and complex conditions.

Jeanne Kehren, head of digital and commercial innovation at Bayer, said: “Building new digital business models is a key element of our business strategy with the ambition to actively shape the future of healthcare.

“We are convinced that a data-driven approach will empower patients to drive better outcomes for themselves and will bring back the person, not the disease, as the point of focus.”

The collaboration with One Drop would also accelerate Bayer’s evolution towards a digital health business, she added.

Under the terms of the agreement, One Drop will receive development fees and success-based commercial milestone payments, while Bayer will be in-line for royalties on sales generated by One Drop. The deal may also see Bayer provide future support for the commercialisation of any jointly-developed digital products.

Best known for its diabetes management platform, One Drop also currently supports patients who have high blood pressure or high cholesterol. Its app has been downloaded over three million times and the company says it can draw on more than 13 billion diverse health data points from its users.

One Drop’s CEO and founder Jeff Dachis said: “To deliver better health outcomes and cost savings at a population level, we must focus on individuals. One Drop delivers a personalised health transformation programme that dynamically tunes to your needs and behaviours each day, empowering each individual to achieve the best possible health outcomes.”

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