Assessing digital biomarker applications that could radically impact pharma's clinical research practice
By precisely and continuously measuring disease symptoms, digital biomarkers can allow pharma to establish valid endpoints for implementation in clinical trials. They are particularly relevant for diseases (such as neurological conditions) where the lack of hard endpoints have hampered product development. They will also have a role in repurposing approved products or shelved chemical entities and will deliver value from designing protocols for refining clinical operations to improving post-marketing surveillance. Where will digital biomarkers deliver real value? Which companies are driving the agenda? What are the challenges of bringing them into mainstream clinical research practice?
New technologies require new thinking and a clear understanding of the future direction this exciting technology could take. That is why in, Digital Biomarkers: Impact on future clinical development and outcomes, we interviewed leading experts to give you a clear perspective of the current thinking, technologies, applications and issues which are shaping this rapidly emerging field.
Experts explore key issues
- In what ways is the healthcare industry currently applying digital biomarkers?
- What are the specific technology platforms or digital biomarkers that are driving this field forward?
- Where have the key areas of investment and collaborations with digital biomarkers been during the last few years?
- What are the key challenges of implementing digital biomarkers as valid endpoints in clinical trials?
- What are the specific regulatory or patient-related challenges that companies need to consider when implementing a digital biomarker strategy in drug development?
- In what therapeutic areas will digital biomarkers have the greatest impact in driving health outcomes and what role will they play in the development of "pill plus" strategies?
What our experts say…
"Five years from now, I'd be astonished if we ever have a new drug come out that doesn't have some sort of digital companion that goes along with it that would augment the effect of the drug if for no other reason than to just get the medication adherence, or to monitor for side effects. If you just look at the structure of drug companies today, we now have positions for Chief Digital Officers. That never existed 15, 20 years ago, but it's incredibly important because everybody knows that technology is really lagging in the treatment of patients. We need to utilise the awesome technology that's been innovated, and include it in really the biggest health problem we face in the world, which is people living longer and having a lot of symptoms, and not being able to deal with them in a cost effective manner."
"Digital health, digital biomarkers are going to become the norm in healthcare in 10 years. It's inevitable, the question is what shape it takes and who actually wins. There's a pretty high likelihood that a non-healthcare company's going to win this. As you're thinking about your next iteration or your growth strategy I would keep in mind that you're going to be hitting up against digital innovation that's going to happen outside of the current healthcare ecosystem. The winner might be a company that is not considered a big healthcare company today. The things that you need to succeed in this market don't exist in many of today's healthcare companies. If companies are planning for their future, retooling, reskilling, thinking about new approaches and how to get that mind-set into their companies, and to think about the consumer differently. These are all going to be important as they think about their next iteration."
"I think digital biomarkers are most advantageous for early stage drug development because there, you need to know whether your drug works or doesn't work, so you can do a large phase three trial and confirm the finding. For Parkinson's disease and Alzheimer's disease, we don't know before you go to phase three whether the drug works, and this has led to some high profile, expensive failures that cost thousands of people years of their life and pharma companies millions of dollars. There's also probably room for post-marketing studies to add evidence of efficacy for drugs that are already approved or for product differentiation for marketing purposes."
Ray Dorsey, MD
University of Rochester Medical Center
What are digital biomarkers?
Digital biomarkers can provide objective, quantifiable, physiological and behavioural data that can be collected and measured by digital devices to explain, influence and/or predict health-related outcomes. Artificial intelligence and machine learning algorithms along with digital technologies will enable researchers to filter datasets to identify appropriate digital biomarkers and monitor response to medication or fluctuations in disease in both clinical and real-world settings.
What to expect
- A detailed investigation of the revolutionary role digital biomarkers could play in clinical research and the technologies/companies which are spearheading change and the challenges the sector needs to overcome
- An examination of 5 key issues which pharma and digital technology developers need to understand and respond to
- 20 targeted questions put to experts
- Their perceptive responses that provided 24 insights supported by 53 directly quoted comments
Each expert has direct experience with digital biomarkers, and has been involved in product development in the pharma sector.
- Ray Dorsey, MD, is the David M. Levy Professor of Neurology and Director of the Center for Health + Technology at the University of Rochester Medical Center. Dr Dorsey is helping investigate new treatments for movement disorders and improve the way care is delivered for individuals with Parkinson disease and other neurological disorders. Using web-based video conferencing, he and his colleagues are seeking to provide care to individuals with Parkinson's and neurological diseases where they live. Ray has a new book coming out, Ending Parkinson's Disease, that discusses the need for better, objective measures of the disease among other topics.
- Kamal Jethwani, MD MPH, is Co-Founder and Chief Product and Technology Officer at Quantiome Inc. Kamal trained as a primary care physician, and then in quantitative and qualitative public health research at Harvard School of Public Health. For the last 12 years, he has headed up digital innovation at Partners HealthCare, where his team is responsible for providing digital tools to help provide better care to patients and to empower providers to manage that care. The team focuses on AI and data analytics, and diagnostic preventative, ongoing monitoring and treatment digital biomarkers.
- Joel Sangerman, Chief Commercial Officer for Click Therapeutics has over 25 years' experience helping payers, employers, providers and suppliers achieve better patient outcomes at a lower cost of care using new health technology. As a vice president of market development at Walgreens, Joel helped insurers optimize patient-centric virtual care in the home health setting. During his tenure at Johnson & Johnson as Director of Payer Relations, Joel designed coordinated care systems to help physicians, hospitals, and suppliers deliver care with aligned incentives to benefit patients. Joel also held various positions with Sanofi Aventis working to contain the costs associated with chronic conditions such as diabetes and cardiovascular disease.
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