The Digital Biomarkers & Digital Measurements East Summit

Carrie Northcott, Ph.D, is a Senior Director within the Digital Medicine and Translational Imaging (DMTI) group in Early Clinical Development (ECD) at Pfizer, located in Cambridge, MA. She leads a diverse team that is developing and evaluating novel digital endpoints using wearable technologies to better understand, monitor and evaluate physiological endpoints to increase the value of medicines and improve patients’ lives. Northcott has a diverse scientific background in pharmacology, toxicology, and physiology which provides unique insight into understanding how these endpoints provide meaningful information to patients, doctors and researchers to better treat and understand diseases. 

Northcott received her Ph.D in pharmacology and toxicology from Michigan State University and her master’s and bachelor of science degrees in agricultural sciences/agronomy from the University of Illinois. She has published numerous scientific publications in various fields of scientific study and is actively involved in various scientific societies and volunteers within the community.

Dr. Abhishek Pratap is a Senior Clinical Program Leader, CNS, at Boehringer Ingelheim. His focuses lie in understanding the personal real-world lived experience of health using digital tech-enabled solutions, and developing novel clinical-grade digital biomarkers/endpoints of real-world symptoms, severity, and triggers of health.

Previously, Dr. Abhishek Pratap led the digital health & AI research group (www.aid4mental.health) at Krembil Center for Neuroinformatics, CAMH (Canada’s largest mental health research hospital). His research focused on understanding the individualized real-world experience of mental health by developing people-augmented digital health solutions and optimal ways for deploying technology in the real world — what works for whom, when, and how long.

Dr. Pratap has collaborated with various stakeholders in the academia, pharma, and tech industry to assess empirical challenges and potential solutions to help generate robust real-world evidence from RWD. Findings from his research have extended the ongoing efforts to objectively evaluate the potential fit of technology in psychiatry in augmenting episodic clinical evaluations with frequent monitoring of mental health in the real world. 

Dr. Pratap has a Ph.D. from the University of Washington in Biomedical Health Informatics specializing in digital health. Dr. Pratap also holds additional faculty appointments at the Department of Psychiatry, University of Toronto, Vector Institute, and University of Washington, Seattle. He is also a visiting fellow at King’s College London, London.

Vivian DeWoskin is the Chief Commercial Officer at NeuraLight, where she oversees all aspects of commercial development of NeuraLight’s digital biomarker and diagnostics platform. Prior to joining NeuraLight, Vivian held multiple leadership roles at Komodo Health, where she led teams responsible for market strategy, product development, and go-to-market initiatives. Before Komodo Health, Vivian spent nearly a decade in life sciences strategy consulting at Trinity Life Sciences, focusing on helping pharma and biotech clients launch novel, innovative therapeutics to the market. Vivian holds a BA in Psychology & Neuroscience from Princeton University, and an MBA from Berkeley Haas.

Benjamin Vandendriessche is Chief Medical Officer at Byteflies, the Belgian-American company behind Sensor Dot, a powerful platform for 24/7 capture of medical insights to deliver care at home and augment clinical trials with real-world data. He is specialized in molecular biology, systems physiology, and data analytics for physiologic waveform and vital sign processing. He completed a PhD in Molecular Biology at Ghent University as an IWT Fellow, followed by a postdoc in Computer Science at Case Western Reserve University (CWRU) as a BAEF Fellow. He currently is an adjunct assistant professor at CWRU.

Sarah Ernst has 10+ years working in healthcare and digital health, and she has spent the last 4 years at Sanofi working on accelerating digital innovation. In her work at Sanofi, Sarah has worked closely to accelerate the adoption of and impact of both digital biomarkers and digital therapeutics across Sanofi’s portfolio. Prior to her time at Sanofi, Sarah worked at PatientsLikeMe, Imprivata, and the Advisory Board Company focused on improving patient care and patient experience by leveraging digital technologies. Sarah has her Masters in Engineering Management from Tufts University, and Bachelors in Neuroscience from the University of Pennsylvania.

Andy Coravos (@andreacoravos) is the CEO/co-founder of HumanFirst FKA Elektra Labs, building a digital medicine platform focusing on digital biomarkers for decentralized clinical trials. Formerly, she served as an Entrepreneur in Residence at the FDA working in the Digital Health Unit (DHU). She serves on the Board of the Digital Medicine Society (DiMe), and she’s an advisor to the Biohacking Village at DEF CON.

Jen Blankenship, PhD is a Senior Research Scientist at VivoSense, a science and analytics company that develops and validates digital clinical measures and provides end-to-end services for their delivery in regulated clinical trials. She has extensive experience deploying wearable sensors and other digital health technologies in real-world study designs to understand the impact of novel treatments and therapeutics on aspects of daily life. At VivoSense, Jen is working to develop novel digital clinical measures derived from wearable sensors that capture aspects of life that matter to patients with Alzheimer’s disease. Jen earned her BS, MS and PhD in Kinesiology at the University of Massachusetts, Amherst.

Ariel V. Dowling, PhD is a Senior Director and Head of the Sensing and Measurement group within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, her group oversees the assessment, validation, and deployment of digital devices and endpoints across the organization. She was previously a Senior Clinical Data Scientist at Biogen Inc where she managed the wearable sensors deployed in clinical trials for Parkinson’s Disease. Ariel was also the algorithm team lead at MC10 Inc and worked at BioSensics LLC. Ariel holds an MS and PhD in Mechanical Engineering from Stanford University and an AB and BE in Mechanical Engineering from Dartmouth College. She currently serves on the Strategic Advisory Board of the Digital Medicine (DiMe) Society.

Candice Taguibao is a program lead at the Digital Medicine Society. Her background in public health and experiences working in the health tech startup, clinical care, and academic research spaces have supported her current role in facilitating collaboration among diverse stakeholders to define digital measures for physical activity which are meaningful to patients. Candice received her MPH from Yale University and her BSc in Anatomy and Cell Biology from McGill University.

Alan Hamilton, PhD, joined the Foundation in early 2022 as the Senior Director of Research. As the program lead for the Foundation’s Patient Inspired Validation of Outcome Tools (PIVOT) initiative, Dr. Hamilton has a major focus on activities related to the development and evaluation of pharmacological and non-pharmacological interventions for COPD, Bronchiectasis, NTM lung disease, and other chronic lung diseases. In addition to his primary role as PIVOT lead, he also provides subject matter expertise to the Foundation on topics related to pulmonary rehabilitation, including exercise training and testing, self-management, and behavior change.

Throughout his decades-long academic and industry career, Dr. Hamilton has shown a passion for developing and evaluating interventions that target the alleviation of breathlessness and associated activity limitations in COPD. Between 2013 and 2021, he represented Boehringer Ingelheim in the COPD Biomarker Qualification Consortium (CBQC). He served as industry co-chair for the Constant Work Rate Exercise Working Group, and recently served as industry co-chair for the CBQC Steering Committee. A highlight of Dr. Hamilton’s career was his role as a global clinical program lead for a once-daily long-acting muscarinic antagonist/beta-agonist combination. He recently joined the planning committee for the American Thoracic Society Pulmonary Rehabilitation Assembly.

Dr. Kieran F. Reid, PhD, MPH, is the Director of the Laboratory of Exercise Physiology and Physical Performance at Brigham and Women’s Hospital and Harvard Medical School. Dr. Reid also serves as the Associate Director of the Function Assessment Core at the Boston Claude D. Pepper Older Americans Independence Center. He has extensive training and experience in conducting clinical trials to maintain the physical and cognitive independence of aging humans.
In addition to his undergraduate studies in Exercise Physiology, Dr. Reid possesses an MPH degree in Epidemiology and Biostatistics from Tufts University and a PhD degree in Clinical Research from Trinity College Dublin, Ireland.

Steve Berman is a Senior Director of Science & Regulatory Affairs at Biotechnology Innovation Organization (BIO), developing and proactively advancing BIO regulatory policy initiatives to promote a public policy environment that spurs biomedical innovation. 

Previously, Steve was a Director of Translational Regulatory Affairs at AstraZeneca,  where he provided strategic and operational regulatory leadership to the development, commercialization, and life cycle management of drugs and devices that leverage digital health technologies, novel methodologies, and novel biomarkers. Steve joined AZ after eight years at FDA, where his responsibilities spanned two main focus areas. He began his federal service focusing on regulatory operations, efficiency, and effectiveness and led numerous improvement efforts including the stand-up of the Oncology Center of Excellence and the creation and adoption of the 21st Century Cures Workplan.  He concluded his time at FDA focused on speeding new therapies to market through drug development tool qualification.  As a member of the Biomarker Qualification Program and the leader for the ISTAND Pilot Program, Steve worked with numerous commercial and noncommercial stakeholders to advance the adoption and qualification of both traditional biomarkers and novel tools, such as digital health technologies and microphysiological systems.  

Prior to joining FDA, Steve held a leadership role in Medical Affairs at Sucampo Pharmaceuticals and also has previous experience in supporting clinical and non-clinical efforts in drug discovery and development.  Steve completed his postgraduate studies in public health at Columbia University and his undergraduate studies in molecular and cell biology at Cornell University.

S Prasad Peri, Ph.D. is a part of the Eli Lilly and Company’s Global Regulatory Affairs Devices Team responsible for the Connected portfolio of products within the Diabetes and Immunology therapeutic areas. These include Combination Products, Devices, Software as a Medical Device and Algorithms that are in development and being currently marketed. He and his team are also responsible for the regulatory assessment of Digital Health Tools, Device Classifications, and Technical Assessments for US, Canada, EU regions. Prior to joining Lilly, Prasad Peri was a Senior Director at Teva Branded Pharmaceutical Products R&D Inc and responsible for the Chemistry, Manufacturing and Controls for Small Molecules, Biologics, Medical Devices, and Combination Products for US based submissions. Prasad Peri also worked with Merck Pharmaceuticals as a Director for Combination Products and worked with the Food and Drug Administration as a Branch Chief responsible for CMC within the Office of New Drug Products Division. Prasad Peri, holds a Bachelors in Pharmacy degree and Ph.D in Pharmaceutical Chemistry.

Robert Goldel is a neuroscientist, founder, and data-driven technologist. His research has applied behavioral and neuroimaging models to analyze core brain functions, including memory, learning, attention, and time-sensitive decisions. With Neumitra his team launched the first smart watch to measure and manage the daily physiology of the brain. Leveraging real-time biofeedback their technologies applied continuous biosensing to personalize software with statistical learning and empathic artificial intelligence. As a White House Presidential Innovation Fellow, Robert’s efforts enabled how the Food and Drug Administration is examining digital biomarkers by founding the Digital Health Platform at the Veterans Health Administration. Starting with 10,000 Veterans nationwide in wellness, psychiatry, endocrinology, cardiology, and mental health, the platform is designed to test and scale digital biomarkers with machine learning to personalize proactive care.

Robert’s work has been supported by the National Science Foundation, the National Institutes of Health, Breakout Labs at the Thiel Foundation, the Defense Advanced Research Projects Agency, the Robert Wood Johnson Foundation, and the founders and innovators of Boston Scientific, General Magic, iRobot, SmartCells, and Yahoo. As Director of Healthcare at LG Electronics, Robert launched the Hospitals-to-Homes strategy leveraging existing capabilities in hospital TVs with home entertainment to better support patients on their care journeys. Through Rock Health and MassChallenge alumnus, he has been inspired by efforts that catalyze ecosystems and infrastructures to build, grow, and sustain organizations for impacts. Robert is currently working on how the brain impacts performance, as for knowledge workers, families, enterprises, national defense, and the social impacts on education and life expectancy. With our brains we are superpowered.

Dr Stephanie Campbell is an experienced eye specialist, vision scientist and founder & CEO of OKKO Health, a digital eye care start up in Bristol, UK. Years of simultaneously working in a hospital eye clinic and studying for a PhD in the early detection of eye disease, Stephanie realised that there was a wide gap between the vision testing possible in a research setting; and what was actually available to the patients and doctors who needed it most.

OKKO’s video game apps collect lab-grade measurements of vision on a smartphone anytime and anywhere and harnesses the modern phone sensors to provide much more clinical information than a regular eye chart ever could. This has the potential to deliver early diagnosis and on-time treatment to millions, with quality eye care now possible in the comfort of the patient’s own home.

OKKO are developing digital biomarkers of visual health to power the remote monitoring, screening and diagnosis of eye disease. This is to fuel vast efficiencies in the eye care industry, driving toward high quality eye care that is affordable and accessible.

Jacqueline Lutz is a behavioral neuroscientist and digital health innovator with 10+ years of experience in academia and the digital health industry. Her academic research focused on understanding the mechanisms of mindfulness-based therapies, using various assessment methods, including neuroimaging, computerized cognitive assessments, and electronic momentary assessments in diverse patient populations.

Currently, Jacqueline is the Medical Science Lead for Mental Health at Biogen Digital Health, where she informs scientific strategy and evidence generation for digital mental health applications and assessments. She also contributes her expertise in Psychiatry and digital mental health as an Assistant Professor at Boston University School of Medicine.

Prior to Biogen, Jacqueline was the Lead Scientist for EndeavorRx, the FDA-cleared prescription digital therapeutic for pediatric ADHD at Akili Interactive. She also led the platform discovery team at Click Therapeutics, testing novel digital treatment components in fully remote, trans-diagnostic pilot trials.

Jacqueline holds a Ph.D. in Neuropsychology from the University of Zurich (Switzerland) and completed postdoctoral training at Harvard Medical School in collaboration with MGH.

Viviktha Ramesh is a physician expert in digital health currently working in the neurology and cardiology spaces at Roche to accelerate digital tool adoption. She is customer obsessed and passionate about supporting digital tool development through evidence generation, financial modeling and customer co-creation. Prior to her current role, she has launched 2 drugs at Genentech and scaled a digital health start up (THB) in India.