The Digital Biomarkers & Digital Measurements East Summit

Jennifer C. Goldsack co-founded and serves as the CEO of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Jennifer’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine and serves on the World Economic Forum Global Leadership Council on mental health.

Previously, Jennifer spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System.

Jennifer spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware.

Jennifer earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Jennifer is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

Anders heads a business entity within Sony that provides connected solutions
leveraging 4G/5G IoT communication technology for application areas such as mobile
health and safety. The vision is to be a facilitator and front-runner for next-generation
digital biomarker solutions.
Anders has a background from the med tech industry and has worked in several major
companies, among them Hewlett-Packard, Siemens and HemoCue. Anders has also
experience from the telecom and cybersecurity industry where he has worked in
several start-up companies providing application platforms, application and consulting
since 2000. This includes companies like Advenica, Appium/Aepona, MIMT, Heyhop,
Bluelabs and moveAround.
Anders has held management functions within business development, R&D and
product management.
The Health Solution Division was established in 2019 as a result from an innovation
competition within Sony and is driven by Anders.
https://www.linkedin.com/in/andersstromberg/
https://sonynetworkcom.com/msafety/

Anzar Abbas is a neuroscientist focused on developing technology to improve measurement of health. He is Director of Digital Solutions at Cambridge Cognition, where he is helping develop a comprehensive bank of validated digital cognitive assessments for use in any context.

Carrie Northcott, PhD is a Director/ Project Lead within Digital Medicine and
Translational Imaging (DMTI), Early Clinical Development (ECD) at Pfizer. She
leads a driven and diverse team that is evaluating and validating the use of
wearable digital devices to more fully understand and characterize
physiological endpoints, such as quantitatively measuring night-time scratch
and sleep. Carrie has a diverse scientific background in Pharmacology,
Toxicology, and Physiology which provides unique insight into understanding
how these novel digital endpoints provide meaningful information to patients,
doctors and researchers to better treat and understand diseases.

Wasim is the Managing Partner at Iaso Ventures, a Boston-based venture capital firm investing at the intersection of life sciences and technology. He serves on the clinical trial leadership at Massachusetts General Hospital as the Director of Biomarker Research, and on the psychiatry faculty at Harvard Medical School. He previously served as the Chief Digital Strategist at Roivant Sciences. He currently sits on the board of the Epilepsy Foundation, Scaffold Therapeutics, Altimate Health, ClexBio and BioTrak Health, and is a Senior Advisor on life sciences at Health Catalyst. With over 100 research publications and patents, he serves on the Steering Committee of the NIH EPPIC-Net and IEEE Brain Initiative, the grant review panels for NSF and NASA TRISH, and the national scientific research councils of 6 countries. He received his doctorate from Oxford, postdoctoral training at MIT, and business education at HBS.

Michelle Holko, PhD, PMP, is a strategic innovator working at the intersection of biology, technology, and security. She is currently a Principal Architect and Scientist at Google working as the technical lead with the Google Cloud healthcare and life sciences team. She also holds a PI appointment at the International Computer Science Institute (ICSI) at Berkeley, leading a research area at the intersection of biotech and cybersecurity. Prior to joining Google, she served in government as a Presidential Innovation Fellow (PIF), during which time she worked with the Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA), the Department of Defense (DoD) Chemical and Biological Defense Program (CBDP), the NIH’s All of Us Research Program, HHS BARDA, OSTP and NSC. Prior to joining the PIF program, she worked with DARPA and HHS BARDA, and was a fellow in the 2018 cohort of Johns Hopkins University’s Center for Health Security’s Emerging Leaders in Biosecurity Initiative. She has also served as a Staff Scientist at NIH’s NCBI, working with the primary data archives to promote re-use and re-analysis of biomedical research data. Dr. Holko’s technical expertise is in genomics and bioinformatics, and she has experience working on pandemic prevention and preparedness, infectious diseases, cancer, biosurveillance, biosecurity, data science, emerging technologies, health technologies, precision medicine, cybersecurity, and machine learning/artificial intelligence. Dr. Holko is an inclusive, empathetic leader, interested in building security into biotechnology and health innovations to promote innovations in biomedical research. She has spent her career leveraging technology to foster scientific discovery.

• Dr. Arnal is Dreem received his Ph.D. in Sleep Physiology at the French Army Biomedical Research Insitute and the University of Lyon-Saint Etienne in France. He has directed clinical trials in sleep with healthy subjects and patients with insomnia and sleep apnea, co-authored 40+ original research publications, and serves as a reviewer for numerous scientific journals in the field of sleep and neuroscience. He is also co-author of different magazine articles, blogs, and books for the general public, including Sleep for Dummies (French edition).

Dr. Abhishek Pratap leads the digital health & AI research group (www.aid4mental.health) at Krembil
Center for Neuroinformatics, CAMH (Canada’s largest mental health research hospital). His research
focuses 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.

Before joining CAMH, Dr. Pratap was a Principal Scientist, Digital Health at Sage Bionetworks (A
Seattle-based non-profit). At Sage, he led the design & deployment of many real-world studies to
evaluate long-term disease trajectories in neurological and psychiatric disorders. 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.

VivoSense VP Marketing and Strategy VP Marketing Strategy at Vivosense. Digital Health expert with extensive experience in wearable sensor hardware and software technology, algorithm and digital endpoint development and the clinical and regulatory environment. Former Research Business Director for MindMed and HealthMode.  Former Senior VP Business Development and Corporate Strategy for ActiGraph. Led Actigraph’s strategy and business development and created a leading hardware and software wearable ecosystem for the clinical trial and academic research markets. Former Head of Healthcare Corporate Finance and director of healthcare venture fund relationships at both First Union and RBC Capital Markets for the Royal Bank of Canada. Directed financing for over $3 billion in funding for a wide range of companies in the biotechnology, medical technology, and healthcare service industries.

B.S. Vanderbilt University

MBA  University of Virginia Darden School of Business

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.

Before joining Vivosense, Ieuan Clay initiated and led the Digital Endpoints group within Novartis Research, implementing new digital measures into clinical trials and advancing the qualification of real-world gait speed with the European Medicines Agency (EMA). At Evidation Health, he helped design and build the Heart Health on Achievement health programs in collaboration with the American College of Cardiology. He served as Chief Scientific Officer for the Digital Medicine (DiMe) society, responsible for scientific strategy and output.

Siva is the President and Co-Founder of JOGO Health, a digital therapeutics company that uses wearable sensors and AI to treat chronic pain and neuromuscular conditions.

Siva has over 23 years of experience in healthcare. His previous venture, an AI based drug and vaccine safety monitoring platform was acquired by IQVIA, where he served as a global head and general manager for six years.  Siva has two patents related to AI in healthcare. In 1998, Siva was recognized for uncovering two major internet security holes, which forever changed how users logged into Internet sites from public computers.

Siva has spoken at major healthcare conferences in 20+ countries.

Larsson Omberg is a VP at Sage Bionetworks and head of Sage’s Digital Health Research Group.  He  oversees a research agenda that focuses both on genomics and participant centered research where data is being collected using remote sensors and mobile phones. The group focuses heavily on using open and team based science to get a large number of external partners to collaborate on data intensive problems. Dr. Omberg has a background in computational biology and has been developing computational methods for disease modeling, populatione genetics and digital biomarkers. Dr Omberg obtained a MSc in Engineering Physics from the Royal Institute of Technology in Stockholm Sweden and a PhD. from the University of Texas at Austin in Physics before performing a postdoctoral fellowship in Computational Biology and Biostatistics at Cornell University.

Sarah Ernst has 10+ years working in the 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 work 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

Dr. Arthur Combs is physician executive in the Life Sciences and a serial entrepreneur. His lengthy career has been equally divided between clinical practice and bringing new medical products to market. He has served as an Officer of 5 successful medical device start-ups and EVP, R&D for a Fortune 500 company. Over the past 5 years Art has been immersed in the wearables – real-world data – digital biomarkers space. He has worked with Big Pharma, DCT designers and academia in the development of real-world biometrics that can be established as disease specific digital biomarkers, and ultimately used as digital endpoints for clinical trials.

Dexter Hadley, MD/PhD has expertise is in translating big data into precision medicine and digital health. His research generates, annotates, and ultimately reasons over large multi-modal data stores to develop clinical intelligence, identify novel biomarkers and potential therapeutics for disease.  He earned his PhD in genomics and computational biology while at medical school at PENN, and he trained in clinical pathology while at residency at Stanford. He first became faculty at University of California San Francisco where he was won various grant funding for developing deep learning methods in medicine including over $5M from NIH.  His contributions have yielded well over 60 peer reviewed publications.  Dr. Hadley is the Founding Chief of AI at UCF College of Medicine and he will introduce his vision for Community Driven AI and share how his team is building a community of patients, clinicians, and data scientists that is needed to make this concept a reality.

Krishna is a physician-scientist, business oriented R&D leader with a wealth of U.S. and global life science industry experience in Medical affairs, Clinical development, academic research, and pharmacovigilance across multiple therapeutic categories. A collaborative and outcomes oriented leader, Krishna’s efforts have contributed to revenue growth through innovation and pipeline development, Rx to OTC Switch, clinical trial design and execution, medical affairs, scientific engagement and stakeholder outreach. Krishna has also successfully managed several FDA and international health authority submissions.

Krishna currently serves as Senior Clinical Lead within the Motion Biosensors Group at Philips Healthcare with global responsibility for ensuring scientific accuracy and value in various external facing engagements, scientific strategy, innovation, clinical development, algorithm validation, FDA engagement and interactions, and streamlining several commercial and sales scientific initiatives. Prior to joining Philips HealthCare, Krishna served in various roles at Merck and Bayer including Global Medical Strategic Director for upper respiratory, switch categories, white space, and women’s health portfolio, Clinical Development lead, and Pharmacovigilance officer. Earlier in her career, Krishna was also a medical writer with Care Management International.

Krishna earned her PhD in neuropharmacology from Southern Illinois University School of Medicine in Carbondale. Prior to this, Krishna also earned her Doctor of Medicine (MD) degree in Family Medicine from Bombay University in India. She has held various research positions at the Johns Hopkins University and University of Virginia in areas of neurodegenerative disorders and cardiovascular research.

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.

Everett leads the commercial organization at Cognito Therapeutics, a clinical-stage company developing a pipeline of disease-modifying therapeutics addressing novel neuro-electrical targets that have proven pathologies in neurodegenerative disorders, including Alzheimer’s disease. Prior to Cognito, Everett held the position of Chief Commercial Officer at AppliedVR, and has also previously served in executive leadership roles at leading digital therapeutic, pharmaceutical, and biotech companies. Everett currently serves on the board of the Digital Therapeutics Alliance.

Jessica Robin is the Director of Clinical Research at Winterlight Labs, leading the research and development of speech-based digital measures. Jessica has a PhD in cognitive neuroscience from the University of Toronto, and over ten years experience conducting behavioural and neuroscientific research on topics including cognition, neurodegenerative disease and psycholinguistics.

riel 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.

Tom is a Principal Scientist and leads the Digital Health efforts in Genentech’s Early Clinical Development organization. His current focus is on delivering a digital health technology strategy focusing on supporting digital health technology enabled endpoint development across the Genentech early development portfolio. Tom has over 22 years of clinical development experience, including 8 years of experience in developing and deploying digital technologies in clinical trials. He has been at Genentech since 2010 serving in a variety of roles within clinical operations, clinical trial innovation, and now digital health. An exercise physiologist by training and an avid bicycle racer since he was 16, he has been continuously tinkering with the various digital gadgets on himself before testing them on other people. He lives in San Mateo, CA with his wife Elizabeth and 4 young children.