Appendix D
Workshop Speaker Biographical Sketches
Amy Abernethy, M.D., Ph.D., is an oncologist and internationally recognized clinical data expert and clinical researcher. As the principal deputy commissioner of food and drugs at the U.S. Food and Drug Administration (FDA), Dr. Abernethy helps oversee FDA’s day-to-day functioning and directs special and high-priority cross-cutting initiatives that affect the regulation of drugs, medical devices, tobacco, and food. As the acting chief information officer, she oversees FDA’s data and technical vision and its execution. She has held multiple executive roles at Flatiron Health and was a professor of medicine at the Duke University School of Medicine, where she ran the Center for Learning Health Care and the Duke Cancer Care Research Program. Dr. Abernethy received her M.D. at Duke University, where she did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University and her B.A. from the University of Pennsylvania and is board-certified in palliative medicine.
Chris Benko, M.B.A., is the chief executive officer and the co-founder of Koneksa Health, the leader in developing and implementing patient-focused digital biomarkers for drug development. By unlocking the potential of real-world data from remote, wearable, and other digital technologies, Koneksa speeds up the time required to understand how a drug is working, requiring fewer patients, and develops real-world evidence for how medicines can affect their daily lives. Prior to founding Koneksa, Mr. Benko was a vice president in Merck’s corporate strategy
office, working with its Global Health Innovation venture capital fund. He began his career at Merck in 1995 and progressed through roles in information technology as well as talent and organizational development, working in research and development, in commercial, and at the corporate level as vice president for global talent management.
Yvonne Yu-Feng Chan, M.D., Ph.D., FACEP, is the senior director of medical affairs for Digital Medicine at Otsuka America Pharmaceutical, Inc. (Otsuka), a national leader in digital medicine research, and is a board-certified emergency physician. At Otsuka, Dr. Chan develops advanced methods, digital tools, and technology platforms to derive real-world clinical and health economics evidence in collaboration with internal and external collaborators. She provides medical input to all aspects of product development at Otsuka’s digital medicine division. Dr. Chan leverages her 15-plus years of medical and digital health experience as a physician–scientist to help lead Otsuka’s pioneering work in digital medicine in support of patients, physicians, and caregivers.
Previously, Dr. Chan was the founding director of the Center for Digital Health at the Icahn School of Medicine at Mount Sinai. The mission of her Center for Digital Health was to drive large-scale patient participation in biomedical research and clinical care by applying the latest digital technology and advanced analytic techniques to uncover novel insights and actionable results.
Dr. Chan is an editorial board member of the Nature Partner Journals (npj) Digital Medicine and Digital Biomarker. She is also a member of the Digital Medicine (DiMe) Society’s scientific leadership board and the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements for Stroke Group. Dr. Chan received her B.A. and M.D. from Rutgers University (New Jersey Medical School) and completed her emergency medicine training at Albert Einstein School of Medicine, Long Island Jewish Medical Center. At the conclusion of her NINDS T32 Cerebrovascular Research Fellowship at Mount Sinai, she was granted the Mount Sinai Institutional KL2 Clinical and Translational Research Career Development Ph.D. Candidate award.
Michelle Crouthamel, D.B.A., is an industry thought leader in digital health with a broad spectrum of research and development experience spanning drug discovery, clinical development, project management, and digital health initiatives. Her passion for driving patient centricity/precision medicine in the pharmaceutical industry led her to become an “intrapreneur” at GlaxoSmithKline and the founding member of its clinical innovation unit, which focuses on harnessing digital technologies and platforms to improve clinical evidence generation and optimize trial
operation. Ms. Crouthamel is currently the director of digital health and innovation at AbbVie Inc., leading digital health strategy and implementation. She is also involved in the industry-wide consortium, including TransCelerate, Innovative Medicine Initiative, and the Digital Medicine Society. Over the past 15-plus years, Ms. Crouthamel led many successful programs in discovery and development. She is an inventor who holds multiple patents and has published extensively in the areas of neuroscience, oncology, and digital health.
Ms. Crouthamel has a bachelor’s degree in nursing, a master’s degree from the Institute of Neuroscience, and a doctorate from the Temple University Fox School of Business, with a research focus on measuring the firm performance of patient centricity in the pharmaceutical industry.
Luca Foschini, Ph.D., M.S., is the co-founder and the chief data scientist at Evidation Health, responsible for data analytics and research and development. At Evidation he has driven research collaborations resulting in numerous publications in the fields of machine learning, behavioral economics, and medical informatics. Previously, Dr. Foschini held research positions in industry and academic institutions, including Ask.com, Google, ETH Zurich, and the University of California, Santa Barbara. He has co-authored several papers and patents on efficient algorithms for partitioning and detecting anomalies in massive networks. He holds an M.S. and a Ph.D. in computer science from the University of California, Santa Barbara, and an M.E. and a B.E. from the Sant’Anna School of Advanced Studies–Pisa, Italy.
Ritu Kapur, Ph.D., is the head of digital biomarkers at Verily Life Sciences (formerly Google Life Sciences), a translational research and engineering organization focused on improving health care by applying scientific and technological advances to significant problems in health and biology. She serves as a cross-functional lead across hardware, software, clinical operations, and data science to develop and implement initiatives that use wearable and passive sensing technology to help better diagnose, monitor, and intervene in disease. Dr. Kapur received a bachelor’s degree (cum laude) in human biology from Stanford University and a doctorate in neuroscience from the University of California, San Francisco, where she specialized in using in vivo awake behaving electrophysiology and signal processing to study the brain systems underlying reward and learning. Prior to joining Verily, she served as a senior clinical research scientist focused on the analysis of biosensor (electrocorticographic) and clinical trial data to provide support for physicians in selecting, implanting, and optimizing therapy with an implantable closed-loop brain stimulator for the treatment of epilepsy.
Sean Khozin, M.D., M.P.H., is an oncologist, a physician–scientist, and a research affiliate at the Massachusetts Institute of Technology. Dr. Khozin is the global head of data strategy for Janssen/Johnson & Johnson, focusing on the incorporation of data science and advanced quantitative methods (including artificial intelligence and machine learning) into research and development (R&D) activities. He joined the company from the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, where he built and led the center’s bioinformatics capabilities and efforts. He was also the founder of Information Exchange and Data Transformation, FDA’s first data science and technology incubator for de-risking solutions through internal R&D and strategic partnerships for improving global biomedical research and advancing national public health priorities. Prior to his tenure in federal government, Dr. Khozin was the co-founder of Hello Health, developing an integrated telemedicine, point-of-care data visualization, and analytical platform for optimizing patient care and clinical research. The company’s core technology offerings were first operationalized in a multidisciplinary network of clinics called SKMD, which he founded and for which he served as the chief medical officer.
Christopher Leptak, M.D., Ph.D., completed his M.D. and Ph.D. in microbiology/immunology at the University of California, San Francisco. After a residency in emergency medicine at Harvard’s combined Mass General and Brigham program, he joined the U.S. Food and Drug Administration in 2007 as a primary reviewer in the Office of New Drugs (OND) division of gastroenterology products, focusing on immunomodulators for inflammatory bowel diseases. In 2010 he joined OND’s guidance and policy team and became OND’s biomarker and companion diagnostics lead. His focus is on biomarker and diagnostic device utility in clinical trials and drug development, both for drug-specific programs. Dr. Leptak is the director of the Center for Drug Evaluation and Research’s biomarker qualification program, which is intended to improve regulatory consistency and policy development in areas of emerging science and technology.
Chris Lunt is the chief technology officer for the All of Us Research Program at the National Institutes of Health (NIH). All of Us is an effort to build a national, large-scale research enterprise with 1 million or more volunteers to extend precision medicine to all diseases. He has 20-plus years of experience designing web services and data platforms. He joined NIH from GetInsured, where he served as the vice president of government solutions. There, he worked with the federal government, states, and the vendor community to improve health insurance shopping and enrollment systems. He also worked as an entrepreneur for the Department of Health and Human Services. Earlier in his career he led an initial
public offering, and he invented more than 10 social networking patents now owned by Facebook.
Camille Nebeker, Ed.D., M.S., is an associate professor of behavioral medicine in the Department of Family Medicine and Public Health in the School of Medicine at the University of California, San Diego. Her research and teaching focus on two intersecting areas: community research capacity building (e.g., citizen science and community engaged research) and digital health research ethics (e.g., consent, privacy expectations, data management). She co-founded and directs the Research Center for Optimal Digital Ethics and leads the Building Research Integrity and Capacity programs and the Connected and Open Research Ethics initiative. Dr. Nebeker’s research has received continuous support from government, foundation, and industry sources since 2002.
Sally Okun, R.N., M.M.H.S., joined UnitedHealth Group Research and Development (UHG R&D) in 2020 to focus on policy and ethics with an emphasis on patient and consumer participation in care, research, and policy. Prior to joining UHG R&D, Ms. Okun was the vice president for policy and ethics at PatientsLikeMe. In her 12-year tenure she led the development of the company’s health data integrity, patient voice taxonomy, drug safety, and pharmacovigilance monitoring platform; the research collaboration agreement with the U.S. Food and Drug Administration; and the ethics and compliance advisory board. Ms. Okun advances the science of patient participation and integration of patient perspective into diverse health policy initiatives at the national and global level. She is a member of numerous expert and advisory boards, including the National Academy of Medicine’s Leadership Consortium for a Value and Science-Driven Health Care System; Public Responsibility in Medicine and Research Public Policy Committee; Duke-Margolis Center for Health Policy Real World Evidence Collaborative Advisory Group; and International Consortium for Health Outcomes Measurement Patient-Reported Outcome Measures National Steering Committee. Prior to joining PatientsLikeMe she practiced as a community-based palliative and end-of-life care specialist. Ms. Okun completed her graduate studies at the Heller School for Social Policy and Management at Brandeis University. She was a 2010 fellow in biomedical informatics for the National Library of Medicine and a 2014 Salzburg Global Fellow in New Paradigms for Behavioral and Mental Health.
Larsson Omberg, Ph.D., as the vice president of systems biology at Sage Bionetworks, oversees a research agenda that focuses both on genomics and on participant-centered research, where data are 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 genomics analysis and disease modeling. Dr. Omberg obtained an M.Sc. in engineering physics from the Royal Institute of Technology in Stockholm Sweden and a Ph.D. in physics from The University of Texas at Austin before performing a postdoctoral fellowship in computational biology and biostatistics at Cornell University.
Eric Perakslis, Ph.D., is a Rubenstein Fellow at Duke University, where his work focuses on collaborative efforts in data science that span medicine, policy, engineering, data science, information technology, privacy, and security. Dr. Perakslis is also a lecturer in the Department of Biomedical Informatics at Harvard Medical School and a strategic innovation advisor to Médecins sans Fontières. Prior to his current role, Dr. Perakslis served as the chief science officer at Datavant and was the senior vice president and head of the Takeda Research and Development Data Science Institute. Prior to Takeda, he was the executive director of the Center for Biomedical Informatics and the Countway Library of Medicine, and before that he served as the chief information officer and chief scientist (informatics) at the U.S. Food and Drug Administration (FDA). In this role, Dr. Perakslis authored the first information technology (IT) strategic plan for FDA and was responsible for modernizing and enhancing the IT capabilities as well as in silico scientific capabilities at FDA. Prior to his time at FDA, Dr. Perakslis was the senior vice president of research and development (R&D) information technology at Johnson & Johnson Pharmaceuticals R&D. Dr. Perakslis has a Ph.D. in chemical and biochemical engineering from Drexel University. He also holds a B.S.Ch.E. and an M.S. in chemical engineering.
Edmondo Robinson, M.D., M.B.A., F.A.C.P., serves as the senior vice president and the chief digital innovation officer for Moffitt Cancer Center. Dr. Robinson is responsible for expanding Moffitt’s ecosystem from within and outside of health care to deliver on consumer-oriented, real-world solutions for clinical practice, research, and administrative processes essential to support growth and competitive advantage. He also oversees Moffitt’s portfolio of digital innovation, including the development and commercialization of health products, tools, and technology. With this role, Moffitt aims to create and test new services, programs, partnerships, and technologies that apply digital innovations, while challenging the status quo to reduce the cost of care, improve quality, increase access to care, and enhance the patient experience. Previously, Dr. Rob-
inson was the chief transformation officer and the senior vice president of consumerism at ChristianaCare, one of the largest health systems in the mid-Atlantic. He was responsible for the transformation of health care delivery to advance population health initiatives and the move from volume-based to value-based care with a special focus on developing and managing ChristianaCare’s consumerism and digital strategies. Dr. Robinson is an associate professor of medicine at Thomas Jefferson University’s Sidney Kimmel Medical College and an adjunct senior fellow in the Leonard Davis Institute of Health Economics at the University of Pennsylvania. He is also a fellow of the American College of Physicians and a senior fellow of the Society of Hospital Medicine. He holds a medical degree from the David Geffen School of Medicine at the University of California, Los Angeles; an M.B.A. with an emphasis in health care management from the Wharton School at the University of Pennsylvania; and a master’s degree in health policy research from the University of Pennsylvania.
Christina Silcox, Ph.D., is a managing associate at the Duke-Margolis Center for Health Policy, working on policy solutions to advance innovation in health and health care and improve the regulation, reimbursement, and long-term evaluation of medical products. Dr. Silcox’s portfolio includes multiple areas in digital health policy and real-world evidence, with a focus on medical devices. Currently, she is concentrating on challenges to regulating and adopting artificial intelligence–enabled software as a medical device, using mHealth to collect real-world data, and characterizing real-world data quality and relevancy. Her projects have included the use of patient-generated health data in medical device evaluations, the exploration of value-based payments for medical devices, and convening the National Evaluation System for Health Technology planning board.
Before she joined Duke-Margolis, Dr. Silcox was a senior fellow at the National Center for Health Research, focused on federal regulation of and policies for medical products. She earned an M.S. from the Massachusetts Institute of Technology (MIT) in electrical engineering and a Ph.D. in medical engineering and medical physics from the Harvard–MIT Division of Health Sciences and Technology.
Alicia Staley, M.B.A., M.S.I.S., is the senior director of patient engagement for mHealth at Medidata. She has more than 20 years of experience in software design and information systems management and works to infuse the patient perspective throughout the product development lifecycle and to help engage patients in novel ways. Ms. Staley is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years she has applied her
engineering background to improve the patient experience for those dealing with cancer. With an extensive network of patient advocates and nonprofit organizations, she collaborates with a wide range of stakeholders to improve processes and policies that affect patient care and clinical trials. She has co-led several research studies on how patients share information in online forums and seek out clinical trial opportunities. An early adopter of social media, she co-founded #BCSM, which attracts more than 250 global participants each week to its scheduled online discussions. This foundational online social media support channel is recognized as the gold standard for disease-specific social media networks. Prior to joining Medidata, Ms. Staley worked at Cure Forward and Science 37, leading their patient recruitment and engagement initiatives to help advance clinical research. As a champion of patient advocacy and engagement, she understands the critical issues facing patients looking to engage in clinical research. With a keen focus on improving access to clinical trials, Ms. Staley is passionate about making a difference for all patients searching for information about clinical trials.
