Appendix C
Planning Committee Biographical Sketches
Jennifer Goldsack, M.Chem., M.A., M.B.A. (Co-Chair), is the interim executive director at the Digital Medicine Society, a new professional organization promoting the adoption of digital technologies for health. Previously, Ms. Goldsack spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led the development and implementation of several projects within CTTI’s mobile program and was the operational co-lead on the first randomized clinical trial using the U.S. Food and Drug Administration’s Sentinel System. Ms. Goldsack spent 5 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, Ms. Goldsack helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Ms. Goldsack earned her master’s degree in chemistry from the University of Oxford, England, her master’s degree in the history and sociology of medicine from the University of Pennsylvania, and her M.B.A. from The George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms. Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.
Joseph P. Menetski, Ph.D. (Co-Chair), received his Ph.D. from the Northwestern University Feinberg School of Medicine with Dr. Stephen Kowalczykowski and completed his postdoctoral training at the Laboratory
of Molecular Biology at the National Institutes of Health with Dr. Martin Gellert. He then started his career in industry in 1993 in the immunopathology department at Parke-Davis (later Pfizer), where he established a discovery research program in cellular inflammation that eventually transitioned to the molecular study of osteoarthritis. Dr. Menetski moved to Merck in 2004. His first position was in the Department of Immunology, where he was involved in the osteoarthritis new targets and biomarker program. While at Merck he has been a member of the molecular profiling group, a member of the knowledge discovery and knowledge management group, and, finally, a director in global competitive intelligence. Over the years he has been a key contributor to many basic research and clinical programs in the areas of arthritis, sarcopenia, osteoporosis, and asthma. He has served as a core research team member on several external basic research projects for the identification of new targets and molecular biomarkers. His industry research and development experiences include target identification, compound selection, translational biomarker identification, clinical study design and analysis, and external scientific collaborations. In the commercial space he has been intimately involved in opportunity and asset identification and qualification and in assessing the competitive landscape of disease areas that he is supporting. During this time, he has been recognized by multiple research and development awards for his contributions.
Linda Brady, Ph.D., serves as the director of the Division of Neuroscience and Basic Behavioral Science at the National Institute of Mental Health (NIMH) at the National Institutes of Health (NIH). In this role she provides scientific, programmatic, and administrative leadership for an extramural research program portfolio in basic neuroscience to support NIMH’s mission of transforming the understanding and treatment of mental illnesses. Dr. Brady has directed programs in neuropharmacology, drug discovery, and clinical therapeutics and has organized consortia focused on ways to accelerate the development and clinical application of radiotracers in clinical research. She has provided leadership for many programs, including Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of Central Nervous System Disorders, the National Cooperative Drug/Device Discovery/Development Groups for the Treatment of Mental Disorders, and First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders. Dr. Brady serves as the co-chair of the neuroscience steering committee for the Biomarkers Consortium, a public–private research partnership of the Foundation for the National Institutes of Health that focuses on discovery, development, and qualification of biological markers to support
drug development, preventive medicine, and medical diagnostics. From 2004 to 2013, she co-led the Molecular Libraries and Imaging Program, a trans-NIH Common Fund initiative to provide biomedical researchers access to small organic molecules that can be used as chemical probes to study the functions of genes, cells, and biochemical pathways in health and disease. Dr. Brady was trained in pharmacology and neuroscience. She completed her Ph.D. at the Emory University School of Medicine, followed by postdoctoral work and research positions at the Uniformed Services University of the Health Sciences and the NIMH intramural research program. She is the author of more than 70 peer-reviewed scientific publications and is a member of the Society for Neuroscience and a fellow in the American College of Neuropsychopharmacology. Dr. Brady has received NIH director’s awards and NIH merit awards in recognition of her activities in biomarker development and drug development for mental disorders.
Ray Dorsey, M.D., M.B.A., is a professor of neurology and the director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center. Dr. Dorsey is investigating new treatments for movement disorders and is working on ways to improve the way that care is delivered for individuals with Parkinson’s disease (PD) and other neurological disorders. Using simple web-based video conferencing, he and his colleagues are seeking to provide care to individuals with PD and neurological diseases. Dr. Dorsey’s research has been published in leading medical and neurology journals and has been featured on National Public Radio and in The New York Times and The Wall Street Journal. He previously directed the movement disorders division at Johns Hopkins University and worked as a consultant for McKinsey & Company. He completed his undergraduate studies at Stanford University, business school at the Wharton School, and medical school at the University of Pennsylvania.
Deborah Estrin, Ph.D., M.S., is the Robert V. Tishman ‘37 Professor at Cornell Tech and in the Department of Computer Science at Cornell University and currently serves as the associate dean for impact at Cornell Tech. She is the founder of the Health Tech Hub and directs the Small Data Lab at Cornell Tech, which develops new personal data application programming interfaces and applications for individuals to harvest the small data traces they generate daily. Dr. Estrin is also the co-founder of the nonprofit startup Open mHealth.
Previously, Dr. Estrin was on the University of California, Los Angeles, faculty where she was the founding director of the National Science Foundation Center for Embedded Networked Sensing, pioneering the development of mobile and wireless systems to collect and analyze real--
time data about the physical world and the people who occupy it. Dr. Estrin was chosen as a 2018 fellow of the MacArthur Foundation.
Geoffrey Ginsburg, M.D., Ph.D., is the founding director for the Center for Applied Genomics & Precision Medicine at the Duke University Medical Center. He is also the founding director for MEDx, a partnership between the schools of medicine and engineering to spark and translate innovation. He is a professor of medicine, pathology, and biomedical engineering and a professor in the Duke University School of Nursing.
While at Duke, Dr. Ginsburg has pioneered translational genomics, the development of novel diagnostics, and precision medicine, initiating programs in genome-enabled biomarker discovery, longitudinal registries with linked molecular and clinical data, biomarker-informed clinical trials, and the development of novel practice models and implementation research for the integration of genomic tools and digital health technologies into heath care delivery systems.
In 1990 he was recruited to the faculty of the Harvard Medical School, where he was the director of preventive cardiology at Beth Israel Hospital and led a laboratory in applied genetics of cardiovascular diseases at Boston Children’s Hospital. In 1997 he joined Millennium Pharmaceuticals Inc. as the senior program director for cardiovascular diseases and was eventually appointed the vice president of molecular and personalized medicine, where he was responsible for developing pharmacogenomic strategies for therapeutics as well as biomarkers for disease and their implementation in the drug development process.
He has received a number of awards, including the Innovator in Medicine Award from Millennium in 2004, the Basic Research Achievement Award in Cardiovascular Medicine from Duke in 2005, and the ILCHUN Molecular Medicine Award from the Korean Society for Biochemistry and Molecular Biology in 2014. In 2015 he was an honored speaker at the White House Champions for Change in Precision Medicine. He received Duke’s Research Mentoring Award in 2017. He is a founding member and a former board member of the Personalized Medicine Coalition, a section editor for the Journal of the American College of Cardiology, and an editorial advisor for Science Translational Medicine. In addition, he is the editor of Genomic and Personalized Medicine (Elsevier), whose third edition was published in 2016. He is a member of the Faculty of 1000. He has been a member of the Department of Veterans Affairs’ Genomic Medicine Program Advisory Committee; a member of the National Institute of General Medical Sciences External Scientific Panel for the Pharmacogenomics Research Network; the Board of External Experts for the National Heart, Lung, and Blood Institute; the National Advisory Council for Human Genome Research at the National Institutes of Health (NIH); the Advisory
Council for the National Center for Advancing Translational Sciences at NIH (where he was the vice chair for the Cures Acceleration Network Board); and the World Economic Forum’s Global Agenda Council on The Future of the Health Sector. He is the co-chair of the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Genomics and Precision Health and the co-chair of the Global Genomic Medicine Collaborative and is a member of the Advisory Committee to the Director of NIH.
Husseini K. Manji, M.D., FRCPC, is the global therapeutic head for neuroscience at Janssen Research & Development, LLC, one of the Johnson & Johnson pharmaceutical companies. He is also a visiting professor at Duke University. Dr. Manji was previously the chief of the Laboratory of Molecular Pathophysiology & Experimental Therapeutics at the National Institutes of Health (NIH) and the director of the NIH Mood and Anxiety Disorders Program, the largest program of its kind in the world.
The major focus of Dr. Manji’s research is the investigation of disease- and treatment-induced changes in gene and protein networks that regulate synaptic and neural plasticity in neuropsychiatric disorders. His work has helped to conceptualize these illnesses as genetically influenced disorders of synaptic and neural plasticity and has led to the investigation of novel therapeutics for refractory patients. Notably, Dr. Manji’s research demonstrated that AMPA- and NMDA-mediated synaptic plasticity may underlie the pathogenesis of depression and that targeting these pathways may produce robust and rapid antidepressant effects. Under his leadership this has led to the approval by the U.S. Food and Drug Administration of the first novel antidepressant mechanism (NMDA-antagonism) in decades. Spravato (an NMDA antagonist) was demonstrated to produce robust and rapid antidepressant effects and is approved for treatment-resistant depression. Phase III studies investigating its efficacy in the treatment of suicidal ideation are under way.
Dr. Manji has received a number of prestigious awards, including the National Institute of Mental Health Director’s Career Award for Significant Scientific Achievement, the A.E. Bennett Award for Neuropsychiatric Research, the Ziskind-Somerfeld Award for Neuropsychiatric Research, the National Alliance for Research on Schizophrenia & Depression Mood Disorders Prize, the Mogens Schou Distinguished Research Award, the American College of Neuropsychopharmacology’s (ACNP’s) Joel Elkes Award for Distinguished Research, the Depression and Bipolar Support Alliance Klerman Senior Distinguished Researcher Award, the Briggs Pharmacology Lectureship Award, the American Federation for Aging Research Award of Distinction, the Caring Kind Alzheimer’s Disease Leadership Award, and the Global Health & the Arts Award of Recog-
nition. He has received Pharmaceutical Research and Manufacturers of America’s Research & Hope Award for Excellence in Biopharmaceutical Research and has also been recognized as one of 14 inaugural “Health Heroes” by Oprah magazine.
Dr. Manji has been inducted into the National Academy of Medicine (NAM) and the World Economic Forum (WEF) Global Future Councils and has held numerous leadership positions within the NAM, the Foundation for the NIH Biomarkers Consortium executive committee, ACNP, and the Society of Biological Psychiatry.
Throughout his career, Dr. Manji has also been committed to undertakings related to medical and neuroscience education and has worked with the National Board of Medical Examiners, the Howard Hughes Medical Institute Research Scholars Program, and numerous national curriculum committees. He founded and co-directed NIH’s Foundation for the Advanced Education in the Sciences graduate course in the Neurobiology of Neuropsychiatric Illness and has received several teaching and mentoring awards. He has also served as the editor and on editorial boards of numerous scientific journals.
Dr. Manji has published extensively on the molecular and cellular neurobiology of severe neuropsychiatric disorders and the development of novel therapeutics, with more than 300 publications in peer-reviewed journals, including Science, Science Translational Medicine, Nature Neuroscience, Nature Reviews Neuroscience, Nature Reviews Drug Discovery, New England Journal of Medicine, Journal of Clinical Investigation, Proceedings of the National Academy of Sciences of the United States of America, Journal of Neuroscience, JAMA Psychiatry, and Molecular Psychiatry.
Deven McGraw, J.D., M.P.H., LLM, is the chief regulatory officer for Ciitizen. Prior to joining Ciitizen, she directed U.S. health privacy and security policy through her roles as the deputy director for health information privacy at the Department of Health and Human Services’ Office for Civil Rights (the office that oversees Health Insurance Portability and Accountability Act [HIPAA] policy and enforcement) and the chief privacy officer (acting) of The Office of the National Coordinator for Health Information Technology. Ms. McGraw also advised the Patient-Centered Outcomes Research Network as well as the federal All of Us Research Program Initiative on HIPAA and patient-donated data research initiatives.
Lauren Oliva, Pharm.D., is the global regulatory policy lead for new technologies at Biogen. She oversees the development and execution of the research and development policy roadmap for digital health tools and gene therapy to enable Biogen’s neuroscience portfolio. In her time at Biogen she launched a widely used regulatory intelligence service
and served as a policy lead and regulatory strategy manager. Dr. Oliva received her Pharm.D. from the Rutgers University Ernest Mario School of Pharmacy and has previously served as adjunct faculty and a lecturer at the Massachusetts College of Pharmacy and Health Sciences in Boston, Massachusetts.
Bray Patrick-Lake, M.F.S., is the director of strategic partnerships at Evidation Health. She develops collaborations to support the design and implementation of participant-centered studies, and serves on the All of Us Research Program national advisory panel, the Digital Medicine Society scientific leadership board, and the Board on Health Sciences Policy at the National Academies of Sciences, Engineering, and Medicine. Previously, Ms. Patrick-Lake led engagement for the Duke Clinical Research Institute Project Baseline Study Coordinating Center and served as the co-chair on the advisory committee to the National Institutes of Health director that authored the Precision Medicine Initiative’s cohort program. Ms. Patrick-Lake holds a B.S. from the University of Georgia and an M.F.S. from National University.
Leonard Sacks, M.D., received his medical education in South Africa, moving to the United States in 1987, where he completed fellowships in immunopathology and infectious diseases. He worked as an attending physician in Washington, DC, and South Africa, and he joined the U.S. Food and Drug Administration in 1998 as a medical reviewer in the Office of New Drugs. Subsequent positions included the acting director of the Office of Critical Path Programs and the associate director for clinical methodology in the Office of Medical Policy in the Center for Drug Evaluation and Research. In this capacity he has led efforts to support the use of electronic technology in clinical drug development. Besides his involvement in the design and analysis of clinical trials, he maintains a special interest in tuberculosis and other tropical diseases and has published and presented extensively on these topics. He is board certified in internal medicine and infectious diseases and holds an academic appointment as an associate clinical professor of medicine at The George Washington University.
Joyce Tung, Ph.D., joined 23andMe in 2007 and manages the 23andMe research team, which is responsible for consumer health and ancestry research and development, academic and industry collaborations, computational analyses for therapeutics, and new research methods and tools development. While a postdoctoral fellow at Stanford University, Dr. Tung studied the genetics of mouse and human pigmentation. She graduated from Stanford University with honors and distinction with a B.S. in
biological sciences and a minor in computer science, and she earned her Ph.D. in genetics from the University of California, San Francisco, where she was a National Science Foundation graduate research fellow.
Effy Vayena, Ph.D., studied medical history and bioethics at the University of Minnesota and completed her habilitation in bioethics and health policy at the University of Zurich. From 2000 to 2007 she worked at the World Health Organization (WHO). In 2007 she joined the Institute of Biomedical Ethics and History of Medicine at the University of Zurich, with which she remains affiliated. She is a consultant to WHO on several projects and visiting faculty at the Harvard Center for Bioethics at the Harvard Medical School. In 2015 she was named a Swiss National Science Foundation Professor of Health Policy and leads the newly established Health Ethics and Policy Lab in the Department of Public Health at the University of Zurich. Her current research focus is on ethics and policy questions in personalized medicine and digital health. At the intersection of multiple fields, she relies on normative analyses and empirical methods to explore how values such as freedom of choice, participation, and privacy are affected by recent developments in personalized medicine and in digital health. She is particularly interested in the issues of ethical oversight of research uses of big data, ethical uses of big data for global health, and the ethics of citizen science. Using the ethics lens in innovative ways, she aims to provide concrete policy recommendations and frameworks that facilitate the use of new technologies for better and more just health.
