Appendix C

Participant Biographies

MARC BERGER, M.D., is vice president, Real-World Data and Analytics, in the Global Health & Value group at Pfizer Inc. Dr. Berger has held senior-level positions in industry, including executive vice president and senior scientist at OptumInsight; vice president, Global Health Outcomes at Eli Lilly & Co.; and vice president, Outcomes Research and Management at Merck & Co., Inc. He has served on the Medicare Evidence Development & Coverage Advisory Committee for the Centers for Medicare & Medicaid Services; the steering committee for the Agency for Healthcare Research and Quality’s Centers for Research and Education on Therapeutics; the board of the International Society for Pharmacoeconomics and Outcomes Research; the Advisory Council for North America of the Drug Information Association; and the editorial advisory board of Value in Health. He has chaired the Innovative Technology Advocacy Committee of Pharmaceutical Research and Manufacturers of America. Dr. Berger has written or co-written more than 100 peer-reviewed articles, book chapters, and other publications on a range of topics, including health services research, outcomes research, health economics, and health policy. He co-edited Health Care, Cost, Quality, and Outcomes—ISPOR Book of Terms, which was published in 2003 and was subsequently translated into nine languages. His current research focuses on rapidcycle analytics of real-world data, including electronic health records to provide timely insights into the outcomes associated with alternative therapeutic strategies and the use of big data and advanced analytics (including machine learning) to develop predictive models in support of precision medicine drug development. He is also actively

involved in promoting best practices for the leveraging of real-world data to inform health care decision making.

JESSE A. BERLIN, S.C.D., received his Doctorate in Biostatistics from the Harvard School of Public Health. After spending 15 years as a faculty member at the University of Pennsylvania (Penn) Center for Clinical Epidemiology and Biostatistics under the direction of Dr. Brian Strom, Dr. Berlin left Penn to join Janssen Research & Development as a senior director in biostatistics. After 2 years, he was promoted to vice president for epidemiology. He now serves as vice president of epidemiology across all of Johnson & Johnson, with responsibility for pharmaceuticals, devices, and consumer products. He has authored or co-authored more than 250 peer-reviewed publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as applied to both randomized trials and epidemiology. He served on an Institute of Medicine committee that developed recently released recommendations for the use of systematic reviews in clinical effectiveness research, and currently serves as chair of the Scientific Advisory Committee to IMEDS (Innovation in Medical Evidence Development and Surveillance), part of the Reagan-Udall Foundation. IMEDS is aimed at understanding methodology for assessing drug safety in large, administrative databases. Dr. Berlin co-chairs the Scientific Oversight Committee (with Greg Pappas from the U.S. Food and Drug Administration) for the Medical Device Epidemiology Network Initiative (MDEpiNet), a public–private partnership that is working toward developing methods and data sources for the evaluation of medical devices. He also serves on the Executive Operations Committee for MDEpiNet. Dr. Berlin serves as a member of working group X for CIOMS (The Council for International Organizations of Medical Sciences), which is developing guidelines for meta-analysis of drug safety data in the regulatory context. He was elected as a Fellow of the American Statistical Association in 2004. In 2013, Dr. Berlin received the Lagakos Distinguished Alumni Award from the Department of Biostatistics at the Harvard School of Public Health.

ROBERT M. CALIFF, M.D., MACC, is the U.S. Food and Drug Administration’s (FDA’s) Commissioner of Food and Drugs. As the top official of FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Previously, Dr. Califf served as FDA’s Deputy Commissioner for Medical Products and Tobacco. In that capacity, he provided executive leadership to the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Tobacco Products. He also oversaw the Office of Special Medical Programs and provided direction for crosscutting clinical,

scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system. Prior to joining FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and as founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature. Dr. Califf has served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and on the IOM Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and the FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health (NIH) and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute; the National Heart, Lung, and Blood Institute; the National Institute of Environmental Health Sciences; and the Council of the National Institute on Aging. While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative, a public–private partnership co-founded by FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco, and a fellowship in cardiology at Duke.

JOHN CARROLL, M.D., FACC, MSCAI, received his A.B. in biology cum laude from Princeton University and his M.D. (Alpha Omega Alpha) from the University of Chicago. He trained in internal medicine and cardiovascular disease at Tufts New England Medical Center, finishing as the Samuel Levine Cardiology Research Fellow of the American Heart Association. He then became a Cardiology Research Fellow at Universitaetsspital in Zurich, Switzerland. From 1982 to 1996, he was a member of the faculty at the University of Chicago Pritzker School of Medicine and directed the Hans Hecht Cardiac Catheterization Laboratory. In 1996 he moved to the University of Colorado as professor of medicine, director of Interventional Cardiology, and co-medical director of the Cardiac and Vascular Center. He is currently a member of various national and international

editorial and advisory boards, the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry Steering Committee, and the Steering Committee of the RESPECT trials. Dr. Carroll is an interventional cardiologist with clinical and investigative interests related to structural/valvular heart disease interventions, clinical trials, and the development of advanced cardiac three-dimensional imaging for image guidance.

JOSEPH CHIN, M.D., M.S., is the deputy director of the Coverage and Analysis Group (CAG) in the Center for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services (CMS). He joined CMS in 1992 as a medical officer in the quality improvement component and transitioned to CAG in 1999, focusing on systematic evidence reviews, Medicare translational science, and preventive services. Prior to joining CMS, Dr. Chin practiced full time in occupational and ambulatory medicine. He is board certified in preventive medicine. He completed his M.D., M.S. in epidemiology, and residency at the University of Maryland School of Medicine, and maintains a primary care practice in Maryland.

CATHY W. CRITCHLOW, Ph.D., is head of the Center for Observational Research (CfOR). Dr. Critchlow provides operational and strategic leadership for the design and conduct of observational research within Amgen Inc. The CfOR Real-World Data Platform provides widespread access to patient health data and visualization and analytic tools based on innovative technologies to aid teams in the generation of real-world evidence in support of drug development and commercialization of Amgen products. Dr. Critchlow joined Amgen Inc. in 2004, and led a number of therapeutic areas prior to being named head of CfOR in 2012. Previously, Dr. Critchlow spent several years as a faculty member in epidemiology in the School of Public Health and Community Medicine at the University of Washington. Her past work focused on infectious disease and reproductive epidemiology. She was a member of the Endocrinologic and Metabolic Advisory Committee of the U.S. Food and Drug Administration and has served on a number of Study Sections and Special Emphasis Panels of the National Institutes of Health. Dr. Critchlow earned her bachelor’s degree from Stanford University, and both her master’s degree in biomathematics and her doctorate degree in epidemiology from the University of Washington. Dr. Critchlow is an affiliate professor of epidemiology at the University of Washington and a fellow of the American College of Epidemiology.

LESLEY CURTIS, Ph.D., is a professor of medicine at the Duke University School of Medicine and directs the Center for Pragmatic Health Services Research in the Duke Clinical Research Institute. A health services researcher by training, Dr. Curtis oversees a portfolio of projects that use

observational data to address questions related to clinical and comparative effectiveness, pharmacoepidemiology, health care delivery, and epidemiological trends. Dr. Curtis has considerable experience analyzing Medicare claims data, large clinical registries, and prescription drug data, and has led the linkage of large clinical registries with longitudinal Medicare claims data. In addition, Dr. Curtis has been responsible for the linkage of those data with longitudinal cohorts in the Cardiovascular Health Study, the Framingham Heart Study, the Jackson Heart Study, and the Multi-Ethnic Study of Atherosclerosis (MESA). Experienced in facilitating large-scale, multi-institutional research through the use of distributed health data networks, Dr. Curtis co-leads the Data Core for the U.S. Food and Drug Administration’s Mini-Sentinel Initiative, co-leads the Electronic Health Record Core for the National Institute of Health’s Health Care Systems Collaboratory, and co-leads the Data Standards, Security, Networking, and Infrastructure Task Force for the Patient-Centered Outcomes Research Institute’s National Clinical Research Network.

LAURA DEMBER, M.D., has more than 20 years of experience as a general nephrologist and has internationally recognized expertise in the systemic amyloidoses, a group of rare disorders that often affect the kidneys. She is a member of the University of Pennsylvania multidisciplinary amyloidosis program that evaluates and treats patients with all types of amyloidosis. Dr. Dember conducts patient-oriented research, including mechanistic studies and clinical trials in chronic kidney disease and end-stage renal disease (ESRD). She has particular interests in hemodialysis vascular access and interventions to improve clinical outcomes in ESRD. Her research is funded by the National Institutes of Health (NIH). Dr. Dember is principal investigator for the Data Coordinating Center of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Hemodialysis Novel Therapies Consortium, which is conducting early-phase clinical trials targeting ESRD-associated inflammation. She is also principal investigator for the “TiME Trial,” a large, pragmatic cluster-randomized clinical trial being conducted through the NIH Health Care Systems Research Collaboratory. The TiME Trial will enroll 6,400 participants at 400 dialysis units throughout the United States using a highly centralized and efficient implementation approach leveraging the infrastructure of dialysis provider organizations. Dr. Dember is also a principal investigator for the NIDDK Hemodialysis Fistula Maturation Study, an observational cohort study designed to elucidate predictors and mechanisms of arteriovenous fistula maturation.

DAVID DORE, Ph.D., Pharm.D., is vice president, epidemiology, and principal epidemiologist at Optum Life Sciences, where he leads Optum’s epidemiology consulting practice. He has worked continuously for Optum as

a pharmacoepidemiologist since 2007, and from 2010 through 2013 was assistant professor of health services, policy, and practice (tenure track) and assistant professor of epidemiology at the Brown University School of Public Health. Dr. Dore has done a number of studies on the safety of incretin-based antihyperglycemic drugs. His current work also covers electronic health records, natural language processing, medical devices, causal inference, and geriatric pharmacoepidemiology. He is an adjunct faculty member and mentor to several Ph.D. students at the Brown University School of Public Health. Dr. Dore received a Pharm.D. from the University of Rhode Island and a Ph.D. in epidemiology from Brown Medical School. He completed a postdoctoral fellowship at the Center for Gerontology and Health Care Research at Brown University.

LOUIS FIORE, M.D., M.P.H., is the executive director of the Massachusetts Veterans Epidemiology Research and Information Center at the U.S. Department of Veterans Affairs (VA) Boston health care system. He has 25 years of experience in clinical research in the areas of clinical trials, biobanking, epidemiology, and informatics. His current primary focus is on embedding clinical research into the clinical care ecosystem through both the Point of Care Clinical Trials Program and the Precision Oncology Program, both sponsored by the VA Office of Research and Development. He is a proponent of data sharing and strives to reduce silos that isolate researchers from each other and from the clinical care world that they ultimately serve.

LUCA FOSCHINI, Ph.D., is co-founder and chief data scientist at Evidation Health, a company dedicated to defining and demonstrating value in digital health. At Evidation, Dr. Foschini is responsible for data analytics, computing, research, and development. Dr. Foschini has driven research collaborations with machine learning experts at New York University, and behavioral economics departments at Harvard Business School and the Wharton School. Prior to this role, Dr. Foschini worked in research and development at Ask.com and was a visiting scholar at Google Research and ETH Zurich, where he developed efficient algorithms for mining spatial data, partitioning large graphs, and detecting traffic anomalies in computer networks. He has published numerous papers in the broader area of computer science and he co-authored several patents in information clustering and behavior phenotyping. He earned a Ph.D. in computer science from the University of California, Santa Barbara.

NAFTALI ZVI FRANKEL, M.S., is an experienced consumer advocate who has volunteered for research and analysis of scientific studies, available treatments, and specialists for many individuals faced with critical medical

decisions. Mr. Frankel serves on multiple health care advisory boards. He is the consumer representative on the U.S. Food and Drug Administration Circulatory Devices Advisory Board. In 2014, Mr. Frankel published an article in JAMA Internal Medicine titled “Surgical Aortic Valve Replacement vs. Transcatheter Aortic Valve Replacement: A Consumer’s Perspective Regarding Data Education and Transparency of Hospitals.” The article highlighted the need for increased hospital outcomes data transparency. Mr. Frankel graduated from Johns Hopkins University with an M.S. in regulatory science.

STEVEN K. GALSON, M.D., M.P.H. (Planning Committee Co-Chair), is senior vice president for Global Regulatory Affairs and Safety at Amgen Inc. From 2010 until 2014, he was vice president for Global Regulatory Affairs at Amgen Inc. Prior to this, he was the senior vice president for Civilian Health Operations and chief health scientist at Science Applications International Corporation and a consultant for Warburg Pincus. In 2009, he completed 23 years of government service, most recently, for 2 years, as Acting Surgeon General of the United States. From January to September 2009, he was also the Acting Assistant Secretary of Health. As Acting Surgeon General in 2008, Dr. Galson launched the Healthy Youth for a Healthy Future Initiative, which brought national attention to the complex issue of childhood obesity prevention, and prompted hundreds of community-based actions. This initiative included visiting 38 states and personally modeling healthy behaviors directly with children. Dr. Galson also convened, with the National Institutes of Health, the Surgeon General’s Workshop on preterm birth in 2008, to jump-start national activities to reduce the incidence of these births. In addition, Dr. Galson published two Surgeon General’s Calls to Action, on Deep Vein Thrombosis and Pulmonary Embolism to bring renewed attention and prevention efforts to a health problem that kills more than 100,000 Americans every year, and on how to Promote Healthy Homes, to bring attention to the connection between housing and health and outline a blueprint for national action. Dr. Galson furthered the nation’s evolution toward personalized medicine by releasing a new My Family Health Portrait, a Web-based tool to enable individuals and families to create, store, and share their family health histories. He also highlighted the importance of preventing underage drinking by visiting states to encourage local efforts on this persistent challenge. Dr. Galson created the Surgeon General’s Perspectives, a column in the journal Public Health Reports, and published eight columns on various prevention topics, bringing a leadership viewpoint to this widely read publication. In addition, Dr. Galson started a regular column for dieticians in the Journal of the American Dietetics Association, and published six columns on topics of interest to this key professional organization. As

Acting Assistant Secretary of Health, Dr. Galson led a U.S. Department of Health and Human Services (HHS)-wide effort to prepare a plan for the $650 million Prevention and Wellness section of the American Recovery and Reinvestment Act of 2009. He also managed 12 core public health programs for HHS. Previously, he served as deputy director and director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research from 2001 until 2007. In that role, he provided leadership for the center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his Public Health Service career as an epidemiological investigator at the Centers for Disease Control and Prevention after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. In addition to his high-ranking positions at HHS, he has held senior-level positions at the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Energy, where he was chief medical officer. Prior to his arrival at FDA, he was director of the EPA’s Office of Science Coordination and Policy, Office of Prevention, Pesticides, and Toxic Substances. Dr. Galson is the recipient of numerous awards, including the Surgeon General’s Medallion, three Secretary of Energy Gold Awards, and The Founders Medal from the Association of Military Surgeons of the United States. Dr. Galson has been a board member of the National Board of Medical Examiners, a Regent of the Uniformed Services University of the Health Sciences, and a peer reviewer for medical journals. Dr. Galson is currently professor-at-large at the Keck Graduate Institute of Applied Life Science, and a member of the Board of Directors of Vanda Pharmaceuticals. He holds a B.S. from Stony Brook University, an M.D. from Mount Sinai School of Medicine, and an M.P.H. from the Harvard School of Public Health and is board certified in preventive medicine and public health and occupational medicine.

JOHN B. HERNANDEZ, Ph.D., M.A., is a health care executive with broad experience in engaging with leading payers, hospital systems, physician organizations, researchers, and others to improve health care value. Dr. Hernandez has demonstrated success in growing businesses with disruptive technologies and driving market expansion. He is widely published in scientific journals, and lectures frequently on diverse topics ranging from health care reforms to real-world evidence strategies. Dr. Hernandez has more than 25 years of specialized research, consulting, and advocacy expertise, with a particular interest in generating evidence to show the value of trans-formative health care innovations. He has extensive clinical and commercial strategy experience in the life sciences industry and he has been directly involved in more than 30 major product launches. He is skilled at building and leading global teams to generate clinical and economic evidence across the product life cycle and executing market access strategies to obtain fund-

ing and develop markets in the Americas, Europe, and Asia. Dr. Hernandez is currently engaged in numerous research initiatives and public–private partnerships leveraging digital health data from multiple sources, including electronic medical records, claims databases, and registries to track and improve health care costs, quality, and outcomes. The goal of these efforts is to support a radical transformation of the U.S. health care system by dramatically expanding real-world evidence collection and embedding research on health care value into mainstream practice.

FREDA LEWIS-HALL, M.D., is chief medical officer and executive vice president of Pfizer Inc. Dr. Lewis-Hall is the senior physician in the company, responsible for enterprise-wide medical, patient safety, regulatory affairs, and quality assurance as well as outreach to doctors and other medical professionals. Dr. Lewis-Hall will serve on Pfizer Inc.’s Executive Leadership Team, its most senior leadership group. She will shape Pfizer Inc.’s regulatory and medical policy during a time of fast-changing expectations for health care companies and a wave of new therapies in development, especially as information technologies change the ways companies develop medicines, clinicians prescribe them, and patients and payers value them. Prior to joining Pfizer Inc., Dr. Lewis-Hall was executive vice president, Medicines Development, Vertex Pharmaceuticals. In that role, she was responsible for clinical and non-clinical development as well as both medical and regulatory; she also served as senior vice president of Medical Affairs at Bristol-Myers Squibb, vice president of Research and Development at Pharmacia, and product team leader at Eli Lilly & Co. Dr. Lewis-Hall is a fellow of the American Academy of Psychiatry. She received her B.A. from Johns Hopkins University and her M.D. from Howard University Hospital and College of Medicine.

MICHAEL MACK, M.D., has practiced cardiothoracic surgery in Dallas since 1982. He is board certified in Internal Medicine, General Surgery, and Thoracic Surgery and is currently the director of the Cardiovascular Service Line for Baylor Scott & White Health, chair of the Baylor Scott & White Cardiovascular Governance Council, and director of Cardiovascular Research at The Heart Hospital Baylor Plano. He also co-founded the Cardiopulmonary Research Science and Technology Institute. He has authored more than 500 peer-reviewed medical publications. He is on the Steering Committee of the Cardiothoracic Surgery Network of the National Institutes of Health and is a member of the American College of Cardiology (ACC) Foundation Board of Trustees, the ACC Interventional Scientific Council, and the Society of Thoracic Surgeons (STS)/ACC National Transcatheter Valve Therapy Registry Steering Committee. He is a member of the U.S. Food and Drug Administration (FDA) Medical Device

Epidemiology Network Initiative (MDEpiNet) Advisory Committee. He is a director of the American Board of Thoracic Surgery and a member of the National Medical Device Planning Board of the FDA/Duke Margolis Institute. Dr. Mack was STS president in 2011 and is past president of the Thoracic Surgery Foundation for Research and Education, the Southern Thoracic Surgical Association, and the International Society for Minimally Invasive Cardiothoracic Surgery. He is an honorary member of the German Society for Thoracic and Cardiovascular Surgery and the Indian Association of Cardiovascular and Thoracic Surgery. He has received the Presidential Citation of the ACC and the Transcatheter Cardiovascular Therapeutics Lifetime Achievement Award.

MARK McCLELLAN, M.D., Ph.D., is the Robert J. Margolis Professor of Business, Medicine, and Policy, and director of the Duke-Margolis Center for Health Policy at Duke University, with offices at Duke University and in Washington, DC. Dr. McClellan is a physician and an economist, and his work has addressed a wide range of strategies and policy reforms to improve health care, including payment reforms to promote better outcomes and lower costs, methods for development and use of real-world evidence, and approaches for more effective drug and device innovation. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the U.S. Food and Drug Administration, where he developed and implemented major reforms in health policy. He was also a senior fellow at Brookings Institution and a professor of economics and medicine at Stanford University.

RHONDA ROBINSON BEALE, M.D., is a seasoned health care executive with more than 30 years of experience in health care systems, managed care, and quality improvement in behavioral health and medical care. She is the senior vice president and chief medical officer for Blue Cross of Idaho, overseeing the Medical and Quality Management Division responsible for medical and behavioral service management for all market segments. Dr. Robinson Beale has served in the past as the chief medical officer/physician executive within several large, national and local health care organizations, such as Optum, a subsidiary within UnitedHealth Group, PacifiCare, Cigna, Blue Cross Blue Shield of Michigan, and Health Alliance Plan in Michigan. She has been involved with many national organizations as a subject-matter expert, including the National Institute of Mental Health, Institute of Medicine (IOM), National Quality Forum, American Psychiatric Association, American Psychological Association, American Society of Addiction Medicine, National Committee for Quality Assurance, and others. Dr. Robinson Beale has served on many national boards, has engaged with key committees and work groups, and has been significantly involved in

influencing changes in the system. She was on the IOM committees that created Crossing the Quality Chasm and To Err Is Human. She was involved in influencing local and national legislation, particularly around parity and Patient Protection and Affordable Care Act issues. She has testified before the Senate’s Committee on Health, Education, Labor and Pensions on the state of behavioral health care. Dr. Robinson Beale has experience in health care as a health plan administrator, a hospital medical director, and a capitated provider of care to commercial and public-sector populations. She has been able to use the experience as a capitated provider for more than 18 years to help organized systems of care restructure their operations to be successful in managing populations within capitation and alternative payment arrangements. Dr. Robinson Beale received her M.D. from Wayne State University and her psychiatric training at Detroit Psychiatric Institute. She is a Diplomat to the American Board of Psychiatry and Neurology and, when in practice, she was a certified addictionologist through the American Society of Addiction Medicine.

ANDREW RODDAM, Ph.D., is currently vice president and head of Epidemiology & Real World Evidence at GlaxoSmithKline, is a member of the HL7 advisory council, and is a renowned expert in epidemiological research, with specific interest in the use of routine data for research purposes. He was a senior researcher at the Cancer Research United Kingdom Cancer Epidemiology Unit at the University of Oxford before starting at Amgen Inc., where he was most recently Regional Head (the European Union and Europe, the Middle East, and Africa) in the Center for Observational Research. Dr. Roddam obtained his Ph.D. in statistics at the University of Oxford, working with Sir David Cox, and he also completed a postdoc in infectious disease epidemiology.

RUSSELL L. ROTHMAN, M.D., M.P.P., is a professor of internal medicine, pediatrics, and health policy, and the vice president for Population Health Research at Vanderbilt University Medical center. He also serves as the director of the Vanderbilt Center for Health Services Research and chief of the Internal Medicine/Pediatrics Section. Dr. Rothman’s current research focuses on improving care for adult and pediatric patients with diabetes, obesity, and other chronic diseases. As director of the Vanderbilt Center for Health Services Research, Dr. Rothman oversees a Center that engages more than 140 faculty across the university who are engaged in more than $50 million of funded research annually related to health services research, implementation science, behavioral research, health disparities research, quality improvement research, and other areas aimed at improving health outcomes. He has been the principal investigator on more than $35 million in extramural funding and has authored more than 120 manu-

scripts. He is currently the principal investigator of the Patient-Centered Outcomes Research Institute (PCORI)-funded Mid-South Clinical Data Research Network, which engages more than 50 hospitals and thousands of ambulatory practices reaching patients across the nation. He is also the principal investigator of the new Centers for Medicare & Medicaid Services (CMS)-funded Mid-South Practice Transformation Network, which engages 4,000 clinicians in quality improvement. Dr. Rothman also serves on the PCORI National Patient-Centered Clinical Research Network (PCORnet) Executive Steering Committee, which is overseeing the development of a national network to support comparative effectiveness research and pragmatic clinical trials, with more than $250 million committed from PCORI to date. Dr. Rothman serves as the co-chair of the Steering Committee of the ADAPTABLE study, an $18 million pragmatic clinical trial enrolling 20,000 patients to evaluate the optimal dose of aspirin in secondary prevention.

NIGAM SHAH, Ph.D., is an associate professor of medicine (biomedical informatics) at Stanford University, assistant director of the Center for Biomedical Informatics Research, and a core member of the Biomedical Informatics Graduate Program. Dr. Shah’s research focuses on combining machine learning and prior knowledge in medical ontologies to enable use cases of the learning health system. Dr. Shah received the American Medical Informatics Association New Investigator Award for 2013 and the Stanford Biosciences Faculty Teaching Award for outstanding teaching in his graduate class on Data-Driven Medicine. Dr. Shah was elected into the American College of Medical Informatics in 2015 and inducted into the American Society for Clinical Investigation in 2016. He holds an MBBS from Baroda Medical College, India, and a Ph.D. from Pennsylvania State University. He completed his postdoctoral training at Stanford University.

RACHEL E. SHERMAN, M.D., M.P.H., is the Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA). On behalf of the Commissioner, she provides leadership, management, and policy direction in planning and implementing major crosscutting medical product policy and programmatic initiatives that are clinical, scientific, or regulatory in nature. She brings more than 25 years of dedication to public health. Areas of focus include medical product development, communication of medication information, and clinical care. Her areas of focus include establishing the Oncology Center for Excellence and the Combination Products Policy Council as well as oversight for the EvGen initiative, the Offices of Good Clinical Practice, Orphan Products Development, and Pediatric Therapeutics; and modernization of Advisory Committee practices. Most recently, Dr. Sherman served as Associate Deputy Commissioner for Medical Products and Tobacco from October 2015 until Septem-

ber 2016. During her previous tenure at FDA (1989 to 2014), she served in a variety of roles, ranging from primary FDA medical reviewer during the AIDS crisis to member of the Executive Leadership Team in FDA’s Center for Drug Evaluation and Research (CDER). From 2009 to 2014, Dr. Sherman served as CDER’s associate center director for medical policy and directed CDER’s Office of Medical Policy. She established and led a large, multidisciplinary staff charged with developing and implementing high-priority policies and programs, including the Sentinel Initiative; FDA’s program for regulating biosimilars; and FDA’s expedited drug development and breakthrough therapy designation programs. She organized multistakeholder public–private partnerships; oversaw development of regulations and guidance for industry; and played a key role in enhancing clinical trial quality and good clinical practice. Her achievements contributed directly to more effective prescription drug promotion and to the modernization of professional drug labeling, generic drug labeling, and medication information for patients. From 2014 to 2015, Dr. Sherman continued her focus on the development of innovative therapies in her role as principal, drug and biological drug products, at Greenleaf Health LLC, a consultancy that provides strategic and technical assistance, with an emphasis on medical product development. Dr. Sherman is an Internist with a subspecialty in Infectious Diseases. She has served over the years as attending physician, Division of Infectious Diseases, at the Veterans Affairs Medical Center; clinical assistant professor of medicine (infectious diseases) at Georgetown University; and volunteer physician with Montgomery Mobile Health. She received her B.A. in mathematics from Washington University in St. Louis, her M.P.H. from Johns Hopkins University, and her M.D. from Mount Sinai School of Medicine.

GREGORY SIMON, M.D., M.P.H. (Planning Committee Co-Chair), is an investigator at Kaiser Permanente Washington Health Research Institute and a psychiatrist in Group Health’s Behavioral Health Service. He is also a research professor in the Department of Psychiatry and Behavioral Sciences at the University of Washington and chair of the national scientific advisory board of the Depression and Bipolar Support Alliance. Dr. Simon completed residency training in internal medicine at the University of Washington, residency training in psychiatry at the Massachusetts General Hospital, and fellowship training in the Robert Wood Johnson Clinical Scholars program at the University of Washington. Dr. Simon’s research focuses on improving access to and quality of care for mood disorders, both unipolar depression and bipolar disorder. Specific areas of research include improving adherence to medication, increasing the availability of effective psychotherapy, evaluating peer support by and for people with mood disorders, suicide prevention, cost-effectiveness of treatment, and co-morbidity of mood disorders

with chronic medical conditions. Dr. Simon currently leads the Mental Health Research Network, a cooperative agreement funded by the National Institute of Mental Health that supports population-based mental health research across 13 large health systems.

SEAN TUNIS, M.D., MHSR, is president and chief executive officer of the Center for Medical Technology Policy (CMTP) in Baltimore. CMTP is an independent, nonprofit organization that provides a neutral platform for multistakeholder collaborations that promote high-value innovation by improving the quality, relevance, and efficiency of clinical research. Through 2005, Dr. Tunis was director of the Office of Clinical Standards and Quality and chief medical officer at the Centers for Medicare & Medicaid Services. He also served as the director of the health program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources. Dr. Tunis serves as vice president of Health Technology Assessment International, a member of the Health Sciences Policy Council for the International Society for Pharmacoeconomics and Outcomes Research, and on several other public and private governing and advisory boards. He received a B.S. in biology and history of science from the Cornell University School of Agriculture and an M.D. and a master’s in health services research from the Stanford University School of Medicine. Dr. Tunis did his residency training at the University of California, Los Angeles, and the University of Maryland in emergency medicine and internal medicine.

PATRICK VALLANCE, M.D., is president of research and development at GlaxoSmithKline (GSK) and a member of the GSK Corporate Executive Team. Prior to joining GSK in 2006, Dr. Vallance was a clinical academic. He was a professor of medicine who led the Division of Medicine at University College London (UCL) and consultant physician at UCL. His academic work was in the field of cardiovascular biology and ranged from chemistry through to use of large electronic health records. Dr. Vallance is a Fellow of the Academy of Medical Sciences. He has been on the Board of the U.K. Office for Strategic Co-ordination of Health Research since 2009. He is also a director of Genome Research Limited.

JON WHITE, M.D., Deputy National Coordinator, is a family physician who has dedicated his career to improving health and health care quality through the use and sharing of electronic health information. Dr. White has been working in partnership with the Office of the National Coordinator for Health Information Technology (ONC) since 2004. ONC is at the forefront of the nation’s efforts to adopt and meaningfully use health information technology, and achieve health information technology interoper-

ability, as a foundational element of better health for everyone in America. Before his service at ONC, Dr. White was director of the Division of Health Information Technology at the Agency for Healthcare Research and Quality (AHRQ). In his role at AHRQ, Dr. White directed hundreds of projects in 48 states, including research, demonstration, and implementation projects on a wide variety of health information technology (IT) applications and issues. Dr. White has extensive experience working with federal government partners (including the Centers for Medicare & Medicaid Services and the U.S. Department of Veterans Affairs) as well as key health care professional, patient, policy, and health IT stakeholder groups to implement major health care initiatives. Dr. White trained in Family Medicine at the University of Virginia and Lancaster General Hospital in Pennsylvania. He is a recipient of the national American Academy of Family Physicians Award for Excellence in Graduate Education.

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