Appendix B

Biographical Sketches of Speakers

Robert M. Califf, MD, is vice chancellor for clinical and translational research at Duke University and leads the Duke Translational Medicine Institute (DTMI), an organization focused on translating scientific discoveries into improved health outcomes. Before leading DTMI, he was founding director of the Duke Clinical Research Institute (DCRI), a premier academic research organization now part of DTMI. Under his leadership, the DCRI grew into an organization with more than 1,000 employees and an annual budget of more than $100 million; DTMI currently has a budget of more than $300 million. He attended Duke both as an undergraduate and for medical school, completing his residency at the University of California, San Francisco, before returning to Duke for a cardiology fellowship. An international leader in cardiovascular medicine, health outcomes, health care quality, and medical economics, he is among the most frequently cited authors in medicine.

Niteesh K. Choudhry, MD, PhD, is an internist and health services researcher whose work focuses on the clinical and economic consequences of using evidence-based therapies for the management of common chronic conditions. He is particularly interested in the design and evaluation of novel strategies to overcome barriers to treatment initiation and long-term medication adherence. His work employs a broad range of methods, including randomized policy evaluations, cost-effectiveness modeling, claims analyses, and surveys, and he regularly collaborates with large health insurers and employers to conduct his research. He has published more than 125 peer-reviewed articles in leading medical and policy journals and has won



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Appendix B Biographical Sketches of Speakers Robert M. Califf, MD, is vice chancellor for clinical and translational research at Duke University and leads the Duke Translational Medicine Institute (DTMI), an organization focused on translating scientific discover- ies into improved health outcomes. Before leading DTMI, he was founding director of the Duke Clinical Research Institute (DCRI), a premier academic research organization now part of DTMI. Under his leadership, the DCRI grew into an organization with more than 1,000 employees and an annual budget of more than $100 million; DTMI currently has a budget of more than $300 million. He attended Duke both as an undergraduate and for medical school, completing his residency at the University of California, San Francisco, before returning to Duke for a cardiology fellowship. An international leader in cardiovascular medicine, health outcomes, health care quality, and medical economics, he is among the most frequently cited authors in medicine. Niteesh K. Choudhry, MD, PhD, is an internist and health services re- searcher whose work focuses on the clinical and economic consequences of using evidence-based therapies for the management of common chronic conditions. He is particularly interested in the design and evaluation of novel strategies to overcome barriers to treatment initiation and long-term medication adherence. His work employs a broad range of methods, in- cluding randomized policy evaluations, cost-effectiveness modeling, claims analyses, and surveys, and he regularly collaborates with large health insur- ers and employers to conduct his research. He has published more than 125 peer-reviewed articles in leading medical and policy journals and has won 77

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78 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM awards from AcademyHealth, the Society of General Internal Medicine, the International Society of Pharmacoeconomics and Outcomes Research, and the National Institute of Health Care Management for his research. Choudhry is an associate professor at Harvard Medical School and associ- ate physician in the Division of Pharmacoepidemiology and Pharmacoeco- nomics and the Hospitalist Program at Brigham and Women’s Hospital. He attended McGill University, received an MD, and completed his residency training in internal medicine at the University of Toronto and then served as chief medical resident for the Toronto General and Toronto Western Hospitals. He did his PhD in health policy at Harvard University, with a concentration in statistics and the evaluative sciences, and was a fellow in pharmaceutical policy research at Harvard Medical School. His work is funded by the Robert Wood Johnson Foundation, the Commonwealth Fund, the Aetna Foundation, CVS Caremark, the Agency for Healthcare Quality and Research, and others. Choudhry practices inpatient general internal/hospital medicine and has won numerous awards for teaching excellence. Elizabeth A. Chrischilles, PhD, professor in the Department of Epidemiol- ogy, holds the Marvin A. and Rose Lee Pomerantz Chair in Public Health in the University of Iowa College of Public Health. Chrischilles is principal investigator of the Iowa Developing Evidence to Inform Decisions about Effectiveness (Iowa DEcIDE) Center and coinvestigator on a pragmatic trial in the National Institutes of Health Common Fund’s Health Care Systems Research Collaboratory. She is also involved in cluster-randomized trials of team management interventions, prospective follow-up of prognostic cohorts, and linkage of claims data to prospective registries and cohorts and is leading a research team that is investigating multiple uses of an Internet- based personal health record designed with older adults. William H. Crown, PhD, is group president of health economics and out- comes research and late-phase research for Optum. From 1982 to 1995, he was a faculty member at the Florence Heller Graduate School, Brandeis University, where he taught graduate courses in statistics and conducted re- search on the economics of aging and long-term-care policy. Prior to joining Optum, Crown was vice president of outcomes research and econometrics at Medstat, where he conducted numerous retrospective database analyses of the burden of illness associated with various diseases, particularly respi- ratory and mental health conditions. Crown’s work in the area of depres- sion was one of the first applications of econometric techniques in outcomes research to control for the effects of selection bias when retrospective data are used. He has 24 years’ experience conducting health policy and income maintenance research for private- and public-sector clients. Crown is the

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APPENDIX B 79 author or coauthor of 4 books and more than 90 referenced journal articles, book chapters, and other publications. P. J. Devereaux, MD, PhD, FRCP(C), obtained an MD from McMaster University. After medical school he completed a residency in internal medi- cine at the University of Calgary and a residency in cardiology at Dalhousie University. He then completed a PhD in clinical epidemiology at McMaster University. Devereaux holds a Heart and Stroke Foundation of Ontario Career Investigator Award. He is the head of cardiology and the Periop- erative Cardiovascular Clinical Program at the Juravinski Hospital and Cancer Centre. He is also the scientific leader of the Perioperative Medicine and Surgical Research Group at the Population Health Research Institute. The focus of his clinical research is vascular complications around the time of surgery. He is undertaking several large international randomized controlled trials and observational studies addressing this issue. Devereaux has published more than 150 peer-reviewed papers and 40 editorials, book chapters, and commentaries. Jeffrey M. Drazen, MD, joined the New England Journal of Medicine (NEJM) as editor-in-chief in July 2000. At NEJM, Drazen’s responsibilities include oversight of all editorial content and policies. His editorial back- ground includes service as an associate editor or editorial board member for the Journal of Clinical Investigation, the American Journal of Respiratory Cell and Molecular Biology, and the American Journal of Medicine. A spe- cialist in pulmonology, Drazen maintains an active research program. Dra- zen has published more than 300 articles on topics such as lung physiology and the mechanisms involved in asthma. In 1999, he delivered the Amber- son Lecture, the major research address at the annual meeting of the Ameri- can Thoracic Society. In 2000, he received the Chadwick Medal from the Massachusetts Thoracic Society for his contributions to the study of lung disease. Drazen is the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, professor of physiology at the Harvard School of Public Health, and a senior physician at Brigham and Women’s Hospi- tal. In 2003, he was elected a member of the Institute of Medicine. Drazen has served on numerous committees for the National Institutes of Health, including the Respiratory and Applied Physiology Study Section; the Lung Biology and Pathology Study Section; the Pulmonary Disease Advisory Council; the National Heart, Lung, and Blood Institute Advisory Council; the Public Access Working Group; and the National Heart, Lung, and Blood Institute’s Division of Lung Disease Executive Planning Committee. He has also served on the National Research Advisory Committee of the U.S. Department of Veterans Affairs. He currently serves on the Global Ini- tiative for Asthma Science Committee and the World Health Organization’s

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80 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM Scientific Advisory Group on Clinical Trials Registration and co-chairs the Institute of Medicine’s Forum on Drug Discovery, Development, and Trans- lation. Drazen earned a bachelor’s degree and graduated summa cum laude from Tufts University. He received a medical degree from Harvard Medical School and completed an internship and residency at Peter Bent Brigham Hospital in Boston, Massachusetts. Drazen has received honorary degrees from the University of Ferrara in Italy, and the National and Kapodistrian University of Athens in Greece. Ruth R. Faden, PhD, MPH, is the Philip Franklin Wagley Professor of Biomedical Ethics and director of the Johns Hopkins Berman Institute. She is also a senior research scholar at the Kennedy Institute of Ethics, George- town University. Faden is the author and editor of many books and articles on biomedical ethics and health policy, including Social Justice: The Moral Foundations of Public Health and Health Policy (with Madison Powers), A History and Theory of Informed Consent (with Tom L. Beauchamp), AIDS, Women and the Next Generation (Ruth R. Faden, Gail Geller, and Madison Powers, eds.), and HIV, AIDS and Childbearing: Public Policy, Private Lives (Ruth R. Faden and Nancy Kass, eds.). Faden is a member of the Institute of Medicine and a fellow of the Hastings Center and the American Psychological Association. She has served on numerous national advisory committees and commissions, including the President’s Advisory Committee on Human Radiation Experiments, which she chaired. She is a co-founder of the Hinxton Group, a global community committed to advancing ethical and policy challenges in stem cell science, and the Second Wave project, an effort to ensure that the health interests of pregnant women are fairly rep- resented in biomedical research and drug and device policies. Faden was the recipient of Lifetime Achievement Awards from the American Society for Bioethics and Humanities and from Public Responsibility in Medicine and Research in 2011. Faden’s current research focuses on questions of social justice in public policy and global health. She also works on ethical chal- lenges in biomedical science and in women’s health. Faden’s work in social justice is concentrated on justice theory and national and global challenges in learning health care systems, health systems design and priority setting, and access to the benefits of global investments in biomedical research. Ryan E. Ferguson, ScD, MPH, is the acting director of the Cooperative Studies Program Coordinating Center of the U.S. Department of Veterans Affairs (VA) in Boston, Massachusetts, where he is involved in the conduct of large multicenter randomized clinical trials. He also currently serves as the program director for the VA Point of Care Research Initiative. Ferguson joined the Cooperative Studies Program in 2001 and has since focused on clinical trial methodologies for conducting pragmatic comparative effective-

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APPENDIX B 81 ness trials. In addition to the conduct of trials, his research interests include general clinical trials methodology, Bayesian statistics, renal epidemiology, molecular and genetic epidemiology, and translational research. Ferguson’s published work includes first-author publications, abstracts, and presenta- tions and a book chapter (currently in press). Ferguson is on the faculty at the Boston University School of Public Health, where he is assistant professor of epidemiology. He is also a member of the Society for Clinical Trials, the Society for Epidemiologic Research, and the American Statistical Association. Kenneth A. Getz, MBA, is the director of sponsored research programs and research assistant professor at the Tufts Center for the Study of Drug Devel- opment, where he studies research and development management practices; pharmaceutical and biotechnology company operating models; and global investigative site, outsourcing, and study volunteer practices, trends, and policies. Getz is also the chairman of Center for Information & Study on Clinical Research Participation, a nonprofit organization that he founded to educate and raise public awareness of the clinical research enterprise, and the founder and owner of CenterWatch, a leading publisher in the clinical trials industry. A well-known speaker at conferences, symposia, universities, and corporations, Getz has published extensively in peer-reviewed journals, the trade press, and books. He holds a number of board appointments in the private and public sectors; is on the editorial boards of Contemporary Clinical Trials, Research Practitioner, the Drug Information Journal, and Pharmaceutical Medicine; and writes a column for Applied Clinical Tri- als that was a 2010 Neal Award finalist. Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch, Getz worked for more than 7 years in manage- ment consulting, where he assisted biopharmaceutical companies with the development and implementation of business strategies to improve clinical development performance. Alan S. Go, MD, completed his internal medicine training and a general internal medicine fellowship in clinical research at the University of Califor- nia, San Francisco (UCSF), before joining the Kaiser Permanente Northern California Division of Research in 1998. He is currently chief of the Car- diovascular and Metabolic Conditions Section, director of the Comprehen- sive Clinical Research Unit, and regional medical director of clinical trials through the Kaiser Permanente Northern California Division of Research. He is also associate professor in the Departments of Epidemiology, Biosta- tistics, and Medicine at UCSF and consulting professor in the Department of Health Research and Policy at the Stanford University School of Medi-

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82 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM cine. Go is also chair of the American Heart Association Epidemiology and Prevention Council’s Statistics and Stroke Statistics Committee. Go is a clinical epidemiologist, outcomes researcher, and clinical trialist in the areas of cardiovascular and renal disease. He also leads several large multicenter cohort studies in these areas, including the National Heart, Lung, and Blood Institute–sponsored Cardiovascular Research Network (CVRN), a research consortium of 14 health plans in the United States. He is principal investigator of the ATRIA-CVRN Study of >34,000 adults with incident atrial fibrillation and the CVRN PRESERVE cohort of >30,000 adults with heart failure and documented systolic function. Go also leads several prospective cohort studies, including the National Institute of Diabetes and Digestive and Kidney Diseases–sponsored Assessment, Serial Assessment, and Subsequent Sequelae of Acute Kidney Injury Study and Chronic Renal Insufficiency Cohort Study. Go’s current research interests include optimiz- ing stroke prevention strategies for atrial fibrillation, the epidemiology and outcomes of heart failure with preserved versus reduced systolic function, improving the quality of care for primary and secondary prevention of car- diovascular diseases, the genetics of cardiovascular diseases, and delineating the roles of acute kidney injury and chronic kidney disease in influencing cardiovascular and renal-related adverse events. Christopher B. Granger, MD, FACC, FAHA, is a professor of medicine in the Division of Cardiology at Duke University and director of the Cardiac Care Unit for the Duke University Medical Center. Granger is a fellow of the American College of Cardiology (ACC), the American Heart Associa- tion (AHA), and the European Society of Cardiology. He is associate editor of the American Heart Journal and serves on the editorial board of the Journal of the American College of Cardiology. He is a cardiology section author for Current Medical Diagnosis and Treatment. He serves on the publication oversight committee of the American Heart Association, and he is chairman of the Advisory Working Group of the American Heart Asso- ciation Mission: Lifeline program. He is a member of the 2011 ACC/AHA ST-Elevation Myocardial Infarction Guidelines Committee. He has served on U.S. Food and Drug Administration advisory committees on an ad hoc basis. He is on the Board of External Experts of the National Heart, Lung, and Blood Institute. Granger’s primary research interest is in the conduct and methodology of large randomized clinical trials in heart disease; he has coauthored more than 400 peer-reviewed articles. He currently serves on a number of clinical trial steering committees and data safety monitor- ing committees. He has coordinated the Duke Clinical Research Institute’s activities in many clinical trials evaluating acute myocardial infarction (MI) reperfusion and antithrombotic strategies in acute coronary syndromes and in atrial fibrillation. Granger is co-chair of the Steering Committee of the

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APPENDIX B 83 ARISTOTLE trial assessing an oral factor Xa inhibitor for stroke preven- tion in atrial fibrillation. In addition, he is co-director of the Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments projects and North Carolina statewide programs to improve reperfusion care for acute MI and care for cardiac arrest. Rosemarie Hakim, PhD, is a senior research advisor at the Centers for Medicare & Medicaid Services (CMS). She has worked extensively with CMS staff and with the public on coverage with evidence development and CMS’s clinical trial policy. She currently works with researchers to develop projects related to coverage, CED, and postcoverage analyses using CMS claims and registry data. She has developed and overseen multiple studies that have used CMS data. She has a doctorate in epidemiology from the Johns Hopkins Bloomberg School of Public Health and has extensive expe- rience in observational study design and analysis, clinical trial design and analysis, and evidence development. Peter Held, MD, PhD, FACC, is currently a medical science director lead- ing an AstraZeneca effort to improve the conduct and delivery of the company’s large clinical outcome studies. He is currently responsible for a number of global ongoing or planned global studies in the cardiovascular and respiratory fields. He has long experience from and interest in the meth- odology and conduct of both traditionally run and simplified trials. During the late 1980s he spent time at the National Heart, Lung, and Blood Insti- tute as a visiting scientist and project officer involved in the planning and conduct of mortality/morbidity trials in heart failure and atherosclerosis. Since 1993 he has been employed by AstraZeneca Research and Develop- ment and is based in Gothenburg, Sweden. He has designed and led many global clinical development programs with a large number of new chemical entities that have led to the successful demonstration of benefit and that have resulted in regulatory approval. A scholar from the Universities of Uppsala, Linköping, and Göteborg in Sweden, he received an MD and a PhD in the mid-1980s. He specialized in cardiology and internal medicine and was appointed associate professor of cardiology in 1989. He was an adjunct professor of clinical cardiovascular research at the University of Gothenburg from 2001 to 2010. Ralph I. Horwitz, MD, MACP, is senior vice president for clinical evalua- tion sciences and senior advisor to the chair of research and development at GlaxoSmithKline (GSK) and is the Harold H. Hines, Jr., Professor Emeri- tus of Medicine and Epidemiology at Yale University. Horwitz trained in internal medicine at institutions (the Royal Victoria Hospital of McGill University and the Massachusetts General Hospital) where science and

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84 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM clinical medicine were connected effortlessly. These experiences as a resi- dent unleashed a deep interest in clinical research training, which he pur- sued as a fellow in the Robert Wood Johnson Clinical Scholars Program at Yale under the direction of Alvan R. Feinstein. He joined the Yale faculty in 1978 and remained there for 25 years as codirector of the Clinical Scholars Program and later as chair of the Department of Medicine. Before joining GSK, Horwitz was chair of medicine at Stanford and dean of Case Western Reserve Medical School. He is an elected member of the Institute of Medicine of the National Academy of Sciences, the American Society for Clinical Investigation, the American Epidemiological Society, and the Association of American Physicians (for which he was president in 2010). He was a member of the Advisory Committee to the National Institutes of Health director (under both Elias Zerhouni and Francis Collins). Horwitz served on the American Board of Internal Medicine and was chair in 2003. He is a master of the American College of Physicians. Rebecca Daniels Kush, PhD, is founder, president, and chief executive of- ficer of the Clinical Data Interchange Standards Consortium, a nonprofit standards-developing organization with a mission to develop and support global, platform-independent standards that enable information system in- teroperability to improve medical research and related areas of health care and a vision of “informing patient care and safety through higher quality medical research.” Kush has more than 25 years of experience in the area of clinical research, including positions with the U.S. National Institutes of Health, academia, a global contract research organization, and biopharma- ceutical companies in the United States and Japan. She earned a doctorate in physiology and pharmacology from the University of California, San Diego, School of Medicine. She is the lead author on the book eClinical Tri- als: Planning and Implementation and has authored numerous publications for journals, including the New England Journal of Medicine and Science Translational Medicine. She developed the Prescription Education Program for elementary and middle schools and in 2008 was named in PharmaVoice as one of the 100 most inspiring individuals in the life sciences industry. Kush has served on the boards of directors for the U.S. Health Information Technology Standards Panel, the Drug Information Association, and cur- rently, Health Level 7; and she was a member of the advisory committee for the World Health Organization International Clinical Trials Registry Platform. Kush served on the appointed Planning Committee for the Office of the National Coordinator for Health Information Technology of the U.S. Department of Health and Human Services–sponsored workshop series the Digital Infrastructure for the Learning Health System for the Institute of Medicine (IOM) of National Academy of Sciences and has presented at other IOM meetings. She is a member of the National Cancer Advisory

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APPENDIX B 85 Board Information Technology Workgroup and was invited to represent re- search as an appointed member of the U.S. Health Information Technology Standards Committee. Kush has developed a course, A Global Approach to Accelerating Medical Research, and has been a keynote speaker at numer- ous conferences in this arena in Australia, Brazil, China, Europe, Japan, South Korea, and the United States. Carole M. Lannon, MD, MPH, is board certified in pediatrics and internal medicine and has a master’s in epidemiology. She is nationally recognized for her expertise in improvement science and systems improvement. She is director of the Learning Networks Core of the James M. Anderson Center for Health Systems Excellence at the Cincinnati Children’s Hospital Medi- cal Center, professor of pediatrics at the University of Cincinnati, and senior quality advisor for the American Board of Pediatrics. Lannon is the design and implementation lead for several results-oriented, outcomes-focused improvement networks, including the Ohio Perinatal Quality Collaborative and the National Pediatric Cardiology Quality Improvement Collaborative. Lannon is principal investigator of the pediatric Center for Education and Research in Therapeutics, funded by the Agency for Healthcare Research and Quality. She is former associate editor of the Journal of Quality and Safety in Healthcare. She played a lead role in the design and start-up of improvement initiatives for the American Academy of Pediatrics and the National Initiative for Children’s Healthcare Quality. Michael S. Lauer, MD, is the director of the Division of Cardiovascu- lar Sciences at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. In this position, Lauer provides leadership for the institute’s national program for research on the causes, prevention, and treatment of cardiovascular (basic, clinical, population, and health sciences) diseases. Lauer joined NHLBI in July 2007. Lauer’s primary research interests include cardiovascular clinical epidemiology and comparative effectiveness, with a focus on diagnostic testing. He also has a strong background in leadership of the cardiovascular community and longstanding interests in medical editing—for 7 years he was a contribut- ing editor for Journal of the American Medical Association—and human subjects protection. Prior to joining NHLBI, Lauer served as the director of the Cleveland Clinic Foundation Exercise Laboratory and vice chair of the clinic’s institutional review board. He also served as co-director of the Coronary Intensive Care Unit and director of clinical research in the clinic’s Department of Cardiology. Lauer earned a bachelor of science degree in biology, summa cum laude, from the Rensselaer Polytechnic Institute in 1983 and a doctor of medicine, magna cum laude, from Albany Medical College in 1985. Following internal medical training at the Massachusetts

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86 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM General Hospital, Harvard Medical School, he completed a clinical fellow- ship in cardiology at the Boston Beth Israel Hospital, Harvard Medical School. His further training in epidemiology included a research fellowship at NHLBI’s Framingham Heart Study, Boston University; the program in clinical effectiveness, Harvard School of Public Health, Harvard University; and the Program for Physician Educators, Harvard Macy Institute. Lauer is an elected fellow of the American College of Cardiology and the American Heart Association and has been elected to membership in the American So- ciety for Clinical Investigation. He also served as chairman of the Exercise, Cardiac Rehabilitation, and Prevention Committee of the American Heart Association’s Council of Clinical Cardiology and has received numerous awards in recognition of his scientific and teaching accomplishments. JoAnn E. Manson, MD, DrPH, is chief of the Division of Preventive Medi- cine at Brigham and Women’s Hospital and the Michael and Lee Bell Professor of Women’s Health at Harvard Medical School. She is an endocri- nologist, epidemiologist, and expert in preventive medicine. She leads sev- eral major research studies addressing prevention of heart disease, diabetes, and cancer, including the VITamin D and omegA 3 triaL (VITAL; www. vitalstudy.org); the Women’s Health Initiative Clinical Center in Boston, Massachusetts; the Women’s Antioxidant and Folic Acid Cardiovascular Study; the cardiovascular component of the Nurses’ Health Study; and the KEEPS center in Boston. Her primary research interests include the role of lifestyle and nutritional factors, particularly vitamin D, omega 3s, and folate, in the prevention of chronic disease, the effects of moderate-intensity versus vigorous exercise, and the risks and benefits of estrogen therapy. Manson has received numerous awards and honors, including the Woman in Science Award from the American Medical Women’s Association, the American Heart Association’s Population Research Prize, the American Heart Association’s Distinguished Scientist Award, and election to the Insti- tute of Medicine and the Association of American Physicians, and she serves as president of the North American Menopause Society. She has published more than 700 articles in the medical literature and is the author or editor of several books, including Prevention of Myocardial Infarction (1996), Clinical Trials in Heart Disease (2004), The 30-Minute Fitness Solution (2001), and Hot Flashes, Hormones, & Your Health (2007). Deven McGraw, JD, is the director of the Health Privacy Project at the Center for Democracy and Technology (CDT). The project is focused on the development and promotion of workable privacy and security protections for electronic personal health information. McGraw is active in efforts to advance the adoption and implementation of health information technol- ogy and electronic health information exchange to improve health care.

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APPENDIX B 87 She was one of three persons appointed by Kathleen Sebelius, the secretary of the U.S. Department of Health and Human Services (HHS), to serve on the Health Information Technology Policy Committee, a federal advisory committee established in the American Recovery and Reinvestment Act of 2009. She also served on two key workgroups of the American Health Information Community, the federal advisory body established by HHS in the George W. Bush Administration to develop recommendations on how to facilitate the use of health information technology to improve health. Spe- cifically, she cochaired the Confidentiality, Privacy and Security Workgroup and was a member of the Personalized Health Care Workgroup. She also served on the Policy Steering Committee of the eHealth Initiative and now serves on its Leadership Committee. She is also on the Steering Group of the Markle Foundation’s Connecting for Health multistakeholder initiative. McGraw has a strong background in health care policy. Prior to joining CDT, McGraw was the chief operating officer of the National Partnership for Women & Families, providing strategic direction and oversight for all of the organization’s core program areas, including the promotion of initia- tives to improve health care quality. McGraw was also an associate in the public policy group at Patton Boggs, LLP, and in the health care group at Ropes & Gray. She also served as deputy legal counsel to the governor of Massachusetts and taught in the Federal Legislation Clinic at the George- town University Law Center. McGraw graduated magna cum laude from the University of Maryland. She earned a JD, magna cum laude, and an LLM from Georgetown University Law Center and was executive editor of the Georgetown Law Journal. She also has a master of public health from the Johns Hopkins School of Hygiene and Public Health. John J. Orloff, MD, is the chief medical officer and senior vice president of global development for Novartis Pharmaceuticals. In this position, Orloff is responsible for providing strategic and scientific leadership for all processes within global development and for representing Novartis externally in various forums interfacing with the scientific, academic, and health policy communities. In addition, Orloff serves as chair of the Pharma Portfolio Stewardship Board, which oversees safety and risk management plans for products within Pharma. Orloff has held a number of roles with increas- ing responsibility at Novartis, including section head for Bone Metabolism in Clinical Development, vice president and therapeutic area head of the Arthritis, Bone Metabolism, and Women’s Health Division within Clinical Development and Medical Affairs, and most recently, head of U.S. Medical and Drug Regulatory Affairs. Orloff graduated from Dartmouth College, received a medical degree from the University of Vermont, and completed specialty training in endocrinology and metabolism at Yale University, where he served on the faculty as an associate professor of medicine be-

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88 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM fore moving on to Merck Research Labs to lead clinical programs in bone metabolism. Richard Platt, MD, MSc, is professor and chair of the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute. He is principal investigator of the U.S. Food and Drug Ad- ministration’s (FDA’s) Mini-Sentinel program and of contracts with FDA’s Center for Drug Evaluation and Research and Center for Biologics Evalu- ation and Research to conduct postmarketing studies of the safety and ef- fectiveness of drugs and biologics. Platt is also principal investigator of a Centers for Disease Control and Prevention (CDC) Prevention Epicenter, a CDC Center of Excellence in Public Health Informatics, and an Agency for Healthcare Research and Quality Health Maintenance Organization Research Network Developing Evidence to Inform Decisions about Effec- tiveness Center. He chaired the FDA Drug Safety and Risk Management Advisory Committee and is a member of the Association of American Medical Colleges’ Advisory Panel on Research. Platt was co-chair of the Board of Scientific Counselors of the CDC Center for Infectious Diseases. Additionally, he chaired the National Institutes of Health study section Epidemiology and Disease Control 2 and the CDC Office of Health Care Partnerships steering committee. Robert E. Ratner, MD, is chief scientific and medical officer for the Ameri- can Diabetes Association, the nation’s largest voluntary health organization leading the fight to Stop Diabetes®. Ratner joined the Association in May 2012 and provides leadership and oversight of scientific and medical activi- ties, including research, clinical affairs, program recognition and certifica- tion, medical information, and professional education. In this capacity, he oversees the Association’s support of a broad range of professional educa- tion activities and the development of the American Diabetes Association Clinical Practice Recommendations, clinical consensus reports, and expert opinions. In 2011, the Association provided $34.6 million in research funds, funding more than 400 grants at 139 leading U.S. research institu- tions. Prior to joining the American Diabetes Association, Ratner was a professor of medicine at Georgetown University Medical School and senior research scientist at the MedStar Health Research Institute in metropolitan Washington, DC. He recently completed a sabbatical as a Robert Wood Johnson Foundation Health Policy Fellow, having served as the study direc- tor for the Institute of Medicine Comparative Effectiveness Research Priori- ties Committee and a program examiner for health reform in the Health Division of the U.S. Office of Management and Budget. He received an MD from the Baylor College of Medicine in Houston, Texas, where he also completed his internal medicine training. He underwent fellowship training

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APPENDIX B 89 in endocrinology and metabolism at Harvard Medical School and the Joslin Diabetes Center in Boston, Massachusetts. He recently completed 6 years of service on the Steering Committee of the National Diabetes Education Program, representing the American Diabetes Association. He has served on the Board of Directors of the National Certification Board for Diabetes Education and the American Association of Diabetes Educators and is past president of the Washington, DC, area affiliate of the American Diabetes Association. He has served as the chair of the Government Relations Com- mittee and the Pregnancy Council of the American Diabetes Association. He was a principal investigator for the Diabetes Prevention Program (DPP) and DPP Outcomes Study of the National Institutes of Health and served on the Steering Committee for the project nationwide. At Georgetown University, he served on the University Research Committee and cochaired the Joint Oversight Committee for Clinical Research. He was an associ- ate editor of the Journal of Clinical Endocrinology and Metabolism. His research interests include diabetes therapeutics and complications, with an emphasis on translational efforts from controlled trials into community- based practice. He is the author of more than 130 original scientific articles and 20 book chapters. Nancy Roach founded Fight Colorectal Cancer (Fight CRC) in 2005, 9 years after her mother-in-law was diagnosed with colorectal cancer. Recognizing the need for an advocacy organization, she established Fight CRC to provide focus, infrastructure, and support for colorectal cancer survivors, caregivers, and those touched by the disease. Since then, Roach has played a vital role in championing the need for a cure for colon and rectal cancer through screening, awareness, and research. Her efforts as an advocate have supported education and support for patients as well as the research community. Her leadership and passion have fostered a com- munity of advocates supporting state and federal policies that have led to increased colorectal cancer research opportunities across the country. Over the last 4 years, Fight CRC has directed more than $250,000 in research funding to young investigators. Roach currently serves as the chair of the Board of Directors and serves on the National Cancer Institute (NCI) Board of Scientific Counselors and the Clinical Trial and Translational Research Advisory Committee. She is on the Executive Committee of the Clinical Tri- als Transformation Initiative, a U.S. Food and Drug Administration–Duke University public–private partnership, and is a past chair of its Finance Committee. She has been involved with cooperative groups and SPORES and currently serves on the NCI Colon Task Force. She served on the U.S. Department of Defense congressionally directed Medical Research Program Integration Panel in 2010, the first year that colorectal cancer research was funded by the program. She is a past chair of the NCI Patient Advocate

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90 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM Steering Committee and received the NCI Director’s Service Award when she stepped down. She has also received the Preventing Colorectal Can- cer Champion Award and the Colon Cancer Alliance Sapphire Visionary Award, in recognition of her efforts on behalf of patients. She has spoken on behalf of patients at meetings such as the American Association for Cancer Research, the Friends of Cancer Research/Brookings Institution Conference on Clinical Research, and the Oxford University-Duke Univer- sity-McMaster University Sensible Guidelines for Clinical Trials. Kate Ryan, MPA, is the senior program coordinator at the National Wom- en’s Health Network (NWHN). In this role, she is responsible for develop- ing and implementing a program of legislative and regulatory advocacy that focuses on reducing women’s exposure to unnecessary drug and medi- cal treatment risks. Ryan leads advocacy efforts to increase research on women’s health and increase women’s participation in clinical trials and health research. Through work with the National Institute of Child Health and Human Development and the U.S. Food and Drug Administration, Ryan brings women’s voices to the health policy debates in Washington, DC, and the states and advocates for a health care system that is accessible to all and meets the needs of diverse women. Prior to joining the NWHN, Ryan worked in the Capitol Hill office of U.S. Representative Joe Sestak (D-PA), where she worked on health care reform and the women’s issues portfolio and managed a variety of constituent services programs. Before moving to Washington, DC, Ryan volunteered in Ghana with the Alliance for Reproductive Health Rights to monitor and assess the availability of and access to women’s sexual and reproductive health services under the Ghanaian National Health Insurance Scheme. As part of this work, Ryan also monitored Ghana’s progress on Millennium Development Goals 4 and 5: to reduce child mortality and improve maternal health. Ryan received an MPA in international public and nonprofit management and policy analy- sis with a focus on women’s rights from the New York University Wagner Graduate School of Public Service. Lewis G. Sandy, MD, is senior vice president for clinical advancement of UnitedHealth Group (a Fortune 25 diversified health and well-being company dedicated to helping people live healthier lives). At UnitedHealth Group, he focuses on clinical innovation, payment/delivery reforms to modernize the U.S. health care system, and physician collaboration. He also is a principal in the UnitedHealth Center for Health Reform and Mod- ernization, with a focus on payment/delivery innovation and policy. From 2003 to 2007, he was executive vice president and chief medical officer of UnitedHealthcare, UnitedHealth Group’s largest business, focusing on the employer/individual health benefits market. From 1997 to 2003, he was

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APPENDIX B 91 executive vice president of the Robert Wood Johnson Foundation (RWJF). At RWJF, he was responsible for the Foundation’s program development and management, strategic planning, and administrative operations. Prior to this, Sandy was a program vice president of the Foundation, focusing on the Foundation’s workforce, health policy, and chronic care initiatives. An internist and former health center medical director at the Harvard Com- munity Health Plan in Boston, Massachusetts, Sandy received BS and MD degrees from the University of Michigan and an MBA degree from Stanford University. A former RWJF Clinical Scholar and Clinical Fellow in Medicine at the University of California, San Francisco, Sandy served his internship and residency at the Beth Israel Hospital in Boston. He is a senior fellow of the Department of Health Policy and Management, University of Min- nesota School of Public Health. Joe V. Selby, MD, MPH, is the first executive director of the Patient- Centered Outcomes Research Institute (PCORI). A family physician, clini- cal epidemiologist, and health services researcher, he has more than 35 years of experience in patient care, research, and administration. He identifies strategic issues and opportunities for PCORI and implements and admin- isters programs authorized by the PCORI Board of Governors. Building on the work of the Board and interim staff, Selby leads the organizational development of PCORI, which was established by Congress through the 2010 Patient Protection and Affordable Care Act. In addition to creating an organizational structure to carry out a national research agenda, Selby leads PCORI’s external communications, including work to establish effective two-way communication channels with the public and stakeholders about PCORI’s work. Selby joined PCORI from Kaiser Permanente, Northern California, where he was director of the Division of Research for 13 years and oversaw a department of more than 50 investigators and 500 research staff working on more than 250 ongoing studies. He was with Kaiser Permanente for 27 years. An accomplished researcher, Selby has authored more than 200 peer-reviewed articles and continues to conduct research, primarily in the areas of diabetes outcomes and quality improvement. His publications cover a spectrum of topics, including effectiveness studies of colorectal cancer screening strategies; treatment effectiveness, population management, and disparities in diabetes mellitus; primary care delivery; and quality measurement. Selby was elected to membership in the Institute of Medicine in 2009 and was a member of the Agency for Healthcare Re- search and Quality Study Section for Health Care Quality and Effectiveness from 1999 to 2003. A native of Fulton, Missouri, Selby received a medical degree from Northwestern University and a master’s in public health from the University of California, Berkeley. He was a commissioned officer in the Public Health Service from 1976 to 1983 and received the Commis-

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92 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM sioned Officer’s Award in 1981. He serves as a lecturer in the Department of Epidemiology and Biostatistics, University of California, San Francisco, School of Medicine, and as a consulting professor in health research and policy at the Stanford University School of Medicine. Selby was appointed PCORI executive director on May 16, 2011, and formally began his duties on July 1, 2011. Rachel E. Sherman, MD, MPH, is the associate director for medical policy, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for developing, implementing, and coordinating medical policy programs and strategic initiatives, includ- ing regulation of prescription drug promotion and advertising, through the Center’s Division of Drug Marketing, Advertising, and Communications. Sherman provides leadership and scientific guidance and advice in clinical trial implementation and facilitates the development and implementation of agency policy related to human subject protection and good clinical practices through the development of regulations, guidance documents, and procedures related to medical policy issues. Key activities involve leveraging of resources and expertise from within FDA and from industry, academia, and other federal agencies to achieve agency goals. Sherman is leading the agency’s implementation of the Sentinel Initiative and the development and implementation of biosimilars policy. Sherman began her career with FDA in the Division of Antiviral Drug Products in CDER in 1989. During her tenure there, both as a medical reviewer and as a team leader, she played a pivotal role in the rapid development of new agents to treat human im- munodeficiency virus infection and other viral diseases. Since 1998, she has held a series of senior management positions in the agency, including deputy office director for the Office of Drug Evaluation I, deputy office director of the Office of Medical Policy in CDER, and associate commissioner for clinical programs. From 2003 until her return to CDER in 2009, Sherman directed the Office of Critical Path Programs in the Office of the Commis- sioner, leading FDA’s Critical Path Initiative, an agency initiative to spur innovation and foster efforts to modernize the way in which FDA-regulated products are developed, evaluated, manufactured, and used. Sherman is a board-certified internist and infectious disease subspecialist. She received an AB in mathematics from Washington University, an MD from the Mt. Sinai School of Medicine, and an MPH from the Johns Hopkins School of Hy- giene and Public Health. Elsie M. Taveras, MD, MPH, is an associate professor of population medi- cine at Harvard Medical School and associate professor of pediatrics at Children’s Hospital Boston. She received bachelor of science and medical doctor degrees from New York University in New York City. After receiv-

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APPENDIX B 93 ing an MD, she did her internship, residency, and chief residency at the Boston Combined Residency Program in Pediatrics, a joint program of Children’s Hospital Boston and Boston Medical Center. In 2001, Taveras joined the Harvard Pediatric Health Services Research Fellowship Program and received a master’s in public health with a concentration in clinical effectiveness from the Harvard School of Public Health. Taveras is the co- director of the Obesity Prevention Program at the Department of Popula- tion Medicine. Taveras is also on staff at Children’s Hospital Boston, where she directs a multidisciplinary childhood obesity prevention clinic in general pediatrics. Taveras’s main focus of research is understanding determinants of obesity in children and adolescents and developing interventions across the life course to prevent obesity in children, especially in underserved populations. Taveras’s publications have examined diet, activity, sleep, and weight determinants in later childhood and origins of obesity early in life in young children.   Tjeerd-Pieter van Staa, MD, PhD, MSc, MA, studied medicine and re- ceived a medical degree in 1987 at the Erasmus University of Rotterdam, Rotterdam, the Netherlands. After several years of working as a practic- ing physician, he joined the pharmaceutical industry and worked as an epidemiologist and was also the European qualified person for drug safety. During this time, he obtained an MSc in epidemiology (McGill University, Canada) and was awarded a PhD in pharmacoepidemiology at Utrecht Uni- versity, Utrecht, the Netherlands, in 1999. He also has an MA in medical law and ethics. In 2006, he joined the Medicines and Healthcare Products Regulatory Agency as director of research of the Clinical Practice Research Datalink (CPRD; the General Practice Research Database [GPRD] is part of CPRD). He has published more than 130 peer-reviewed articles and is a well-recognized speaker in the field of pharmacoepidemiology, pharmaco- vigilance, and osteoporosis. He has been awarded several academic affilia- tions (Utrecht University; Medical Research Council, Southampton, United Kingdom) and is honorary professor at the London School of Hygiene and Tropical Medicine. van Staa is the recipient of the 2005 Iain I Boyle Award of the European Calcified Tissue Society (which consists of a monetary award to the scientist who has made significant contributions to bone disease research [http://www.ectsoc.org]). His current research activities concern the implementation of randomized clinical trials that use routinely collected electronic health records (as outlined in a recent article in the Brit- ish Medical Journal). Two cluster trials (on randomization practices) and a large pharmacogenetic study within GPRD are close to completion. van Staa is also involved in the implementation of multiple linkages of GPRD to other health care data sets, including cancer and registries, cardiovascular

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94 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM disease registries, air pollution, and bowel screening data. Visualization and evaluation of data quality are other research interests. James B. Young, MD, is professor of medicine and executive dean of the Cleveland Clinic Lerner College of Medicine of Case Western Reserve Uni- versity and chair of the Endocrinology and Metabolism Institute. He is also physician director of institutional relations and development and a medical director of the Kaufman Center for Heart Failure. He holds the George and Linda Kaufman Chair and is the study chairman of the National Institutes of Health, U.S. Food and Drug Administration, and Centers for Medi- care & Medicaid Services Interagency Registry for Mechanical Circulatory Assist Support. He has a joint appointment to the Clinic’s Multiorgan Transplant Center. Young is certified as a diplomat of the American Board of Internal Medicine as well as the subspecialty of cardiovascular disease and holds medical licensure from the states of California, Illinois, Ohio, Pennsylvania, and Texas. Young spent his early years in the San Francisco, California, Bay Area and then attended the University of Kansas, where he received a bachelor of arts degree with honors in biology and was a resi- dent of Stephenson Scholarship Hall. He matriculated to the Baylor College of Medicine in Houston, Texas, where he was awarded a medical doctor degree with honors in 1974 and was elected to the Alpha Omega Alpha medical honor society. Young remained in Houston at the Baylor Affiliated Hospitals to complete his clinical training, joining the faculty and becoming a professor of medicine with tenure in 1992. He was the clinical coordina- tor and scientific director for Michael E. DeBakey’s Multiorgan Transplant Center at The Methodist Hospital and the Baylor College of Medicine. He subsequently relocated to the Cleveland Clinic in Ohio in 1995, when he became head of the Section of Heart Failure and Cardiac Transplant Medi- cine in the Department of Cardiovascular Disease. In 1998 Young, along with his surgical colleague, Patrick McCarthy, created the Kaufman Center for Heart Failure at the Cleveland Clinic. Young’s research activities began during his residency and fellowship training when he was a Lipid Research Clinic physician. He subsequently focused his efforts on heart failure, me- chanical circulatory support, and cardiac transplant therapeutics, including early experiences with dopamine receptor agonists, angiotensin-converting- enzyme inhibitors, beta blockers, calcium channel blockers, angiotensin re- ceptor blockers, many new immunosuppressants, and a variety of parenteral inotropes and vasodilators. He has collaborated extensively with his basic science research associates, focusing on translational research with respect to the molecular biology of cardiac remodeling, allograft arteriopathy, and transplanted heart rejection. Young served as the United States principal or co–principal investigator for the HOPE, RESOLVED, SPICE, VMAC, MIRACLE-ICD, RED-HF, ACCLAIM, ONTARGET, TRANSCEND, and

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APPENDIX B 95 CHARM multicenter clinical trials. He has participated in more than 150 clinical trials as an investigator. Young has published almost 600 articles and several textbooks. Professionally, Young is most proud of his contribu- tions to the development and administration of donor organ procurement programs, his efforts to secure recognition for the newly emerging cardiol- ogy subspecialty of heart failure and cardiac transplant medicine, his col- laborations with basic and clinical scientists, his contributions to a unique medical school curriculum, and the programs that he helped develop in Houston and Cleveland. Bram Zuckerman, MD, is a graduate of the Boston University Medical School. He completed postgraduate training in internal medicine at Balti- more City Hospital and cardiology at the Johns Hopkins program. Prior to joining the U.S. Food and Drug Administration (FDA) in 1992, he was involved in basic research in hemodynamics at the University of Colo- rado Medical School and practiced noninvasive and invasive cardiology in Denver, Colorado, and Northern Virginia. He joined the FDA Division of Cardiovascular Devices (DCD) as a medical officer in 1992 and has been actively involved in the development and review of clinical trials for many new cardiovascular devices. In May 2001 he was appointed a deputy direc- tor in DCD. He was appointed to his current position as director of the FDA Division of Cardiovascular Devices in September 2002.

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