Appendix B
Biographical Sketches of Workshop Participants

Wade M. Aubry, M.D., has had experience in technology assessment, coverage decisions, and research with a number of different organizations in the private and public sectors. He is Associate Director of the Center for Medical Technology Policy (CMTP), which provides a neutral forum for payers, manufacturers, researchers, clinicians, and patients to work together to identify evidence gaps and fund prospective, real-world research to inform healthcare decisions. He is also Senior Medical Advisor for the California Technology Assessment Forum, an open forum process of technology assessment using evidence-based criteria. Dr. Aubry has twice been a member of the CMS MEDCAC, is a former Chair of the national BCBSA TEC Medical Advisory Panel, and has recently been appointed to a 2-year term on the AHRQ Effective Health Care Stakeholder Group. He is Associate Clinical Professor of Medicine at the UCSF Institute for Health Policy Studies, where he works on the California Health Benefits Review Program, an assessment program for proposed health plan mandates for the California legislature. Previously, he was Senior Advisor for the Health Technology Center (HealthTech), Vice President of the Lewin Group, Senior Vice President and Chief Medical Officer for Blue Shield of California, and Medicare Part B Medical Director for Northern California. He has served on numerous national advisory committees for the NIH, IOM, NCQA, and others. Dr. Aubry received his B.S. degree Phi Beta Kappa from Stanford University, his M.D. degree from the UCLA School of Medicine, and his postgraduate training in internal medicine and endocrinology at Cedars-Sinai Medical Center. Among his publications on medical technology, he is co-author of a comprehensive case study on bone marrow transplants for



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Appendix B Biographical Sketches of Workshop Participants Wade M. Aubry, M.D., has had experience in technology assessment, cov- erage decisions, and research with a number of different organizations in the private and public sectors. He is Associate Director of the Center for Medical Technology Policy (CMTP), which provides a neutral forum for payers, manufacturers, researchers, clinicians, and patients to work together to identify evidence gaps and fund prospective, real-world research to inform healthcare decisions. He is also Senior Medical Advisor for the California Technology Assessment Forum, an open forum process of technology assessment using evidence-based criteria. Dr. Aubry has twice been a member of the CMS MEDCAC, is a former Chair of the national BCBSA TEC Medical Advisory Panel, and has recently been appointed to a 2-year term on the AHRQ Effective Health Care Stakeholder Group. He is Associate Clinical Professor of Medicine at the UCSF Institute for Health Policy Studies, where he works on the California Health Benefits Review Program, an assessment program for proposed health plan mandates for the California legislature. Previously, he was Senior Advisor for the Health Technology Center (HealthTech), Vice President of the Lewin Group, Senior Vice President and Chief Medical Officer for Blue Shield of California, and Medicare Part B Medical Director for Northern California. He has served on numerous national advisory committees for the NIH, IOM, NCQA, and others. Dr. Aubry received his B.S. degree Phi Beta Kappa from Stanford University, his M.D. degree from the UCLA School of Medicine, and his postgraduate training in internal medicine and endocrinology at Cedars- Sinai Medical Center. Among his publications on medical technology, he is co-author of a comprehensive case study on bone marrow transplants for 

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 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM breast cancer, which was published in January 2007 by Oxford University Press and titled False Hope: Bone Marrow Transplantation for Breast Cancer. Jerry Avorn, M.D., is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmaco-epidemiology and Pharmaco-economics in the Department of Medicine at Brigham and Women’s Hospital. An internist, geriatrician, and drug epidemiologist, he studies the intended and adverse effects of drugs, physician prescribing practices, and medication policy. Dr. Avorn pioneered the “academic detailing” approach in which evidence-based information about drugs is provided to doctors through educational outreach programs run by noncommercial sponsors; such pro- grams are now in widespread use throughout the United States, Canada, Australia, Europe, and the developing world. He completed his under- graduate training at Columbia University in 1969, received an M.D. from Harvard Medical School in 1974, and was a resident in internal medicine at the Beth Israel Hospital in Boston. He has served on several national and international panels as an expert on the determinants and consequences of medication use, and is a past President of the International Society of Pharmaco-Epidemiology. Dr. Avorn is the author of more than 200 papers in the medical literature on medication use and its outcomes, and he is one of the most highly cited researchers working in the area of medicine and the social sciences. His book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, was published by Knopf in 2004 and re-issued in 2005. Peter B. Bach, M.D., is Associate Attending Physician at Memorial Sloan- Kettering Cancer Center in New York and is board certified in internal medicine, pulmonary medicine, and critical care medicine. He is a National Institutes of Health-funded researcher with expertise in quality of care and epidemiologic research methods. His research on health disparities, variations in healthcare quality, and lung cancer epidemiology has appeared in The New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of the National Cancer Institute. Bach served as a senior adviser to the Administrator of the Centers for Medicare & Medicaid Services from February 2005 through November 2006, where his work focused on improving evidence about the effect of therapies and devices and revising payment to enhance care quality. He was the agency lead on cancer policy. During the Rwandan Civil War, he was a camp physician in Goma, Zaire, caring for refugees. Bach received his bachelor’s degree in English and American Literature from Harvard College, his M.D. from the University of Minnesota, and his master’s degree in public policy from the University of Chicago, where he was also a Robert Wood Johnson

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9 APPENDIx B Clinical Scholar. He completed his clinical training in internal medicine, pulmonary and critical care at the Johns Hopkins Hospital. Donald A. Berry, Ph.D., is Head and Chair of the Division of Quantita- tive Sciences in the Department of Biostatistics at the University of Texas M.D. Anderson Cancer Center and an international expert in the field of biostatistics. He holds the Frank T. McGraw Memorial Chair for Cancer Research at The University of Texas M.D. Anderson Cancer Center. His primary interest is the prevention and treatment of breast cancer. He serves as the faculty statistician on the Breast Cancer Committee of the Cancer and Leukemia Group B (CALGB), a national oncology group. In this role he designs and supervises the conduct and analysis of clinical trials in breast cancer. A native of Massachusetts, Dr. Berry received his Ph.D. in statistics from Yale University and previously served on the faculty at the University of Minnesota and at Duke University, where he held the Edger Thompson Professorship in the College of Arts and Sciences. The author of more than 200 published articles as well as several books on bio- statistics in medical research, Dr. Berry has been the principal investigator for numerous medical research programs funded by the National Institutes of Health and the National Science Foundation. A current project funded by the National Cancer Institute (NCI) describes the usage and benefits of breast cancer treatment. He was also the principal investigator of an NCI project CISNET: Cancer Intervention and Surveillance Network. This project focused on statistical modeling to assess the relative contribution of screening mammography, tamoxifen, and chemotherapy to the drop in breast cancer mortality observed in the United States since 1990. Another focus of Dr. Berry’s statistical research is designing clinical trials that utilize patients more efficiently and that treat patients in the trials more effec- tively. Dr. Berry is a statistics editor for the Journal of the National Cancer Institute and associate editor for Breast Cancer Research and Treatment and also for Clinical Cancer Research, and he is a Fellow of the American Statistical Association and of the Institute of Mathematical Statistics. Ashley B. Boam, M.S., currently serves as Acting Deputy Director for Science and Review Policy in the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. Ms. Boam earned her B.S.E and M.S.B.E. in biomedical engineering from Tulane University and the University of Alabama at Birmingham, respectively. She joined the FDA in 1993 as a sci- entific reviewer in the Division of Ophthalmic and ENT Devices. In 2002, she joined the Division of Cardiovascular Devices as Chief of the Interven- tional Cardiology Devices Branch. Products reviewed by the branch include drug-eluting stents, embolic protection devices, cardiac occluders, and other devices associated with coronary percutaneous interventional procedures.

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90 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM Robert M. Califf, M.D., is currently Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Institute (DTMI), and Profes- sor of Medicine in the Division of Cardiology at the Duke University Medi- cal Center in Durham, North Carolina. For 10 years he was Director of the Duke Clinical Research Institute, a premier academic research organization. A native of South Carolina, Dr. Califf graduated from Duke University, summa cum laude and Phi Beta Kappa, in 1973 and from Duke University Medical School in 1978, where he was selected for Alpha Omega Alpha. He performed his internship and residency at the University of California at San Francisco and his fellowship in Cardiology at Duke University. He is board certified in internal medicine (1984) and cardiology (1986) and is a Fellow of the American College of Cardiology (1988). Dr. Califf has served as an editor for the first and second editions of the landmark textbook, Acute Coronary Care, published by Mosby, Inc., and is the Editor-in Chief of Mosby’s American Heart Journal. He is a section editor for the Textbook of Cardiovascular Medicine and has been an author or coauthor of more than 600 peer-reviewed journal articles. He is a contributing editor for theheart.org, an online information resource for academic and practicing cardiologists. Dr. Califf has led the Duke Clinical Research Institute (DCRI) efforts for many of the best-known clinical trials in cardiovascular disease. With his colleagues from the Duke Databank for Cardiovascular Disease, he has written extensively about clinical and economic outcomes in chronic heart disease. He is considered an international leader in the fields of health outcomes, quality of care, and medical economics. Dr. Califf has served on the Cardiorenal Advisory Panel of the U.S. FDA and the Pharmaceutical Roundtable of the Institute of Medicine (IOM). He also served on the IOM Committee that recommended Medicare coverage of clinical trials, which Congress recently approved. He is director of the coordinating center for the Centers for Education & Research on Therapeutics™ (CERTs), a public–private partnership among AHRQ, DCRI, academia, industry, and consumer groups. This partnership focuses on research and education that will advance the best use of medical products. Carolyn M. Clancy, M.D., is Director of the Agency for Healthcare Research and Quality (AHRQ). Prior to 2002 she was Director of the Agency’s Center for Outcomes and Effectiveness Research (COER). Dr. Clancy, a general internist and health services researcher, is a graduate of Boston College and the University of Massachusetts Medical School. Following clinical training in internal medicine, Dr. Clancy was a Henry J. Kaiser Family Foundation Fellow at the University of Pennsylvania. She was also an assistant pro- fessor in the Department of Internal Medicine at the Medical College of Virginia in Richmond before joining AHRQ in 1990. Dr. Clancy holds an academic appointment at George Washington University School of Medi-

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9 APPENDIx B cine (Clinical Associate Professor, Department of Medicine), and she is the Senior Associate Editor of Health Services Research and serves on multiple editorial boards (currently Annals of Family Medicine, American Journal of Medical Quality, and Medical Care Research and Review). Dr. Clancy has published widely in peer-reviewed journals and has edited or contributed to seven books. She is a member of the Institute of Medicine and was elected a Master of the American College of Physicians in 2004. Denis A. Cortese, M.D., is President and Chief Executive Officer of Mayo Clinic and Chair of the Executive Committee. He has been a member of the Board of Trustees since 1997 and previously served on that Board from 1990 to 1993. Following service in the U.S. Naval Corps, he joined the staff of the Mayo Clinic in Rochester, Minnesota, in 1976 as a special- ist in pulmonary medicine. He was a member of the Board of Governors in Rochester before moving to the Mayo Clinic in Jacksonville, Florida, in 1993. From 1999 to 2002 he served as Chair of the Board of Gover- nors at the Mayo Clinic and Chair of the Board of Directors at St. Luke’s Hospital in Jacksonville, Florida. He is a Director and former President of the International Photodynamic Association and has been involved in the bronchoscopic detection, localization, and treatment of early-stage lung cancer. He is a member of the Healthcare Leadership Council and the Harvard/Kennedy School Healthcare Policy Group, and he is a former member of the Center for Corporate Innovation. He served on the Steering Committee for the RAND Ix Project, “Using Information Technology to Create a New Future in Healthcare,” and the Principals Committee of the National Innovation Initiative. He also is a charter member of the Advisory Board of World Community Grid and a founding member of the American Medical Group Association Chairs/Presidents/CEOs Council. Dr. Cortese is a graduate of Temple University, completed his residency at the Mayo Graduate School of Medicine, and is a professor of medicine in Mayo Clinic College of Medicine. Dr. Cortese is a member of the Institute of Medicine, a Fellow of the Royal College of Physicians in England, and an honorary member of the Academia Nacional de Mexicana (Mexico). William H. Crown, Ph.D., is President of i3 Innovus, the Health Eco- nomics and Outcomes Research division of Ingenix. From 1982 to 1995, Dr. Crown was a faculty member at the Florence Heller Graduate School, Brandeis University, where he taught graduate courses in statistics and con- ducted research on the economics of aging and long-term care policy. Prior to joining Ingenix in 2004, Dr. 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 respiratory and mental health conditions.

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92 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM Dr. Crown’s work in the area of depression was one of the first applications of econometric techniques in outcomes research to control for the effects of selection bias when using retrospective data to evaluate drug technologies. He has 25 years of experience conducting health policy and income main- tenance research for private-sector and public-sector clients. Dr. Crown is author or co-author of four books and more than 90 refereed journal articles, book chapters, and other publications. Brian G. Firth, M.D., Ph.D., is Worldwide Vice President, Health Affairs, Cordis Corporation, a Johnson & Johnson company. Cordis develops and markets devices for circulatory disease management. Among Dr. Firth’s responsibilities are worldwide strategic medical input for the corporation and liaison with major medical societies, publishing results of Cordis’ clini- cal research articles, and inter-company cardiovascular research and health policy activities within Johnson & Johnson. He was appointed to this posi- tion in August 2007. Dr. Firth began his career at Johnson & Johnson in 1995 as Vice President, Research and Development, Johnson & Johnson Interventional Systems, now part of Cordis. He was named Vice President, Research and Development at Cordis in 1996, and the following year, was appointed Worldwide Vice President, Medical Affairs and Chief Scientific Officer. From June 1999 to July 2007, he served as Worldwide Vice Presi- dent of Medical Affairs and Health Economics. In this capacity, he was one of the chief architects behind the successful launch of the CYPHER Sirolimus-eluting stent. Dr. Firth obtained his medical degree (bachelor of medicine; bachelor of surgery) with honors from the University of Cape Town in South Africa. He then attended Oxford University as a Rhodes Scholar where he obtained a doctorate of philosophy in cardiovascular physiology. He completed his residency in internal medicine and fellowship in cardiology at the Groote Schuur Hospital in Cape Town. He also com- pleted a fellowship in cardiology at the University of Texas Southwestern Medical Center in Dallas, Texas, and then served as a cardiologist and Pro- fessor of Medicine at that institution for more than 10 years. He received his master of business administration from Amber University in Dallas. He is also a Fellow of the Royal College of Physicians, UK, The American College of Cardiology, and the American Heart Association. A member of many professional medical societies, committees, and educational boards, Dr. Firth has published more than 80 manuscripts and co-authored several books on cardiology. David R. Flum, M.D., M.P.H., is a gastrointestinal surgeon and outcomes researcher at the University of Washington. He holds the rank of Associ- ate Professor in the Schools of Medicine and Public Health and serves as the Director of the Surgical Outcomes Research Center (SORCE) at the

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9 APPENDIx B University of Washington. He is one of the Principal Investigators of the Longitudinal Assessment of Bariatric Surgery (LABS) study and the Medical Director of the Surgical Clinical Outcomes Assessment Program (SCOAP), a statewide surgical QI activity. He is also a contributing editor for the Journal of the American Medical Association. Dr. Flum’s areas of particu- lar expertise include surgical management of gastrointestinal disorders and advanced laparoscopy with an interest in biliary tract disorders and com- plex abdominal wall hernias. Annetine C. Gelijns, Ph.D., is Co-Director (with Alan Moskowitz) of the International Center for Health Outcomes and Innovation Research (InCHOIR) and a Professor of Surgical Sciences and Public Health in the Department of Surgery, College of Physicians and Surgeons, and the Divi- sion of Health Policy and Management of the Mailman School of Public Health, Columbia University, New York City. She is also a Division Chief in the Department of Surgery. Her current research focuses on measurement of the long-term clinical outcomes and economic impact of clinical interven- tions, patient safety research, and the factors driving the development and diffusion of medical technology. She has special expertise in cardiovascular disease, particularly in the design, coordination, and analysis of multicenter left ventricular assist devices (LVAD) trials. She has been the Director of the Data Coordinating Center for the NHLBI-sponsored REMATCH trial, is the PI of the DCC for a SCCOR grant on the biology of long-term LVAD implantation, and co-PI for the NHLBI-sponsored CT Surgery Network. She co-chairs the cost-effectiveness section of the INTERMACS registry of mechanical circulatory support devices. Peter K. Honig, M.D., M.P.H., is Executive Vice President for Global Regulatory Affairs, Global Clinical Research Operations and Data Manage- ment, Product Safety, Quality Assurance and OTC Development at Merck Research Laboratories. He is former Director of the Office of Drug Safety in FDA’s Center for Drug Evaluation and Research (CDER). He joined CDER as a medical officer in the Division of Oncology and Pulmonary Drug Prod- ucts in 1993 and assumed many roles and responsibilities during his FDA career, including FDA representative to the CERTs Steering Committee, and CDER liaison to the Harvard and Johns Hopkins Clinical Investigators fellowship training programs. Dr. Honig was also active internationally as the FDA representative to the International Conference on Harmonization (ICH) MedDRA (Medical Dictionary for Regulatory Activities) Manage- ment Board and the E2B Expert Working Group and currently serves as PhRMA member of the ICH Steering Committee. Dr. Honig received his baccalaureate, medical, and public health degrees from Columbia Uni- versity in New York. He has postgraduate training and is board certified

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9 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM in internal medicine and clinical pharmacology and was elected a Fellow of the American College of Physicians (FACP). Dr. Honig retains faculty appointments at the Uniformed Services University of the Health Sciences and Georgetown University Medical School. He is a past President of the American Society of Clinical Pharmacology and Therapeutics (ASCPT). Kathy Hudson, Ph.D., is the founder and Director of the Genetics and Public Policy Center (GPPC) and an Associate Professor in the Berman Bioethics Institute, Institute of Genetic Medicine, and the Department of Pediatrics at Johns Hopkins University. Hudson founded the GPPC to fill an important niche in the science policy landscape and to focus exclusively on public policy issues raised by advances in human genetics. She leads the GPPC’s efforts to address legal, ethical, and policy issues related to human reproductive genetic technologies, genetic testing quality and oversight, and public engagement in genetic research. Hudson serves on the boards of the Health Privacy Project, the Guttmacher Institute, the Annual Review of Genomics and Human Genetics and PXE International, the Personalized Healthcare Working Group for the U.S. Department of Health and Human Services, the Committee on Science, Engineering and Public Policy for the American Association for the Advancement of Science, and the Social Issues Committee for the American Society of Human Genetics. She has published articles about and is a frequent speaker on issues related to biotechnology, genetics, and public policy. Before founding the GPPC, Hudson was the Assistant Director of the National Human Genome Research Institute (NHGRI) responsible for communications, legislation, planning, and educa- tion activities. Previously, Hudson served as a Senior Policy Analyst in the U.S. Department of Health and Human Services and worked on Capitol Hill. She holds a Ph.D. in molecular biology from the University of Cali- fornia at Berkeley, an M.S. in microbiology from the University of Chicago, and a B.A. in biology from Carleton College. Isaac S. Kohane, M.D., Ph.D., is the director of the Children’s Hospital Informatics Program and is the Henderson Associate Professor of Pediatrics and Health Sciences and Technology at Harvard Medical School (HMS). He is also the co-Director of the HMS Center for Biomedical Library and Director of the HMS Countway Library of Meidicine. Dr. Kohane leads multiple collaborations at Harvard Medical School and its hospital affili- ates in the use of genomics and computer science to study cancer and the development of the brain (with emphasis on autism). He also has developed several computer systems to allow multiple hospital systems to be used as “living laboratories” to study the genetic basis of disease while preserving patient privacy. Dr. Kohane has published more than 160 papers in the medical literature and authored a widely used book on microarrays for an

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9 APPENDIx B integrative genomics. He has been elected to multiple honor societies includ- ing the American Society for Clinical Investigation and the American Col- lege of Medical Informatics. He leads a doctoral program in genomics and bioinformatics at MIT. He is also a practicing pediatric endocrinologist. Alan M. Krensky, M.D., is the first Director of the Office of Portfolio Analysis and Strategic Initiatives (OPASI) and a Deputy Director of the National Institutes of Health. He was at Stanford University for 23 years where he served as the Shelagh Galligan Professor of Pediatrics, Associate Dean for Children’s Health, Associate Chair for Research, Chief of the Divi- sion of Immunology and Transplantation Biology, and Executive Director of the Children’s Health Initiative. A medical graduate of the University of Pennsylvania in 1977, he trained in pediatrics and nephrology at Boston Children’s Hospital and immunology at the Dana-Farber Cancer Institute. He moved to Stanford as Assistant Professor of Pediatrics in 1984, was appointed Shelagh Galligan Professor in 1995, and has been at the NIH since July 2007. Dr. Krensky’s research program was continuously funded by the NIH from 1984 to his assumption of the NIH post. He has made important contributions to understanding the role of human T lymphocytes in disease and applying this information to the development of new diag- nostic and therapeutic approaches. He has published more than 250 scien- tific articles, served on numerous editorial and scientific advisory boards, and holds 10 patents. Dr. Krensky is a member of the American Society of Clinical Investigation and Association of American Physicians, and he served as President of the Society for Pediatric Research and Secretary-Trea- surer of the American Society of Nephrology. Joel Kupersmith, M.D., is the Chief Research and Development Officer of the Department of Veterans Affairs. He is a graduate of New York Medical College where he also completed his residency in internal medicine. Sub- sequently, he completed a cardiology fellowship at Beth Israel Medical Center/Harvard Medical School, after which he joined the faculty of the Mt. Sinai School of Medicine where he rose to the rank of Professor and Director of the Clinical Pharmacology section. After this he became Chief of Cardiology and V.V. Cooke Professor of Medicine at the University of Louisville, Professor and Chairperson, Department of Medicine at the College of Human Medicine at Michigan State University, and then Dean, School of Medicine and Graduate School of Biomedical Sciences, Vice President for Clinical Affairs at Texas Tech University as well as CEO of the Faculty Practice. In this position there were many advances in the medical center, including a marked stepwise drop in the faculty attrition rate; legis- lative initiatives; growth of the research enterprise; important recruitments; many educational initiatives; construction projects; improved scores of

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9 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM entering students; and increased number of minority students. Subsequently, Dr. Kupersmith was a Scholar-in-Residence at both the Institute of Medicine and the Association of American Medical Colleges before assuming duties as Chief Research and Development Officer at VHA. Dr. Kupersmith has 154 publications and 2 books. His earlier research interests were in the area of electrophysiology, the causes and treatment of heart rhythm abnormali- ties, and implantable cardioverter defibrillators. Subsequently, he published on cost effectiveness of heart disease treatments, and most recently his work has been on health policy issues. Dr. Kupersmith has been on many national and international committees involved in heart disease and journal editorial boards. He is a member of numerous professional organizations including the American Society for Clinical Investigation. Dr. Kupersmith also has been a Visiting Scholar at the Hastings Center for Ethics. Eric B. Larson, M.D., M.P.H., M.A.C.P., is Executive Director of Group Health’s Center for Health Studies. A graduate of Harvard Medical School, he trained in internal medicine at Beth Israel Hospital in Boston, completed a Robert Wood Johnson Clinical Scholars and M.P.H. program at the University of Washington, and then served as Chief Resident of Univer- sity Hospital in Seattle. He served as Medical Director of the University of Washington Medical Center and Associate Dean for Clinical Affairs from l989 to 2002. His research spans a range of general medicine topics and has focused on aging and dementia, including a long-running study of aging and cognitive change set in the Group Health Cooperative—The UW/Group Health Alzheimer’s Disease Patient Registry/Adult Changes in Thought Study. He has served as President of the Society of General Internal Medicine, Chair of the OTA/DHHS Advisory Panel on Alzheimer’s Disease and Related Disorders and was Chair of the Board of Regents (2004–2005) of the American College of Physicians. He is an elected member of the Institute of Medicine. Michael Lauer, M.D., joined NHLBI in July 2007 as Director of the Divi- sion of Prevention and Population Science. A board-certified cardiologist, he received his M.D. from Albany Medical College in 1985 and underwent postgraduate training within the Harvard University system at Massa- chusetts General Hospital, Boston Beth Israel Hospital, and the Harvard School of Public Health. After completing specialized research training in Cardiovascular Epidemiology at the Framingham Heart Study, he joined the staff at the Cleveland Clinic in 1993. During 14 years at the clinic, he established a world-renowned clinical epidemiology research program with primary focus on diagnostic testing and comparative effectiveness. His research led to more than 150 publications in top medical journals, grant support from the American Heart Association and the NIH, and election

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9 APPENDIx B to the American Society of Clinical Investigation. Dr. Lauer has served as Contributing Editor for JAMA, co-Director of the Cleveland Clinic Coronary Care Unit, Director of Cardiac Clinical Research, and as first Vice-Chair of the Cleveland Clinic IRB. He achieved distinction in medical education, leading the development of a clinical research curriculum at the newly founded Cleveland Clinic Lerner Medical College at Case Western Reserve University, where he was Professor of Medicine, Epidemiology, and Biostatistics. In his current position at NHLBI, Dr. Lauer is leading a $300 million per year research division that oversees major programs in cardiovascular epidemiology and prevention. Teri Manolio, M.D., Ph.D., is Director of the Office of Population Genomics of the National Human Genome Research Institute (NHGRI) at the NIH. She received her M.D. from the University of Maryland in 1980 and her Ph.D. in human genetics/genetic epidemiology from Johns Hopkins Uni- versity in 2001. She joined the National Heart, Lung, and Blood Institute in 1987 where she was heavily involved in large-scale cohort studies such as the Cardiovascular Health Study and the Framingham Heart Study. She moved to NHGRI in 2005 to lead efforts in applying genomic technologies to population research, including the Genetic Association Information Net- work (GAIN) and the Genes and Environment Initiative (GEI). She is the author of more than 190 original research papers and has research interests in the epidemiology of subclinical cardiovascular disease, ethnic differences in disease risk, and genomewide association studies of complex diseases. JoAnn E. Manson, M.D., Dr.P.H., is Professor of Medicine and the Elizabeth Fay Brigham Professor of Women’s Health at Harvard Medical School, Chief of Preventive Medicine at Brigham and Women’s Hospital (BWH), and co-Director of the Connors Center for Women’s Health and Gender Biology at BWH. An endocrinologist and epidemiologist, Dr. Manson is actively involved in women’s health research, including several large-scale clinical trials and observational studies of cardiovascular disease, diabetes, cancer, and osteoporosis. Her research has focused on the role of repro- ductive and hormonal factors, lifestyle variables such as diet and physical activity, and novel plasma and genetic markers as predictors of CVD and diabetes. Dr. Manson is Principal Investigator of the Boston center for the Women’s Health Initiative (WHI), the CVD component of the Harvard Nurses’ Health Study, the Boston site for the Kronos Early Estrogen Pre- vention Study (KEEPS), the Women’s Antioxidant and Folic Acid Cardio- vascular Trial, and other studies. She has published more than 600 articles in medical/scientific journals. Dr. Manson is the recipient of numerous awards, including the “Woman In Science Award” from the American Medical Women’s Association, the Bowditch Award for Excellence in Public

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9 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM Health from the Massachusetts Medical Society, the Postmenopausal Cardio- vascular Health Research Award from the North American Menopause Society, the International Prize “Premio Benessere Stresa” for “Women’s Wellbeing and Health in Midlife,” and was included in the National Library of Medicine’s exhibit “History of American Women Physicians.” Mark B. McClellan, M.D., Ph.D., became the Director of the Engelberg Center for Healthcare Reform at the Brookings Institution in July 2007. The Center studies ways to provide practical solutions for access, quality, and financing challenges facing the U.S. healthcare system. In addition, Dr. McClellan is the Leonard D. Schaeffer Chair in Health Policy Studies. Dr. McClellan has a highly distinguished record in public service and in aca- demic research. He is the former administrator for the Centers for Medicare & Medicaid Services (2004–2006) and the former Commissioner of the Food and Drug Administration (2002–2004). He also served as a member of the President’s Council of Economic Advisers and Senior Director for Health Care Policy at the White House (2001–2002). In these positions, he developed and implemented major reforms in health policy. Dr. McClellan was also an associate professor of economics and associate professor of medicine (with tenure) at Stanford University, from which he was on leave during his government service. He directed Stanford’s Program on Health Outcomes Research, and he was also associate editor of the Journal of Health Economics and co-Principal Investigator of the Health and Retire- ment Study (HRS), a longitudinal study of the health and economic status of older Americans. His academic research has been concerned with the effectiveness of medical treatments in improving health, the economic and policy factors influencing medical treatment decisions and health outcomes, the impact of new technologies on public health and medical expendi- tures, and the relationship between health status and economic well being. Dr. McClellan is a Member of the Institute of Medicine of the National Academies and a Research Associate of the National Bureau of Economic Research. A graduate of the University of Texas at Austin, Dr. McClellan earned his M.P.A. from Harvard’s Kennedy School of Government in 1991, his M.D. from the Harvard-MIT Division of Health Sciences and Technol- ogy in 1992, and his Ph.D. in economics from MIT in 1993. J. Michael McGinnis, M.D., M.P.P., is Senior Scholar at the Institute of Medicine of the National Academy of Sciences, leading its initiative on evidence-based medicine. From 1999 to 2005, he served as Senior Vice President and founding Director of the Health Group and as Counselor to the President at the Robert Wood Johnson Foundation. From 1977 to 1995, he held continuous appointments as Assistant Surgeon General, Deputy Assistant Secretary for Health, and founding Director, Disease

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99 APPENDIx B Prevention and Health Promotion, through the Carter, Reagan, Bush and Clinton Administrations. Programs and policies created and launched at his initiative include the Healthy People process on national health objectives, now in its third decade; the U.S. Preventive Services Task Force, now in its fourth iteration; the Dietary Guidelines for Americans (with USDA), now in its sixth edition; the RWJF Health & Society Scholars Program; the RWJF Young Epidemiology Scholars Program; and the RWJF Active Living family of programs. His international service includes appointments as Chair of the World Bank/European Commission Task Force on post-war reconstruc- tion of the health sector in Bosnia (1995–1996) and State Coordinator for the World Health Organization smallpox eradication program in Uttar Pradesh, India (1974–1975). He is an elected member of the IOM, Fellow of the American College of Epidemiology, and Fellow of the American College of Preventive Medicine. Current and recent board memberships include the Nemours Foundation Board of Directors; the IOM Committee on Children’s Food Marketing (Chair); the NIH State-of-the-Science Panel on Multivitamins in Chronic Disease Prevention (Chair); the Health Profes- sionals Roundtable on Preventive Services (Chair); the FDA Food Advisory Committee/Subcommittee on Nutrition; and the Board of the United Way of the National Capital Area (Chair, Resource Development). Alan J. Moskowitz, M.D., F.A.C.P., co-directs (with Annetine Gelijns) the International Center for Health Outcomes and Innovation Research (InCHOIR) and is a practicing internist at Columbia University. His aca- demic appointments are in the College of Physicians and Surgeons and Mailman School of Public Health of Columbia University, where he is a Professor of Clinical Medicine, Surgery and Health Policy and Manage- ment. His research is focused in the areas of cardiovascular and cerebro- vascular diseases. He is a principal investigator in the NINDS-supported ARUBA trial, an international RCT comparing watchful waiting to lesion eradication for unruptured brain arteriovenous malformations, co-Principal Investigator on an NHLBI-sponsored SCCOR grant studying mechanical circulatory support devices in advanced heart failure patients, and co- Principal Investigator on the NHLBI-sponsored cardio-thoracic surgery network. Dr. Moskowitz is a member of the Institutional Review Board of Columbia University and co-chairs the cost-effectiveness section of the INTERMACS registry of mechanical circulatory support devices. Garry Neil, M.D., is Corporate Vice President, Corporate Office of Science and Technology (COSAT), Johnson & Johnson (J&J). In this role, Garry leads a team that catalyzes sustained growth for J&J by identifying and launching emerging technologies that underpin the creation of future busi- nesses. Neil has broad experience in science, medicine, and pharmaceutical

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00 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM development. He has held a number of senior positions within J&J, most recently Group President, J&J Pharmaceutical Research and Development, where he was responsible for maximizing existing strengths and leveraging collective resources to bring innovative new molecular entities (NMEs) to market quickly and cost effectively. Through a number of new initiatives he helped transform J&J’s pharmaceutical R&D to a much more capable and productive organization and helped to recruit a number of top scientists. Under his leadership a number of important new medicines for the treat- ment of cancer, anemia, infections, central nervous system and psychiatric disorders, pain, and genitourinary and gastrointestinal diseases gained ini- tial or new and/or expanded indication approvals. Before joining J&J, he held senior-level positions with Astra Merck Inc., Astra Pharmaceuticals, Astra Zeneca, and Merck KGaA. Neil has written more than 50 articles and book chapters. He holds an M.D. from the University of Saskatchewan, College of Medicine and completed his postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. He is a Fellow of the American College of Physicians, a Fellow of the Ameri- can College of Gastroenterology, a member of the American Association of Immunologists, and the Society for Clinical Trials. He is a member of the Board of the Reagan-Udall Foundation and the J&J Development Corporation, and he is J&J’s representative to and Vice Chairman of the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Committee. John E. Niederhuber, M.D., is the Director of the National Cancer Institute (NCI). Both a surgeon and researcher, Dr. Niederhuber has dedicated his four-decade career to the treatment and study of cancer—as a professor, cancer center director, National Cancer Advisory Board chair, external advi- sor to the NCI, grant reviewer, and laboratory investigator supported by NCI and the NIH. In addition to his management of NCI, Dr. Niederhuber remains involved in research, through his laboratory on the National Insti- tutes of Health campus. Under his leadership, the Laboratory of Tumor and Stem Cell Biology, which is a part of the Cell and Cancer Biology Branch of NCI’s Center for Cancer Research, is studying tissue stem cells as the cell-of-origin for cancer. He is working to identify, fully characterize, and isolate this population of cells, with the hypothesis that they might become a therapeutic target. Dr. Niederhuber also holds a clinical appointment on the NIH Clinical Center Medical Staff. As a surgeon, Dr. Niederhuber’s clinical emphasis is on gastrointestinal cancer, hepatobiliary cancer, and breast cancer. Prior to his appointment, Dr. Niederhuber was NCI’s Chief Operating Officer and Deputy Director for Translational and Clinical Sci- ences, a position he assumed in September 2005. In June 2002, President Bush appointed Dr. Niederhuber as Chair of the National Cancer Advi-

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0 APPENDIx B sory Board. He resigned that position in order to become NCI’s Deputy Director. Sharon-Lise T. Normand, Ph.D., is a Professor of Biostatistics in the Department of Health Care Policy, Harvard Medical School and in the Department of Biostatistics at the Harvard School of Public Health. Dr. Normand’s methodological research focuses on Bayesian biostatistics with special emphasis on statistical methods for health services and outcomes research including assessment of quality of care, medical guideline con- struction, profiling, and meta-analysis. Normand has developed a long line of research on methods for the analysis of patterns of treatment and quality of care for patients with cardiovascular disease and patients with mental disorders. Her work in the area of profiling medical care providers involves developing analytic methods for (1) comparing providers using outcomes-based measures and for (2) determining the appropriate unit of analysis, e.g., health plan-level analysis or physician-level analysis, using process-based measures. Ronald A. Paulus, M.D., M.B.A., is Geisinger’s Chief Technology and Innovation Officer, responsible for ensuring system-wide innovation. His responsibilities include Geisinger Ventures, the system’s new business for- mation and intellectual property commercialization function; and Clinical Innovation, leading the system’s initiatives focused on care transformation through patient activation, novel technologies, and care redesign. Prior to joining Geisinger Health System, Dr. Paulus was Chief Healthcare Officer for Quovadx, Inc. (NASDAQ: QVDX), which acquired CareScience, Inc., a NASDAQ company providing clinical solutions to improve healthcare quality and efficiency where he had been President and CEO. Before join- ing CareScience, Dr. Paulus served as Vice President, Operations of Salick Health Care, Inc., a NASDAQ company providing oncology and dialysis services, which was subsequently acquired by AstraZeneca Pharmaceuticals. Dr. Paulus received his M.D. degree from The School of Medicine, Univer- sity of Pennsylvania, and his M.B.A., concentration in healthcare man- agement, and B.S. in economics from The Wharton School, University of Pennsylvania. Greg Pawlson, M.D., M.P.H., is the Executive Vice President of National Committee for Quality Assurance (NCQA). NCQA is a leading evaluator of healthcare services and is especially well known for its development of HEDIS® clinical performance measures. At NCQA, beyond his role as a senior member of the leadership team, Dr. Pawlson has oversight and responsibility for research and analysis, federal and state contracting, and performance measure development. While at NCQA, Dr. Pawlson has

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02 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM played a major role in development and maintenance of the current set of HEDIS® measures and other NCQA measures including those used in physician recognition programs and pay for performance projects. Before joining NCQA in January 2000, Dr. Pawlson was Senior Associate Vice President for Health Affairs and worked with the quality and utilization management efforts of the GW Health Plan and Faculty Practice. Prior to that Dr. Pawlson had served as Chairman of the Department of Health Care Sciences (DHCS) and Director of the Institute for Health Policy, Out- comes and Human Values at GW. During a sabbatical year at GW in 1987, Dr. Pawlson served as a Robert Wood Johnson Health Policy Fellow and health policy aide on the staff of Senator George Mitchell (D-Maine), and in 1997–1998 he was a scholar in residence at the American Association of Medical Colleges, at its Center for the Assessment and Management of Change in Academic Medicine. Within organized medicine Dr. Pawlson served as president or on the board of a number of organizations including the American Geriatrics Society, the Society for General Internal Medicine, the Bon Secours Health System, and the American College of Medical Quality. Dr. Pawlson has more than 100 publications in peer-reviewed journals and has received numerous awards and citations for his teaching and research. Richard Platt, M.D., M.S., is a Professor and Chair of the Department of Ambulatory Care and Prevention. He is an internist trained in infectious diseases and epidemiology. He is a member of the Association of American Medical Colleges Advisory Panel on Research and the IOM Roundtable on Evidenced-Based Medicine, and he currently chairs the FDA Drug Safety and Risk Management Advisory Committee. He has chaired the Executive Committee of the HMO Research Network, was co-chair of the Board of Scientific Counselors of the CDC’s Center for Infectious Diseases, chaired the NIH study section, Epidemiology and Disease Control 2, and the CDC Office of Health Care Partnerships Steering Committee. His research focuses on developing multi-institution automated record linkage systems for use in pharmacoepidemiology and for population-based surveillance, reporting, and control of both hospital- and community-acquired infec- tions, including bioterrorism events. He is Principal Investigator of the CDC-sponsored Center of Excellence in Public Health Informatics, the AHRQ sponsored HMO Research Network Center for Education and Research in Therapeutics (CERT), co-Principal Investigator of a Modeling Infectious Disease Agent Study (MIDAS), and the CDC-sponsored Eastern Massachusetts Prevention Epicenter. Wayne A. Ray, Ph.D., is a Professor of Preventive Medicine and the Director of the Division of Pharmacoepidemiology at Vanderbilt University School

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0 APPENDIx B of Medicine. His undergraduate work was in Mathematics at the University of Washington (1971) and he has a master’s degree in biostatistics (1974) and computer science (1981), both from Vanderbilt. He is a Fellow of the International Society for Pharmacoepidemiology. Dr. Ray also founded and directs the master of public health program at Vanderbilt. Dr. Ray has had a long-standing research interest in population-based studies of therapeutic interventions and has published more than 150 studies that use observational methods to assess safety and efficacy or seek to define and improve suboptimal use of therapeutic interventions. Dr. Ray pioneered the methodology for using large automated databases, particularly Medicaid, for these types of studies. His work includes fundamental studies of psycho- tropic drugs and injuries, nonsteroidal anti-inflammatory drugs (NSAIDs) and upper gastrointestinal disease, NSAIDs/coxibs and the risk of coronary heart disease, and medications and sudden cardiac death. He also has been a strong advocate of the need to reform the present drug regulatory system to better protect public health. Mark S. Roberts, M.D., M.P.P., is an internist and Professor of Medicine, Health Policy and Management and Industrial Engineering at the University of Pittsburgh, where he is Chief of the Section of Decision Sciences and Clinical Systems Modeling. He earned a B.A. in economics from Harvard College, completed medical school at Tufts University and a masters in public policy (MPP) from the Kennedy School of Government. After resi- dency and fellowship in internal medicine, he joined the Harvard Medical School faculty until moving to Pittsburgh in 1993. He has spent his entire academic career in decision sciences and health policy, and he is the author of more than 100 papers and book chapters. His research has been directed toward developing and enhancing decision analytic methods in order to build models that are more clinically realistic and directed towards clini- cal and policy decisions. The modeling of complex biologic processes and evaluating the tension between realistic models of clinical process and their analytic tractability is a major area of interest and expertise. Over the past 10 years, he has helped to advance the applications of analytic techniques from industrial engineering and management science, such as simulation and optimization to problems in health and medicine. He has served as a consultant to Archimedes, Inc. on multiple projects. A. John Rush, M.D., is Vice Chair for the Department of Clinical Sci- ences, Rosewood Corporation Chair in Biomedical Science and Professor of Psychiatry at the University of Texas Southwestern Medical Center at Dallas. His research has focused on the development and testing of innovative treatments for mood disorders including medications, medi- cation combinations, somatic treatments and psychotherapy, as well as

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0 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM disease management protocols (treatment algorithms) for severe and per- sistent mental illnesses, especially mood disorders. He has authored more than 470 papers and chapters and 10 books and has received continuous NIMH research support for 30 years. He was Principal Investigator on the NIMH-sponsored STAR*D (Sequenced Treatment Alternatives to Relieve Depression) trial. He presently directs the NIMH Depression Trials Net- work (DTN), which conducts efficacy-effectiveness research with depressed patients. His past awards include the Mood Disorders Research Award of the American College of Psychiatrists, the Paul Hoch Award from the American Psychopathological Association, the Edward J. Sachar Visiting Scholar Award from Columbia, the Nola Maddox Falcone Prize from NARSAD, the American Psychiatric Association Award for Research in Psychiatry, and the Gold Medal Award from the Society of Biological Psy- chiatry. He is past President of the Society of Biological Psychiatry and the Society for Psychotherapy Research. Lewis G. Sandy, M.D., M.B.A., of UnitedHealth Group (United Health- Care), has been with UnitedHealth Group since 2003. He is currently Senior Vice President of clinical advancement, where he leads efforts to promote efficient and effective health care, provide tools and information to doctors and patients to promote health, and foster the growth of evidence- based medicine. From 1997 to 2003, he was Executive Vice President of the Robert Wood Johnson Foundation (RWJF), the nation’s largest health- focused private foundation. At RWJF, he was responsible for the foun- dation’s program development and management, strategic planning, and administrative operations. An internist and former Health Center Medical Director at the Harvard Community Health Plan in Boston, Massachusetts, Dr. Sandy received his B.S. and M.D. degrees from the University of Michi- gan and an M.B.A. degree from Stanford University. Sebastian Schneeweiss, M.D., Sc.D., is Associate Professor of Medicine at Harvard Medical School and Associate Professor of Epidemiology at the Harvard School of Public Health. He is Director for Drug Evalua- tion and Outcomes Research and Vice-Chief of the Division of Pharmaco- epidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital in Boston. After his medical training he received a doctorate in pharmacoepidemiology from Harvard. He served on the faculty of the University of Munich Medical School before leading a research group in Boston. His current NIH-funded research in pharmacoepidemiology and pharmaceutical outcomes research uses large claims databases and phar- macoepidemiologic methods. He is Director of the Brigham and Women’s Hospital DEcIDE Research Center funded by AHRQ that conducts studies and develops methods on the comparative effectiveness of biopharma-

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0 APPENDIx B ceuticals. Dr. Schneeweiss has published more than 150 articles in peer- reviewed journals, received several research merit awards, and is Fellow of the American College of Epidemiology and the International Society for Pharmacoepidemiology. J. Sanford (Sandy) Schwartz, M.D., is Leon Professor of Medicine and Health Management and Economics, School of Medicine and Wharton School; Senior Fellow, Leonard Davis Institute of Health Economics (LDI); and Senior Scholar, Center for Clinical Epidemiology/Biostatistics. Former Executive Director, LDI (University of Pennsylvania’s center for health services and policy research), Schwartz is a clinically oriented health ser- vices researcher focusing on assessment of medical interventions (including cost/quality trade-offs and healthcare disparities), medical decision making, and medical innovation adoption/diffusion. Dr. Schwartz has served as advisor to federal agencies (NIH, AHRQ, CDC, IOM, NAS, CMS, DOD); nonprofit groups (Robert Wood Johnson, W.K. Kellogg, John A. Hartford, AAMC, NCQA); pharmaceutical, insurance, and managed care organiza- tions; and state health/regulatory agencies. Founding Director of American College of Physicians’ Clinical Efficacy Assessment Project (the medical profession’s first evidence-based guideline program) and past-President of the American Federation of Clinical Research and Society for Medical Deci- sion Making, he served in editorial capacities for the American Journal of Managed Care, Journal of General Internal Medicine and Medical Decision Making. Dr. Schwartz is a member of the NHLBI Adult Treatment Panel III National Cholesterol Education Program; Blue Cross and Blue Shield Associations Medical Advisory Panel; CMS Medicare Coverage Advisory Committee (MCAC); and several policy-related American Heart Associa- tion Disease Management, Reimbursement and Policy Workgroups. Joe V. Selby, M.D., M.P.H., has been the Director of the Division of Research (DOR), Kaiser Permanente, Northern California, since 1998. He is a family physician, clinical epidemiologist, and health services researcher. Prior to becoming DOR Director, Dr. Selby served for 7 years as DOR’s Assistant Director for Health Services Research. He also serves as Lecturer in the Department of Epidemiology and Biostatistics, University of California, San Francisco School of Medicine, and as a Consulting Professor, Health Research and Policy, Stanford University School of Medicine. Dr. Selby is a member of the Agency for Healthcare Policy and Research study section for Health Care Quality and Effectiveness. He was a commissioned officer in the Public Health Service from 1976 to 1983 and received the Commis- sioned Officer’s Award in 1981. Dr. Selby has authored or co-authored more than 100 peer-reviewed scientific publications and has written numer- ous book chapters. His publications cover a spectrum of topics from colon

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0 REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM cancer screening and diabetes complications to the delivery of primary care. Donald M. Steinwachs, Ph.D., is the Chair of the Department of Health Policy and Management at Johns Hopkins University. He also holds the Fred and Julie Soper Professorship of Health Policy and Management. Dr. Steinwachs’s current research includes studies of medical effectiveness and patient outcomes for individuals with specific medical, surgical, and psychiatric conditions; studies of the impact of managed care and other organizational and financial arrangements on access to care, quality, uti- lization, and cost; and studies to develop better methods to measure the effectiveness of systems of care, including case mix (e.g., Ambulatory Care Groups), quality profiling, and indicators of outcome. He has a particular interest in the role of routine management information systems (MIS) as a source of data for evaluating the effectiveness and cost of health care. This includes work on the integration of outcomes management systems with existing MIS in managed care settings. Alexander M. Walker, M.D., Dr.P.H., is Adjunct Professor of Epidemiology at Harvard School of Public Health, where he was formerly a professor and Chair of the Department of Epidemiology. His research encompasses the safety of drugs, devices, vaccines, and medical procedures. Current studies include postmarketing safety studies for recently approved drugs, natural history of disease studies to provide context for Phase III clinical trials, studies of the impact of drug labeling and warnings on prescribing behavior, and determinants of drug uptake and discontinuation. Additional areas of research and expertise include health effects of chemicals used in the work- place and statistical methods in epidemiology. Dr. Walker received an M.D. degree from Harvard Medical School in 1974 and a doctorate of public health in epidemiology from the Harvard School of Public Health in 1981. Dr. Walker is associate editor of Pharmacoepidemiology and Drug Safety, and he is on the Board of Directors of the International Society for Phar- macoepidemiology, for which he also served as President in 1995–1996. He was a statistical consultant for the New England Journal of Medicine from 1992 through 1996 and a Contributing Editor of The Lancet from 1999 through 2001. From 2000 through 2007, he served as Senior Vice Presi- dent for Epidemiology at Ingenix. Dr. Walker has written or contributed to more than 250 peer-reviewed articles in drug safety, epidemiology, and occupational health, and is the author of a book of essays, Observation and Inference: An Introduction to the Methods of Epidemiology. Philip S. Wang, M.D., Dr.P.H., is the Director of the Division of Services and Intervention Research at the National Institute of Mental Health. He

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0 APPENDIx B also remains on leave from his faculty appointments at Harvard Medical School. He completed his undergraduate, medical school, psychiatry resi- dency, as well as doctoral training in epidemiology, all at Harvard University. His research has focused on three areas: psychopharmacoepidemiology; psychopharmacoeconomics; and mental health services research. He was the Principal Investigator of the NIMH-sponsored Work Outcomes Research and Cost-effectiveness Study (WORCS), a large-scale trial to examine the return-on-investment of enhanced depression care for workers. Dr. Wang has served as a voting member on the FDA Psychopharmacologic Drugs Advi- sory Committee, FDA Neurological Devices Panel, and FDA Endocrinologic and Metabolic Drugs Advisory Committee. He also served on the NIMH Services Research and Clinical Epidemiology Study Section. He is currently Chair of the WHO World Mental Health Study Services Research Work Group. He is a member of the American Psychiatric Association’s DSM- V Task Force and has consulted on several APA work groups to develop evidence-based treatment guidelines. Dr. Wang is an author of approxi- mately 140 scientific publications.

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