Appendix B
Speaker Biographies

SYMPOSIUM MODERATORS

GAIL H. CASSELL, PhD (Member, IOM Forum on Drug Discovery, Development, and Translation), is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Institutes of Health (NIH) during the decade of her leadership. She obtained her BS from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female graduates of the twentieth century. She obtained her PhD in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is past President of the American Society for Microbiology (the oldest and single largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), and served as chair of the board. She recently served a 3-year term on the advisory board of the Director of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Preparedness. Currently she is a member of the Science Board of the U.S. Food and Drug Administration (FDA). Since



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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Appendix B Speaker Biographies SYMPOSIUM MODERATORS GAIL H. CASSELL, PhD (Member, IOM Forum on Drug Discovery, Development, and Translation), is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Institutes of Health (NIH) during the decade of her leadership. She obtained her BS from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female graduates of the twentieth century. She obtained her PhD in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is past President of the American Society for Microbiology (the oldest and single largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), and served as chair of the board. She recently served a 3-year term on the advisory board of the Director of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Preparedness. Currently she is a member of the Science Board of the U.S. Food and Drug Administration (FDA). Since

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary 1996 she has been a member of the U.S.–Japan Cooperative Medical Science Program, responsible for advising the respective governments (U.S. State Department/Japanese Ministry of Foreign Affairs) on joint research agendas. She has served on several editorial boards of scientific journals and has authored more than 250 articles and book chapters. Dr. Cassell has received national and international awards and an honorary degree for her research in infectious diseases. She is a member of the Institute of Medicine (IOM) and is currently serving a 3-year term on the IOM Council, the institution’s governing board. Dr. Cassell has been intimately involved in the formulation of science policy and legislation related to biomedical research and public health. For 9 years she was chair of the Public and Scientific Affairs Board of the American Society for Microbiology; she has served as an advisor on infectious diseases and indirect costs of research to the White House Office of Science and Technology Policy, and has been an invited participant in numerous congressional hearings and briefings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education (LCME), the accrediting body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences. She recently completed a term on the Leadership Council of the School of Public Health of Harvard University. Currently she is a member of the Executive Committee of the Board of Visitors of Columbia University School of Medicine, the Executive Committee of the Board of Directors of the Burroughs Wellcome Fund, Research!America, and the Advisory Council of the Johns Hopkins School of Nursing. R. ALTA CHARO (Member, IOM Drug Safety Committee) is Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin at Madison, where she is on the faculty of the Law School and the Medical School’s Department of Medical History and Bioethics. She also serves on the faculty of the university’s Masters in Biotechnology Studies program and lectures in the Master of Public Health program of the Department of Population Health Sciences. She received her BA in biology from Harvard University in 1979 and JD from Columbia University School of Law in 1982. She has been elected to membership in the Wisconsin Academy of Sciences, Arts and Letters and the IOM. Ms. Charo serves on the expert advisory boards of several organizations with an interest in stem cell research, including CuresNow, the Juvenile Diabetes Research Foundation, the International Society for Stem Cell Research, and WiCell, as well as on the advisory board of the Wisconsin Stem Cell Research Program. In 2005 she was appointed to the ethics standards working group of the California Institute for Regenerative Medicine. Also in 2005, she

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary helped draft the National Academies’ Guidelines for Embryonic Stem Cell Research, and in 2006 she was appointed to co-chair the National Academies’ Human Embryonic Stem Cell Research Advisory Committee. In 1994 Ms. Charo served on the NIH Human Embryo Research Panel, and from 1996 to 2001 she was a member of President Clinton’s National Bioethics Advisory Commission. Since 2001 she has been a member of the National Academy of Sciences’ Board on Life Sciences. She served as its liaison to the Committee on Research Standards and Practices to Prevent Destructive Applications of Biotechnology, as well as serving on its Advisory Committee on Human Embryonic Stem Cell Research. She also served as a member of the IOM’s Committee on Smallpox Vaccination Program Implementation, and in 2006 was appointed to the IOM’s Board on Population Health and Public Health Practice. In 2005–2006, she served on the IOM Committee on the Assessment of the U.S. Drug Safety System, which reviewed the FDA and the U.S. national system for the assurance of drug safety. ANDY STERGACHIS, PhD, MS, RPh (Member, IOM Drug Safety Committee), is Professor of Epidemiology and Adjunct Professor of Pharmacy and Interim Chair, Department of Pathobiology, School of Public Health and Community Medicine, University of Washington. He was previously Chair of the university’s Department of Pharmacy and founding Director of its Program in Pharmaceutical Outcomes Research and Policy. Through his affiliation with the university’s Northwest Center for Public Health Practice, he focuses on education, training, and research in emergency preparedness in collaboration with the public health and pharmacist communities. Dr. Stergachis has served on NIH’s Epidemiology and Disease Control Study Section; the Agency for Healthcare Research and Quality’s (AHRQ) Health Systems Research Study Section; committees of the National Committee on Quality Assurance; and the IOM’s Committee on Poison Prevention and Control and Committee to Study the Interactions of Drugs, Biologics, and Chemicals in the U.S. Military. He held several positions with Group Health Cooperative of Puget Sound and served on its Pharmacy and Therapeutics Committee for 12 years. In 1998 he joined drugstore.com, for which he has served as Vice President and Chief Pharmacist and currently serves as Pharmacy Advisor. He co-founded and served as principal of Formulary Resources and presently serves as the company’s consultant on managed care pharmacy. Dr. Stergachis is also pharmacoepidemiology consultant to United HealthCare for its pharmacoepidemiology cooperative agreement with the FDA. He was the 1990 American College of Preventive Medicine/Burroughs Wellcome Scholar in Pharmacoepidemiology. The American Association of Pharmaceutical Research Scientists presented him with the 1994 Research Achievement

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Award in Economic, Marketing and Management Sciences. In 1999 he was selected as one of the 50 Most Influential Pharmacists in the United States by American Druggist. He was awarded the 2002 Pinnacle Award by the American Pharmaceutical Association Foundation for career contributions toward improving the quality of care through the medication use process. Dr. Stergachis’ research in the prevention of pelvic inflammatory disease helped lead to new recommendations from CDC and to the Health Plan Employer Data and Information System (HEDIS) measure “Chlamydia Screening in Women.” Dr. Stergachis serves as board member for the American Pharmacists Association Foundation and the Group Health Community Foundation, and he is a fellow of the International Society for Pharmacoepidemiology. His research interests include pharmacoepidemiology and the epidemiology of biological and chemical hazards. He received his PhD and MS from the University of Minnesota and his BPharm from Washington State University. Session 1: Preserving the Public Trust: Ensuring Drug Safety, Efficacy, and Availability TOMMY THOMPSON, JD, was Secretary of Health and Human Services (HHS) from 2001 to 2005 and four-term Governor of Wisconsin, 1987 to 2001; he made state history when he was reelected to office for a third term in 1994 and a fourth term in 1998. He is Chair of the Deloitte Center for Health Solutions and a partner at the law firm of Akin Gump Strauss Hauer & Feld LLP. He also serves as Honorary Chair of the Coalition for a Stronger FDA. Secretary Thompson has dedicated his professional life to public service and is one of the nation’s leading advocates for the health and welfare of all Americans. At Deloitte and Akin Gump, he is building on his efforts as HHS Secretary and Governor of Wisconsin to develop innovative solutions to the health care challenges facing American families, businesses, communities, and states and the nation as a whole. The focus is on improving the use of information technology in hospitals, clinics, and doctors’ offices; promoting healthier lifestyles; strengthening and modernizing Medicare and Medicaid; and expanding the use of medical diplomacy around the world. JANE E. HENNEY, MD, is Senior Vice President and Provost for Health Affairs at the University of Cincinnati. Beginning in 1980, she served for 5 years as Deputy Director of the National Cancer Institute. Subsequently, she joined the University of Kansas Medical Center as Vice Chancellor for Health Programs. She then served as the FDA’s Deputy Commissioner for Operations until assuming the position of First Vice President for Health Sciences at the University of Mexico. In 1998 she was appointed

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Commissioner of the FDA by President Clinton, a position she held until 2001. After leaving the FDA, Dr. Henney was appointed Senior Scholar in Residence at the Association of Academic Health Centers. She serves on a number of boards of directors related to her work in Cincinnati, including UC Foundation, UC Physicians, University Hospital, Health Alliance of Greater Cincinnati, Hoxworth Blood Center, Medical Center Fund of Cincinnati, Bio/Start, and OMERIS. Additionally, she serves on the boards of The Commonwealth Fund and the China Medical Board in New York City, AmerisourceBergen Corporation and CIGNA Corporation in Philadelphia, and AstraZeneca PLC in London. Dr. Henney has received many honors and awards in her field, including election to the IOM and the Society of Medical Administrators and honorary membership in the American Colleges of Health Care Executives. Dr. Henney received her undergraduate degree from Manchester College and her medical degree from Indiana University, and completed her subspecialty training in medical oncology at the M.D. Anderson Hospital and Tumor Institute and the National Cancer Institute. ELLEN V. SIGAL, PhD, is founder and Chair of Friends of Cancer Research, a nonprofit organization based in the Washington, DC, metropolitan area. She serves on the National Cancer Institute’s Board of Scientific Advisors; the NIH Foundation Board, chairing its Public-Private Partnerships Committee; the American Association for Cancer Research Foundation Board; the M. D. Anderson Cancer Center External Advisory Board; the Johns Hopkins Cancer Center Advisory Council; the Duke University Cancer Center Board of Overseers; and the Howard University Cancer Center Board of Visitors. She served on the NIH’s prestigious Director’s Council of Public Representatives from 2003 to 2006. She was a presidential appointee to the National Cancer Advisory Board from 1992 to 1998, chairing its Budget and Planning Committee, which oversees the federal cancer budget. She is a past member of the American Society of Clinical Oncology Foundation Board. Dr. Sigal received the Association of American Cancer Institutes’ Public Service Award, the American Society of Clinical Oncology Special Recognition Award, the Sidney Kimmel Cancer Center National Leadership Award, and the American Association for Cancer Research National Leadership Award. She has been honored by Research!America, George Washington University Cancer Institute, International Spirit of Life Foundation, and Washingtonian magazine as a Washingtonian of the Year. STEVEN K. GALSON, MD, MPH (Member, IOM Forum on Drug Discovery, Development, and Translation), was named Director of the FDA’s Center for Drug Evaluation and Research (CDER) in July 2005. He pro-

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary vides leadership for the center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his Public Health Service (PHS) career as an epidemiological investigator at CDC after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He has held senior-level positions at the Environmental Protection Agency (EPA); the Department of Energy, where he was Chief Medical Officer; and the Department of Health and Human Services. Prior to his arrival at the FDA, he was Director of the EPA’s Office of Science Coordination and Policy, and the Office of Prevention, Pesticides and Toxic Substances. Dr. Galson joined the FDA in April 2001 as CDER Deputy Director. He is the recipient of numerous PHS awards, including the Outstanding Service Medal for his leadership and management of CDER while serving as Acting Center Director from November 2001 to February 2002. He is also the recipient of three Secretary of Energy Gold Awards. Dr. Galson is a board member of the National Board of Medical Examiners and a regular peer reviewer for medical journals. He holds a BS from Stony Brook University, an MD from Mt. Sinai School of Medicine, and an MPH from the Harvard School of Public Health. He is board certified in preventive medicine and public health and occupational medicine. Session 2: Integration of Pre- and Postmarket Review HUGH TILSON, MD, DrPH (Washington University, St. Louis, Missouri, 1964, and Harvard School of Public Health, 1972), is a practicing epidemiologist and outcomes researcher whose career in public health and preventive medicine spans 40 years. Fifteen years of public service included duties as a U.S. Army Preventive Medicine Officer in Germany; consultant to the U.S. Office of Economic Opportunity, National Center for Health Services Research, and Veterans Health Administration; Local Public Health Officer and Human Services Director for Multnomah County (Portland), Oregon (National Association of County and City Health Officials [NACCHO] President, 1976); and State Public Health Director for North Carolina. During his 15 years working in the multinational pharmaceutical industry for the Wellcome Foundation, he is credited with introducing many epidemiological principles and innovations. Upon his retirement from GlaxoWellcome in 1996, he joined the clinical faculty of the University of North Carolina. He is an advisor to government and industry in health outcomes, drug safety, and evidence-based health policy, including, most recently, public health preparedness. He was a member of the working groups on drug safety of the Council for International Organisations for the Medical Sciences (CIOMS) from 1990 to 2001 and an advisor to the recent CIOMS VI and to the World Health

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Organization’s Collaborating Centres. In the United States, he chairs the National Steering Committee for the Centers for Education and Research on Therapeutics program for AHRQ, and serves as senior advisor and epidemiologist for the international Antiretrovirals in Pregnancy Registry. He was a member of the recently adjourned IOM Clinical Research Roundtable and served as a consultant to the IOM’s landmark study The Future of Drug Safety, released in fall 2006. He recently chaired two IOM study committees—Safety of Therapeutic Devices in Children and Prevention of HIV for Injection Drug Users. Dr. Tilson has been designated a Lifetime National Associate of the IOM. GARRET A. FITZGERALD, MD (Member, IOM Forum on Drug Discovery, Development, and Translation), is Professor of Medicine and Elmer Bobst Professor of Pharmacology, University of Pennsylvania, where he chairs the Department of Pharmacology and directs the Institute for Translational Medicine and Therapeutics. Previously, he was Professor and Chair of the Department of Medicine and Experimental Therapeutics, University College, Dublin, Ireland, as well as founding Director of the Center for Cardiovascular Science. Prior to that, he was William Stokes Professor of Experimental Therapeutics and Director of the Division of Clinical Pharmacology, Vanderbilt University School of Medicine, Nashville, Tennessee. Dr. FitzGerald holds membership in a number of learned societies in the United States and the United Kingdom, and has received numerous honors. He has authored 257 original articles in the fields of cardiovascular medicine and pharmacology. His work has contributed to the adoption of low-dose aspirin for cardiac prophylaxis, and he was the first to predict a cardiovascular hazard from selective inhibition of COX-2. He also pioneered the emergence of isoprostanes as biomarkers of oxidant stress. More recently, his group defined the role of peripheral clocks in vascular function and metabolism. ROBERT TEMPLE, MD, is Director of the Office of Medical Policy of CDER and Acting Director of the Office of Drug Evaluation I (ODE-I). Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972 he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later assumed the position of Director of the Division of Cardio-Renal Drug Products. In his position as Acting Director of ODE-1, he oversees that office’s regulation of cardio-renal, neuropharmacological, and psychopharmacological drug products. He also oversees the Office of Medical Policy, which is responsible for the regulation of promotion through the Division of Drug Marketing, Advertising, and Communication. He has served in this capacity since the office’s establishment in 1995.

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary ELLIS F. UNGER, MD, is Acting Deputy Director of CDER’s Office of Surveillance and Epidemiology (OSE). He obtained his medical degree from the University of Cincinnati, and received postdoctoral training at the Medical College of Virginia (internal medicine) and The Johns Hopkins Hospital (clinical cardiology). Dr. Unger was a Senior Investigator in the Cardiology Branch of NIH’s National Heart, Lung, and Blood Institute from 1983 to 1997, where he directed a research program in angiogenesis, developing new approaches for the treatment of coronary artery disease and peripheral vascular disease. From 1997 to 2003, he served as Medical Officer, Team Leader, and subsequently Branch Chief in the Office of Therapeutics Research and Review (OTRR) in the FDA’s Center for Biologics Evaluation and Research. In 2003, Dr. Unger assumed the responsibilities of Deputy Director, Division of Cardiovascular and Renal Products, in CDER. He served as FDA representative to CIOMS Working Group VII, and presently represents the agency on the International Conference on Harmonization Expert Working Group on E2F, the Development Safety Update Report. Dr. Unger has authored, co-authored, and edited numerous scientific articles and is a co-holder of two patents. TIMOTHY R. FRANSON, MD, is currently Vice President of Global Regulatory Affairs for Lilly Research Laboratories and Assistant Professor of Medicine at Indiana University School of Medicine. He received his undergraduate degree in pharmacy (with honors) at Drake University and his MD (James Scholar, with honors) at the University of Illinois; he completed internal medicine training at the University of Iowa, followed by a fellowship in infectious diseases and epidemiology at the Medical College of Wisconsin. He is board certified in internal medicine and infectious diseases. He was previously Assistant Professor of Medicine and Hospital Epidemiologist at the Medical College of Wisconsin, where he was an NIH-funded investigator and a member of the State of Wisconsin’s Governors Task Force on AIDS. He joined Eli Lilly and Company in 1986, where he has served as Director of Anti-Infectives; Group Medical Director, Europe (based in the United Kingdom); Executive Director of Health Economics Research and Decision Sciences; Executive Director of North American Regulatory Affairs; and from 1997 to 2003, Vice President of Clinical Research and Regulatory Affairs-U.S. In 2002 he received the Lilly Chairman’s Ovation Award. Dr. Franson has authored more than 50 articles and a text in the fields of infectious disease, epidemiology, pharmacoeconomics, and antibiotic utilization. He has served as Chair of the Clinical Steering Committee and as a member of the Regulatory Affairs Coordinating Committee of the Pharmaceutical Research and Manufacturers’ Association (PhRMA), previously chaired PhRMA’s GMP Steering Committee, and now chairs its FDA Committee Staff Work Group. He

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary was co-chair of the joint FDA–industry working group addressing clinical aspects of the FDA Modernization Act of 1997, including renewal of the Prescription Drug User Fee Act (PDUFA); he co-chaired the industry–FDA committee for PDUFA-III renewal and has testified as an industry representative at several congressional hearings. Dr. Franson also co-chaired an FDA–industry safety interventions working group, was a member of the American Association of Medical Colleges PhRMA Clinical Trials Forum, and is a member of the Regulatory Advisory Board for the Centre for Medicines Research International. He previously served on the Board of Directors of the National Patient Safety Foundation (2001–2006) and on the Editorial Advisory Board for the FDA’s Advertising and Promotional Manual. He is now chair of the Board of Directors of the Villages of Indiana child welfare services and a member of the Indiana State Museum Foundation, as well as the Board of Trustees of Xavier University of Louisiana; he also serves on the American Association of Colleges of Pharmacy Professional Education Advisory Council. He is a fellow of the Infectious Diseases Society of America and the American College of Physicians, served on the European Working Party for Antimicrobial Trial Guidelines, and was principal respondent for industry at the FDA Advisory Committee review of the FDA/Infectious Diseases Society of America (IDSA) Antimicrobial Trial Guidelines project. Session 3: Enhancing Postmarket Safety Monitoring GERALD DAL PAN, MD, MHS, is Director of OSE in CDER. He previously was Director of CDER’s Division of Surveillance, Research, and Communication Support, Office of Drug Safety (now OSE), a position he held from 2003 to 2005. Dr. Dal Pan joined the agency in 2000 and spent 3 years as a medical reviewer in the Division of Anesthetic Critical Care and Addiction Drug Products before assuming his position in the Office of Drug Safety. Prior to joining CDER, Dr. Dal Pan directed clinical research, including clinical trial design and interpretation of clinical data, for Guilford Pharmaceuticals and HHI, LLC, Clinical Research and Statistical Services. He also served on the faculty of The Johns Hopkins University School of Medicine, where he conducted clinical research in addition to teaching medical students. He continues there as a part-time Assistant Professor in the Department of Neurology. MARK B. MCCLELLAN, MD, PhD, is former Administrator for the Centers for Medicare and Medicaid Services (CMS) and former Commissioner of food and drugs. He has had a highly distinguished tenure of public service. In the George W. Bush administration, he served as a member of the President’s Council of Economic Advisers and Senior Director for

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Health Care Policy at the White House (2001–2002), FDA commissioner (2002–2004), and CMS Administrator. In these positions, he developed and implemented major reforms in health policy. In the Clinton administration, Dr. McClellan was Deputy Assistant Secretary of the Treasury for Economic Policy from 1998 to 1999, supervising economic analysis and policy development on a range of domestic policy issues. He subsequently directed Stanford’s Program on Health Outcomes Research, and was a Research Associate of the National Bureau of Economic Research and a visiting scholar at the American Enterprise Institute. Additionally, he was Associate Editor of the Journal of Health Economics and co–principal investigator of the Health and Retirement Study, a longitudinal study of the health and economic well-being of older Americans. A graduate of the University of Texas at Austin, he earned his MPA from Harvard’s Kennedy School of Government in 1991, his MD from the Harvard-MIT Division of Health Sciences and Technology in 1992, and his PhD in economics from MIT in 1993. He completed his residency training in internal medicine at Brigham and Women’s Hospital, Boston. Dr. McClellan has been board certified in internal medicine and has been a practicing internist during his academic career. 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 expenditures, and the relationship between health status and economic well-being. He has twice received the Kenneth J. Arrow Award for Outstanding Research in Health Economics. RICHARD PLATT, MD, MSc, is Professor and Chair of the Department of Ambulatory Care and Prevention, Harvard Medical School. 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 currently chairs the FDA’s 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 CDC’s Center for Infectious Diseases, and 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 pharmaco-epidemiology and population-based surveillance, reporting, and control of both hospital- and community-acquired infections, including bioterrorism events. He is principal investigator of the CDC-sponsored Center of Excellence in Public Health Informatics (www.phiconnect.org) and the AHRQ-sponsored HMO Research Network Center for Education and

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Research in Therapeutics (www.certs.hhs.gov), and co–principal investigator of the Modeling Infectious Disease Agent Study (http://www.nigms.nih.gov/Initiatives/MIDAS) and the CDC-sponsored Eastern Mas-sachusetts Prevention Epicenter. BARBARA M. ALVING, MD, is Acting Director of NIH’s National Center for Research Resources (NCRR). NCRR provides funding for general clinical research centers, biomedical technology, preclinical models, and other resources to enhance the research environment of biomedical investigators engaged in health-related research. Dr. Alving earned her medical degree (cum laude) from Georgetown University School of Medicine, where she also completed an internship in internal medicine. She received her residency training in internal medicine at The Johns Hopkins University Hospital, followed by a fellowship in hematology. She then became a research investigator in the FDA’s Division of Blood and Blood Products. In 1980 she joined the Department of Hematology at the Walter Reed Army Institute of Research, where she became Chief in 1992. She left the Army at the rank of colonel in 1996 to become Director of the Medical Oncology/Hematology Section at Washington Hospital Center in Washington, DC. In 1999 she joined the National Heart, Lung, and Blood Institute (NHLBI), serving as Director of the extramural Division of Blood Diseases and Resources until becoming Deputy Director in September 2001. From September 2003 to February 1, 2005, she served as Acting Director of NHLBI. She became Acting Director of NCRR in March 2005. Dr. Alving is Professor of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Maryland; a Master in the American College of Physicians; a former member of the Subcommittee on Hematology of the American Board of Internal Medicine; and a former member of the FDA’s Blood Products Advisory Committee. She is a co-inventor on two patents, has edited three books, and has published more than 100 papers in the areas of thrombosis and hemostasis. ALEXANDER M. WALKER, MD, DrPH, is Senior Vice President for Epidemiology in the i3 Drug Safety group at Ingenix. He is Adjunct Professor of Epidemiology at Harvard School of Public Health, where he was formerly Professor and Chair of the Department of Epidemiology. His research encompasses the safety of drugs, devices, vaccines, and medical procedures. Current studies address postmarketing safety for recently approved drugs, the natural history of disease as context for Phase III clinical trials, the impact of drug labeling and warnings on prescribing behavior, and determinants of drug uptake and discontinuation. His additional areas of research and expertise include health effects of chemicals used in the workplace and statistical methods in epidemiology.

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Dr. Walker received his MD from Harvard Medical School in 1974 and his doctorate in public health in epidemiology from the Harvard School of Public Health in 1981. He is associate editor of Pharmacoepidemiology and Drug Safety and is on the Board of Directors of the International Society for Pharmacoepidemiology, which he also served as President in 1995 to 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. Dr. Walker has written or contributed to more than 250 peer-reviewed articles on drug safety, epidemiology, and occupational health, and is the author of a book of essays entitled Observation and Inference: An Introduction to the Methods of Epidemiology. RONALD L. KRALL, MD (Member, IOM Forum on Drug Discovery, Development, and Translation), is Senior Vice President and Chief Medical Officer for GlaxoSmithKline (GSK). He is responsible for all matters of human safety for all GSK compounds used in development and medicinal and vaccine products, and for pharmaceutical regulatory affairs and GxP compliance. Dr. Krall joined GSK in 2003. Previously, he held positions at AstraZeneca Pharmaceuticals, Abbott Laboratories, and Lorex Pharmaceuticals. He earned his bachelor’s degree in mathematics from Swarthmore College and his MD from the University of Pittsburgh, trained as a Staff Associate at the NIH Epilepsy Branch, and completed his training in neurology and clinical pharmacology at the University of Rochester. He is board certified in neurology, and is a former member of the Board of Directors of the National Sleep Foundation, a member of the Board of Directors of the Delaware Valley Science Fairs, a member of the University of Pennsylvania Center for Bioethics Advisory Board, and a past Trustee of the American Academy of Pharmaceutical Physicians. Session 4: Conducting Confirmatory Drug Safety and Efficacy Studies JANET WOODCOCK, MD (Member, IOM Forum on Drug Discovery, Development, and Translation), is Deputy Commissioner for Operations and Chief Medical Officer, FDA. She is responsible for overseeing agency operations and cross-cutting regulatory and scientific processes. Dr. Woodcock served as CDER Director from 1994 to 2005. She previously served in other positions at the FDA, including Director, Office of Therapeutics Research and Review, and Acting Deputy Director, Center for Biologics Evaluation and Research. Dr. Woodcock received her MD from Northwestern Medical School, and completed further training and held teaching appointments at the Pennsylvania State University and the University of California, San Francisco. She joined the FDA in 1986.

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary ROBERT CALIFF, MD (Member, IOM Forum on Drug Discovery, Development, and Translation), is currently Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Institute, and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. For 10 years he was Director of the Duke Clinical Research Institute (DCRI), the largest academic research organization in the world. He is editor-in-chief of Elsevier’s American Heart Journal. He has been an author or co-author of more than 650 peer-reviewed journal articles and is a contributing editor for www. theheart.org. Dr. Califf led DCRI for many of the best-known clinical trials in cardiovascular disease. In cooperation with his colleagues from the Duke Databank for Cardiovascular Disease, he has written extensively about the clinical and economic outcomes of chronic heart disease. He is considered an international leader in the fields of health outcomes, quality of care, and medical economics. He has served on the FDA’s Cardiorenal Advisory Panel and the IOM’s Pharmaceutical Roundtable. He served on the IOM committees that recommended Medicare coverage of clinical trials and the banning of Ephedra, and he is currently serving on the IOM’s Committee on Identifying and Preventing Medication Errors. He is Director of the coordinating center for the Centers for Education and Research on Therapeutics, a public–private partnership among AHRQ, the FDA, academia, the medical-products industry, and consumer groups. Dr. Califf graduated from Duke University (summa cum laude) in 1973 and from Duke University Medical School in 1978. He performed his internship and residency at the University of California, San Francisco, and his fellowship in cardiology at Duke University. He is board certified in internal medicine and cardiology and is a fellow of the American College of Cardiology. DEBORAH A. ZARIN, MD, is Director, ClinicalTrials.gov, and Assistant Director for Clinical Research Projects, Lister Hill National Center for Biomedical Communications, National Library of Medicine. In this capacity, she oversees the development and operation of an international registry of clinical trials. Previously, she served as Director, Technology Assessment Program, AHRQ, and Director, Practice Guidelines Program, American Psychiatric Association. In these positions, she conducted systematic reviews and related analyses to support the development of clinical and policy recommendations. Dr. Zarin’s academic interests are in the area of evidence-based clinical and policy decision making. She graduated from Stanford University and received her doctorate in medicine from Harvard Medical School. She completed a clinical decision-making fellowship and is board certified in general psychiatry, as well as in child and adolescent psychiatry.

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary GRETCHEN DIECK, PhD, is Senior Vice President, Safety and Risk Management, Pfizer Inc., where she is responsible for providing risk management support and compliance functions across the product portfolio. Included in these responsibilities are case processing and risk management functions related to epidemiology and medical safety evaluation, as well as safety and risk management–related analysis and documentation. Dr. Dieck has been at Pfizer for more than 20 years, having started as a staff epidemiologist in 1986. She was a founding board member of the International Society for Pharmacoepidemiology and is a member of the International Conference on Harmonization (ICH) Risk Communication Working Group. In addition, she is past Chair of the Pharmacovigi-lance and Epidemiology Technical Group of PhRMA and heads the Risk Management Working Group of PhRMA’s Pharmaceuticals Innovation Steering Committee. Dr. Dieck represented PhRMA during PDUFA III discussions, and both co-leads the PostMarket Safety Group and serves on the Steering Committee for PDUFA IV. She received an AB in biological sciences from Smith College; she received an MPhil and PhD in epidemiology and also completed a postdoctoral fellowship in cardiovascular disease epidemiology at Yale University. Session 5: Enhancing Postmarket Regulation and Enforcement CHRISTOPHER H. SCHROEDER, MDiv, JD (Member, IOM Drug Safety Committee), is Charles S. Murphy Professor of Law and Professor of Public Policy Studies and Director of the Program in Public Law at Duke University. He served as Deputy Assistant Attorney General in the Office of Legal Counsel, U.S. Department of Justice, and in 1996–1997 was Acting Assistant Attorney General in charge of that office. Previously, he worked for the Senate Judiciary Committee, serving as its Chief Counsel in 1992–1993. Dr. Schroeder’s scholarship includes work on constitutional law, Congress, risk regulation and theory, and tort. Current projects include a book on democratic theory and executive power. He co-authors a leading environmental law casebook, Environmental Regulation: Law, Science and Policy (5th Edition, 2006) with Robert Percival, Alan Miller, and James Leape. He also serves as Vice President of the Center for Progressive Reform, a network of scholars who write about and adovcate progressive approaches to environmental, health, and safety policy. Along with Rena Steinzor, he is co-editor of the center’s book The New Progressive Agenda for Public Health and the Environment (2005) (www.progressivereform.org). His work with O’Melveny & Myers focuses on appellate litigation. PETER BARTON HUTT, JD, LLM, is Senior Counsel in the Washington, DC, law firm of Covington & Burling LLP, specializing in food and

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary drug law. He graduated from Yale College and Harvard Law School and obtained a master of laws degree in food and drug law from New York University Law School. Mr. Hutt served as Chief Counsel for the FDA between 1971 and 1975. He is co-author of the casebook used to teach food and drug law throughout the country, and has published more than 175 book chapters and articles on food and drug law and health policy. Since 1994 he has taught a full course on this subject each year during winter term at Harvard Law School, and in 1998 he taught this course during spring term at Stanford Law School. Mr. Hutt has been a member of the IOM since it was founded in 1971. He serves on academic, philanthropic, and venture capital advisory boards and the boards of startup biotechnology companies. He is a member of the FDA’s Science Board Working Group, which reviews the agency’s science needs to perform its regulatory mission. He is a member of the Board of Directors of the AERAS Global TB Vaccine Foundation, and he recently served on the Panel on the Administrative Restructuring of the National Institutes of Health and the Working Group to Review Regulatory Activities within the Division of AIDS of the National Institute of Allergy and Infectious Diseases. Mr. Hutt was named by Washingtonian magazine as one of Washington’s 50 best lawyers and one of Washington’s 100 most influential people; by the National Law Journal as one of the 40 best health care lawyers in the United States; and by European Counsels as the best FDA regulatory specialist in Washington, DC. In June 2003, Business Week referred to him as the “unofficial dean of Washington food and drug lawyers.” In naming Mr. Hutt in September 2005 as one of the 11 best food and drug lawyers, the Legal Times also referred to him as “the dean of the food-and-drug bar.” In April 2005, Mr. Hutt was presented the FDA Distinguished Alumni Award by FDA Commissioner Crawford. In May 2005, the Foundation for Biomedical Research gave him the Lifetime Achievement Award for research advocacy. EVE E. SLATER, MD, FACC, is a graduate of Vassar College and of Columbia University’s College of Physicians and Surgeons. She completed her internship and residency at the Massachusetts General Hospital (MGH) and is board certified in both internal medicine and cardiology. In 1976 Dr. Slater became the first woman Chief Resident in Medicine at MGH, and from 1977 through 1982 she served as Chief of the hospital’s Hypertension Unit and was Assistant Professor of Medicine at Harvard Medical School. She joined Merck Research Laboratories (MRL) in 1983 and became Head of Regulatory Affairs in 1988, Vice President of Clinical and Regulatory Development in 1990, and Senior Vice President in 1994. In 2001 she was named Senior Vice President of MRL External Policy and Vice President, Corporate Public Affairs. Dr. Slater supervised

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary worldwide regulatory activities for all Merck medicines and vaccines, which included responsibility for FDA and international agency liaison, worldwide New Drug Application (NDA) submissions, product labeling, quality assurance, and pharmacovigilance. She served on the International Conference on Harmonization Subcommittee on the Structure and Content of Clinical Studies Reports (Chair), and on both the Regulations Advisory (Chair) and Policy Boards for the UK Centre for Medicines Research. She was named by President George W. Bush as Assistant Secretary for Health, Department of Health and Human Services, in September 2001 and received Senate confirmation to this position in January 2002, becoming the first woman to hold the position. She served HHS Secretary Tommy Thompson as Chief Health Policy Advisor, with special emphasis on translational medicine, including electronic systems (eHealth) and innovation, biosecurity, protection of human subjects, women’s health, elder care, and HIV/AIDS. She resigned in 2003, and is currently serving as Director of Vertex Pharmaceuticals, Cambridge, Massachusetts; Phase Forward, Waltham, Massachusetts; VaxGen, Brisbane, California; and Theravance, South San Francisco, California. She is Commissioner of the Urban Indian Health Commission and a member of the Scientific Advisory Committee for the Global Alliance for TB Drug Development and the FDA Science Board Working Group. MARY K. PENDERGAST, JD, LLM, is President of Pendergast Consulting, a legal and regulatory consulting firm founded in 2003. Previously she was Executive Vice President, Government Affairs, at Elan Corporation (1998–2003) and Deputy Commissioner and Senior Advisor to the Commissioner at the FDA (1990–1998). Ms. Pendergast also served as Associate Chief Counsel for Enforcement at the FDA from 1979 to 1990 and as Attorney, Office of the General Counsel, Department of Health and Human Services, from 1977 to 1979. At the FDA, she was responsible for the agency’s efforts to regulate emerging areas such as biotechnology, cellular and tissue-based therapies, genetic testing, xeno-transplantation, and acute-care research. She also served as the FDA’s “crisis manager,” handling sensitive and precedent-setting situations, and led the agency’s efforts to assist the Newly Independent States after the breakup of the Soviet Union. Ms. Pendergast has testified on many occasions before the U.S. Congress and has spoken to numerous international organizations, foreign governments, and scientific and academic institutions. She is on the Board of Directors of Nuvelo, Inc. and Child Trends, a research organization focused on children. She received her LLM, JD, and BA degrees from Yale Law School, the University of Iowa College of Law, and Northwestern University, respectively.

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary MARLENE E. HAFFNER, MD, MPH, recently joined Amgen as Executive Director, Global Regulatory Intelligence and Policy. Previously she was for 20 years Director of the Office of Orphan Products Development at the FDA. She received her MD from The George Washington University School of Medicine, with further training in internal medicine, hematology, and dermatology. She received her MPH from The Johns Hopkins University School of Hygiene and Public Health. A career public health administrator and educator, she has a passion for addressing issues of the underserved, including the development of therapeutics for grievous illness and patients’ access to therapy for their illnesses. Session 6: Drug Safety Regulation: Looking to the Future MYRL WEINBERG, CAE, is President of the National Health Council, an umbrella organization that has served as the place where “the health community meets” for 85 years. The council’s 115 members are national organizations that are committed to quality health care, and its core constituency of more than 50 leading voluntary health agencies represents approximately 100 million people with chronic diseases and/or disabilities. Ms. Weinberg has a long history of board and committee service, including serving as a member of the American Heath Information Community’s Consumer Empowerment Workgroup, the IOM’s Health Sciences Policy Board, the AcademyHealth Coalition for Heath Services Research Board, the Center for Information and Study on Clinical Research Participation Advisory Board, the Roche International Genetics Science and Ethics Advisory Committee, and the IOM’s Committee on Clinical Trial Registries, and as a founding member of the Association for the Accreditation of Human Research Protection Programs and Chair-Elect of the Governing Board of the International Alliance of Patients’ Organization. Ms. Weinberg also served on the congressionally mandated IOM committee created to assess how research priorities are established at NIH and on the National Research Council/IOM Committee on the Organizational Structure of NIH.

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