B
Biographies

ROUNDTABLE MEMBERS

RONALD W. ESTABROOK, Ph.D. (Chair), graduated with a B.S. from Rensselaer Polytechnic Institute, Troy, New York. Dr. Estabrook did his graduate training in biochemistry at the University of Rochester, Rochester, N.Y. (Ph.D. 1954). He then accepted a postdoctoral position in biophysics to work with Britton Chance at the Johnson Research Foundation, University of Pennsylvania. In 1959, Dr. Estabrook joined the faculty of the School of Medicine of the University of Pennsylvania where he advanced to the rank of professor of physical biochemistry. It was during this time, in the early 1960s, that Dr. Estabrook, together with Drs. David Cooper and Otto Rosenthal of the Department of Surgery of the University of Pennsylvania, carried out studies in which they discovered the enzymatic (functional) properties of the heme protein, now known as cytochrome P450. In 1968, Dr. Estabrook moved to Dallas, Texas, to serve as Virginia Lazenby O'Hara Professor of Biochemistry and Chairman of the Department of Biochemistry at the University of Texas Southwestern Medical School. He served as the first Dean of the Graduate School of Biomedical Sciences at the Dallas campus of the University of Texas. Dr. Estabrook has coauthored more than 260 publications and has edited 14 books. He has received many honors including election to the National Academy of Sciences in 1979 and the awarding of an honorary Doctor of Medicine from the Karolinska Institut in Stockholm, Sweden, in 1981, and a Doctor of Science from the University of Rochester, also in 1981.

ARTHUR L. BEAUDET, M.D., is an investigator at the Howard Hughes Medical Institute. Dr. Beauder is also the Henry and Emma Meyer Professor of



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Rational Therapeutics for Infants and Children: Workshop Summary B Biographies ROUNDTABLE MEMBERS RONALD W. ESTABROOK, Ph.D. (Chair), graduated with a B.S. from Rensselaer Polytechnic Institute, Troy, New York. Dr. Estabrook did his graduate training in biochemistry at the University of Rochester, Rochester, N.Y. (Ph.D. 1954). He then accepted a postdoctoral position in biophysics to work with Britton Chance at the Johnson Research Foundation, University of Pennsylvania. In 1959, Dr. Estabrook joined the faculty of the School of Medicine of the University of Pennsylvania where he advanced to the rank of professor of physical biochemistry. It was during this time, in the early 1960s, that Dr. Estabrook, together with Drs. David Cooper and Otto Rosenthal of the Department of Surgery of the University of Pennsylvania, carried out studies in which they discovered the enzymatic (functional) properties of the heme protein, now known as cytochrome P450. In 1968, Dr. Estabrook moved to Dallas, Texas, to serve as Virginia Lazenby O'Hara Professor of Biochemistry and Chairman of the Department of Biochemistry at the University of Texas Southwestern Medical School. He served as the first Dean of the Graduate School of Biomedical Sciences at the Dallas campus of the University of Texas. Dr. Estabrook has coauthored more than 260 publications and has edited 14 books. He has received many honors including election to the National Academy of Sciences in 1979 and the awarding of an honorary Doctor of Medicine from the Karolinska Institut in Stockholm, Sweden, in 1981, and a Doctor of Science from the University of Rochester, also in 1981. ARTHUR L. BEAUDET, M.D., is an investigator at the Howard Hughes Medical Institute. Dr. Beauder is also the Henry and Emma Meyer Professor of

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Rational Therapeutics for Infants and Children: Workshop Summary Molecular and Human Genetics and acting chair of that department at the Baylor College of Medicine in Texas. LESLIE Z. BENET, Ph.D., is Professor and former Chairman (1978–1998), Department of Biopharmaceutical Sciences, University of California, San Francisco, and Chairman of the Board, AvMax, Inc. He received his A.B. in English, B.S. in pharmacy, and M.S. from the University of Michigan and Ph.D. from the University of California. He has received five honorary doctorates: Uppsala University, Uppsala, Sweden (Pharm. D., 1987); Leiden University, Leiden, The Netherlands (Ph.D., 1995); University of Illinois at Chicago (D.Sc., 1997); Philadelphia College of Pharmacy and Science (D.Sc., 1997); and Long Island University (D.Sc., 1999). His research interests and more than 390 publications are in the areas of pharmacokinetics, biopharmaceutics, and pharmacodynamics. He is a Fellow of the Academy of Pharmaceutical Sciences, the American Association of Pharmaceutical Scientists, and of the American Association for the Advancement of Science (AAAS). In 1982, Dr. Benet received the American Pharmaceutical Association's Academy of Pharmaceutical Sciences Research Achievement Award in Pharmaceutics and the University of Michigan's College of Pharmacy Distinguished Alumnus Award. In 1985, he served as President of the Academy of Pharmaceutical Sciences. In 1987, Dr. Benet was elected to membership in the Institute of Medicine of the National Academies. He presently serves as Chair of the U.S. Food and Drug Administration's Expert Panel on Individual Bioequivalence and Chair of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation, and the Board of Directors of the American Foundation for Pharmaceutical Education. He is a board member, scientific board member, or consultant for more than 20 pharmaceutical and biotechnology companies and Treasurer for the International Society for the Study of Xenobiotics. Dr. Benet is the editor of several medical and scientific hooks. D. BRUCE BURLINGTON, M.D. (ex officio), is Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA). He was formerly Deputy Director of the Office of Drug Evaluation II in the Center of Drug Evaluation and Research. Dr. Burlington served as Acting Director of the Office of Generic Drugs for 1 year and served as Deputy Director for Medical Affairs of the Center for almost 2 years. In his medical affairs position, he was active in jurisdictional issues, international harmonization of drug approval standards, the planning and implementation of user fees, accountability of program actions on clinical holds and refusal to file, and the effective use of FDA's scientific advisory committees. ROBERT M. CALIFF, M.D., is Associate Vice Chancellor for Clinical Research, Committee on Health Information Policy and Services, and chief execu-

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Rational Therapeutics for Infants and Children: Workshop Summary tive officer of the Duke Clinical Research Institute. He graduated from Duke University summa cure laude and Phi Beta Kappa in 1973 and from Duke University Medical School in 1978, where he was selected for Alpha Omega Alpha. He is a certified specialist in internal medicine (1984) and cardiovascular disease (1986) and a Fellow of the American College of Cardiology (1988). He did his internship and residency at the University of California, San Francisco, and a fellowship in cardiology at Duke University. He is currently Associate Vice Chancellor for Clinical Research, Director of the Duke Clinical Research Institute, and Professor of Medicine, Division of Cardiology, at the Duke University Medical Center, Durham, North Carolina. He is also editor of the American Heart Journal. Dr. Califf has led the Coordinating Center effort for many of the best-known cardiology trials of recent years, including CAVEAT (Coronary Angioplasty Versus Excisional Atherectomy Trial), GUSTO (Global Utilization of Streptokinases and t-PA for Occluded Coronary Arteries), EPIC (Evaluation of c7E3 Fab in Preventing Ischemic Complications of High-Risk Angioplasty), and TAMI (Thrombolysis and Angioplasty in Myocardial Infarction). In conjunction with colleagues at the Duke Databank for Cardiovascular Disease, he has written extensively about clinical and economic outcomes in chronic ischecon heart disease. He is editor of Acute Coronary Care, second edition. He is a section editor in the Textbook of Cardiovascular Medicine and is the author of more than 500 peer-reviewed articles. MICHAEL D. CLAYMAN, M.D., is Vice President of Cardiovascular Research and Decision Phase Medical for Lilly Research Laboratories, a division of Eli Lilly & Company. He had been Vice President of Product Development and Technology for Advanced Cardiovascular Systems, Inc., a subsidiary of Eli Lilly & Company located in Santa Clara, California, since 1992. He received a Bachelor of Arts degree, cum laude, in molecular biophysics and biochemistry from Yale University in 1974. In 1978 he was awarded a doctor of medicine degree from the University of California at San Diego School of Medicine. Following completion of his internship and residency in internal medicine at the Herbert C. Moffitt University of California Hospitals at San Francisco in 1981, Dr. Clayman completed clinical and research fellowships in nephrology at the University of Pennsylvania. He is recipient of the Physician Scientist Award from the National Institutes of Health. Dr. Clayman joined Lilly in 1987 as an associate clinical research physician. He was named clinical research physician in 1989. In 1990, he became Director of the Internal Medicine Division and later that year became Director of Clinical Pharmacology at the Lilly Clinic, serving in that capacity until 1992. He is a member of the American Society of Nephrology, the American Federation for Clinical Research, the American Association of Immunologists, and the American Heart Association.

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Rational Therapeutics for Infants and Children: Workshop Summary ADRIAN L. EDWARDS, M.D., is a retired private practice cardiologist in New York State. Dr. Edwards received his bachelor's degree from Wagner College in New York and his medical degree from Howard University in Washington, D.C. Previously, Dr. Edwards was Clinical Assistant Professor of Medicine at Cornell University Medical College. He was a diplomat for the American Board of Internal Medicine and a fellow for the American College of Physicians. He is a former fellow in cardiology at the New York Hospital, member of the National Medical Association, and a past member of the Board of Governors of St. Barnabas Hospital in the Bronx. Dr. Edwards also served on the Institute of Medicine's Committee on Enhancing the Practice of Occupational and Environmental Medicine. DAVID W. FEIGAL, JR., M.D., M.P.H. (ex officio), is Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA). He received his B.S. from the University of Minnesota, M.D. from Stanford University Medical School, and M.P.H. from the University of California at Davis Medical Center, where he remained as Chief Resident and later Residency Program Coordinator before entering a fellowship program in Clinical Epidemiology at the University of California at San Francisco (UCSF). He joined the UCSF faculty in 1984 with joint appointments in the School of Medicine and School of Dentistry as a member of the Department of Medicine and of the Department of Epidemiology and Biostatistics. His academic research interests included clinical epidemiology and clinical trials methodology, in particular, in the therapy of hypertension and AIDS. He came to the FDA in 1992 to head the Division of Anti-Viral Drug Products, a position held until 1997. In 1996, he was also the acting Division Director of the Anti-Infective Drug Division. From 1994 to 1997, he was the Director of the Office of Drug Evaluation IV. In the fall of 1997, he moved to the Center for Biologics Evaluation and Research (CBER) as the Medical Deputy Director. He also served as the CBER ombudsman and had responsibility for the Center's advisory committees. He has been a member of a number of committees and panels sponsored by the World Health Organization, National Institutes of Health, Institute of Medicine, and Centers for Disease Control and Prevention. He has represented FDA at the International Conference on Harmonization, the Tripartite Meetings, and many regulatory meetings. STEPHEN GROFT, Pharm. D. (ex officio), began his pharmacy career with the Public Health Service in 1970. Stationed first in Chamberlain, South Dakota, and later in Pawnee, Oklahoma, he was responsible for providing pharmacy services to the Indian Health Services Clinics and Hospital in these two service unit areas. In 1974, Dr. Groft transferred to the U.S. Food and Drug Administration (FDA) and served as Executive Secretary to the Psychopharmacologic Agents and the Neurologic Drugs Advisory Committees. Upon receiving his

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Rational Therapeutics for Infants and Children: Workshop Summary Pharm. D. degree in 1979 from Duquesne University in Pittsburgh, Pennsylvania, Dr. Groft became involved in FDA's efforts to initiate the Patient Package Insert Program for the labeling of drug products. In 1982, he joined Dr. Marion Finkel in FDA's Office of Orphan Products Development, where his primary area of responsibility was to review those orphan products potentially useful in the treatment of neurologic and psychiatric disorders. Dr. Groft was the Executive Secretary of the U.S. Department of Health and Human Services' Orphan Products Board from 1982 to 1986, and until 1989 coordinated the activities of the National Commission on Orphan Diseases as the Executive Director. When the Office of Rare Diseases was formally created at the National Institutes of Health in 1993, Dr. Groft was selected as its Director. He also served as the first Acting Director of the National Institutes of Health's Office of Alternative Medicine from 1991 to 1992. ANNE B. JACKSON, M.A., R.N., recently completed her second term on the Physician Payment Review Commission. She is a member of the National Legislative Council for the American Association of Retired Persons and has served as chair of the Education Advocacy and Community Service Advisory Committee and as minority spokesperson. Ms. Jackson retired as Professor of Nursing at City University of New York, and has also served as a consumer representative for the Joint Commission on Accreditation of Healthcare Organizations. Ms. Jackson is also a member of the Institute of Medicine Committee on Health Outcomes for Older People. ROBERT I. LEVY, M.D., joined American Home Products Corporation in 1992 as President of Wyeth-Ayerst Research. On March 6, 1998, he was appointed Senior Vice President, Science and Technology, American Home Products. Before joining American Home Products Corporation, Dr. Levy served as President of The Sandoz Research Institute from 1988 to 1992. Before that he had a distinguished career in research and research management in both government and academia. He was Vice President for Health Sciences and Professor of Medicine at the Columbia University College of Physicians and Surgeons and Vice President and Dean of Tufts University School of Medicine. Dr. Levy also served at the National Institutes of Health (NIH), with the last 6 years as Director of the National Heart, Lung, and Blood Institute. His 18-year tenure at NIH included pathfinding work in the areas of cholesterol, lipids, lipoproteins, atherosclerosis, and heart disease. Dr. Levy is a graduate of Cornell University and Yale University School of Medicine, cure laude. He is a member of numerous honorary and professional societies including Phi Beta Kappa, Alpha Omega Alpha, and the American College of Cardiology. He is also a member of the Institute of Medicine of the National Academy of Sciences. He also serves as chairman of the Pharmaceuticals Research and Manufacturers of America Sci-

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Rational Therapeutics for Infants and Children: Workshop Summary ence and Regulatory Section Executive Committee. Dr. Levy is the author or coauthor of more than 300 scientific publications. MICHAEL R. McGARVEY, M.D., is Chief Medical Officer for Horizon Blue Cross Blue Shield of New Jersey. As Chief Medical Officer, Dr. McGarvey is responsible for medical policy development and application, health care data analysis and cost management activities, and clinical quality improvement work. Dr. McGarvey has more than 25 years of experience in health care delivery and administration. Before joining Horizon Blue Cross Blue Shield of New Jersey he was Managing Director of Health Strategies for the Alexander & Alexander Consulting Group, a leading international human resources and benefits consulting organization. Previously, he was an executive with Empire Blue Cross and Blue Shield, New York, first as Vice President of Health Services Management, and then as Corporate Vice President of Health Affairs. He is a former Chief Medical Officer and Deputy Director for the New York State Department of Health's Office of Health Systems Management and a former Vice President for Health Affairs and Professor of Health Services at Hunter College of the City University of New York. Dr. McGarvey is a member of the National Council on Medical Management of the Blue Cross and Blue Shield Association, a former trustee of the New York Academy of Medicine, and former chairman of the New York Statewide Cardiac Advisory Committee. Dr. McGarvey received his medical degree from the University of Southern California School of Medicine and his bachelor's degree from Reed College. KSHITIJ MOHAN, Ph.D., is a Corporate Vice President for Baxter International Inc. He is responsible for corporate research and technical services, including research centers in the United States and Europe, as well as emerging technology ventures and technology strategy development. He is also the founder and leader of the Baxter Technical Council, which includes Baxter's technical leaders from around the world, and he serves on the Baxter Operating Management Team. Dr. Mohan joined Baxter in 1988. Before joining Baxter, Dr. Mohan served in various capacities in the U.S. Food and Drug Administration (FDA). Between 1979 and 1983, Dr. Mohan served in the White House Office of Management and Budget with responsibilities for national research and development (R&D) policies, programs of the National Science Foundation, and the National Aeronautic and Space Administration's Aeronautical and Space Research and Technology programs. During this time, he also served on two task forces of the White House and led an interagency study of the U.S. Antarctic program. Before 1979, Dr. Mohan was a researcher at the National Bureau of Standards (now the National Institute for Standards and Technology) in the fields of applied optics and superconductivity. He has published widely in the fields of health policies, regulations, research and development policies, and applied physics. He has lectured and consulted extensively in the United States,

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Rational Therapeutics for Infants and Children: Workshop Summary Britain, Spain, Brazil, the Philippines, Japan, Australia, and the People's Republic of China. He is the recipient of numerous awards from Baxter, the White House, and U.S. government agencies and civic groups, including FDA's highest award, the Award of Merit, on two occasions. He is a director of the Health Industry Manufacturers' Association and KeraVision, Inc. He is or has been a member of the Baxter Japan Board, the Corporate Advisory Boards of Engineering Schools at Dartmouth College and the University of California, the Review Board of the President Truman Foundation, the Board of Directors of the Regulatory Affairs Professional Society, and various editorial boards. Dr. Mohan earned a Ph.D. in physics from Georgetown University and has received extensive training in management. STUART L. NIGHTINGALE, M.D. (ex officio), is Associate Commissioner for Health Affairs and Senior Health Adviser, Office of International and Constituent Relations, U.S. Food and Drug Administration (FDA). He received a B.A. degree from Yale University and an M.D. degree from the New York University School of Medicine. He served his internship and residency in internal medicine at Montefiore Hospital and Medical Center in New York. He received additional training in anatomical pathology (Bellevue Hospital) and adolescent medicine (Montefiore Hospital). He served on the faculties of the Johns Hopkins University School of Medicine, and the State University of New York (Downstate) School of Medicine. He worked for the State of Maryland Department of Health and Mental Hygiene and entered federal service at the Special Action Office for Drug Abuse Prevention, Executive Office of the President. Before joining FDA he spent 3 years at the National Institute on Drug Abuse as a division director. At FDA he has held a number of positions in the Bureau of Drugs (predecessor to the Center for Drug Evaluation and Research) and in the Office of the Commissioner that have included responsibility for coordinating FDA's outreach to health professional organizations and outreach to the human subject protection community and for coordinating FDA's international activities, especially its relations with the World Health Organization. He has written extensively on regulatory and health professional matters. PAUL GRANT ROGERS, J.D., is a partner in the law firm of Hogan & Hartson in Washington, D.C. He was a member of the U.S. Congress from 1955 to 1979 and Chairman of the House of Representatives Subcommittee on Health and the Environment. Some of the prominent pieces of legislation that Mr. Rogers sponsored or played a major role in enacting are National Cancer Act of 1971 and 1977; Health Manpower Training Act; Heart, Lung and Blood Act; Research on Aging Act; Comprehensive Drug Abuse Prevention and Control Act of 1970; Medical Device Amendments of 1976; Emergency Medical Services Act; Health Maintenance Organization Act; Clean Air Act; Safe Drinking Water Act; and the Medicare-Medicaid Anti-Fraud and Abuse Amendments of 1977. Mr. Rogers

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Rational Therapeutics for Infants and Children: Workshop Summary serves as Chair at Research! America, the National Foundation for Infectious Diseases Board of Trustees, the National Osteoporosis Foundation, and the Friends of the National Library of Medicine. He is Cochair of the National Leadership Coalition on Health Care. Mr. Rogers has received honorary degrees from various universities and has received many distinguished service awards. He is a member of the Harvard School of Public Health Dean's Council, the Board of Trustees of the University of Pennsylvania Medical Center, the Council of the Washington University School of Medicine, the University of Chicago Council for the Division of the Biological Sciences and the Pritzker School of Medicine, and the Whitehead Institute Board of Advisors. He is also a member of the Institute of Medicine of the National Academy of Sciences. DANIEL SECKINGER, M.D., was formerly Group Vice President of Professional Standards at the American Medical Association. His responsibilities included science and technology, medical education, ethics and quality/managed care. Previously, Dr. Seckinger was the President of the College of American Pathologists (CAP). Prior to his election as President of the CAP, Dr. Seckinger served on the Board of Governors for six years and as Chairman of the Council on Scientific Affairs for four years. Dr. Seckinger has practiced in South Florida for the past 30 years. In 1984 he was elected President of the Dade County Medical Association and has also served as President of the American Center Society in South Florida. Dr. Seckinger was formerly Clinical Professor of Pathology at the University of Miami School of Medicine and founder and director of the Oncology Laboratory in his primary practice environment of Cedars Medical Center. Dr. Seckinger has published extensively on tumor markers and DNA ploidy and cell cycle studies in the Prognosis of Cancer. For four years he directed the Cancer Program at Cedars, interacting with over 40 medical, surgical, radiological, and gynecological oncologists. Dr. Seckinger received his M.D. from George Washington University in Washington, D.C., in 1954 and served as resident in Pathology for five years and Surgery for three years. He is certified by the American Board of Pathology in Anatomic and Clinical Pathology. WHAIJEN SOO, M.D., Ph.D., is Vice President, Clinical Sciences, Hoffmann-La Roche Inc. As Vice President of Clinical Sciences at Hoffmann-La Roche Inc., Dr. Soo is responsible for the planning and execution of global development and life cycle management, and of new anticancer drugs and antiviral and immunotherapies against AIDS and other viral diseases, as well as drugs used for transplantation. His groups in Nutley, N. J., Basel, Switzerland, Welwyn, United Kingdom, Mannheim, Germany, and Palo Alto, Calif., also provide clinical expert advice to global research projects at all stages and participate in the transition planning and execution of projects from research to development. In addition, his groups participate in global licensing activities and strategic planning at the therapeutic area level with research and business colleagues. For

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Rational Therapeutics for Infants and Children: Workshop Summary the United States-based groups, Dr. Soo also has administrative responsibilities for all clinical science groups, including the four clinical science therapeutic clusters covering all therapeutic areas, clinical pharmacology group, and clinical safety surveillance and risk management group. Dr. Soo received a Ph.D. in biochemistry from the University of California, Berkeley. He also has a M.D. from the University of California, San Francisco, and received postgraduate training at Harvard Medical School in Boston. He has extensive experience with drug development in various therapeutic areas including virology, immunology, oncology, nervous systems, and endocrinology and metabolism. Overall, he has either been directly involved or supervised the successful submissions and registration of 14 new drug or biologics applications worldwide. REED V. TUCKSON, M.D., is Senior Vice President for the American Medical Association (AMA). Dr. Tuckson's areas of responsibility include medical education (undergraduate, graduate, and continuing medical education); ethics; science, technology, and public health; quality and managed care; and the National Patient Safety Foundation. Before joining AMA, Dr. Tuckson was President of the Charles R. Drew University School of Medicine and Science in Los Angeles, California, from 1991 to 1997. From 1986 to 1990, Dr. Tuckson was Commissioner of Public Health for the District of Columbia. From 1990 to 1991, he served as Senior Vice President for Programs at the March of Dimes Birth Defects Foundation. He also serves on a number of health care, academic, and federal boards and committees, and is a nationally known lecturer on topics concerning community-based medicine, the moral responsibilities of health professionals, and physician leadership. Dr. Tuckson is a graduate of the Georgetown University School of Medicine. He completed his internship, residency, and fellowship in general internal medicine at the Hospital of the University of Pennsylvania. During his fellowship, he also became a Robert Wood Johnson Foundation Clinical Scholar at the University of Pennsylvania, where he studied health care administration and health policy at the Wharton School of Business and where he was active in ambulatory, student health, prevention, and geriatric clinical care settings. JANET WOODCOCK, M.D. (ex officio), is Director of the Center for Drug Evaluation and Research. Before that she was Director of the Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Dr. Woodcock is an internist/rheumatologist with research experience in immunology. She joined FDA in 1985. She served as Director of the Division of Biological Investigational New Drugs in CBER from 1988 to 1992 and was Acting Deputy Director of the Center in 1991 and 1992. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held faculty ap-

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Rational Therapeutics for Infants and Children: Workshop Summary pointment at the Pennsylvania State University and the University of California at San Francisco. SUMNER YAFFE, M.D. (ex officio), Director of the Center for Research for Mothers and Children at the National Institutes of Health, received his A.B. in chemistry and M.A. in pharmacology from Harvard University and his medical degree from the University of Vermont School of Medicine. Dr. Yaffe's honors include a Fulbright Scholarship; the Lederle Medical Faculty Award, Wall Memorial Lecturer; Editor, Pediatric Clinics of North America; Upjohn Lecturer; Louisville Pediatric Lectureship; Guest Editor, Clinics in Perinatology; Creasy Visiting Professorship; and the Hardt Memorial Lecturer. He is an honorary member of the Society of Perinatal Obstetricians and a member of the Alpha Omega Alpha and Sigma Xi honorary societies. Dr. Yaffe has held academic and staff appointments at Stanford University Medical Center, State University of New York at Buffalo, Children's Hospital of Buffalo, and at the University of Pennsylvania and Children's Hospital of Philadelphia. Dr. Yaffe has also served as a member or chair of more than 40 committees and advisory boards of organizations dealing with child health and clinical pharmacology. Dr. Yaffe has published more than 200 articles in the area of pediatrics and clinical pharmacology. KATHRYN ZOON, Ph.D. (ex officio), became Director of the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), in March 1992. Dr. Zoon was formerly the Director of the Division of Cytokine Biology in CBER, where she was actively involved with regulatory issues related to cytokines, growth factors, and studies on interferon purification, characterization, and receptors. Dr. Zoon worked at the National Institutes of Health (NIH) from 1975 to 1980 with Nobel Prize Laureate Christian B. Anfinsen on the production and purification of human interferons. She continued her work on interferons and reviewed cytokine products when she joined FDA in 1980. She received her B.S. degree, cum laude, in chemistry from Rensselear Polytechnic Institute in 1970 and was granted a Ph.D. in biochemistry from The Johns Hopkins University in 1975. Dr. Zoon is an editor of the Journal of Interferon Research and the author of numerous scientific papers on interferons. She has received numerous awards, including the NIH Lectureship (1994), Sydney Riegelman Lectureship (1994), Biopharm Person of the Year Award (1992), the Genetic Engineering News Award (1994) for streamlining and improving the regulatory process for biologics and biotechnology products, and the Meritorious Executive Rank Award (1994) for sustained superior performance in revitalizing and reorganizing CBER to meet the challenges of new responsibilities and new technologies.

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Rational Therapeutics for Infants and Children: Workshop Summary STUDY STAFF JONATHAN R. DAVIS, Ph.D., is a Senior Program Officer at the Institute of Medicine (IOM). His primary charge is the Study Director of IOM's Forum on Emerging Infections and the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. Dr. Davis was formerly the Science Officer for the Emerging Infectious Diseases and HIV/AIDS Program in the U.S. Department of State's Bureau of Oceans and International Environmental and Scientific Affairs. Before his work at the State Department, Dr. Davis was an Assistant Professor of Medicine and Head of the Malaria Laboratory at the University of Maryland School of Medicine, where he was the principle and coprinciple investigator on grants investigating the fundamental biology of malaria transmission and on the development and testing of candidate malaria vaccines in human volunteers. Dr. Davis has an M.S. in medical entomology and parasitology from Clemson University and a Ph.D. in immunology and infectious diseases from The Johns Hopkins University School of Hygiene and Public Health. Dr. Davis is an ad hoe reviewer for several professional scientific journals and holds adjunct faculty appointments at The Johns Hopkins University School of Hygiene and Public Health, the University of Maryland School of Medicine, and the Uniformed Services University School of the Health Sciences. PETER BOUXSEIN, J.D., is a Senior Program Officer in the Institute of Medicine. Mr. Bouxsein has an undergraduate degree in science from Carnegie Mellon University and a law degree from the University of Chicago. He has 23 years of service with the federal government, including the U.S. Department of Justice, the Office of Economic Opportunity, the Health Care Financing Administration, and the Agency for Health Care Policy and Research, in the areas of civil rights, higher education, and health care. Seven of those years were spent as counsel to the Subcommittee on Health and the Environment, U.S. House of Representatives, focusing on Medicare, health care technology, graduate medical education, and clinical research. In addition, Mr. Bouxsein has served as the Deputy Director of the Institute for Public Policy Studies, University of Michigan, and Deputy Executive Vice President of the American College of Physicians. He is also a research associate and lecturer at the Johns Hopkins School of Public Health. SARAH PITLUCK, M.S., is a research assistant in the Division of Health Sciences Policy at the Institute of Medicine (IOM). Sarah helps support the IOM's Committee on Understanding the Biology of Sex and Gender Differences and the Roundtable on Environmental Health Sciences, Research, and Medicine. She also assists the Forum on Emerging Infections and the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. She received her undergraduate degree in political science at Washington University in St. Louis, Missouri, before completing her master's degree in public policy and public administration at the London School of Economics and Political Science.

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Rational Therapeutics for Infants and Children: Workshop Summary Sarah's master's thesis addresses the sources of divergent policies toward screening for prostate cancer in the United States and United Kingdom. Sarah's most recent IOM publications include Fluid Resuscitation: State of the Science for Treating Combat Casualties and Civilian Injuries and Organ Procurement and Transplantation Policy: Assessing Current Policies and the Potential Impact of the DHHS Final Rule. VIVIAN P. NOLAN, M.A., is the Research Associate for the Forum on Emerging Infections and for the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. Before joining the Institute of Medicine, Ms. Nolan was a science assistant in the Division of Environmental Biology at the National Science Foundation (NSF) where she worked on grants administration, research projects, and policy analyses on environmental and conservation biology issues. Ms. Nolan is a recipient of an NSF Directors Award for the policyoriented, interdisciplinary Water and Watersheds collaborative NSF/Environmental Protection Agency grants program. Ms. Nolan is pursuing her doctorate degree in environmental science and public policy from George Mason University. Her graduate work has included research and policy analysis on such issues as environmental, biodiversity conservation, sustainable development, human health, and emerging and teemerging infectious diseases. In August 1998, she participated in an educational program in Kenya where she studied the relationship between ecological degradation and emerging infectious diseases. Ms. Nolan was awarded an M.A. in science, technology, and public policy in 1994 from the George Washington University, and in 1987, she simultaneously earned two bachelor's degrees in international studies and Latin American studies. NICOLE AMADO was the Project Assistant for the Forum on Emerging Infections, as well as for the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. Ms. Amado was formerly a Project Coordinator for the Cystic Fibrosis Foundation. Before her work at the Cystic Fibrosis Foundation, she was a Panel Assistant with the Chemical Manufacturers Association. Ms. Amado brings to the Institute of Medicine considerable experience in project organization, research and analysis, and administrative problem solving. Ms. Amado earned a bachelor's degree in biology from the University of Louisville in 1994.