G
Committee and Staff Biographies

COMMITTEE

WILLIAM E. BUNNEY, JR., is Distinguished Professor and Della Martin Chair of Psychiatry in the Department of Psychiatry, College of Medicine, University of California, Irvine. He received his M.D. from the University of Pennsylvania Medical School and took his residency at Yale School of Medicine. His previous positions have included Chief, Biological Psychiatry Branch, National Institute of Mental Health (NIMH), and Director, Division of Narcotic Addiction and Drug Abuse, NIMH. He has been past President of the American College of Neuropsychopharmacology and the Collegium Internationale Neuropsychopharmacologicum (CINP). Dr. Bunney is a member of the Institute of Medicine (IOM) of the National Academy of Sciences. He served for a number of years as the Cochair of an IOM division previously named the Division of Biobehavioral Sciences and Mental Disorders. He has been a past member of the Scientific Advisory Council of NIMH and currently. is on the Scientific Advisory Boards for National Alliance for Research on Schizophrenia and Depression (NARSAD) and the NDMA Associations. Dr. Bunney serves on 13 editorial boards and has published more than 340 scientific articles.

DANIEL L. AZARNOFF is President of D.L. Azarnoff Associates. He brings to the group more than 20 years of academic experience in research and clinical medicine, plus 8 years as Past President of Research and Development for the Searle Pharmaceutical Company and 10 years as a consultant in drug development. Before joining Searle he was Distinguished Professor of Medicine and Pharmacology and Director of the Clinical Pharmacology Toxicology Center at the University of Kansas Medical Center, a job he held for 16 years. He has published more than 175 articles in scientific and medical journals, Dr. Azarnoff is a member of the Institute of Medicine and a fellow of the American Association of Pharmaceutical Scientists, New York Academy of Sciences, American Association for the Advancement of Science, and the American College of Physicians. He



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Halcion: An Independent Assessment of Safety and Efficacy Data G Committee and Staff Biographies COMMITTEE WILLIAM E. BUNNEY, JR., is Distinguished Professor and Della Martin Chair of Psychiatry in the Department of Psychiatry, College of Medicine, University of California, Irvine. He received his M.D. from the University of Pennsylvania Medical School and took his residency at Yale School of Medicine. His previous positions have included Chief, Biological Psychiatry Branch, National Institute of Mental Health (NIMH), and Director, Division of Narcotic Addiction and Drug Abuse, NIMH. He has been past President of the American College of Neuropsychopharmacology and the Collegium Internationale Neuropsychopharmacologicum (CINP). Dr. Bunney is a member of the Institute of Medicine (IOM) of the National Academy of Sciences. He served for a number of years as the Cochair of an IOM division previously named the Division of Biobehavioral Sciences and Mental Disorders. He has been a past member of the Scientific Advisory Council of NIMH and currently. is on the Scientific Advisory Boards for National Alliance for Research on Schizophrenia and Depression (NARSAD) and the NDMA Associations. Dr. Bunney serves on 13 editorial boards and has published more than 340 scientific articles. DANIEL L. AZARNOFF is President of D.L. Azarnoff Associates. He brings to the group more than 20 years of academic experience in research and clinical medicine, plus 8 years as Past President of Research and Development for the Searle Pharmaceutical Company and 10 years as a consultant in drug development. Before joining Searle he was Distinguished Professor of Medicine and Pharmacology and Director of the Clinical Pharmacology Toxicology Center at the University of Kansas Medical Center, a job he held for 16 years. He has published more than 175 articles in scientific and medical journals, Dr. Azarnoff is a member of the Institute of Medicine and a fellow of the American Association of Pharmaceutical Scientists, New York Academy of Sciences, American Association for the Advancement of Science, and the American College of Physicians. He

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Halcion: An Independent Assessment of Safety and Efficacy Data maintains a teaching appointment at the University of Kansas School of Medicine. Dr. Azarnoff is on the editorial board of several journals and has been on committees within the U.S. Food and Drug Administration, World Health Organization, American Medical Association, National Academy of Sciences, Institute of Medicine, and National Institutes of Health, advising them on drags and drag development. BYRON WM. BROWN, JR., is Professor and Head of the Division of Biostatistics in the Department of Health Research and Policy, School of Medicine, Stanford University. He received a Ph.D. degree in 1959 in biostatistics from the University of Minnesota, where he served on the faculty from 1959 to 1968. Leaving the position there as Division Chief in Biometry to join the faculty at Stanford University, he has served as Division Head of Biostatistics since 1968 and served as Chairman of the Department of Health Research and Policy from 1988 to 1996. His special interests are in the design and analysis of clinical trials, in biological assay statistical methodology, and in the role and methodology of statistics in health enhancement and health policy. He has served on the Veterans Administration Cooperative Studies Evaluation Committee and the Clinical Cancer Investigations Review Committee and as a consultant to the Federal Trade Commission, the U.S. Food and Drug Administration, the INCAP, numerous clinical trial advisory boards and review committees, and government and private industry. He is Past President of the Society for Controlled Clinical Trials and the Western Region of the Biometrics Society and a Fellow of the American Statistical Association and the American Heart Association. He is an elected member of the Institute of Medicine and the International Institute of Statistics. ROBERT CANCRO obtained his M.D. degree in 1955 from State University of New York, Downstate Medical Center, and his Doctor of Medical Science degree in 1962 from the same institution. His more recent academic activities have involved serving as Professor and Chair of the Department of Psychiatry at the New York University Medical Center since 1976. He is Director of the Nathan Kline Institute for Psychiatric Research, which is a New York State-funded research institute. His major professional interest has been at the brain-behavior interface in psychoses and in particular the schizophrenic disorders. This interest has led to a deep involvement with psychoactive medications, including their use and misuse. ROBERT D. GIBBONS received his Ph.D. from the University of Chicago in 1981. He is currently a Professor of Biostatistics at the University of Illinois at Chicago. In 1985 he received a Young Scientist Award from the Office of Naval Research, which funded his statistical research in the areas of the analysis of multivariate binary data and the analysis of longitudinal data. Dr. Gibbons has also received additional grant support from the National Institutes of Health and the John D. and Catherine T. MacArthur Foundation. He currently has a Research Scientist Award from the National Institutes of Health that provides full-time. support for statistical research. Applications of Dr. Gibbons work are widespread in the general areas of mental health and environmental sciences. Dr. Gibbons has authored more than 100 peer-reviewed scientific papers and two books. He is currently working on a new book entitled Statistical Methods for Detection and Quantification of Environmental Contamination, which will be published by John Wiley & Sons.

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Halcion: An Independent Assessment of Safety and Efficacy Data JOHN CHRISTIAN GILLIN received a B.A. degree (magna cure laude) from Harvard College and a M.D. degree from Case-Western Reserve School of Medicine, performed his psychiatric residency at Stanford University, and participated in the Intramural Program of the National Institute of Mental Health. Dr. Gillin is currently Professor of Psychiatry at the University of California, San Diego (UCSD), and is Director of the UCSD Mental Health Clinical Research Center. He is past Director of the Fellowship Program in Psychopharmacology and Psychobiology, (UCSD) Department of Psychiatry, the past President of the Sleep Research Society and Society for Light Therapy and Biological Rhythms, and Chair of the Mental Health Panel, United States Pharmacopeia (1994-present. He is a Board Certified Diplomate of the American Board of Neurology and Psychiatry and he currently serves on the Board of Directors of the American Sleep Disorders Association. Dr. Gillin was a member of the Institute of Medicine's Steering Committee, Study on the Appropriate Use of Hypnotic Agents; the National Academy of Sciences Health Systems Panel of the Strategic Technologies for the Army (STAR); the National Institutes of Health (NIH)-NIMH National Consensus Development Conference on Drugs and Insomnia: The Use of Medications to Promote Sleep; the Surgeon General's Initiative on Insomnia and Sleep Disorders (Project Sleep) and the Advisory Board of the National Center for Sleep Disorders Research, NIH. Dr. Gillin is on numerous editorial boards of prestigious medical journals. SANDRAL HULLETT is Executive Director of West Alabama Health Services, a community health center located in rural west Alabama. She has a bachelor's degree from Alabama A&M University in Normal, Alabama, a medical degree from the Medical College of Pennsylvania, Philadelphia, and a master's degree in public health from the University of Alabama at Birmingham. Since completing a residency in family practice and fulfilling a National Health Services Corp. obligation, Dr. Hullett developed an interest in rural health care, including health care planning and delivery to the underserved, underinsured, and poor in rural areas. Dr. Hullett is a member of the Board of Trustees of the University of Alabama System and has been appointed a member of the Practicing Physicians Advisory Council of the U.S. Department of Health and Human Services. Dr. Hullett is a member of the Institute of Medicine and the Alabama Health Care Reform Task Force. KEITH F. KILLAM, Professor Emeritus, is the Founding Chair of the Department of Pharmacology and Toxicology at the University of California, Davis, and has previously served as President of the American Society of Pharmacology and Experimental Therapeutics, President of the American College of Neuropsychopharmacology, President of the College on Problems of Drug Dependence, an adviser on President John F. Kennedy's Scientific Board, and a member of numerous Study Sections of the National Institutes of Health (NIH). Two of his NIH-funded active programs are (1) the study of the interaction of drug abuse and AIDS and (2) the study of opioid receptors on immune cells. Both grants involve important areas of research whose continued progress are in the interest of the public. JOHN H. KRYSTAL is Associate Professor of Psychiatry at Yale University and Director of the Division of Cognitive and Clinical Neuroscience at the Abraham Ribicoff Research Facilities, Connecticut Mental Health Center. His research has covered aspects of the

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Halcion: An Independent Assessment of Safety and Efficacy Data neurobiology and psychopharmacology of psychiatric and substance abuse disorders, with a particular focus on alcoholism and schizophrenia. He graduated from the University of Chicago and completed medical school and psychiatry residency training at Yale University. Since joining the faculty of the Yale Department of Psychiatry in 1988, his work has highlighted the human psychopharmacology of drugs acting at glutamate receptors. This work has employed drugs acting at NMDA receptors and the strychnine-insensitive glycine site as probes of altered receptor sensitivity in pathological conditions. It has evaluated ketamine in a model psychosis, including the study of the capacity of drugs to block the effects of ketamine in humans. His ketamine research, in turn, stimulated an interest in the role of amino acid neurotransmission in the function of the frontal cortex. To this end, he recently initiated studies employing functional magnetic resonance imaging, magnetic resonance spectroscopy, and SPECT neuroreceptor imaging to better characterize cortical pathology associated with psychiatric and substance abuse disorders. DAVID J. KUPFER, Thomas Detre Professor and Chair of the Department of Psychiatry and · Professor of Neuroscience at the University of Pittsburgh School of Medicine. He received his bachelor's (magna cure laude) and M.D. degrees from Yale University. Following completion of an internship, Dr. Kupfer continued his postgraduate clinical and research training at the Yale New Haven Hospital and at the National Institute of Mental Health (NIMH). In 1969 he was appointed an Assistant Professor of Psychiatry at Yale University School of Medicine. Dr. Kupfer joined the faculty at the University of Pittsburgh in 1973 as an Associate Professor of Psychiatry and Director of Research and Research Training at Western Psychiatric Institute and Clinic. He was promoted to Professor of Psychiatry in 1975 and became Chair of the department in 1983. In 1994 he was named the Thomas Detre Chair in Psychiatry. For more than 20 years Dr. Kupfer's research has focused primarily on the conceptualization, diagnosis, and treatment of mood disorders. He has written more than 600 articles, books, and book chapters that examine the use of medication in recurrent depression, the causes of depression, and the relationship between biological rhythm, sleep and depression. In recognition of his contributions to the field, Dr. Kupfer has been the recipient of numerous awards and honors. He was elected to the Institute of Medicine of the National Academy of Sciences in 1990. PAUL D. STOLLEY is Professor and Chair of the Department of Epidemiology and Preventive Medicine at the University of Maryland at Baltimore School of Medicine. Dr. Stolley is an epidemiologist and internist who trained at the Epidemic Intelligence Service of the Centers for Disease Control and Prevention and the Johns Hopkins School of Hygiene and Public Health, where he has also joined the faculty in the Department of Epidemiology. He then founded and led the Clinical Epidemiology Unit at the University of Pennsylvania, where he served as the Herbert Rorer Professor of Medicine. Dr. Stolley has had a long interest and experience in the investigation of obscure illnesses and epidemics: asthma mortality in Europe, hexachlorophene poisoning in France, and Legionnaires' disease and the eosinophilia-myalgia syndrome in the United States. He is a member of the Institute of Medicine of the National Academy of Sciences and is past President of the American Epidemiological Society, the American College of Epidemiology, and the Society of Epidemiology Research. Dr. Stolley's research interests include epidemiology, public health, stroke, minority health, uterine fibroid

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Halcion: An Independent Assessment of Safety and Efficacy Data growth, and violence. His current research includes studies on repeat victims of violence, women's health issues, and the epidemiology of adverse drug reactions. IOM STAFF ANDREW M. POPE is Senior Staff Officer and Study Director in the Institute of Medicine's Division of Health Sciences Policy. With expertise in physiology, toxicology, and epidemiology, his primary interests focus on the environmental and occupational influences on human health. As a Research Fellow in the Division of Pharmacology and Toxicology at the U.S. Food and Drug Administration, Dr. Pope's research focused on the biochemical, neuroendocrine, and reproductive effects of various environmental substances on food-producing animals. During his tenure at the National Academy of Sciences and since 1989 at the Institute of Medicine, Dr. Pope has directed and edited numerous reports on environmental and occupational issues; topics include injury control, disability prevention, biologic markers, neurotoxicology, indoor allergens, and the inclusion of environmental health content in medical and nursing school curricula. THELMA L. COX is a Project Assistant in the Division of Health Sciences Policy. During her seven years at the Institute of Medicine, she has also provided assistance to the Division of Health Care Services and the Division of Biobehavioral Sciences and Mental Disorders. Ms. Cox has worked on several Institute of Medicine (IOM) projects, including Designing A Strategy for Quality Review and Assurance in Medicare; Evaluating the Artificial Heart Program of the National Heart, Lung, and Blood Institute; Federal Regulation of Methadone Treatment; Legal and Ethical Issues Relating to the Inclusion of Women in Clinical Studies; and Review of the Fialuridine (FIAU/FIAC) Clinical Trials. In 1995, she received the National Research Council Recognition Award and, in 1994, the IOM Staff Achievement Award. GEOFFREY S. FRENCH is a research assistant in the Division of Health Sciences Policy. He has been with the Institute of Medicine (IOM) for two years, having supported the Office of Finance and Administration and the IOM Committee Assessing Rehabilitation Science and Engineering. His undergraduate degree is in History and Anthropology, and he completed his master's degree in National Security Studies at Georgetown University. VALERIE PETIT SETLOW is the Director of the Division of Health Sciences Policy. In this capacity, she is responsible for the development of public policy activities related to (1) biomedical research, including fundamental science and clinical research; (2) infrastructure to Support research; (3) drug development and regulation; (4) education, training, and mentoring of health professionals; and (5) the ethical, legal, and social implications of biomedical advances. Dr. Setlow received her B.S. in chemistry from Xavier University and her Ph.D. in molecular biology from Johns Hopkins University. Dr. Setlow has conducted research in molecular hematology and virology and has had a distinguished career in government serving in numerous positions including Director of the Cystic Fibrosis Research programs at the National Institutes of Health and, in her last position, Acting Director of the National AIDS

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Halcion: An Independent Assessment of Safety and Efficacy Data Program Office. Her expertise includes molecular biology and genetics, health science program management, health policy analysis, and program development. She also holds an adjunct appointment at Howard University in the Department of Community and Family Medicine. CONSTANCE M. PECHURA has been at the Institute of Medicine since 1988 and is presently director of the Division of Neuroscience and Behavioral Health. She received a B.S. in psychology (1980) from Virginia Commonwealth University and a Ph.D. in anatomy (1987) from F. Edward Hebert School of Medicine, Uniformed Services University of the Health Sciences (USUHS). She has directed a number of projects on topics including assessing the health affects of chemical weapons exposure on World War II human subjects, ethical and public policy issues of cross-species organ transplantation, science base of medically assisted conception and fetal research, research opportunities regarding mental and addictive disorders in women, integrating computer technologies to map the human brain, microbial pathogenesis, developmental neurobiology, sleep research, and health and human rights. A recipient of a National Academy of Sciences Special Achievement Award (1993), an Outstanding Teaching Award (USUHS, Class of 1988), and a National Science Foundation Graduate Fellowship (1981), Dr. Pechura has taught medical school courses at USUHS and the George Washington University Medical School. She completed a postdoctoral fellowship at the National Institute of Neurological Disorders and Stroke, Laboratory of Neurophysiology. Dr. Pechura holds an adjunct faculty position at the George Washington University School of Medicine, is the Health Policy Tutor in the Stanford in Washington Program, and chairs the Board of Directors for Student Pugwash, USA.