Appendix F
Biographies of Committee Members

WILLIAM N. KELLEY, M.D., is the Executive Vice President of the University of Pennsylvania, with responsibilities as Chief Executive Officer for the Medical Center, Dean of the School of Medicine, and Robert G. Dunlop Professor of Medicine and Biochemistry and Biophysics. He has held this position since October 1, 1989. Over the years, Dr. Kelley has played an important personal role in research, patient care, and teaching. At the time of his move to the University of Pennsylvania, he had served continuously as a principal investigator on investigator-initiated grants from the National Institutes of Health, principal investigator at the NIH-funded Michigan Multipurpose Arthritis Center, and principal investigator on the program project proposal entitled ''Experimental Models of Gene Therapy," which was the first program project in the field of gene therapy funded by NIH. In his own research, he was the first to directly administer a human gene in vivo and obtain expression in an experimental animal. He was honored to serve as the keynote speaker at the First International Congress of Human Gene Therapy in Beijing, China, in October 1992. Dr. Kelley has had an opportunity to serve as president or chairman of six national professional organizations. He also currently serves as Chairman of the Membership Committee of the Institute of Medicine of the National Academy of Sciences. His honors include the John Phillips Memorial Award and medal of the American College of Physicians for his contributions to American medicine. Prior to his position at the University of Pennsylvania, Dr. Kelley was the John G. Searle Professor and Chairman of the Department of Internal Medicine and Professor of Biological Chemistry at the University of Michigan. He was Chief of Rheumatic and Genetic Diseases at the Duke University Medical Center prior to moving to Michigan. Dr. Kelley received his



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Careers in Clinical Research: Obstacles and Opportunities Appendix F Biographies of Committee Members WILLIAM N. KELLEY, M.D., is the Executive Vice President of the University of Pennsylvania, with responsibilities as Chief Executive Officer for the Medical Center, Dean of the School of Medicine, and Robert G. Dunlop Professor of Medicine and Biochemistry and Biophysics. He has held this position since October 1, 1989. Over the years, Dr. Kelley has played an important personal role in research, patient care, and teaching. At the time of his move to the University of Pennsylvania, he had served continuously as a principal investigator on investigator-initiated grants from the National Institutes of Health, principal investigator at the NIH-funded Michigan Multipurpose Arthritis Center, and principal investigator on the program project proposal entitled ''Experimental Models of Gene Therapy," which was the first program project in the field of gene therapy funded by NIH. In his own research, he was the first to directly administer a human gene in vivo and obtain expression in an experimental animal. He was honored to serve as the keynote speaker at the First International Congress of Human Gene Therapy in Beijing, China, in October 1992. Dr. Kelley has had an opportunity to serve as president or chairman of six national professional organizations. He also currently serves as Chairman of the Membership Committee of the Institute of Medicine of the National Academy of Sciences. His honors include the John Phillips Memorial Award and medal of the American College of Physicians for his contributions to American medicine. Prior to his position at the University of Pennsylvania, Dr. Kelley was the John G. Searle Professor and Chairman of the Department of Internal Medicine and Professor of Biological Chemistry at the University of Michigan. He was Chief of Rheumatic and Genetic Diseases at the Duke University Medical Center prior to moving to Michigan. Dr. Kelley received his

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Careers in Clinical Research: Obstacles and Opportunities undergraduate and medical degrees from Emory University in Atlanta and training in internal medicine, rheumatology and genetics at the University of Texas Southwestern Medical School and Parkland Memorial Hospital in Dallas, the Massachusetts General Hospital and Harvard Medical School in Boston, and the National Institutes of Health in Bethesda, where he received the John D. Lane Award of the U.S. Public Health Service for his research contributions. Dr. Kelley's bibliography lists in excess of 240 publications and 12 books, and he has participated as a member of the editorial boards of 12 medical journals. He is the founder and senior editor of The Textbook of Rheumatology, which is now in its 4th edition, and is the founder and editor-in-chief of The Textbook of Internal Medicine. KAREN H. ANTMAN, M.D., is Professor of Medicine and Chief of the Division of Medical Oncology at Columbia-Presbyterian Medical Center. Dr. Antman received her M.D. from the College of Physicians & Surgeons of Columbia University and joined the Harvard Medical School faculty in 1979. She previously was Associate Professor at the Harvard Medical School, where she was Clinical Director of the Dana Farber Cancer Institute and Beth Israel Hospital Solid Tumor Autologous Marrow Program and coordinated the sarcoma and mesothelioma clinical research and treatment programs at the Dana Farber Cancer Institute. Dr. Antman moved to Columbia-Presbyterian Medical Center in 1993. She has published extensively on bone marrow transplantation, hematopoietic cytokines, and sarcomas and mesotheliomas, and is coeditor of two textbooks, Asbestos Related Malignancy and High Dose Cancer Therapy. The latter examines the state of the art of bone marrow transplantation, hematopoietic stem cells and hematopoietic cytokines. The solid tumor marrow transplant program under her direction initially began pilot trials of new regimens in incurable breast cancer and other solid tumors on the basis of laboratory-based observations and has expanded to randomized trials with significantly less toxic regimens with curative intent. She has consulted for the U.S. Department of Justice on asbestos-related malignancies and served on the Health and Human Services Advisory Board Study of Coverage of Investigational Therapy, on the Physicians Payment Review Commission/American Medical Association Consensus Panel for Evaluation and Management of Services, and on the Harvard Resource Based Relative Value Scale Technical Consulting Panel. She is currently an associate editor of Cancer Research, is on the editorial board of Annals of Internal Medicine and the New England Journal of Medicine, and is president of the American Society for Clinical Oncology. DOROTHY BROOTEN, Ph.D., R.N., is the Director of the Center for Low Birthweight: Prevention and Care, Professor in the Health Care of Women and Childbearing Division at the University of Pennsylvania School of Nursing, and the Overseers Term Chair in Perinatal Research. She is a member of the

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Careers in Clinical Research: Obstacles and Opportunities Institute of Medicine. She is a former member of the governing council of the American Academy of Nursing and was cochair of the expert panel on Prevention and Care of Low Birthweight Infants for the National Center for Nursing Research at the National Institutes of Health. She is also a member of the Nursing Research Study section of NIH. Dr. Brooten was awarded the first Baxter Foundation Episteme Award from Sigma Theta Tau International, which acknowledges a major breakthrough in nursing knowledge development. She received the award for her randomized clinical trial on "Early Discharge of Very Low Birthweight Infants." The title Episteme Luareate was conferred upon her. Her study was published in the New England Journal of Medicine and received national and international coverage in the print media and on the Cable News Network as well as on local television newscasts across the country. The study represented a milestone for nursing research. MARY E. CHARLSON, M.D., is an Associate Professor of Medicine and Chief of the Division of Internal Medicine at Cornell University Medical College. After completing her residency at Johns Hopkins Hospital, she graduated from the Robert Wood Johnson Clinical Scholar Program at Yale University. After joining the faculty at Cornell, she founded the Clinical Epidemiology Unit and a multidisciplinary research methodology group. She has published extensively on research methodology for clinical research and on strategies for measuring and improving prognoses and outcomes. She is the author of over 60 publications and serves on the editorial board of the Journal of Clinical Epidemiology. She is actively involved in the conduct of patient-oriented clinical investigation. ROBERT C. COLLINS, M.D., is Frances Stark Professor and Chairman, Department of Neurology, University of California, Los Angeles (UCLA). Dr. Collins was recruited to the Chairmanship at UCLA in 1987 from Washington University, where he was Professor of Neurology and of Anatomy and Neurobiology. At UCLA, Dr. Collins is Director of the Read Neurological Research Center, which in the past five years has expanded programs in molecular and cellular neurosciences as well as in human brain mapping targeted on human neurological diseases. The Center is known for its work on multiple sclerosis, epilepsy, Parkinson's disease, Alzheimer's disease, neurootology, and neuroimaging. Prior to his appointment, Dr. Collin's research explored basic mechanisms of cerebellar metabolism and blood flow in experimental animals. A graduate of Cornell University Medical School, he completed an internship at Massachusetts General Hospital, research training at the National Institutes of Health, and neurology training at Cornell-New York Hospital before moving to Washington University. Dr. Collins is a coeditor of Neurobiology of Disease, a textbook for medical students. He serves on the editorial board of Annals of Neurology, and is co-founding editor of Clinical Neuroscience. He serves on

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Careers in Clinical Research: Obstacles and Opportunities committees for the American Neurological Association, National Institute of Neurological Diseases and Stroke, and the Institute of Medicine. HAILE T. DEBAS, M.D., is Professor and Chairman of the Department of Surgery at the University of California, San Francisco (UCSF). He was born in Eritrea. He obtained his medical degree from McGill University in 1963 and completed his surgical residency at the University of British Columbia, where he later joined the faculty. In 1980, Dr. Debas was appointed Professor of Surgery at the University of California, Los Angeles, Chief of Gastrointestinal Surgery at Wadsworth Veterans Administration Medical Center, and Key Investigator at the Center for Ulcer and Research and Education (CURE). In 1985, he moved to the University of Washington in Seattle as Professor and Chief of Gastrointestinal Surgery. He was named Chair of the Department of Surgery at UCSF in 1987. In addition to being a member of the Institute of Medicine, Dr. Debas is involved in the following organizations: Director, American Board of Surgery; American College of Surgeons; American Surgical Association; International Hepato-Biliary Pancreatic Association; Society for Surgery of the Alimentary Tract; American Gastroenterological Association; Association of Academic Minority Physicians; and Pacific Coast Surgical Society. His university service includes: Chair of the UCSF Academic Senate and cochair, UCSF Planning Committee for the 21st Century. He also serves on the editorial boards of the following publications: Gastroenterology, American Journal of Surgery, Western Journal of Medicine, and Regulatory Peptide Letter . Dr. Debas's major research interests are peptic ulcer, gastrointestinal endocrinology, and gastrointestinal physiology. WILLIAM L. DEWEY, Ph.D., is Vice President for Research and Graduate Studies and Professor of Pharmacology, Virginia Commonwealth University (VCU). Dr. Dewey joined VCU in 1972 as an Associate Professor after serving as Assistant Professor of Pharmacology at the University of North Carolina for three years. He was promoted to the rank of Full Professor in 1976. In 1981, he was named Assistant Dean in the School of Graduate Studies, and in 1982 he became the Associate Dean of the VCU School of Basic Health Sciences. He was named Associate Provost for Research and Graduate Studies in 1987, a post he held until promoted to his current position in 1992. Dr. Dewey has authored or coauthored approximately 250 papers, book chapters, or review articles as well as over 250 abstracts on the pharmacology of drug abuse. He has served as the primary adviser for 15 doctoral students and one master's degree recipient. Twenty-nine postdoctoral fellows or foreign scientists have studied in his laboratory. He served as President of the American Society for Pharmacology and Experimental Therapeutics, the Federation of American Societies for Experimental Biology, and the College on Problems of Drug Dependence as well as serving as Chairman of Study Sections for the National

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Careers in Clinical Research: Obstacles and Opportunities Institute on Drug Abuse. He has served as field editor for the Journal of Pharmacology and Experimental Therapeutics and currently serves on the National Advisory Council for the National Institute on Drug Abuse. JANICE ELECTA GREEN DOUGLAS, M.D., is a graduate of Fisk University and Meharry Medical College. She began her formal training in biomedical research supported by National Institutes of Health Endocrinology Training Fellowship at Vanderbilt University School of Medicine, where she also served as an Instructor in the Department of Medicine. She continued her research training in Bethesda, Maryland, as a Senior Staff Fellow at the National Institutes of Health, National Institute of Child Health and Human Development, Section on Hormonal Regulation. She is currently a Professor of Medicine and Professor of Physiology and Biophysics at Case Western Reserve University School of Medicine. She is also the Director of the Endocrinology and Hypertension Division. In addition, she was appointed Vice Chairperson for Academic Affairs for the Department of Medicine in 1991. Dr. Douglas is internationally renowned as a physician-scientist and conducts studies on cellular and molecular mechanisms of blood pressure regulation with a focus on the renin angiotensin system and racial/ethnic diversity in the pathophysiology of essential hypertension. She is author or coauthor of many medical publications and is (or has been) a member of editorial boards and publication committees, and has been associate editor (or guest editor) for a number of prestigious medical journals, including the Journal of Clinical Investigation, American Journal of Physiology, Journal of Laboratory and Clinical Medicine, Circulation, Ethnicity and Disease, and the Endocrine Society, to name a few. She has been elected to membership in a number of prestigious organizations for physician-scientists, including the American Society for Clinical Investigation and the Association for American Physicians, and she is a fellow of the High Blood Pressure Council of the American Heart Association, the Association for Academic Minority Physicians, and the Central Society for Clinical Research. Dr. Douglas has served on numerous National Institutes of Health review and advisory committees, U.S. Department of Veterans Affairs Merit Review Board for Cardiovascular Studies, and the Council for the National Heart, Lung, and Blood Institute (NHLBI). This Council is the principal advisory body to the NHLBI, makes decisions about research and training support, and advises on programmatic issues. She is currently serving on an advisory group for President Clinton's White House Task Force on Health Reform. IRVING H. FOX, M.D., is Vice President of Medical Affairs, Biogen, Inc. Dr. Fox joined Biogen in 1991 following a 17-year career in academic medicine. During 13 years at the University of Michigan, Dr. Fox held positions that included Program Director of the Clinical Research Center at the University of Michigan Hospital (1978–1990) and Interim Division Chief in

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Careers in Clinical Research: Obstacles and Opportunities Rheumatology. His academic appointments include full professorships in internal medicine (1978–1990) and biological chemistry (1984–1990) at the University of Michigan. He is currently Clinical Professor of Medicine at Harvard Medical School and Clinical Associate at the Massachusetts General Hospital. A well-known medical scientist, Dr. Fox has consulted on many task forces and committees including the National Institute of Arthritis and Musculoskeletal and Skin Diseases Task Force for the National Institutes of Health (1991 to present). Among his many memberships in professional societies are the American Society for Clinical Investigation, American Society for Biological Chemistry and Molecular Biology, American College of Physicians, American Federation for Clinical Research, and American College of Rheumatology. Dr. Fox has published more than 110 peer-reviewed articles in scientific journals and over 75 review articles and chapters in medical textbooks. ROBERT J. GENCO, D.D.S., Ph.D., is the Distinguished Professor of Oral Biology and Periodontology; Chair, Department of Oral Biology; and Associate Dean for Graduate Studies and Research, State University of New York (SUNY) at Buffalo School of Dental Medicine. Professor Genco joined SUNY Buffalo in 1967 after completing his Ph.D. degree and clinical training in Periodontology at the University of Pennsylvania. His work since then has involved laboratory and clinical studies of the causes, prevention, and treatment of oral diseases including dental caries and periodontal disease. He established a periodontal clinical training program in 1968, which combined a Ph.D. in oral biology with clinical specialty training, that has resulted in the training of a number of successful clinician-scientists who are presently active in research and academics throughout the country. In 1977, he founded the Periodontal Disease Research Center at SUNY Buffalo, which is one of five national centers dedicated to evaluation of clinical advances in periodontology. He edited Contemporary Periodontics with Drs. Henry Goldman and Walter Cohen, a popular text among dental students and residents in the United States and other countries. He has been active in many professional organizations and was chairman of the Dental Section of the American Association for the Advancement of Science. In 1985 he was President of the American Association for Dental Research, and in 1991 he served as President of the International Association for Dental Research, which has over 9,000 members. Since 1988 Dr. Genco has been the editor of the Journal of Periodontology and was recently awarded the Gold Medal for Excellence in Research by the American Dental Association. Dr. Genco has also been a member of the Institute of Medicine since 1988. DAVID J. KUPFER, M.D., is Professor and Chairman of the Department of Psychiatry and Professor of Behavioral Neuroscience at the University of Pittsburgh School of Medicine. He received his bachelor (magna cum laude) and M.D. degrees from Yale University. Following completion of

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Careers in Clinical Research: Obstacles and Opportunities 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. 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. In 1975, he became Professor of Psychiatry and Chairman of the Department in 1983. 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 500 articles, books, and book chapters examining the use of medication in recurrent depression, the causes of depression, and the relationship between biological rhythms, sleep, and depression. In recognition of his contribution to the field, Dr. Kupfer has been the recipient of numerous awards and honors, including the A.E. Bennett Research Award in Clinical Science, the Anna-Monika Foundation Prize, the Daniel E. Efron Award, the Twenty-Sixth Annual Award of the Institute of Pennsylvania Hospital in Memory of Edward A. Strecker, M.D., and the William R. McAlpin, Jr., Research Achievement Award. He was elected to the Institute of Medicine in 1990. NICHOLAS F. LARUSSO, M.D., is Professor of Medicine and Professor of Biochemistry and Molecular Biology, Mayo Medical School, Clinic and Foundation, Rochester, Minnesota. Dr. LaRusso received his undergraduate degree in biology (magna cum laude) from Boston College and his M.D. degree from New York Medical College. The majority of his clinical training in internal medicine and gastroenterology, in which he is board certified, was received at the Mayo Graduate School. His initial research training was as a National Institutes of Health postdoctoral research fellow at the Mayo Clinic and subsequently as a Mayo Foundation scholar and guest investigator in the Department of Biochemical Cytology at the Rockefeller University, where he worked with the Nobel Laureate Christian de Duve. He joined the faculty of the Mayo Medical School in 1977, and in 1990 became Chairman of the Division of Gastroenterology, a position he currently holds. Dr. LaRusso is involved in both basic and patient-oriented clinical research. His basic research focuses on digestion and transport in hepatic epithelia and has been supported by NIH since 1978; he currently holds a MERIT award from NIH for this research. In addition, he is currently involved in industry-and federally funded research on the pathophysiology and therapy of hepatobiliary diseases. In 1991, he became Editor of Gastroenterology, the premier subspecialty journal in the field. ALBERT G. MULLEY, JR., M.D., is Associate Professor of Medicine and Associate Professor of Health Policy at Harvard Medical School, Chief of the General Internal Medicine Division and Director of the Medical Practices Evaluation Center at Massachusetts General Hospital. After receiving

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Careers in Clinical Research: Obstacles and Opportunities degrees in medicine and public policy from Harvard, he completed his residency training in internal medicine at Massachusetts General Hospital. He is author and editor of the text Primary Care Medicine, and of many articles in the medical and health services research literature. Dr. Mulley's recent research has focused on the use of decision analysis, outcomes research, and preference assessment methods to distinguish between warranted and unwarranted variations in clinical practice. This work has led to development of research instruments and approaches, including shared decision making programs utilizing interactive videodisc technology to inform patients about treatment options and to catalyze large-scale prospective clinical trials. JOHN D. STOBO, M.D., is the William Osler Professor of Medicine and Director of the Department of Medicine at the Johns Hopkins University School of Medicine and Physician-in-Chief for the Johns Hopkins Hospital. He received his B.A. from Dartmouth College and his M.D. from the State University of New York at Buffalo. Dr. Stobo was an intern and assistant resident and served as chief medical resident on the Osler Medical Service of the Johns Hopkins Hospital. He is a member of the Institute of Medicine and currently serves on the Board of Governors of the American Board of Internal Medicine and serves as Secretary/Treasurer of the Association of Professors of Medicine. MYRON L. WEISFELDT, M.D., is the Chair of the Department of Medicine, the Samuel Bard Professor of Medicine, and Director of the Medical Service and Head of the Cardiovascular Center at Columbia-Presbyterian Medical Center in New York. Following two years of college at Northwestern University he entered a five-year medical school program at the Johns Hopkins University School of Medicine. During medical school he spent a pivotal year in research training at the National Institutes of Health (NIH) studying cardiovascular physiology. After graduating from medical school, Dr. Weisfeldt performed an internship and one-year of residency in internal medicine at Columbia-Presbyterian Medical Center. Dr. Weisfeldt then spent two years at NIH performing research on cardiovascular aging and then completed his residency and fellowship training at the Massachusetts General Hospital in Boston. He became a faculty member at Johns Hopkins in 1972. Dr. Weisfeldt's research interests have included reperfusion injury following a period of ischemia or reduced blood flow, the relaxation phase of cardiac contraction and the relationship of relaxation properties to heart failure, and the mechanisms of blood movement during cardiopulmonary resuscitation. In 1975, Dr. Weisfeldt was appointed Director of the Cardiology Division at Johns Hopkins University School of Medicine. Three years later he was promoted to full professor and appointed the Robert L. Levy Professor of Cardiology. Dr. Weisfeldt moved to Columbia-Presbyterian Medical Center in 1991. He currently serves on the

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Careers in Clinical Research: Obstacles and Opportunities editorial boards of the journals Circulation, Circulation Research, and the Journal of the American College of Cardiology. Dr. Weisfeldt served as President of the American Heart Association in 1990. From 1987 to 1990 he was Chairman of the Cardiology Advisory Committee to the National Heart, Lung, and Blood Institute of NIH. CATHERINE M. WILFERT, M.D., received her B.A. with distinction from Stanford University in 1958 and her M.D., cum laude, from Harvard Medical School in 1962. After completing one-year of internal medicine residency on the Harvard Service at the Boston City Hospital, she entered pediatric residency at the Bowman-Gray School of Medicine in Winston-Salem, North Carolina, and Children's Hospital Medical Center of Boston. Two years of fellowship in infectious diseases under the direction of Dr. John F. Enders and Dr. Samuel Katz were completed in 1967, at which time she became a faculty member in pediatrics at Harvard. In 1969 Dr. Wilfert was appointed Assistant Professor of Pediatrics at Duke University School of Medicine and was promoted to Professor in 1980, and she remains Chief of the Division of Infectious Diseases in the Department of Pediatrics at the present time. Her career in infectious diseases has included clinical investigations of a variety of immunogens in children and service on the Microbiology and Infectious Diseases Advisory Committee of the National Institute of Allergy and Infectious Diseases, as well as being Chair of the Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention. Recently she has been the principal investigator of the Pediatric AIDS Clinical Trial Unit and in that capacity has formed a statewide consortium of Pediatric Centers caring for children with human immunodeficiency virus infection to provide access to the clinical trials as well as to regionalize care. Dr. Wilfert has also been a member of the Advisory Committee to the Center for Biologics Evaluation and Research and has been the Chair of the Pediatric Committee of the AIDS Clinical Trials Group.

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