G
Biographical Sketches of Committee Members

PHILIP PIZZO (Chair) is dean of the Stanford University School of Medicine where he is also Professor of Pediatrics and of Microbiology and immunology. Dr. Pizzo has previously served as the physician-in-chief and Chairman of the Department of Medicine at Children’s Hospital Boston and professor and Chair of Pediatrics at Harvard Medical School. Dr. Pizzo’s research efforts have focused on the treatment of childhood cancers and on the diagnosis, management, and prevention of infectious complications in immunocompromised hosts. He and his colleagues pioneered the development of new treatments for children with symptomatic HIV infection and changed the process of drug development for children with catastrophic disease. Positions he has held within the government include: pediatric oncology investigator at the National Institutes of Health, clinical associate with the National Cancer Institute (NCI), Chief of Pediatrics and Head of the Infectious Disease Section at NCI, and Acting Scientific Director of NCI’s Division of Clinical Sciences. Dr. Pizzo is a member of both the Institute of Medicine, and the National Academy of Sciences.


GAIL H.CASSELL is Vice President, Scientific Affairs, Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly & Company. Previously, she was the Charles H.McCauley Professor and (since 1987) Chair, Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department which, under her leadership, has ranked first in research funding from the National Institutes of Health since 1989. She is a member of the Director’s Advisory Committee of the Centers for Disease Control and Prevention. Dr. Cassell is past president of the American Society for Microbiology (ASM) and is serving her third three-year term as chairman of the Public



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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary G Biographical Sketches of Committee Members PHILIP PIZZO (Chair) is dean of the Stanford University School of Medicine where he is also Professor of Pediatrics and of Microbiology and immunology. Dr. Pizzo has previously served as the physician-in-chief and Chairman of the Department of Medicine at Children’s Hospital Boston and professor and Chair of Pediatrics at Harvard Medical School. Dr. Pizzo’s research efforts have focused on the treatment of childhood cancers and on the diagnosis, management, and prevention of infectious complications in immunocompromised hosts. He and his colleagues pioneered the development of new treatments for children with symptomatic HIV infection and changed the process of drug development for children with catastrophic disease. Positions he has held within the government include: pediatric oncology investigator at the National Institutes of Health, clinical associate with the National Cancer Institute (NCI), Chief of Pediatrics and Head of the Infectious Disease Section at NCI, and Acting Scientific Director of NCI’s Division of Clinical Sciences. Dr. Pizzo is a member of both the Institute of Medicine, and the National Academy of Sciences. GAIL H.CASSELL is Vice President, Scientific Affairs, Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly & Company. Previously, she was the Charles H.McCauley Professor and (since 1987) Chair, Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department which, under her leadership, has ranked first in research funding from the National Institutes of Health since 1989. She is a member of the Director’s Advisory Committee of the Centers for Disease Control and Prevention. Dr. Cassell is past president of the American Society for Microbiology (ASM) and is serving her third three-year term as chairman of the Public

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary and Scientific Affairs Board of ASM. She is a former member of the National Institutes of Health Director’s Advisory Committee and a former member of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She has also served as an advisor on infectious diseases and indirect costs of research to the White House Office on Science and Technology and was previously chair of the Board of Scientific Counselors of the National Center for Infectious Diseases, Centers for Disease Control and Prevention. Dr. Cassell served eight years on the Bacteriology-Mycology-II Study Section and served as its chair for three years. She serves on the editorial boards of several prestigious scientific journals and has authored over 275 articles and book chapters. She has been intimately involved in the establishment of science policy and legislation related to biomedical research and public health. Dr. Cassell has received several national and international awards and an honorary degree for her research on infectious diseases. ELLEN WRIGHT CLAYTON is one of the preeminent scholars in the field of law and genetics. She joined the Vanderbilt faculty in 1988 and holds appointments in both the Medical School and Law School. She has numerous publications in books, medical journals, interdisciplinary journals, and law journals on the intersection of law, medicine, and public health. Professor Clayton has collaborated with faculty in the Law School, Medical School, and Sociology Department in producing interdisciplinary research. She has been an active participant in policy debates advising the National Human Genome Research Institute as well as numerous bodies concerned with the ethical conduct of research involving human subjects for many years. In addition to teaching in the Law School and Medical School, Professor Clayton is a practicing pediatrician at the Vanderbilt Medical Center. Recently she was appointed Director of the Genetics and Health Policy Center, and holds the Rosalind E.Franklin Chair in Genetics and Health Policy. Dr. Clayton obtained her undergraduate degree from Duke University, earned her M.D. from Stanford and her J.D. from Yale. DAVID COX is Chief Scientific Officer of Perlegen Sciences Inc. Dr. Cox is an active participant in the Human Genome Project while carrying out research involving the molecular basis of human genetic disease. After receiving his B.A. and M.S. degrees from Brown University in Rhode Island, Dr. Cox obtained his M.D. and Ph.D. degrees from the University of Washington, Seattle. He then completed his Pediatric Residency at the

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Yale-New Haven Hospital in New Haven, Connecticut and was a Fellow in both genetics and pediatrics at the University of California San Francisco. From 1980 to 1993, Dr. Cox held faculty positions in the Departments of Pediatrics, Biochemistry and Psychiatry at the University of California San Francisco. In 1993, he accepted a position as a Professor of Genetics and Pediatrics at the Stanford University School of Medicine as well as the Co-director of the Stanford Genome Center. In October of 2000, Dr. Cox took a leave of absence from his position at Stanford University to become the Chief Scientific Officer of Perlegen Sciences, Inc. Dr. Cox is certified by both the American Board of Pediatrics and the American Board of Medical Genetics. He has served on several international and national councils and commissions including the Council of the Human Genome Organization (HUGO) and the National Bioethics Advisory Commission (NBAC). He presently serves as a member of the Health Sciences Policy Board of the Institute of Medicine. Dr. Cox’s honors include election to the Institute of Medicine of the National Academy of Sciences. NANCY DUBLER is the Director of the Division of Bioethics, Montefiore Medical Center and Professor of Epidemiology and Population Health at the Albert Einstein College of Medicine. She received her B.A. from Barnard College and her LL.B. from the Harvard Law School. Ms. Dubler has founded the Bioethics Consultation Service at Montefiore Medical Center in 1978, as a support for analysis of difficult cases presenting ethical issues in the health care setting. She lectures extensively and is the author of numerous articles and books on termination of care, home care and long-term care, geriatrics, prison and jail health care, research with human subjects and AIDS. She is Co-Director of the Certificate Program in Bioethics and the Medical Humanities, conducted jointly by Montefiore Medical Center, Albert Einstein College of Medicine with The Hartford Institute of Geriatric Nursing at New York University. Her most recent books are: Ethics On Call: Taking Charge of Life and Death Choices in Today’s Health Care System, published by Vintage in 1993 and Mediating Bioethical Disputes, published in 1994 by the United Hospital Fund in New York City. The Ethics and Regulation of Research with Human Subject (Coleman, Menikoff, Goldner and Dubler) will be published in Spring 2005 by Anderson Press. She consults often with federal agencies, national working groups and bioethics centers.

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary ROBERT GIBBONS is Professor of Biostatistics and Director of the Center for Health Statistics at the University of Illinois at Chicago. He received his doctorate in statistics and psychometrics from the University of Chicago in 1981. 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, including a Research Scientist Award from the National Institutes of Health. Applications of Dr. Gibbons’ work are widespread in the general areas of health and environmental sciences. Dr. Gibbons has authored more than 150 peer-reviewed scientific papers and three books. He has served on several IOM committees including the Committee on Halcion: An Assessment of Data Adequacy and Confidence as well as the Committee on Organ Procurement and Transplantation Policy. Dr. Gibbons is a member of the Institute of Medicine of the National Academy of Sciences. LYNN R.GOLDMAN is a pediatrician and an epidemiologist. She is a Professor at the Johns Hopkins University Bloomberg School of Public Health, where her areas of focus are environmental health policy and children’s environmental health. In 1993, Dr. Goldman was appointed by the President and confirmed by the Senate to serve as Assistant Administrator for the EPA’s Office of Prevention, Pesticides and Toxic Substances (OPPTS). In that position, she was responsible for the nation’s pesticide, toxic substances and pollution prevention laws. Under her watch, EPA expanded right-to-know under the Toxics Release Inventory and overhauled the nation’s pesticides laws. Dr. Goldman made significant progress on the issues of testing high volume industrial chemicals and identification of chemicals that disrupt endocrine systems. At the EPA she was successful in promoting children’s health issues and furthering the international agenda for global chemical safety. Prior to joining the EPA, Dr. Goldman served in several positions at the California Department of Health Services, most recently as head of the Division of Environmental and Occupational Disease Control. She has conducted public health investigations on pesticides, childhood lead poisoning and other environmental hazards. She has a B.S. in Conservation of Natural Resources from the University of California, Berkeley, an M.P.H. from the Johns Hopkins University School of Public Health, and an M.D. from

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary the University of California, San Francisco. Dr. Goldman completed pediatric training at Children’s Hospital, Oakland, California. BERNARD GOLDSTEIN is Dean of the University of Pittsburgh Graduate School of Public Health. Previously he served as the Director of the Environmental and Occupational Health Sciences Institute, a joint program of Rutgers, the State University of New Jersey and the University of Medicine and Dentistry of New Jersey (UMDNJ)—Robert Wood Johnson Medical School. He was also Principal Investigator of the Consortium of Risk Evaluation with Stakeholder Participation (CRESP). Dr. Goldstein was Assistant Administrator for Research and Development, U.S. Environmental Protection Agency, 1983–1985. His past activities include Member and Chairman of the NIH Toxicology Study Section and EPA’s Clear Air Scientific Advisory Committee; Chair of the Institute of Medicine Committee on the Role of the Physician in Occupational and Environmental Medicine, the National Research Council Committees on Biomarkers in Environmental Health Research and Risk Assessment Methodology and the Industry Panel of the World Health Organization Commission on Health and Environment. He is a member of the Institute of Medicine where he has chaired the Section on Public, Biostatistics, and Epidemiology. MARTHA N.HILL is Dean and professor at the Johns Hopkins University School of Nursing. She holds joint appointments in the Bloomberg School of Public Health and the School of Medicine. Dr. Hill, the 1997–1998 president of the American Heart Association, is a Fellow in the American Academy of Nursing and a member of the Institute of Medicine of the National Academy of Sciences. She serves on the IOM Board on Health Sciences Policy and was the Co-vice chair of the IOM Report Unequal Treatment: Confronting Ethnic and Racial Disparities in Health Care. Dr. Hill received her Bachelor of Science degree in nursing from Johns Hopkins University, her masters degree from the University of Pennsylvania, and her doctoral degree in behavioral sciences from the Johns Hopkins University School of Public Health. Dr. Hill is internationally known for her work and research in preventing and treating hypertension and its complications among underserved blacks, particularly among young, urban black men. She is an active investigator and consultant on several NIH funded clinical trials. She has published extensively and serves on numerous review panels, editorial boards, and advisory committees including. Dr. Hill has also consulted on hyperten-

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary sion and other cardiovascular-related issues outside of the U.S. including South Africa, Scotland, Israel, and Australia. ALAN LESHNER is Chief Executive Officer of the American Association for the Advancement of Science (AAAS) and Executive Publisher of Science magazine. From 1994–2001, he was Director of the National Institute on Drug Abuse at NIH, and from 1988–1994 he was Deputy Director and Acting Director of the National Institute of Mental Health. Prior to that, he spent nine years at the National Science Foundation, where he held a variety of senior positions, focusing on basic research in the biological, behavioral and social sciences, and on science education. He began his career at Bucknell University, where he was Professor of Psychology. His research has focused on the biological bases of behavior, particularly the role of hormones in the control of behavior. Dr. Leshner is a member of the Institute of Medicine and a fellow of AAAS and many other professional societies. He has received numerous awards form both professional and lay groups for his national leadership in science, mental illness and mental health, and substance abuse and addiction. DANIEL MASYS is Professor and Chair of the Department of Biomedical Informatics at Vanderbilt University Medical Center. An honors graduate of Princeton University and the Ohio State University College of Medicine, he completed postgraduate training in Internal Medicine, Hematology and Medical Oncology at the University of California, San Diego, and the Naval Regional Medical Center, San Diego. Previously, he served as Director of Biomedical Informatics and Adjunct Professor of Medicine at the University of California, San Diego School of Medicine. Prior to that, he served as Chief of the International Cancer Research Data Bank of the National Cancer Institute, National Institutes of Health, and from 1986 through 1994 was Director of the Lister Hill National Center for Biomedical Communications. In this capacity, Dr. Masys served as the chief program architect and first director of the National Center for Biotechnology Information (NCBI) that was established within the National Library of Medicine in 1987 to support molecular databases and computational tools. NCBI is home to GenBank, the national DNA sequence database, and a growing variety of bioinformatics resources. Dr. Masys is a Diplomate of the American Board of Internal Medicine in Medicine, Hematology, and Medical Oncology. He is a Fellow of the American College of Physicians, and a Fellow of the Ameri-

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary can College of Medical Informatics. He is a founding associate editor of the Journal of the American Medical Informatics Association, and has received numerous awards including the NIH Director’s Award, Public Health Service Outstanding Service Medal, and the US Surgeon General’s Exemplary Service Medal. JONATHAN MORENO is the Emily Davie and Joseph S.Kornfeld Professor of Biomedical Ethics at the University of Virginia where he is also Director of the Center for Biomedical Ethics. Dr. Moreno is a member of the National Human Research Protection Advisory Committee, a bioethics consultant for the Howard Hughes Medical Institute, a Senior Research Fellow at the Kennedy Institute of Ethics at Georgetown University, and a Fellow of the Hastings Center. During 1995–96 he was Senior Policy and Research Analyst for the President’s Advisory Committee on Human Radiation Experiments. E.ALBERT REECE is Vice Chancellor and Dean of the University of Arkansas College of Medicine. Dr. Reece received his undergraduate degree from Long Island University, his M.D. from New York University, his Ph.D. degree in biochemistry from the University of the West Indies, and his M.B.A. degree from the Fox School of Business and Management of Temple University. He completed a residency in OB/GYN at Columbia University—Presbyterian Hospital, and a fellowship in maternal-fetal medicine at Yale University School of Medicine. He served on the faculty at Yale for 10 year and was the Chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at Temple University. Dr. Reece has published over 400 journal articles, papers, book chapters, and abstracts and 9 textbooks including Diabetes in Pregnancy; Medicine of the Fetus & Mother; and Fundamentals of Ultrasound in Obstetrics & Gynecology. He is an editor for the Journal of Maternal-Fetal Medicine and a reviewer for several other scientific journals. His research focuses on diabetes in pregnancy, birth defects and prenatal diagnosis. Dr. Reece is a member of the Institute of Medicine. MYRL WEINBERG is President of the National Health Council, an umbrella organization encompassing more than 100 national health-related groups. Previously, Ms. Weinberg served as Vice President for Corporate Relations and Public Affairs for the American Diabetes Association and was in charge of government relations, public relations, and

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary corporate marketing. Ms. Weinberg has a long history of board and committee service, including work with the National Chronic Care Consortium’s National Resource Center, the American Medical Association’s Ethical FORCE initiative, the American Society of Association Executives’ Ethics Committee, the Funding First Program, the Foundation for Accountability, the National Legal Center for the Medically Dependent and Disabled, Inc., and the Accreditation for Services for Mentally Retarded and Other Developmentally Disabled Persons. She holds an M.A. in special education from George Peabody College and a B.A. in psychology from the University of Arkansas. MICHAEL WELCH is Professor of Radiology, Co-Director of the Division of Radiology Sciences of The Edward Mallinckrodt Institute of Radiology, and is Professor of Molecular Biology and Pharmacology at Washington University School of Medicine. He received his B.A. and M.A. degrees in Natural Sciences from Cambridge University and his Ph.D. degree in Radiochemistry at the University of London. Dr. Welch has published several books, numerous journal articles, and book chapters in the area of radiology. Dr. Welch is a member of the Institute of Medicine. MARY WOOLLEY is the President of Research!America, a non-profit, membership supported grassroots public education and advocacy organization committed to making health-related research a much higher national priority. Ms. Woolley serves on the University of California, Berkeley, School of Public Health Dean’s Council, the Lovelace Respiratory Research Institute and is a Founding Member of the Board of Associates of the Whitehead Institute for Biomedical Research. For her work on behalf of medical research, she has been awarded the Distinguished Contribution to Research Administration Award from the Society for Research Administrators; the American Hospital Association Silver Touchstone Award for Public Affairs Programming; the Columbia University College of Physicians and Surgeons Dean’s Award for Distinguished Service; the Federation of American Societies for Experimental Biology (FASEB) Special Award for Science Advocacy and the Friends of the National Institute for Nursing Research’s Health Advocacy Award. She is a member of the Institute of Medicine and a fellow of the American Association for the Advancement of Science (AAAS).