Appendix C
Committee Biographies

James H. Ware, Ph.D. (Committee Chair) is Dean for Academic Affairs and Frederick Mosteller Professor of Biostatistics at the Harvard School of Public Health. His research focuses on methods for the analysis of longitudinal and environmental data, and on the application of biostatistics to environmental epidemiology and clinical research. Dr. Ware recently served as the Director of the Data Coordinating Center for the Treatment of Lead Exposed Children Trial. This trial, sponsored by the National Institute of Environmental Health Sciences, investigated the effects of chelation to lower blood lead levels in children with high blood lead levels on subsequent cognitive development. Dr. Ware is a statistical consultant to the New England Journal of Medicine, teaches courses on clinical trials and analysis of longitudinal data, and writes occasional papers on statistical issues in clinical research. He previously served on the Institute of Medicine (IOM) Committee to Review the Health Consequences of Service During the Persian Gulf War and on the National Research Council (NRC) Panel on Statistics for an Aging Population.


R. Alta Charo, J.D., is the Associate Dean for Research and Faculty Development at the University of Wisconsin (UW) Law School, and is the Elizabeth S. Wilson-Bascom Professor of Law and Bioethics on the faculties of both the Law School and the Medical School’s Department of Medical History and Bioethics. In addition, she has served on the UW Hospital clinical ethics committee, the UW Institutional Review Board for the pro-



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Review of the HIVNET 012 Perinatal HIV Prevention Study Appendix C Committee Biographies James H. Ware, Ph.D. (Committee Chair) is Dean for Academic Affairs and Frederick Mosteller Professor of Biostatistics at the Harvard School of Public Health. His research focuses on methods for the analysis of longitudinal and environmental data, and on the application of biostatistics to environmental epidemiology and clinical research. Dr. Ware recently served as the Director of the Data Coordinating Center for the Treatment of Lead Exposed Children Trial. This trial, sponsored by the National Institute of Environmental Health Sciences, investigated the effects of chelation to lower blood lead levels in children with high blood lead levels on subsequent cognitive development. Dr. Ware is a statistical consultant to the New England Journal of Medicine, teaches courses on clinical trials and analysis of longitudinal data, and writes occasional papers on statistical issues in clinical research. He previously served on the Institute of Medicine (IOM) Committee to Review the Health Consequences of Service During the Persian Gulf War and on the National Research Council (NRC) Panel on Statistics for an Aging Population. R. Alta Charo, J.D., is the Associate Dean for Research and Faculty Development at the University of Wisconsin (UW) Law School, and is the Elizabeth S. Wilson-Bascom Professor of Law and Bioethics on the faculties of both the Law School and the Medical School’s Department of Medical History and Bioethics. In addition, she has served on the UW Hospital clinical ethics committee, the UW Institutional Review Board for the pro-

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Review of the HIVNET 012 Perinatal HIV Prevention Study tection of human subjects in medical research, and the UW Bioethics Advisory Committee. Professor Charo is the author of over 75 articles, book chapters, and government reports on topics including voting rights, environmental law, family planning and abortion law, medical genetics law, reproductive technology policy, and science policy and ethics. Professor Charo is a member of the board of the Alan Guttmacher Institute and the Foundation for Genetic Medicine, a member of the National Medical Advisory Committee of the Planned Parenthood Federation of America, and has been on the boards of the Society for the Advancement of Women’s Health Research and the American Association of Bioethics. She serves on several expert advisory boards of organizations with an interest in stem cell research and is a consultant to the California Institute for Regenerative Medicine. She has served as a consultant to the Institute of Medicine and the National Institutes of Health (NIH) Office of Protection from Research Risks. In 1994 Professor Charo served on the NIH Human Embryo Research Panel, and from 1996-2001, she was a member of the presidential National Bioethics Advisory Commission, where she participated in drafting its reports on topics such as human cloning, stem cell research, and ethical and policy issues relating to clinical trials in developing countries. Since 2001 she has been a member of the National Academy of Sciences’ Board on Life Sciences and serves as its liaison to its committee to develop national voluntary guidelines for stem cell research. She also served as a member of the Institute of Medicine’s Committee on Smallpox Vaccination Program Implementation. Ezra C. Davidson, Jr., M.D., is Associate Dean, Primary Care and Professor (past chairman 1971–1996) of the Department of Obstetrics and Gynecology at the Charles R. Drew University of Medicine and Science. He is Professor of Obstetrics and Gynecology at the David Geffen School of Medicine, University of California, Los Angeles. He was Chief-of-Service, Department of Obstetrics and Gynecology, at the King/Drew Medical Center in Los Angeles (1991–1996). He was a Robert Wood Johnson Health Policy Fellow at the Institute of Medicine (1979-1980) and has served on a number of Institute of Medicine committees including the Committee on Perinatal Transmission of HIV. He served as the President of the American College of Obstetricians and Gynecologists and its National Secretary for 6 years. His other major organizational responsibilities have included Chair of the Board of Trustees of the National Medical Association, President of the North American Society of Pediatric and Adolescent Gynecology, and President of the Association of Professors of Gynecology and Obstetrics. He has chaired the Secretary’s Advisory Committee on Infant Mortality (U.S. Department of Health and Human Services) and the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Adminis-

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Review of the HIVNET 012 Perinatal HIV Prevention Study tration (FDA). He served on the National Institutes of Health Advisory Committee to the Director and the Advisory Committee on Clinical Research. He was a member of the Council on Graduate Medical Education and Past Chair of the Board of Directors for the California Wellness Foundation. He is Chair of the Board of Trustees of the Blue Shield of California Foundation and Immediate Past President of the Association of Academic Minority Physicians. He has been elected to the National Black College Alumni Hall of Fame, Fellowship ad eundem, Royal College of Obstetricians and Gynecologists, and the Institute of Medicine. Wafaa El-Sadr, M.D., M.P.H., M.P.A., is Professor of Clinical Medicine and Epidemiology, Mailman School of Public Health, Columbia University, and Chief of the Division of Infectious Diseases at Harlem Hospital Center. Dr. El-Sadr has led the Division of Infectious Diseases at Harlem Hospital since 1988 and was instrumental in the development of an acclaimed comprehensive HIV program at that institution. She developed HIV care programs that were specifically designed to meet the needs of patients from the Harlem community, including women and substance users with HIV/AIDS. She is the Director of the Center for Infectious Diseases Epidemiologic Research and the International Center for AIDS Care and Treatment Programs (ICAP) at the Mailman School of Public Health. She has been involved in the design and conduct of HIV and tuberculosis (TB) research studies domestically and internationally for many years. She established the Harlem AIDS Treatment Group in 1989, one of the Units of the Community Programs for Clinical Research on AIDS (CPCRA), and serves as its principal investigator. She has played various leadership roles in that network, most recently as the Co-Chair of its Steering Committee. She led efforts in the design and implementation of several CPCRA-supported clinical trials. She currently co-chairs the SMART study, one of the largest clinical trials in HIV therapeutics. Dr. El-Sadr is also the principal investigator of the New York Unit of the HIV Prevention Trials Network. In terms of tuberculosis research, Dr. El-Sadr has played a similar leadership role. She is principal investigator of the Harlem Unit of the Centers for Disease Control and Prevention (CDC)-funded Tuberculosis Clinical Trials Consortium (TBTC) and the Tuberculosis Epidemiologic Studies (TBES) Network. She is also a member of the Core Science Group for the TBTC. Dr. El-Sadr, as Director of the International Center for AIDS Care and Treatment Programs, has successfully led efforts to establish HIV care and treatment programs in 10 resource-limited countries (primarily in sub-Saharan Africa) around the world through support by foundations, CDC, and U.S. Agency for International Development (USAID). She serves as a member of the Department of Health and Human Services (DHHS)-supported Panel on Guidelines for Use of Antiretroviral Drugs in Adults and Adolescents.

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Review of the HIVNET 012 Perinatal HIV Prevention Study She obtained her M.D. from Cairo University, an MPH (Epidemiology) from the Columbia University Mailman School of Public Health, and an MPA from the Kennedy School for Government at Harvard University. Mark W. Kline, M.D., is Professor of Pediatrics, Chief of Retrovirology, Director of the AIDS International Training and Research Program, and Director of the Baylor-CDC Global AIDS Project, all at the Baylor College of Medicine and Texas Children’s Hospital in Houston. Dr. Kline has extensive experience in pediatric HIV/AIDS care and treatment, health professional training, and clinical research in the United States, Africa, and Eastern Europe. He is the author of more than 200 scientific papers and textbook chapters. Dr. Kline is board-certified in pediatrics and infectious diseases. He has served on the Executive Committee for Infectious Diseases of the American Academy of Pediatrics, and is immediate past-Chair of that organization’s Committee on Pediatric AIDS. He is a Fellow of the Infectious Diseases Society of America and a member of the Society for Pediatric Research and the American Pediatric Society. Stephen W. Lagakos, Ph.D., is Henry Pickering Walcott Professor of Biostatistics and Chair of the Department of Biostatistics at Harvard School of Public Health. Dr. Lagakos is also currently Director of Harvard’s Center for Biostatistics in AIDS Research. Dr. Lagakos’ research interests involve a variety of statistical issues arising in clinical trials and other longitudinal studies, with particular emphasis on statistical methods and analyses relating to HIV and other infectious diseases. Dr. Lagakos is a member of the Institute of Medicine and has served on several committees including the Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy and the Roundtable for the Development of Drugs and Vaccines Against AIDS and is currently serving on the Committee on Postmarket Surveillance of Pediatric Medical Devices. He received his Ph.D. from The George Washington University. J. Richard Landis, Ph.D., is Professor of Biostatistics in the School of Medicine, and holds a secondary appointment as Professor of Statistics in the Wharton School, within the University of Pennsylvania. He serves as Director of the Division of Biostatistics, and Vice-Chair of the Department of Biostatistics and Epidemiology, as well as Director of the Biostatistics Unit within the Center for Clinical Epidemiology and Biostatistics (CCEB), a multidisciplinary research center within the School of Medicine. Dr. Landis also serves as Co-Director of the Clinical Research Computing Unit (CRCU), a designated core research facility formed within the CCEB to support the conduct of multicenter clinical trials and patient-oriented clinical research projects. Dr. Landis is a Fellow of the American Statistical

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Review of the HIVNET 012 Perinatal HIV Prevention Study Association, elected member of the International Statistical Institute, recipient of the Mortimer Spiegelman Gold Medal Award, and recipient of an Environmental Protection Agency Scientific and Technical Achievement Award. He previously served on the IOM Committee for Assessment of Centers of Excellence Programs at NIH. Dr. Landis received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 1975, and served on the biostatistics faculty at the University of Michigan for 13 years, and at the Pennsylvania State University for 9 years, prior to moving to the University of Pennsylvania in 1997. George W. Rutherford III, M.D., is Salvatore Pablo Lucia Professor of Preventive Medicine, Professor-in-Residence of Epidemiology, Preventive Medicine, Pediatrics and Family and Community Medicine, Head of the Division of Preventive Medicine and Public Health, and Director of the Institute for Global Health at the University of California, San Francisco School of Medicine. He is also Adjunct Professor of Epidemiology and Health Administration at the School of Public Health at the University of California, Berkeley. Dr. Rutherford is a leading expert on the epidemiology of AIDS and HIV infection and the public health aspects of the AIDS epidemic. He served as State Health Officer and State Epidemiologist for the California Department of Health Services from 1990–1995. He also formerly served as the Director of the AIDS Office in the San Francisco Department of Public Health in the 1980s and as Director of the Division of Immunizations for the New York City Department of Public Health. His principal research interests are the natural history of HIV infection and the epidemiology and prevention of AIDS and HIV infection in California and Latin America. He is the Coordinating Editor for the Cochrane Collaborative Review Group on AIDS and HIV Infection, an international effort to systematically review intervention trials in the treatment and prevention of AIDS and HIV infection. He is the former Chair of the Department of Veterans Affairs’ National Research Advisory Council. He served on the Institute of Medicine Committee on the Ryan White CARE Act: Data for Resource Allocation, Planning, and Evaluation, and currently serves on the Committee on Gulf War and Health: Review of the Medical Literature Relative to Gulf War Veterans’ Health. Dr. Rutherford received his M.D. from Duke University. Charles M. van der Horst, M.D., is Professor of Medicine and Associate Chief, Division of Infectious Diseases, in the School of Medicine at the University of North Carolina-Chapel Hill (UNC). He is the Developmental Core Director for the UNC Center for AIDS Research. He is also a Visiting Professor at University of the Witwatersrand in Johannesburg, South Africa. Dr. van der Horst’s interests include the treatment of HIV/AIDS in

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Review of the HIVNET 012 Perinatal HIV Prevention Study resource-poor settings, prevention of mother-to-child transmission during breast feeding, as well as use of weaning foods and nutrition of pregnant mothers. Dr. van der Horst has been providing care for HIV/AIDS patients since 1981. He has conducted research and published extensively on the treatment of HIV and opportunistic infections since 1986. He has conducted HIV clinical trials both domestically and in Africa for 20 years. He received his M.D. from Harvard Medical School.

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