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Methodological Challenges in Biomedical HIV Prevention Trials Appendix E Committee Biographies Stephen Lagakos, Ph.D. (Chair), is a Professor of Biostatistics and the Director of the Center for Biostatistics in AIDS Research at the Harvard School of Public Health. Dr. Lagakos’ current research involves 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. From 1989 to 1996, he served as Director of the Statistical and Data Analysis Center at the AIDS Clinical Trials Group, and from 1999 to 2006 he served as Chair of the Department of Biostatistics at Harvard. Currently, Dr. Lagakos serves on the Senior Biomedical Research Service Credentials Committee at the U.S. Food and Drug Administration (FDA), and is on the Editorial Board (Statistical Consultant) at the New England Journal of Medicine. Since 2002 he has served as Associate Editor for the Journal of the American Statistical Association. Dr. Lagakos studied at Carnegie Mellon (B.S., Mathematics) and at George Washington University (M.P.H., Ph.D., Mathematical Statistics). In 2002 he was elected to the Institute of Medicine (IOM). He has served on a number of IOM studies, including the Committee on Reviewing the HIVNET 012 Perinatal HIV Prevention Study, Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy, the Roundtable for the Development of Drugs and Vaccines Against AIDS, and the Committee on Postmarket Surveillance of Pediatric Medical Devices. Harvey J. Alter, M.D., is Chief of the Infectious Diseases Section and Associate Director for Research of the Department of Transfusion Medicine at the Warren Grant Magnuson Clinical Center of the National Institutes of
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Methodological Challenges in Biomedical HIV Prevention Trials Health (NIH). He is also Clinical Professor of Medicine at Georgetown University in Washington, DC. Dr. Alter has devoted most of his research career to the study of blood-transmitted infections, particularly viral hepatitis. He was the principal investigator in the first study to biophysically characterize the “Australia antigen,” which was later shown to be the envelope protein of the hepatitis B virus. He led the prospective studies that identified the clinical entity known as non-A, non-B hepatitis and confirmed that it was a transmissible agent. He was the principal investigator in sequential prospective studies of transfusion-associated hepatitis, which influenced national blood policy mandating donor-screening assays. Dr. Alter’s unique, long-term prospective studies identified transfusion risks, as well as donorscreening measures to alleviate those risks, and measured the outcome of these interventions. After the cloning of the hepatitis C virus (HCV), he conducted the key study that established HCV as the major cause of transfusion-associated hepatitis and demonstrated the clinical efficacy of anti-HCV screening assays. For his contributions to the discovery of the non-A, non-B/hepatitis C virus, and for his vital role in reducing hepatitis risk and improving the safety of the blood supply, Dr. Alter has received many awards and other recognition, including the Clinical Lasker Award. Dr. Alter is an elected member of both the Institute of Medicine and the National Academy of Sciences. Ronald Bayer, Ph.D., is a Professor at the Center for the History and Ethics of Public Health in the Department of Sociomedical Sciences at the Joseph F. Mailman School of Public Health, Columbia University. Prior to coming to Columbia, he was at the Hastings Center, a research institute devoted to the study of ethical issues in medicine and the life sciences. Dr. Bayer’s research has examined ethical and policy issues in public health. His empirical work has focused especially on HIV/AIDS, tuberculosis, illicit drugs, and tobacco. His broader project is to develop an ethics of public health. He is an elected member of the Institute of Medicine, and has served on the Board on Population Health and Public Health Practice and several IOM committees addressing the social impact of AIDS, tuberculosis elimination, vaccine safety, smallpox vaccination, and the Ryan White CARE Act. He has published extensively on ethical issues raised by the HIV/AIDS epidemic, including books such as Private Acts, Social Consequences: AIDS and the Politics of Public Health (1989); AIDS Doctors: Voices from the Epidemic (2000, written with Gerald Oppenheimer), and Mortal Secrets: Truth and Lies in the Age of AIDS (2003, written with Robert Klitzman). Dr. Bayer holds a Ph.D. in political science from the University of Chicago. Solomon Benatar, M.D., is Professor of Medicine at the University of Cape Town (1980–) and Founding Director of the University of Cape Town
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Methodological Challenges in Biomedical HIV Prevention Trials Bioethics Centre (1992–). He was Professor and Chair of the University of Cape Town’s Department of Internal Medicine and Chief Physician at Groote Schuur Hospital from 1980 to 1999. Other positions include Visiting Professor of Medical Ethics at the University College London Medical School (1997–), Visiting Professor in Public Health Sciences and Medicine at the University of Toronto (2000–), President of the International Association of Bioethics (2001–2003), and Chair of the South African National Health Research Ethics Committee (2001–2005). After graduating from the University of Cape Town in 1965, he trained in anesthetics and medicine in Cape Town and London. His academic interests include respiratory medicine, academic freedom, medical ethics and the humanities in medicine, human rights, health care systems, health economics, international research ethics, and global health. He has published more than 250 journal articles and book chapters on these topics. Dr. Benatar is a corresponding member of the National Academy of Sciences’ Committee on Human Rights, and has been a member of several multidisciplinary, international research groups. During the 1994/95 academic year, he was a Fellow in the Program in Ethics and the Professions at Harvard University and Visiting Professor at Harvard Medical School. He has been an advisor to UNAIDS in Geneva and to Médecins Sans Frontières in Holland. He is currently an ethics consultant to the U.S. HIV Prevention Trials Network, Director of the International Research Ethics Network for Southern Africa (an NIH Fogarty International Center-funded capacity-building program) (2003–2010), and a member of the Canadian Institutes of Health Research Standing Committee on Ethics (2006–). He is an elected Foreign Member of the Institute of Medicine (IOM) and of the American Academy of Arts and Sciences, and served on the IOM Committee for Examining the Probable Consequences of Alternative Patterns of Widespread Antiretroviral Drug Use in Resource-Constrained Settings. Ronald Brookmeyer, Ph.D., is Professor of Biostatistics and Chair of the M.P.H. program at the Johns Hopkins Bloomberg School of Public Health. Dr. Brookmeyer’s research focuses on the development and application of statistical methods and models in epidemiology. A main theme of Dr. Brookmeyer’s work concerns statistical approaches for estimating and forecasting disease incidence and prevalence to track the health of populations, and the analysis and interpretation of disease surveillance data. Dr. Brookmeyer’s most recent research concerns statistical models for anthrax outbreaks and other bioterrorism threats. Dr. Brookmeyer has worked extensively on developing statistical methods in AIDS epidemiology, including methods for tracking the course of the HIV/AIDS epidemic. Dr. Brookmeyer is the coauthor of AIDS Epidemiology: A Quantitative
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Methodological Challenges in Biomedical HIV Prevention Trials Approach. His publications and research interests in biostatistical methodology include topics in survival analysis, truncated data, epidemic models, epidemiological statistics, and multidimensional longitudinal data. Dr. Brookmeyer is a Fellow of the American Association for the Advancement of Science and the American Statistical Association. He is also the 2007 Chair of the Statistics Section of the American Association for the Advancement of Science. He received his undergraduate degree from Cooper Union College in New York City and a Ph.D. in Statistics from the University of Wisconsin. He has served on a number of IOM panels, including the Committee on Perinatal Transmission of HIV, the Panel on Needle Exchange and Bleach Distribution Programs, and the Panel on Statistical Issues in AIDS Research. Carlos del Rio, M.D., is Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine, and Vice Chair for Grady Affairs in the Department of Medicine. He is Director for Clinical Sciences and International Research of the Emory Center for AIDS Research, and Director of the Emory AIDS International Training and Research Program. Dr. del Rio is a native of Mexico, where he attended medical school at Universidad La Salle. He did his Internal Medicine and Infectious Diseases residencies at Emory University. In 1989 he returned to Mexico, where he was Executive Director of the National AIDS Council of Mexico (CONASIDA), the federal agency responsible for AIDS policy. In November 1996 he returned to Emory, where he has been involved in patient care, teaching, and research. Dr. del Rio’s research interests include the epidemiology of opportunistic infections in HIV and other immune deficiencies; the epidemiology and transmission dynamics of HIV and other sexually transmitted diseases; and issues related to early diagnosis of HIV, access to care, and compliance with antiretrovirals. He is also an investigator for the Adult AIDS Clinical Trials Group and an investigator on HIV vaccine trials. Dr. del Rio is a Member of the Board of Directors of the International AIDS Society-USA; a member of the Monitoring of the AIDS Pandemic (MAP) Network; a member of the Education Committee of Infectious Diseases Society of America; Associate Editor of AIDS Clinical Care and AIDS Research and Human Retroviruses; and a member of the Editorial Board of Journal of AIDS, Women, Children and HIV, and Global Public Health. Dr. del Rio has been a member of the Centers for Disease Control and Prevention and Health Resources and Services Administration Advisory Committee on HIV and STD Prevention and Treatment (2000–2003), and a member of the IOM Committee on the Ryan White CARE Act: Data for Resource Allocation, Planning, and Evaluation. He has coauthored five books, 30 book chapters, and more than 100 scientific papers.
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Methodological Challenges in Biomedical HIV Prevention Trials David Feigal, M.D., M.P.H., is Senior Vice President for Global Regulatory Affairs and Global Safety Surveillance for Élan Pharmaceuticals. Most recently, he was a partner in NDA Partners LLC, a product development consultancy to the biopharmaceutical and medical device industries. He has also held several senior positions at the FDA. He first joined the FDA in 1992, when he was recruited to head the HIV Division in the Center for Drug Evaluation and Research. He then served as Director of the Division of Anti-Infective Drug Products, Director of the Office of Drug Evaluation IV, Medical Deputy Director of the Center for Biologics Evaluation and Research, and Director for the Center for Device and Radiological Health. Dr. Feigal holds an M.D. from Stanford University and an M.P.H. from the University of California, Berkeley. He completed his Internal Medicine Residency at the University of California, Davis, and a Fellowship in Clinical Epidemiology at the University of California, San Francisco. Els Goetghebeur, Ph.D., is Associate Professor in the Department of Applied Mathematics and Computer Science at Ghent University, Belgium, and Adjunct Associate Professor in the Department of Biostatistics of the Harvard School of Public Health. At Ghent University she chairs the Center for Statistics and directs the Advanced Master in Statistical Data Analysis. She started her career in the Clinical Trials Unit at the London School of Hygiene and Tropical Medicine, and has had a keen interest in clinical trials ever since. A research position linked to the Janssen Research Foundation and LUC in Belgium allowed her to develop statistical methods for handling partial compliance with randomized drug therapy. The study of causal inference and noncompliance in clinical trials became a long-term research interest. Dr. Goetghebeur has served on the Editorial Board of several international journals, currently Statistical Methods in Medical Research and Lifetime Data Analysis. She collaborates with colleagues locally and abroad on studies of the prevention and treatment of HIV and AIDS, among other areas. She currently serves as a Statistical Expert for the European Agency for the Evaluation of Medicinal Products (EMEA). Her publications and research focus on statistical methods for clinical trials, noncompliance, causal inference more generally, and survival analysis. Laura A. Guay, M.D., is Associate Professor in the Department of Pathology and Pediatrics at the Johns Hopkins University School of Medicine (JHU) and a Pediatric Infectious Disease Specialist. She has conducted HIV research in Uganda in collaboration with faculty from the Makerere University School of Medicine since 1988, living onsite in Kampala for 11 of these years. Dr. Guay is currently principal investigator of the NIH Division of AIDS–sponsored HIV Prevention Trial Network and DAIDS Clinical Trial Network MU-JHU Unit in Kampala, Uganda. She has participated in the
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Methodological Challenges in Biomedical HIV Prevention Trials design, implementation, and analysis of several HIV perinatal prevention trials in women and children in Uganda. She is the study protocol chair of HPTN 027, the first clinical safety trial in Africa of a vaccine to prevent mother-to-child transmission (PMTCT) of HIV through breast-feeding, which began enrolling participants in October 2006. She is also Co-Chair of the HPTN 046 phase 3 Trial (to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breast-feeding), and an investigator on a study of high-titer HIV immunoglobulin for prevention of HIV-1 infection in breast-feeding infants. Her research interests include pediatric HIV-1 infection, prevention of HIV transmission from mother to child, and primary HIV prevention in women. Dr. Guay has established a comprehensive maternal-child HIV study clinic and immunology laboratory capable of supporting phase 1–3 clinical trials. In addition to the research activities in Uganda, Dr. Guay was instrumental in establishing a PMTCT program in all prenatal clinics at Mulago Hospital, which provides free HIV testing, counseling, PMTCT services, and access to HIV care to more than 35,000 pregnant women each year. Previous work includes studies of the natural history of HIV-1 infection, the neurodevelopmental effects of HIV-1 infection, and methods for early diagnosis of HIV-1 infection in Ugandan children. Sally Hodder, M.D., is Professor of Medicine, Director of HIV Programs, and Vice Chair of the Department of Medicine at the New Jersey Medical School of the University of Medicine and Dentistry of New Jersey. Dr. Hodder received her B.A. from Mount Holyoke College and her M.D. from Case Western Reserve University. After completing training in Internal Medicine and Infectious Diseases, she was a faculty member in the Department of Medicine, Division of Infectious Diseases, at University Hospitals of Cleveland and Case Western Reserve University School of Medicine. In 2001, she joined Bristol-Myers Squibb, and was Vice President of U.S. Virology Medical Affairs, overseeing more than 100 HIV clinical trials worldwide. In February 2005 she joined the Infectious Disease Division at New Jersey Medical School, and since that time has directed a large clinic for HIV-infected persons in Newark. She leads a group of investigators evaluating outcomes and complications of HIV-infected urban residents in greater Newark, and she has a particular interest in outcomes of HIV-infected women in the United States. She is also an investigator for the Adult AIDS Clinical Trials Group. Dr. Hodder has received numerous awards, and has served as a member of various committees, including the National Board of Medical Examiners and the HIV Forum. She has published in many scientific and medical journals.
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Methodological Challenges in Biomedical HIV Prevention Trials Shabbar Jaffar, Ph.D., is a Reader in Epidemiology at the London School of Hygiene and Tropical Medicine (LSHTM). He has been based at LSHTM for more than 12 years, with more than 10 of those in the Infectious Disease Epidemiology Unit. Dr. Jaffar’s main research area is HIV/AIDS. He is primary investigator of a large cluster-randomized trial comparing homebased and facility-based delivery of antitretroviral treatment in southeastern Uganda. That trial is also examining virological failure, cost effectiveness, and adherence. Dr. Jaffar has provided statistical and epidemiological support to a large trial of pneumococcal conjugate vaccine in Gambian infants, a school-randomized trial of an HIV prevention strategy in Zimbabwe, studies of severe malaria in children in Yemen, a birth cohort of rotavirus infections in India, and a trial of micronutrient-fortified complimentary feeding of children in an area of high HIV prevalence in Zambia. He has lived and worked in West Africa (The Gambia), Uganda, and South Africa. Edward K. Kirumira, Ph.D., Chair of the Uganda National Academy of Science Forum on Health and Nutrition, is Dean of the Faculty of Social Sciences at Makerere University, Kampala, Uganda. He holds a Ph.D. from the Department of Sociology at the University of Copenhagen in conjunction with Harvard University (Department of Population and International Health); an M.A. in Population Research from the Institute of Population Studies, Exeter University, UK; and a B.A. in Sociology from Makerere University. He has worked extensively on various aspects of population, fertility, and health in the Ugandan context, with reference to the HIV/AIDS crisis in sub-Saharan Africa. He has participated in numerous international conferences. Dr. Kirumira has risen through the academic and administrative ranks from Teaching Assistant in the Sociology Department to the position of Professor and Dean. He has been an External Examiner and Visiting Professor at a number of international universities in Europe, Asia, and the United States. He is a member of various professional bodies, including the Population Association of Uganda, the Organization of Social Sciences Research in East and Southern Africa, and the International Union of the Scientific Study of Population. He is also a Council Member and Fellow of the Uganda National Academy of Sciences. Dr. Kirumira has published widely on population and development, reproductive health, sexuality, and HIV/AIDS. George Rutherford, M.D., is Director of the Institute for Global Health, Salvatore Pablo Lucia Professor of Epidemiology, Preventive Medicine, and Pediatrics, and Vice Chair of the Department of Epidemiology and Biostatistics in the School of Medicine at the University of California, San Francisco (UCSF). He is also Adjunct Professor of Epidemiology and Health
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Methodological Challenges in Biomedical HIV Prevention Trials Administration at the School of Public Health at the University of California, Berkeley. Educated at Stanford University and Duke University School of Medicine, Dr. Rutherford is board certified in Pediatrics and General Preventive Medicine and Public Health. Following training in Epidemiology in the Epidemic Intelligence Service of the U.S. Centers for Disease Control and Prevention (CDC), he spent his early professional career in public health practice, with primary emphasis on the epidemiology and control of communicable diseases. He has held a number of positions at public health agencies, including serving as the State Health Officer and State Epidemiologist for the California Department of Health Services, Director of the AIDS Office for the San Francisco Department of Public Health, and the Director of the Division of Immunizations for the New York City Department of Health. He also directs the Joint UCSF–University of California, Berkeley, Residency Program in Public Health and General Preventive Medicine and the International Core for the Center for AIDS Prevention Studies. He is also Coordinating Editor of the Cochrane Collaborative Review Group on HIV Infection and AIDS at UCSF. His current research interests include the epidemiology and control of HIV infection and AIDS-related opportunistic infections (especially in developing countries), the prevention of coccidioidomycosis, sexually transmitted disease control in California, pediatric vaccination policy, the role of public health in managed care, evidence-based public health practice, the epidemiology and control of tuberculosis in California, emerging infectious diseases, and bioterrorism. Dr. Rutherford currently chairs the American Academy of Pediatrics Section on Epidemiology, and the California Tuberculosis Elimination Advisory Committee. Dr. Rutherford has served on a number of IOM committees, including the Committee on the Ryan White CARE Act: Data for Allocation, Planning, and Evaluation; the Committee on the Review of HIVNET 012 Perinatal HIV Prevention Study; and the Committee on Gulf War and Health: Review of the Medical Literature Relative to Gulf War Veterans’ Health. He currently chairs the Committee on Gulf War and Health: Traumatic Brain Injuries. Olive Shisana, M.A., Sc.D., holds a Doctor of Science from the Johns Hopkins University School of Public Health in Baltimore. She was accepted into Johns Hopkins University’s society of scholars programme in 1999 for outstanding contribution to public health. Dr. Shisana is currently the President and Chief Executive Officer of the South African Human Sciences Research Council (HSRC). She previously served as Executive Director of a South African national research programme on social aspects of HIV/AIDS and health at the HSRC, the founder of the program. Prior to that she served as Professor of Health Systems at the National School of Public Health at the Medical University of Southern Africa, where she was a leading founder
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Methodological Challenges in Biomedical HIV Prevention Trials of a postgraduate diploma on the management of HIV/AIDS in the world of work, launched by the South African Deputy President in 2001. Before this appointment, she served as Executive Director of Family and Community Health at the World Health Organization in Geneva. In the latter portfolio, she established the WHO HIV/AIDS/STI initiative, reviving the role of WHO in this area, becoming a founding member of the Partnership on AIDS in Africa. Prior to this appointment she served as Director General of South Africa’s postapartheid government, the first African and the first woman to hold the post. She has written among other subjects on HIV/AIDS, including the subject on AIDS: a human security issue, gender, HIV among health workers and educators. She was a principal investigator on the Mandela/HSRC study of HIV/AIDS, which is the first systematic national HIV/AIDS prevalence, behavioral risks, and mass media impact survey. She was also principal investigator of the 2005 HIV prevalence, incidence, and behaviour population-based survey in South Africa, and currently is the coprincipal of the same repeat survey for 2008. She was also the principal investigator of a survey of HIV prevalence among health workers and ambulatory and hospitalized patients in South Africa and also examined the impact of HIV/AIDS on South Africa’s health care system. She also was a principal investigator on the national study on HIV/AIDS among public educators in South Africa. Dr. Shisana serves on the Board of the Nelson Mandela “46664” HIV/AIDS campaign and the Emory Global Health Institute Board. She also chaired the 2007 South African AIDS conference, which attracted people from 60 countries, adding to the 4,000-strong South African participants. Gina Wingood, Sc.D., M.P.H., is the Agnes Moore Endowed Faculty in HIV/ AIDS Research; Director of the Social and Behavioral Sciences Core, Center for AIDS Research; and Associate Professor in the Rollins School of Public Health at Emory University. Dr. Wingood serves as the principal investigator on several NIH-funded R01/U10 HIV prevention trials designed to reduce high-risk sexual behavior and sexually transmitted infections among women and heterosexual couples. Dr. Wingood also serves as the Director of a study funded by the National Institute of Allergy and Infectious Diseases to reduce high-risk sexual behaviors and HIV incidence among Xhosa-speaking women in South Africa. Dr. Wingood has published several CDC-defined evidence-based HIV prevention interventions for women, which CDC is disseminating nationally. Dr. Wingood is also known for applying the Theory of Gender and Power, a social-structural theory that examines the factors that increase women’s vulnerability to HIV. She received her Sc.D. from Harvard University School of Public Health (1995) and an M.P.H. from University of California, Berkeley (1990).