Board on Global Health
 
COMMITTEE ON METHODOLOGICAL CHALLENGES IN HIV PREVENTION TRIALS

Stephen Lagakos, Ph.D. (Chair)
Dr. Lagakos 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 1989-1996, he served as Director of the Statistical and Data Analysis Center at the AIDS Clinical Trials Group. Currently, Dr. Lagakos serves on the Senior Biomedical Research Service Credentials Committee at the 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.
Dr. Harvey Alter 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 Health. 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 donor-screening 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.
Dr. Ronald Bayer 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 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 in 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.
Dr. Solomon Benatar is Professor of Medicine at the University of Cape Town (1980-) and Founding Director of the University of Cape Town Bioethics Center (1992-). He was Professor and Chairman of the University of Cape Town's Department of Internal Medicine and Chief Physician at Groote Schuur Hospital from 1980-1999. 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 Chairman 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 - on which topics he has published over 250 journal articles and book chapters. 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 US HIV Prevention Trials Network, Director of the International Research Ethics Network for southern Africa - a US 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 has 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.
Dr. Ronald Brookmeyer 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 is focused 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 the development of 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 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 at both 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 Ph.D. in Statistics from the University of Wisconsin. He has served on a number of Institute of Medicine 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, MD
Dr. Carlos del Rio 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 of the Mexican Government responsible for AIDS Policy throughout Mexico). 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.  In addition, he is an investigator for the Adult AIDS Clinical Trials Group and investigator on HIV vaccine trials.  Dr. del Rio is a Member of the Board of Directors of the International AIDS Society-USA; Member of the Monitoring of the AIDS Pandemic (MAP) Network; member of the Education Committee of Infectious Diseases Society of America; Associate Editor of AIDS Clinical Care and AIDS Research and Human Retroviruses; and 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 Institute of Medicine Committee on the Ryan White Care Act: Data for Resource Allocation, Planning and Evaluation. He has co-authored five books, 30 book chapters, and over 100 scientific papers.

David Feigal, M.D., M.P.H.
Dr. David Feigal 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. Prior to this, he 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. Subsequently, he 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. degree from Stanford University and an M.P.H. from the University of California Berkeley. He completed his internal medicine residency training at the University of California at Davis and a fellowship in clinical epidemiology at the University of California at San Francisco.

Els Goetghebeur, Ph.D.
Dr. Els Goetghebeur 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. In 1983, she obtained an undergraduate degree in Mathematics from the Catholic University of Louvain, Belgium, and began her career as a volunteer teacher in Burundi. Upon completion of her Ph.D. in Biostatistics at the Limburgs University Center (LUC), Belgium, she became lecturer at the London School of Hygiene and Tropical Medicine, where she worked on clinical trials and became interested in problems of participant nonadherence in trials. She moved back to Belgium for a postdoctoral fellowship with the Janssen Research Foundation and LUC to develop methods for causal inference following partial compliance in randomized clinical trials. She continued this line of research as an Assistant Professor at Maastricht University and in 1996 she moved to a tenured position at Ghent University. At Ghent, she set up a research unit in statistics and started a new Master curriculum in statistical data analysis. She is and has been on the editorial board of several journals. She collaborates with medical colleagues locally and abroad on studies of the prevention and treatment of HIV and AIDS, among other areas. She is a statistical expert for the European Medicines Agency (EMEA). Her research interests include methods for the design and analysis of (sequentially) randomized trials, with special attention given to non-compliance, causal inference more generally, and survival analysis.

Laura A. Guay, M.D.
Dr. Laura Guay 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 on site in Kampala for eleven of these years.  Dr. Guay is currently the 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 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 breastfeeding, which began enrolling participants in October 2006. She is also co-chair of the  HPTN 046 Phase III 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 Breastfeeding" and an investigator on a study of high titer HIV immunoglobulin for prevention of HIV-1 infection in breastfeeding 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 I-III clinical trials.  In addition to the research activities in Uganda, Dr. Guay was instrumental in establishing a PMTCT program in all antenatal 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.
Dr. Sally Hodder is Professor of Medicine, Director of HIV Programs, and Executive 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 the Mount Holyoke College and her M.D. from Case Western Reserve University. She was a fellow in the Infectious Disease Division at CASE Western/University Hospitals in Cleveland, where she also worked as an attending physician, consultant and Associate Professor until 1999. She then joined Bristol-Myers Squibb, ultimately creating an effective scientific operations trial group and was later appointed Senior Director of U.S. Virology Scientific Operations and then Vice-President of the U.S. Virology Medical Affairs. In February 2005, she joined the Infectious Disease Division at New Jersey Medical School. Dr. Hodder has received numerous awards including the President's Award from Bristol-Myers Squibb Co., 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.

Shabbar Jaffar, M.Sc., Ph.D.
Dr. Shabbar Jaffar is a Reader in Epidemiology at the London School of Hygiene and Tropical Medicine (LSHTM). He has been based at LSHTM for over 12 years, more than 10 of those in the Infectious Disease Epidemiology Unit. He organizes and teaches study units in epidemiology. Dr. Jaffar's main research area is HIV/AIDS. He is primary investigator of a large cluster-randomized trial comparing home-based with facility-based delivery of ART in southeastern Uganda that is 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 a 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.
Dr. Edward Kirumira, the Chair to the Uganda National Academy of Science Forum on Health and Nutrition, is the Dean 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); a Master of Arts in Population Research from the Institute of Population Studies, Exeter University, United Kingdom; and a Bachelor of Arts in Sociology from Makerere University. He has worked extensively with various aspects of population, fertility, and health in regard to the Ugandan context, and also with reference to the present HIV/AIDS crisis all over 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 Associate Professor and Dean Faculty of Social Sciences at Makerere University. He has been an external examiner and visiting professor at a number of international universities in Europe, the Far East, and the United States of America. 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.
Dr. George Rutherford is Director of the Institute for Global Health, Salvatore Pablo Lucia Professor of Preventive Medicine, and Head of the Division of Preventive Medicine and Public Health in the Department of Epidemiology and Biostatistics in the School of Medicine at University of California, San Francisco (UCSF). He is also Adjunct Professor of Epidemiology and Health Administration at the School of Public Health at UC Berkeley. Educated at Stanford University and the 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 Centers for Disease Control and Prevention's Epidemic Intelligence Service, 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 in public health agencies, including serving as the State Health Officer and the State Epidemiologist for the California Department of Health Services, the 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. At UCSF Dr. Rutherford directs the Institute for Global Health and serves as Vice Chair of the Department of Epidemiology and Biostatistics.  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 the 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 Institute of Medicine studies, 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.  

Olive Shisana, Sc.D., M.A.
Dr. Olive Shisana is the first woman and black President and CEO of the South African Human Sciences Research Council.  She is a public health professional with extensive research, management and policy development spanning over 20 years.  She served as Executive Director of the Social Aspects of HIV/AIDS and Health at the Human Sciences Research Council where she established and headed a national programme and Africa-wide network on Social Aspects of HIV/AIDS.  Prior to this she served as Professor and Head of Department of Health Systems Management and Policy at the Medical University of Southern Africa.  She has global health experience, obtained while serving as Executive Director of the World Health Organization’s Family and Community Health, where she oversaw HIV/AIDS, reproductive health, women’s health and child and youth development programmes.  At the national level, Dr. Shisana served as Director General of the South African Department of Health, the first woman to head national health services.  She has previously served as specialist scientist at the South African Medical Research Council. She also co-ordinated the establishment of the School of Public Health at the University of the Western Cape which has been in operation since 1993.  Dr. Shisana served as the chief Statistical Advisor to the District of Columbia responsible for public health, mental health and social services research. She obtained her Doctor of Science degree in Behavioural Sciences at the Johns Hopkins University, School of Public Health. She is the recipient of numerous awards for her contributions to public health in South Africa and abroad. She is a founding member of the South African Academy of Sciences.

Gina Wingood, Sc.D., M.P.H.
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 (CFAR) and an Associate Professor at the Rollins School of Public Health, 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 Study Director, of an NIAID funded study 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.   Additionally, Dr. Wingood is known for applying the Theory of Gender and Power, a social structural theory to examine gender and structural 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).