Committee: Identifying and Prioritizing New Preventive Vaccines for Development

Committee Membership Information


Project Title:	Identifying and Prioritizing New Preventive Vaccines for Development
PIN:	IOM-BPH-10-14
Major Unit:	Institute of Medicine
Sub Unit:	Board on Population Health and Public Health Practice
RSO:	Madhavan, Guru
Subject/Focus Area:	Health and Medicine

Committee Membership

Date Posted: 08/08/2012

Dr. Lonnie J. King - (Chair)
The Ohio State University

Lonnie King, D.V.M., is dean of the College of Veterinary Medicine, and executive dean for the Health Science Colleges at the Ohio State University. Earlier, King was the director of the National Center for Zoonotic, Vector-Borne and Enteric Diseases at the Centers for Disease Control and Prevention (CDC). Before serving as director, King was the first chief of the CDC’s Office of Strategy and Innovation. King has also served as dean of the Michigan State University College of Veterinary Medicine for 10 years. Prior to this, King was the administrator for the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service. He served as the country’s chief veterinary officer for five years, and worked extensively in global trade agreements within North American Free Trade Agreement and the World Trade Organization. He has served as president of the Association of American Veterinary Medical Colleges and was the vice chair for the National Commission on Veterinary Economic Issues. King received his B.S. and D.V.M. degrees from the Ohio State University, an M.S. in epidemiology from the University of Minnesota, and an M.P.A. from American University. He is a member of the Institute of Medicine.

Dr. Jonathan Carlson
Microsoft Research

Jonathan Carlson, Ph.D., is a researcher in the eScience group at Microsoft Research, where he studies viral evolution, immunology and vaccine design through statistical modeling. His models of viral escape have achieved broad recognition in the HIV community, where they have led to the discovery of novel viral-host interactions, insights into mechanisms of natural immune control, and the identification of vaccine candidates that are slated for clinical trials. He has served on advisory panels for the Bill and Melinda Gates Foundation and the Center for HIV/AIDS Vaccine Immunology. Carlson received his B.A. from Dartmouth, where he was awarded the top senior thesis prizes in both biology and computer science, and his Ph.D. in computer science from the University of Washington, where he was awarded the university’s distinguished dissertation award, and was a finalist for the U.S. Council of Graduate School’s dissertation award, for his work on HIV adaptation.

Mr. Paul Citron
Medtronic, Inc. [Retired]

Paul Citron, M.S.E.E., retired as vice president of technology policy and academic relations from Medtronic, Inc., after a thirty-two year career there. His previous positions include vice president of science and technology, vice president of ventures technology, and vice president as well as director of applied concepts research. He is currently a senior fellow at the William J. von Liebig Center for Entrepreneurism and Technology and an adjunct professor in the Department of Bioengineering at University of California, San Diego. Citron received a B.S. in electrical engineering from Drexel University and an M.S. in electrical engineering from the University of Minnesota. He has authored many publications, has served on several committees of the National Academies, and holds several medical device pacing-related patents. Citron was elected a founding fellow of the American Institute of Medical and Biological Engineering and has twice won the American College of Cardiology Governor’s Award for Excellence and was inducted as a fellow of the Medtronic Bakken Society, the company's highest technical honor. Citron is a member of the National Academy of Engineering.

Dr. Rita R. Colwell
University of Maryland, College Park

Rita Colwell, Ph.D., is a distinguished university professor both at the University of Maryland at College Park and at Johns Hopkins University Bloomberg School of Public Health. Her interests are focused on global infectious diseases, water, and health, and she is currently developing an international network to address emerging infectious diseases and water issues, including safe drinking water for both the developed and developing world. Colwell has shown how changes in climate, adverse weather events, shifts in ocean circulation, and other ecological processes can create conditions that allow infectious diseases to spread. In addition to her academic roles, Colwell is senior adviser and chairperson of Canon U.S. Life Sciences, and chairman and president of CosmosID, which is exploring the potential applications of molecular diagnostic technologies to the field of life sciences. Colwell served as the 11th director of the National Science Foundation from 1998 to 2004. Colwell has previously served as chairman of the board of governors of the American Academy of Microbiology and also as president of the American Association for the Advancement of Science, the Washington Academy of Sciences, the American Society for Microbiology, the Sigma Xi National Science Honorary Society, and the International Union of Microbiological Societies. Colwell has also been awarded 54 honorary degrees from institutions of higher education, including her alma mater, Purdue University. Colwell holds a B.S. in bacteriology and an M.S. in genetics, from Purdue University, and a Ph.D. in oceanography from the University of Washington. Colwell is a member of the Royal Swedish Academy of Sciences, the American Academy of Arts and Sciences, and the American Philosophical Society. She is the recipient of the Order of the Rising Sun bestowed by the emperor of Japan and the National Medal of Science bestowed by the president of the United States. She is a U.S. science envoy and a member of the National Academy of Sciences.

Dr. Kathryn M. Edwards
Vanderbilt University School of Medicine

Kathryn Edwards, M.D., is the Sarah H. Sell Professor of Pediatrics in the Division of Infectious Diseases at Vanderbilt University School of Medicine. As a graduate of the University of Iowa College Of Medicine, Edwards was elected to Alpha Omega Alpha. She completed her pediatric residency and fellowship in infectious diseases at Children’s Memorial Hospital, Northwestern University School of Medicine in Chicago, Illinois, and then served as a postdoctoral fellow and instructor in immunology at Rush Medical School, Presbyterian St. Luke’s Hospital, also in Chicago. Then she joined the faculty of the Vanderbilt University School of Medicine in Nashville, Tennessee, where she has remained and risen in the ranks to professor and director of the Vanderbilt Vaccine Research Program. Edwards has spent much of her career evaluating the safety and effectiveness of vaccines. As a member of both the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices and the U.S. Food and Drug Administration Vaccines and Related Products Advisory Committee, she has played a critical role in recommending new vaccines for licensure and establishing guidelines for their use. She has also been a frequent advisor to the U.S. National Institutes of Health, where she was a member of the advisory council of the National Institute of Allergy and Infectious Diseases, and to the CDC in improving ways to evaluate vaccines and to ensure their safety. Edwards served on numerous data safety and monitoring boards for national and international trials in high-risk groups such as pregnant women, infants, children, and members of developing nations. She is a member of the Institute of Medicine.

Dr. Dennis G. Fryback
University of Wisconsin-Madison

Dennis Fryback, Ph.D., is professor emeritus of population health sciences and industrial and systems engineering at the University of Wisconsin, Madison. He specializes in methodological issues underpinning medical decision making, cost-effectiveness analysis of health care interventions, and health policy. Fryback was a member of the U.S. Preventive Services Task Force and also of the U.S. Panel on Cost-Effectiveness in Health and Medicine—two working groups that have been influential for national policy on comparative effectiveness research methods in health care. Among other honors he has received the Career Achievement Award of the Society for Medical Decision Making, which he helped to found over 30 years ago. He is a member of the Institute of Medicine.

Dr. Glenda E. Gray
University of the Witwatersrand

Glenda Gray, M.B.B.Ch., is executive director of the Perinatal HIV Research Unit and associate professor of pediatrics at University of the Witwatersrand, South Africa. She is based at the Chris Hani Baragwanath Hospital where she is the principal investigator of the Soweto Clinical Trials Unit. She has expertise in the field of mother to child transmission of HIV, adolescent HIV prevention and treatment, and HIV vaccine and microbicide research. She has received the Femina “Woman of the Nineties” award, Nelson Mandela Health and Human Rights award, and International Association of Physicians Against AIDS’s “Hero of Medicine” award for her research contributions. Gray received her medical degree from the University of Witwatersrand and was a fellow of College of Physicians of South Africa in Pediatrics. She was awarded a Fogarty Training Fellowship at Columbia University and completed an intensive program in clinical epidemiology at Cornell University. She is a member of the Academy of Science in South Africa and a member of the Institute of Medicine.

Dr. Michel Guillot
University of Pennsylvania

Michel Guillot, Ph.D., is an associate professor of sociology at the University of Pennsylvania, and a Research Associate at Penn’s Population Studies Center. He is a demographer specializing in the areas of formal demography and population health. Initially trained in France, Guillot obtained a Ph.D. in Demography and Sociology from the University of Pennsylvania in 2000. After a postdoctoral fellowship at the Harvard Center for Population and Development, he joined the Department of Sociology of the University of Wisconsin, and subsequently returned to the University of Pennsylvania as a faculty member. In the area of formal demography, Guillot’s research deals with designing new approaches for measuring population health and understanding population dynamics.

Dr. Victoria G. Hale
Medicines360

Victoria Hale, Ph.D., is founder, former chief executive officer, and chair emeritus of OneWorld Health, the first nonprofit pharmaceutical company in the United States. Under her leadership the organization developed a new cure for visceral leishmaniasis and developed a platform technology to reduce the cost of malaria drugs by more than ten-fold. Presently, Hale is founder and chief executive officer of Medicines360, a second generation nonprofit pharmaceutical company. Their first product is a hormonal IUD, currently in phase 3 clinical trials in the United States. Hale established her expertise in all stages of bio- and pharmaceutical drug development at the U.S. Food and Drug Administration and at Genentech, Inc. She earned her Ph.D. from the University of California, San Francisco, where she maintains an adjunct associate professorship in Biomedical Engineering and Therapeutic Sciences. Her honors include being named a MacArthur Fellow and receiving the President’s Award of Distinction from the American Association of Pharmaceutical Scientists and the Economist’s Social and Economic Innovation Award. She is a member of the Institute of Medicine.

Dr. Joseph M. Jasinski
IBM Research

Joseph Jasinski, Ph.D., is an IBM Distinguished Engineer and the Global Industry Executive for Smarter Healthcare and Life Sciences at IBM Research. In this role he is responsible for developing strategies and coordinating research efforts across IBM's Research Division in areas ranging from the use of information technology in payer/provider healthcare to computational studies in molecular biology. Prior to his current position, Jasinski was worldwide operations manager for IBM Life Sciences, responsible for day to day operations and strategy for one of IBM's fastest growing new businesses. He has also served as the Senior Manager of the Computational Biology Center at IBM Research and managed and carried out research in nanotechnology, materials chemistry and chemical kinetics in his career with IBM. Jasinski graduated from Dartmouth College with an A.B. in mathematics and chemistry, and received a Ph.D. in chemistry from Stanford University where he held a National Science Foundation pre-doctoral fellowship. Following post-doctoral work at the University of California, Berkeley, he joined the IBM Thomas J. Watson Research Center as a Research Staff Member in 1982. Jasinski is a fellow of the American Physical Society and the American Association for the Advancement of Science.

Dr. Tracy Lieu
Kaiser Permanente, Northern California

Tracy Lieu, M.D., M.P.H., is director of the Division of Research at Kaiser Permanente Northern California. She was previously professor of population medicine and of pediatrics, and director of the Center for Child Health Care Studies at Harvard Medical School and the Harvard Pilgrim Health Care Institute. Lieu has studied vaccine safety, delivery, and economics for almost two decades and has published many papers about the effectiveness and cost-effectiveness of immunization programs. Her research includes the seminal cost-effectiveness analyses of varicella vaccine and pneumococcal conjugate vaccine for children, conducted with collaborators from the Centers for Disease Control and Prevention (CDC) and Kaiser Permanente Northern California. She has served as senior investigator of several related evaluations of the economic impact of pneumococcal conjugate vaccination, including an economic impact evaluation for PneumoADIP. In addition to research, Lieu serves as the Children’s Hospital Boston site director of the Harvard Pediatric Health Services Research Fellowship, teaches in the Harvard School of Public Health, and practices pediatrics part time with Harvard Vanguard Medical Associates. She was a member of CDC’s Advisory Committee on Immunization Practices, the expert group that issues authoritative recommendations on vaccine use in the United States.

Dr. Charles E. Phelps

Charles Phelps, Ph.D., is university professor and provost emeritus at the University of Rochester. Phelps began his research career at the RAND Corporation, where he served as senior staff economist and director of the Program on Regulatory Policies and Institutions. At RAND Phelps’s research included the economics of health care, U.S. petroleum price regulations, water markets in California, and environmental regulatory policy. In 1984, Phelps moved to the University of Rochester, where he held appointments in the departments of economics and political science and served as director of the Public Policy Analysis Program and chair of the Department of Community and Preventive Medicine in the School of Medicine and Dentistry. He served as provost of the University of Rochester from 1994 to 2007. Phelps’s research cuts across the fields of health economics, health policy, medical decision analysis, cost-effectiveness analysis of various medical interventions, and other related topics. He wrote a leading textbook in the field, Health Economics (Addison Wesley, now in its fifth edition), and Eight Questions You Should Ask About Our Health Care System—Even if the Answers Make You Sick (Hoover Institution Press). Phelps has testified before congressional committees on health policy and intellectual property issues. He serves on the board of directors of VirtualScopics, Inc. and as a consultant to Gilead Sciences, Inc. and CardioDx. He is a founding member of the Health Care Task Force of the Hoover Institution at Stanford University. He received his B.A. in mathematics from Pomona College, an M.B.A. in hospital administration, and Ph.D. in business economics from the University of Chicago. Phelps is a fellow of the National Bureau of Economic Research and a member of the Institute of Medicine.

Dr. Rino Rappuoli
Novartis Vaccines

Rino Rappuoli, Ph.D., is global head of vaccines research for Novartis Vaccines. Previously, he was chief scientific officer and vice president, Vaccines Research, Chiron Corporation. Rino joined IRIS, the Chiron S.p.A. Research Institute, in 1992 and obtained various leadership positions in vaccine discovery and research within the company. Prior to that, he was a head of the Laboratory of Bacterial Vaccines at the Sclavo Research Center and a visiting scientist at Harvard Medical School and the Rockefeller Institute. He is the author of more than 500 original papers in peer-reviewed journals and has served as reviewer for numerous scientific publications. Rappuoli obtained his doctoral degree in biological sciences at the University of Siena, delivering his experimental thesis on the use of nuclear magnetic resonance imaging in biological systems. Rappuoli has been awarded the Albert Sabin Gold Medal in recognition of his work in the field of vaccine discoveries and the Gold Medal by the Italian President for contributions to public health. He is a member of the National Academy of Sciences.

Dr. Arthur L. Reingold
University of California, Berkeley

Arthur Reingold, M.D., is Edward Penhoet Distinguished Professor of Global Health and Infectious Diseases at the School of Public Health, University of California, Berkeley (UCB). He is also professor of epidemiology and biostatistics and clinical professor of medicine at the University of California, San Francisco (UCSF). His research interests include emerging and reemerging infections and vaccine-preventable diseases in the United States and developing countries. Reingold serves on the World Health Organization's Strategic Advisory Group of Experts on vaccines and vaccine policy as vice-chair. He is also director of the California Emerging Infections Program, and of the U.S. National Institutes of Health Fogarty AIDS International Training and Research Program at the UCB/UCSF. His recent publications include articles on the impact of the introduction of pneumococcal conjugate vaccine in the United States and related topics. Before joining the faculty at UCB, Reingold worked for eight years at the Centers for Disease Control and Prevention. He is a member of the Institute of Medicine.

Dr. Edward H. Shortliffe
Arizona State University

Edward Shortliffe, M.D., Ph.D., is clinical professor at Arizona State University, adjunct professor of Biomedical Informatics at Columbia University, and a scholar in residence at the New York Academy of Medicine. Previously, he served as president and chief executive officer of the American Medical Informatics Association. He has also served on the faculty of the University of Texas Health Science Center and the University of Arizona College of Medicine. Before that he was the Rolf A. Scholdager Professor and chair of the Department of Biomedical Informatics at Columbia University College of Physicians and Surgeons, and professor of medicine and of computer science at Stanford University. He received his A.B. in applied mathematics from Harvard College, a Ph.D. in medical information sciences, and an M.D. from Stanford University. His research interests include the broad range of issues related to integrated decision-support systems, their effective implementation, and the role of the Internet in health care. He is a master of the American College of Physicians and editor-in-chief of the Journal of Biomedical Informatics. Shortliffe is a fellow of the American College of Medical Informatics and the American Association for Artificial Intelligence and an elected member of the American Society for Clinical Investigation and the Association of American Physicians. He is a member of the Institute of Medicine.

Dr. Oyewale Tomori
Redeemer's University

Oyewale Tomori, D.V.M, Ph.D., is vice-chancellor emeritus and professor at Redeemer’s University in Nigeria. Tomori received his D.V.M. from the Ahmadu Bello University, Zaria and his Ph.D. in virology of the University of Ibadan. Tomori's research interests include a wide range of human viruses, and zoonotic and veterinary viruses including the Yellow fever virus, the Lassa fever virus, the poliomyelitis virus, the measles virus, the Ebola virus and a hitherto unknown virus, the Orungo virus, which he elucidated the properties of and registered with the International Committee of Virus Taxonomy. He has served as head of the department of virology at the University of Ibadan, and was later appointed as the Regional Virologist for the World Health Organization (WHO) Africa Region. During the ten year tenure with the WHO, he set up the African Regional Polio Laboratory Network, comprising of 16 laboratories, providing diagnostic support to the global polio eradication initiative. In addition, Tomori has served on several WHO advisory committees and expert groups. He has received the Nigerian National Order of Merit, the country’s highest award for academic and intellectual attainment and national development and the Nigeria National Ministry of Science and Technology Merit Award for excellence in medical research. Tomori is a fellow of the Academy of Science of Nigeria, a fellow of the College of Veterinary Surgeons of Nigeria, a fellow of the Royal College of Pathologists of the United Kingdom. He is president-elect of the Nigerian Academy of Sciences.

Dr. Detlof von Winterfeldt
University of Southern California

Detlof von Winterfeldt, Ph.D., is a professor of Industrial and Systems Engineering at the Viterbi School of Engineering at the University of Southern California (USC). He also holds appointments as professor of Public Policy at the USC Sol Price School of Public Policy and as Centennial Professor of Management Science at the London School of Economics and Political Science. He has served as director of the International Institute for Applied Systems Analysis (IIASA) in Austria and has been recently elected by the council as an honorary IIASA scholar. He co-founded and directed the National Center for Risk and Economic Analysis of Terrorism Events (CREATE), the first university-based Center of Excellence funded by the U.S. Department of Homeland Security. His research interests are in the foundation and practice of decision and risk analysis as applied to the areas of technology development, environmental risks, natural hazards and terrorism. He has served on many committees and panels of the National Science Foundation and the National Academies. He is an elected fellow of the Institute for Operations Research and the Management Sciences (INFORMS) and of the Society for Risk Analysis. He has received the Ramsey Medal for distinguished contributions to decision analysis from the Decision Analysis Society of INFORMS, the Gold Medal from the International Society for Multicriteria Decision Making for advancing the field.

Mr. Robert Steinglass
John Snow, Inc.

Robert Steinglass, M.P.H., is immunization team leader for the Maternal and Child Health Integrated Program at John Snow, Inc. and project director for the Africa Routine Immunization System Essentials at John Snow Research and Training Institute, Inc. Steinglass received his M.P.H. from the Johns Hopkins University School of Hygiene and Public Health and has led immunization projects for John Snow, Inc. since 1990. In this capacity and in partnership with global, regional, and country partners, he has overseen the technical agenda and implementation of a series of projects funded by the U.S. Agency for International Development engaged primarily in strengthening routine immunization program performance, introducing new vaccines, and controlling vaccine-preventable diseases. Steinglass has served in leadership positions on IMMUNIZATIONbasics, BASICS II, BASICS, REACH II, and REACH at John Snow, Inc. Steinglass began his career in smallpox eradication for the World Health Organization (WHO) in Ethiopia and Yemen and served for 10 years as the resident WHO technical officer for the Expanded Program on Immunization in Yemen, Oman, and Nepal. Steinglass’s immunization work has taken him to nearly 50 developing and transitional countries. His recent and current involvement at the global level includes work in such areas as the epidemiology of the unimmunized child, the role of gender and sex in immunization, the effect of new vaccine introduction on immunization systems and health systems, and the feasibility of measles eradication. He is a member of WHO's Immunization Practices Advisory Committee, the Vaccine Presentation and Packaging Advisory Group, the Program Advisory Group of Project Optimize, and the Cold Chain and Logistics Task Team. He has recently led one of the delivery working groups for the Decade of Vaccines and advised both the US Centers for Disease Control and Prevention and WHO on their global immunization implementation research agenda.

Committee Membership Roster Comments

Note (03-25-2011): There has been a change in committee membership with the resignation of Enriqueta Bond and the appointment of Charles Phelps.
Note (04-14-2011): There has been a change in committee membership with the appointment of Robert Steinglass.
Note (08-08-2012): The terms of Joshua Epstein, Patricia Garcia, Demissie Habte, William Paul, and Vinod Sahney ended on 6/30/2012 following the completion of phase I. There has been a change in the committee membership for phase II. The new members appointed for phase II are Jonathan Carlson, Glenda Gray, Michel Guillot, Joseph Jasinski, Edward Shortliffe, Oyewale Tomori, and Detlof von Winterfeldt.

Statement of Committee Composition

Disclosure of Conflict of Interest: Rino Rappuoli (NAS)

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who is actively involved in vaccine discovery and commercialization. To meet the need for this expertise and experience, Dr. Rino Rappuoli (NAS) is proposed for appointment to the committee even though we have concluded that he has a conflict of interest. Dr. Rappuoli is Global Head of Vaccines Research at Novartis. Previously, he was Chief Scientific Officer and Vice President, Vaccines Research, Chiron Corporation. Dr. Rappuoli is a leader in bacteriology as well as industrial vaccinology. He can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work. After an extensive search, we have been unable to find another individual with the equivalent combination of basic research as well as industrial leadership who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Disclosure of Conflict of Interest: Paul Citron (NAE)

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who has experience in developing as well as setting priorities for platform health technologies. To meet the need for this expertise and experience, Mr. Paul Citron (NAE) is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he owns 1000 shares of unrestricted stock in IChor Medical Systems, a privately funded start-up focused on delivery of DNA drugs for applications including therapeutic cancer vaccines, therapeutic proteins and vaccines for serious infectious disease. Paul Citron is retired Vice President of Technology Policy and Academic Relations at Medtronic, Inc. He has held several positions in Medtronic, including Vice President of Science and Technology, Vice President, Ventures Technology, Vice President, Applied Concepts Research, Director, Applied Concepts Research, Design and Staff Engineer, Project and Program Manager. He has authored many publications and holds several medical device pacing-related patents. Citron was elected Founding Fellow of the American Institute of Medical and Biological Engineering and has twice won the American College of Cardiology Governor's Award for Excellence and has been was inducted as a Fellow of the Medtronic Bakken Society. Citron is a member of the National Academy of Engineering. His experience in new technology development for health conditions is critical for the committee in meeting its task. We believe that Mr. Citron can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work. After an extensive search, we have been unable to find another individual with the equivalent combination of experience in medical devices and health-related platform technologies who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Disclosure of Conflict of Interest: Glenda Gray (IOM)

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established, its membership must include among others, at least one person who is involved in vaccine research and the implementation of immunization programs in South Africa. To meet the need for this expertise and experience, Dr. Glenda Gray is proposed for appointment to the committee even though we have concluded that she has a conflict of interest because she is on the scientific advisory board of the International AIDS Vaccine Initiative which receives funding from several private companies and foundations funding vaccine research. Dr. Gray is also a lead investigator for a study funded by the Bill and Melinda Gates Foundation as well as a team leader for a phase III trial testing Sanofi and Novartis HIV vaccines, funded by the NIH and the Gates Foundation. Dr Gray is knowledgeable of both South African government immunization policy and research and industry research. In addition, Dr. Gray has conducted research and advised on implementation activities for two vaccine candidates being used as test cases in the phase II of this study. After an extensive search, we have been unable to find another individual with the equivalent combination of field experience and research expertise relating to immunization programs in South Africa as Dr Gray who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.