Mary Lou Clements, M.D., D.T.M.H., M.P.H., is Professor and Head of the Division of Vaccine Sciences, Department of International Health, and Director of the Center for Immunization Research at Johns Hopkins University School of Hygiene and Public Health. She received her M.D. from the University of Texas Southwestern Medical School, her D.T.M.H from the London School of Tropical Medicine and Hygiene, and her M.P.H. from Johns Hopkins University. She completed her medical training in internal medicine at Temple University Hospital in Philadelphia. From 1975 to 1977, she served as special epidemiologist for the World Health Organization's (WHO) Smallpox Eradication Program in India. Beginning in 1979, Dr. Clements was a faculty member at the University of Maryland School of Medicine at the Center for Vaccine Development; in 1985, she joined the faculty of the Johns Hopkins University School of Hygiene and Public Health and School of Medicine. During 1991–1992, she spent 6 months on sabbatical leave assisting the Vaccine Development Unit of WHO's Global Program on AIDS, helping to establish AIDS vaccine evaluation units in Uganda, Brazil, and Thailand. Dr. Clements is a member of several professional societies and serves on the Advisory Committee on Immunization Practices and the National Consultative Group for Vaccine Development.

Ciro de Quadros, M.D., M.P.H., is the Senior Adviser on Immunization for the Pan American Health Organization (PAHO). Since 1977 he has been responsible for the implementation of the Expanded Program on Immunization (EPI) in the Region of the Americas, according to policies and strategies outlined by PAHO's directing bodies. He is also the Technical Secretary of the PAHO's Immunization Technical Advisory Group and of an Inter-Agency Coordinating Committee, which collaborates to enhance the implementation of EPI in the Americas, including the efforts to eradicate poliomyelitis. He is the editor of the PAHO publication ''EPI Newsletter." Dr. de Quadros received his medical degree as well as his M.P.H in Brazil, the latest one in the National School of Public Health in Rio de Janeiro, where he served as Senior Lecturer in Epidemiology before joining the World Health Organization's Smallpox Eradication Program as the Chief Epidemiologist for the program in Ethiopia from 1970 to 1976. Dr. de Quadros is a member of the Task Force for Child Survival and Development and of several professional and scientific associations.

Michael A. Epstein, J.D., is a nationally recognized expert in intellectual property law, and a Partner in the international law firm Weil, Gotshal & Manges. He graduated from the New York University School of Law and Lehigh University (concentrating in biology and chemistry), both with high honors. His current practice involves both litigation and transactional work, including structuring and negotiating technology and intellectual property acquisitions, technology transfer and licensing arrangements, and joint ventures and other targeted alliances. He is the author of several books on intellectual property, including Modern Intellectual Property, Drafting License Agreements, and International Intellectual Property, as well as numerous articles on intellectual property law. Mr. Epstein has lectured frequently on intellectual property matters including trade secrets, biotechnology law, computer law, unfair competition, trademark law, and licensing agreements. He is a founder and co-editor of The Journal of Proprietary Rights and a member of the Editorial Board of the Computer Lawyer.

Ronald W. Hansen, Ph.D., is Associate Dean for Academic Affairs at the William E. Simon Graduate School of Business Administration. He came to the School in 1971 as Assistant Professor and became Director of the Systems Analysis Program in 1972. From 1977 to 1986, he was the Associate Director of the Center for Research in Government Policy and Business, now the Bradley Policy Research Center. He was the first recipient of the Merrell Dow Professorship of Pharmaceutical Administration in the College of Pharmacy at the Ohio State University (1986–1988). Dr. Hansen is widely recognized for his research in drug development policy and regulation of the pharmaceutical industry. He has presented papers in the United States, Sweden, Australia, Canada, and Switzerland. In addition, he helped establish, and is economic consultant to, the Center for the Study of Drug Development. Formerly a member of the National Advisory Council on Health Care Technology Assessment (1985–1988), Dr. Hansen has also been a consultant to the congressional Office of Technology Assessment for a panel on the Patent Term Restoration Act.

Donald E. Hill, B.S., retired from his position as Director of Product Certification, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA), in 1990, and is now a Regulatory Consultant to the biologics industry. Mr. Hill received his B.S. degree from Ohio State University College of Pharmacy in 1960. In the same year, he received a commission into the U.S. Public Health Service, where he served his entire government career of 30 years. As Director of Product Certification, he was directly involved in the licensing and quality control of biological products in the United States. He provided guidance to industry on facility requirements, licensing standards, joint manufacturing arrangements, and product promotion and advertisement. Mr. Hill has published several articles on FDA facility and licensing requirements for manufacturers of biologics and is a frequent guest lecturer at industry and professional society meetings and at educational seminars. In 1987, he was honored with the R. E. Greco Award as Regulatory Professional of the Year.

John Lloyd Huck, B.S., retired from his position as Chairman of the Board of Merck and Co., Inc., in 1986. After receiving his B.S. degree in chemistry from Pennsylvania State University, he served in the U.S. Army Air Corps during World War II. Mr. Huck began his career in the pharmaceutical industry as a research chemist with Hoffmann LaRoche in 1946. In 1958, Mr. Huck joined the Merck Sharp & Dohme Division of Merck & Co., Inc., as Director of Marketing. After progressing through a number of marketing and managerial positions, he was elected President and Chief Operating Officer of Merck & Co., Inc., in 1978 and Chairman of the Board in 1985. After retiring from Merck in 1986, he joined the Board of Directors of Nova Pharmaceutical Corporation and served as Chairman of the Board and Chief Executive Officer for several years. He is past Chairman of the Board of Pennsylvania State University and of the Morristown Memorial Hospital. In addition, he has served on the boards of a number of corporate, professional, and not-for-profit organizations.

David T. Karzon, M.D., is Professor in the Departments of Pediatrics and Microbiology and Immunology, Vanderbilt University School of Medicine. He received a B.S. and M.S. from Ohio State University and his M.D. from the Johns Hopkins University School of Medicine. Dr. Karzon has taught since 1948, including 16 years at the State University of New York at Buffalo in both the Department of Bacteriology and Immunology and the Department of Pediatrics. Concurrently, he held an appointment as Director of the New York State Virology Laboratory, Buffalo, New York. From 1968 to 1986, Dr. Karzon served as Pediatrician-in-Chief, Vanderbilt University Hospital, Chair of the Department of Pediatrics, and Medical Director of the Children's Hospital of the Vanderbilt University Medical Center. He is currently Professor of Pediatrics as well as Professor of Microbiology and Immunology at Vanderbilt University Medical Center. Dr. Karzon has received awards from the U.S. Public Health Service, the Lowell M. Palmer Senior Fellowship, the Markle Scholar in Medical Science, and the Research Career Awards, U.S. Public Health Service, National Institutes of Health. He has served on several advisory committees and currently sits on the National Vaccine Advisory Committee.

Thomas D. Kiley, J.D., is an attorney, investor, and consultant residing in Hillsborough, California. He received his B.S. in chemical engineering from Pennsylvania State University and J.D. with highest distinction from the George Washington University School of Law. He is a member of the board of directors of Athena Neurosciences, Inc.; Cellpro, Inc.; GenPharm International, Inc.; InSite Vision, Inc.; Pharmacyclics, Inc.; Signition, Inc.; Geron Corporation; and the Argent Biosciences Fund. Mr. Kiley served as an Examiner at the U.S. Patent and Trademark Office from 1965 to 1967 and as Patent Solicitor for E. I. du Pont de Nemours & Co., Inc., from 1967 to 1969. From 1969 to 1980, Mr. Kiley practiced with the Los Angeles law firm of Lyon & Lyon, specializing in patent and other intellectual property litigation. From 1980 to 1988, he was an officer of Genentech, Inc., serving variously as Vice President and General Counsel, Vice President for Legal Affairs, and Vice President for Corporate Development.

Richard T. Mahoney, Ph.D., is Vice President and Director of Technology Promotion at the Program for Appropriate Technology in Health (PATH). He received a B.A. from Purdue University and his Ph.D. from the University of California, San Diego. Before joining PATH, Dr. Mahoney worked for the Ford Foundation's Population Office, where he was responsible for the international program in scientific research and development of fertility control. In 1979, he began as a representative for PATH in Asia, serving in Manila and Jakarta for 4 years. His current responsibilities at PATH include management of licensing, patents, copyrights, and trademarks; financing of business ventures; and the formulation of product development strategies and feasibility studies. Dr. Mahoney is a Founding Member of the International Task Force for Hepatitis B Immunization and has written over 20 publications in chemistry, family planning, and vaccine-related topics.

Wendy, K. Mariner, J.D., LL.M., M.P.H., presently holds three academic appointments: Professor, Boston University School of Public Health; Professor of Socio-Medical Science and Community Medicine, Boston University School of Medicine; and Lecturer in Social Medicine, Harvard Medical School. She is also a senior faculty member of the Law, Medicine and Ethics Program at Boston University. Ms. Mariner received her B.A. from Wellesley College, J.D. from Columbia University Law School, LL.M. from New York University Law School, and M.P.H. from the Harvard School of Public Health. She has lectured and published on such topics as drug and vaccine policy, patient's rights, and health care reform. The research grants that she has received include Legal and Ethical Issues in AIDS Vaccine Development, Comparison of Compensation Programs for Vaccine Injury, and Informed Consent in Childhood Immunization. She is contributing editor to Health Law and Ethics for the American Journal of Public Health, and serves as a member of the AIDS Policy Advisory Committee at the National Institutes of Health.

David C. Mowery, Ph.D., is Associate Professor of Business and Public Policy at the Walter A. Haas School of Business, University of California at Berkeley. He received his undergraduate and doctoral degrees in economics from Stanford University, was a postdoctoral research fellow at the Harvard Business School, and has taught at Carnegie-Mellon University. His research deals with the economics of technological innovation and the impact of public policy on innovation. During 1987 to 1988, Dr. Mowery served as Study Director for the National Academy of Sciences' Panel on Technology and Employment. In 1988, he served in the Office of the U.S. Trade Representative as a Fellow for the Council on Foreign Relations, International Affairs. He has testified before congressional committees, been a consultant for various federal agencies and industrial firms, and has written and edited several books. These include Technology and the Pursuit of Economic Growth, Alliance Politics and Economics: Multinational Joint Ventures in Commercial Aircraft, Technology and Employment: Innovation and Growth in the U.S. Economy, The Impact of Technology Change on Employment and Economic Growth, and International Collaborative Ventures in U.S. Manufacturing.

Mark Novitch, M.D., is Vice Chair of the Board of the Upjohn Company. He is responsible for pharmaceutical control, regulatory affairs, strategy and planning, business development, legal and government affairs, and public relations. He received a B.A. from Yale University and M.D. from New York Medical College. His medical staff positions and experience include Peter Bent Brigham Hospital and Harvard Medical School. He also worked as Assistant to the Deputy Assistant Secretary for Health and Scientific Affairs and was Assistant Staff Director of the Task Force on Prescription Drugs from 1967 to 1969. In addition, Dr. Novitch served as Federal Executive Fellow at the Brookings Institution from 1970 to 1971. Subsequently, after serving as Deputy Commissioner of the U.S. Food and Drug Administration (FDA), he went on to become Acting Commissioner of the FDA from 1983 to 1984. Dr. Novitch serves as President of the United States Pharmaceutical Convention. In addition, he serves on the Board of Directors of the American Foundation for Pharmaceutical Education, the National Fund for Medical Education, and the Council on Excellence in Government and is a Trustee of Kalamazoo College.

Suryanarayan Ramachandran, Ph.D., is the immediate Past Secretary of the Department of Biotechnology, Government of India. He obtained his master's degree from Banaras Hindu University, India, and his Ph.D. from the University of Illinois. For many years, he worked in the area of microbial biochemistry. As a visiting scientist at the Indiana University Medical Center (1967–1968), he worked on insulin antibodies and diabetic ketoacidosis. As Head of the Biochemistry Department of the Hindustan Antibiotics Research Center, and later as its Research Director, he was associated with characterization and the modes of action of antibiotics. He and his colleagues did extensive work on enzymes of both medical and industrial importance. He has several publications in these areas, as well as patents on large-scale immobilization of enzymes and enzyme-linked immunosorbent assay-based immunodiagnostic kits. From 1978 to 1982 he was the Chief Executive of Bengal Immunity Ltd., Calcutta, where he piloted the development of improved technologies for antimalarial agent production and the development of new technologies for antibacterial vaccines and antitoxins. In 1982, he was appointed the first member Secretary of the Interministerial National Biotechnology Board formed by the Government of India, and in 1986, he was appointed Secretary of the Department of Biotechnology. In this position, he guided the initiation of a number of programs in modern biology and biotechnology. He is a member of the Biotechnology Advisory Committee of the United Nations Educational, Scientific, and Cultural Organization; chair, Management Advisory Committee, Children's Vaccine Initiative; and a member of the Working Party of the United Nations Conference on Sustainable Development. He is an elected fellow of the National Academy of Medical Sciences, India; and the National Academy of Sciences, India.

Anthony Robbins, M.D., M.P.A., is currently Professor of Public Health at the Boston University School of Medicine. Dr. Robbins received his B.A. from Harvard University, his M.D. from Yale University School of Medicine, and his M.P.A. from John F. Kennedy School of Government, Harvard University. From 1981 to 1986, he served as a staff member for the Committee on Energy and Commerce, U.S. House of Representatives. Other past positions include Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services; Executive Director, Colorado Department of Health; and State Health Commissioner, Vermont Department of Health. Other academic institutions with which Dr. Robbins has been affiliated include McGill University and the Harvard Medical School and School of Public Health. He also served as President of the American Public Health Association in 1983 and has published several articles on vaccine development, supply, and policy over the last several years.

Jerald C. Sadoff, M.D., Colonel (MC), U.S. Army, is currently the Director of the Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research (WRAIR), where he is responsible for directing the Department of Defense's development, production and testing of vaccines against shigella, cholera, enterotoxigenic Escherichia coli, typhoid, Neisseria meningitidis, Neisseria gonorrhoeae, pseudomonas, lipid A, hepatitis A and E viruses, dengue, malaria, and leishmania. He serves as chairman of the Program for Vaccine Development Committee on Diarrheal Diseases of the United Nations Development Program/World Health Organization (UNDP/WHO) and as Chairman of the UNDP/WHO Program for Vaccine Development (PVD), Task Force in Oral Delivery of Vaccines; and Chairman of the UNDP/WHO PVD Task Force on Cholera. He is also a member of the UNDP/WHO PVD Committee on Trans-Disease Vaccinology. He has been an attending physician in Internal Medicine and Infectious Diseases at Walter Reed Hospital since 1972. He received his B.A. and M.D. from the University of Minnesota and completed internal medicine and infectious diseases graduate training at the Minneapolis Veterans Hospital. He was an Infectious Disease Officer in the Department of Bacterial Diseases from 1972, where he became chief in 1987. He is an Associate Professor of Medicine of the Uniformed Services University of the Health Sciences. Dr. Sadoff is a member of several scientific societies, including the Infectious Disease Society of America, the American Society for Microbiology, the American Venereal Disease Association, the Pseudomonas Club (Founding Member), and the International Endotoxin Society. He has received the Paul A. Siple Memorial Medallion, the Impact Meritorious Service Medal, and the Legion of Military Medical Merit.

Jay Philip Sanford, M.D., is Professor of Medicine, University of Texas Southwestern Medical School, and Dean Emeritus, Uniformed Services University of the Health Sciences (USUHS). He received his M.D. with honors from the University of Michigan Medical School in 1952 and Doctor of Military Medicine (honoris causa) from USUHS in 1991. Dr. Sanford served as Dean of the School of Medicine of USUHS beginning in 1975, became President of the University in 1981, and retired in 1991. In 1992, he was reappointed Professor of Medicine at the University of Texas Southwestern Medical School. Other past professional positions that Dr. Sanford has held include Chief, Bacteriology Laboratory, Parkland Memorial Hospital, Dallas, Texas, and Professor of Internal Medicine, University of Texas Southwestern Medical School. Dr. Sanford has received numerous honors, including the Distinguished Public Service Medal and the Distinguished Civilian Service Medal, U.S. Department of Defense; the Bristol Award, Infectious Disease Society of America; Medaille d'Honneur du Service de Sante des Armees (France); and Member, Institute of Medicine (IOM). In his professional career, Dr. Sanford has served on numerous advisory committees, boards, and panels, including several at the National Institutes of Health, the U.S. Food and Drug Administration, the National Aeronautics and Space Administration, the U.S. Department of Defense, the American Board of Internal Medicine, the Centers for Disease Control and Prevention, and the U.S. Public Health Service. These committee assignments included two terms on the Advisory Committee on Immunization Practices, the Armed Forces Epidemiologic Board Commission on Immunization, the Bureau of Biologics Panel on Review of Bacterial Vaccines and Toxoids, the IOM Committee on Private-Public Sector Relations in Vaccine Development (Chairman), and the IOM Board on Health Promotion-Disease Prevention. He is author of 190 articles in peer-reviewed journals and 130 textbook chapters.

George R. Siber, M.D., is the Director of the Massachusetts Public Health Biologic Laboratories, a state-operated and federally licensed facility that produces vaccines against diptheria, tetanus, and pertussis and other diseases for Massachusetts. He received his B.Sc. from Bishop's University, Quebec, and his M.D. from McGill University. He has been an Associate Professor of Medicine at Harvard Medical School since 1986 and has served as Attending Physician for Infectious Diseases Services at Beth Israel Hospital, Dana-Farber Cancer Institute, The Children's Hospital, and Brigham and Women's Hospital. His primary research interests have been in the development of vaccines and immune globulins directed against specific infections and in the assessment of the human immune response to vaccines. He is a member of the American College of Physicians, the American Society for Microbiology, the Infectious Diseases Society of America, the Pediatric Infectious Disease Society, the International Endotoxin Society, and the Society for Pediatric Research.

Jane E. Sisk, Ph.D., Professor in the Division of Health Policy and Management, joined the faculty at the Columbia University School of Public Health in January 1992. She holds a Ph.D. in economics from McGill University, an M.A. in economics from George Washington University, and a B.A. with honors in international relations from Brown University. From 1981 to 1992 she directed health policy projects at the Congressional Office of Technology Assessment, where she was a Senior Associate and Project Director in the Health Program. Her reports addressed such topics as information for consumers on the quality of medical care, Medicare payment for physician services, Medicare payment for recombinant erythropoietin, federal policies toward the medical devices industry, and the cost-effectiveness of influenza and pneumococcal vaccines. Dr. Sisk is the immediate past President of the International Society of Technology Assessment in Health Care. Her research interests include technology assessment, prevention, and the organization and financing of medical care.

STAFF

Violaine S. Mitchell, MSc., is a Program Officer in the Division of International Health of the Institute of Medicine (IOM). She received her B.A. in development studies from Brown University and her MSc. in tropical public health from the Harvard School of Public Health. Prior to joining the IOM in 1990, she spent several years in Egypt running an animal health and production project among Cairo's traditional garbage collectors, the zabbaleen. Other projects during her three years at the National Academy of Sciences and the Institute of Medicine include work with the Committee on Malaria Prevention and Control, Board on International Health, and the International Forum for AIDS Research. Ms. Mitchell is a recipient of the Institute of Medicine 1991 Staff Achievement Award for her work on the Institute of Medicine report Malaria: Obstacles and Opportunities (1991).

Nalini Philipose joined the Division of International Health in October 1991 to work as a Research Assistant for the study on the Children's Vaccine Initiative. She graduated in May 1991 from Cornell University with a B.A. in Soviet Studies and Political Science. She was actively involved in all aspects of the study, from the formation of the committee to writing chapters of the report. She will attend Stanford Law School this fall.

Delores H. Sutton has an Associate Degree in Business Administration from the University of the District of Columbia and the University of Maryland. She joined the Institute of Medicine in 1987 and served as Assistant to the Director, Division of Health Care Services, until September 1992. She provides support for the Children's Vaccine Initiative Study, the Study on Female Morbidity and Mortality in Sub-Saharan Africa, and the Board on International Health. She is responsible for the logistics of meetings, travel and hotel arrangements for committees and staff, briefing materials, study files, correspondence, memos for staff, and assists with projects outside the immediate office.

Greg W. Pearson is a self-employed writer and editor with an expertise in the sciences, science policy, and health. He received a B.A. (1981) in biology from Swarthmore College and a master's in journalism (1988) from The American University. Over the past 4 years, Greg has worked on a number of projects for the Institute of Medicine and the National Academy of Sciences. He served as a consultant for the Children's Vaccine Study, Institute of Medicine.

Robert D. Crangle is an attorney and has been president of the Rose & Crangle, Ltd. management consulting firm since 1984. He received his Management Consultant certificate in 1980 from the Institute of Management Consultants and his J.D. from Harvard Law School in 1969. Mr. Crangle also received a B.S. from Kansas State University in 1966. His expertise is in human resources, science policy, government operations, information systems, economic development, and juridical services. He served as a consultant for the Children's Vaccine Initiative Study.