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APPENDIX D Biographical Sketches Leslie Z. Benet, Ph.D. (Chair), is a professor and former chairman of the Department of Biopharmaceutical Sciences at the University of Califor- nia, San Francisco. His research interests, more than 440 publications, and 10 patents are in the areas of pharmacokinetics, biopharmaceutics, and pharmacodynamics. His most recent work has addressed the interplay of metabolic enzymes and transport proteins as related to the disposition of immunosuppressive, anticancer, anti-AIDS, and antiparasitic drugs, as well as drugs of importance to women's health. He is a fellow of the American Association for the Advancement of Science, the American As- sociation of Pharmaceutical Scientists (AAPS), and the Academy of Phar- maceutical Research and Science. He is the chairman of the board at AvMax, Inc., and OxoN Medica, Inc., and serves as a consultant to several pharmaceutical and biotechnology companies. Dr. Benet is a recipient of the AAPS Distinguished Pharmaceutical Scientist Award, the American Pharmaceutical Association Higuchi Research Prize, the American Soci- ety for Clinical Pharmacology Rawls-Palmer Award for Progress in Medi- cine, the International Pharmaceutical Federation (FIP) Høst-Madsen Medal, and five honorary doctorates. He previously served as chair for the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research External Peer Review Committee, the FDA Expert Panel on Individual Bioequivalence, and the FIP Board of Pharmaceutical Sciences and as a member of the FDA Science Board and the Board of Directors of the American Foundation for Pharmaceutical Education. An elected mem- ber of the Institute of Medicine (IOM), Dr. Benet has served as the chair or 131

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132 GIVING FULL MEASURE TO COUNTERMEASURES a member of various IOM committees; he is currently a member of the Board on Health Sciences Policy. Walter E. Brandt, Ph.D., is a senior program officer for the Malaria Vac- cine Initiative (MVI) at the Program for Appropriate Technology in Health (PATH), an organization focused on the acceleration of the development of malaria vaccine candidates. He also serves on the scientific advisory council for the Sabin Vaccine Institute. He previously served as chair for the World Health Organization Subcommittee on Dengue and Japanese Encephalitis Vaccines and as chair of a National Vaccine Program Office subcommittee on the safety of a vaccinia-vectored rabies vaccine. Before joining MVI, Dr. Brandt was a senior scientist at Science Applications In- ternational Corporation where he advised on vaccine development strat- egy and plans and prepared documents for the Army on vaccines for an- thrax, botulism, and plague for FDA review. As a project manager in the U.S. Army Medical Research and Materiel Command he had oversight of the development, manufacture, and testing of vaccines and immune globulins, responsibility for more than 50 active Investigational New Drug applications with the FDA, and management of resources and activities that contributed to licensure of four vaccines. As a microbiologist and assistant chief of the Department of Virus Diseases, Walter Reed Army Institute of Research, he worked on teams studying dengue fever virus infections and the immune response, markers for live attenuated vaccine candidates, and characterization of reagents for diagnostic tests. Barry S. Coller, M.D., serves as the David Rockefeller Professor of Medi- cine, head of the laboratory of blood and vascular biology, and vice presi- dent for medical affairs at the Rockefeller University. Dr. Coller's research is devoted primarily to investigating platelet physiology, vascular biol- ogy, and adhesion phenomena in sickle cell disease. He is responsible for the production of the monoclonal antibody that later was modified to be- come the drug abciximab (ReoPro), which is used to prevent ischemic complications of percutaneous coronary interventions and unstable an- gina. He has served on professional society committees and held several professional society offices and editorial positions, including coediting the fifth and sixth editions of Williams Hematology. He is on the Board of Gov- ernors of the National Institutes of Health (NIH) Clinical Center and on the Board of Extramural Advisors of the National Heart, Lung, and Blood Institute. He has served as a consultant to Centocor, Inc., and Genentech. Dr. Coller was elected a member of the IOM in 1999 and the National Academy of Sciences in 2003. He is a scientific advisor to two biotechnol- ogy companies.

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APPENDIX D 133 Glenna M. Crooks, Ph.D., is the founder and president of Strategic Health Policy International, Inc. (SHPI), an organization devoted to assisting busi- nesses and governments with the management of health care policy and political issues. Dr. Crooks's clients include pharmaceutical and vaccine companies. She gained experience in public policy, health care, and line management in government and business during her tenure as vice presi- dent for worldwide operations of Merck's vaccine business and as Deputy Assistant Secretary for Health in the Reagan administration. Dr. Crooks serves on the board of directors for Partnership for Prevention and was formerly on the board of American Biogenic Sciences, Inc., chairman of the National Commission on Rare Diseases, and a member of the National Council of the Institute for Child Health and Human Development. Her awards include the Surgeon General's Medallion, awarded by C. Everett Koop, and the Congressional Exemplary Service Award for Orphan Prod- ucts Development. R. Gordon Douglas, Jr., M.D., is a consultant in infectious diseases, vac- cines, and global health. In 1999 he retired from Merck after serving as president of the Vaccine Division and a member of the Management Com- mittee for nine years. He is currently director of strategic planning of the Vaccine Research Center, National Institute of Allergy and Infectious Dis- eases and adjunct professor of medicine at Cornell University. He also serves as a director of the biotechnology companies Vical, Elusys Thera- peutics, Advancis Pharmaceutical Corporation, Iomai, and VaxInnate and the nonprofit organizations International AIDS Vaccine Initiative and Aeras Global TB Vaccine Foundation. Dr. Douglas is a graduate of Princeton University and Cornell University Medical College. He served as head of the Infectious Diseases Clinic at the University of Rochester (1970­1982) and chairman of the Department of Medicine at New York Hospital, Cornell University (1982­1990) before joining Merck. He is au- thor of more than 200 original scientific publications dealing with viral pathogenesis, vaccines, and antivirals, and was co-editor of Principals and Practices of Infectious Diseases, the standard reference in the field. Dr. Dou- glas is the recipient of the R.R. Hawkins Award (Association of American Publishers, 1980), the Harry Feldman award (Infectious Diseases Society of America, 1992) and the Maxwell Finland Award (National Foundation for Infectious Diseases, 2000). He is also a member of IOM, the Associa- tion of American Physicians, and the American Society of Clinical Investi- gators. Dr. Douglas served on the IOM committee that issued the report Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military.

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134 GIVING FULL MEASURE TO COUNTERMEASURES Jacques S. Gansler, Ph.D., is the Roger C. Lipitz Chair in Public Policy and Private Enterprise at the University of Maryland School of Public Af- fairs. He served as the Under Secretary of Defense for Acquisition, Tech- nology, and Logistics from 1997 to 2001. As the third-ranking civilian in the Department of Defense, Dr. Gansler was responsible for acquisition, research and development, logistics, advanced technology, international programs, environmental security, and nuclear, chemical, and biological programs. Prior to his appointment, he served in several other roles in the private technology sector and as Deputy Assistant Secretary of Defense (Materiel Acquisition). He has published and taught on subjects related to the defense industry and served as an honorary professor at the Indus- trial College of the Armed Forces as well as a visiting professor at the University of Virginia. Dr. Gansler is a member of the National Academy of Engineering. Anthony L. Itteilag is an independent consultant on business and man- agement issues pertaining to the federal government. Prior to consulting, he served in multiple capacities at the NIH: senior advisor to the director, deputy director for management and chief financial officer, as well as act- ing chief information officer. He continues to work as a volunteer for the Office of the Director at NIH. He has employed his budget and program analysis experience at the Departments of Health and Human Services (formerly Health, Education and Welfare), Interior, and Defense for al- most four decades. He is a member of the American Society for Public Administration and a graduate of the Federal Executive Institute. Over the course of his career, Mr. Itteilag has received numerous public service awards, including the Clifford R. Gross Award for Federal Public Service from the American Society for Public Administration (Maryland Chapter) in 2001, four Senior Executive Service presidential rank awards, Distin- guished Service Awards from the Secretaries of the Interior and Health and Human Services, and an exemplary service award from the Surgeon General. Dennis L. Kasper, M.D., is executive dean for academic programs, Will- iam Ellery Channing Professor of Medicine, and professor of microbiol- ogy and molecular genetics at Harvard Medical School. He also serves as director of the Channing Laboratory and as a senior physician at Brigham and Women's Hospital. With his colleagues and students, Dr. Kasper studies the molecular basis of bacterial pathogenesis, applying the result- ing knowledge to enhance understanding of the interactions of bacterial surface virulence factors with host defenses. Dr. Kasper's studies focus on the molecular and chemical characterization of important bacterial viru-

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APPENDIX D 135 lence factors such as capsular polysaccharides, surface proteins, and tox- ins. The ultimate goal is to develop vaccines and immunomodulatory molecules to prevent bacterial infections and their complications. Dr. Kasper is a fellow of the American Academy of Microbiology and the American Association for the Advancement of Science as well as a mem- ber of IOM. He is a consultant to two pharmaceutical companies and serves on the scientific advisory board of Microbia. Steven Kelman, Ph.D., is Albert J. Weatherhead III and Richard W. Weatherhead Professor of Public Management at the John F. Kennedy School of Government, Harvard University, where he conducts research on public sector operations management with a focus on organizational design and change. He is the former Office of Federal Procurement Policy administrator in the Office of Management and Budget, where he was involved in the Federal Acquisition Streamlining Act of 1994 and the Fed- eral Acquisition Reform Act of 1995. He is the author of several books in the area of public policy, including his 1990 book entitled Procurement and Public Management: The Fear of Discretion and the Quality of Government Per- formance. He is currently completing research on the spread of procure- ment reform innovations at the working levels of government organiza- tions. Dr. Kelman is on the editorial board of the Journal of Public Administration Research and Theory and is a fellow of the National Acad- emy of Public Administration. Richard F. Kingham, J.D., is a partner in the law firm of Covington & Burling, assigned to the Washington, DC, and London offices. Since join- ing the firm in 1973, he has concentrated on pharmaceutical regulation, product liability, and related issues. He represented vaccine manufactur- ers in connection with the swine flu program in 1976, the childhood vac- cine injury compensation legislation in 1986, and legislative and adminis- trative matters relating to vaccines and other products to protect against bioterrorism. He has served as a member of the National Advisory Al- lergy and Infectious Diseases Council of NIH and as a member of or advi- sor to committees of IOM. From 1977 to 1990, he served as a lecturer at the University of Virginia School of Law; he presently serves as an adjunct professor at the Georgetown University Law Center and lectures in the graduate program of pharmaceutical medicine of the University of Wales. He received his law degree from the University of Virginia in 1973. Peter M. Palese, Ph.D., is a professor of microbiology and chairman of the Department of Microbiology at the Mount Sinai School of Medicine. He has more than 200 scientific publications that include research on the rep- lication of RNA-containing viruses with a special emphasis on influenza

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136 GIVING FULL MEASURE TO COUNTERMEASURES viruses, which are negative-strand RNA viruses. He elucidated the ge- netic maps of influenza A, B, and C viruses and obtained precise measure- ments of their mutation rates, and also developed the reverse genetics system that for the first time enabled the manipulation and analysis of influenza and other minus-strand RNA viruses. He serves on the editorial board for the Proceedings of the National Academy of Sciences and as an edi- tor for the Journal of Virology. He is a member of the Vaccines and Related Biological Products Advisory Committee, Center for Biologics Evaluation and Research at the FDA. Dr. Palese was elected to the National Academy of Sciences in 2000 for his seminal studies on influenza viruses. Paul Parkman, M.D., retired as director of the Center for Biologics Evalu- ation and Research of the FDA in 1990, after 30 years of federal service (18 at FDA) in infectious disease research and biological product regulation. He is currently a consultant in the development and production of biologics, including both the traditional vaccines and the newer products of modern biotechnology. His research led to the discovery of rubella vi- rus and diagnostic tests for rubella. He and his colleagues developed and tested the first successful experimental rubella vaccine in 1965. The use of rubella vaccines, starting in 1969, produced major reductions of this dis- ease and the consequent congenital defects common in babies whose mothers had been infected early in pregnancy. Ronald J. Saldarini, Ph.D., is currently a consultant to several biotechnol- ogy companies and is a director at Alphavax, Medarex, and Cellegy Phar- maceuticals. He is chairman of Therion Biologics and Idun Pharmaceuti- cals. He is an associate in Naimark and Associates, consultants to the healthcare industry, and is also a consultant to the Malaria Vaccine Initia- tive. From 1986 until his retirement in 1999, he was the president of the global vaccine business of American Cyanamid (Lederle Praxis) and American Home Products (Wyeth Lederle). He has been a member of the Board of Trustees of the National Foundation of Infectious Diseases, the Infectious Disease Institute of New Jersey, the Immunization Advisory Council of the New York State Department of Health, the Corporate Coun- cil for the Children's Health Fund, the policy board of the Albert B. Sabin Vaccine Foundation, and the Board of Directors of the Institute for Ad- vanced Studies of Immunology and Aging. Recently, Dr. Saldarini was a member of the IOM committee that issued the report Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military; he also served on the IOM Committee on Immunization Finance Workshops. Jane E. Sisk, Ph.D., is an economist and professor in the Department of Health Policy and a co-director of the Center on Evidence-Based Medi-

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APPENDIX D 137 cine and Aging at the Mount Sinai School of Medicine. Her current re- search areas are the evaluation of strategies to improve quality of care with a focus on the reduction of disparities among population subgroups; the organizational and financial arrangements for the delivery of care, including managed care and Medicaid; and the cost-effectiveness of health care interventions, with an emphasis on preventive care. Prior to joining the faculty at Mount Sinai, Dr. Sisk was a professor of health policy at Columbia University. Before that, she was a senior associate and project director on health policy projects at the congressional Office of Technol- ogy Assessment. She has served on several IOM committees over the last 20 years and was elected to IOM in 2001. She currently serves as a mem- ber on the IOM Committee on Medicare Coverage of Routine Thyroid Screening. In addition to her involvement with IOM, Dr. Sisk has been a member of the Study Section on Health Care Quality and Effectiveness for the U.S. Agency for Healthcare Research and Quality. Elaine I. Tuomanen, M.D., is director of the Children's Infection Defense Center and chair of the Department of Infectious Diseases at St. Jude Children's Research Hospital in Memphis. She is a board-certified pedia- trician with subspecialty training in pediatric infectious diseases. Previ- ously, Dr. Tuomanen was head of the Laboratory of Molecular Infectious Diseases at the Rockefeller University. Her research focus is the induction of inflammation and the molecular pathogenesis of infection by gram- positive Streptococcus pneumoniae bacteria, with a view to understanding the host­pathogen relationship. She has a strong interest in the develop- ment of novel therapeutics, including vaccines and antibiotics, and is cur- rently involved in the development of a new Good Manufacturing Prac- tice (GMP) manufacturing facility at St. Jude's. Benjamin J. Weigler, D.V.M., M.P.H., Ph.D., is associate professor of comparative medicine in the School of Medicine and adjunct associate professor of epidemiology in the School of Public Health at the University of Washington, Seattle. He also serves as director of animal health re- sources for the Fred Hutchinson Cancer Research Center in Seattle. He is board-certified by the American College of Laboratory Animal Medicine and the American College of Veterinary Preventive Medicine. His research is in the area of infectious disease epidemiology and public health, with concentration in zoonotic diseases. Dr. Weigler is a member of several professional veterinary medical organizations and is on the editorial board for the scientific journal Comparative Medicine. He recently served on the National Research Council (NRC) Committee on Occupational Health and Safety in Care of Nonhuman Primates and the steering committee for the

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138 GIVING FULL MEASURE TO COUNTERMEASURES Centers for Disease Control and Prevention and Eagleson Institute Sev- enth National Biosafety Symposium in Atlanta. Janet Westpheling, Ph.D., is an associate professor of genetics at the Uni- versity of Georgia. Her primary areas of research involve the control of gene expression in Streptomyces bacteria, with emphasis on the study of carbon utilization and primary metabolism, as well as the strategies used by bacteria to regulate genes involved in morphogenesis and antibiotic production. Streptomyces are of particular interest because they produce most of the natural product antibiotics used in human and animal health care. Dr. Westpheling serves on the Journal of Bacteriology editorial board and was chair of the Gordon Research Conference on Microbial Stress Response in 1996. She serves as a member of the scientific advisory boards of several biotechnology companies interested in natural product drug discovery and is a consultant to pharmaceutical and biotechnology com- panies. Dr. Westpheling participates annually in a course on fermentation technology offered by the Chemical Engineering Department at the Mas- sachusetts Institute of Technology. She has previously served on three NRC committees: the Committee on Opportunities in Biotechnology for Future Army Applications, the Committee on Biobased Industrial Prod- ucts: National Research and Commercialization Priorities, and the Com- mittee on Bioprocess Engineering. Board of the Medical Follow-up Agency Liaison to the Committee Timothy R. Gerrity, Ph.D., is the founding director of the Bioengineering Institute at Worcester Polytechnic Institute (WPI) and a research profes- sor in the Department of Biomedical Engineering. The Bioengineering In- stitute is dedicated to translational research converting the products of research into usable medical devices. Before joining WPI, Dr. Gerrity was executive director of the Georgetown School of Medicine Chronic Pain and Fatigue Research Center, which focuses on a multidisciplinary ap- proach to understanding the underlying mechanisms of chronic multisymptom illness. He has also served as special assistant chief re- search and development officer (1997­1999) and deputy director for medi- cal research (1994­1997) at the Department of Veterans Affairs (VA). Ear- lier, he carried out air pollution research with the Environmental Protection Agency. Dr. Gerrity's research interests have included the ef- fects of air pollution on human cardiopulmonary function, improved un- derstanding of the behavior of inhaled aerosols in the human lungs, and the mechanisms by which particles are cleared from the lungs. Dr. Gerrity received his B.S., M.S., and Ph.D. degrees in physics from the University

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APPENDIX D 139 of Illinois at Chicago and postdoctoral training in pulmonary physiology from the Department of Medicine at the University of Illinois. Consultant to the Committee James D. Marks, M.D., Ph.D., is professor of anesthesia and pharmaceu- tical chemistry at the University of California, San Francisco. He is board certified in internal medicine, anesthesia, and critical care medicine. From 1996 to 2001 he was the medical director of the Medical-Surgical Inten- sive Care Unit at San Francisco General Hospital and continues to attend in the intensive care unit and operating rooms there. Dr. Marks is a pio- neer in the field of antibody engineering, where he has developed widely used technology for generating and optimizing human therapeutic anti- bodies. He currently directs a research group using antibody gene diver- sity libraries and display technologies to dissect the molecular basis of infectious diseases and cancer and to develop novel antibody-based therapeutic approaches for these diseases. In the field of oncology, his research has elucidated the impact of antibody biophysical properties on tumor targeting, and his laboratory has generated a novel antibody-based drug that is being commercialized for breast cancer therapy. His labora- tory is also funded by the Department of Defense and the National Insti- tute of Allergy and Infectious Diseases (NIAID) to develop antibody- based therapies for the biothreat agent botulinum neurotoxin. Dr. Marks has served on Health and Human Services and NIAID expert advisory panels on the botulinum neurotoxins. He has more than 110 publications in the field of antibody engineering and is an inventor on 62 issued or pending patents.

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