Appendix D
Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

Robert S. Lawrence (IOM), Chair, is the Center for a Livable Future (CLF) professor and director of the CLF in the Department of Environmental Health Sciences, professor of health policy and international health in the Johns Hopkins Bloomberg School of Public Health, and professor of medicine in the Johns Hopkins University School of Medicine. His expertise and research interests include community and social medicine, human rights, health promotion and disease prevention, evidence-based decision rules for prevention policy, and food security. Dr. Lawrence is a master of the American College of Physicians and a fellow of the American College of Preventive Medicine. He is a member of the Institute of Medicine and has served on numerous National Academies committees, most recently the Committee on Adolescent Health Care Services and Models of Care for Treatment, Prevention, and Health Development and the Committee to Evaluate Measures of Health Benefits for Environmental, Health, and Safety Regulation. Dr. Lawrence received his MD from Harvard Medical School and trained in internal medicine at the Massachusetts General Hospital.


Jeffery B. Bender is an associate professor of veterinary public health in the College of Veterinary Medicine and has an adjunct appoint in the School of Public Health of the University of Minnesota. He serves as the director of the Center for Animal Health and Food Safety. His main research interests are zoonoses and emerging diseases, food safety, and antimicrobial resistance. Dr. Bender teaches courses on veterinary public health, diseases common to humans and animals, factors in the emergence of zoonotic diseases, methods for epide-



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Appendix D Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II Robert S. Lawrence (IOM), Chair, is the Center for a Livable Future (CLF) professor and director of the CLF in the Department of Environmental Health Sciences, professor of health policy and international health in the Johns Hop- kins Bloomberg School of Public Health, and professor of medicine in the Johns Hopkins University School of Medicine. His expertise and research interests include community and social medicine, human rights, health promotion and disease prevention, evidence-based decision rules for prevention policy, and food security. Dr. Lawrence is a master of the American College of Physicians and a fellow of the American College of Preventive Medicine. He is a member of the Institute of Medicine and has served on numerous National Academies committees, most recently the Committee on Adolescent Health Care Services and Models of Care for Treatment, Prevention, and Health Development and the Committee to Evaluate Measures of Health Benefits for Environmental, Health, and Safety Regulation. Dr. Lawrence received his MD from Harvard Medical School and trained in internal medicine at the Massachusetts General Hospital. Jeffery B. Bender is an associate professor of veterinary public health in the College of Veterinary Medicine and has an adjunct appoint in the School of Public Health of the University of Minnesota. He serves as the director of the Center for Animal Health and Food Safety. His main research interests are zoonoses and emerging diseases, food safety, and antimicrobial resistance. Dr. Bender teaches courses on veterinary public health, diseases common to humans and animals, factors in the emergence of zoonotic diseases, methods for epide- 185

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186 A Risk-Characterization Framework for Decision-Making at FDA miologic investigations, and infectious disease surveillance. He has published numerous scientific articles and two book chapters, and he is a diplomate of the American College of Veterinary Preventive Medicine. Dr. Bender received his DVM from the University of Minnesota. Francisco Diez-Gonzalez is an associate professor in the Department of Food Science and Nutrition of the University of Minnesota. His research expertise is in food-safety microbiology, foodborne pathogens, safety of fresh fruits and vegetables, preharvest control of pathogenic E. coli, bioterrorism agents, and safety of organic food. Dr. Diez-Gonzalez teaches courses in food safety and food microbiology. He has served on the University of Minnesota Institutional Biosafety Committee, and he has advised undergraduate and graduate students. He is the author of more than 50 peer-reviewed publications and 10 book chap- ters. He is a member of the Editorial Boards of the Journal of Food Protection and the Journal of Food Analytical Methods. Dr. Diez-Gonzalez received his PhD in food science from Cornell University. Kathryn M. Edwards (IOM) is Sarah H. Sell Chair in Pediatrics and the direc- tor of the Vanderbilt Vaccine Research Program of Vanderbilt University Medi- cal Center. Her research focuses on the evaluation of vaccines for the prevention of infectious diseases in adults and children. She is a fellow of the Infectious Diseases Society of America and the American Academy of Pediatrics. Dr. Ed- wards has served as a member of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration. She is a member of the Institute of Medicine, a member of the National Academies Committee on Special Immunizations Program for Labora- tory Personnel Engaged in Research on Countermeasures for Selected Agents, and a past member of the National Academies Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. Dr. Edwards received her MD from the University of Iowa College of Medicine. Susan S. Ellenberg is professor of biostatistics and associate dean for clinical research in the University of Pennsylvania School of Medicine. Her research focuses on the design and analysis of clinical trials and the assessment of medi- cal-product safety. Dr. Ellenberg is associate editor of Clinical Trials and of the Journal of the National Cancer Institute. She is a fellow of the American Statis- tical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science. She has served as a member of the National Academies Planning Committee for the IOM Drug Safety Report: Resource Implications, Committee on the Assessment of the U.S. Drug Safety System, and Committee on Applied and Theoretical Statistics. Dr. Ellenberg received her PhD in mathematical statistics from George Washington University.

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Appendix D 187 Paul S. Fischbeck is professor of social and decision sciences, professor of en- gineering and public policy, and director of the Center for the Study and Im- provement of Regulation in Carnegie Mellon University. His research focuses on the quantification and communication of uncertainty, including theoretical improvements in decision analysis and numerous applied real-world problems. Dr. Fischbeck has written extensively on various applications of decision and risk-analysis methods and has won several awards from the Institute for Opera- tions Research and the Management Sciences. He is a member of the National Research Council Marine Board and has served on several committees, includ- ing the Committee on Marine Salvage Response Capability: A Workshop and the Committee on Risk Assessment and Management of Marine Systems. Dr. Fischbeck received his PhD in industrial engineering and engineering manage- ment from Stanford University. Karen E. Jenni is president of Insight Decisions LLC, focusing on the applica- tion of decision analysis methods to energy and environmental policy issues. Much of that work emphasizes the assessment, quantification, and modeling of a variety of risks and leads to recommendations about productive areas for applied research and effective risk-management strategies. Recent public-sector projects include participation in a probabilistic volcanic-hazard analysis for the Yucca Mountain region and a multidisciplinary study of a selenium mobilization from large-scale ground disturbances, transport through environmental media, and potential effects on biota. She served as a consultant to the National Academies committee that produced Prospective Evaluation of Applied Energy Research and Development at DOE (Phase Two). Dr. Jenni earned her PhD in engineering and public policy from Carnegie Mellon University. Helen H. Jensen is a professor of economics and head of the Food and Nutri- tion Policy Division of the Center for Agricultural and Rural Development of Iowa State University. Her research fields are food and nutrition policy, analysis of food-consumption behavior, economics of food safety and hazard control. She has been a member of the Board of Directors of the Agricultural and Ap- plied Economics Association and the American Council on Consumer Interests and has served on the editorial boards of a number of professional journals. Dr. Jensen serves or has served on several National Academies committees, includ- ing the Institute of Medicine Committee to Review Child and Adult Care Food Program and Meal Requirements and the National Research Council Committee on Assessing the Nation’s Framework for Addressing Animal Diseases, the Committee on Biological Threats to Agricultural Plants and Animals, the Board on Agriculture Panel on Animal Health and Veterinary Medicine, and the Com- mittee on National Statistics Panel to Review USDA’s Measurement of Food Insecurity and Hunger. She is a member of the World Health Organization Ini- tiative to Estimate the Global Burden of Foodborne Diseases, Foodborne Dis- ease Burden Epidemiology Reference Group. Dr. Jensen received her PhD in agricultural economics from the University of Wisconsin-Madison.

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188 A Risk-Characterization Framework for Decision-Making at FDA L. Robin Keller is a professor of operations and decision technologies at the University of California, Irvine. Her research is in decision analysis, risk analy- sis, creative problem-structuring, and behavioral decision theory. She is the edi- tor-in-chief of Decision Analysis. Dr. Keller has served as program director for the Decision, Risk, and Management Science Program of the U.S. National Sci- ence Foundation, and she has conducted studies with the U.S. Environmental Protection Agency and the Department of Energy. She has served as a member of the National Research Council Committee to Assess the Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident, and she is a member of the U.S. National Committee for the International Institute for Applied Systems Analysis. Dr. Keller received her PhD from the University of California, Los Angeles. James D. Mckean is an extension veterinarian and professor in the Department of Veterinary Diagnostic and Production Animal Medicine and associate direc- tor of the Iowa Pork Industry Center at Iowa State University. His interests in- clude the assessment and prevention of chemical and drug residues in feed and food animals, quality assurance, food safety, food law, pseudorabies control, and animal welfare and well-being. At Iowa State University’s Food Safety Consor- tium, his research involves sulfamethazine depletion in market-weight swine, medical and feed management for sulfamethazine, and comparing sul- famethazine depletion with sulfamethazine activity from previous experiments. Dr. McKean has previously served on several national committees on govern- ment policy development, including the Swine Futures Team, the Task Force on the Future of FSIS Veterinarians, and, as chair, the American Association of Swine Veterinarians Pork Safety Committee. He has also served as a member of the National Research Council Committee on Implications of Dioxin in the Food Supply. Dr. McKean earned his JD from Drake University and his DVM from the University of Illinois. David O. Meltzer is an associate professor in the Department of Medicine, chief of the Section of Hospital Medicine, and an associate faculty member of the Harris School and the Department of Economics of the University of Chi- cago. He is also director of the Center for Health and the Social Sciences and codirector of the Program on Outcomes Research Training. Dr. Meltzer’s re- search explores problems in health economics and public policy with a focus on theoretical foundations of medical cost-effectiveness analysis and the effects of managed care and medical specialization on the cost and quality of care. He is the recipient of numerous awards, including the National Institutes of Health Medical Scientist Training Program Fellowship, the National Science Founda- tion Graduate Fellowship in Economics, and the Lee Lusted Prize of the Society for Medical Decision Making, of which he is the immediate past president. Dr. Meltzer has served on several National Academies committees, most recently the Committee on the Assessment of the U.S. Drug Safety System and the

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Appendix D 189 Committee on Establishing a National Cord Blood Stem Cell Bank Program. He received his MD and his PhD in economics from the University of Chicago. Sanford A. Miller is a senior fellow of the Joint Institute for Food Safety and Applied Nutrition of the University of Maryland. He was named professor and dean emeritus of the Graduate School of Biomedical Sciences of the University of Texas Health Science Center in December 2000 after serving as dean from 1987 to 2000. He is a former director of the Center for Food Safety and Applied Nutrition of the Food and Drug Administration. Dr. Miller has served on many national and international government and professional-society advisory com- mittees, including the National Advisory Environmental Health Sciences Coun- cil of the National Institutes of Health and the Joint World Health Organization- United Nations Food and Agriculture Organization Expert Advisory Panel on Food Safety. He is a member of the National Academies Food and Nutrition Board and the Committee on Use of Dietary Supplements by Military Personnel. Dr. Miller received his PhD in physiology and biochemistry from Rutgers, the State University of New Jersey, New Brunswick. Richard Platt is professor and chair of the Department of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. His research focuses on the safety and effectiveness of marketed drugs and vaccines and on infectious diseases in the community and hospital settings. Dr. Platt is a former chair of the Food and Drug Administration Drug Safety and Risk Man- agement Advisory Committee. He is a member of the Advisory Panel for Re- search of the Association of American Medical Colleges and has chaired the Executive Committee of the HMO Research Network, the Epidemiology and Disease Control Study Section of the National Institutes of Health, and the Steering Committee of the Centers for Disease Control and Prevention Office of Health Care Partnerships. He has served on several National Academies com- mittees and is a member of the Roundtable on Evidence-Based Medicine. Dr. Platt received his MD from Harvard Medical School. John T. Watson is a professor of bioengineering at the University of California, San Diego. Formerly, he was director of clinical and molecular medicine at the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and contributed a total of 27 years of service to NIH. Dr. Watson is a me- chanical engineer and physiologist who is interested in finding ways to reduce the time that it takes medical technology to move from a concept into the clinic. The subjects of his research include heart failure, medical-implant design and science, and biomaterials. Dr. Watson is a founding fellow and former president of the American Institute for Medical and Biological Engineering and has re- ceived numerous honors, including membership on the Greatest Engineering Achievements of the 20th Century selection committee and invitations to be a member of the Japanese Kyoto Prize nominating committee and the National Academy of Engineering Draper Prize selection committee. He is a member of

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190 A Risk-Characterization Framework for Decision-Making at FDA the National Academy of Engineering and has participated in several National Research Council activities, including being a speaker at a Workshop on Innova- tion and Invention in Medical Devices and a member of the Committee to De- velop a Research Agenda for Test Methods and Models to Simulate Accelerated Aging of Infrastructure Materials. Dr. Watson earned his PhD from the Univer- sity of Texas Southwestern Medical Center at Dallas.