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B Committee Biographies David R. Challoner, MD (Chair), is vice president for health affairs emeritus of the University of Florida. He previously served as served as dean and pro- fessor of medicine of the St. Louis University School of Medicine from 1975 to 1982 and as the University of Florida vice president for health affairs and chairman of the Board of Directors of Shands Health Care from 1982 to 1998. He is a member of the Institute of Medicine (IOM), in which he served as chairman of the Membership Committee, as a member of the Governing Council, and as foreign secretary from 1998 to 2006. He was instrumental in the founding of the InterAcademy Medical Panel, the first global orga- nization of the world’s medical academies, and served as its cochair. His science-policy positions include appointment by President Reagan to chair the President’s Committee on the National Medal of Science from 1988 to 1990. He served on the Advisory Committee to the director of the National Institutes of Health; on the National Academies’ umbrella Committee on Science, Engineering, and Public Policy; and on the Governing Board of the National Research Council. He was the recipient of the American Medi- cal Association’s Dr. William Beaumont Award in 1982 for “outstanding contributions to the profession of medicine by a physician under the age of 50” and of IOM’s McDermott Medal in 2010 for distinguished service to IOM and the National Academies. Dr. Challoner received his MD cum laude from Harvard Medical School. Gary S. Dorfman, MD, is vice-chairman for research and a professor in the Department of Diagnostic Radiology at Weill Cornell Medical College. He has served as the president of the New England Society of Cardiovascular 279
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280 MEDICAL DEVICES AND THE PUBLIC’S HEALTH and Interventional Radiology, the Radiological Society of Rhode Island, and the Cardiovascular and Interventional Radiology Society (now the Society of Interventional Radiology) and as the chairman of the Board of the Cardiovascular and Interventional Radiology Research and Educational Foundation. Dr. Dorfman has also served as acting chief of the Image Guided Intervention Branch and special assistant to the associate director of the National Cancer Institute (NCI) Cancer Imaging Program. He is a fellow of the Society of Interventional Radiology, the American Heart As- sociation’s Council on Cardiovascular Radiology, the American College of Angiology, and the American College of Radiology. He is on the faculty of the Radiological Society of North America (RSNA) Clinical Trials Method- ology Workshop; is chair of the Clinical and Transitional Science Awards Imaging Working Group’s Clinical Trials Committee, in which capacity he leads the Uniform Protocols for Imaging in Clinical Trials Process; is the organizing faculty member for the RSNA Interventional Oncology Sympo- sium; and was a member of NCI’s Translational Research Working Group and its Writing Committee. Dr. Dorfman received his MD from the Yale University School of Medicine. Barbara Evans, PhD, JD, LLM, is a law professor, codirector of the Health Law and Policy Institute, and director of the Center on Biotechnology and Law at the University of Houston Law Center. She is an adjunct research professor of clinical pharmacology at the Indiana University School of Medicine and an affiliated investigator of the Indiana University Center for Bioethics. Earlier in her career, she was a partner in the international regulatory practice of a large New York law firm and advised clients on US medical-device regulatory matters. She holds a bachelor’s degree in electrical engineering from the University of Texas at Austin, an MS in applied earth science and a PhD in earth sciences from Stanford University, a JD from Yale Law School, and an LLM in health law from the University of Houston, and she completed a postdoctoral fellowship in clinical ethics at the M.D. Anderson Cancer Center. Lazar J. Greenfield, MD, retired as chairman of the Department of Surgery and surgeon-in-chief of University of Michigan Hospitals in 2002 and became interim executive vice-president for medical affairs. He serves as editor-in-chief of Surgery News and associate editor of e.FACS, the Web portal of the American College of Surgeons. He is a member of the In- stitute of Medicine. Dr. Greenfield is board-certified in general, vascular, and cardiothoracic surgery. He has been listed in Best Doctors in America since 1992. Dr. Greenfield is the inventor of the Greenfield vena caval fil- ter for protection against pulmonary embolism, for which he received the
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281 APPENDIX B Jacobson Innovation Award of the American College of Surgeons. From 2003 to 2004, he was on sabbatical at the US Food and Drug Administra- tion’s Center for Devices and Radiological Health, working on a project to improve postmarket surveillance, and he later worked as an adviser to the MedSun program. Dr. Greenfield received his MD with honors from Baylor College of Medicine and completed his surgical training at the Johns Hopkins Hospital. Steven Gutman, MD, MBA, is associate director of the Technology Evalua- tion Center of Blue Cross/Blue Shield. He is also a visiting professor of pa- thology and a founding faculty member of the University of Central Florida College of Medicine. He has more than a decade of experience as chief of the Clinical Laboratory of the Buffalo VA Medical Center and 17 years of experience as a regulatory scientist at the Food and Drug Administration (FDA). He was a founding member and first director of the Office of In Vitro Diagnostic Devices, a unique office in the FDA Center for Devices and Radiological Health, which integrates premarket, compliance, and patient-safety oversight of laboratory tests. He represented the FDA on the Clinical Laboratory Improvement Amendment Committee, the Department of Health and Human Service’s Secretary’s Advisory Committee on Genom- ics, Health and Society (SACGHS), and the Member of the International Standards Organization Technical Committee for Laboratory Tests (ISO-TC 212). At the FDA, Dr. Gutman helped to develop transparent standardized review processes for diagnostic devices, worked to formulate new policy in drug-diagnostic codevelopment, and participated in patient-safety initiatives to capture real-world use of laboratory tests better. Dr. Gutman is a board- certified pathologist with an MD from Cornell University Medical College and an MBA from the State University of New York at Buffalo. Yusuf M. Khan, PhD, is an assistant professor of the University of Con- necticut Health Center in Farmington, Connecticut, and has appointments in the Department of Orthopedic Surgery and the Department of Chemical, Materials, and Biomolecular Engineering. His research focuses on the engi- neering of tissue to address such problems as the treatment of musculoskel- etal defects, particularly bone defects, due to trauma, congenital defects, or other anomalies. Dr. Khan is a member of the American Society for Testing and Materials and holds the positions of program chair of the Orthopaedic Biomaterials Special Interest Group and vice chair of the Biomaterials Edu- cation Special Interest Group for the Society of Biomaterials. His expertise spans biomaterials, cell biology, drug delivery, composite materials fabrica- tion, small-animal surgery, and histology. He holds a PhD in biomedical engineering from Drexel University.
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282 MEDICAL DEVICES AND THE PUBLIC’S HEALTH David Korn, MD, is vice-provost for research of Harvard University and professor of pathology of Harvard Medical School. Earlier, he was senior vice president for biomedical and health-sciences research of the Associa- tion of American Medical Colleges in Washington, DC. Dr. Korn served as Carl and Elizabeth Naumann Professor and dean of the Stanford University School of Medicine from October 1984 to April 1995, and as vice president of Stanford University from January 1986 to April 1995. Before that, he had been professor and chairman of the Department of Pathology at Stanford and chief of the Pathology Service at the Stanford University Hospital since 1968. Dr. Korn has been chairman of the Stanford University Committee on Research and president of the American Association of Pathologists (now the American Society for Investigative Pathology), from which he received the Gold-Headed Cane Award for lifetime achievement in 2003. He was a founder in 1987 and then chairman of the Board of Directors of the California Transplant Donor Network, one of the nation’s largest organ-procurement organizations, and a founder in 2001 of the Association for the Accreditation of Human Research Protection Programs, the only such accrediting body in the United States. He is a member of the Institute of Medicine and a founder of the Clinical Research Roundtable. Dr. Korn has been a member of many National Academies committees and is now cochairman of the Committee on Science, Technology, and Law, on which he has served since its inception. Dr. Korn received his MD from Harvard Medical School. Elizabeth W. Paxton, MA, is the director of Kaiser Permanente’s Surgical Outcomes and Analysis Department, which is responsible for monitoring implant performance. Ms. Paxton was instrumental in the development and implementation of the national Kaiser Permanente orthopedic and cardiac registries, and she manages all operational aspects of the national depart- ment and is responsible for statistical and methodologic consultation, data- base design and management, statistical analyses and reporting of registry findings, and consultation on research design and implementation for five orthopedic and three cardiac implant registries. She serves as reviewer for the American Journal of Sports Medicine. Ms. Paxton earned her MA in psy- chology from San Diego State University and is an industrial–organizational psychology PhD candidate at Northcentral University. Shari Lawrence Pfleeger, PhD, is the director of research of the Institute for Information Infrastructure Protection, a consortium of leading universities, national laboratories, and nonprofit institutions dedicated to strengthening the cyber infrastructure of the United States. She was previously a senior researcher at the RAND Corporation, where she worked on policy and decision-making issues that help organizations and government agencies to
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283 APPENDIX B understand whether and how information technology supports their mis- sion and goals. From 1982 to 2002, Dr. Pfleeger was president of Systems/ Software, Inc., a consultancy specializing in software engineering and tech- nology, and was also a visiting professor of the University of Maryland’s Department of Computer Science. She was founder and director of Howard University’s Center for Research in Evaluating Software Technology and was a visiting scientist of the City University (London) Centre for Software Re- liability, principal scientist of MITRE Corporation’s Software Engineering Center, and manager of the measurement program of the Contel Technology Center. She is associate editor of IEEE Security and Privacy and has served as the associate editor-in-chief of IEEE Software and IEEE Transactions on Software Engineering and as a member of the Editorial Board of Prentice Hall’s Software Quality Institute series. Dr. Pfleeger was an elected member of the Executive Committee of the Technical Council on Software Engineer- ing from 1996 to 2000. She received her PhD in information technology and engineering from George Mason University and an MS in planning and an MA in mathematics from the Pennsylvania State University. William W. Vodra, JD, recently retired from the active practice of law at Arnold & Porter LLP after more than 30 years with the firm. While there, he specialized in crisis management and regulatory issues involving the safety, effectiveness, quality, and marketing of medical products, including pharmaceuticals, biologicals, and medical devices. He led teams defending embattled products and represented companies in Food and Drug Admin- istration (FDA) enforcement proceedings, white-collar criminal investiga- tions, and civil litigation. Before joining Arnold & Porter, Mr. Vodra served at the FDA from March 1974 to April 1979 as the associate chief counsel for drugs. Before that, from January 1971 to March 1979, Mr. Vodra was assistant chief counsel for the Drug Enforcement Administration. While in government, he drafted many agency regulations still in use, including those implementing the Controlled Substances Act of 1970 and FDA’s rules for good manufacturing practices for pharmaceuticals, good laboratory practices, good clinical practices, bioequivalency, and the Orange Book. He received the Drub Enforcement Administration Special Achievement Award in 1973, and FDA Awards of Merit in 1976, 1978, and 1979. Mr. Vodra has authored or coauthored more than 25 published papers and book chapters on legal and regulatory matters. He received his JD from Columbia University. Brian Wolfman, JD, is a visiting associate professor of law and codirector of the Institute of Public Representation of Georgetown University Law School. Professor Wolfman joined the faculty of Georgetown Law School in 2009 after spending nearly 20 years at the national public-interest law firm
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284 MEDICAL DEVICES AND THE PUBLIC’S HEALTH Public Citizen Litigation Group, where he served for the past 5 years as the group’s director. Before that, for 5 years, Professor Wolfman conducted trial and appellate litigation at Legal Services of Arkansas, a rural poverty-law program. Professor Wolfman has handled a broad array of litigation, includ- ing cases involving health and safety regulation, class-action governance, court-access issues, federal pre-emption, consumer law, public-benefits law, and government transparency. In health and safety, he has concentrated on regulation of motor vehicles, consumer products, prescription drugs, and medical devices. Professor Wolf has argued five cases before the Supreme Court (winning four) and has litigated hundreds of other cases before the Supreme Court and in federal and state appellate courts and trial courts around the country. He directed Public Citizen’s Supreme Court Assistance Project, which helps “underdog” public-interest clients to litigate before the Supreme Court. He has testified before Congress and federal rules committees on a variety of issues, and he was an adviser to the American Law Institute’s project on its recently published Principles of the Law of Aggregate Litigation. In addition to his position on the Georgetown law faculty, Professor Wolfman regularly teaches a course on appellate courts at Harvard Law School, and he has previously taught at Stanford, Vanderbilt, and American University law schools. Professor Wolfman received his JD from Harvard University. Kathryn C. Zoon, PhD, is the director of the Division of Intramural Re- search and scientific director of the National Institute of Allergy and Infec- tious Diseases (NIAID), a component of the National Institutes of Health (NIH). Dr. Zoon is a member of the Institute of Medicine and has served on the Committee on US Military Malaria Vaccine Research: A Program Review, the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, and the Forum on Drug Development. She has served in several prominent roles in the government and in research, including being the director of the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER). Dr. Zoon was director of the Division of Cytokine Biology in CBER, principal deputy director of the Cen- ter for Cancer Research at the NIH National Cancer Institute, and deputy director for planning and development of the NIAID Division of Intramural Research. She has received numerous awards, including the BioPharm Per- son of the Year Award in 1992, the NIH Lectureship in 1994, the Sydney Riegelman Lectureship in 1994, the Genetic Engineering News Award for streamlining and improving the regulatory process for biologics and bio- technology products in 1994, the Meritorious Executive Rank Award for sustained superior performance in revitalizing and reorganizing the CBER to meet the challenges of new responsibilities and new technologies in 1994, the National Cancer Patients Grateful Patients Award in 1996, the Rens-
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285 APPENDIX B selaer Polytechnic Institute Alumni Association Fellows Award in 1997, the Department of Health and Human Services (HHS) Secretary’s Award for Distinguished Service as a member of the FDA Reform Legislation Working Group in 1998, the HHS Secretary’s Award for Distinguished Service for outstanding leadership in positioning FDA as an important contributor to the nation’s capability to respond to bioterrorism in 2001, and the HHS Secretary’s Award for Distinguished Service for the Tissue Action Plan Team in 2005. Dr. Zoon received a PhD in biochemistry from the Johns Hopkins University.
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