Appendix B
Biographical Sketches of Workshop Participants

David Blumenthal, M.D., M.P.P., is director of the Harvard University Interfaculty Program for the Improvement of Health Care Policy and Systems, director of the Institute for Health Policy at Massachusetts General Hospital/Partners HealthCare System, and the Samuel O. Thier Professor of Medicine and Health Care Policy at Harvard Medical School. He has served as senior vice president at Boston’s Brigham and Women’s Hospital, a 720-bed Harvard teaching hospital, from 1987 to 1991, as well as executive director of the Center for Health Policy and Management and lecturer on public policy at the John F. Kennedy School of Government at Harvard (1981–1987). During the late 1970s, he served as a professional staff member on Senator Edward Kennedy’s Senate Subcommittee on Health and Scientific Research. He is a member of the Institute of Medicine (IOM) and serves on several editorial boards, including The New England Journal of Medicine, American Journal of Medicine, and the Journal of Health Politics, Policy and Law. He is the founding chairman of the Academy for Health Services Research and Health Policy, the national organization of health services researchers.


Marc M. Boutin, J.D., is the executive vice president and chief operating officer of the National Health Council. He previously served as the executive vice president and prior to that as the vice president, policy development and advocacy. In addition to overseeing financial management and operations at the National Health Council, Mr. Boutin builds consensus among member patient advocacy organizations enabling them to speak with one voice on systemic policy initiatives resulting in legislation and



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Appendix B Biographical Sketches of Workshop Participants David Blumenthal, M.D., M.P.P., is director of the Harvard University Interfaculty Program for the Improvement of Health Care Policy and Sys- tems, director of the Institute for Health Policy at Massachusetts General Hospital/Partners HealthCare System, and the Samuel O. Thier Professor of Medicine and Health Care Policy at Harvard Medical School. He has served as senior vice president at Boston’s Brigham and Women’s Hospital, a 720-bed Harvard teaching hospital, from 1987 to 1991, as well as execu- tive director of the Center for Health Policy and Management and lecturer on public policy at the John F. Kennedy School of Government at Harvard (1981–1987). During the late 1970s, he served as a professional staff member on Senator Edward Kennedy’s Senate Subcommittee on Health and Scientific Research. He is a member of the Institute of Medicine (IOM) and serves on several editorial boards, including The New England Journal of Medicine, American Journal of Medicine, and the Journal of Health Politics, Policy and Law. He is the founding chairman of the Academy for Health Services Research and Health Policy, the national organization of health services researchers. Marc M. Boutin, J.D., is the executive vice president and chief operating officer of the National Health Council. He previously served as the execu- tive vice president and prior to that as the vice president, policy develop- ment and advocacy. In addition to overseeing financial management and operations at the National Health Council, Mr. Boutin builds consensus among member patient advocacy organizations enabling them to speak with one voice on systemic policy initiatives resulting in legislation and 2

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2 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING regulations that address the collective needs of patients and their family caregivers. Throughout Mr. Boutin’s career, he has been highly involved in health advocacy, policy and legislation. He has designed and directed advocacy strategies for legislative initiatives, which have included issues ranging from access to health care to cancer prevention. Before joining the Council, Mr. Boutin most recently served as the Vice President of Govern- ment Relations and Advocacy at the American Cancer Society for New England. In addition, he was a faculty member at Tufts University Medical School, where he lectured on health care policy. David J. Brailer, M.D., Ph.D., holds doctoral degrees in both medicine and economics. He earned his M.D. from West Virginia University and his Ph.D. in economics from The Wharton School. He became board certified in internal medicine after an internship and a residency at the Hospital of the University of Pennsylvania, and practiced in HIV medicine and immune deficiency until 2002. Dr. Brailer was appointed a Charles A. Dana Fellow and a Robert Wood Johnson Clinical Scholar at the University of Pennsylvania. He founded and was chair and chief executive officer (CEO) of CareScience, Inc., which set a new standard for healthcare quality and accountability by developing the nation’s first online physician and hospi- tal quality reports, the first healthcare Internet-based application service provider, and the first health information exchange. Under his leader- ship, the company built a network of hospitals and physicians that is still improving quality of care today. In May 2004, President George W. Bush tapped him to be the nation’s change agent and chief evangelist for health information technology (HIT). Dr. Brailer led federal and private-sector efforts to improve healthcare quality, accountability, and efficiency through widespread deployment of HIT. Dr. Brailer was voted the Most Powerful Person in Health Care by the readers of Modern Healthcare in 2004. In just 2 years, Dr. Brailer set the nation’s healthcare industry on a course toward modernized health information standards, certification of health information tools, state-of-the-art information-sharing architectures, and new policies for protection of consumer privacy. He pushed information technology (IT) solutions for adverse drug events, bioterrorism, pandemic flu, and other public health threats. Having set the foundation for the nation’s digital era of medicine in place, Dr. Brailer left the federal govern- ment to return to the private sector. In May 2007, Dr. Brailer founded and became chair of Health Evolution Partners, a private equity fund focused on transforming the healthcare industry. Health Evolution Partners finances innovative ways for health care to be financed, organized, and delivered. Simon P. Cohn, M.D., M.P.H., is the associate executive director of Health Information Policy for The Permanente Federation, Kaiser Permanente.

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29 APPENDIX B Dr. Cohn has been a leader in Kaiser Permanente’s efforts to develop and implement comprehensive health information systems to support both the delivery of health care and health research. He is a nationally recognized expert on health information policy, including the Health Insurance Por- tability and Accountability Act (HIPAA) Administrative Simplification, healthcare data management, clinical and administrative classifications, and the electronic transmission of healthcare data. Dr. Cohn is chair of the National Committee on Vital and Health Statistics (NCVHS), the statu- tory public advisory committee to the Department of Health and Human Services (HHS) on health information policy, HIPAA, and the national health information infrastructure. He was also a member of the IOM’s Committee on Data Standards for Patient Safety and was a member of the American Medical Association (AMA) Common Procedural Terminology Editorial Panel from 1997 to 2005. In 2002, Dr. Cohn was a recipient of the President’s Award from the American Medical Informatics Association for his contributions to the field and was also elected a Fellow of the Ameri- can College of Medical Informatics. In 2005, he was the recipient of the Leadership in Technology Award from the Workgroup on Electronic Data Interchange in recognition of his national leadership related to healthcare electronic data interchange and e-commerce. Dr. Cohn’s medical specialty is emergency medicine, and he is a Fellow of the American College of Emergency Physicians. Peter A. Covitz, Ph.D., is chief operating officer of the National Cancer Institute (NCI) Center for Bioinformatics in Rockville, Maryland. He previ- ously led the core infrastructure group at the NCI Center for Bioinformat- ics, and was responsible for developing the NCI’s platform for interoperable information systems, a model-driven, service-oriented architecture called caCORE. Prior to joining the NCI, Dr. Covitz was vice president of profes- sional services at InforMax, Inc., where he ran the bioinformatics service and support division of the company. Earlier in his career, Dr. Covitz worked as a research scientist and manager at Incyte Pharmaceuticals and Molecular Applications Group. Dr. Covitz did his graduate work on transcriptional regulation at Columbia University, and postdoctoral train- ing in genomics and bioinformatics at Stanford University. William H. Crown, Ph.D., is president of i3 Innovus, the Health Eco- nomics and Outcomes Research division of Ingenix. From 1982 to 1995, Dr. Crown was a faculty member at the Florence Heller Graduate School, Brandeis University, where he taught graduate courses in statistics and conducted research on the economics of aging and long-term care policy. Prior to joining Ingenix in 2004, Dr. Crown was vice president of Outcomes Research and Econometrics at Medstat, where he conducted numerous

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20 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING retrospective database analyses of the burden of illness associated with various diseases—particularly respiratory and mental health conditions. Dr. Crown’s work in the area of depression was one of the first applications of econometric techniques in outcomes research to control for the effects of selection bias when using retrospective data to evaluate drug technolo- gies. He has 25 years of experience conducting health policy and income maintenance research for private- and public-sector clients. Dr. Crown is author or coauthor of 4 books and more than 90 refereed journal articles, book chapters, and other publications. Carol C. Diamond, M.D., M.P.H., is the managing director of the Health Program of the Markle Foundation and chairs Connecting for Health, a public-private collaborative working to realize the full potential of infor- mation technology in health and health care in the United States. Con- necting for Health engages more than 100 diverse organizations and institutions in an approach rooted in core values, including achieving medical excellence, fostering patient participation, and protecting per- sonal privacy. Before joining the Markle Foundation, Dr. Diamond was president of U.S. Quality Algorithms® (USQA®), Aetna U.S. Healthcare’s performance measurement affiliate. Prior to joining USQA, Dr. Diamond was a consultant for Johnson & Johnson (J&J) Health Care Systems and The Robert Wood Johnson Foundation (RWJF). Dr. Diamond sits on the American Academy of Family Physicians (AAFP) Public Advisory Board and the Electronic Health Record Safety Institute Advisory Board of the Geisinger Center for Health Research, and is a member of the IPRO Advi- sory Board for the Centers for Medicare & Medicaid Services’ Doctor’s Office Quality-Information Technology (DOQ-IT) project in New York. Dr. Diamond earned her dual B.A./M.D. at the Medical School of the State University of New York at Brooklyn and her master’s degree in public health at the University of Medicine and Dentistry of New Jersey, part of Rutgers University. Mary L. Durham, Ph.D., is the director of the Center for Health Research (CHR) and Vice President/Research for Kaiser Permanente. In addition to her leadership roles, Dr. Durham conducts her own research on workplace health and translational research. She has designed and conducted research studies with employers as partners in the research, such as the Work, Fam- ily Health Network, and has over 20 years of hands-on content knowledge and experience in workplace policies and practices. Dr. Durham is also the Associate Director of the Oregon Clinical and Translational Research Insti- tute, (OCTRI), one of the first 12 NIH Clinical and Translational Science Awards. In a unique partnership with Oregon Health & Science University, CHR role in OCTRI contributes to the science of translating research to

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2 APPENDIX B practice and developing strong interactions between discovery and dis- semination. In tandem with her distinguished health research career, Dr. Durham has worked with state and federal lawmakers in crafting policy- level decisions across a wide range of topics, such as privacy, mental health law, genetics, research, and human subjects protection. She was a Com- missioner for the State of Oregon’s Senate Commission for Health Care Access and Affordability. She has had diverse roles, from providing expert testimony to the President’s National Bioethics Advisory Commission to consulting to the World Health Organization. Dr. Durham has served on the boards of the Association for Health Services Research (Academy Health), Group Health Community Foundation, and Kaiser Permanente Health Care Alternatives. A professor in the Department of Public Health and Preventive Medicine at the Oregon Health & Science University, Dr. Durham is also an adjunct professor in the Department of Sociology at Portland State University. She is a former commissioner of the American Bar Association, where she served on the ABA’s Commission on Mental and Physical Disability Law. Dr. Durham received her Ph.D. in sociology from the University of Oklahoma in 1978, specializing in medical sociology. Before moving to Portland, she was deputy director of Group Health Cooperative of Puget Sound Center for Health Studies and on the faculty at the University of Washington School of Public Health and Community Medicine, in the Department of Health Services. Alexander D. Eremia, J.D., LL.M., is associate general counsel and chief privacy officer for MedStar Health, Inc., one of the largest providers of healthcare services in the Mid-Atlantic region. MedStar Health has more than 25,000 employees and 5,000 affiliated physicians. Mr. Eremia provides legal guidance to the MedStar Health system on a wide range of regulatory and compliance matters, including implementation of Office of Inspector General (OIG) workplan initiatives, the regulatory requirements for clinical research, laboratory activities, Nuclear Regulatory Commission regulations, and the health information privacy and security requirements under HIPAA. He also serves as legal counsel to the various corporate committees charged with oversight of these functions. In addition, Mr. Eremia provides general legal counsel to the physicians and staff on many other legal issues, includ- ing contracting, employment, litigation/subpoenas, mental health law, and patient care issues, among others. Mr. Eremia came to MedStar Health from the Civil Recoveries Branch in the Office of Counsel to the Inspector Gen- eral, OIG, HHS, where he was an associate counsel. During this period, he was also appointed as a special assistant U.S. attorney for the Eastern Dis- trict of Virginia to prosecute healthcare fraud matters. He received his J.D. from DePaul College of Law with certification as a health lawyer; he was a

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22 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING staff writer on the Journal of Health Law at DePaul. He received his LL.M. (Master of Laws, Health Law) from Loyola University–Chicago School of Law, where he was awarded the LL.M. Fellowship and was senior editor of the Annals of Health Law. Lynn M. Etheredge is an independent consultant working on healthcare and social policy issues. His career started at the White House Office of Management and Budget (OMB). During the Nixon and Ford administra- tions, he was OMB’s principal analyst for Medicare & Medicaid and led its staff work on national health insurance proposals. He returned to OMB as a senior career executive and headed its professional health staff in the Carter and Reagan administrations. He was a coauthor of the Jackson Hole Group’s proposals for healthcare reform and a cofounder of the Health Insurance Reform Project at George Washington University. During the past several years, Mr. Etheredge has authored policy studies about Medicare reform, Medicaid, evidence-based medicine (EBM), and expanding health insurance coverage. His current projects include: (1) developing a “tax credits + Medicaid” model for health insurance coverage; (2) assessing the role of technology in health sector changes; and (3) developing a national rapid learning system for new technologies, including the use of electronic health records. He is author of more than 70 publications and is a graduate of Swarthmore College. Christopher B. Forrest, M.D., Ph.D., serves as senior vice president and chief transformation officer at the Children’s Hospital of Philadelphia (CHOP). He is leading the development of the Institute to Transform and Advance Children’s Healthcare (iTACH). The goals of iTACH are to harness clinical and business information to improve children’s health, make their health care more efficient, and transform the delivery system. Dr. Forrest is a general pediatrician and professor of pediatrics in the Division of General Pediatrics at the University of Pennsylvania School of Medicine. He lectures on transforming health care, health information technology innovations, and child health. Dr. Forrest has methodological expertise in health services and outcomes research and evaluation, health status assessment of children and adolescents, primary care, and use of health informatics to improve child health. He has authored numerous scientific manuscripts and reviews, and his research is supported by a broad mix of public, foundation, and private funders. Dr. Forrest received his B.A. and M.D. at Boston University as part of a dual-degree program. He trained in pediatrics at CHOP, where he also served as chief resi- dent. He completed a Ph.D. in health services research at Johns Hopkins University.

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2 APPENDIX B Carmen Hooker Odom, M.R.P., is president of the Milbank Memorial Fund. She was appointed as secretary of the North Carolina Department of Health and Human Services by Governor Mike Easley in 2001. Ms. Hooker Odom, a former Massachusetts lawmaker and healthcare lobbyist, has spent her professional life working in health and human services. Prior to her appointment, she served as vice president of government relations for Quintiles Transnational Corporation in Research Triangle Park and as the group vice president for Carolinas HealthCare System. She is also an adjunct professor at the University of North Carolina School of Public Health. From 1995 to 1996, Ms. Hooker Odom worked as a project officer for the Milbank Memorial Fund, a New York–based foundation that conducts nonpartisan analysis, study, and research on significant issues in health policy. Prior to moving to North Carolina in 1995, Ms. Hooker Odom served as a member of the Massachusetts House of Representatives for nearly 11 years. She was the primary legislative author of both the 1991 Massachusetts comprehensive health reform legislation and the Children’s Medical Security Plan, which targeted young children not covered by medi- cal insurance. Ms. Hooker Odom cochaired the North Carolina Health Care Reform Commission and is a member of the North Carolina Institute of Medicine. She received a bachelor’s degree in sociology and political science from Springfield College and a master’s degree in regional planning from the University of Massachusetts at Amherst. Courtney Hudson, M.B.A., cofounded EmergingMed in 2000 after spend- ing 3 years as a health services analyst and institutional sales representative with CIBC Oppenheimer. Prior to joining Oppenheimer, Ms. Hudson was cofounder and vice president of business development and information sys- tems with a multistate, Medicaid-focused health maintenance organization (HMO) start-up. In addition to two other HMO start-ups, Ms. Hudson has worked for a variety of academic medical centers and county public health agencies and clinics, where she cultivated expertise in the design and operation of efficient healthcare delivery systems for vulnerable popula- tions. Ms. Hudson holds an M.B.A. (supplemented with extensive training through the School of Public Health) from the University of Washington as well as a B.S. in biology from Yale University. George Isham, M.D., M.S., is the Chief Health Officer and Plan Medical Director at HealthPartners where he is responsible for quality, utiliza- tion management, health promotion and disease prevention, research, and health professionals’ education at HealthPartners. He is active in strategic planning and policy issues. He is a founding board member of the Institute for Clinical Systems Improvement, a collaborative of Twin Cities medical groups and health plans that is implementing clinical practice guidelines

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2 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING in Minnesota. Isham is a past member of the board of directors of the American’s Health Insurance Plans and he is currently on the board of directors of the Alliance of Community Health Plans. He is past co-chair and current member of the National Committee for Quality Assurance’s (NCQA’s) Committee on Performance Measurement which oversees health plan quality measurement standards. He has served on the Center for Dis- ease Control’s (CDC’s) Task Force on Community Preventive Services and on the Agency for Healthcare Research and Quality’s (AHRQ’s) Advisory Board for the National Guideline Clearinghouse. He has served on the Institute of Medicine’s Board on Population Health and Public Health Services and chaired the committee that authored the report Priority Areas for National Action, Transforming Health Care Quality. In 2003, Isham was appointed as a lifetime National Associate of the National Academies of Science in recognition of his contributions to the work of the Institute of Medicine. Epidemic of Care, published in April 2003, with co-author George Halvorson, is Isham’s examination of the impending healthcare crisis with suggestions on ways to solve it. Prior to his current position, Isham was medical director for MedCenters Health Plan in Minneapolis and executive director for University Health Care, Inc., in Madison, Wis- consin. His practice experience as a primary care physician includes eight years at the Freeport Clinic in Freeport, Illinois, and 3 and one-half years as clinical assistant professor in Medicine at the University of Wisconsin. Dr. Isham has a B.A. in Zoology and completed his doctoral training at the University of Illinois followed by an internship and residency at the University of Wisconsin in Madison. Peter Juhn, M.D., Ph.D., is responsible for shaping EBM policies at the J&J corporate level, especially as payers use EBM as a basis for decisions on reimbursement and coverage of pharmaceuticals and medical devices. He works with the various J&J operating companies on a global basis to anticipate the methods and types of evidence needed in this evolving payer environment. He also provides policy coverage for developments in new regulations for advanced therapies, HIT initiatives, and “pay-for-perfor- mance” programs. He is a member of the Agency for Healthcare Research and Quality (AHRQ) Effective Healthcare Program Stakeholder Group and is the industry representative on the Medicare Evidence Development and Coverage Advisory Committee. Most recently, he was vice president, Health Improvement Resources, at WellPoint Health Networks, where he managed the disease management programs for all the operating units. He also held senior positions at Kaiser Permanente, including founding executive direc- tor, Care Management Institute, Kaiser’s corporate disease management and clinical policy entity, and president and CEO of CareTouch, Inc., an e-health start-up venture. He has a B.A. from the University of Chicago,

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2 APPENDIX B an M.D. from Harvard, and an M.P.H. from the University of Washington, where he was a Robert Wood Johnson Clinical Scholar. He completed his internal medicine residency at the University of Pennsylvania. Jim Karkanias is a partner and the senior director of Applied Research and Technology at Microsoft Corporation. His background is in science, engineering, technology, and business. Formally trained as a researcher, Mr. Karkanias began his career in the labs as a bench scientist conducting neuroscience research for McNeil Pharmaceutical, a subsidiary of J&J. His research continued across several labs and companies, including Merck Research Laboratories. His preclinical research career expanded to encom- pass clinical research in the neurosciences and graduate work in bioengi- neering, spanning neuroplasticity, sensorium integration, pain modulation, cognition, memory, and network theory. Mr. Karkanias also developed significant technical skills in computer hardware and software to help streamline his activities. This led to a position with Merck’s Worldwide Clinical Information Systems, where he managed a group that created the systems infrastructure necessary to conduct research. The group’s most notable innovation was a distributed system that allowed for the remote collection of data from physicians, which in 1993 predated both distributed system environments and the widespread use of the Internet as a business tool. He is now applying his skills in the Health Solutions Group, which aims to revolutionize health care through paradigm-shifting approaches that integrate next-generation business, process, and technology. He has a B.S. in neuroscience from Rutgers University and did graduate work in bio- engineering, with a specialization in artificial intelligence, at the University of Pennsylvania and Drexel University. Brian J. Kelly, M.D., M.B.A., M.S., is executive director in Accenture’s Health & Life Sciences division, focusing on the federal health market. He also serves as the lead for Accenture’s Global Electronic Health Record practice. He joined Accenture in 2003 after retiring from the Navy Medical Corps and concentrates on helping governments and commercial organiza- tions optimize health care through effective business process transformation and the appropriate use of information technology. He has done work for HHS, Medicare, and a variety of commercial health plans and pharmaceu- tical companies. During his 20-year career in the Navy, he held a variety During of clinical (hospital-based and operational) and teaching positions, and he provided clinical leadership within the Department of Defense in the fields of medical informatics and HIPAA. Dr. Kelly has an M.D. from New York Dr. Medical College, an M.B.A. from George Washington University, an M.S. in bioengineering from Clemson University, and a B.A. in Russian/pre-Med from Holy Cross College. He received his residency training in neurology at

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2 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING Bethesda Naval Hospital and fellowship training in critical care medicine at the University of California–San Francisco. He is an associate profes- sor of neurology and informatics at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and an associate professional lecturer in the School of Business and Public Management at George Wash- ington University. Pierre-André La Chance is the chief information officer and the research privacy officer for the Kaiser Permanente Center for Health Research. He also serves as a compliance consultant to the Kaiser Permanente National Research Council. Additionally, Mr. La Chance is the codirec- tor of biomedical informatics for the Oregon Clinical and Translational Research Institute, a partnership between TCHR and Oregon Health & Science University. Across his various roles, one of Mr. La Chance’s primary accountabilities is data warehousing as it applies to sustain- able, rapid, cheap, safe, and high-quality data sharing across numerous research institutions. Michael Lauer, M.D., joined the National Heart, Lung, and Blood Institute (NHLBI) in 2007 as director of the Division of Prevention and Population Science. A board-certified cardiologist, he received his M.D. from Albany Medical College in 1985 and underwent postgraduate training within the Harvard University system at Massachusetts General Hospital, Boston Beth Israel Hospital, and the Harvard School of Public Health. After complet- ing specialized research training in cardiovascular epidemiology at the Framingham Heart Study, he joined the staff at the Cleveland Clinic in 1993. During 14 years at the clinic, he established a world-renowned clinical epidemiology research program with primary focus on diagnostic testing and comparative effectiveness. His research led to more than 150 publications in top medical journals, grant support from the American Heart Association and the National Institutes of Health (NIH), and election to the American Society of Clinical Investigation. Dr. Lauer has served as contributing editor for the Journal of the American Medical Association, co-director of the Cleveland Clinic Coronary Care Unit, director of cardiac clinical research, and first vice chair of the Cleveland Clinic Institutional Review Board. He achieved distinction in medical education, leading the development of a clinical research curriculum at the newly founded Cleve- land Clinic Lerner Medical College at Case Western Reserve University, where he was professor of medicine, epidemiology, and biostatistics. In his current position at NHLBI, Dr. Lauer is leading a $300 million per year research division that oversees major programs in cardiovascular epidemiol- ogy and prevention.

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2 APPENDIX B Cato T. Laurencin, M.D., Ph.D., is the Lillian T. Pratt Professor and Chair of Orthopedic Surgery, university professor, and professor of biomedical engineering and chemical engineering at the University of Virginia (UVa). Prior to his appointment at UVa’s Department of Biomedical Engineering, he was at Drexel University as the Helen I. Moorehead Professor of Chemi- cal Engineering, and clinical associate professor of Orthopedic Surgery at The Medical College of Pennsylvania and Hahnemann University School of Medicine. Dr. Laurencin attended Princeton University, where he received his B.S.E. in chemical engineering, pursuing a topical program in polymer science and engineering. On completion of his undergraduate program, Dr. Laurencin began pursuing research at Massachusetts Institute of Tech- nology (MIT), earning a Ph.D. in biochemical engineering/biotechnology. In parallel with his research training, Dr. Laurencin attended the Harvard Medical School, graduating magna cum laude. While directing his MIT lab- oratory, Dr. Laurencin undertook clinical residency training in orthopedic surgery at Harvard, and served as chief resident in orthopedic surgery at the Beth Israel Hospital, Harvard Medical School. Dr. Laurencin subsequently completed fellowship training in shoulder surgery and sports medicine at the Hospital for Special Surgery in New York, Cornell University, working with the team physicians for the New York Mets, and St. John’s University. The focus of Dr. Laurencin’s research is novel methods for bone and musculo- skeletal tissue engineering and polymeric systems for drug delivery. Arthur A. Levin, M.P.H., is cofounder and director of the Center for Medical Consumers, a New York City–based nonprofit organization committed to informed consumer and patient healthcare decision making; patient safety; evidence-based, high-quality medicine; and healthcare system transparency. Mr. Levin was a member of the IOM Committee on the Quality of Health Care that published To Err Is Human and Crossing the Quality Chasm. He has served on several other IOM committees and is a member of the IOM Board on Health Care Services. Mr. Levin serves on the National Committee for Quality Assurance’s (NCQA’s) Committee on Performance Measures and is a member of the National Quality Forum Consensus Standards Approval Committee. He has just completed a 4-year term as the consumer represen- tative member of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and continues to serve on select FDA advisory committees as a consultant expert in drug safety and risk management, representing consumers. John (Jack) C. Lewin, M.D., has been CEO of the American College of Cardiology (ACC) since 2006. Under Dr. Lewin’s leadership, ACC has aspired to contribute significantly to national leadership in advocacy related to expanding access to care for uninsured persons, and in reform-

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2 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING ing Medicare, Medicaid, and the financing and delivery of quality health care. These efforts are part of ACC’s mission to promote “heart health” and reductions in cardiovascular morbidity and mortality worldwide. Before coming to ACC, Dr. Lewin was CEO of the California Medical Association and its subsidiaries. He was also Hawaii’s director of health from 1986 to 1994. In this role, he helped Hawaii achieve near-universal access to health care and revitalize statewide public health systems. In Hawaii, he was also CEO of the statewide 13-facility Community Hospital System. As a com- missioned officer in the U.S. Public Health Service, he was the founder and first director of the Navajo Nation Department of Health, serving the needs of America’s largest Indian tribe, straddling the three states of Arizona, New Mexico, and Utah. Trained in internal medicine, Dr. Lewin has also enjoyed many years of practicing primary care medicine during his career in Arizona, Hawaii, and California. He serves on numerous national boards and advisory bodies, including being founder and president of the Physicians’ Foundations. He received his B.A. in biological sciences from the University of California–Irvine, and his M.D. from the University of Southern California. William D. Marder, Ph.D., is senior vice president and general manager of the research and pharmaceutical units of Thomson Healthcare. Dr. Marder is a health economist whose work has focused on issues pertaining to physician behavior and medical markets. He is responsible for directing Thomson Healthcare’s research, and database development services for the federal government, private research, and policy development organiza- tions, and the pharmaceutical/medical technology industry. For the past 12 years, Dr. Marder has been responsible for developing and enhancing Thomson Healthcare’s MarketScan® databases. As a professional econo- mist and health services researcher, Dr. Marder has written on a variety of topics. His articles have been published in numerous scholarly journals, including the American Journal of Public Health, Inquiry, Journal of Health Economics, Journal of Human Resources, and Medical Care. Recently, his work has examined trends in spending and use for the privately insured U.S. population, with special focus on the interaction of clinical and economic incentives in healthcare delivery. He holds a Ph.D. in economics from the University of Chicago. He is a past president of the Illinois Economics Association and chair of the Health Economics Committee of the American Public Health Association. Elliot E. Maxwell, J.D., advises public- and private-sector clients on stra- tegic issues involving the intersection of business, technology, and public policy in the Internet and e-commerce domains. He is a Fellow of the communications program at Johns Hopkins University and Distinguished

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29 APPENDIX B Research Fellow at the eBusiness Research Center of Pennsylvania State University. From 1998 until 2001, Mr. Maxwell served as special adviser for the digital economy, including the Internet and e-commerce, to U.S. Secretary of Commerce William Daley and U.S. Secretary of Commerce Norm Mineta. After leaving the government in 2001, he was senior fellow for the Digital Economy and director of the Internet Policy Project for the Aspen Institute. Previously Mr. Maxwell worked for a number of years as a consultant and as assistant vice president for corporate strategy of Pacific Telesis Group. He has served at the Federal Communications Com- mission as special assistant to the chair, deputy chief of the Office of Plans and Policy, and deputy chief of the Office of Science and Technology. He also worked for the U.S. Senate as senior counsel to the U.S. Senate Select Committee on Intelligence Activities. Mr. Maxwell graduated from Brown University and Yale University Law School. Mark B. McClellan, M.D., Ph.D., became director of the Engelberg Center for Healthcare Reform at the Brookings Institution in 2007. The center studies ways to provide practical solutions for access, quality, and financing challenges facing the U.S. healthcare system. In addition, Dr. McClellan is the Leonard D. Schaeffer Chair in Health Policy Studies. Dr. McClellan has a highly distinguished record in public service and in academic research. He is the former administrator for the Centers for Medicare & Medicaid Services (CMS) (2004–2006) and the former commissioner of the FDA (2002–2004). He also served as a member of the President’s Council of Economic Advisors and senior director for healthcare policy at the White House (2001–2002). In these positions, he developed and implemented major reforms in health policy. Dr. McClellan was also an associate pro- fessor of economics and associate professor of medicine (with tenure) at Stanford University, from which he was on leave during his government service. He directed Stanford’s Program on Health Outcomes Research and was also associate editor of the Journal of Health Economics, and coprincipal investigator of the Health and Retirement Study, a longitudinal study of the health and economic status of older Americans. His academic research has been concerned with the effectiveness of medical treatments in improving health; the economic and policy factors influencing medical treatment decisions and health outcomes; the impact of new technologies on public health and medical expenditures; and the relationship between health status and economic well-being. Dr. McClellan is a member of the IOM and a research associate at the National Bureau of Economic Research. A graduate of the University of Texas–Austin, Dr. McClellan earned his M.P.A. from Harvard’s Kennedy School of Government in 1991, his M.D. from the Harvard–MIT Division of Health Sciences and Technol- ogy in 1992, and his Ph.D. in economics from MIT in 1993.

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290 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING J. Michael McGinnis, M.D., M.P.P., a longtime contributor to national and international health policy leadership, is now senior scholar at the IOM, and executive director of the IOM Roundtable on Evidence-Based Medicine. He is also an elected member of the IOM. He previously was senior vice president at RWJ, and, unusual for political posts, held con- tinuous appointment through the Carter, Reagan, (George H.W.) Bush, and Clinton administrations, with responsibility for coordinating activities and policies in disease prevention and health promotion. Programs and policies created and launched at his initiative include: the Healthy People process setting national health objectives, the U.S. Preventive Services Task Force, the Dietary Guidelines for Americans (with the U.S. Department of Agriculture), the Ten Essential Serices of Public Health, the RWJF Health and Society Scholars Program, the RWJF Young Epidemiology Scholars Program, and the RWJF Actie Liing family of programs. Internationally, he chaired The World Bank/European Commission Task Force on postwar reconstruction of the health sector in Bosnia, and worked both as field epidemiologist and state coordinator for the World Health Organization’s successful smallpox eradication program in India. Peter M. Neupert, M.B.A., is corporate vice president for health strategy at Microsoft Corporation and is responsible for Microsoft’s collaboration with the healthcare ecosystem to address global infrastructure issues of sig- nificant scale. Before rejoining Microsoft, Mr. Neupert served as president and CEO of Drugstore.com, Inc., from 1998 to 2001, and then as chair of the board of directors from 1999 to 2004. He led Drugstore.com to become a top online retail store and information site for health, wellness, beauty, and pharmacy products. Mr. Neupert served in various capacities at Microsoft from 1987 to 1998. He started at Microsoft as the director of operating systems responsible for shipping OS/2, and later was responsible for MSNBC as vice president of news and publishing for the interactive media group. He served on President George W. Bush’s Information Tech- nology Advisory Committee (PITAC) from 2003 to 2005. On that com- mittee, he cochaired the Health Information Technology subcommittee and helped drive the report Reolutionizing Health Care Through Information Technology, published in 2004 by PITAC. In 2000, Mr. Neupert received an Ernst & Young Entrepreneur of the Year award for his work at Drugstore. com. He holds a bachelor’s degree from Colorado College and an M.B.A. from the Tuck School of Business at Dartmouth College. James M. Ostell, Ph.D., is chief of the Information Engineering Branch (IEB) of the National Center for Biotechnology Information (NCBI) at the NIH. The IEB is responsible for designing, building, and deploying nearly all the production resources at the NCBI, including PubMed, PubMed Central,

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29 APPENDIX B GenBank, BLAST, RefSeq, OMIM, dbSNP, dbGaP, and many others. The NCBI is one of the most heavily used biomedical information websites in the world, supporting millions of users a day at rates up to 5,000 hits a second. Dr. Ostell received his Ph.D. in cellular and developmental biology from Harvard University. He then wrote a commercially successful molecu- lar biology software package. He joined the NIH and created the IEB when the NCBI was founded in 1988 and has run it ever since. Dr. Ostell was recently elected to the IOM. Steve E. Phurrough, M.D., M.P.A., is director of the Coverage and Analysis Group at CMS. Using EBM principles, Dr. Phurrough assists in developing national policy on the appropriate devices, diagnostics, and procedures that should be provided by the Medicare program. Dr. Phurrough joined CMS in 2001 as the director of the Division of Medical and Surgical Services in the Coverage and Analysis Group after completing a long, distinguished career in the U.S. Army. In addition to being a practicing family practitioner, his military career also included managing Department of Defense regional healthcare delivery systems, creating national and international healthcare policy for the Army, and developing practice guidelines. Dr. Phurrough received his M.D. from the University of Alabama in Birmingham and an M.P.A. from the University of Colorado in Colorado Springs. He is board certified by the American Board of Family Practice and is a certified physi- cian executive by the American College of Physician Executives. Barbra G. Rabson, M.P.H., has been the executive director of the Massa- chusetts Health Quality Partners (MHQP) since 1998. Under Ms. Rabson’s leadership, MHQP has become a trusted source of physician performance information in Massachusetts, and MHQP is nationally recognized for its collaborative approach to collecting and reporting performance information to improve care. MHQP is one of six quality coalitions selected nationwide to be an AQA/BQI pilot site for aggregating commercial and Medicare claims data. Ms. Rabson was the principal investigator for the RWJF Rewarding Results grant awarded to MHQP to evaluate how financial and nonfinancial incentives impact the quality of care. Ms. Rabson is a founding member of the Network for Regional Healthcare Improvement, a national network of regional quality collaboratives. She serves on the Board of the Massachusetts eHealthCollaborative, and is a member of Health Care for All’s Advisory Committee on Quality Initiatives. Ms. Rabson brings broad-based experience from the managed-care, hospital, and healthcare arenas to her collaborative role at MHQP. She received her undergraduate degree from Brandeis Uni- versity and her M.P.H. from Yale University. She was selected to participate in the Executive Leadership Development Program at the Hauser Center for

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292 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING Nonprofit Organizations, where she studied strategy and nonprofit leadership at the Kennedy School of Government at Harvard University. Alison Rein, M.S., is a senior manager at AcademyHealth. She works on several projects related to quality improvement and consumer engage- ment, primarily within AHRQ’s Knowledge Transfer program. Ms. Rein also serves as the AcademyHealth project manager for the AHRQ Quality- Based Purchasing Knowledge Transfer project, and is working to expand AcademyHealth’s involvement in state and national efforts to integrate health information exchange systems into the U.S. healthcare system. She serves on a number of advisory bodies related to health information exchange, including the Confidentiality, Privacy, & Security workgroup of the American Health Information Community, and the Health Information Protection Taskforce of the State Alliance for e-Health. Prior to joining AcademyHealth, Ms. Rein was assistant director of food and health policy at the National Consumers League, where she represented consumer interests in a variety of issues. Ms. Rein served as a healthcare consultant to a number of private and non- profit organizations, for which she conducted strategic evaluations, market studies, and research efforts aimed at evaluating the relative effectiveness of numerous drug, biologic, and device interventions. She holds a master’s in public policy analysis from the University of Rochester, and has coauthored several articles published in peer-reviewed medical journals. Eve E. Slater, M.D., joined Pfizer as senior vice president for worldwide policy in 2007. Dr. Slater is a member of the Worldwide Public Affairs and Policy Leadership Team. She spent 19 years with Merck in a number of critical scientific, strategy, and public policy positions. In 1983 she came to Merck Research Laboratories as senior director of biochemical endocrinol- ogy, and in 1988 she was promoted to vice president, regulatory affairs. She advanced to vice president of clinical and regulatory development for Merck Research Laboratories in 1990, and senior vice president in 1994. In 2001 she was named senior vice president of external policy for Merck Research Laboratories, and vice president of Merck Corporate Public Affairs. An expert on HIV treatment research, she served as a member of the U.S. Keystone National Policy Dialogue on HIV, as well as the NIH Office of AIDS Research Advisory Council. She was appointed by the president in 2001 as assistant secretary of health. In this role, she served HHS Secretary Tommy Thompson as chief health policy adviser, with special emphasis on e-health and innovation, biosecurity, clinical trial protocols, women’s health, eldercare, and HIV/AIDS. She received her B.A. from Vassar and her M.D. from Columbia University, and she is board certified in internal medicine and cardiology. She was the first woman named as chief resident at Massachusetts General Hospital, where she later led the hypertension

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29 APPENDIX B unit. She also served as assistant professor of medicine at Harvard Medical School. She continues to serve patients as an associate attending physician at New York Presbyterian Hospital and the medical profession as an associ- ate professor of medicine at Columbia. Peter K. Smith, M.D., is professor and chief of cardiothoracic surgery at Duke University. He is a graduate of Princeton University (Phi Beta Kappa), Duke Medical School (AOA), and the Duke general surgery and thoracic surgery residencies. He has received the AHA Clinician Scientist Award and an NIH Research Career Development Award, and is currently the Duke principal investigator in the NHLBI Cardiac Surgery Research Network. He has authored or coauthored 140 peer-reviewed publications. He has a long-standing interest in clinical databases and has managed the Duke Cardiac Surgery clinical database since 1987, collaborating with the STS National Cardiac Database since its inception. His most recent work has focused on comparative effectiveness of PCI and CABG and he is the surgeon member of the AHA/ACC Appropriateness Criteria writing committee. He pioneered the use of clinical databases to improve the accuracy of the Medicare Physician Fee Schedule as the thoracic surgery member of the AMA Relative Value Update Committee. In 2006 he received the Distinguished Service Award of the Society of Thoracic Surgeons. Donald M. Steinwachs, Ph.D., is a professor in the Department of Health Policy and Management and director of the Health Services Research and Development Center at the Johns Hopkins University Bloomberg School of Public Health. Dr. Steinwachs’s research seeks to identify opportunities to improve quality of health care and patient outcomes and, when fea- sible, evaluate promising quality improvement interventions. His previous research includes studies of medical effectiveness and patient outcomes for individuals with specific medical (e.g., asthma), surgical (e.g., cataract sur- gery), and psychiatric (e.g., schizophrenia) conditions. Dr. Steinwachs has contributed to the literature on the impact of managed-care and payments systems on access to care, quality, use, and cost. He was a codeveloper of the widely used Adjusted Clinical Groups (ACG) case mix adjustment. He has developed methods for measuring provider continuity, needs and unmet needs for care, and measures of the timeliness of care. He has a particular interest in the role of the routine management information system (MIS) as a source of data for evaluating the effectiveness and cost of health care. This includes work on the integration of outcomes management systems with existing MIS in managed-care settings. He is a member of the IOM Board on Health Care Services. An NCVHS member since 2002, he chairs its Sub- committee on populations and serves on its executive committee. He also

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29 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING serves on the Board of Mathematica Policy Research, Inc. Dr. Steinwachs holds a B.S. in engineering mathematics, a M.S. in systems engineering from the University of Arizona, and a Ph.D. in operations research from Johns Hopkins University. Eugene Steuerle, Ph.D., is a senior fellow at the Urban Institute and codirector of the Urban-Brookings Tax Policy Center. He is also the author, coauthor, editor, or coeditor of 13 books and nearly 1,000 reports, articles, columns, testimonies, and reports. His latest book is Contemporary U.S. Tax Policy (2nd ed.). In the area of health, Dr. Steuerle serves on the NCVHS and has published articles on issues such as the financing of health care, the use of mandates, and the economic effect of health insurance subsidies. He has provided Congress with testimony and served as “faculty” at health reform retreats by both the Senate Finance Committee and the House Ways and Means Committee. He has made proposals to focus on children, as well as to make better combined use of both incentives and mandates as a way to approach coverage goals that neither alone can attain. His proposals on the use of tax penalties as a way to enforce individual mandates recently have been adopted by a number of states as one mechanism for enforcement. Nicolas P. Terry, LL.M., is the Chester A. Myers Professor of Law and codirector of the Center for Health Law Studies at Saint Louis Univer- sity School of Law. He is an internationally recognized scholar on health law whose research interests lie primarily at the intersection of medicine, law, and technology. His recent scholarship has concentrated on techno- logically mediated health care (including telemedicine), privacy of medical information, electronic medical records, and the use of information and other technologies to reduce medical error. Educated at Kingston Univer- sity and the University of Cambridge, Mr. Terry began his academic career as a member of the law faculty of the University of Exeter in England. In 1980 he joined Saint Louis University School of Law, where he has taught torts, products liability, healthcare law, eHealth, Internet law, and insur- ance law. Mr. Terry has served as a visiting professor at the University of Missouri–Columbia School of Law, Washington University School of Law, Santa Clara University School of Law, and most recently at the University of Iowa College of Law. During the 1996–1997 academic year, he was on leave from the law school and served as d19irector of legal education for LEXIS-NEXIS. He is a senior fellow at Melbourne Law School and holds the secondary appointment of professor of health management and policy at the Saint Louis University School of Public Health. Since 2000, Mr. Terry has been codirector of the Center for Health Law Studies at Saint Louis University—consistently ranked by U.S. News & World Report as the finest

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29 APPENDIX B health law program in the nation. The Center publishes the Saint Louis Uniersity Journal of Health Law & Policy. Steven E. Waldren, M.D., is director of the American Academy of Fam- ily Physicians’ (AAFP’s) Center for Health Information Technology. Dr. Waldren joined the AAFP in 2004 because of his knowledge of design and management of health information systems, computer science, and medical informatics. Prior to joining the AAFP, Dr. Waldren was a National Library of Medicine Medical Informatics Fellow at the University of Mis- souri–Columbia. Dr. Waldren is also a residency-trained and board-certified family physician. He also participates in many healthcare informatics ini- tiatives, including vice chair of the ASTM International E31 Health Infor- mation Standards Committee; cochair of the Ambulatory Functionality Working Group of the Certification Commission for Health-IT; and cochair of the AQA Alliance’s Data Aggregation and HIT Subcommittee. Dr. Wal- dren combines his strong technical informatics knowledge and his clinical knowledge to further the adoption of standards-based HIT by physicians and consumers to improve the quality and safety of health care. Alexander Walker, M.D., Dr.P.H., is Adjunct Professor of Epidemiology at Harvard School of Public Health, where he was formerly a professor and Chair of the Department of Epidemiology. He is also a principal of World Health Information Science Consultants, LLC. His research encompasses the safety of drugs, devices, vaccines, and medical procedures. Current studies include post-marketing safety studies for recently approved drugs, natural history of disease studies to provide context for Phase III clinical trials, studies of the impact of drug labeling and warnings on prescribing behavior, and determinants of drug uptake and discontinuation. Additional areas of research and expertise include health effects of chemicals used in the workplace and statistical methods in epidemiology. Dr. Walker received an M.D. degree from Harvard Medical School in 1974, and a doctorate of Public Health in Epidemiology from the Harvard School of Public Health in 1981. Dr. Walker is associate editor of Pharmacoepidemiology and Drug Safety and is on the Board of Directors of the International Society for Pharmacoepidemiology, which he also served as President in 1995–1996. He was a statistical consultant for the New England Journal of Medicine from 1992 through 1996 and a Contributing Editor of The Lancet from 1999 through 2001. From 2000 through 2007, he served as Senior Vice President for Epidemiology at Ingenix. Dr. Walker has written or contrib- uted to more than 250 peer-reviewed articles in drug safety, epidemiology, and occupational health, and is the author of a book of essays, Obseration and Inference: An Introduction to the Methods of Epidemiology.

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29 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING Alan F. Westin, Ph.D., LL.B., is professor emeritus of public law and gov- ernment, Columbia University, author of Priacy & Freedom (1967) and Databanks in a Free Society (1972), and recipient in 2005 of the Privacy Leadership Award of the International Association of Privacy Professionals. One of his main areas of activity has been the impact of information technology applications in health care. In 1976 he led the first field study of computer applications and privacy issues in U.S. health care, for the National Bureau of Standards, and served in the 1980s as research direc- tor for the National Commission on Confidentiality of Health Records. In 2005, with Vivian van Gelder, he wrote Building Priacy by Design into Emerging Electronic Health Record Systems. He has made keynote presen- tations on health privacy issues since the 1960s to more than 120 health conferences, health professional meetings, congressional hearings, and pri- vacy conferences. Dr. Westin has been the designer and academic adviser for 10 national surveys (with Harris Interactive) on health privacy issues, beginning with the 1993 survey on Health Information Privacy and, most recently (2003–2008) in 10 national surveys focused on HIPAA privacy issues, privacy in health research (for the IOM, 2007), and electronic health records-and-privacy developments. Marcy Wilder, J.D., is a partner at Hogan & Hartson, LLP, where she spe- cializes in health information law, including compliance with HIPAA and federal and state privacy laws. Ms. Wilder assists clients in identifying, eval- uating, and managing risks associated with privacy and information secu- rity practices and data breaches. She counsels clients on matters related to electronic data sharing, including the use of health information in e-health and Internet ventures, electronic medical and billing systems, research reg- istries, tissue banks, and marketing initiatives. Her clients include informa- tion technology vendors, informatics companies, healthcare clearinghouses, e-health organizations, healthcare providers, pharmaceutical and medical device companies, health plans, universities, and research institutions. Prior to joining Hogan & Hartson, Ms. Wilder served as deputy general counsel of HHS, where she was lead attorney in the development of HIPAA privacy regulations. Ms. Wilder has been a featured speaker at HIT and HIPAA conferences and seminars across the country, and she lectures frequently on data privacy and security, data mining, and clinical and records research. After receiving her law degree, Ms. Wilder was a fellow in women’s law and public policy at the Georgetown University Law Center. Janet Woodcock, M.D., is deputy commissioner and chief medical offi- cer at the FDA. She shares responsibility and collaborates with the FDA commissioner in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agency’s scientific and medical regulatory

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29 APPENDIX B activities in order to achieve the FDA’s mission. Dr. Woodcock has close interactions with diverse constituencies, including the clinical and scientific communities, members of Congress and the administration, national media, patient and consumer advocacy groups, the international drug regulatory community, the regulated industry, and representatives of federal and state agencies. She frequently appears in or is quoted by the national media and has testified repeatedly before Congress. Dr. Woodcock has led many cross-agency initiatives while at the FDA. She introduced the concept of pharmaceutical risk management in 2000 as a new approach to drug safety. She has led the Pharmaceutical Quality for the 21st Century Initia- tive since 2002. This effort, to modernize pharmaceutical manufacturing and its regulation through the application of modern science and quality management techniques, has been highly successful in meeting its objec- tives. She has spearheaded an initiative on pharmacogenomics that has led to unprecedented agency-industry interactions on pharmacogenomics use in drug development. Over the past 2 years, she has been leading the FDA’s Critical Path Initiative, which is designed to improve the scientific basis for medical product development. Dr. Woodcock was director of the Center for Drug Evaluation and Research from 1994 to 2005. During this period, review times for new and generic drugs were cut in half, while the standards for quality, safety, and effectiveness were improved. Dr. Woodcock also oversaw initiatives to automate submission and review of applications and adverse-event reports. Now nearing completion, these initiatives will allow the center to make much more drug information publicly available.

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