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Appendix B Committee Biographies Lawrence O. Gostin, J.D. (Chair), is professor of law at Georgetown Uni- versity; professor of public health at the Johns Hopkins University; and the director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities. He is research fellow at the Centre for Socio- Legal Studies at Oxford University. Professor Gostin is a member of the Institute of Medicine (IOM) of the National Academy of Sciences. For the IOM, he serves on the Board on Health Sciences Policy, the Institutional Review Board, and three expert study committees, including the Commit- tee on Assuring the Health of the Public in the 21st Century. He is also an elected lifetime fellow of the Hastings Center. He was appointed by the Secretary of Health and Human Services to serve on the Advisory Council of the Office of AIDS Research at the National Institutes of Health. Pro- fessor Gostin also consults for the World Health Organization, UNAIDS (Joint United Nations Programme on HIV/AIDS), and the Council of In- ternational Organizations for Medical Sciences. He is the Health Law and Ethics Editor of the Journal of the American Medical Association. He is also on the editorial board of scholarly journals. Professor Gostin has led major law reform initiatives for the U.S. De- partment of Health and Human Services and a consortium of states. In the wake of September 11, 2001, the Center for Law and the Public’s Health drafted the Model Emergency Health Powers Act to combat bioterrorism and other emerging health threats. Professor Gostin was a member of the President’s Task Force on National Health Care Reform. His principal areas of work were on the ethical foundations of the new health care sys- tem, public health, and privacy. He was formerly executive director of the 331

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332 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS American Society of Law, Medicine & Ethics and adjunct professor of law and public health at Harvard University. In the United Kingdom, Professor Gostin was the chief executive of the National Council for Civil Liberties, legal director of the National Association of Mental Health, and faculty member of Oxford University. Professor Gostin received the Rosemary Del- bridge Memorial Award from the National Consumer Council (UK) for the person “who has most influenced Parliament and government to act for the welfare of society.” He also received the key to Tohoku University in Japan for distinguished contributions to human rights in mental health. Professor Gostin’s latest books are both published by the University of California Press and the Milbank Memorial Fund: Public Health Law: Power, Duty, Restraint (2000) and Public Health Law and Ethics: A Reader (2002). Daniel Carpenter, Ph.D., A.M., is the Allie S. Freed Professor of Govern- ment and director of the Center for American Political Studies in the Faculty of Arts and Sciences at Harvard University. For the 2011-2012 academic year, he was a Walter Channing Cabot Faculty Fellow at Harvard and a visiting researcher at the Institut d’Études Politiques at the Université de Strasbourg in France. He graduated from Georgetown University in 1989 with distinction in government and received his doctorate in political science from the University of Chicago in 1996. He taught previously at Princeton University (1995-1998) and the University of Michigan (1998- 2002). He joined the Harvard University faculty in 2002. Professor Car- penter mixes theoretical, historical, statistical, and mathematical analyses to examine the development of political institutions, particularly in the United States. He focuses upon public bureaucracies and government regulation, particularly regulation of health and financial products. His dissertation received the 1998 Harold D. Lasswell Award from the American Political Science Association and as a book, The Forging of Bureaucratic Auton- omy: Reputations, Networks and Policy Innovation in Executive Agencies, 1862-1928, was awarded the APSA’s Gladys Kammerer Prize as well as the Charles Levine Prize of the International Political Science Association. His recently published book on pharmaceutical regulation in the United States is entitled Reputation and Power: Organizational Image and Phar- maceutical Regulation at the FDA and has received the 2011 Allan Sharlin Memorial Award from the Social Science History Association. Professor Carpenter has held fellowships from the John Simon Guggenheim Founda- tion, the Radcliffe Institute for Advanced Study, the Center for Advanced Study in the Behavioral Sciences, the Brookings Institute, and the Santa Fe Institute. He has received grants from the National Endowment for the Humanities, the National Science Foundation, the Robert Wood Johnson Foundation, the Alfred P. Sloan Foundation, the Russell Sage Foundation, and the Edmond J. Safra Center for Ethics. Professor Carpenter is the win-

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APPENDIX B 333 ner of both the 2011 Herbert Simon Award of the Midwest Political Science Association for a scholar “who has made a significant career contribution to the scientific study of bureaucracy,” as well as the 2011 David Collier Award of the American Political Science Association for career contribu- tions to qualitative and multi-method research. In addition to his ongoing teaching and scholarship on the political economy of government regula- tion and health, Professor Carpenter has recently launched a long-term project on petitioning in North American political development, examining comparisons and connections to petitioning histories in Europe and India. He hopes to draw upon the millions of petitions in local, state, and federal archives to create an educational, genealogical, and scholarly resource for citizens, students, and scholars. Hans Hogerzeil, M.D., Ph.D., FRCP Ed., is a professor of global health at Gronigen University. He qualified as a medical doctor from Leiden Uni- versity in the Netherlands and received a Ph.D. in public health in 1984. For five years, he was a mission doctor in India and Ghana. In 1985, he joined the World Health Organization (WHO) Action Programme of Es- sential Drugs, first in the Regional Office for the Eastern Mediterranean in Alexandria, Egypt, and later in the WHO headquarters in Geneva, Swit- zerland. As a WHO staff member, he has advised more than 40 developing countries on the development of their national medicines policies, essential drugs lists, and essential drugs programs. As secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, he initiated the recent changes in procedures for updating the Model List of Essential Medicines, which places stronger emphasis on evidence-based selections. He is director of essential medicines and pharmaceutical policies and chair of the Interagency Pharmaceutical Coordination Group. Dr. Hogerzeil is the editor of several WHO books on essential medicines policies, the quality use of medicines, medicines in emergency situations, and essential medicines for reproductive health. He has published more than 50 scientific papers in peer-reviewed journals and teaches every year at international courses all over the world. In 1996 he was invited to become a fellow of the Royal College of Physicians in Edinburgh, Scotland, and in 1998, he received an honorary doctorate of science from the Robert Gordon University in Aberdeen, Scotland. Ann Marie Kimball, M.D., M.P.H., is a senior program officer in epide- milogy and surveillance at the Bill & Melinda Gates Foundation. she was previously a professor and director of the master’s in public health program at the University of Washington School of Public Health and Community Medicine. She is also adjunct professor in medicine with the University of Washington School of Medicine. Her research interests are in emerging

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334 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS infections and global epidemic, prevention, surveillance, investigation, and control of infectious diseases. She has worked extensively in the areas of trade policy and disease control and telecommunications and disease surveillance and alert systems. Formerly, Dr. Kimball served as Regional Advisor for HIV/AIDS with the Pan American Health Organization. She has also served as director of the Washington State HIV/AIDS/STD Program with the state Department of Health and as chair of the National Alliance of State and Territorial AIDS Directors in the United States. Dr. Kimball has served on numerous editorial and scientific and technical committees. She serves on the editorial board of the Control of Communicable Diseases Manual (APHA, 2000) and as a member of the Institute of Medicine com- mittee to review the Global Emerging Infections Surveillance program. She is a fellow of the American College of Preventive Medicine. She is chair of the University of Washington Hogness Symposium. Thomas P. Layloff, Ph.D., M.S., is a principal program associate at Man- agement Sciences for Health (MSH) who works on pharmaceutical prod- uct and laboratory quality issues with both the Rational Pharmaceutical Management Plus and Strategies for Enhancing Access to Medicines pro- grams. He has over 25 years’ experience directing U.S. Food and Drug Administraiton pharmaceutical control laboratory operations and more than 10 years of service as an elected expert on the Committee of Revision of the U.S. Pharmacopeia (USP), which included 5 years on the Reference Standards Committee, 5 years as chair of the General Chapters Committee, and 2 years as chair of the Division of Standards Development Executive Committee. Prior to joining MSH, he served at USP as vice president and director of the Pharmaceutical Standards Division. He is a past president and elected fellow of AOAC International, a nonprofit scientific association that publishes chemical analysis methods. He is also a charter member and elected fellow of the American Association of Pharmaceutical Scientists. Dr. Layloff received a B.A. in psychology and chemistry and M.S. in organic chemistry from Washington University in St. Louis, Missouri. He received a Ph.D. in analytical chemistry with a minor in mathematics from the Uni- versity of Kansas in Lawrence. Patrick Lukulay, Ph.D., is currently the director of the United States Agency for International Development–funded program Promoting the Quality of Medicines, implemented by U.S. Pharmacopeia. He oversees the work of about 20 staff to provide technical assistance to developing countries to strengthen quality assurance and quality systems for pharmaceuticals. Dr. Lukulay has a Ph.D. in analytical chemistry from Michigan State Univer- sity. He worked in the pharmaceutical industry for Wyeth and Pfizer for a combined 12 years as senior principal scientist. He is the author of several

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APPENDIX B 335 articles in separation science and spectroscopy and is a frequent speaker and national and international conferences. Margareth Ndomondo-Sigonda, M.Sc., M.B.A., served as director general of the Tanzania Food and Drugs Authority for 7 years and registrar of the Tanzanian Pharmacy Board for 5 years before that. Ms. Ndomondo- Sigonda has been involved in medicines regulation harmonization initiatives in the Southern Africa Development Community and East African Commu- nity. She has consulted for the World Health Organization on assessment of medicines regulatory systems in Carribean Community member states, the Dominican Republic, Egypt, Kenya, Sudan, and Zambia. She has also been a consultant for the assessment of medicines regulatory systems in Egypt, Kenya, Sudan, and Zambia. She now works as a pharmaceutical coordina- tor for the African Union New Partnership for Africa’s Development. Ms. Ndomondo-Sigonda is responsible for coordinating the pharmaceutical development programs, including the African Medicines Regulatory Har- monization initiative. She has a master’s degree in pharmaceutical services from the University of Bradford in the United Kingdom, an M.B.A. from Maastricht School of Management in the Netherlands, and a bachelor’s degree in pharmacy from the University of Dar es Salam. Arti K. Rai, J.D., is the Elvin R. Latty Professor of Law at Duke University Law School and a member of the Duke Institute for Genome Science and Policy. She is an authority in patent law, administrative law, and innovation policy. Ms. Rai has also taught at Harvard, Yale, the University of Penn- sylvania, and the University of San Diego law schools. Ms. Rai’s academic research on innovation policy in areas such as synthetic biology, green tech- nology, drug development, and software has been funded by the National Institutes of Health (NIH), the Kauffman Foundation, and Chatham House. She has published widely in both peer-reviewed journals and law reviews, including Nature Biotechnology, PLoS Biology, PLoS Medicine, the Annals of Internal Medicine, and the Columbia, Georgetown, and Northwestern law reviews. She is the editor of Intellectual Property Law and Biotechnol- ogy: Critical Concepts (Edward Elgar, 2011) and has also co-authored a casebook on law and the mental health system. From 2009 to 2010, Ms. Rai took a leave of absence from Duke Law School to serve as the administrator of the Office of External Affairs at the U.S. Patent and Trademark Office. Prior to that, she served on President- Elect Obama’s transition team reviewing the Patent and Trademark Office and as an expert advisor to the Department of Commerce’s Office of Gen- eral Counsel. Prior to entering academia, Ms. Rai clerked for the Honor- able Marilyn Hall Patel of the U.S. District Court for the Northern District of California; was a litigation associate at Jenner & Block (doing patent

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336 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS litigation as well as other litigation); and was a litigator at the Federal Pro- grams Branch of the U.S. Department of Justice’s Civil Division. Ms. Rai has served as a peer reviewer for Science, Research Policy, the Journal of Legal Studies, various National Academy of Sciences reports on intellec- tual property, and various NIH study sections. She has also testified before Congress on innovation policy issues and regularly advises federal agencies on policy issues (including intellectual property policy issues) raised by the research that they fund. Recently, her work has focused on advising the Defense Advanced Research Projects Agency. Ms. Rai is currently the chair of the Intellectual Property Committee of the Administrative Law Section of the American Bar Association. She is also a fellow of the American Bar Foundation. In 2011, Ms. Rai won the World Technology Network Award for Law. Ms. Rai graduated from Harvard College, magna cum laude, with a B.A. in biochemistry and history (history and science), attended Harvard Medical School for the 1987-1988 academic year, and received her J.D., cum laude, from Harvard Law School in 1991. Marco Antonio Stephano, M.S., Ph.D., is a veterinarian and pharmaceuti- cal biochemist at the University of São Paulo. He worked for 14 years at the Butantan Institute as a researcher in serums and vaccines in applied immunology and served as director of quality assurance there for 4 years. Currently, Dr. Stephano is a professor at the Pharmaceutical Sciences School in quality assurance and biotechnology. He is a member of the Brazilian Pharmacopoeia in the area of biological products. He holds a master’s de- gree in pharmacology from Campinas State University and a doctorate in pharmaceutical biochemistry from University of São Paulo. John Theriault, M.B.A., has had senior leadership roles with the Federal Bureau of Investigation, Pfizer, and Apple. Today, he is recognized interna- tionally as an expert on the subject of product counterfeiting and the devel- opment of effective programs to combat its far-ranging impact on society. Mr. Theriault served as a special agent of the Federal Bureau of Investiga- tion (FBI) for more than 25 years, rising to the Bureau’s Senior Executive Service. For 7 years he was diplomatically accredited as the legal attaché at various U.S. embassies and was responsible for managing all of the FBI’s law enforcement, counterintelligence, and counterterrorism relationships with senior government officials of the host countries. In 1996 he joined Pfizer as vice president and chief security officer. In response to widespread counterfeiting of their medicines, he created, staffed and led the company’s global anti-counterfeiting program, which became a model for the industry. He has testified before the U.S. Senate Special Committee on Aging, the U.S. House of Representatives Committee on Energy and Commerce, and

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APPENDIX B 337 the U.S. Surgeon General’s Drug Importation Task Force. He has briefed the U.S. Secretary of Commerce and other senior government officials on the dangers of counterfeit medicines, and he has appeared on a number of broadcasts including 60 Minutes, Larry King Live, CNN Late Edition, BBC Radio, and others. In 2007 Mr. Theriault was recruited by Apple to create a global security organization with a strong focus on combating their growing counterfeiting problem. In November 2011 he retired from Apple to return to the East Coast and pursue other interests. Mr. Theriault earned a B.A. from the University of Memphis and an M.B.A. degree from Emory University. Mary E. Wilson, M.D., is an associate professor of Global Health and Population at the Harvard School of Public Health. Her academic interests include the ecology of infections and emergence of microbial threats, travel medicine, tuberculosis, and vaccines. Her undergraduate degree in French, English, and philosophy was awarded by Indiana University; she received her M.D. from the University of Wisconsin and completed an internal medi- cine residency and infectious disease fellowship at the Beth Israel Hospital in Boston (now Beth Israel–Deaconess Medical Center). Dr. Wilson was chief of infectious diseases at Mount Auburn Hospital, a Harvard-affiliated community teaching hospital in Cambridge, Massachusetts, for more than 20 years. She is a fellow in the Infectious Diseases Society of America and the American College of Physicians. Dr. Wilson has served on the Advisory Committee for Immunization Practices of the U.S. Centers for Disease Con- trol and Prevention, the Academic Advisory Committee for the National Institute of Public Health in Mexico, and on four committees for the Insti- tute of Medicine of the National Academies, including the Committee on Emerging Microbial Threats to Health in the 21st Century. She has worked in Haiti at the Albert Schweitzer Hospital and leads the Harvard–Brazil Collaborative Course on Infectious Diseases, which is taught in Brazil. In 1996 she was a resident scholar at the Bellagio Study Center, Italy, and in 2002 she was a fellow at the Center for Advanced Study in the Behavioral Sciences in Stanford, California. Dr. Wilson was member of the Pew Na- tional Commission on Industrial Farm Animal Production whose report, Putting Meat on the Table: Industrial Farm Animal Production in America, was released in the spring of 2008. A former GeoSentinel site director, she now serves as a special advisor to the global GeoSentinel Surveillance Network. She has lectured and published widely, serves on several editorial boards, and is an associate editor for Journal Watch Infectious Diseases. She is the author of A World Guide to Infections: Diseases, Distribution, Diagnosis; senior editor, with Richard Levins and Andrew Spielman, of Dis- ease in Evolution: Global Changes and Emergence of Infectious Diseases; and editor of the volume New and Emerging Infectious Diseases, published

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338 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS in 2008. She joined the Board of Trustees for the International Centre for Diarrheal Disease Research, Bangladesh and is a member of the Board of Scientific Counselors for the Centers for Disease Control and Prevention, the FXB-USA board, and the Alliance for Prudent Use of Antibiotics Board of Directors. Prashant Yadav, Ph.D., M.B.A., is a senior research fellow and director of the Healthcare Research Initiative at the William Davidson Institute at the University of Michigan. Previously he was a professor in Supply Chain Management at the Massachusetts Institute of Technology (MIT)-Zaragoza International Logistics Program and a research affiliate at the MIT Center for Transportation and Logistics. Dr. Yadav’s research explores the func- tioning of pharmaceutical supply chains using a combination of empirical, analytical, and qualitative approaches. His more recent work involves sup- ply chains for medicines in sub-Saharan Africa and other poor countries. In this work he collaborates closely with leading policy organizations and philanthropic foundations. Dr. Yadav serves as a consultant and adviser in the area of pharmaceutical supply chains to the World Bank, World Health Organization, UK Department for International Development, Roll Back Malaria Partnership, the Bill & Melinda Gates Foundation, the Medicines for Malaria Venture, and many other global health organizations. He is the author of many scientific publications and his work has been featured in prominent print and broadcast media. Dr. Yadav obtained his bachelor’s degree in engineering from the Indian Institute of Technology, his M.B.A. from the FORE School of Management, and his Ph.D. from the University of Alabama. Before academia, he worked for many years in the area of pharmaceutical strategy, analytics, and supply chain consulting.