Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 283
Appendix B Committee Biographies Lawrence O. Gostin, J.D. (Chair) is professor of law at Georgetown University; 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 Promotion and Disease Prevention, the Institutional Review Board, and three expert study committees, including the Committee 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 for Health and Human Services to serve on the Advisory Council of the Office of AIDS Research at the National Institutes of Health. Professor Gostin also consults for the World Health Organization, UNAIDS, and the Council of International 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. Department 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 on were on the ethical foundations of the new health care system, public health, and privacy. He was formerly executive director of the 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 Delbridge Memorial Award from the National Consumer Council (U.K.) 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 Government 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. Dr. Carpenter 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 Autonomy: 283 PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 284
COUNTERING THE PROBLEM OF FALSIFIED AND COUNTERFEIT DRUGS 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 Pharmaceutical 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 Foundation, 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 Sloan Foundation, and the Russell Sage Foundation and the Safra Center for Ethics. Professor Carpenter is the winner 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 contributions to qualitative and multi-method research. In addition to his ongoing teaching and scholarship on the political economy of government regulation 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 University 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 WHO Action Programme of Essential Drugs, first in the Regional Office for the Eastern Mediterranean in Alexandria, Egypt, and later in the WHO headquarters in Geneva, Switzerland. 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 epidemilogy and surveillance at the Bill and 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 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 284 PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 285
COMMITTEE BIOGRAPHIES 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 IOM committee to review the Global Emerging Infections Surveillance program. She is a fellow in 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 Management Sciences for Health (MSH) who works on pharmaceutical product and laboratory quality issues with both the Rational Pharmaceutical Management Plus and Strategies for Enhancing Access to Medicines Programs. He has over 25 years experience directing FDA pharmaceutical control laboratory operations and more than 10 years of service as an elected expert on the Committee of Revision of the United States 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 non-profit 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 University of Kansas in Lawrence. Patrick Lukulay, Ph.D., is currently the director of the USAID-funded program, Promoting the Quality of Medicines, implemented by United States 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 University. 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 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 seven years and registrar of the Tanzanian Pharmacy Board for five years before that. She has been involved in medicines regulation harmonization initiatives in the Southern Africa Development Community and East African Community. She has consulted for the WHO on assessment of medicines regulatory systems in Sudan, Egypt, Kenya, Zambia, CARICOM member states, and the Dominican Republic. She has also been a consultant for assessment of medicines regulatory systems in Zambia, Sudan, Egypt, and Kenya. She now works as a pharmaceutical coordinator 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 Harmonization 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. 285 PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 286
COUNTERING THE PROBLEM OF FALSIFIED AND COUNTERFEIT DRUGS 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 Pennsylvania, and the University of San Diego law schools. Ms. Rai’s academic research on innovation policy in areas such as synthetic biology, green technology, drug development, and software has been funded by 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 Biotechnology: Critical Concepts (Edward Elgar, 2011) and has also co-authored a casebook on law and the mental health system. From 2009-2010, 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 General Counsel. Prior to entering academia, Ms. Rai clerked for the Honorable Marilyn Hall Patel of the U.S. District Court for the Northern District of California; was a litigation associate at Jenner & Block (doing patent litigation as well as other litigation); and was a litigator at the Federal Programs 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 intellectual 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 pharmaceutical 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 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 Pharmacopeia in the area of biological products. He holds a masters degree 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 internationally as an expert on the subject of product counterfeiting and the development of effective programs to combat its far ranging impact on society. Mr. Theriault served as a special agent of the 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 286 PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 287
COMMITTEE BIOGRAPHIES 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. His has testified before the U.S. Senate Special Committee on Aging, the U.S. House of Representatives Committee on Energy and Commerce, and 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 medicine residency and infectious disease fellowship at the Beth Israel Hospital in Boston (now Beth Israel-Deaconess Medical Center). She 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. She has served on the Advisory Committee for Immunization Practices of the U.S. Centers for Disease Control and Prevention, the Academic Advisory Committee for the National Institute of Public Health in Mexico, and on four committees for the Institute 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. She was member of the Pew National 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 Disease in Evolution: Global Changes and Emergence of Infectious Diseases, and editor of the volume New and Emerging Infectious Diseases published 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 CDC, 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 MIT-Zaragoza International Logistics Program and a research affiliate at the MIT Center for Transportation and Logistics. Dr. Yadav’s research explores 287 PREPUBLICATION COPY: UNCORRECTED PROOFS
OCR for page 288
COUNTERING THE PROBLEM OF FALSIFIED AND COUNTERFEIT DRUGS the functioning of pharmaceutical supply chains using a combination of empirical, analytical and qualitative approaches. His more recent work involves supply 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, Bill and 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. Prashant obtained his Bachelor of 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, Prashant worked for many years in the area of pharmaceutical strategy, analytics, and supply chain consulting. 288 PREPUBLICATION COPY: UNCORRECTED PROOFS