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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:
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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
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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.
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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
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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
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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.
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