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Suggested Citation:"Appendix E: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 107
Suggested Citation:"Appendix E: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 108
Suggested Citation:"Appendix E: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 109
Suggested Citation:"Appendix E: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 110
Suggested Citation:"Appendix E: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 111
Suggested Citation:"Appendix E: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 112

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Appendix E Committee Member Biographies COMMITTEE MEMBERS Alastair J. J. Wood, MB, ChB, FRCP, FACP (NAM) (Chair), was Professor of both Medicine and Pharmacology at Vanderbilt University Medical School and served as Assistant Vice Chancellor for Clinical Research and Associate Dean, Vanderbilt Medical School, before being appointed Emeritus Professor of Medicine and Emeritus Professor of Pharmacology in 2006. He was a Partner at Symphony Capital LLC, a Private Equity Company investing in the clinical development of novel bio-pharmaceutical products from 2006-2018. He has also periodically consulted for pharmaceutical companies (AMAG, Sanofi, etc.) in the past 12 months. Dr. Wood has been honored by being elected to National Academy of Medicine, the American Association of Physicians (AAP), the American Society for Clinical Investigation (ASCI), Honorary Fellow, American Gynecological and Obstetrical Society (AGOS), Fellowship of the American College of Physicians, Fellowship of the Royal College of Physicians of London, and Fellowship of the Royal College of Physicians of Edinburgh. He was the 2005 recipient of the Rawls-Palmer Award and in 2008 received the honorary degree of Doctor of Laws, honoris causa, from the University of Dundee. Dr. Wood has served on a number of editorial boards including the New England Journal of Medicine Editorial Board and was the Drug Therapy Editor of the New England Journal of Medicine from 1985 to 2004. His research has resulted in more than 300 articles, reviews and editorials. He served on the FDA’s Cardio renal and the Non-Prescription Drug Advisory Committee, which he also chaired. He is currently the Chair of the Burroughs Welcome Fund Regulatory Science Award committee and serves on the board of Critical Path Institute. David Beier, JD, is Managing Director of Bay City Capital, a life sciences and drug development investment firm, and has been with the firm since 2013. He is a globally recognized leader in health care policy, pricing, intellectual property, government affairs, regulatory affairs, health care economics, and product commercialization. In addition, having spent two decades as part of the senior management teams for Amgen and Genentech, the two largest biotechnology companies in the world, he contributes invaluable perspective regarding strategy for entrepreneurial biotech’s, the needs of potential acquirers, and the global health care industry in general. Mr. Beier served in the White House as the Chief Domestic Policy Advisor to Vice PREPUBLICATION COPY: UNCORRECTED PROOFS E-1

APPENDIX E President Al Gore during the Clinton administration. He has served as an appointee of President Clinton on his Advisory Committee for Trade Policy and Negotiations, on the Institute of Medicine panel on the Future of Health and Human Services, and as an advisor to the President’s Council of Advisors on Science and Technology. Mr. Beier was also formerly a partner in international law firm Hogan and Hartson and was formerly Counsel to the U.S. House of Representatives Committee on the Judiciary. He has testified before Congress and the Federal Trade Commission, has written numerous law review articles and technical legal works, is regularly invited to author expert OpEds on health care, and has contributed to books on topics ranging from intellectual property, trade, privacy, and justice issues. He currently serves as an appointee of Governor Brown on the California State Government Organization and the Economy Commission, as a Fellow of the Center for Global Enterprise, and teaches as an Adjunct Lecturer at the Haas School of Business at the University of California, Berkeley. Thomas Bollyky, JD, is director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations (CFR). He is also an adjunct professor of law at Georgetown University. Mr. Bollyky is the author of Plagues and the Paradox of Progress: Why the World is Getting Healthier in Worrisome Ways (MIT Press, 2018). He has written extensively on trade, health policy, and food and drug regulation, including on international regulatory cooperation and drug pricing. His expertise is in trade, health policy, and food and drug regulation. Prior to coming to CFR, Mr. Bollyky was a fellow at the Center for Global Development and a director at the Office of the U.S. Trade Representative (USTR), where he led the negotiations on medical technology regulation in the U.S.-Republic of Korea Free Trade Agreement and represented USTR in the negotiations with China on the safety of food and drug imports. He was a Fulbright scholar to South Africa, where he worked as a staff attorney at the AIDS Law Project, and an attorney at Debevoise & Plimpton LLP, where he represented clients before the International Court of Justice and the U.S. Supreme Court. Mr. Bollyky is a former law clerk to Chief Judge Edward R. Korman and was a health policy analyst at the U.S. Department of Health and Human Services. Mr. Bollyky has served in a variety of capacities at the National Academies, including as co-chair of its workshop on international regulatory harmonization and as a member of committees on strengthening food and drug regulation in developing countries and on the role of science, technology, and innovation in the future of the U.S. Agency for International Development. He has been a consultant to the Bill & Melinda Gates Foundation and a temporary legal advisor to the World Health Organization. In 2013, the World Economic Forum named Mr. Bollyky as one of its global leaders under forty. Katherine Bond, ScD, is Vice President, International Public Policy and Regulatory Affairs, for the U.S. Pharmacopeia (USP). She develops and executes USP’s global policy, advocacy and regulatory affairs agenda in alignment with strategic organizational objectives and in support of medicines quality globally. Her expertise is in regulatory policy, systems strengthening and cooperation, including medicines quality. Dr. Bond brings more than twenty-five years of demonstrated public health leadership experience—in the field and in management, having held positions at the U.S. Food and Drug Administration Office of International Programs as Associate Director of Technical Cooperation and Capacity Building and Director of the Office of Strategy, Partnerships, and Analytics. Prior to public service, Dr. Bond focused her energies on priority public health issues such as pandemics, infectious diseases and health systems impacting Southeast Asia and Africa. She worked as Associate Director of The Rockefeller Foundation’s PREPUBLICATION COPY: UNCORRECTED PROOFS E-2

APPENDIX E Asia Regional Office and Africa Regional Office, and Deputy Director of the Mekong Regional Office of the Program for Appropriate Technology in Health (PATH). Dr. Bond has also held many consultancies and academic appointments—as both lecturer and researcher—at universities in the United States and abroad. She additionally appears as lead or contributing author on a variety of peer-reviewed research papers and technical documents in areas of regulatory systems strengthening, global health security, health systems, and intervention strategies for specific at-risk populations. Martha Brumfield, PhD, MS, is President and Chief Executive Officer of Critical Path Institute, an Arizona based nonprofit (501(c)(3)). In this role, Dr. Brumfield leads the institute in its mission to catalyze the development of new tools to advance medicine innovation and regulatory science, which is accomplished by leading teams that share data, knowledge and expertise resulting in sound, consensus based science. Brumfield assumes the role of CEO after most recently serving as Critical Path Institute’s Director of International & Regulatory Programs. She also has her own consulting practice (Martha A. Brumfield LLC) focusing on concordance in global regulatory initiatives and regulatory science qualification programs. Other areas of focus in her practice include excellence in clinical trial conduct and pharmacovigilance, facilitation of scientific consortia and programs supporting patient access to medicines. She is past Chair of the Board of Directors for the Regulatory Affairs Professional Society and facilitated the Global Curriculum Coordinating Committee with FDA’s Office of International Policy, which developed a training curriculum framework for regulators in developing countries. She has worked with nonprofits such as GlobalMD to deliver educational workshops on regulatory and clinical trial topics in Asia. She has served on and contributed to the Institute of Medicine consensus committees, which were commissioned by U.S. FDA focusing on global regulatory systems and on falsified and substandard drugs. She also serves on the Steering Committee of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. She is on the Board of Directors of the Institute for Advanced Clinical Trials for Children in Rockville, Maryland and of Parkinson’s Wellness Recovery in Tucson, Arizona. Dr. Brumfield brings 20 years of experience from Pfizer Inc., most recently, as senior vice president of worldwide regulatory affairs and quality assurance. There, she led a global team that supported lifecycle pharmaceutical research, development and commercialization through creation and implementation of regulatory strategies and quality assurance oversight. Dr. Brumfield also played a key role in managing the broader company relationships with global regulators, trade associations, academics and others on regulatory policy issues. David Cockburn, BSc (Hons.), is the recently retired Head of Manufacturing and Quality Compliance with the European Medicines Agency (EMA). A Pharmacy graduate, Mr. Cockburn has grounding in the pharmaceutical industry augmented by roles in the authorities at national and EU level. Industry exposure included Regulatory Affairs at GD Searle and in Production at Glaxo Operations, both in the United Kingdom. Mr. Cockburn joined the U.K. Medicines and Healthcare products Regulatory Agency as a Principal Medicines Inspector and spent 14 years there before moving to the EMA for 15 years and becoming Head of Manufacturing and Quality Compliance. He worked part-time for the last 3 years of his career at the EMA and during that time acted as EU’s technical lead in the process towards establishing the EU-USA Mutual Recognition Agreement on GMP Inspections. Since retiring from the European Medicines Agency, Mr. Cockburn has formed associations with a number of organizations promoting PREPUBLICATION COPY: UNCORRECTED PROOFS E-3

APPENDIX E training and education on Good Manufacturing Practice and medicines’ quality. Currently these organisations comprise Pharma Consult Global and Euromed Communications as well as The European Qualified Persons Association and University College London (UCL) Innovation & Enterprise, which are non-profit organisations. Elizabeth Golberg, GradD, is currently a Senior Fellow at the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School. Her areas of expertise are regulatory policy development and oversight, international regulatory cooperation, external relations, assistance program coordination and management and international trade. She was Director of Better Regulation at the European Commission and a member of the Bureau of the OECD Regulatory Policy Committee. Previously, she managed units in the Secretariat General responsible for external relations and the G7/G20 and for the President’s briefings as well as the unit in the Environment Directorate General responsible for strategic planning and coordination. She held various advisory posts in the European Commission and was coordinator of the European Union’s technical assistance program in the Czech Republic and Slovakia. Lawrence Gostin, JD, LLD, is University Professor, Georgetown University’s highest academic rank conferred by the University President. Professor Gostin directs the O’Neill Institute for National and Global Health Law and is the Founding O’Neill Chair in Global Health Law. He is Professor of Medicine at Georgetown University and Professor of Public Health at the Johns Hopkins University. Professor Gostin is the Director of the World Health Organization (WHO) Collaborating Center on National and Global Health Law. He has also been appointed high-level positions at the WHO, such as International Health Regulations (IHR) Roster of Experts and the Expert Advisory Panel on Mental Health. He co-chairs the Lancet Commission on Global Health Law and he is the Legal and Global Health Correspondent for the Journal of the American Medical Association. He is Founding Editor-in-Chief of Laws (an international open access law journal). He also holds multiple international academic professorial appointments, including at Oxford University, the University of Witwatersrand (South Africa), and Melbourne University. In 2016, President Obama appointed Prof. Gostin to the National Cancer Advisory Board, on which he currently serves. He has expertise in areas such as, health law and ethics, global health and global governance, AIDS law and ethics, human rights, privacy and consent. In his previous positions, he served as Associate Dean for Research at Georgetown Law, The WHO Director-General’s Advisory Committee on Reforming the World Health Organization, as well as numerous WHO expert advisory committees, including on the Pandemic Influenza Preparedness Framework, smallpox, genomic sequencing data, and human rights. He served on the WHO/Global Fund Blue Ribbon Expert Panel: The Equitable Access Initiative to develop a global health equity framework. He also served on the drafting team for the G-7 Summit in Tokyo 2016, focusing on global health security and Universal Health Coverage. He was formally the Editor-in-Chief of the Journal of Law, Medicine & Ethics. Professor Gostin served on the Governing Board of Directors of the Consortium of Universities for Global Health. He is a member of the National Academy of Medicine. Gavin Huntley-Fenner, PhD, is a human factors and safety consultant at Huntley-Fenner Advisors. His areas of expertise are risk management and communication. He has a unique problem-solving skill set and communication style developed over 20 years as a researcher, author, educator and business consultant. He regularly provides consumer product hazard PREPUBLICATION COPY: UNCORRECTED PROOFS E-4

APPENDIX E analyses and has served as an expert witness for matters relating to risk perception, instruction manuals, warnings, labeling, safety and human development, human reaction time and decision- making. Dr. Huntley-Fenner has been invited to speak at national and international scientific and nonscientific gatherings on topics ranging from basic and applied research to forensic consulting and to education. He is a former member of the U.S. Food and Drug Administration Risk Communication Advisory Committee. Barbara Koremenos, PhD, MPP, is Professor of Political Science at the University of Michigan. She received a National Science Foundation CAREER Award for her research – the first such winner to study international relations and law. She has given seminars in the United States, Canada, Denmark, France, Germany, Greece, Italy, Japan, Latvia, South Korea, Spain, Sweden, and Switzerland. Her award-winning book, The Continent of International Law: Explaining Agreement Design (Cambridge University Press, 2016), focuses on how international law can be structured to make international cooperation most successful. She received her PhD from the University of Chicago. Murray Lumpkin, MD, is Deputy Director, Global Health/Integrated Development, and Lead for Global Regulatory Systems Initiatives at the Bill & Melinda Gates Foundation. The Global Regulatory Systems Initiatives are focused on working with partners such as WHO (Geneva), PAHO, AFRO, regulatory regionalization initiatives, and NRAs in all parts of the world, to make more efficient and effective (without sacrificing product quality, efficacy, or safety) the regulatory processes through which health care products must pass to be developed, be eligible for procurement, and be legally marketed in low- and middle-income countries on which the Foundation focuses. Before joining the Bill & Melinda Gates Foundation, Dr. Lumpkin was the Director, Division of Anti-infective Drug Products (CDER); Deputy Center Director for Review Management (CDER); and Deputy Commissioner for International Programs at the US Food and Drug Administration, serving at the U.S. FDA from 1989 to 2014. Lembit Rägo, MD, PhD, is the Secretary-General of the Council for International Organizations of Medical Sciences. He is also a current member of the WHO expert panel for the WHO Expert Committee on Pharmaceutical Specifications, which develops international drug quality assurance standards and guidelines. His research interests include international drug regulation, pharmaceutical policy, and regulatory cooperation. When he was previously working at the World Health Organization (WHO), he worked on activities related to International Non- proprietary Names (INNs), quality assurance, pharmacovigilance, regulatory support, fighting falsified medicines and prequalification of medicines. His previous positions include Professor of Clinical Pharmacology at Tartu University, founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines, Coordinator of Quality Assurance and Safety: Medicines (QSM) team at WHO, and Head of WHO’s Regulation of Medicines and Other Health Technologies unit. PREPUBLICATION COPY: UNCORRECTED PROOFS E-5

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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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