Alastair J. Wood, M.D., FRCP - (Chair)
Alastair Wood 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 The National Academy of Medicine (formerly the IOM), 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 over 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 W. Beier
David Beier 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 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 US 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 UC Berkeley.
Thomas J. Bollyky
Thomas J. Bollyky 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. 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, 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. 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. Bollyky has served in a variety of capacities at the National Academy of Medicine, 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 Bollyky as one of its global leaders under forty.
Katherine C. Bond
Katherine C. Bond 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 United States 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 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 A. Brumfield
Martha A. Brumfield is President and Chief Executive Officer of Critical Path Institute, an Arizona based non-profit (501(c)(3)). In this role, Dr. Brumfield leads the institute in its mission to catalyze the development of new tools to advance medical product 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, MD and of Parkinson’s Wellness Recovery in Tucson, AZ. 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.