Appendix B


Participant Biographies

Thomas J. Bollyky, J.D. (Workshop Co-Chair), is Senior Fellow for Global Health, Economics, and Development at the Council on Foreign Relations. He is also an adjunct professor of law at Georgetown University and consultant to BMGF. Prior to joinng the Council on Foreign Relations, Mr. Bollyky was a Fellow at the Center for Global Development and director of intellectual property and pharmaceutical policy at the Office of the U.S. Trade Representative, where he led the negotiations for pharmaceuticals, biotechnology, and medical technologies in the U.S.- Republic of Korea Free Trade Agreement and represented the U.S. Trade Representative in the negotiations with China on the safety of food and drug imports. He was also a Fulbright Scholar to South Africa, where he worked as a staff attorney at the AIDS Law Project on treatment access issues related to HIV/AIDS, and an attorney at Debevoise & Plimpton, LLP, where he represented Mexico before the International Court of Justice in Avena and other Mexican Nationals (Mexico versus United States of America) and José Ernesto Medellín before the U.S. Supreme Court in Medellin v. Dretke. Mr. Bollyky is a former law clerk to Chief Judge Edward R. Korman, an International Affairs Fellow at Council on Foreign Relations, an Eesti and Eurasian public service fellow at the Estonian Ministry of Education, and a health policy analyst, through the Outstanding Scholar Program at the U.S. Department of Health and Human Services. His research and writing focuses on trade, legal, and regulatory issues in global health and development, in particular tobacco and noncommunicable diseases, technological innovation and



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Appendix B Participant Biographies Thomas J. Bollyky, J.D. (Workshop Co-Chair), is Senior Fellow for Global Health, Economics, and Development at the Council on Foreign Rela- tions. He is also an adjunct professor of law at Georgetown University and consultant to BMGF. Prior to joinng the Council on Foreign Rela- tions, Mr. Bollyky was a Fellow at the Center for Global Development and director of intellectual property and pharmaceutical policy at the Office of the U.S. Trade Representative, where he led the negotiations for pharmaceuticals, biotechnology, and medical technologies in the U.S.- Republic of Korea Free Trade Agreement and represented the U.S. Trade Representative in the negotiations with China on the safety of food and drug imports. He was also a Fulbright Scholar to South Africa, where he worked as a staff attorney at the AIDS Law Project on treatment access issues related to HIV/AIDS, and an attorney at Debevoise & Plimpton, LLP, where he represented Mexico before the International Court of Justice in Avena and other Mexican Nationals (Mexico versus United States of America) and José Ernesto Medellín before the U.S. Supreme Court in Medellin v. Dretke. Mr. Bollyky is a former law clerk to Chief Judge Edward R. Korman, an International Affairs Fellow at Council on Foreign Relations, an Eesti and Eurasian public service fellow at the Estonian Ministry of Education, and a health policy analyst, through the Outstanding Scholar Program at the U.S. Department of Health and Human Services. His research and writing focuses on trade, legal, and regulatory issues in global health and development, in particular tobacco and noncommunicable diseases, technological innovation and 91

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92 INTERNATIONAL REGULATORY HARMONIZATION delivery, clinical trials, and import safety. He has testified before the U.S. Senate on international regulatory issues in global health, and his most recent work has appeared in the Journal of the American Medical Association, Foreign Policy, The Atlantic, Clinical Trials, and Stanford Jour- nal for Law, Science & Policy. He is a member of the IOM’s Committee for Strengthening Food and Drug Regulation in Developing Countries and has served as a temporary legal advisor to WHO. Mr. Bollyky received his B.A. in biology and history at Columbia University and his J.D. at Stanford Law School, where he was the president of the Stanford Law & Policy Review. He is a term member of the Council on Foreign Relations and a member of the New York and U.S. Supreme Court bars and the American Society of International Law. Steven K. Galson, M.D., M.P.H. (Workshop Co-Chair), is Vice President for Global Regulatory Affairs at Amgen Inc. as of October 2010. He was the Senior Vice President for Civilian Health Operations and chief health scientist at Science Applications International Corporation. In October 2009, he completed 23 years of government service, most recently—for 2 years—as Acting Surgeon General of the United States. Previously, he served as Director of the FDA’s CDER from July 2005, where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his Public Health Ser- vice career as an epidemiological investigator at CDC after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He has held senior-level positions at the Environmental Protection Agency (EPA); the Department of Energy, where he was chief medical officer; and the U.S. Department of Health and Human Services. Prior to his arrival at FDA, he was Director of the EPA’s Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Sub- stances. Dr. Galson joined FDA in April 2001 as CDER deputy director. He is the recipient of numerous awards, including the Surgeon General’s Medallion and three Secretary of Energy Gold Awards. Dr. Galson has been a board member of the National Board of Medical Examiners and a peer reviewer for medical journals. He holds a B.S. from Stony Brook University, an M.D. from Mount Sinai School of Medicine, and an M.P.H. from the Harvard School of Public Health. He is professor-at-large at the Keck Graduate Institute of Applied Life Science and is board certified in preventive medicine and public health and occupational medicine. Vincent Ahonkhai, M.D., FAAP, is Deputy Director, Regulatory Affairs for Global Health at BMGF. His role is to provide strategic regulatory over- sight for on-time development and registration of foundation health tech- nologies, including vaccines, drugs, diagnostics, and public health pesticide

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APPENDIX B 93 products. His background is in biopharmaceutical global health research and development (R&D), including clinical development, medical affairs, regulatory affairs, and product safety and pharmacovigilance. His specialty is infectious disease. Deborah Autor, J.D., is FDA’s Deputy Commissioner for Global Regula- tory Operations and Policy. Ms. Autor’s Directorate, one of four created in July 2011, includes the Office of Regulatory Affairs and the Office of International Programs. The Office of Regulatory Affairs, with a staff of more than 4,000 U.S. employees, is responsible for imports, inspections, and enforcement policy for all FDA-regulated products. The Office of International Programs, with a staff of more than 80 employees around the world, is responsible for maximizing the impact of FDA’s global inter- actions. Ms. Autor leads FDA’s strategy for confronting the challenges of globalization and import safety. She co-chaired the group that prepared FDA’s 2011 report, Pathway to Global Product Safety and Quality, which describes the paradigm shift that FDA must make to face the challenges of globalization today and in the future. Ms. Autor has been with FDA since 2002. Prior to assuming the role of Deputy Commissioner, she served for 5 years as Director of the Office of Compliance of FDA’s CDER. In that role, she led policy making and enforcement for key public health pro- grams for drugs, including current good manufacturing practices; human subject protection and bioresearch monitoring; marketing unapproved drugs; pharmaceutical import and export; pharmacy compounding; Inter- net and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls. Ms. Autor engaged in many international activities in this role, including leading the negotiation of the work plan under the Memorandum of Agreement between the U.S. FDA and China’s State FDA. She won the 2011 Meritorious Executive Presidential Rank Award. This award is presented annually to a select group of career civil service senior executives whose integrity, strength, leadership, and relent- less commitment to excellence in public service have earned them one of the most prestigious honors in government. Ms. Autor is also a 2011 recipient of the Food and Drug Law Institute’s Distinguished Service and Leadership Award in recognition by her peers of remarkable professional achievements and dedicated support to the food and drug law field and community. In addition, Ms. Autor was a 2010 finalist for the prestigious Service to America Medal for the innovative and strategic action that she took to tackle the serious public health issue of marketed unapproved drugs. She has also received 24 awards from FDA, 24 awards from the CDER, 1 award from the U.S. Department of Health and Human Ser- vices, and 6 awards from the U.S. Department of Justice. Before joining

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94 INTERNATIONAL REGULATORY HARMONIZATION FDA, Ms. Autor was a trial attorney for 7 years in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA and other federal law enforcement agen- cies. She began her legal career practicing food and drug law at the firms of Weil, Gotshal & Manges and Buc Levitt & Beardsley. Leslie Ball, M.D., has served as Assistant Commissioner of Interna- tional Programs and Deputy Director of FDA’s Office of International Programs since September 2012. The Office of International Programs leads FDA’s international activities and oversees the operation of FDA’s 13 regional and country offices. Prior to this position, Dr. Ball served as Acting Director of the Office of Scientific Investigations, and previously Director of the Division of Scientific Investigations, Office of Compli- ance, CDER, FDA. While in the Division of Scientific Investigations she was active in developing a risk model for selecting clinical trial sites for inspection, collaborating with EMA and other international regulatory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions. Dr. Ball joined FDA in 1996 as a medical officer in the Center of Biologics ­ Evaluation and Research. Dr. Ball graduated with a B.S. in biology from Georgetown University, where she also received her M.D. and completed a residency in pediatrics. She completed a Fellowship in ­ pediatric infectious diseases at the Walter Reed Army Medical Center. She served as a practicing pediatrician at the U.S. Naval Hospital, Subic Bay, Republic of the ­ hilippines, in private practice in Maryland, at the P National Naval Medical Center, Bethesda. Michael Brennan, Ph.D., is the Senior Advisor for Global Affairs at the Aeras Global TB Vaccine Foundation. He develops strategies for the timely introduction of new TB vaccines into low-income countries, and he works closely with National Regulatory Authorities responsible for clinical trial approval and new product licensure. Dr. Brennan also heads projects on the development of correlates and biomarkers for TB vaccines. Prior to joining AERAS, he spent more than 20 years at FDA, where he was an Associate Director at the Office of Vaccines Research and Review, and was also head of the TB vaccine program. In 2001, he worked in Geneva assist- ing WHO in its development of a new TB Vaccine Initiative. Dr. Brennan has published more than 90 scientific articles on vaccines and infectious diseases, and his early research paved the way for widespread whooping cough immunizations. An authority on vaccine development and regula- tory review, he sits on several international advisory committees, includ- ing the Stop TB Partnership, WHO, and the U.S. National Institutes of Health (NIH). He received a Ph.D. from Albany Medical College.

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APPENDIX B 95 Martha A. Brumfield, Ph.D., is Director of International and Regulatory Programs at C-Path. Dr. Brumfield has a consulting practice focusing on concordance in global regulatory initiatives; examining regulatory science qualification programs; and providing educational workshops on these and related topics. Other areas of focus include excellence in clinical trial conduct; facilitation of scientific consortiums; and programs supporting patient access to medicines. At present she is engaged with the nonprofit C-Path as a consultant to guide international program development and to provide regulatory guidance to consortiums. She is also engaged with other nonprofits, Regulatory Harmonization Institute and GlobalMD, to deliver educational workshops on regulatory and clinical trial topics in Asia. She is leading work through C-Path to TB drug regimens toward the identification of regulatory pathways in high-burden TB countries. Dr. Brumfield served on the IOM committee Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Most recently, Dr. Brumfield was senior vice president, Worldwide Regulatory Affairs and Quality Assurance at Pfizer Inc. She led a global team that supported lifecycle pharmaceutical research, development, and commer- cialization 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. Dr. Brumfield has been active in several external organizations, includ- ing PhRMA, CMR, and the APEC Life Sciences Innovation Forum and has worked extensively with the PhRMA Simultaneous Global Develop- ment program. During 20 years at Pfizer, Dr. Brumfield held a variety of leadership positions in which she led regulatory teams responsible for the U.S., Europe, and emerging markets. Dr. Brumfield also served as the com­ any’s head of drug safety surveillance and reporting, and p managed global adverse event reporting requirements and the integra- tion of ­ harmacia’s related safety operations. Dr. Brumfield earned a B.S. P and M.S. in chemistry from Virginia Commonwealth University, a Ph.D. in organic chemistry from the University of Maryland, and served as a postdoctoral Fellow at the Rockefeller University. Raymond Chua, M.B.B.S., M.Sc., DLSHTM, M.B.A., began his medical career after graduating from the Faculty of Medicine in the National Uni- versity of Singapore (1997). He underwent numerous medical and surgi- cal postings in the public-sector hospitals and Singapore Civil Defence Force until October 2000. Dr. Chua then took up his public health special- ist training with the Ministry of Health, Singapore (October 2000 until April 2006), and became certified as a registered public health specialist and Fellow with the Academy of Medicine, Singapore (2007). He was also

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96 INTERNATIONAL REGULATORY HARMONIZATION awarded a scholarship by the Ministry of Health, Singapore, to earn an M.S. in public health with the London School of Hygiene and ­ ropical T Medicine, University of London (2002–2003). Dr. Chua also holds an M.B.A. with a Merit Pass, from the University of Nottingham, as well as a Graduate Diploma in Change Management, Institute of Public Admin- istration and Management, Singapore (2007). He left the public service to join Eisai Co Ltd in June 2007 as the managing director and regional medi- cal director of Eisai Clinical Research Singapore Pte Ltd, to oversee, exe- cute, and manage the growth, development, and operations of the global and regional clinical research activities within the Asia-Pacific, Oceania, and Middle East countries. In 2010, he joined Shire Pharmaceuticals as international medical director. In July 2011, Dr. Chua joined Health Sci- ence Authority as the Deputy Group Director of the Health Products Regulation Group and took over the helm as Group Director in May 2012. He oversees the pre- and postmarketing regulation of all health prod- ucts, including drugs, medical devices, complementary health products, advanced therapy products, and tobacco in Singapore. He also holds other appointments as council member of the Singapore Medical Council. He is also an appointed member of the International Committee, Faculty of Pharmaceutical Physicians, London as well as a Fellow Physician of the Royal College of Physicians and Surgeons (Glasgow) and a Fellow of the Royal College of Public Health (London). Carolyn Compton, M.D., Ph.D., is the President and Chief Executive O ­ fficer, C-Path. C-Path works with industry, academia, and nonprofit groups to engage in focused collaborative activities that involve prioritiza- tion of issues, sharing of data and expertise, consensus building, and pub- lication. Specifically, C-Path drives consensus building to achieve product development tool qualification in order to increase the efficiency and robustness of regulatory approval. Dr. Compton has a broad background in translational research, in the discovery, pre­ linical, and clinical phases c of medical product development. She is board certified in both anatomic and clinical pathology with a track record of leadership in medical innova- tion and practice. Immediately prior to her leadership of C-Path, she spent 7 years as the director of the Office of Biorepositories and Bio­ pecimen s Research in the Office of the Director of the National Cancer Institute. She came to the National Cancer Institute from McGill University, where she had been the Strathcona Professor and Chair of Pathology and the pathol- ogist-in-chief of McGill University Health ­ enter from 2000 to 2005. Prior C to this, she had been a professor of pathology at Harvard Medical School, director of gastrointestinal pathology at the Massachusetts General Hos- pital, and the pathologist-in-chief of the Shriners’ Hospital for Crippled Children, Boston Burns Unit for 15 years. She is a professor in the College

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APPENDIX B 97 of Medicine-Tucson Department of Pathology, and clinical professor in the College of Pharmacy Department of Pharmacy Practice and Science at the University of Arizona. She holds a full professorship at Arizona State University in the School of Life Sciences. She is also an adjunct professor of pathology at the Johns Hopkins School of Medicine. Dr. Compton has held many national and international leadership positions in pathology and cancer-related professional organizations. She is a Fellow of the Col- lege of American Pathologists (CAP) and a Fellow of the Royal Society of Medicine. Currently, she is chair of the American Joint Committee on Cancer, serves on the Executive Committee of the Commission on Cancer of the American College of Surgeons, and serves as the pathology section editor for Cancer. She is a past chair of the Cancer Committee of CAP and was editor of the first edition of the CAP Cancer Protocols (Reporting on Cancer Specimens) used as standards for COC accreditation. Among her awards are the ISBER Award for Outstanding Achievement in Bio­ banking, the NIH Director’s Award, the NIH Award of Merit, and the CAP Frank W. ­ artman Award. She has published more than 500 original H scientific papers, reports, review articles, and books. Hans-Georg Eichler, M.D., M.Sc., is the Senior Medical Officer at EMA in London, United Kingdom, where he is responsible for coordinating activities between the Agency’s scientific committees and giving advice on scientific and public health issues. From January until December 2011, Dr. Eichler was the Robert E. Wilhelm Fellow at the Massachusetts Insti- tute of Technology’s (MIT’s) Center for International Studies, partici- pating in a joint research project under the MIT’s NEWDIGS initiative. He divided his time between the MIT and the EMA in London. Prior to joining EMA, Dr. Eichler was at the Medical University of Vienna in Austria for 15 years. He was Vice Rector for Research and Interna- tional Relations since 2003, and Professor and Chair of the Department of Clinical Pharmacology since 1992. His other previous positions include President of the Vienna School of Clinical Research and Co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association. His industry experience includes time spent at Ciba-Geigy Research Labs, United Kingdom, and Outcomes Research at Merck & Co., in New Jersey. Dr. Eichler graduated with an M.D. from Vienna University Medical School and an M.S. in toxicology from the University of Surrey in Guildford, United Kingdom. He trained in internal medicine and clinical pharmacology at the Vienna University Hospital as well as at Stanford University. James Fitzgerald, B.Sc. (Pharm), Ph.D., is Coordinator, Medicines and Technologies, Area of Health Systems based on Primary Health Care,

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98 INTERNATIONAL REGULATORY HARMONIZATION PAHO, WHO. Dr. Fitzgerald is a national of Ireland, and holds a Ph.D. in pharmaceutical sciences from the University of Dublin. He began his career in international public health when he joined PAHO in 1997 work- ing in Haiti until 2002, Washington (2002–2005), and Brazil (2005–2008) as adviser in Medicines, Vaccines, and Health Technologies. In 2008, he assumed the coordination of the regional work program at PAHO in medicines and biologicals, and later health technologies. He is the author and co-author of numerous articles, has presented in numerous interna- tional congresses, and is a member of a number of professional societies and advisory groups associated with his profession and area of work. Cindy Flannery, M.S., is a Senior Health Physicist in the Office of Federal and State Materials and Environmental Management Programs at the U.S. Nuclear Regulatory Commission (NRC). In this position, she serves as office lead for safety culture activities and is also a working group member responsible for revisions to the radiation protection regulations to increase alignment with international recommendations. She joined the NRC in 2004 and served as the Team Leader of the Medical Radia- tion Safety Team for 5 years. Ms. Flannery has 19 years of experience as a health physicist in the medical industry as well as in military and research organizations. Prior to NRC, she served as Branch Chief and Radiation Safety Officer for the Defense Threat Reduction Agency and as the Radia- tion Safety Officer/Health Physicist at FDA. Before her employment by the federal government, she worked as a health physics consultant for Krueger-Gilbert Health Physics, Inc., in Maryland and as a nuclear medi- cine technologist at the Mayo Clinic in Minnesota. Ms. Flannery gradu- ated from Georgetown University with an M.S. in health physics and from the University of Wisconsin with a B.S. in nuclear medicine technology. She was certified by the American Board of Health Physics in 2001. She currently serves as Vice Chair of the American Board of Health Physics Part I Examination Panel, Associate Editor for the Health Physics News monthly newsletter, and topic editor for the “Ask the Experts” feature of the Health Physics Society website. Timothy Franson, B.S.Pharm., M.D., is currently a Principal and Senior Vice President with FaegreBD Consulting in Washington, DC, and India- napolis, where he leads the regulatory affairs practice; he also serves as President of the U.S. Pharmacopeial Convention (2010–2015). In 2008, Dr. Franson retired from the position of Vice President of Global Regulatory Affairs and Patient Safety after a 21-year career at Eli Lilly. During his time at Lilly, he led a number of industry initiatives, including Co-chair of the Committee for PDUFA (Prescription Drug User Fee Act)-III Renewal, and has testified at several congressional hearings, as well as serving

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APPENDIX B 99 as Chair of PhRMA’s Clinical Steering Committee and FDA Committee Staff Work Group. He also previously served as a member of the AAMC- PhRMA Clinical Trials Forum, member of the Regulatory Advisor Board for the Centre for Medicines Research International, board member of the National Patient Safety Foundation, trustee for Xavier University (Louisiana), member of Auburn University Pharmacy Dean’s Advisory Board and civic board leadership roles (Little Red Door Cancer Agency, Indiana State Museum Foundation, Villages Child Welfare Services). Dr. Franson is board certified in internal medicine and infectious diseases. He co-authored a recent chapter in the book PDUFA and the Expansion of FDA User Fees: Lessons from Negotiators. Hans V. Hogerzeil, M.D., Ph.D., FRCP, is Professor of Global Health, University of Groningen. Dr. Hogerzeil qualified as a medical doctor from Leiden University in the Netherlands and received a Ph.D. in public health in 1984. For 5 years he was a mission doctor in India and Ghana and in 1985 he joined the WHO Action Programme of Essential Drugs, first in the Regional Office for the Eastern Mediterranean in Alexandria, and later in WHO’s headquarters in Geneva. As a staff member of WHO, he has advised more than 40 developing countries, especially in Africa and Asia, on the formulation of their national medicines policy, essen- tial drugs list, and essential drugs program. As secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, he initiated the 2002 changes in procedures for updating the Model List of Essential Medicines, with stronger emphasis on evidence-based selec- tions. He established the Web-based WHO Essential Medicines Library and was one of the editors of the WHO Model Formulary in 2006. Under his direction of the Department of Policy and Standards (2004–2008), the WHO PQP was established. From 2008 to 2011, he was Director for Essential Medicines and Pharmaceutical Policies, being responsible for all of WHO’s global policies, nomenclature, norms and standards on medi- cines, the WHO PQP, as well as all technical country support to member states in the field of medicines (currently support programs in more than 100 countries, covering access to essential medicines, quality, and rational use). He was also Chair of the Interagency Pharmaceutical Coordina- tion Group, which coordinates the pharmaceutical policies of WHO, all major UN agencies, the Global Fund, the World Bank, and UNITAID. Dr. Hogerzeil is the editor of several WHO books on essential medicines poli- cies, 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 international courses all over the world. In 1996, he was invited to become a Fellow of the Royal College of Physicians in Edinburgh and in 1998, he received

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100 INTERNATIONAL REGULATORY HARMONIZATION an honorary Doctorate of Science from the Robert Gordon University in Aberdeen, Scotland. His recent interests include essential medicines for reproductive health, access to essential medicines as part of the fulfillment of the right to health, the development of a patent pool for combination therapies for the second-line treatment of HIV/AIDS, and regional regula- tory harmonization in Africa. Peter Honig, M.D., M.P.H., is Global Vice President, Regulatory Affairs, AstraZeneca. Dr. Honig received his baccalaureate, medical, and public health degrees from Columbia University. He has postgraduate training and is board certified in internal medicine and clinical pharmacology and has authored numerous peer-reviewed publications and book chapters. He has held senior leadership positions at FDA and Merck Research Labo- ratories. He is and has been the PhRMA representative to the ICH Steering Committee since 2002 and the current co-chair of the ICH GCG whose mission is to promote regulatory harmonization in non-ICH countries and regions. Dr. Honig has a faculty appointment at the Uniformed Services University of the Health Sciences, is a past president of the American Society for Clinical Pharmacology and Therapeutics, and is an associate editor of Nature Clinical Pharmacology and Therapeutics. Judith M. Kramer, M.D., M.S., is board certified and has practiced both clinical pharmacy and general internal medicine. For the past 27 years she has been engaged in clinical research administration in industry and academia (10 years at Burroughs Wellcome Co., 1 year at Glaxo Wellcome, ­ and 16 years at Duke University). Currently she is Professor of Medicine at Duke University Medical Center, where she is involved full time in research-related activities at Duke Clinical Research Institute. Dr. Kramer was the first Executive Director of the Clinical Trials Transformation Ini- tiative (CTTI), a public–private partnership cofounded by Duke Uni- versity and FDA with a goal of improving the quality and efficiency of clinical trials. She is now a Senior Scientific Advisor for CTTI. Previously at Duke she served as Chief Medical Officer of the Duke Clinical Research Institute (1997–2006), Principal Investigator for Duke’s Center for Edu- cation and Research on Cardiovascular Therapeutics (CERTs), focused on cardio­ ascular disease (2000–2007), and regulatory consultant to the v Duke Translational Medicine Institute (2006–2008). From 1999 to 2001, Dr. Kramer developed and was the founding director of the ­ aster’s M Program in Clinical Research at Campbell University, in Research ­ riangle T Park, North Carolina. She has served on numerous FDA advisory com- mittees as a member of the Drug Safety and Risk Management Advi- sory Committee from 2006 to 2011 and remains a special government employee. Dr. Kramer received her B.S. and M.S. in pharmacy and M.D.

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APPENDIX B 101 from the University of North Carolina (UNC) at Chapel Hill. She did her residency in primary care internal medicine at Massachusetts General Hospital, and a senior residency in internal medicine at UNC at Chapel Hill. She is a member of The Rho Chi Society, the academic honor soci- ety in pharmacy, and Alpha Omega Alpha Honor Medical Society. Her research interests have focused on developing safe and effective cardio- vascular therapies, ensuring persistent use of life-saving medications, and studying how clinical trials are conducted. Hubert Leufkens, Pharm.D., Ph.D., obtained his Pharm.D. and Ph.D. from Utrecht University. In 1998, he was appointed as full Professor at the Department of Pharmacoepidemiology and Pharmacotherapy of the same university. This is one of the leading groups in pharmacoepidemiology (output included more than 50 publications per year in peer-reviewed press, highly visible profile, resource for innovative methodologies). From 2003 to 2005, he was the Scientific Director of the Utrecht Institute for Pharmaceutical Sciences. During 2006–2007, he was Dean of Pharmaceuti- cal Sciences of the Faculty of Science in Utrecht. Since 2007, he has been appointed as Chair of Dutch Medicines Evaluation Board. Moreover, Dr. Leufkens is one of the co-founders of the SIR Institute for Pharma Practice and Policy in Leiden and active at several (inter)national platforms on pharmacoepidemiology (e.g., since 2009, co-opted member for pharma- coepidemiology of the EMA CHMP, past-President of ISPE), pharmaco- vigilance (past-member EMA Pharmacovigilance Working Party), orphan drugs (past-Chair of the Dutch Steering Committee on Orphan Drugs), pharma policy (since 2008, Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy Analysis and Pharmacoepidemiology), regulatory science, and scenario planning. He is co-author of more than 375 papers in peer-reviewed journals, book chapters, and research reports. Lawrence E. Liberti, M.Sc., R.Ph., RAC, is Executive Director, CIRS (for- merly the CMR International Institute for Regulatory Science). For the past 34 years, Mr. Liberti has worked in and with the pharmaceutical industry, in the fields of regulatory affairs and clinical R&D. He began his career at Wyeth Laboratories working in product development, as a regulatory writer in clinical R&D, and as manager of safety surveillance in medical affairs. He served as the Editorial Director for the North Ameri- can operations of ADIS International after which he founded PIA Ltd., a company specializing in regulatory writing and consulting. He co-founded A ­ strolabe Analytica, where he helped develop, patent, and commercialize the Astrolabe Message Mapping System™. Both organizations became part of Thomson Reuters in 2005. Since 2009, he has served as the executive director of CIRS, an independent division of the IP and Science business of

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102 INTERNATIONAL REGULATORY HARMONIZATION Thomson Reuters. Mr. Liberti has been actively involved in promulgating best practices in the regulatory aspects of medicines development, espe- cially in the emerging markets. He lectures on regulatory issues concerning expediting patient access to medicines, new paradigms of drug develop- ment, and ways to improve communications among regulators, HTAs, and sponsors. He serves on the boards of other not-for-profit organizations, including CONTACT Greater Philadelphia (a suicide prevention and elder outreach provider). Mr. Liberti is a pharmacist with a master’s degree in pharmacognosy (both from the Philadelphia College of Pharmacy and Sci- ence). He is currently undertaking paralegal certification. He was awarded the status of Regulatory Affairs Certified by the Regulatory Affairs Profes- sional Society. He is a Fellow of the American Medical Writers Association and a recipient of its Golden Apple award for excellence in teaching. Richard C. Meibach, Ph.D., is currently the Global Head of Regulatory Affairs for Neuroscience and Ophthalmology at Novartis Pharmaceuti- cals. Prior to joining Novartis, Dr. Meibach had been Vice President of Clinical Science at Hoffmann-La Roche Inc., Pharmaceuticals. For 10 years he had global responsibility for central and peripheral nervous system diseases, and urology. He received his Ph.D. in biomedical sciences from the Graduate School of Biomedical Sciences, New Jersey Medical School (1976). Dr. Meibach did a 2-year postdoctoral fellowship in neurology at Albert Einstein College of Medicine, New York. In 1978, he became an assistant professor of pharmacology at Mount Sinai School of Medicine in New York. His research interests were in the anatomical and func- tional connections of the limbic and extrapyramidal systems in the brain. Major discoveries included the determination of the origin of the fornix system, localization and visualization of serotoninergic type 2 receptors in the brain, and the localization of phencylclidine (angel dust) effects on brain metabolism. Dr. Meibach left basic academic research in 1983 to pursue a clinical research career in the pharmaceutical industry. In addi- tion to Novartis and Roche, he has worked for two other major pharma- ceutical companies: Ayerst Laboratories, a division of American Home ­ roducts (now Wyeth), and Janssen Pharmaceuticals, a division of Johnson P ­ & ­ohnson. Dr. Meibach has had several successful NDA submissions in J his 30 years of industry experience. Of 20 drugs that have achieved more than $2 billion in sales (MedAd News, May 2005), Dr. Meibach developed 2 of them (Risperdal for schizophrenia and Duragesic transdermal patch for chronic pain). Dr. Meibach has published 90 research papers and abstracts. His paper on the Phase III study with risperidone, published in 1994, was the number one cited paper of the decade in schizophrenia, with more than 400 citations. Dr. Meibach is called on to review articles for several leading brain research and psychiatric journals.

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APPENDIX B 103 Alan Morrison, B.Sc., is Vice President, International Regulatory Affairs and Safety, Amgen Inc. Mr. Morrison leads Amgen’s International Regu- latory Affairs and Safety functions of approximately 300 staff both in the United Kingdom and across more than 30 local affiliate offices world- wide. As well as part of the Global Regulatory Affairs and Safety leader- ship, he is also a key member of Amgen’s cross-functional International Management Committee, which sets and guides the international busi- ness overall strategic direction. Mr. Morrison joined Amgen in 2004, hav- ing previously held a number of regulatory affairs and safety positions at other companies, including Baxter Bioscience. He is currently Chair of the BioIndustry Association’s Regulatory Affairs Group and serves on a number of trade association committees related to biotechnology/ biopharmaceuticals. Moheb M. Nasr, Ph.D., joined GlaxoSmithKline in September 2011 as Vice President for CMC Regulatory Strategy. Prior to joining GlaxoSmithKline, Dr. Nasr served as the Director of the Office of New Drug Quality Assess- ment (ONDQA), CDER, FDA. Dr. Nasr established and led ONDQA for 8 years. Dr. Nasr represented FDA at ICH and was instrumental in the development of the QBD concept and several quality regulatory guidelines. Dr. Nasr obtained his Ph.D. in chemistry at the University of Minnesota in Minneapolis. Dr. Nasr is an elected Fellow of the Ameri- can Association of Pharmaceutical Scientists (AAPS), the recipient of the AAPS Regulatory Science Achievement Award, and the University of Wisconsin Pharmaceutical Analysis Excellence Award. Margareth Ndomondo-Sigonda, M.Sc., M.B.A., is Pharmaceutical Coor- dinator, African Union-NEPAD Planning and Coordinating Agency. Ms. Ndomondo-Sigonda 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. She has been involved in medicines regula- tion harmonization initiatives in Southern Africa Development Commu- nity and EAC. She has consulted for WHO on assessment of medicines regulatory systems in Sudan, Egypt, Kenya, Zambia, CARICOM member states, and the Dominican Republic. Ms. Ndomondo-Sigonda 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-NEPAD. Ms. Ndomondo-Sigonda is responsible for coordinating the pharmaceutical development programs, including the AMRH initiative. She holds a master’s degree in pharma- ceutical services from 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 Salaam.

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104 INTERNATIONAL REGULATORY HARMONIZATION Lembit Rägo, M.D., Ph.D., was a Professor of Clinical Pharmacology (Tartu University) and Founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines. In December 1999, he joined WHO Headquarters, Geneva, as Coordinator of the Qual- ity Assurance and Safety: Medicines team, which is located in the Depart- ment of Essential Medicines and Health Products dealing with medicines regulation and standards. Today the unit is composed of seven interlinked technical programs dealing with International Nonproprietary Names, Quality Assurance, Pharmacovigilance, Regulatory Support, Fighting Falsified Medicines, Prequalification of Medicines, and Blood Products and Related Biologicals. In 2001, he initiated the WHO PQP and has con- tributed to its development since then. Since 2002, he has organized the WHO biennial International Conference of Drug Regulatory Authorities, bringing together regulators from approximately 100 countries world- wide. His unit publishes the quarterly WHO Drug Information Journal and bimonthly WHO Pharmaceutical Newsletter. He is the WHO observer to the ICH Steering Committee, ICH Regulators Forum, and ICH GCG. He also serves as vice chair of the Uppsala Monitoring Centre Board, which hosts the WHO Global Database of Individual Case Safety Reports (adverse drug reaction reports). He has numerous international publications on regulatory affairs, medicines quality, and safety issues. Amrit Ray, M.D., M.B.A., FCMI, serves as Chief Medical Officer for Johnson & Johnson’s pharmaceutical division, Janssen Research & Devel- opment LLC. In this capacity, Dr. Ray has primary responsibilities for ensuring the safe, effective, and appropriate use of Johnson & Johnson’s 1,000-plus pharmaceutical products globally, and for supporting an innovative research pipeline of new medical solutions in areas of unmet patient need. He is chair of the Global Safety Council, the organization’s most senior governance body for product safety matters with oversight for identifying, evaluating, and managing medical risk for drugs, biolog- ics, vaccines, and other categories of medicines, across all disease areas from first human exposure through clinical trials and market activity. Dr. Ray leads the Global Medical Organization, including departments for medical safety, development, and medical affairs for established products, and centers of special expertise, such as for pediatric drug development. He has served as Chief Safety Officer since 2009, and was subsequently appointed as Chief Medical Officer in 2012. Dr. Ray is an experienced physician with a U.S., EU, and Asia background in medical leadership across multiple areas of pharmaceutical research. Prior to joining Johnson & Johnson, he served in positions of increasing responsibility at Pfizer Inc. and Bristol-Myers Squibb. His experience includes directing the Phase III‐IV development, launch, and commercialization of several new medi-

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APPENDIX B 105 cines; overseeing departments for medical affairs, safety, and epidemiol- ogy; and co-leading Pfizer’s acquisition/integration of Pharmacia. At both Pfizer and Bristol-Myers Squibb, Dr. Ray was awarded distinctions for driving the development of medicines in immunology, cardiovascular, and women’s health. Dr. Ray earned a B.Sc. (with Honors) in immunology and an M.D. from Edinburgh University Medical School, Scotland. He obtained bench research experience with antibodies at Sir Joseph Lister Laboratories, and clinical medicine training at Edinburgh Royal Infirmary. He began his career serving as a hospital physician delivering patient care in the U.K. National Health Service, and initiated his clinical research experience in obesity at the Mayo Clinic. Dr. Ray also earned an M.B.A. from Dartmouth College and is a former McKinsey management consul- tant with business experience in valuation, corporate finance, and mergers and acquisitions. Dr. Ray has authored numerous scientific papers and been invited to advise WHO, U.S. Agency for International Development, U.K. Medicines and Healthcare Products Regulatory Agency, Canadian Agency for Drugs and Technologies in Health, China’s State FDA, and a number of international expert forums on how medicines can create value and have a positive impact on patient lives. Andreas Seiter, M.D., is a Senior Health Specialist, Pharmaceuticals, Health, Nutrition, and Population, World Bank. He joined the bank in January 2004 and is responsible for analytical and advisory work in all areas of pharmaceutical policy, such as regulation, governance, quality assurance, financing, purchasing, supply chain, and rational use. He has been working with bank teams, policy makers, and experts on the client side in several countries in Africa, Eastern Europe, the Middle East, Latin America, and South Asia. He is leading the work on medicines regula- tory harmonization, with a focus on AMRH. In 2010, he published the book A Practical Approach to Pharmaceutical Policy. Dr. Seiter, a German national, is a physician by training and practiced medicine before joining a multinational pharmaceutical company in 1984. He held various posi- tions in medical operations, product management, communications, and stakeholder relations in the industry prior to joining the World Bank. Andy Stergachis, Ph.D., M.S., is Professor of Epidemiology and Global Health and Adjunct Professor of Pharmacy and Health Services, School of Public Health, University of Washington. His research focus is pharmaco- epidemiology, global medicines safety, pharmaceutical outcomes research, and public health systems research. He has served as Chair of the Depart- ment of Pharmacy and Department of Pathobiology. He also served as Associate Dean of the School of Public Health. He was Vice President and Chief Pharmacist of drugstore.com. He was Founding Director of

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106 INTERNATIONAL REGULATORY HARMONIZATION the Pharmaceutical Outcomes Research and Policy Program, University of Washington. A registered pharmacist, he earned his pharmacy degree from Washington State University and his M.S. and Ph.D. from the Uni- versity of Minnesota. His Postdoctoral Fellowship was from the Health Services Research Center, St. Louis Park Medical Center, Minneapolis. He was the 1990 Burroughs Wellcome-American College of Preventive Medi- cine Scholar in Pharmacoepidemiology. At the University of Washington he directs the Global Medicines Program, www.globalmedicines.org. He directs the University of Washington components of two projects funded by BMGF, including pharmacovigilance with the Malaria in Pregnancy Consortium. He also directs the University of Washington component of a U.S. Agency for International Development-funded cooperative agree- ment with Management Sciences for Health on Systems for Improved Access to Pharmaceuticals and Services in developing countries. He is author of more than 100 peer-reviewed publications and has received numerous awards, including the American Pharmaceutical Association Foundation 2002 Pinnacle Award for his career commitment to improving the quality of the medication use process and is a Fellow of the Interna- tional Society for Pharmacoepidemiology. He served as a professor in residence with the Infectious Diseases Institute, Makerere University, Uganda. He is an elected member of the IOM and has served on several IOM committees, including the Committee on Assessment of the U.S. Drug Safety System and the Committee on Strengthening Regulatory Systems in Developing Countries. He serves as a special government employee for FDA, is a Senior Advisor to the Safety Surveillance Working Group of BMGF, and is a member of the Advisory Group to Global Alert and Response for WHO. Douglas C. Throckmorton, M.D., is the Deputy Director for Regulatory Programs in the CDER at FDA. In this role, he shares responsibility for overseeing the regulation of research, development, manufacture, and marketing of prescription, over-the-counter, and generic drugs in the United States. From aspirin to cancer treatments, CDER works to ensure that the benefits of approved drug products outweigh their known risks. Dr. Throckmorton is board certified in internal medicine and nephrol- ogy, having received his training at the University of Nebraska Medical School, Case Western Reserve University, and Yale University. Prior to joining FDA, he practiced medicine at the Medical College of Georgia. Toshiyoshi Tominaga, Ph.D., is Professor and Director of the Food and Drug Evaluation Center, Osaka City University Hospital. In his capacity, he supervises all the clinical studies conducted in the hospital. He has been in his current position since August 2012. He joined Japan’s Min-

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APPENDIX B 107 istry of Health, Labor, and Welfare (MHLW), after he acquired his Ph.D. from Faculty of Pharmaceutical Sciences, University of Tokyo (1987). As a carrier official, he worked in narcotics control, NDA review, and drug price setting in the country’s health insurance system as well as in sev- eral international fronts of MHLW, including a 1-year stint at FDA, and a 3-year stay in Vienna as a diplomat. He also spent 2 years at Harvard School of Public Health. Between 2009 and 2012, as Director of Office of International Programs of PMDA, sister agency to MHLW, he represented PMDA in various bi- and multilateral activities, including ICH in its Steer- ing Committee. Mary Lou Valdez, M.S.M., is Associate Commissioner for International Programs and Director, Office of International Programs, FDA. Ms. Valdez joined FDA in 2009. The FDA Office of International Programs is the focal point for the agency’s international efforts, in close alignment with FDA program centers and offices. Ms. Valdez leads, manages, and coordinates Office of International Programs’s staff of about 100 around the world, catalyzing FDA global engagement in collaboration with international health and regulatory partners, ministries of health and agriculture, other U.S. government agencies, industry, academia, multilateral organizations, and other relevant stakeholders. In addition to FDA headquarters, Office of International Programs staff are strategically located in Belgium, Chile, China, Costa Rica, India, Italy, Jordan, Mexico, South Africa, and the United Kingdom. Ms. Valdez has a master of science in management from the University of Maryland University College, and a B.S. in biology from the University of Texas at El Paso. She is proficient in reading, writ- ing, and speaking Spanish. Ms. Valdez came to FDA after serving for 18 years in the Department of Health and Human Services, where she was extensively involved in international health diplomacy. As the Deputy Director of the Office of Global Health Affairs from 2003 to 2008, Ms. Valdez led the development of U.S. policy positions on a wide range of complex public health issues, promulgated them within the governance processes of multilateral organizations, and conducted negotiations with other member governments that resulted in the successful acceptance of many of these positions within the larger international community. Ms. Valdez has extensive experience in hands-on negotiations and diplomacy. She is a member of U.S. government delegations to meetings of the gov- erning bodies of multilateral organizations, including the WHO Executive Board and the World Health Assembly; the Executive Board of the UN Children’s Fund, PAHO’s Executive Committee, Directing Council, and Pan American Sanitary Conference; the Health Committee of the Organ- isation for Economic Co-operation and Development and UN special ses- sions and councils, including the UN Special Session for Children in 2002.

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108 INTERNATIONAL REGULATORY HARMONIZATION Mike Ward is Manager of the International Programs Division of the Therapeutic Products Directorate of Health Canada. He joined Health Canada in 1986 following 9 years of industrial experience in the QA/QC area. Since then he has held a variety of regulatory positions, including good manufacturing practice specialist, premarket quality reviewer and manager, and senior policy analyst. He served as the Canadian Observer to the ICH Steering Committee and a former regulatory co-chair of the GCG. He chairs the RHSC of the APEC Life Sciences Innovation Forum and is an alternate representative for NAFTA on the Pan American Regu- latory Harmonization Steering Committee. David Wood, Ph.D., is Coordinator, Quality, Safety and Standards, WHO. Dr. Wood holds a Ph.D. in virology from the University of Manchester, United Kingdom (1984). After initial work in diagnostic virology in Man- chester, he transferred to the UK National Institute for Biological Stan- dards and Control (NIBSC) (1988) with responsibility for batch release, standardization, and research on poliovirus vaccines, hepatitis A, and yellow fever vaccines. While at NIBSC he became closely involved with WHO activities, working on global standards for biological medicines and with the polio eradication initiative, which is now very close to the goal of eradicating wild-type polioviruses. In February 2001, he transferred to WHO, initially coordinating the research agenda for development of post- certification polio immunization policy and also standardization of virus vaccines. In June 2003, he assumed overall responsibility for all WHO biological standardization activities. He is secretary to the WHO Expert Committee on Biological Standardization. Since January 2006, as Coordi- nator of the Quality, Safety and Standards Team, he has been responsible for all aspects of regulatory support provided by WHO to countries and UN agencies for biological medicines, including the vaccines prequalifi- cation scheme. He is also responsible for a laboratory network of WHO Collaborating Centres for biological standardization. Diane Zezza, Ph.D., is currently Vice President, Global Regulatory CMC, Novartis Pharmaceuticals Corporation. In this role, Dr. Zezza has global responsibilities for CMC regulatory strategies and activities for all devel- opment products and lifecycle management for commercial products for both small molecule and biologics portfolios. This includes global CMC support and regulatory dossier creation for products in all phases of clinical trials, product development through global product registrations, and product lifecycle support and optimization. Prior to joining Novartis, Dr. Zezza was Vice President, Global Regulatory Affairs, CMC, at Merck. Previously, she held several positions and led groups with responsibilities for global Regulatory CMC aspects for small molecules and biologics at

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APPENDIX B 109 Schering Plough Corporation and at Eli Lilly and Company. Dr. Zezza has been involved in numerous industry and joint FDA-sponsored initiatives that have supported ICH global harmonization efforts for ICH Q8 Phar- maceutical Development, ICH Q9 Quality Risk Management, and ICH Q10 Pharmaceutical Quality Systems efforts. These included co-chairing or organizing joint industry-FDA conferences on Pharmaceutical Quality Assessment, QBD, Regulatory Agreements, and Specification Setting for Small Molecules and Biologics. She has been an active member for many years on several PhRMA Committees focused on technical, CMC, quality, and regulatory topics. She holds a B.S. in biology and a Ph.D. in genetics/ molecular biology.

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