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Stronger Food and Drug Regulatory Systems Abroad (2020)

Chapter: Appendix A: Committee Member Biographies

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Suggested Citation:"Appendix A: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
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Page 163
Suggested Citation:"Appendix A: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
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Page 164
Suggested Citation:"Appendix A: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
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Page 165
Suggested Citation:"Appendix A: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 166
Suggested Citation:"Appendix A: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 167
Suggested Citation:"Appendix A: Committee Member Biographies." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
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Page 168

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Appendix A Committee Member Biographies Catherine Woteki, PhD, RD (Chair), is a professor in the Department of Food Science and Human Nutrition at Iowa State University and visiting distinguished institute professor at the University of Virginia’s Biocomplexity Institute. From 2010 – 2016, she served as chief scientist and Under Secretary for the U.S. Department of Agriculture’s (USDA’s) Research, Education, and Economics mission area. In that role, she developed the Office of the Chief Scientist, established the USDA Science Council, and instituted the department’s first scientific integrity and open data policies. She was called to lead scientific delegations to China and the first Meeting of Agricultural Chief Scientists held under the auspices of the G-20. Dr. Woteki is an advocate for building the platforms needed to enhance domestic and international food and agricultural research. Prior to joining USDA, Dr. Woteki served as the global director of Scientific and Regulatory Affairs for Mars, Incorporated, where she managed the company’s scientific policy on matters of health, nutrition, and food safety. From 2002–2005, she was dean of Agriculture and a professor of Human Nutrition at Iowa State University, and also head of the Agricultural Experiment Station. Dr. Woteki served as the first Under Secretary for Food Safety at USDA from 1997–2001, where she oversaw the safety of meat, poultry, and egg products. Lystra Antoine, JD, MBA, joined the Global Food Safety Partnership (GFSP) as its CEO in August 2016. Under her leadership, the GFSP focused on (1) building capacity for science-based food control systems for all food – exported and domestically consumed, in developing countries; (2) convening key stakeholders to increase their involvement and attention to food safety capacity building globally; and (3) increasing awareness for the importance of food safety for achieving the Sustainable Development Goals. For 4 years prior to joining the GFSP, Ms. Antoine worked as the global director for DuPont Pioneer’s sustainable agriculture development efforts and was responsible for designing and leading the implementation of agriculture development initiatives that helped smallholder farmers improve their livelihoods and increase their contribution to the value chain. Ms. Antione spent 16 years at the World Bank prior to joining DuPont. She champions results-driven strategies to improve the human condition through safe, reliable, and sustainable food systems. Ms. Antione holds an MBA from SUNY Buffalo and a JD from the Georgetown University Law Center. Mikel Arriola, JD, MPP, LLM, has a degree in law from the Universidad Anáhuac del Norte, a Master in Public Policy and Public Administration from the London School of Economics and Political Science in London, England, as well as a Master of Laws from the University of Chicago. His career has been developed mainly in the public sector. In 2002, he was Banrural’s litigation coordinator. From 2003 to 2005 he worked at Financiera Rural, where he held the positions of regulatory compliance manager and corporate deputy director of the General Directorate. In 2007 he joined the Ministry of Finance and Public Credit, an institution in which PREPUBLICATION COPY: UNCORRECTED PROOFS A-1

A-2 STRONGER REGULATORY SYSTEMS ABROAD he was advisor to the secretary, general director of Income Planning of the Undersecretary of revenue and, as of 2009, head of the Tax Legislation Unit of the Undersecretary of Revenue. In March 2011 he was appointed federal commissioner for Protection against Health Risks of the Ministry of Health. In December 2012 he was confirmed to head Cofepris. In February 2016, Mr. Arriola was appointed general director of the Mexican Institute of Social Security. Mr. Arriola also participated in the modification of the regulation of the General Health Law in the matter of advertising, to take out of the air dozens of “miracle” products that promised weight loss, giving guidelines to the health prevention model against chronic-degenerative diseases. Maria Elena Bottazzi, PhD, is the associate dean of the National School of Tropical Medicine, co-section head and professor of Pediatric Tropical Medicine, professor of Molecular Virology and Microbiology at Baylor College of Medicine in Houston, Texas, and a distinguished professor in the Department of Biology at Baylor University in Waco, Texas. Dr. Bottazzi is also the co-director for the Texas Children’s Hospital Center for Vaccine Development, a Product Development Partnership (PDP) at Baylor College of Medicine. Dr. Bottazzi is an internationally recognized scientist with more than two decades of experience in translational research and vaccine development for emerging and neglected tropical diseases. In addition, her major interest is in the role of vaccines as control tools integrated into international public health programs and initiatives. As a global leader she has received national and international awards, has more than 120 scientific papers, and has participated in more than 200 conferences worldwide. Currently, she is an Emerging Leader in Health and Medicine Scholar of the National Academy of Medicine, is the editor in chief of Current Tropical Medicine Reports, Springer, U.S., and is the associate editor for Public Library of Science (PLOS) Neglected Tropical Disease Journal. Dr. Bottazzi’s philosophy focuses on motivating and empowering peers and young generations of scientists building strong inter- and intra-relationships and positively contributing to scientific and global health effectiveness. Dr. Bottazzi has a bachelor’s degree in microbiology and clinical chemistry from the National Autonomous University in Honduras, and a doctorate in molecular immunology and experimental pathology from the University of Florida. Her post-doctoral training in cellular biology was completed at the University of Miami and University of Pennsylvania. Her academic tenure initiated at The George Washington University where she served for 11 years as an associate professor and a vice chair for administration in the Department of Microbiology, Immunology and Tropical Medicine prior to relocating to Houston in 2011. Julie Caswell, MS, PhD, is a distinguished professor emeritus in the Department of Resource Economics at the University of Massachusetts (UMASS) Amherst. Her research focuses on understanding the operation of domestic and international food systems, with particular interest in the economics of food quality and labeling, especially for safety and nutrition, and international trade. Dr. Caswell is a fellow of the Agricultural and Applied Economics Association (AAEA) and she is a past-president of AAEA. She held a Fulbright Distinguished Lectureship at the University of Tuscia in Viterbo, Italy in 2009. Dr. Caswell has served on several National Academies committees in the United States, including chairing the committee that published Supplemental Nutrition Assistance Program: Examining the Evidence to Define Benefit Adequacy in 2013, and she is currently serving on the Food and Nutrition Board. Dr. PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX A A-3 Caswell was senior associate dean for Education and Student Development in the College of Social and Behavioral Sciences at UMass Amherst. Dr. Caswell received her PhD jointly in Agricultural Economics and Economics from the University of Wisconsin–Madison. Clare Narrod, PhD, MS, is the director of the Risk Analysis Program at the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and leads the monitoring and impact effort associated with the evaluation of JIFSAN’s capacity building efforts. She received a PhD in Energy Management and Environmental Policy in 1997 and a master’s degree in International Development and Appropriate Technology from the University of Pennsylvania. From 1998– 2000 she served as an American Association for the Advancement of Science Risk Analysis fellow at the U.S. Department of Agriculture (USDA). Prior to coming to JIFSAN, she worked at the International Food Policy Research Institute, USDA, and at the Food and Agriculture Organization. She has consulted for the World Bank and the Inter-American Institute for Cooperation on Agriculture. She has field experience in Brazil, China, Costa Rica, Ethiopia, Ghana, Hong Kong, India, Indonesia, Kenya, Mali, Mexico, Nigeria, Thailand, Vietnam, and Zambia. She has taught in China, Colombia, India, Malaysia, Russia, and the United States. She started her career in government, where she conducted and reviewed risk assessments and cost– benefit analyses of proposed and final rules for agency clearance associated with reducing the risk of animal and plant diseases and improving food safety. In addition to her work at JIFSAN, she is also a scientific advisory board member of the Institute for Food and Agricultural Literacy at the University of California Davis, World Food Center and is on the board of directors for the Center for Foodborne Illness, Research & Prevention. In the past she has been a working group member on a Global Food Ethics Project at the John Hopkins Berman Institute for Bioethics, a member of the expert panel for a Global Regulatory Competency and Curricula, and a consensus committee member on the Institute of Medicine’s study on Strengthening Core Elements of Regulatory Systems in Developing Countries. Jonathan Quick, MD, MPH, is an adjunct professor of global health at the Duke Global Health Institute, Duke University. He is a senior fellow emeritus at Management Sciences for Health (M.S.H.), where he previously served as president and chief executive officer from 2004–2017. In January 2017, he transitioned to the role of senior fellow. A family physician and health management specialist, Dr. Quick focuses on global health security. He is the author of The End of Epidemics: The Looming Threat to Humanity and How to Stop It. Dr. Quick was director of essential drugs and medicines policy at the World Health Organization from 1996 to 2003. Prior to that, he served with MSH as the founding director of the drug management program/center for pharmaceutical management, then as a long-term advisor for the Afghanistan Health Sector Support Project and the Kenya Health Care Financing Project. He has worked in international health since 1978 and has carried out assignments in more than 70 countries in Africa, Asia, Latin America, and the Middle East. He is the senior editor of Managing Drug Supply, co-author of the Financial Times Guide to Executive Health, and has written over 100 other books, articles, and chapters. He is on the faculty of the Harvard Medical School Department of Global Health and Social Medicine and the Boston University School of Public Health, and is a fellow of the Royal Society of Medicine. He has a first degree from Harvard University, an MD with distinction in research, and an MPH from the University of Rochester. PREPUBLICATION COPY: UNCORRECTED PROOFS

A-4 STRONGER REGULATORY SYSTEMS ABROAD Joshua Sharfstein, MD, is the vice dean for Public Health Practice and Community Engagement and a professor of the practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the director of the Bloomberg American Health Initiative. Previously, Dr. Sharfstein served as the secretary of the Maryland Department of Health and Mental Hygiene, as principal deputy commissioner of the U.S. Food and Drug Administration, and as the health commissioner of Baltimore City. He is an elected member of the National Academy of Medicine and the National Academy of Public Administration. Markus Taussig, DBA, is an associate professor in the Management and Global Business Department at Rutgers Business School. Previous to his doctoral studies in strategy at Harvard Business School, Dr. Taussig lived in Vietnam for 11 years, where he researched development of that country’s nascent private sector for the World Bank, The Asia Foundation, and various bilateral aid organizations. His academic work on business strategy in developing countries has been published in American Political Science Review, Strategic Management Journal, Journal of Law, Economics and Organization, Journal of International Business Studies, Journal of East Asian Studies, and Business Horizons. His more recent work on strategies for increasing regulatory compliance in developing countries is published in the Academy of Management Journal and in the American Political Science Review and was funded by the Jameel Poverty Action Lab, the World Bank, and the National University of Singapore. The work has received best paper awards from the Academy of Management’s Public and Non-Profit Division and the International Association for Chinese Management Research. He is currently working on follow– up studies on regulatory compliance in Malaysia and Myanmar. Raymond Wigenge, MSc, MBA, is a food technologist with more than 25 years of experience in food safety and regulation. He attained his MSc in Food Science and Technology at Ghent University Belgium in 1997. He is also a holder of a BSc in Food Science and Technology obtained at Sokoine University of Agriculture, Tanzania, in 1989. Other academic qualifications include an MBA obtained in 2013 at Eastern and Southern African Management Institute, Arusha, Tanzania, and a diploma in animal production in 1980 in Mbeya, Tanzania. Since 1982, he has been employed as a public servant and served in different capacities, such as livestock extension officer and agricultural tutor for 3.5 years. He has served in different roles including food control officer, chief food inspector, zone offices and local government authority coordinator, and as director of Food Safety for the Tanzanian Food and Drug Authority (FDA). During his career, he developed food regulations and guidelines, conducted food inspections, and was engaged in developing and implementing the food safety control system in Tanzania. He led development of the draft national food safety policy. He also designed a system for surveillance and investigation of foodborne diseases and acted as a key liaison between the Tanzania FDA and United Nations agencies such as Food and Agriculture Organization, Word Health Organization, and the Codex Alimentarius Commission. Veronika Wirtz, MSc, PhD, is an associate professor in the Department of Global Health at the Boston University School of Public Health, where she is also the director of the World Health Organization Collaborating Center in Pharmaceutical Policy. Her research focuses on health system strengthening and policy and program evaluations of medicines access and utilization. PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX A A-5 She is a visiting professor of the National Institute of Public Health (INSP) in Mexico and the coordinator of a student exchange program between the institutions of her affiliation. Her interest and expertise include medicines price analysis, generic medicines policies, quality use of medicines, access to medicines for noncommunicable diseases, and the role of the private sector to promote equitable access and efficient use of medicines in low- and middle-income countries. Between 2014 and 2016 she was the co-chair of The Lancet Commission on Essential Medicine Policies. From 2004 to 2012 she was a researcher and a lecturer at the National INSP in Mexico and a founding member and the head of the Medicines in Public Health Research Group, which is a multidisciplinary team of 15 experts in health economics, epidemiology, and social science carrying out pharmaceutical policy analysis in Mexico and Latin America. Over the last few years she has regularly taught short courses in Pharmacoepidemiology and Medicines Utilization Research at INSP in Mexico. She has worked as a technical adviser for various international organizations, among them the World Health Organization; the Pan American Health Organization; World Bank; the Global Fund to Fight AIDS, Tuberculosis and Malaria; the Bill & Melinda Gates Foundation; the Alliance for Health Systems and Policy Research; Health Action International; and the Ford Foundation. She has also worked with the Ministry of Health in Mexico on various program evaluations and capacity–building initiatives. She is published widely in international peer-review journals such as The Lancet, British Medical Journal, World Health Organization Bulletin, Health Policy and Planning, Health Policy, Value in Health, Social Science and Medicine, and Tropical Medicine and International Health. Since fall 2016 she has been associate editor of Health Systems & Reform, a leading journal publishing health system and policy research. She received her training as a pharmacist from Albert-Ludwigs- University in Freiburg, Germany, and her master in clinical pharmacy and a PhD from the University of London. Prashant Yadav, MBA, PhD, is a globally recognized scholar in the area of health care supply chains. He is a visiting fellow at the Center for Global Development, Affiliate Professor of Technology and Operations Management at INSEAD, and a lecturer at Harvard Medical School. He is the author of many peer–reviewed scientific publications and his work has also been featured in prominent print and broadcast media including The Economist, The Financial Times, Nature, and the BBC. Outside academia, Dr. Yadav works closely with governments and global organizations in the area of policy and investment strategy design for health care supply chains. Until recently Dr. Yadav was Strategy Leader-Supply Chain at the Bill & Melinda Gates Foundation. Dr. Yadav serves on the advisory boards of many global organizations and social enterprises. He has been invited for expert testimony on the issue of medicine supply chains in the U.S. Congress and legislative bodies in other countries. He was a commissioner on the Lancet Commission on Essential Medicines and has been a member of multiple National Academy of Medicine Expert Committees. He was the chair of the Market Dynamics Advisory Group of the Global Fund to Fight AIDS, TB and Malaria, Geneva and co-chair of Procurement and Supply Chain Management at the Roll Back Malaria Partnership. Dr. Yadav’s research papers have been the recipient of the best paper awards from the Production and Operations Management Society, INFORMS, and other professional societies. He was inducted as a Chartered Fellow of the Chartered Institute of Logistics and Transport in 2011. Before his current role, Dr. Yadav was vice president of healthcare at the William Davidson Institute at the PREPUBLICATION COPY: UNCORRECTED PROOFS

A-6 STRONGER REGULATORY SYSTEMS ABROAD University of Michigan and a faculty member at the Ross School of Business at the University of Michigan. Before that, he was Professor of Supply Chain Management at the MIT-Zaragoza International Logistics Program and a Research Affiliate at the MIT Center for Transportation and Logistics. PREPUBLICATION COPY: UNCORRECTED PROOFS

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Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone.

The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress.

The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

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