Appendix F

Committee Member Biographies

Jim E. Riviere, DVM, PhD, DSc (Chair), is the Burroughs Wellcome Fund Distinguished Professor of Pharmacology and Alumni Distinguished Graduate Professor and director of the Center for Chemical Toxicology Research and Pharmacokinetics at the College of Veterinary Medicine, North Carolina State University (NCSU). In the summer of 2012, Dr. Riviere will be the University Distinguished Professor and McDonald Chair of Veterinary Medicine at Kansas State University. Dr. Riviere received his BS (summa cum laude) and MS degrees from Boston College, his DVM and PhD in pharmacology as well as a DSc (hon) from Purdue University. He is an elected member of the Institute of Medicine of the National Academies, serves on its Food and Nutrition Board, and is a fellow of the Academy of Toxicological Sciences. He is a member of Phi Beta Kappa, Phi Zeta, and Sigma Xi, and he has served on the Science Board of the Food and Drug Administration (FDA). His honors include the 1999 O. Max Gardner Award from the Consolidated University of North Carolina, the 1991 Ebert Prize from the American Pharmaceutical Association, the Harvey W. Wiley Medal and FDA Commissioner’s Special Citation, and the Lifetime Achievement Award from the European Association of Veterinary Pharmacology and Toxicology. He is the editor of the Journal of Veterinary Pharmacology and Therapeutics, co-founder and co-director of the U.S. Department of Agriculture (USDA) Food Animal Residue Avoidance Databank (FARAD) program, and was formerly the director of the Biomathematics Program in the College of Physical and Mathematical Sciences at NCSU. He has served as an officer in various Specialty Sections of the Society of Toxicology, and hevhas served on the editorial boards of various toxicology, pharmacol-



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Appendix F Committee Member Biographies Jim E. Riviere, DVM, PhD, DSc (Chair), is the Burroughs Wellcome Fund Distinguished Professor of Pharmacology and Alumni Distinguished Gradu- ate Professor and director of the Center for Chemical Toxicology Research and Pharmacokinetics at the College of Veterinary Medicine, North Carolina State University (NCSU). In the summer of 2012, Dr. Riviere will be the University Distinguished Professor and McDonald Chair of Veterinary Medicine at Kansas State University. Dr. Riviere received his BS (summa cum laude) and MS degrees from Boston College, his DVM and PhD in pharmacology as well as a DSc (hon) from Purdue University. He is an elected member of the Institute of Medicine of the National Academies, serves on its Food and Nutrition Board, and is a fellow of the Academy of Toxicological Sciences. He is a member of Phi Beta Kappa, Phi Zeta, and Sigma Xi, and he has served on the Science Board of the Food and Drug Administration (FDA). His honors include the 1999 O. Max Gardner Award from the Consolidated University of North Carolina, the 1991 Ebert Prize from the American Pharmaceutical Association, the Harvey W. Wiley Medal and FDA Commissioner’s Special Citation, and the Lifetime Achieve- ment Award from the European Association of Veterinary Pharmacology and Toxicology. He is the editor of the Journal of Veterinary Pharmacology and Therapeutics, co-founder and co-director of the U.S. Department of Agriculture (USDA) Food Animal Residue Avoidance Databank (FARAD) program, and was formerly the director of the Biomathematics Program in the College of Physical and Mathematical Sciences at NCSU. He has served as an officer in various Specialty Sections of the Society of Toxicology, and hevhas served on the editorial boards of various toxicology, pharmacol- 319

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320 ENSURING SAFE FOODS AND MEDICAL PRODUCTS ogy, and veterinary journals. He has published more than 490 full-length research papers and chapters, holds 6 U.S. patents, has authored/edited 10 books in pharmacokinetics, toxicology, and food safety, and received more than $18 million as principal investigator on extramural research grants. His current research interests relate to the development of animal models; applying biomathematics to problems in toxicology, including the risk assessment of chemical mixtures, pharmacokinetics, nanomaterials, absorption of drugs and chemicals across skin; and the food safety and pharmacokinetics of tissue residues in food producing animals. Thomas Bollyky, JD, is 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 and consultant to the Bill and Melinda Gates Foundation. Prior to joining to CFR, Mr. Bollyky was a fellow at the Center for Global Development and director of intel- lectual property and pharmaceutical policy at the Office of the U.S. Trade Representative (USTR), where he led the negotiations for pharmaceuticals, biotechnology, and medical technologies 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 also a Fulbright Scholar in South Africa, where he worked as a staff attorney at the AIDS Law Project on treatment access issues related to HIV/AIDS, and a senior attorney at Debevoise & Plimpton LLP, where he represented Mexico before the Inter- national Court of Justice in Avena and other Mexican Nationals (Mexico v. United States of America) and José Ernesto Medellín before the United States Supreme Court in Medellin v. Dretke. Mr. Bollyky is a former law clerk to Chief Judge Edward R. Korman, an International Affairs Fellow at the 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. He received his BA in biology and history at Columbia University and his JD at Stanford Law School, where he was the President of the Stanford Law & Policy Review. Mr. Bollyky is a term mem- ber 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. Corrie Brown, DVM, PhD, is a professor in the Department of Pathology at the University of Georgia, College of Veterinary Medicine. Her research interests include the pathogenesis of disease in food-producing animals, emerging diseases, and animal health infrastructure in developing nations. She teaches courses in general pathology, systemic pathology, and interna- tional veterinary medicine. She is currently associate editor of Emerging Infectious Disease and serves on the editorial boards of Transboundary and

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321 APPENDIX F Emerging Diseases, Zoonoses and Public Health, and Veterinary Pathology. She received a DVM from the University of Guelph and a PhD from the University of California, Davis. Dr. Brown has served on three National Academies committees: the Committee on Genomics Databases for Bio- terrorism Threat Agents: Striking a Balance for Information Sharing (2003- 2004); the Committee on Assessing the Nation’s Framework for Addressing Animal Diseases (2003-2004); and the Committee on Achieving Sustainable Global Capacity for Surveillance and Response to Emerging Diseases of Zoonotic Origin (2008). Martha Brumfield, PhD, has a consulting practice focusing on concordance in global regulatory requirements and providing educational workshops toward that goal. Other areas of focus include excellence in clinical trial conduct and facilitation of scientific consortia and programs supporting patient access to medicines. At present she is engaged with the non-profit Critical Path Institute as a consultant to guide international program development and to provide reg- ulatory guidance to consortia. She is also engaged with other non-profits, Regulatory Harmonization Institute and GlobalMD, to deliver educational workshops on regulatory and clinical trial topics in Asia. Most recently, Dr. Brumfield was senior vice president, Worldwide Reg- ulatory Affairs and Quality Assurance at Pfizer, Inc. She led a global team that supported lifecycle pharmaceutical research, development, and com- mercialization 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. Brum- field has been active in several external organizations including PhRMA, the CMR International Institute for Regulatory Science, and the Asia-Pacific Economic Cooperation Life Sciences Innovation Forum and has worked extensively with the PhRMA Simultaneous Global Development program. During 20 years at Pfizer, Dr. Brumfield held a variety of leadership posi- tions in which she led regulatory teams responsible for the United States, Europe, and emerging markets. Dr. Brumfield also served as the company’s head of drug safety surveillance and reporting, and managed global adverse event reporting requirements and the integration of Pharmacia’s related safety operations. Dr. Brumfield earned a BS and MS in Chemistry from Virginia Commonwealth University, a PhD in organic chemistry from the University of Maryland, and served as a postdoctoral fellow at the Rock- efeller University. Robert Buchanan, MS, MPhil, PhD, is director of the University of Maryland’s AGNR Center for Food Safety and Security Systems, received

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322 ENSURING SAFE FOODS AND MEDICAL PRODUCTS his BS, MS, MPhil, and PhD degrees in food science from Rutgers Uni- versity, and postdoctoral training in mycotoxicology at the University of Georgia. He has 35 years of experience teaching, conducting research in food safety, and working at the interface between science and public health policy, first in academia, then in government service in both the USDA and the FDA and most recently at the University of Maryland. His scientific interests are diverse and include extensive experience in predictive microbiology, quantitative microbial risk assessment, microbial physiology, mycotoxicology, and food safety systems. He has published extensively on a wide range of subjects related to food safety and is one of the co-developers of the widely used USDA Pathogen Modeling Program. Dr. Buchanan has served on numerous national and international advisory bodies including serving as a member of the International Commission on Microbiological Specification for Foods for 20 years, a six-term member of the National Advisory Committee for Microbiological Criteria for Foods, the U.S. Del- egate to the Codex Alimentarius Committee on Food Hygiene for 10 years, and a participant on multiple expert consultations for World Health Or- ganization (WHO) and Food and Agriculture Organization of the United Nations (FAO). Jake Yue Chen, MS, PhD, is an associate professor with tenure at Indiana University School of Informatics and Purdue University Department of Computer and Information Science in Indianapolis (IUPUI). He is the founding director of the Indiana Center for Systems Biology and Personal- ized Medicine, a member of the Indiana University Simon Cancer Center, and a member of the Center for Computational Biology and Bioinformatics at Indiana University School of Medicine. He is also an ACM senior mem- ber, IEEE senior member, and chair of the IEEE Engineering in Biology and Medicine Society Central Indiana Chapter. He currently serves on the editorial boards of several international bioinformatics journals including BMC Systems Biology, organized more than 100 academic meetings in informatics and computer science, and served on many grant review panels for the National Institutes of Health, the National Science Foundation, the Department of Defense, and the Department of Education. He is the recipient of the Canary Foundation 2008 Bioinformatics Dissemination Award, a Translational Research into Practice (TRIP) scholar at Indiana University, and a 2010 Cambridge Health Institute’s Translational Medicine Conference Distinguished Faculty. He holds master’s and doctoral degrees in computer science and engineering from the University of Minnesota and a bachelor’s degree in biochemistry and molecular biology from Peking University of China. His research expertise spans over biological data management, bio- logical data mining, bioinformatics, systems biology, and clinical applica-

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323 APPENDIX F tions of genomics in predictive and personalized medicine, with more than 100 research publications—including 2 edited books, Biological Database Modeling and Biological Data Mining—and more than 100 invited talks worldwide. He also has considerable experience in leading informatics R&D projects in the biopharmaceutical industry. Prior to joining academia in 2004, he helped design commercial GeneChip microarray products for humans, mice, and rats at Affymetrix, Inc. in San Jose, California, and led a team to data mine the world’s first comprehensive human protein interactome collected at Myriad Proteomics, Inc. in Salt Lake City, Utah. In Indiana, he co-founded the non-profit Indiana Biomedical Entrepreneur’s Network to promote biotechnology commercialization efforts and two biotech startup businesses to promote predictive and personalized medicine practices. Junshi Chen, MD, graduated from the Beijing Medical College in 1956 and has been engaged in nutrition and food safety research for more than 50 years at the Institute of Nutrition and Food Safety, Chinese Center for Disease Control and Prevention (the former Chinese Academy of Preven- tive Medicine). He has conducted large epidemiologic studies on diet, nutrition, and chronic diseases, in collaboration with Dr. T. Colin Campbell of Cornell University and Professor Richard Peto from the University of Oxford since 1983. In the late 1980s, he conducted a series of studies on the protective effects of tea on cancer, including laboratory studies and human intervention trials. He is the member of the expert panel that authored the World Cancer Research Fund/American Institute for Cancer Research report Food, Nutrition and the Prevention of Cancer: a Global Perspective (1997). Recently, he was appointed as the chair of the Chinese National Expert Committee for Food Safety Risk Assessment and the vice-chair of the National Food Safety Standard Reviewing Committee. Internationally, he serves as the Chairperson of the Codex Committee on Food Additives, a member of the WHO Food Safety Expert Panel, and director of the International Life Sciences Institute Focal Point in China. Dr. Chen has published more than 140 articles in peer-reviewed journals. Jane Henney, MD, has served in a series of senior health policy leadership positions in the public sector for nearly 30 years. Beginning in 1980, she served for 5 years as the deputy director of the National Cancer Institute. Subsequently, she joined the University of Kansas Medical Center as vice chancellor of health programs, and, for 18 months, interim dean of the School of Medicine. She then served as deputy commissioner for operations of the Food and Drug Administration, where she stayed until assuming the

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324 ENSURING SAFE FOODS AND MEDICAL PRODUCTS position as the first vice president for health sciences at the University of New Mexico. In 1998 she was nominated by President Bill Clinton and confirmed by the U.S. Senate as the commissioner of the FDA. She served in this capac- ity until January 2001. After leaving the FDA, she was appointed senior scholar in residence at the Association of Academic Health Centers. From July 2003 until the beginning of 2008 Dr. Henney served as senior vice president and provost for health affairs at the University of Cincinnati. In addition to her current academic responsibilities at the university, she also serves on the boards of the Commonwealth Fund in New York, the China Medical Board in Boston, and the Association of Academic Health Centers in Washington, DC. She is a member of the Board of Directors of Ameri- sourceBergen Corporation and CIGNA in Philadelphia and AstraZeneca PLC in London. In addition, she serves on a wide range of foundations, associations, and governmental advisory committees. Dr. Henney has received many honors and awards in her field, includ- ing election to the Institute of Medicine of the National Academies, the Society of Medical Administrators, and honorary membership in the Ameri- can College of Health Care Executives. She is a recipient of the Excellence in Women’s Health Award from the Jacobs Institute, the Public Health Leadership Award from the National Organization of Rare Disorders, the HHS Secretary’s Recognition Award, and, on two separate occasions, the PHS Commendation Medal. She has received honorary degrees from North Carolina State University, Manchester College, and the University of Rochester. A native of Indiana, Dr. Henney received her undergraduate degree from Manchester College and her medical degree from Indiana University, and completed her subspecialty training in medical oncology at the M.D. Anderson Hospital and Tumor Institute and the National Cancer Institute. Carlos M. Morel, MD, PhD, is a member of the Brazilian Academy of Science, a physician, and a doctor of science. He studied at the Faculty of Medicine at the Federal University of Pernambuco and at the Carlos Chagas Filho Biophysics Institute of the Federal University of Rio de Janeiro (UFRJ). He has a PhD from UFRJ based on work done at the Swiss Institute for Experimental Cancer Research in Lausanne. Dr. Morel was a professor at the Faculty of Medicine and the Institute of Biological Science at the Federal University of Brasilia. His scientific production includes 79 original papers published in indexed journals, 15 book chapters, and a book, Genes and Antigens of Parasites, acknowledged by Nature. He is a researcher at the Oswaldo Cruz Foundation (Fiocruz) where he created the Department of Biochemical and Molecular Biology, gathering an internationally renowned team in molecular parasitology and biotech-

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325 APPENDIX F nology. He served as director of the Oswaldo Cruz Institute from 1985 to 1989 and as president of Fiocruz from 1993-1997. From 1998-2004, Dr. Morel was the director of a special program of United Nations Children’s Fund/United Nations Development Programme, the World Bank, and the WHO for research and training in tropical diseases. He contributed ac- tively to the conception of several international programs for research and development on neglected diseases: Global Forum for Health Research; Medicines for Malaria Venture; Global Alliance for Tuberculosis Drug De- velopment; the Drugs for Neglected Diseases Initiative; and the Foundation for Innovative New Diagnostics. He is currently the Fiocruz representative on the Board of Directors of the Drugs for Neglected Diseases Initiative. He was the first president of the Board of Directors of the Global Alliance for TB Drug Development and served on this board until 2007. Since 2004 he has coordinated the establishment of the Fiocruz Center for Technological Development in Health (CDTS). His current research and teaching activities are in technological devel- opment, scientific and technological networks, and innovation manage- ment, with a focus on health and neglected diseases. He is a professor of the post-graduate program in public politics, strategies and development at the UFRJ Institute of Economy. He has recently published in Science, Nature, and the electronic journal Innovation Strategy Today. Clare Narrod, PhD, has been a research scientist and risk analysis program manager at the University of Maryland’s Joint Institute for Food Safety and Applied Nutrition (JIFSAN) since January 2012. Before joining JIFSAN, Dr. Narrod was a senior research fellow in the Markets Trade and Institu- tions Division of the International Food Policy Research Institute (IFPRI). Dr. Narrod worked at the USDA, Office of the Chief Economist, as a risk assessor and regulatory economist where she reviewed food safety and ani- mal and plant health rules for departmental clearance. She also has worked at the FAO where she led a number of livestock projects that focused on understanding the policy, technology and environmental determinants and implications of scaling up livestock production. From 1998-2000 Dr. Nar- rod served as an American Association for the Advancement of Science (AAAS) Risk Fellow at USDA. In the past she has held consultant positions at the World Bank and at the Inter-American Institute for Cooperation on Agriculture. She has conducted field work in Brazil, China, Ethiopia, Ghana, India, Indonesia, Kenya, Mali, Mexico, Nigeria, the Philippines, Thailand, United States, Vietnam, and Zambia. She received her PhD in energy management and environmental policy and her master’s degree in international development and appropriate technology both from the Uni- versity of Pennsylvania.

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326 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Andy Stergachis, PhD, MS, BPHARM, focuses on pharmacoepidemiology, global medicines safety, pharmaceutical outcomes research, and public health systems research. He directs the Global Medicines Program in the Department of Global Health at the University of Washington (UW). He is currently the principal investigator of the University of Washington components of two projects funded by the Bill & Melinda Gates Founda- tion, including the pharmacovigilance component of a multi-center global clinical trials program of alternative antimalarial case management and pre- vention strategies in pregnancy. He is the principal investigator of the UW component of a USAID-funded cooperative agreement with Management Sciences for Health on strengthening pharmaceutical systems in developing countries. Through his affiliation with the Northwest Center for Public Health Practice, he also works on workforce development and public health systems research in emergency preparedness with the public health commu- nity. He is also affiliated with the UW’s Pharmaceutical Outcomes Research and Policy program. He is author of more than 100 peer-reviewed publica- tions, including an assessment of pharmacovigilance activities in low- and middle-income countries. He has earned numerous awards for his work in pharmacy, medication safety, and public health, including the American Pharmaceutical Association Foundation 2002 Pinnacle Award for his career commitment to improving the quality of the medication use process. He is a Fellow of the International Society for Pharmacoepidemiology. He has served on Institute of Medicine committees, including the Committee on Poison Prevention and Control System and the Committee on Assessment of the U.S. Drug Safety System. His international responsibilities include the Virtual Advisory Group to Global Alert and Response for the World Health Organization. Locally, he is a member of the Public Health Reserve Corps. Prashant Yadav, MBA, PhD, is the director of a research initiative focused on health care supply chains in the developing world at the William Davidson Institute at the University of Michigan. He also holds faculty appointments at the Ross School of Business and the School of Public Health at the Uni- versity of Michigan. Dr. Yadav’s research explores the functioning of health care supply chains using a combination of empirical, analytical, and qualitative ap- proaches. He serves as an advisor in the area of pharmaceutical supply chains to the Bill and Melinda Gates Foundation, World Bank, World Health Organization, UNITAID, UK Department for International Devel- opment, and many other global health organizations. He is the author of many scientific publications, and his work has been featured in prominent print and broadcast media including The Economist, The Financial Times, Nature, and “BBC.” He serves on the advisory boards of several public–

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327 APPENDIX F private partnerships and currently serves as co-chair of the Procurement and Supply Chain Working Group of the Roll Back Malaria Partnership. Prior to joining the William Davidson Institute at the University of Michigan, Dr. Yadav was a professor of supply chain management at the MIT-Zaragoza International Logistics Program and a research affiliate at the MIT Center for Transportation and Logistics where he led the cre- ation of a high-impact research initiative focused on pharmaceutical sup- ply chains in developing countries. From 2008-2010 he was also a visiting scholar at the INSEAD Social Innovation Center. Dr. Yadav obtained his bachelor’s degree in chemical engineering from the Indian Institute of Technology, his MBA from the FORE School of Management, and his PhD from the University of Alabama. Before aca- demia, he worked for many years in the area of pharmaceutical strategy, analytics, and supply chain consulting.

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