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Dietary Supplements: A Framework for Evaluating Safety Appendix M Biographical Sketches of Committee Members Barbara O. Schneeman, Ph.D. (Chair), currently serves as a professor of nutrition in the Department of Nutrition and in the Division of Clinical Nutrition and Metabolism, is Associate Vice Provost for University Outreach, and previously served as dean, College of Agricultural and Environmental Sciences at the University of California at Davis. Her professional activities include membership on the U.S. Department of Agriculture (USDA)/Department of Health and Human Services 1990 and 1995 Dietary Guidelines for Americans Advisory Committee, the Board of Trustees of the International Life Sciences Institute-North America, and the editorial boards of Proceedings of the Society of Experimental Biology and Medicine, Food and Nutrition Series of Academic Press, Nutrition Reviews, Journal of Nutrition, and California Agriculture. Professional honors include the Institute of Food Technologists’ Samuel Cate Prescott award for research, the Commissioner’s Special Citation, and the Harvey W. Wiley Medal from the Food and Drug Administration (FDA) in recognition of her contributions toward the advancement of scientific research. Dr. Schneeman has also been active in developing state and national nutrition policy as an appointed member of the California State Board of Food and Agriculture and USDA public advisory board. She is currently president of the Dannon Institute, is a member of the Board of Trustees of the International Life Sciences Institute, and has been elected a Fellow of the American Association for the Advancement of Science. She recently served as Assistant Administrator for Human Nutrition of the USDA Agricultural Research Service (on leave from U.C. Davis). Dr. Schneeman’s research areas include fat absorption, complex carbohydrates, dietary fiber, and gastrointestinal function.
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Dietary Supplements: A Framework for Evaluating Safety Daniel L. Azarnoff, M.D., is president of D.L. Azarnoff Associates, through which he does consulting with the pharmaceutical industry. He also serves as senior vice president of Clinical/Regulatory Affairs at Cellegy Pharmaceuticals, Inc. Dr. Azarnoff’s expertise includes pharmaceutical industry administration, pharmacology, clinical pharmacology, and general internal medicine. His research interests include the drug approval process, including preclinical (pharmacology, toxicology, pharmaceutics) and clinical (therapeutic, bioequivalence trials), drugs to treat hyperlipoproteinemia, and transdermal drug delivery. Dr. Azarnoff earned his M.D. from the University of Kansas where he became KUMC Distinguished Professor of Medicine and Pharmacology and previously served as president of Research and Development for the Searle Pharmaceutical Company. Cindy L. Christiansen, Ph.D., is director, Statistics Section, Center for Health Quality, Outcomes, and Economic Research, which is a Veterans Health Administration Center of Excellence, and is an associate professor of health services at Boston University School of Public Health. Dr. Christiansen, a fellow of the American Statistical Association, has served as chair of their Section on Health Policy Statistics, is an associate editor for the American Statistician, and a column editor for the publication Chance. She is one of the country’s leading experts on hierarchical and predictive models and their use in health services research. Her research interests include the development and implementation of multilevel and prediction models for health service and medical applications, and her methodological work has focused on Poisson models and on models for grouped ordinal data. Alice M. Clark, Ph.D., serves as vice chancellor for Research and Sponsored Programs at the University of Mississippi and is a Frederick A.P. Barnard Distinguished Professor, as well as a professor of pharmacognosy and research professor of the Research Institute of Pharmaceutical Sciences at the University. Prior to assuming her current position in July 2001, Dr. Clark was director of the National Center for Natural Products Research (NCNPR), which operates as a drug discovery and development program that works on acquisition, preparation, and in vitro evaluation of extracts of higher plants and marine organisms for beneficial activity. Dr. Clark’s research interests are in evaluation of natural compounds for antibiotic and antifungal activity, as well as in the utilization of microorganisms as predictive models for drug metabolism and as synthetic adjuncts. She was part of an NCNPR group working on a Centers for Disease Control and Prevention-funded project to evaluate the potential for botanical dietary supplements to interact with pharmaceuticals, to review the scientific literature on specific botanicals, and to review consumer use of botanical dietary supplements. Dr. Clark also serves as associate editor for the Journal of Natural Products.
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Dietary Supplements: A Framework for Evaluating Safety Norman R. Farnsworth, Ph.D., is a distinguished university professor, research professor of pharmacognosy, director of the Pharmacognosy Graduate Program, and the director of the Program for Collaborative Research in the Pharmaceutical Sciences at the University of Illinois at Chicago (UIC). Dr. Farnsworth also serves as Director of the UIC/National Institutes of Health (NIH) Dietary Supplements Research Center at UIC. He is credited with designing a worldwide computer database, NAPRALERT, that compiles scientific literature on the safety and efficacy of herbal medicines, plants, marine organisms, and fungi. Dr. Farnsworth is also director of the World Health Organization (WHO) Collaborating Center for Traditional Medicine; using the NAPRALERT database, he has lead WHO’s publication of numerous monographs reviewing traditional medicinals. He is a member of Health Canada’s Expert Advisory Committee on Natural Health Products and served on the U.S. Commission on Dietary Supplement Labels authorized by the Dietary Supplement Health and Education Act of 1994. Dr. Farnsworth serves on the Scientific Advisory Board of the Herb Research Foundation, the Board of Trustees of the American Botanical Council, and the editorial advisory board of several peer-reviewed journals and Herbalgram. He has authored a number of publications about botanicals, including Botanical Dietary Supplements Quality, Safety, and Efficacy. His research interests include analysis of chemical and biological data on natural products, and isolation, identification, and structure elucidation of biologically active plant constituents. Ted Gansler, M.D., M.B.A., is director of Medical Information Strategy at the American Cancer Society (ACS) and editor of the ACS publication CA: A Cancer Journal for Clinicians. At ACS, Dr. Gansler is responsible for assuring the accuracy of printed and electronic information products for patients, the general public, and health professionals. He is a graduate of Duke University, University of Pittsburgh School of Medicine, and Georgia State University School of Business Administration, and he completed a pathology residency and cytopathology fellowship at the University of Pennsylvania. Until recently, Dr. Gansler practiced cytopathology and surgical pathology at Emory University, and is currently an adjunct associate professor of pathology at Emory. James E. Gibson, Ph.D., is a research professor of pharmacology and toxicology with the Brody School of Medicine at East Carolina University. Prior to his current appointment, Dr. Gibson was with Dow Agro Sciences, a world leader in the development and manufacture of chemicals and biotechnology for agriculture; former positions include global director for Regulatory, Toxicology and Environmental Affairs for Dowlanco and director of Toxicology Affairs for the Dow Chemical Company. In addition to teaching and establishing a program in toxicology, Dr. Gibson is currently pursuing research in developing and evaluating innovative in vitro
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Dietary Supplements: A Framework for Evaluating Safety methods for the safety and exposure assessments of biotechnology products. He received the Alexander von Humboldt Senior U.S. Scientist Award and is a recipient of the Society of Toxicology Achievement Award. Stephen A. Goldman, M.D., F.A.P.M, F.A.P.A., is the managing member of Stephen A. Goldman Consulting Services, LLC, an independent consultancy that specializes in all aspects of medical product safety. He has extensive experience in academic/clinical medicine, public health, federal medical product safety regulation, and the pharmaceutical industry, with fellowship training in both clinical pharmacology/regulatory drug evaluation sciences and consultation-liaison psychiatry. Dr. Goldman was formerly medical director of the FDA MedWatch postmarketing surveillance and medical product safety information program. Prior to his work at FDA, he was director, Pharmacoepidemiology, at Knoll Pharmaceutical Company (Abbott Laboratories). He has performed original lithium/neuroleptic neurotoxicity research utilizing the FDA Spontaneous Reporting System database, and published numerous articles on medical product safety, adverse event reporting, and clinical psychiatry. Among honors received at FDA were the Commissioner’s Special Citation/Harvey W. Wiley Medal and the Office of the Commissioner’s Commendable Service Award. He is a fellow of the Academy of Psychosomatic Medicine and distinguished fellow of the American Psychiatric Association and holds an academic appointment as adjunct assistant professor of psychiatry at the Uniformed Services University of the Health Sciences. Dr. Goldman is a recognized expert in assessment, communication, and management of risk associated with medical product use. Philip S. Guzelian, M.D., serves as the director of Medical Toxicology and codirector of the Hepatobiliary Research Center at the University of Colorado Health Sciences Center. Dr. Guzelian earned his M.D. at the University of Wisconsin-Madison. His research interests include liver disease, hepatic drug metabolism and toxicity, medical toxicology, and cytochrome P450. His research objective is to understand how cells recognize the presence of foreign chemicals and activate host defenses. Dr. Guzelian has been elected to membership in the Association of American Physicians and the Academy of Toxicological Sciences. He has been a member of the NIH National Advisory Environmental Health Sciences Council, chairman of the Toxicology Advisory Committee of the Burroughs Wellcome Fund, and a member of the drug safety scientific advisory committee for Rhone-Poulenc Rorer Pharmaceuticals, the Board of Scientific Directors of the International Life Sciences Institute, and the Board of Scientific and Policy Advisors of the American Council of Science and Health. He is also an ad hoc member of the Environmental Protection Agency’s (EPA) Office of Science Coordination and Policy Scientific Advisory Panel and has served on EPA’s Science Review Board for the Food Quality Protection Act.
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Dietary Supplements: A Framework for Evaluating Safety Elizabeth Jeffery, Ph.D., serves as professor of nutritional toxicology at the Department of Food Science and Human Nutrition, the Division of Nutritional Sciences and the Department of Pharmacology at the University of Illinois, Urbana-Champaign. She has a Ph.D. in biochemistry from the University of London (U.K.) and teaches and conducts research in the area of safety and efficacy of functional foods and dietary supplements. Dr. Jeffery investigates the potential for soy to affect bone health and for broccoli and other crucifers to prevent cancer. Dr. Jeffery is a past editor of the American Society for Pharmacology and Experimental Therapeutics Drug Metabolism Newsletter and past associate editor of Toxicology and Applied Pharmacology. She is presently chair of the Bioactive Components Research Interest Section of the American Society for Nutritional Sciences, chair of the Toxicology Division of the American Society for Pharmacology and Experimental Therapeutics, and secretary/treasurer of the Food Safety Specialty Section of the Society of Toxicology. Loren D. Koller, D.V.M., Ph.D., is an independent consultant with over 30 years of experience as a researcher in the areas of pathology, toxicology, immunology, carcinogenesis, and nutrition. Dr. Koller’s past employment has been with National Institute of Environmental Health Sciences, Oregon State University, and University of Idaho. He has published in numerous refereed journals in his areas of interest, and served on several editorial boards, grant review panels, and as a consultant to government, business, and private firms. Dr. Koller has been engaged in biomedical environmental research relating to health effects in humans most of his career, including while serving as a dean in the College of Veterinary Medicine at Oregon State University for 10 years. He has experience and knowledge in agriculture, biomedicine, and environmental health, with an appreciation and sensitivity of the issues involved in developing federal regulations. He has served on committees for the National Cancer Institute, Agency for Toxic Substance and Disease Registry, Centers for Disease Control and Prevention, and U.S. Army, and on the National Advisory Committee to Establish Acute Exposure Guidelines for Hazardous Substances. Dr. Koller is a fellow of the Academy of Toxicological Science. He has cotaught veterinary microscopic anatomy, pathology, advanced clinical and diagnostic toxicology, tumor pathology, principles of toxicology, environmental and comparative toxicology, and target organ toxicology. Joseph Lau, M.D., is a professor of medicine at the Tufts University School of Medicine and professor of clinical research at the Sackler School of Graduate Biomedical Sciences at Tufts University. He is also director of the Boston branch of the U.S. Cochrane Center and director of one of the 13 Agency for Health Care Research and Quality designated Evidence-based Practice Centers, located at the Tufts-New England Medical Center in Boston. Dr. Lau also directs the evidence review team of the National
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Dietary Supplements: A Framework for Evaluating Safety Kidney Foundation’s clinical practice guidelines program. Dr. Lau is interested in methodological issues in meta-analysis and the translation of evidence into practice. He has published extensively on the methodologies and clinical applications of meta-analysis. He is a member of the editorial board of Clinical Evidence and has served on FDA advisory committees and on study sections for the Agency for Health Care Research and Quality. Dr. Lau received his M.D. from the Tufts University School of Medicine. Russell J. Molyneux, Ph.D., is a research chemist and project leader with the Western Regional Research Center of USDA in Albany, CA. He received his Ph.D. in organic chemistry from the University of Nottingham, United Kingdom, and was a postdoctoral fellow at the University of Oregon. Dr. Molyneux’s primary field of interest is natural products chemistry, especially isolation and identification of compounds responsible for toxicity of plants to mammals, insects, or other plants (allelopathy). His recent research has focused on fused bicyclic alkaloids of the pyrrolizidine, quinolizidine, indolizidine, and nortropane classes, in particular the isolation and detection of new structural types from novel sources. Dr. Molyneux’s current research is concerned with polyhydroxylated alkaloids, phytochemical constituents of crop plants that confer resistance to colonization and contamination by toxin-producing fungi, and metabolites of fungi responsible for grapevine diseases. He served as associate editor of the journal Phytochemical Analysis and is currently associate editor of the Journal of Agricultural and Food Chemistry, an American Chemical Society publication. Susan S. Percival, Ph.D., is a professor of food science and human nutrition at the University of Florida. Dr. Percival is a recipient of the Future Leaders Award from the International Life Sciences Institute Nutrition Foundation. Her research interests include nutrition and immunity; effects of botanicals, phytochemicals, and trace elements on immune function; antioxidant bioavailability and impact on immunity; efficacy of dietary supplements in humans; and mechanistic studies in animal and cell culture models. While much of her research has focused on the metabolism of copper and other trace elements, Dr. Percival’s research currently focuses on health effects of different fruit phytochemicals, Echinacea, and components of green tea. Cheryl L. Rock, Ph.D., R.D., is a professor in the Department of Family and Preventive Medicine and the Cancer Prevention and Control Program at the University of California, San Diego, School of Medicine. She received her doctoral degree in nutritional sciences from the University of California, Los Angeles, School of Public Health. Dr. Rock’s primary research efforts are focused on the role of nutritional and dietary factors in the development and progression of cancer in women, particularly breast and cervical cancer, and her research efforts also address eating pathology
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Dietary Supplements: A Framework for Evaluating Safety and weight concerns in women. She is presently involved in randomized trials that are testing whether modifications in diet and level of physical activity can alter biological processes and progression of cancer. She currently serves on editorial boards for several peer-reviewed journals and has been an invited participant in several NIH review committees, workshops, and meetings. Jerrold M. Ward, D.V.M., Ph.D., recently became chief, Infectious Disease Pathogenesis Section, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, under a contract to So Bran, Inc.; most recently he was chief of the Veterinary and Tumor Pathology Section, Center for Cancer Research, National Cancer Institute (NCI), Frederick, Maryland, during the period of report preparation. He was also formerly head, Tumor Pathology, National Toxicology Program (NTP), NCI, Bethesda. Dr. Ward is an expert in the field of veterinary and toxicologic pathology. He was involved with the early development of the NCI bioassay program, publication of the first 200 NCI and NTP carcinogenesis bioassay reports (blue books), and was later a member of the NTP Technical Reports Subcommittee of the NTP Board of Scientific Councilors. Dr. Ward received his D.V.M. from Cornell University and his Ph.D. in comparative pathology from the University of California, Davis, and is board-certified in veterinary pathology (Diplomate, ACVP). He has served on several editorial boards of pathology journals and as an advisor for safety evaluation of toxins, carcinogenesis, and pathology in several capacities. Dr. Ward has also contributed to writing the Society for Toxicologic Pathology Guidelines for Toxicologic Pathology and has over 350 publications. He is the recipient of the NIH Director’s Award for the discovery of a new Helicobacter and the FDA Commissioner’s Special Citation for contribution to the Interagency Working Group on Nitrite Research.
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