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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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