Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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Appendix B Speaker Biographies
Appendix B Speaker Biographies
Pages 93-110
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From page 93... ...
, is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H
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From page 94... ...
Ms. Charo serves on the expert advisory boards of several organizations with an interest in stem cell research, including CuresNow, the Juvenile Diabetes Research Foundation, the International Society for Stem Cell Research, and WiCell, as well as on the advisory board of the Wisconsin Stem Cell Research Program.
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From page 95... ...
Since 2001 she has been a member of the National Academy of Sciences' Board on Life Sciences. She served as its liaison to the Committee on Research Standards and Practices to Prevent Destructive Applications of Biotechnology, as well as serving on its Advisory Committee on Human Embryonic Stem Cell Research.
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measure "Chlamydia Screening in Women." Dr. Stergachis serves as board member for the American Pharmacists Association Foundation and the Group Health Community Foundation, and he is a fellow of the International Society for Pharmacoepidemiology.
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Dr. Sigal received the Association of American Cancer Institutes' Public Service Award, the American Society of Clinical Oncology Special Recognition Award, the Sidney Kimmel Cancer Center National Leadership Award, and the American Association for Cancer Research National Leadership Award.
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Office of Economic Opportunity, National Center for Health Services Research, and Veterans Health Administration; Local Public Health Officer and Human Services Director for Multnomah County (Portland) , Oregon (National Association of County and City Health Officials [NACCHO]
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In 1972 he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later assumed the position of Director of the Division of Cardio-Renal Drug Products.
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at the University of Illinois; he completed internal medicine training at the University of Iowa, followed by a fellowship in infectious diseases and epidemiology at the Medical College of Wisconsin. He is board certified in internal medicine and infectious diseases.
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He is now chair of the Board of Directors of the Villages of Indiana child welfare services and a member of the Indiana State Museum Foundation, as well as the Board of Trustees of Xavier University of Louisiana; he also serves on the American Association of Colleges of Pharmacy Professional Education Advisory Council. He is a fellow of the Infectious Diseases Society of America and the American College of Physicians, served on the European Working Party for Antimicrobial Trial Guidelines, and was principal respondent for industry at the FDA Advisory Committee review of the FDA/Infectious Diseases Society of America (IDSA)
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From page 102... ...
He has chaired the Executive Committee of the HMO Research Network, was co-chair of the Board of Scientific Counselors of CDC's Center for Infectious Diseases, and chaired the NIH study section Epidemiology and Disease Control 2 and the CDC Office of Health Care Partnerships Steering Committee. His research focuses on developing multi-institution automated record linkage systems for use in pharmacoepidemiology and population-based surveillance, reporting, and control of both hospital- and community-acquired infections, including bioterrorism events.
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From page 103... ...
Current studies address postmarketing safety for recently approved drugs, the natural history of disease as context for Phase III clinical trials, the impact of drug labeling and warnings on prescribing behavior, and determinants of drug uptake and discontinuation. His additional areas of research and expertise include health effects of chemicals used in the workplace and statistical methods in epidemiology.
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From page 104... ...
He is board certified in neurology, and is a former member of the Board of Directors of the National Sleep Foundation, a member of the Board of Directors of the Delaware Valley Science Fairs, a member of the University of Pennsylvania Center for Bioethics Advisory Board, and a past Trustee of the American Academy of Pharmaceutical Physicians. Session 4: Conducting Confirmatory Drug Safety and Efficacy Studies JANET WOODCOCK, MD (Member, IOM Forum on Drug Discovery, Development, and Translation)
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He has served on the FDA's Cardiorenal Advisory Panel and the IOM's Pharmaceutical Roundtable. He served on the IOM committees that recommended Medicare coverage of clinical trials and the banning of Ephedra, and he is currently serving on the IOM's Committee on Identifying and Preventing Medication Errors.
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SCHROEDER, MDiv, JD (Member, IOM Drug Safety Committee) , is Charles S
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He is a member of the Board of Directors of the AERAS Global TB Vaccine Foundation, and he recently served on the Panel on the Administrative Restructuring of the National Institutes of Health and the Working Group to Review Regulatory Activities within the Division of AIDS of the National Institute of Allergy and Infectious Diseases.
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From page 108... ...
Bush as Assistant Secretary for Health, Department of Health and Human Services, in September 2001 and received Senate confirmation to this position in January 2002, becoming the first woman to hold the position. She served HHS Secretary Tommy Thompson as Chief Health Policy Advisor, with special emphasis on translational medicine, including electronic systems (eHealth)
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From page 109... ...
Ms. Weinberg has a long history of board and committee service, including serving as a member of the American Heath Information Community's Consumer Empowerment Workgroup, the IOM's Health Sciences Policy Board, the AcademyHealth Coalition for Heath Services Research Board, the Center for Information and Study on Clinical Research Participation Advisory Board, the Roche International Genetics Science and Ethics Advisory Committee, and the IOM's Committee on Clinical Trial Registries, and as a founding member of the Association for the Accreditation of Human Research Protection Programs and ChairElect of the Governing Board of the International Alliance of Patients' Organization.
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