FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research

Transcription

1 FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research FDA White Oak Campus, Building 31, the Great Room (Rm. 1503) White Oak Conference Center, Silver Spring, Maryland DRAFT OPEN SESSION MEETING ROSTER DESIGNATED FEDERAL OFFICER (Non-Voting) Kalyani Bhatt, BS, MS Division of Advisory Committee and Consultant Management Office of Executive Programs, CDER, FDA BONE, REPRODUCTIVE AND UROLOGIC DRUGS ADVISORY COMMITTEE MEMBERS (Voting) Kathryn M. Curtis, PhD Health Scientist Division of Reproductive Health Centers for Disease Control and Prevention Atlanta, Georgia Amy H. Herring, ScD Professor and Associate Chair Department of Biostatistics The University of North Carolina at Chapel Hill Chapel Hill, North Carolina Stuart S. Howards, MD Professor of Urology Department of Urology University of Virginia Charlottesville, Virginia Julia V. Johnson, MD (Chairperson) Professor and Chair University of Massachusetts Medical School Worcester, Massachusetts Vivian Lewis, MD Vice Provost for Faculty Development & Diversity Professor, Obstetrics and Gynecology University of Rochester Rochester, New York Amy K. Whitaker, MD, MS University of Chicago Chicago, Illinois Page 1 of 5

2 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBERS (Voting) Brian L. Erstad, PharmD Professor and Head The University of Arizona College of Pharmacy Department of Pharmacy Practice & Science Tucson, Arizona Tobias Gerhard, PhD, RPh Associate Professor of Pharmacoepidemiology Ernest Mario School of Pharmacy, and Institute for Health, Health Care Policy and Aging Research Rutgers University New Brunswick, New Jersey Marjorie Shaw Phillips, MS, RPh, FASHP Pharmacy Coordinator, Clinical Research and Education Georgia Regents Medical Center Clinical Professor of Pharmacy Practice University of Georgia College of Pharmacy Augusta, Georgia Linda S. Tyler, PharmD, FASHP Administrative of Pharmacy Services University of Utah Hospitals & Clinics Professor (Clinical) and Associate Dean, Pharmacy Practice University of Utah College of Pharmacy Salt Lake City, Utah Jeanmarie Perrone, MD, FACMT Professor, Emergency, Division of Medical Toxicology Department of Emergency Perelman School of at the University of Pennsylvania Philadelphia, Pennsylvania Page 2 of 5

3 TEMPORARY MEMBERS (Voting) Gregory Akerman, PhD Senior Biologist Health Effects Division Office of Pesticide Programs U.S. Environmental Protection Agency Washington, District of Columbia Elizabeth Bell-Perkins, MPH (Consumer Representative for the Gastrointestinal Drugs Advisory Committee) Lecturer, University of Massachusetts Amherst School of Public Health and Health Sciences Williamsburg, Massachusetts Louise A. Brinton, PhD Chief, Hormonal and Reproductive Epidemiology Branch Division of Cancer Epidemiology and Genetics National Cancer Institute Bethesda, Maryland Kathleen R. Cho, MD Peter A. Ward Professor and Vice-Chair for Academic Affairs Department of Pathology University of Michigan Medical School Ann Arbor, Michigan James W. Crissman, DVM, PhD, DACVP Senior Pathologist Vet Path Services, Inc. Mason, Ohio Anne Davis, MD, MPH Associate Professor, Family Planning Fellowship Department Obstetrics and Gynecology Columbia University Medical Center Marcela G. del Carmen, MD, MPH Associate Professor Clinical Division of Gynecologic Oncology Massachusetts General Hospital Harvard Medical School Boston, Massachusetts Darlene Dixon, DVM., PhD Head, Molecular Pathogenesis National Toxicology Program (NTP) NTP Laboratory, DNTP National Institute of Environmental Health Sciences Research Triangle Park, North Carolina Lora Hedrick Ellenson, MD Professor and of Gynecologic Pathology Department of Pathology and Laboratory New York Presbyterian Hospital-Weill Cornell Medical College Eve Espey, MD MPH Professor and Chair University of New Mexico Albuquerque, New Mexico Page 3 of 5

4 TEMPORARY MEMBERS (Voting) (cont.) Ralph Freedman MD, PhD Clinical Professor Dept Gynecologic Oncology and Reproductive University of Texas MD Anderson Cancer Centre Houston, Texas Colleen M. Gallagher, PhD, FACHE Associate Professor, Chief and Executive Section of Integrated Ethics in Cancer Care The University of Texas MD Anderson Cancer Center Houston, Texas Angelica W. Hardison (Patient Representative) Augusta, Georgia Gavin Huntley-Fenner, PhD Huntley Fenner Advisors Irvine, California Anne Drapkin Lyerly, MD, MA Associate, Center for Bioethics Associate Professor, Social University of North Carolina Chapel Hill, North Carolina Lewis S. Nelson, MD Professor and Vice Chair Department of Emergency New York University School of Karen S. Regan, DVM, DABT, Dipl ACVP Consultant Veterinary Pathologist Regan Path/Tox Services, Inc. Ashland, Ohio James E. Wheeler, MD Professor Emeritus Department of Pathology and laboratory University of Pennsylvania Perlman School of Philadelphia, Pennsylvania John M. Kittelson PhD Professor of Biostatistics Colorado School of Public Health University of Colorado Anschutz Medical Campus Aurora, Colorado Page 4 of 5

5 FDA PARTICIPANTS (Non-Voting) John Jenkins, MD Office of New Drugs (OND) CDER, FDA Julie Beitz, MD Office of Drug Evaluation III (ODE III) OND, CDER, FDA Hylton V. Joffe, MD, MMSc Division of Bone, Reproductive and Urologic Products (DBRUP) ODE III, OND, CDER, FDA Lisa Soule, MD Medical Team Leader Lesley McKinney, PhD Pharmacology/Toxicology Reviewer Gerald Dal Pan, MD Office of Surveillance and Epidemiology (OSE) CDER, FDA Rita Ouellet-Hellstrom, PhD, MPH Associate, Epidemiology Division of Epidemiology II (DEPI-II) Office of Office of Pharmacovigilance & Epidemiology (OPE) OSE, CDER, FDA CDR David Moeny, RPh, MPH, USPHS Deputy DEPI-II, OPE, OSE, CDER, FDA Lynnda Reid, PhD Pharmacology/Toxicology Supervisor Ronald J. Orleans, MD Medical Officer Page 5 of 5