December 18, 2014
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
Julia V. Johnson, MD (Chairperson)
Professor and Chair
Department of Obstetrics and Gynecology University of Massachusetts Medical School Worcester, Massachusetts
Amy H. Herring, ScD
Professor and Associate Chair Department of Biostatistics
The University of North Carolina at Chapel Hill Chapel Hill, North Carolina
Vivian Lewis, MD
Vice Provost for Faculty Development & Diversity
Professor, Obstetrics and Gynecology University of Rochester
Rochester, New York Stuart S. Howards, MD Professor of Urology Department of Urology University of Virginia Charlottesville, Virginia Amy K. Whitaker, MD, MS
Department of Obstetrics and Gynecology University of Chicago
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
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
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
Linda S. Tyler, PharmD, FASHP
Administrative Director 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 Medicine
Director, Division of Medical Toxicology Department of Emergency Medicine
Perelman School of Medicine at the University of Pennsylvania
TEMPORARY MEMBERS (Voting) Gregory Akerman, PhD
Senior Biologist
Health Effects Division Office of Pesticide Programs
U.S. Environmental Protection Agency Washington, District of Columbia
Anne Davis, MD, MPH Associate Professor
Director, Family Planning Fellowship Department Obstetrics and Gynecology Columbia University Medical Center New York, New York
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
Marcela G. del Carmen, MD, MPH Associate Professor
Clinical Director
Division of Gynecologic Oncology Massachusetts General Hospital Harvard Medical School
Boston, Massachusetts Louise A. Brinton, PhD
Chief, Hormonal and Reproductive Epidemiology Branch
Division of Cancer Epidemiology and Genetics National Cancer Institute
Bethesda, Maryland
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 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
Lora Hedrick Ellenson, MD
Professor and Director of Gynecologic Pathology Department of Pathology and Laboratory
Medicine
New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York James W. Crissman, DVM, PhD, DACVP
Senior Pathologist Vet Path Services, Inc. Mason, Ohio
Eve Espey, MD MPH Professor and Chair
Department of Obstetrics and Gynecology University of New Mexico
TEMPORARY MEMBERS (Voting) (cont.) Ralph Freedman MD, PhD
Clinical Professor
Dept Gynecologic Oncology and Reproductive Medicine
University of Texas MD Anderson Cancer Centre
Houston, Texas
Anne Drapkin Lyerly, MD, MA Associate Director, Center for Bioethics Associate Professor, Social Medicine University of North Carolina
Chapel Hill, North Carolina
Colleen M. Gallagher, PhD, FACHE Associate Professor, Chief and Executive Director
Section of Integrated Ethics in Cancer Care The University of Texas MD Anderson Cancer Center
Houston, Texas
Lewis S. Nelson, MD Professor and Vice Chair
Department of Emergency Medicine New York University School of Medicine New York, New York
Angelica W. Hardison (Patient Representative) Augusta, Georgia
Karen S. Regan, DVM, DABT, Dipl ACVP Consultant Veterinary Pathologist
Regan Path/Tox Services, Inc. Ashland, Ohio
Gavin Huntley-Fenner, PhD
Huntley Fenner Advisors Irvine, California
James E. Wheeler, MD Professor Emeritus
Department of Pathology and laboratory Medicine University of Pennsylvania Perlman School of Medicine
Philadelphia, Pennsylvania John M. Kittelson PhD
Professor of Biostatistics
Colorado School of Public Health
University of Colorado Anschutz Medical Campus
FDA PARTICIPANTS (Non-Voting) John Jenkins, MD
Director
Office of New Drugs (OND) CDER, FDA
Lesley McKinney, PhD
Pharmacology/Toxicology Reviewer DBRUP, ODE III, OND, CDER, FDA
Julie Beitz, MD Director
Office of Drug Evaluation III (ODE III) OND, CDER, FDA
Gerald Dal Pan, MD Director
Office of Surveillance and Epidemiology (OSE) CDER, FDA
Hylton V. Joffe, MD, MMSc Director
Division of Bone, Reproductive and Urologic Products (DBRUP)
ODE III, OND, CDER, FDA
Rita Ouellet-Hellstrom, PhD, MPH Associate Director, Epidemiology Division of Epidemiology II (DEPI-II) Office of Office of Pharmacovigilance & Epidemiology (OPE)
OSE, CDER, FDA Lisa Soule, MD
Medical Team Leader
DBRUP, ODE III, OND, CDER, FDA
CDR David Moeny, RPh, MPH, USPHS Deputy Director
DEPI-II, OPE, OSE, CDER, FDA
Lynnda Reid, PhD
Pharmacology/Toxicology Supervisor DBRUP, ODE III, OND, CDER, FDA
Ronald J. Orleans, MD Medical Officer
