FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research

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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

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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

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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

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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

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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

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