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ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEMBERS (Voting)

David M. Capuzzi, M.D., Ph.D. Abraham Thomas, M.D., M.P.H.

Professor of Medicine and Biochemistry Division Head

Thomas Jefferson University & Endocrinology, Diabetes, Bone, and Mineral Disorders

Lankenau Institute for Medical Research Henry Ford Hospital

Philadelphia, Pennsylvania Whitehouse Chair of Endocrinology

Detroit, Michigan

Eric I. Felner, M.D. Lamont G. Weide, M.D., Ph.D., F.A.C.E.

Associate Professor of Pediatrics Chief, Diabetes & Endocrinology

Director of Diabetes and Endocrinology Professor, Internal Medicine

Hughes Spalding Children's Hospital University of Missouri-Kansas City

Emory University School of Medicine Truman Medical Centers

Atlanta, Georgia Diabetes Center

Kansas City, Missouri

Allison B. Goldfine, M.D.

Associate Professor, Harvard Medical School Section Head of Clinical Research

Joslin Diabetes Center, Research Division Boston, Massachusetts

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEMBER (Non-Voting)

Enrico P. Veltri, M.D.

Industry Representative

Pharmaceutical Industry Consultant Princeton, New Jersey

DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBERS (Voting) Elaine H. Morrato, Dr.P.H., M.P.H., C.P.H. Allen J. Vaida, Pharm.D., F.A.S.H.P.

Assistant Professor Executive Vice President

Departments of Health Systems, Management & Policy Institute for Safe Medication Practices

Clinical Pharmacy and Pediatrics Horsham, Pennsylvania

Assistant Director

Children’s Outcomes Research Program Anschutz Medical Campus

University of Colorado Denver Aurora, Colorado

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DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBERS (Voting)

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Lewis Nelson, M.D., F.A.C.E.P., F.A.C.M.T. Associate Professor of Emergency Medicine New York University School of Medicine Director, Fellowship in Medical Toxicology New York City Poison Control Center New York, New York

DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBER (Non-Voting)

D. Bruce Burlington, M.D.

Industry Representative Pharmaceutical Consultant Gaithersburg, Maryland

CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting)

Kenneth D. Burman, M.D.

Acting Chair

Chief, Endocrine Section Washington Hospital Center Washington, District of Columbia

Nancy L. Geller, Ph.D. Director

Office of Biostatistics Research

National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health (NIH)

Bethesda, Maryland

Ruth S. Day, Ph.D.

Director, Medical Cognition Laboratory Duke University

Durham, North Carolina

Jessica W. Henderson, Ph.D.

Acting Consumer Representative

Professor of Community Health Education Division of Health and Physical Education

Western Oregon University Monmouth, Oregon

Katherine M. Flegal, Ph.D.

Senior Research Scientist Distinguished Consultant

National Center for Health Statistics Centers for Disease Control and Prevention Hyattsville, Maryland

Susan R. Heckbert, M.D., Ph.D.

Professor of Epidemiology University of Washington

Cardiovascular Health Research Unit Seattle, Washington Thomas R. Fleming, Ph.D. Professor of Biostatistics Department of Biostatistics University of Washington Seattle, Washington

Dale E. Hammerschmidt, M.D., F.A.C.P.

Associate Professor of Medicine University of Minnesota Due Diligence Officer

(for Human Subjects' Protections) Minneapolis, Minnesota

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CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting)

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Curt D. Furberg, M.D., Ph.D.

Professor of Public Health Sciences and

Senior Advisor to the Dean for Health Services Research and Health Policy

Wake Forest University Health Sciences Winston-Salem, North Carolina

Arthur J. Moss, M.D.

Professor of Medicine/Cardiology University of Rochester

School of Medicine & Dentistry Rochester, New York

Sanjay Kaul, M.D.

Director, Fellowship Training Program in Cardiovascular Diseases

Cedars-Sinai Heart Institute

Professor, David Geffen School of Medicine at UCLA Division of Cardiology

Cedar Sinai Medical Center Los Angeles California

David Oakes, Ph.D.

Professor and Interim Chair Department of Biostatistics and Computational Biology

University of Rochester Rochester, New York

Rebecca W. Killion, M.A.

Patient Representative

Professional Development Manager Hogan Lovells, US LLP

Washington, District of Columbia

Richard Platt, M.D.

Professor

Chair, Department of Population Medicine Harvard University Medical School Boston, Massachusetts

William C. Knowler, M.D., Dr.P.H.

Chief, Diabetes Epidemiology and Clinical Research Section

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institutes of Health (NIH) Phoenix, Arizona

Michael A. Proschan, Ph.D.

Mathematical Statistician Biostatistics Research Branch

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH) Bethesda, Maryland

Marvin A. Konstam, M.D.

Chief Physician Executive Professor of Medicine Division of Cardiology

Tufts-New England Medical Center Boston, Massachusetts

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CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting)

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Howard Mann, M.D.

Program Associate Division of Medical Ethics University of Utah School of Medicine Salt Lake City, Utah

Clifford J. Rosen, M.D.

Director of Clinical and Translational Research and Senior Scientist

Maine Medical Center Research Institute Scarborough, Maine

Peter J. Savage, M.D.

Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)

National Institutes of Health (NIH) Bethesda, Maryland

Gerald van Belle, Ph.D.

Director, Clinical Trials Center

Resuscitation Outcome Consortium (ROC)

Professor, Departments of Biostatistics and Environmental and Occupational Health Sciences

University of Washington Seattle, Washington

Morris Schambelan, M.D.

Professor Emeritus of Medicine

Associate Chair for Clinical and Translational Research San Francisco General Hospital

University of California San Francisco San Francisco, California

Mark Woods, Pharm.D., F.A.S.H.P., B.C.P.S.

Clinical Coordinator and Residency Program Director Pharmacy Department

Saint Luke's Hospital Kansas City, Missouri

John R. Teerlink, M.D., F.A.C.C., F.A.H.A., F.E.S.C.

Professor of Medicine

University of California, San Francisco

Director, Heart Failure Program, San Francisco

Director, Clinical Echocardiography, San Francisco Veterans Affairs Medical Center

San Francisco VA Medical Center

Almut G. Winterstein, Ph.D.

Associate Professor

Pharmaceutical Outcomes & Policy (POP) College of Pharmacy

Epidemiology & Biostatistics

College of Public Health and Health Professions

Director, FDA/CDER Graduate Training Program in POP Research

Gainesville, Florida

GUEST SPEAKERS (Non-Voting, Limited to Presenting Only) Maria Mori Brooks, Ph.D.

Associate Professor of Epidemiology and Biostatistics University of Pittsburgh

Pittsburgh, Pennsylvania

Hertzel C. Gerstein M.D., M.Sc, FRCPC

McMaster University Dept. of Medicine Hamilton, Ontario, Canada

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GUEST SPEAKERS (Non-Voting, Presentation Only)

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Thomas E. Moritz, M.S.

Acting Associate Director for Scientific & Technical Operations Edward Hines Jr. VA Hospital/Research Service/Cooperative Studies Program Coordinating Center (CSPCC)

Hines, Illinois

Dean Follmann, Ph.D. (Regular Government Employee)

Mathematical Statistician Biostatistics Research Branch NIAID, NIH

Bethesda, Maryland

SPEAKER (Non-Voting, Presentation Only) Steve E. Nissen, M.D.

Medical Director, Cleveland Clinic Cardiovascular Coordinating Center Department of Cardiovascular Medicine Cleveland, Ohio

FDA PARTICIPANTS AT THE TABLE (Non-Voting) Janet Woodcock, M.D.

Director

Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)

John K. Jenkins, M.D.

Director

Office of New Drugs (OND) CDER, FDA

Robert J. Temple, M.D.

Director, Office of Medical Policy

Director, Office of Drug Evaluation (ODE) I OND, CDER, FDA

Curtis Rosebraugh, M.D., M.P.H.

Director, ODE II OND, CDER, FDA

Gerald J. Dal Pan, M.D., M.H.S.

Director

Office of Surveillance and Epidemiology (OSE) CDER, FDA

Mary H. Parks, M.D.

Director

Division of Metabolism and Endocrinology Products (DMEP)

ODE II, OND,CDER, FDA

Robert T. O’Neill, Ph.D.

Director

Office of Biostatistics (OB) CDER, FDA

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