Endocrinologic and Metabolic Drugs Advisory Committee

July 1 2, 2008 Hilton Hotel, Silver Spring Silver Spring, Maryland ______________________________Meeting Roster___________________________ ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEMBERS (Voting)

Kenneth D. Burman, M.D. (Acting Chair) Chief, Endocrine Section Washington Hospital Center Washington, District of Columbia

Katherine M. Flegal, Ph.D. Senior Research Scientist Distinguished Consultant National Center for Health Statistics Centers for Disease Control and Prevention Hyattsville, Maryland Jessica W. Henderson, Ph.D. Associate Professor Division of Health and Physical Education Western Oregon University Monmouth, Oregon Clifford J. Rosen, M.D. Senior Staff Scientist Maine Center for Osteoporosis St. Joseph Hospital Bangor, Maine

Thomas P. Bersot, M.D., Ph.D. Associate Investigator Gladstone Institute of Cardiovascular Disease San Francisco, California

Michael A. Proschan, Ph.D. Biostatistician Biostatistics Research Branch National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, Maryland Allison B. Goldfine, M.D. Assistant Director of Clinical Research Joslin Diabetes Center, Research Division Boston, Massachusetts

Eric Felner, M.D. Emory University School of Medicine Department of Pediatrics Division of Endocrinology Atlanta, Georgia

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEMBERS, INDUSTRY REPRESENTATIVE (Non-Voting) Enrico P. Veltri, MD Group Vice President Global Clinical Development Cardiovascular and Metabolic Diseases Shering-Plough Research Institute Kenilworth, New Jersey

Endocrinologic and Metabolic Drugs Advisory Committee

July 1 2, 2008 Hilton Hotel, Silver Spring Silver Spring, Maryland

DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBER (Voting) Timothy S. Lesar, Pharm.D. Director of Pharmacy Albany Medical Center Albany, New York

CENTER FOR DRUG EVALUATION AND RESEARCH Special Government Employees (SGEs), TEMPORARY VOTING MEMBERS(Voting)

Thomas Fleming, Ph.D (Discussant + Speaker) Professor of Biostatistics University of Washington Seattle, Washington Eric S. Holmboe, M.D., F.A.C.P. Vice President for Evaluation Research Director, Clinical Performance Services American Board of Internal Medicine Philadelphia, Pennsylvania Ruth S. Day, Ph.D. Director, Medical Cognition Laboratory Duke University Durham, North Carolina

Rebecca W. Killion Patient Representative Bowie, Maryland

Marvin A. Konstam, M.D. Tufts-New England Medical Center Boston, Massachusetts

REGULAR GOVERNMENT EMPLOYEES (RGEs) (Voting) Judith Fradkin, M.D. Director Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK, National Institutes of Health Bethesda, Maryland Peter Savage, M.D. Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK, National Institutes of Health Bethesda, Maryland

Endocrinologic and Metabolic Drugs Advisory Committee

July 1 2, 2008 Hilton Hotel, Silver Spring Silver Spring, Maryland

CENTER FOR DRUG EVALUATION AND RESEARCH SGE, TEMPORARY NON-VOTING MEMBER (Non-Voting) Saul Genuth, M.D. Case Western Reserve University Cleveland, Ohio

CENTER FOR DRUG EVAULATION AND RESEARCH SGEs GUEST SPEAKERS (Non-Voting) Steve Nissen, M.D. (Limited to Speaking Only) Medical Director, Cleveland Clinic Cardiovascular Coordinating Center Department of Cardiovascular Medicine Cleveland, Ohio Robert Califf, M.D. (Limited to Speaking Only) Vice Chancellor for Clinical Research Duke University Durham, North Carolina

CENTER FOR DRUG EVALUATION AND RESEARCH GUEST SPEAKERS (Non-Voting) David Nathan, M.D. Director of the General Clinical Research Center and of the Diabetes Center at Massachusetts General Hospital, and a Professor of Medicine at Harvard Medical School. Professor Rury Holman Professor of Diabetic Medicine Diabetes Trials Unit Director OCDEM, University of Oxford Robert E. Ratner, M.D. Vice-President of Scientific Affairs MedStar Research Institute Hyattsville, Maryland

Hertzel C. Gerstein MD MSc FRCPC McMaster University Dept. of Medicine, Hamilton, Ontario, Canada

Endocrinologic and Metabolic Drugs Advisory Committee

July 1 2, 2008 Hilton Hotel, Silver Spring Silver Spring, Maryland

FDA PARTICIPANTS (Non-Voting) Gerald Dal Pan, M.D., M.H.S. Director Office of Surveillance and Epidemiology CDER, FDA John Jenkins, M.D. Director Office of New Drugs CDER, FDA Mary H. Parks, M.D. Director Division of Metabolism and Endocrinology Products CDER, FDA Robert Temple, M.D. Director Office of Medical Policy CDER, FDA Curtis Rosebraugh, M.D., M.P.H. Acting Director Office of Drug Evaluation II CDER, FDA Hylton Joffe, M.D. Lead Medical Officer Division of Metabolism and Endocrinology Products CDER, FDA