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1 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. This content has not been altered or updated since it was archived.
2 ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEMBERS (Voting) David M. Capuzzi, M.D., Ph.D. Professor of Medicine and Biochemistry Thomas Jefferson University & Lankenau Institute for Medical Research Philadelphia, Pennsylvania Eric I. Felner, M.D. Associate Professor of Pediatrics of Diabetes and Endocrinology Hughes Spalding Children's Hospital Emory University School of Medicine Atlanta, Georgia Abraham Thomas, M.D., M.P.H. Division Head Endocrinology, Diabetes, Bone, and Mineral Disorders Henry Ford Hospital Whitehouse Chair of Endocrinology Detroit, Michigan Lamont G. Weide, M.D., Ph.D., F.A.C.E. Chief, Diabetes & Endocrinology Professor, Internal Medicine University of Missouri-Kansas City Truman Medical Centers 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. Assistant Professor Departments of Health Systems, Management & Policy Clinical Pharmacy and Pediatrics Assistant Children s Outcomes Research Program Anschutz Medical Campus University of Colorado Denver Aurora, Colorado Allen J. Vaida, Pharm.D., F.A.S.H.P. Executive Vice President Institute for Safe Medication Practices Horsham, Pennsylvania
3 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBERS (Voting) 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, 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 Ruth S. Day, Ph.D., Medical Cognition Laboratory Duke University Durham, North Carolina Katherine M. Flegal, Ph.D. Senior Research Scientist Distinguished Consultant National Center for Health Statistics Centers for Disease Control and Prevention Hyattsville, Maryland Thomas R. Fleming, Ph.D. Professor of Biostatistics Department of Biostatistics University of Washington Seattle, Washington Nancy L. Geller, Ph.D. Office of Biostatistics Research National Heart, Lung and Blood Institute (NHLBI) Jessica W. Henderson, Ph.D. Acting Consumer Representative Professor of Community Health Education Division of Health and Physical Education Western Oregon University Monmouth, Oregon Susan R. Heckbert, M.D., Ph.D. Professor of Epidemiology University of Washington Cardiovascular Health Research Unit 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
4 CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting) 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 Sanjay Kaul, M.D., 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 Rebecca W. Killion, M.A. Patient Representative Professional Development Manager Hogan Lovells, US LLP Washington, District of Columbia Arthur J. Moss, M.D. Professor of Medicine/Cardiology University of Rochester School of Medicine & Dentistry Rochester, New York David Oakes, Ph.D. Professor and Interim Chair Department of Biostatistics and Computational Biology University of Rochester Rochester, New York 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) Phoenix, Arizona Michael A. Proschan, Ph.D. Mathematical Statistician Biostatistics Research Branch National Institute of Allergy and Infectious Diseases (NIAID) Marvin A. Konstam, M.D. Chief Physician Executive Professor of Medicine Division of Cardiology Tufts-New England Medical Center Boston, Massachusetts
5 CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting) 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. 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) 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 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, Heart Failure Program, San Francisco, Clinical Echocardiography, San Francisco Veterans Affairs Medical Center San Francisco VA Medical Center Gerald van Belle, Ph.D., Clinical Trials Center Resuscitation Outcome Consortium (ROC) Professor, Departments of Biostatistics and Environmental and Occupational Health Sciences University of Washington Seattle, Washington Mark Woods, Pharm.D., F.A.S.H.P., B.C.P.S. Clinical Coordinator and Residency Program Pharmacy Department Saint Luke's Hospital Kansas City, Missouri Almut G. Winterstein, Ph.D. Associate Professor Pharmaceutical Outcomes & Policy (POP) College of Pharmacy Epidemiology & Biostatistics College of Public Health and Health Professions, 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
6 GUEST SPEAKERS (Non-Voting, Presentation Only) Thomas E. Moritz, M.S. Acting Associate 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 SPEAKER (Non-Voting, Presentation Only) Steve E. Nissen, M.D. Medical, Cleveland Clinic Cardiovascular Coordinating Center Department of Cardiovascular Medicine Cleveland, Ohio FDA PARTICIPANTS AT THE TABLE (Non-Voting) Janet Woodcock, M.D. Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) John K. Jenkins, M.D. Office of New Drugs (OND) CDER, FDA Robert J. Temple, M.D., Office of Medical Policy, Office of Drug Evaluation (ODE) I OND, CDER, FDA Curtis Rosebraugh, M.D., M.P.H., ODE II OND, CDER, FDA Gerald J. Dal Pan, M.D., M.H.S. Office of Surveillance and Epidemiology (OSE) CDER, FDA Mary H. Parks, M.D. Division of Metabolism and Endocrinology Products (DMEP) ODE II, OND,CDER, FDA Robert T. O Neill, Ph.D. Office of Biostatistics (OB) CDER, FDA
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