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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
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEMBERS (Voting)
-continued-
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
CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting)
-continued-
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
CENTER FOR DRUG EVALUATION AND RESEARCH TEMPORARY MEMBERS (Voting)
-continued-
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
GUEST SPEAKERS (Non-Voting, Presentation Only)
-continued-
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