Joint Meeting
Endocrinologic and Metabolic Drugs Advisory Committee
and
Drug Safety and Risk Management Advisory Committee
Hilton Washington DC North/Gaithersburg
July 13 – 14, 2010
Meeting Roster
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
Director of Diabetes and Endocrinology
Hughes Spalding Children’s Hospital
Emory University School of Medicine
Atlanta, Georgia
Allison B. Goldfine, M.D.
Assistant Director of Clinical Research
Joslin Diabetes Center, Research Division
Boston, Massachusetts
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
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 Director
Children’s Outcomes Research Program
Anschutz Medical Campus
University of Colorado Denver
Aurora, Colorado
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
Allen J. Vaida, Pharm.D., F.A.S.H.P.
Executive Vice President
Institute for Safe Medication Practices
Horsham, Pennsylvania
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)
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
Kenneth D. Burman, M.D.
Acting Chair
Chief, Endocrine Section
Washington Hospital Center
Washington, District of Columbia
Ruth S. Day, Ph.D.
Director, 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. Director
Office of Biostatistics Research
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Bethesda, Maryland
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
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.
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
Rebecca W. Killion, M.A.
Patient Representative Professional Development Manager
Hogan Lovells, US LLP
Washington, District of Columbia
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
Marvin A. Konstam, M.D.
Chief Physician Executive
Professor of Medicine
Division of Cardiology
Tufts-New England Medical Center Boston, Massachusetts
Howard Mann, M.D.
Program Associate Division of Medical Ethics
University of Utah
School of Medicine
Salt Lake City, Utah
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
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
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
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
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
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
GUEST SPEAKERS (Non-Voting, Limited to Presenting Only)
Maria Mori Brooks, Ph.D.
Associate Professor of Epidemiology and Biostatistics
University of Pittsburgh
Pittsburgh, Pennsylvania
Dean Follman, Ph.D. (Regular Government Employee)
Mathematical Statistician
Biostatistics Research Branch
NIAID, NIH
Bethesda, Maryland
Hertzel C. Gerstein M.D., M.Sc, FRCPC
McMaster University Dept. of Medicine Hamilton
Ontario, Canada
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
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)
Gerald J. Dal Pan, M.D., M.H.S.
Director
Office of Surveillance and Epidemiology (OSE)
CDER, FDA
John K. Jenkins, M.D.
Director
Office of New Drugs (OND)
CDER, FDA
Robert T. O’Neill, Ph.D.
Director
Office of Biostatistics (OB)
CDER, FDA
Mary H. Parks, M.D.
Director
Division of Metabolism and Endocrinology Products (DMEP)
ODE II, OND,CDER, FDA
Curtis Rosebraugh, M.D., M.P.H.
Director, ODE II
OND, CDER, FDA
Robert J. Temple, M.D.
Director, Office of Medical Policy
Director, Office of Drug Evaluation (ODE) I
OND, CDER, FDA
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)