Transcript for the January 9, 2018 Meeting of the Bone, Reproductive and Urologic Drugs Advisory ...

363 Pages·2017·1.05 MB·English

by  Janet Watkins

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1 FOOD AND DRUG ADMINISTRATION
2 CENTER FOR DRUG EVALUATION AND RESEARCH
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6 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS
7 ADVISORY COMMITTEE (BRUDAC) MEETING
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10 Tuesday, January 9, 2018
11 7:59 a.m. to 4:24 p.m.
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15 College Park Marriott Hotel and Conference Center
16 General Vessey Ballroom
17 3501 University Boulevard East
18 Hyattsville, Maryland
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A Matter of Record
[phone]
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1 Meeting Roster
2 DESIGNATED FEDERAL OFFICER (Non-Voting)
3 Kalyani Bhatt, BS, MS
4 Division of Advisory Committee and Consultant
5 Management
6 Office of Executive Programs, CDER, FDA
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8 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS ADVISORY
9 COMMITTEE MEMBERS (Voting)
10 Douglas C. Bauer, MD
11 Professor of Medicine and Epidemiology &
12 Biostatistics
13 University of California, San Francisco
14 San Francisco, California
15
16 Roger T. Dmochowski, MD (via phone)
17 Professor of Urology
18 Director, Pelvic Medicine and Reconstruction
19 Fellowship
20 Department of Urology
21 Vanderbilt University Hospital
22 Nashville, Tennessee
A Matter of Record
[phone]
3
1 Matthew T. Drake, MD, PhD
2 Associate Professor of Medicine
3 Chair, Metabolic Bone Disease Core Group
4 Division of Endocrinology
5 Mayo Clinic College of Medicine
6 Rochester, Minnesota
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8 Beatrice J. Edwards, MD, MPH, FACP
9 Associate Professor
10 Department of General Internal Medicine
11 Division of Internal Medicine
12 University of Texas MD Anderson Cancer Center
13 Houston, Texas
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15 Margery Gass, MD
16 Executive Director Emerita
17 North American Menopause Society
18 Fred Hutchinson Cancer Research Center
19 Seattle, Washington
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A Matter of Record
[phone]
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1 Vivian Lewis, MD
2 (Chairperson)
3 Vice Provost for Faculty Development & Diversity
4 Professor, Obstetrics and Gynecology
5 University of Rochester
6 Rochester, New York
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8 Pamela A. Shaw, PhD
9 Associate Professor
10 Department of Biostatistics and Epidemiology
11 University of Pennsylvania School of Medicine
12 Philadelphia, Pennsylvania
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14 Sarah Sorscher, JD, MPH
15 (Consumer Representative)
16 Deputy Director of Regulatory Affairs
17 Center for Science in the Public Interest
18 Washington, District of Columbia
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A Matter of Record
[phone]
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1 BONE, REPRODUCTIVE, AND UROLOGIC DRUGS ADVISORY
2 COMMITTEE MEMBERS (Non-Voting)
3 Gerard G. Nahum, MD, FACOG
4 (Industry Representative)
5 Vice President of Global Development, General
6 Medicine
7 Women’s Healthcare, Long-Acting Contraception,
8 Medical Devices, and Special Projects
9 Bayer HealthCare Pharmaceuticals, Inc.
10 Parsippany, New Jersey
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12 TEMPORARY MEMBERS (Voting)
13 Robert A. Adler, MD
14 Chief, Endocrinology and Metabolism
15 McGuire Veterans Affairs Medical Center
16 Professor of Internal Medicine and of Epidemiology
17 Virginia Commonwealth University School of Medicine
18 Richmond, Virginia
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A Matter of Record
[phone]
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1 George Bishopric
2 (Patient Representative)
3 Fort Lauderdale, Florida
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5 Robert Brannigan, MD
6 Chief of Male Reproductive Medicine and Men's
7 Health in the Department of Urology
8 Professor of Urology
9 Northwestern University School of Medicine
10 Chicago, Illinois
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12 Glenn D. Braunstein, MD
13 Professor of Medicine
14 Cedars-Sinai Medical Center
15 Los Angeles, California
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A Matter of Record
[phone]
7
1 Tobias Gerhard, PhD, RPh
2 Associate Professor of Pharmacoepidemiology
3 Ernest Mario School of Pharmacy, and
4 Institute for Health, Health Care Policy and Aging
5 Research
6 Rutgers University
7 New Brunswick, New Jersey
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9 Stuart S. Howards, MD
10 Professor of Urology
11 Department of Urology
12 University of Virginia
13 Charlottesville, Virginia
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15 Ziya Kirkali, MD
16 Senior Scientific Advisor
17 National Institute of Kidney
18 National Institute of Health
19 Bethesda, Maryland
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A Matter of Record
[phone]
8
1 A. Michael Lincoff, MD
2 Director, Cleveland Clinic Coordinating Center for
3 Clinical Research (C5Research)
4 Vice Chairman, Department of Cardiovascular
5 Medicine and Lerner Research Institute
6 Professor of Medicine
7 Cleveland, Ohio
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9 Donald E. Mager, PharmD, PhD
10 Associate Professor of Pharmaceutical Sciences
11 University of Buffalo, SUNY
12 Department of Pharmaceutical Sciences
13 School of Pharmacy and Pharmaceutical Sciences
14 Buffalo, New York
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16 Robert Rej, PhD
17 Associate Professor, School of Public Health,
18 Biomedical Sciences
19 Wadsworth School of Laboratory Sciences
20 Albany Medical College
21 Albany, New York
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A Matter of Record
[phone]
9
1 Peter W. F. Wilson, MD
2 Professor of Medicine, Division of Cardiology
3 Emory University School of Medicine
4 Atlanta, Georgia
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6 FDA PARTICIPANTS (Non-Voting)
7 Hylton V. Joffe, MD, MMSc
8 Director
9 Division of Bone, Reproductive and Urologic
10 Products (DBRUP)
11 Office of Drug Evaluation III (ODE III)
12 Office of New Drugs (OND), CDER, FDA
13
14 A. Roger Wiederhorn, MD, DMSci
15 Medical Officer
16 DBRUP, ODE III, OND, CDER, FDA
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18 Dhananjay D. Marathe, PhD
19 Pharmacometrics Reviewer
20 Division of Pharmacometrics (DPM)
21 Office of Clinical Pharmacology (OCP)
22 Office of Translational Sciences (OTS), CDER, FDA
A Matter of Record
[phone]
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1 Preston Dunnmon, MD
2 Medical Officer
3 Division of Cardiovascular and Renal
4 Products (DCRP)
5 ODE I, OND, CDER, FDA
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7 Chongwoo Yu, PhD
8 Clinical Pharmacology Reviewer
9 Division of Clinical Pharmacology-III (DCP-III)
10 OCP, OTS, CDER, FDA
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A Matter of Record
[phone]