Transcript for the February 09, 2016 Meeting of the Arthritis Advisory Committee

436 Pages·2016·0.88 MB·English

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1 FOOD AND DRUG ADMINISTRATION
2 CENTER FOR DRUG EVALUATION AND RESEARCH
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4
5
6 ARTHRITIS ADVISORY COMMITTEE (AAC)
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10
11
12 Tuesday, February 9, 2016
13 8:00 a.m. to 5:13 p.m.
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18 FDA White Oak Campus
19 Building 31, The Great Room
20 White Oak Conference Center
21 Silver Spring, Maryland
22
A Matter of Record
[phone]
2
1 Meeting Roster
2 DESIGNATED FEDERAL OFFICER (Non-Voting)
3 Stephanie Begansky, PharmD
4 Division of Advisory Committee and
5 Consultant Management
6 Office of Executive Programs, CDER, FDA
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8 ARTHRITIS ADVISORY COMMITTEE MEMBERS (Voting)
9 Mara L. Becker, MD, MSCE
10 Associate Professor of Pediatrics
11 University of Missouri-Kansas City
12 Director, Division of Pediatric Rheumatology
13 Children’s Mercy Kansas City
14 Kansas City, Missouri
15
16 Liron Caplan, MD, PhD
17 (Acting Chairperson)
18 Associate Professor of Medicine
19 University of Colorado
20 Aurora, Colorado
21
22
A Matter of Record
[phone]
3
1 Jeffrey Curtis, MD, MS, MPH
2 William J. Koopman Endowed Professor in
3 Rheumatology and Immunology
4 University of Alabama at Birmingham (UAB)
5 Division of Clinical Immunology & Rheumatology
6 Director, UAB Arthritis Clinical Intervention
7 Program
8 Co-Director, UAB Center for Education and
9 Research on Therapeutics (CERTS)
10 Co-Director, UAB PharmacoEpidemiology and
11 Economic Research (PEER) Group
12 Birmingham, Alabama
13
14 Jennifer Horonjeff, PhD
15 (Consumer Representative)
16 Research Fellow & Patient Advocate
17 Center for Immune Disease with Onset in Childhood
18 Division of Rheumatology
19 Department of Medicine
20 New York, New York
21
22
A Matter of Record
[phone]
4
1 Beth L. Jonas, MD
2 Director, Rheumatology Fellowship Training Program
3 University of North Carolina School of Medicine
4 Chapel Hill, North Carolina
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6 Donald R. Miller, PharmD, FASHP
7 Professor of Pharmacy Practice
8 North Dakota State University
9 College of Health Professions
10 Fargo, North Dakota
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12 Veena K. Ranganath, MD, MS
13 Associate Clinical Professor
14 Division of Rheumatology
15 David Geffen School of Medicine at UCLA
16 Los Angeles, California
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A Matter of Record
[phone]
5
1 Eric J. Tchetgen Tchetgen, BS, PhD
2 (via phone)
3 Professor of Biostatistics and Epidemiologic
4 Methods
5 Harvard TH Chan School of Public Health
6 Departments of Biostatistics and Epidemiology
7 Boston, Massachusetts
8
9 Therese M. Wolpaw, MD, MHPE
10 Vice Dean for Educational Affairs
11 The Pennsylvania State University
12 College of Medicine
13 Hershey, Pennsylvania
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15 TEMPORARY MEMBERS (Voting)
16 Diane Aronson
17 (Patient Representative)
18 Naples, Florida
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A Matter of Record
[phone]
6
1 Wilma Bergfeld, MD, FAAD
2 Professor of Dermatology and Pathology
3 Senior Dermatologist & Emeritus Director
4 Dermatopathology
5 Director, Dermatopathology Fellowship
6 Departments Of Dermatology and Pathology
7 Cleveland Clinic
8 Cleveland, Ohio
9
10 Erica Brittain, PhD
11 Deputy Branch Chief and Mathematical Statistician
12 Biostatistics Research Branch
13 National Institute of Allergy and Infectious
14 Diseases (NIAID), National Institutes of Health
15 (NIH)
16 Bethesda, Maryland
17
18 Steve Cramer, PhD
19 William Weightman Walker Professor
20 Department of Chemical and Biological Engineering
21 Rensselaer Polytechnic Institute
22 Troy, New York
A Matter of Record
[phone]
7
1 Linda Feagins, MD
2 Associate Professor
3 Internal Medicine Division of Digestive and
4 Liver Diseases
5 University of Texas – Southwestern Medical Center
6 Director of Inflammatory Bowel Disease Clinic
7 Veteran Affairs North Texas Health Care System
8 Dallas, Texas
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10 Ivan Fuss, MD
11 Staff Clinician
12 Mucosal Immunity Section
13 Laboratory of Host Defenses
14 Division of Intramural Research
15 NIAID, NIH
16 Bethesda, Maryland
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18 Jogarao Gobburu, PhD, MBA, FCP
19 Professor
20 School of Pharmacy
21 University of Maryland
22 Baltimore, Maryland
A Matter of Record
[phone]
8
1 Eric O. Long, PhD
2 Chief, Molecular and Cellular Immunology Section
3 Laboratory of Immunogenetics
4 Division of Intramural Research
5 NIAID, NIH
6 Bethesda, Maryland
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8 Donald E. Mager, PharmD, PhD
9 Associate Professor of Pharmaceutical Sciences
10 School of Pharmacy and Pharmaceutical Sciences
11 University at Buffalo
12 State University of New York
13 Buffalo, New York
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15 Mary E. Maloney, MD
16 (via phone)
17 Chief, Division of Dermatology
18 Professor of Medicine
19 University of Massachusetts Medical School
20 Worchester, Massachusetts
21
22
A Matter of Record
[phone]
9
1 Antonio R. Moreira, PhD
2 Vice Provost for Academic Affairs
3 Professor of Chemical, Biochemical and
4 Environmental Engineering
5 University of Maryland, Baltimore County
6 Baltimore, Maryland
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8 John E. Schiel, PhD
9 Research Chemist
10 Bioanalytical Science Group
11 Biomolecular Measurement Division
12 Material Measurement Laboratory
13 National Institute of Standards and Technology
14 Gaithersburg, Maryland
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16 Tor A. Shwayder, MD, LRAM, FAAP, FAAD
17 Director of Pediatric Dermatology
18 Department of Dermatology
19 Henry Ford Hospital
20 Detroit, Michigan
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A Matter of Record
[phone]
10
1 Richard M. Siegel, MD, PhD
2 Chief, Immunoregulation Section
3 Autoimmunity Branch
4 Clinical Director, Intramural Research Program
5 National Institute of Arthritis and
6 Musculoskeletal and Skin Diseases, NIH
7 Bethesda, Maryland
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9 Steven Solga, MD
10 Solga Gastroenterology
11 Chief, Gastroenterology
12 St. Luke’s University Hospital
13 Bethlehem, Pennsylvania
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15 ACTING INDUSTRY REPRESENTATIVE TO THE COMMITTEE
16 (Non-Voting)
17 Sean P. Curtis, MD
18 (Acting Industry Representative)
19 Head, Global Scientific Affairs
20 Merck Research Laboratories
21 Merck and Co, Inc
22
A Matter of Record
[phone]