8:00 Call to Order and Opening Remarks Allan Gibofsky, M.D., J.D.
Introductions Chair,
AAC
Conflict of Interest Statement Jayne
E. Peterson, R.Ph., J.D.
Acting
Executive Secretary, AAC, FDA
8:15 Welcome Brian E. Harvey, M.D., Ph.D.
Acting Director, Div. of Anti-Inflammatory,
Analgesic, and Ophthalmologic Drug Products
(DAAODP), FDA
Uric Acid and Gout James P. Witter, M.D., Ph.D.
8:45 Gout:
An Evolving Problem at a Therapeutic Robert
A. Terkeltaub, M.D.
Crossroads Chief,
VAMC Rheumatology Section
Professor
of Medicine in Residence
University
of California, San Diego
9:30 Cardiome
Pharma, Inc.
Introduction Alan
Moore, Ph.D.
Executive
Vice President,
Clinical Development and
Reg. Affairs
Gout: a Serious Progressive Disease Ralph Snyderman, M.D.
Chancellor for Health Affairs,
Duke Univ.
President/CEO, Duke Univ. Health
System
Oxypurinol Efficacy and
Safety Garth Dickinson, M.D.
Depts. of Medicine and Emerg.
Medicine
University of Ottawa
OXPL213
Analysis Robert
W. Makuch, Ph.D.
Professor and Head,
Biostatistics
Dept. of Epidemiology and Public
Health
Yale University School of
Medicine
Unmet Medical Need/Clinical Leonard
Calabrese, D.O.
Experience and Post-Approval
Issues Vice Chair, Dept. of
Rheumatic and Immunologic Diseases
Head,
Section of Clinical Immunology
RJ
Fasenmyer Chair of Clin. Immunology
Cleveland
Clinic Foundation
Issue: Trial
Design and Endpoints for Drugs for Chronic Gout
10:30 Break
10:45 Oxypurinol, Treatment of Symptomatic Lourdes Villalba, M.D.
Gout in Allopurinol Intolerant Patients Medical
Officer, DAAODP, FDA
11:30 Lunch
1:00 Open Public Hearing
2:00 Committee Discussion and
Questions
3:15 Break
5:00 Adjourn
Special Government Employee
(SGE) Consultants (Voting)
H. James Williams, M.D.
Professor of Medicine, Dept.
of Internal Medicine
Div. of Rheumatology
University of Utah
50 North Medicine Drive
Salt Lake City, Utah 84132
Brian F. Mandell, M.D., Ph.D.
Clinical Professor of
Medicine
Penn State Hershey School of
Medicine
Cleveland Clinic, Div. of
Medicine
Dept. of Rheumatology
9500 Euclid Ave., A50
Cleveland, Ohio 44195
David T. Felson, M.D., MPH
Professor of Medicine and
Public Health
School of Medicine, Boston
University
80 East Concord Street, A
201
Boston, Massachusetts 02118
Government Employee
Participants/Discussants (Voting)
Marc C. Hochberg, M.D., MPH
Professor of
Medicine
Head, Div. of
Rheumatology and
Clinical Immunology
School of Medicine
University of Maryland
22 South Greene Street
Baltimore, Maryland 21201
Government Employee Speaker
(Non-Voting)
Robert Terkeltaub, M.D.
Chief, VAMC Rheumatology
Section
Professor of Medicine in
Residence, UCSD
Director, UCSD Rheumatology
Training Program
Associate Division Director,
UCSD Rheumatology
Allergy-Immunology Division
VANC 1111-K, 3350 La Jolla
Village Drive
San Diego, California 02161