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
10:45 Oxypurinol, Treatment of Symptomatic Lourdes Villalba, M.D.
Gout in Allopurinol Intolerant Patients Medical Officer, DAAODP, FDA
1:00 Open Public Hearing
2:00 Committee Discussion and Questions
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
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
VANC 1111-K, 3350 La Jolla Village Drive
San Diego, California 02161