Conflict of Interest
Statement Kimberly
Littleton Topper, M.S.
Executive
Secretary
Acting
Director, Center for Drug
Evaluation
and Research (CDER)
Director,
Office of Drug
Evaluation V, CDER
COX-2 Specific
Inhibitors
Southwestern
Events and
Specific Inhibitors of COX-2
Vioxx (rofecoxib)
Sponsor Presentation:
Senior Director
Merck Research Laboratories
FDA Presentation:
Cardiovascular Safety Medical
Officer, CDER
Celebrex (celecoxib)
Sponsor Presentation:
Senior Vice President,
Pfizer
Global Research and Development, and
President,
Worldwide Development
Cardiovascular Safety and Kenneth
M. Verburg, Ph.D.
Risk/Benefit
Assessment of Celecoxib Vice
President, Inflammation and
Immunology,
Clinical Research and Development, Pfizer Global Research and Development
FDA Presentation:
Lead
Medical Officer, CDER
NIH and Investigator Presentation:
The APC Trial Ernest
Hawk, M.D., MPH
(Prevention of Sporadic Colorectal Director,
Office of Centers,
Adenomas with Celecoxib) Training,
& Resources
NCI/OD/NIH
The PreSAP Trial Bernard Levin, M.D
(Prevention of Colorectal Sporadic
Adenomatous Polyps) The
Cardiovascular Safety and Risk/Benefit Kenneth M. Verburg, Ph.D.
Assessment of Valdecoxib and Parecoxib
Closing Joseph
M. Feczko, M.D.
FDA Presentation:
Sponsor Presentation:
Vice President, Regulatory Affairs
Bayer
HealthCare
Consumer
Care Division
Martin H. Huber, M.D.
Vice
President, Global Head
Drug
Safety Risk Management, Hoffmann-La Roche, Inc.
Conflict of Interest Statement Kimberly Littleton Topper, M.S.
Cardiovascular Risk of
Non-steroidal Drugs
Cardiovascular Risk with Selected
NSAIDs Medical Officer, CDER
Arcoxia (etoricoxib)
Sponsor
Presentation:
Senior Director, Clinical
Research
Merck Research Laboratories
FDA
Presentation:
Events With Etoricoxib Medical
Officer, CDER
Lumiracoxib
Sponsor
Presentation:
Senior
Vice President and Global Head, Drug Regulatory Affairs
Novartis Pharmaceuticals Corporation
Gastrointestinal and
Cardiovascular Safety Patrice
Matchaba, M.D.
of Lumiracoxib, Ibuprofen, and Naproxen Global Medical Director
Lumiracoxib Program, Novartis Pharmaceuticals
Corporation
FDA Presentation:
11:00 Lumiracoxib Lourdes
Villalba, M.D.
Medical Officer, CDER
Conflict of Interest Statement Kimberly Littleton Topper, M.S.
Naproxen Investigator Presentation:
(Alzheimer’s Disease Anti-Inflammatory The John Hopkins Hospital
Prevention Trial)
Additional Background
Presentations
in the Frequency of
Events When the
Number of Events is Small Southwestern
Medical School
Future Directions for COX-2 selective NSAIDs Director, Office of Medical
Policy,
CDER
Cardiovascular Events to the
Exposed Population Director, Office of Biostatistics, CDER
Deputy
Director, Div. of
Anti-Inflammatory,
Analgesic and Ophthalmologic Drug Products, CDER