Wednesday, February 16, 2005


8:00                 Call to Order                                                               Alastair J. J. Wood, M.D., Chair

                        Conflict of Interest Statement                                     Kimberly Littleton Topper, M.S.

                                                                                                            Executive Secretary


8:10                 Welcome                                                                    Steven Galson, M.D., M.P.H.

                                                                                                            Acting Director, Center for Drug

                                                                                                            Evaluation and Research (CDER)


8:20                 Regulatory History                                                      Jonca Bull, M.D.

                                                                                                            Director, Office of Drug

Evaluation V, CDER


8:30                 Gastrointestinal Effects of NSAIDs and                      Byron Cryer, M.D.

                        COX-2 Specific Inhibitors                                           University of Texas

Southwestern Medical School


9:00                 Mechanism Based Adverse Cardiovascular              Garret A. FitzGerald, M.D.

                        Events and Specific Inhibitors of COX-2                    University of Pennsylvania

                                                                                                            School of Medicine


9:30                 Committee Questions to Speakers   


9:50                 Break  


Vioxx (rofecoxib)

                        Sponsor Presentation:

10:00               Rofecoxib                                                                    Ned S. Braunstein, M.D.

Senior Director

Merck Research Laboratories

                        FDA Presentation:

10:45               Vioxx                                                                            Lourdes Villalba, M.D.

Cardiovascular Safety                                                Medical Officer, CDER          


11:30               Committee Questions to Speakers   


12:15               Lunch 


Celebrex (celecoxib)

                        Sponsor Presentation:

1:00                 Introduction                                                                 Joseph M. Feczko, M.D.

Senior Vice President,

Pfizer Global Research and Development, and

President, Worldwide Development


Wednesday, February 16, 2005 (cont.)


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:

1:45                 COX-2 CV Safety: celecoxib                                      James Witter, M.D., Ph.D.

                                                Lead Medical Officer, CDER


NIH and Investigator Presentation:

2:15                 Celecoxib in Adenoma Prevention Trials:                  

   The APC Trial                                                          Ernest Hawk, M.D., MPH

                           (Prevention of Sporadic Colorectal                          Director, Office of Centers,

    Adenomas with Celecoxib)                                     Training, & Resources



                             The PreSAP Trial                                                   Bernard Levin, M.D

                             (Prevention of Colorectal Sporadic                        M.D. Anderson Cancer Center

                               Adenomatous Polyps)                                         The University of Texas


2:35                 Committee Questions to Speakers   


3:15                 Break  


Bextra (valdecoxib) and parecoxib

3:30                 Sponsor Presentation:

Cardiovascular Safety and Risk/Benefit                     Kenneth M. Verburg, Ph.D.

  Assessment of Valdecoxib and Parecoxib              


Closing                                                                        Joseph M. Feczko, M.D.


                        FDA Presentation:

4:00                 COX-2 CV Safety: valdecoxib – parecoxib                 James Witter, M.D., Ph.D.



                        Sponsor Presentation:

4:30                 Bayer and Roche Joint Presentation on Naproxen    Leonard M. Baum, R.Ph.

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.

5:10                 Committee Questions to Speakers   


Thursday, February 17, 2005


8:00                 Call to Order                                                               Alastair J. J.  Wood, M.D., Chair

Conflict of Interest Statement                                     Kimberly Littleton Topper, M.S.


8:10                 Interpretation of Observational Studies of                  Richard Platt, M.D., M.S.

Cardiovascular Risk of Non-steroidal Drugs              Harvard Medical School


8:40                 Review of Epidemiologic Studies on                          David Graham, M.D., M.P.H.

Cardiovascular Risk with Selected NSAIDs               Medical Officer, CDER


9:10                 Committee Questions to Speakers   


Arcoxia (etoricoxib)

                        Sponsor Presentation:

9:30                 Etoricoxib                                                                    Sean P. Curtis, M.D.

Senior Director, Clinical Research

Merck Research Laboratories

                        FDA Presentation:

10:00               Analysis of Cardiovascular Thromboembolic             Joel Schiffenbauer, M.D.

Events With Etoricoxib                                               Medical Officer, CDER


10:15               Break  



                        Sponsor Presentation:

10:30               Lumiracoxib:  Introduction                                           Mathias Hukkelhoven, Ph.D.

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


11:15               Committee Questions to Speakers   


12:00               Lunch 


1:00                 Open Public Hearing  


3:00                 Break  


3:15                 Committee Discussion



Friday, February 18, 2005


8:00                 Call to Order                                                               Alastair J. J. Wood, M.D.,Chair

Conflict of Interest Statement                                     Kimberly Littleton Topper, M.S.


Naproxen       Investigator Presentation:

8:10                 Alzheimer’s Prevention Study :  ADAPT                     Constantine Lyketsos, M.D.

                         (Alzheimer’s Disease Anti-Inflammatory                   The John Hopkins Hospital

                         Prevention Trial)


Additional Background Presentations

8:25                 Interpretation of Observed Differences                      Milton Packer, M.D.

in the Frequency of Events When the                        University of Texas

Number of Events is Small                                         Southwestern Medical School


8:55                 Committee Questions to Speakers


9:10                 Clinical Trial Design and Patient Safety:                   Robert Temple, M.D.

Future Directions for COX-2 selective NSAIDs          Director, Office of Medical

                                                                                    Policy, CDER


9:40                 Issues in Projecting Increased Risk of                       Robert O’Neill, Ph.D.

Cardiovascular Events to the Exposed Population    Director, Office of Biostatistics, CDER


10:10               Committee Questions to Speakers   


10:30               Break  


10:40               Summary of Meeting Presentations                           Sharon Hertz, M.D.

                                                                                                            Deputy Director, Div. of

Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products, CDER


11:10               Advisory Committee Discussion of Questions


12:00               Lunch 


1:00                 Advisory Committee Discussion of Questions


3:00                 Break  


3:15                 Advisory Committee Discussion of Questions


4:45                 Meeting Wrap-up                                                        Alastair J. J. Wood, M.D.


5:00                 Adjourn