FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

AGENDA

March 19, 2002

 Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD

 NDA 21-245, Picovir^™ (pleconaril), ViroPharma Incorporated, proposed for treatment of acute picornaviral upper respiratory illness (common cold) in adults

8:00 a.m.            Call to Order                                       Roy M. Gulick, M.D., M.P.H.
                                                                                     Chair, AVAC

                        Introduction of Committee

            Conflict of Interest Statement                   Tara P. Turner, Pharm.D.
                                                                                      Executive Secretary, AVAC

 8:15 a.m.          Introduction/Opening Remarks          Debra B. Birnkrant, M.D.
                                                                                       Director
                                                                                       Division of Antiviral Drug Products
                                                                                       FDA

8:30 a.m.           Sponsor Presentation                         ViroPharma, Incorporated

                        Introduction                                               Mark McKinlay, Ph.D.
                                                                                        Vice President
                                                                                        Research and Development

                        Impact of the Common Cold                       Frederick G. Hayden, M.D.
                                                                                         University of Virginia
                                                                                         School of Medicine

                        A New Option for Treating Colds                Mark McKinlay, Ph.D.

                        Clinical Efficacy and Safety                         Ellen C. Cooper, M.D., M.P.H.
                                                                                          Vice President
                                                                                          Clinical and Regulatory Affairs 

                         Benefit/Risk                                               Ellen C. Cooper, M.D., M.P.H.

 9:30 a.m.            FDA Presentation                                  Russ Fleischer, PA-C, M.P.H.                                                                                                   Senior Clinical Analyst
                                                                                          Division of Antiviral Drug Products

                                                                                          Thomas Hammerstrom, Ph.D.
                                                                                          Statistical Reviewer
                                                                                          Division of Antiviral Drug Products

10:30 a.m.            Break                                                                                                          

10:45 a.m.            Questions to the Presenters

12:00 p.m.            Lunch                          

 1:00 p.m.            Open Public Hearing

2:00 p.m.            Questions to the Committee/Discussion

5:00 p.m.            Adjourn