Center for Drug Evaluation and Research



Draft Agenda

August 20, 2003

Holiday Inn, Versailles Ballroom, 8120 Wisconsin Avenue, Bethesda, MD 20814


Clinical Trial Design Issues

in the Development of Topical Microbicides

for the Reduction of HIV Transmission


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.         Opening Remarks                                Debra B. Birnkrant, M.D.


                                                                                    Division of Antiviral Drug Products,



8:30 a.m.         HIV and STIs in Women:                    Salim S. Abdool Karim, M.D., Ph.D.

                        The Urgent Need for an Efficacious    University of Natal

                        Microbicide                                        Durban, South Africa


8:50 a.m.         Lessons Learned from COL-1492,      Lut Van Damme, M.D., M.Sc.

                        a Nonoxynol-9 Vaginal Gel Trial        Contraceptive Research and

                                                                                    Development Program (CONRAD)

                                                                                    Arlington, VA


9:10 a.m.         Considerations for Topical                 Teresa C. Wu, M.D., Ph.D.

                        Microbicide Phase 2 and 3 Trial        Medical Officer

                        Designs, a Regulatory Perspective      DAVDP, FDA


9:30 a.m.         Considerations for Topical                 Andrew Nunn, M.Sc.

                        Microbicide Phase 2 and 3 Trial        Medical Research Center

                        Designs, an Investigator’s                   London, UK



9:50 a.m.         Questions from the Committee


10:05a.m.        Break


10:25 a.m.       Statistical Considerations for              Thomas Fleming, Ph.D.

                        Topical Microbicide Phase 2 and       Chair, Department of Biostatistics

                        3 Trial Designs, an Investigator’s       University of Washington

                        Perspective                                         Seattle, WA


10:50 a.m.       Statistical Considerations for              Rafia Bhore, Ph.D.

                        Topical Microbicide Phase 2 and       Mathematical Statistician

                        3 Trial Designs, a Regulatory             Division of Biometrics

            Perspective                                         FDA


11:15 a.m.       Questions from the Committee


12:00 p.m.       Lunch


1:00 p.m          Open Public Hearing


1:45 p.m.         Charge to the Committee/                    Debra B. Birnkrant, M.D.

                        Questions for Discussion


5 p.m.              Adjourn