Food and Drug Administration

Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee

Teleconference Meeting

November 20, 2008

National Institutes of Health

Building 29B/Conference Room C




Open Session


1:00 p.m.         Call to Order                                                               John Modlin, M.D., Acting Chair

                        Administrative Matters                                               Christine Walsh R.N., FDA


Presentation of Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research


1:10                 Overview of Research/Site Visit Process,                  Carolyn Wilson, Ph.D., FDA

Center Biologics Evaluation and Research (CBER)             


1:20                 Overview Office of Vaccines Research                     Konstantin Chumakov, Ph.D., FDA

                        and Review (OVRR), CBER


1:30                 Overview Division of Viral Products (DVP),            Jerry Weir, Ph.D., FDA



1:40                 Overview Laboratory of DNA Viruses                      Philip Krause, Ph.D., FDA


2:15                 Q&A


2:30                 Open Public Hearing (if no speakers, will move directly to closed session)                         

3:30                 Closed Session


4:00                 Adjourn Meeting