Food and Drug Administration

Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee Meeting

November 14, 2007

National Institutes of Health

Building 29B/Conference Room A/B


1:00 p.m. Call to Order Ruth A. Karron, M.D., Chair

Administrative Matters Christine Walsh R.N., FDA


Open Session Presentation of Laboratory of Method Development, Division of Viral Products; Laboratory of Mycobacterial Diseases & Cellular Immunology, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review


1:10 Overview of Research/Site Visit Process, Michael Brennan, Ph.D., FDA

Center Biologics Evaluation and Research (CBER)

1:15 Overview Office of Vaccines Research Michael Brennan, Ph.D., FDA

and Review (OVRR), CBER

1:20 Overview Division of Viral Products (DVP), Jerry Weir, Ph.D., FDA



1:25 Overview Laboratory of Method Konstantin Chumakov, Ph.D., FDA

Development, DVP


1:50 Q&A

1:55 Overview Division of Bacterial Parasitic & Milan Blake, Ph.D., FDA

Allergenic Products (DBPAP), OVRR


2:00 Overview Laboratory of Mycobacterial Sheldon Morris, Ph.D., FDA

Diseases & Cellular Immunology, DBPAP


2:25 Q&A


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

3:30 Closed Session


4:30 Adjourn Meeting