Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee

September 25, 2008

Crowne Plaza Hotel,

8777 Georgia Ave, Silver Spring, MD

DRAFT AGENDA

Open Session

8:30 a.m. Call to Order and Opening Remarks John Modlin, M.D., Acting Chair

8:35 Administrative Matters Christine Walsh, R.N., FDA

Topic 1: Office of Vaccines Research and Review Response to January 25, 2007 Office Site Visit Report

8:45 Response to the OVRR Site Visit Report Erik Henchal, Ph.D., FDA

9:15 Committee Discussion

9:45 Break

Topic 2: Use of MDCK Cells for Manufacture of Live Attenuated Influenza Virus Vaccines

10:00 Introduction CDR Timothy Nelle, Ph.D., FDA

10:15 Manufacturer’s Presentation MedImmune Inc.

11:15 Background CDR Timothy Nelle, Ph.D., FDA

12:00 p.m. Lunch

1:00 Tumorigenicity Issues Andrew Lewis, M.D., FDA

1:30 Issues Associated with Residual Keith Peden, Ph.D., FDA

Cell Substrate DNA

2:00 Open Public Hearing

3:00 Committee Discussion

4:00 Adjourn Meeting