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

AGENDA

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

Open Session

Topic 1: Update: Office of Vaccines Research and Review Site Visit Report

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

9:15 Committee Questions/Clarifications

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

10:20 Manufacturer’s Presentation George Kemble, Ph.D.,

MedImmune, Inc.

11:20 Tumorigenicity and Oncogenicity Issues Keith Peden, Ph.D., FDA

12:30 Lunch

1:30 Open Public Hearing

2:30 Committee Discussion

4:00 Adjourn Meeting