Food And Drug Administration
Center For Biologics
Evaluation And Research
September 25, 2008
Crowne Plaza Hotel,
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