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