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




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