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





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