FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
May 16-17, 2001

Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland

AGENDA

Wednesday, May 16

8 AM Session 1 CLOSED SESSION

9:00 Session 2 OPEN Session Use of Novel ("Designer") Cells as Substrates for Manufacture of Viral Vaccines

9:00 Call to Order, Introductions, Administrative Matters, Dr. Robert S. Daum, Committee Chair

9:15 Introduction to the Session on Designer Cell Substrates, Dr. Andrew Lewis, FDA

9:30 Designer Cell Substrates for Vaccine Development: Concepts and Issues,  Dr Steve Hughes

9:50 Adenovirus Biology as Related to Development and Use of Adenovirus Vectors, Dr. Estuardo Aguilar-Cordova

10:10 Break

10:30 Adenovirus Transformation of Human Cells and the Development of 293 and PER.C6 Cells for the Manufacture of Defective Adenovirus Vectors, Dr. Alex van der Eb

11:00 Adenovirus Transformed Cell Tumorigenicity and Transformed Cell-Host Interaction that Determine their Tumor-Forming Capability, Dr. James Cook

11:30 Quantitative Assessment of the Risks of Residual DNA, Dr. Keith Peden, FDA

11:55 Lunch

1 PM Introduction to Adventitious Agent Issues Dr. Philip Krause, FDA

1:10 Transmissible Spongiform Encephalopathy Agents as an Issue in the Use of Neoplastic Cell Substrates Dr.  Sue Priola, NIH

1:30 Adventitious Agent Testing of Neoplastic Cell Substrates   Dr. Philip Krause, FDA

2:00   Review of OVRR-CBER Issues with the Use of Adenovirus-vectored Vaccines and their Complementing "Designer Cell Substrates" Dr. Hana Golding, FD

2:15 Open Public Hearing

3:15 Break

3:30 Committee Discussion

6:00 Adjourn for the Day

 

Thursday, May 17

8 AM Session 3 CLOSED SESSION

12:30 End of Closed Session and Adjournment