FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

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

SLIDES

Wednesday, May 16

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

 Introduction to the Session on Designer Cell Substrates, Andrew M. Lewis Jr. MD, FDA   pdf

Immunological Determinants of the Tumorigenicity of Adenovirus-Transformed Cells, James Cook   pdf

Quantitative Assessment of the Risks of Residual DNA, Dr. Keith Peden, FDA   pdf

Introduction to Adventitious Agent Issues Dr. Philip Krause, FDA   pdf

Transmissible Spongiform Encephalopathy (TSE) or Prion Diseases, Dr.  Sue Priola, NIH   pdf

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