Gene Therapy Vector Production Conference
Held  March 21, 2001 - Bethesda, MD

The Gene Therapy Vector Production meeting was held March 21, 2001 in Bethesda, Washington. The meeting addressed vector production issues, with an emphasis on novel vector systems. Participants from the FDA, Academia and Industry were among the 200 attendees.

The meeting was rated as outstanding by the vast majority of respondents, attesting to the quality of the material presented.

Morning sessions consisted of presentations by the FDA and The Biologics Consulting Group on regulatory issues associated with vector production. Slides from these presentations can be viewed below.

• Expectations for Early Phase cGMP
  Andra Miller
  The Biologics Consulting Group
  [ VIEW ONLINE ]        [ DOWNLOAD ]
  
  

• Gene Therapy Production Facility Considerations
  Robert Sausville
  Center for Biologics Evaluation and Research
  Office of Compliance and Biologics Quality
  Division of Case Management
  [ VIEW ONLINE ]        [ DOWNLOAD ]
  
  

• Current Good Manufacturing Practice - 21 CFR 210, 211
  Joyce L. Frey, PhD
  Deputy Director
  Division of Cellular and Gene Therapies
  OTRR/CBER/FDA
  [ VIEW ONLINE ]        [ DOWNLOAD ]
  
  

• Ensuring Product Quality in Gene Transfer Clinical Trials
  Stephanie Simek Ph.D.
  Division of Cellular and Gene Therapies
  OTRR/CBER/FDA
  [ VIEW ONLINE ]        [ DOWNLOAD ]
  
  

• QC/QA
  Mary Malarkey
  Director, Division of Case Management
  Office of Compliance and Biologics Quality
  Center for Biologics Evaluation and Research
  [ VIEW ONLINE ]        [ DOWNLOAD ]