BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

November 16-17, 2000

Slides

FDA Introduction - Structural Characterization of Gene Transfer Vectors, Steven Bauer, PhD, CBER  ppt  html

DNA Sequencing of Viral Gene Therapy Vectors During Preclinical and Clinical Development, Louis Zumstein, PhD, Introgen Therapeutics Inc   ppt   html

FDA Introduction - Preclinical Animal Models in Gene Transfer Research, Anne Pilaro, PhD, CBER   ppt   html

FDA Introduction - Vector Classes with Potential for Long-Term Risks, Carolyn Wilson, PhD, CBER  ppt  html

Long-Term Follow-UP of Subjects in Gene Transfer Clinical Trials, Philippe Bishop, MD, CBER  ppt   html

FDA Introduction - Preclinical Considerations for Gene Transfer Clinical Trials:  Vector Biodistribution,  Mercedes Serabian, MS, CBER  ppt  html

Risk of Germ Line Transduction After Director Injection of Retroviral Vectors, Deborah Hurst, MD, Chiron Corp.  ppt  html