Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
AGENDA
Meeting #31, Holiday Inn, Gaithersburg, MD
October 24-26, 2001
Thursday, October 25
8:00 a.m. Opening Remarks
Dr. Daniel Salomon, Chair
8:15 Conflict of Interest Statement
Gail Dapolito, Executive Secretary
8:20 Introduction of Committee
OPEN COMMITTEE DISCUSSION
Topic 1 – Lentivirus Vectors in Gene Transfer Clinical Trials
8:30 Lentiviral Vectors
Dr. Inder Verma,
Salk Institute for Biological Studies
9:00 Q&A
9:15 Lentiviral Vectors: Safety Issues
Dr. Daniel Takefman
Office of Therapeutics Research and Review, CBER
9:45 Q&A
10:00 Break
10:15 Lentiviral Gene Therapy
Dr. Dale Ando
Cell Genesys, Inc.
LentiKat™ Vectors Overview
Dr. Veres Gabor
Cell Genesys, Inc.
11:00 Q&A
Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
AGENDA
Meeting #31, Holiday Inn, Gaithersburg, MD
October 24-26, 2001
Thursday, October 25 (cont’d)
11:15 Lentivirally Delivered GDNF for Parkinson’s Disease Dr. Jeffrey Kordower
Rush Presbyterian Medical Center
12:00 Q&A
12:15 p.m. Lunch
1:15 Lentiviral Vectors for the Treatment of Cancer, Neurodegenerative Diseases and AIDS
Dr. Susan Kingsman
Oxford BioMedica (UK) Ltd.
2:00 Q&A
2:15 p.m. Predicting Lentiviral Vector Safety In Vivo
Dr. John Kappes
University of Alabama at Birmingham
2:45 Q&A
3:00 Open Public Hearing
3:15 Break
3:30 Committee Discussion of Questions
6:00 Adjourn
Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
AGENDA
Meeting #31, Holiday Inn, Gaithersburg, MD
October 24-26, 2001
Friday, October 26
8:00 a.m. Opening Remarks
Dr. Daniel Salomon, Chair
OPEN COMMITTEE DISCUSSION
Topic 2 – Lentivirus Vector Gene Transfer Product for Treatment of People with HIV
8:15 Autologous T Cells Transduced with VRX496 - HIV-1 Based Lentiviral Vector Treatment of Patient-Subjects Infected with HIV-1
Dr. Boro Dropulic
VIRxSYS Corp.
9:45 Q&A
10:00 Break
10:15 Open Public Hearing
10:30 Committee Discussion of Questions
12:00 noon Lunch
12:30 p.m. Committee Discussion (cont’d)
2:00 Adjourn