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