FOOD AND DRUG ADMINISTRATION

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

Meeting #39

Teleconference, Rockwall II Building, Room 1113

5515 Security Lane, Rockville, MD

 

AGENDA

 

                        Open Committee Discussion

 

2:00  p.m. (ET)            Welcome and Administrative Remarks

                                                            Mahendra Rao, M.D., Ph.D., Chair

 

                                    Conflict of Interest Statement

                                                            Gail Dapolito, Executive Secretary

 

2:10                             Update Clinical Proteomics Program

                                    Center for Biologics Evaluation and Research

                                                            Raj Puri, M.D., Ph.D., Director

                                                            Division of Cellular and Gene Therapies

                                                                                               

                                    Update Research Programs, Division of Therapeutic Proteins,

                                    Center for Drugs Evaluation and Research

 

2:15                                                     Amy Rosenberg, M.D., Director, Division of Therapeutic Proteins

 

2:25                                                     Raymond Donnelly, Ph.D., Senior Investigator,

                                                            Laboratory of Immunology

 

2:35                                                     Gibbes Johnson, Ph.D., Chief, Laboratory of Chemistry

2:45                                         Q&A

 

2:55                             Open Public Hearing

 

3:55                             Closed Session Committee Discussion

                       

4:30 p.m.                      Adjourn