Food and Drug Administration
Center for Biologics Evaluation and Research
Hilton Hotel, Gaithersburg, Maryland

May 9, 2002                     


8:00 a.m.             Session I -  Open Session
                                    Update Research Programs
                                                Laboratory of Gene Regulation, DTP, CBER
                                                Laboratory of Immunobiology, DMA, CBER

8:45                 Session II - Closed Session

9:05                 Break

9:15                 Session III – Open Session
                                                Ooplasm Transfer in Assisted Reproduction

9:15-9:45                    Welcome/Administrative Remarks
                                    Presentation of Certificate of Appreciation to Dr. Edward Sausville
                                                Jesse Goodman, M.D., CBER
                                                Jay P. Siegel, M.D., CBER

9:35-9:45                    FDA Introduction
Deborah Hursh, Ph.D.
                                                Division of Cellular and Gene Therapies, CBER

                        Guest Presentations

9:45-10:25                              Susan Lanzendorf, Ph.D., HCLD
            Jones Institute of Reproductive Medicine

10:25-10:35                            Q&A

 10:35-10:45                Break

 10:45-11:25                            Jacques Cohen, Ph.D.
            St. Barnabas Medical Center

 11:25-11:35                            Q&A

 11:35-12:20 p.m.                    Eric Shoubridge, Ph.D.
            Montreal Neurological Institute

 12:20-12:40                            Q&A

12:40 –1:40 p.m.            Lunch

                                     Guest Presentations (Cont’d)

1:40-2:25                                Jonathon VanBlerkom, Ph.D.
            University of Colorado at Boulder

 2:25-2:35                                Q&A

 2:35-3:05                                Lori P. Knowles, LL.B.,B.C.L.,M.A.,L.L.M.
                                                The Hastings Institute

3:05-3:15                                Q&A

3:15-3:45                    Open public hearing 

3:45-4:00                    Break

4:00-6:30                    Committee discussion of questions