Food and Drug Administration        

Center for Drug Evaluation and Research


Advisory Committee for Reproductive Health Drugs


September 30, 2003


Hilton Hotel, the Ballrooms

620 Perry Parkway, Gaithersburg, MD




8:30      Call to Order and Opening Remarks                    Linda Giudice, M.D., Ph.D.

             Introduction of Committee                                    Chair



            Conflict of Interest Statement                             Shalini Jain, PA-C, M.B.A.                                                                                                                   Executive Secretary, FDA


            Opening Remarks                                              Daniel Shames, M.D.

Director, Division of Reproductive and Urologic Drug Products (DRUDP)



Issue: Discussion of NDA 21-322, Luveris® (lutropin alfa for injection), Serono, Inc., a  recombinant human luteinizing hormone (r-hLH) drug product, proposed for concomitant administration with recombinant human follicle stimulating hormone

 (r-hFSH), for the proposed indication of induction of ovulation in infertile women with severe luteinizing hormone and follicle stimulating hormone deficiency.



8:45      Clinical Presentation of                                       James H. Liu, M.D.

Hypogonadotropic Hypogonadism                        Professor and Chair

             in Women                                                              Dept. of Reproductive Biology

Case Western Reserve University

                                                                              Cleveland, OH                                                            



9:30      Genetics of Hypogonadotropic                              Lawrence C. Layman, M.D.

Hypogonadism in Women                                     Chief, Section of Reproductive                        

                                                                                             Endocrinology, Infertility and Genetics

 Medical College of Georgia

                                                                                            Augusta, GA



10:30    Questions from the Committee               



10:45    Break              




             SERONO, INC

Introduction & Regulatory History                       Pamela Williamson Joyce, RAC

                                                                                            Vice President

                                                                                                 Regulatory Affairs & Quality                                                                                                          Assurance-United States

                                                                                                 Serono, Inc.


Need for and Role of LH: HH Women                 Jerome Strauss, M.D., Ph.D.

            with Profound Gonadotropin Deficiency             Luigi Mastroianni Jr. Professor


                                                                                            Center for Research on Reproduction

                                                                                            and Women’s Health

                                                                                            University of Pennsylvania


Luveris® Clinical Development Program             Paul Lammers, M.D.

                                                                                            Chief Medical Officer

                                                                                            Serono, Inc.


Clinical Perspective and Risk/Benefit                  Nanette F. Santoro, M.D.

             Assessment                                                            Professor and Director                       

Division of Reproductive Endocrinology                                                                                                                                                                          Department of Obstetrics &

                                                                                            Gynecology and Women’s Health

                                                                                            Albert Einstein College of Medicine                                                                                   


Summary and Conclusions                                    Pamela Williamson Joyce, RAC


12:00    Questions from the Committee


12:15    Lunch



1:00      Luveris®: The FDA perspective                         Shelley R. Slaughter, M.D., Ph.D.

                                                                                            Medical Officer Team Leader

                                                                                            Division of Reproductive

                                                                                            And Urologic Drug Products (DRUDP)


                                                                                            Kate Meaker, M.S.

                                                                                                                               Statistical Reviewer

                                                                                            Division of Biometrics II, FDA


1:45      Questions from the Committee               


2:15      Open Public Hearing                 


3:15      Presentation of Questions and Committee discussion


5:00      Adjourn