Gastrointestinal Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Marriott Washingtonian Center, 9751 Washington Boulevard, Gaithersburg, MD

New drug application (NDA) 21-597, Serostimâ (somatropin), Serono Inc.

“For the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support. Serostim therapy should be used in conjunction with optimal management of Short Bowel Syndrome.”

Agenda for June 25, 2003

8:30 Call to Order, Introductions: M. Michael Wolfe, M.D., Acting Chair

Meeting Statement: Thomas H. Perez, M.P.H., Executive Secretary

8:45 Opening Comments: Robert Justice, M.D., M.S., Director,

Division of Gastrointestinal and Coagulation Drug Products

8:50 Serono Inc. Presentation

Introduction & Regulatory History Pamela Williamson Joyce, RAC

Vice President, Regulatory Affairs & Quality Assurance, Serono, Inc.

Short Bowel Syndrome (SBS): Douglas W. Wilmore, M.D., FACS
Unmet Medical Need Brigham & Women’s Hospital Harvard Medical School

SBS Phase III Clinical Study Joseph Gertner, M.B., M.R.C.P., Vice President,
IMP 20317 Efficacy and Safety Head, Metabolic & Endocrine Clinical Develop. Unit Serono, Inc.

Risk/Benefit and Conclusions Pamela Williamson Joyce, RAC

Vice President, Regulatory Affairs & Quality Assurance, Serono, Inc.

10:00 Break

10:15 Questions on Presentations

10:45 FDA Presentation

Clinical Summary Hugo Gallo-Torres, M.D., Ph.D., PNS, Medical Team Leader

Division of Gastrointestinal and Coagulation Drug Products

11:30 Questions on Presentations

12:00 Lunch

1:00 Open Public Hearing

2:00 Charge to the Committee Robert Justice, M.D., M.S., Director,

Division of Gastrointestinal and Coagulation Drug Products

2:05 Discussion of Questions

3:00 Break

3:15 Discussion of Questions – continued

5:00 Adjourn