DRAFT AGENDA
BLOOD PRODUCTS ADVISORY COMMITTEE
93rd Meeting – January 9, 2009
Hilton Hotel, 1750 Rockville Pike, Rockville, MD
Friday, January, 9, 2009
1:30 p.m. Topic II: GTC Biotherapeutics Inc. Biologics License Application for Recombinant Antithrombin III Derived from Genetically Engineered Goats for Treatment of Patients with Hereditary Antithrombin III Deficiency to Prevent Thrombosis During High Risk Situations like Surgery and Obstetrical Procedures
A. Introduction, Nisha Jain, M.D., DH, OBRR, FDA (10’)
B. GTC Biotherapeutics, Inc. Presentations (60’)
i. Introduction, Richard Scotland, GTC Biotherapeutics, Inc.
ii. Recombinant Antithrombin Production Process – from Gene to Product, William Gavin, D.V.M., GTC Biotherapeutics, Inc. and Carol Ziomek, Ph.D., GTC Biotherapeutics, Inc.
iii. Atryn Clinical Program
- Hereditary Antithrombin Deficiency, Stephan Moll, M.D., Ph.D. University North Carolina Chapel Hill
- Clinical Trial Results, Johan Frieling, M.D., Ph.D. GTC Biotherapeutics, Inc.
C. FDA Review of Manufacturing, Roman Drews, Ph.D., DH, OBRR, FDA (30’)
D. FDA Review of Clinical Data, Nisha Jain, M.D., DH, OBRR, FDA (30’)
3:45 a.m. Break
4:00 p.m. Open Public Hearing
5:00 p.m. Open Committee Discussion
E. Questions for the Committee
F. Committee Discussion
6:00 p.m. Adjournment