DRAFT AGENDA

                                                                                               

BLOOD PRODUCTS ADVISORY COMMITTEE

93^rd  Meeting – January 9, 2009

Hilton Hotel, 1750 Rockville Pike, Rockville, MD

 

Friday, January, 9, 2009

 

8:00 a.m.    Opening Remarks, Frederick P. Siegal, M.D., Medical Director, Comprehensive HIV Center,

                   Saint Vincent’s Catholic Medical Centers, New York, NY, Chairperson, BPAC

                               

                   Statement of Conflicts of Interest, Announcements      

 

8:15 a.m.    Topic I: CSL Behring’s Biologics License Application for Plasma-Derived Fibrinogen

                                Concentrate for Treatment of Bleeding in Congenital Fibrinogen Deficiency

 

A.     Introduction, Nisha Jain, M.D., DH, OBRR, FDA (10’)

 

B.      CSL Behring Presentations (60’)

 

i.                    Introduction, Paul Hartman, R.Ph., Senior Director US Regulatory Affairs, R&D CSLB

 

ii.                  Unmet Medical Need, Amy Shapiro, M.D., Indiana Hemophilia & Thrombosis Center

 

iii.                Clinical Program Efficacy and Safety, Christian Peters, M.D., Ph.D. Sr. Director Head of US  R&D CSLB

 

iv.                Clinical Perspective, Marilyn Manco-Johnson, M.D., Professor of Pediatrics,

                        University of Colorado Denver and the Children's Hospital

 

C.      FDA Review of Manufacturing, Timothy Lee, Ph.D., DH, OBRR, FDA (15’)

 

D.     FDA Review of Clinical Data, Nisha Jain, M.D., DH, OBRR, FDA (30’)

 

10:15 a.m.    Break

 

10:30 a.m.     Open Public Hearing

 

11:00 a.m.    Open Committee Discussion

 

                     D.   Committee Discussion

 

                     E.   Questions for the Committee

 

12:00 p.m.    Lunch

 

1:00 p.m.      Committee Update

           

-          FDA Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs and Overview of the Center for Veterinary Medicine’s Review of the New Animal Drug Application Pertaining to the Genetically Engineered Animals Producing Milk that Contains Recombinant Antithrombin III and the Environmental Assessment for the Application,  Larisa Rudenko, Ph.D., Center for Veterinary Medicine, FDA  (30’)   

 

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