DRAFT AGENDA 6/20/2005

 

BLOOD PRODUCTS ADVISORY COMMITTEE

83nd Meeting July 21, 2005

Gaithersburg Holiday Inn, 2 Montgomery Village Avenue

Gaithersburg, MD 20877

 

Thursday, July 21, 2005

8:00 a.m. Welcome, Statement of Conflict of Interest, Announcements

 

8:10 a.m. Committee Updates

-         Summary of May 2005 Meeting of the DHHS Advisory Committee on Blood Safety and Availability Jerry Holmberg, PhD, Executive Secretary, Advisory Committee on Blood Safety and Availability (10)

-         Disseminated intravascular coagulation associated with acute hemoglobinemia following anti-D IGIV administration for idiopathic thrombocytopenic purpura Ann Gaines, FDA (15)

 

-         Update on Safety of Albumin Laurence Landow, M.D., FDA (5)

 

-         Summary of June 2005 Workshop on Biological Therapeutics for Rare Plasma Protein Disorders Mark Weinstein, Ph.D., FDA (10)

 

-         Summary of July 2005 Workshop on Leukoreduction- Alan Williams, Ph.D., FDA (10)

 

-         Update on West Nile Virus Guidance Alan Williams, PhD, FDA (10)

 

 

9:30 a.m. Open Committee Discussion

 

I.              Management of Donors and Units that Test Positive for Hepatitis B Virus (HBV) DNA by Nucleic Acid Tests (NAT)

 

A. Introduction and Background Robin Biswas, MD, OBRR, FDA (15)

B. Roche Tom Clement (10)

C. National Genetics Institute Dr. Richard Smith (10)

10:15 a.m. BREAK

10:30 a.m. OPEN PUBLIC HEARING

 

11:00 a.m. Open Committee Discussion

D. FDA Perspective and Questions for the Committee

E. Committee Discussion and Recommendations

 

12:00 p.m. LUNCH

 

 

1:00 p.m.

 

II.         Scientific Basis for Review of Varicella Zoster Immune Globulin

 

A.  Background Dorothy Scott, M.D., FDA (10)

B.  VZIG manufacture, potency testing, and current supply status D. Ambrosino, M.D., MPHBL (15)

C.  Varicella Zoster Disease, Indications for VZIG P. La Russa, M.D., Columbia University (30)

D.  VZIG licensure history and clinical trials (FDA, Scott or Ko) (15)

E.  ACIP Recommendations for VZIG use Mona Marin, M.D., CDC (10)

F.  Vaccine trials, correlates of protection, implications for donors of IGIV Philip Krause, M.D., FDA (10)

 

2:30 p.m. OPEN PUBLIC HEARING

 

3:00 p.m. Open Committee Discussion

G. FDA Perspective and Questions for the Committee

H. Committee Discussion and Recommendations

 

3:45 p.m. Break

 

4:00 p.m.

 

III.    Dextran 1 Pre-treatment For Safe Use of Dextran 40/70

 

A.          Introduction and Background Lawrence Landow, M.D., FDA (10)

B.          Swedish Studies With Dextran 1 Ljungstrom M.D.(25)

5:00 p.m. OPEN PUBLIC HEARING

 

5:30 p.m. Open Committee Discussion

D. FDA Perspective and Questions for the Committee

E. Committee Discussion and Recommendations

 

6:30 p.m. Adjournment