AGENDA

 

BLOOD PRODUCTS ADVISORY COMMITTEE

91st Meeting, May 1-2, 2008

Hilton Hotel, 1750 Rockville Pike, Rockville, MD

 

Thursday, May 1, 2008

 

8:30 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 Conflict of Interest, Acknowledgement of New Members, Announcements

       

8:45 a.m.    Committee Updates

 

Summary of August 22-23, 2007 and January 9-10, 2008 Meetings of the DHHS Advisory Committee on Blood Safety and Availability, Jerry A. Holmberg, Ph.D., Executive Secretary, Advisory Committee on Blood Safety and Availability (15’)

 

2007 West Nile Virus Epidemiology and the Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Maria Rios, Ph.D., DETTD, OBRR, FDA and Melissa A. Greenwald, M.D., CDR, USPHS, DHT, OCTGT, FDA, (15’)  

 

Implementation of Blood Donor Screening for Infection with Trypanosoma cruzi (T. cruzi) and the Use of Serological Tests to Reduce the Risk of Transmission of T. cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Robert Duncan, Ph.D., DETTD, OBRR, FDA and Melissa A. Greenwald, M.D., CDR, USPHS, DHT, OCTGT, FDA (15’)

 

FDA’s Proposal to Lower the Minimum Recommended Lot Release Titer for Measles Antibodies in Immune Globulin Intravenous (Human) (IGIV) and Immune Globulin Subcutaneous (Human) (IGSC), Dorothy Scott, M.D., DH, OBRR, FDA (15’) 

 

Gambro/Fenwal PASSPORT Post Marketing Study - 7 Day Platelets, Larry Dumont, MBA, Ph.D., Director of Cell Labeling Laboratory, Assistant Professor Dartmouth Medical School  (15’)

 

Risk Analysis Related to PASSPORT Study, Louis M. Katz, M.D., Executive VP, Medical Affairs Mississippi Valley Regional Blood Center (15’)

 

FDA Perspective on PASSPORT Study, Salim Haddad, M.D., DH, OBRR, FDA (10’)

 

10:25 a.m.        BREAK

 

10:50 a.m.       Informational Presentations: Report on CBER Safety Teams Related to Blood and     Tissue

                                                

                     A.  CBER Blood Safety Team, Jonathan C. Goldsmith, M.D., Deputy Director, OBRR, FDA (30’)

           

B. CBER Tissue Safety Team, Ruth Solomon, M.D., Supervisory Medical Officer, OCTGT, FDA (30’)

 

11:50 a.m.      Open Public Hearing

                               

12:20 p.m.    LUNCH

 

1:20 p.m.    Topic I:  BEST (Biomedical Excellence for Safer Transfusion) Committee Report on     Red Blood      

                   Cell Recovery Standards

 

A.     FDA's Approaches of Evaluation of Red Blood Cell Products, Ping He, M.D., Medical Officer, DH, OBRR, FDA (30’)

 

B.     Red Blood Cell Recovery and Survival: In Vivo Studies, Richard J. Davey, M.D., Professor of Pathology and Laboratory Medicine. Director, Transfusion Medicine, The Methodist Hospital, Houston, TX (30’)

 

C.     Age of Transfused Blood: Short-term Mortality and Long-term Survival after Cardiac Surgery, Mark Stafford-Smith, M.D. FRCPC.  Professor of Anesthesiology, Duke University Medical Center (30’)

 

D.     Evaluation of Proposed FDA Criteria for the Evaluation of Radiolabeled Red Cell Recovery Trials, Larry Dumont, MBA, Ph.D., Director of Cell Labeling Laboratory, Assistant Professor, Dartmouth Medical School (30’)

 

E.   FDA’s Perspective on Statistical Methods in the Evaluation of Red Blood Cell Products (In vivo study), Jessica Kim, Ph.D., OBE, FDA (30’)

 

3:50 p.m.    BREAK

 

4:20 p.m.    Open Public Hearing

 

4:50 p.m.    Open Committee Discussion

                  

F.    Questions for the Committee

 

G.    Committee Discussion

 

5:50 p.m.      Adjournment

 

Friday, May 2, 2008  

 

8:30 a.m.    Topic II:  Lev Pharmaceuticals, Inc. Clinical Trial for the Use of Plasma-Derived C1 Esterase

                   Inhibitor (Cinryze) for the Prophylaxis of Hereditary Angioedema Attacks

                  

A.      Introduction, Felice D'Agnillo, Ph.D., DH, OBRR, FDA (10’)

 

B.     Lev Pharmaceuticals Presentation (60’)

 

i.                    Introduction, Jason Bablak, Lev Pharmaceuticals

 

ii.                  Unmet Need and Pathophysiology, Michael Frank, M.D., Duke University

 

iii.                Clinical Program, Ira Kalfus, M.D., Lev Pharmaceuticals

 

iv.                Clinical Considerations for Patient Care, Paula Busse, M.D., Mount Sinai Medical Center

 

C.     FDA Review of Clinical Data, Basil Golding M.D., Director, DH, OBRR, FDA (30’)

 

D.     Statistical Issues, Boris Zaslavsky, Ph.D. Dr.Sc., OBE, FDA, (10’)

 

10:20 a.m.   BREAK

 

10:40 a.m.    Open Public Hearing

 

11:10 a.m.     Open Committee Discussion                 

 

E.      Questions for the Committee 

 

F.      Committee Discussion

 

12:10 p.m.  LUNCH

 

1:10 p.m.         Topic III:  Review of the Research Programs in the Laboratory of Hepatitis and Related Emerging   Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER (Site Visit, November 8, 2008)

           

A.  Overview of CBER Research, Carolyn Wilson, Ph.D., Acting Associate Director for Research, CBER, FDA (15')

 

B.     Overview of OBRR Research, C.D. Atreya, Ph.D., Associate Director for Research, OBRR, FDA (15')

 

C.     Overview of the Division of Emerging and Transfusion Transmitted Diseases Research Program,   Hira Nakhasi, Ph.D., DETTD, OBRR, FDA (15’)

 

D.     Overview of the Laboratory of Hepatitis and Related Emerging Agents and Review of its Scientific Program, Gerardo Kaplan, Ph.D., DETTD, OBRR, FDA (30’)

 

E.      Questions & Answers (15’)

 

2:40 p.m.    Open Public Hearing 

           

3:00 p.m.    BREAK

 

3:15 p.m.   Closed Committee Discussion

 

4:00 pm.    Adjournment