90th Meeting – August 16, 2007

Doubletree Hotel & Executive Meeting Center

8120 Wisconsin Avenue, Bethesda, MD



Thursday, August 16, 2007


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 Conflict of Interest, Acknowledgement of New Members, Announcements


8:15 a.m.     Committee Updates


-          Summary of May 10-11, 2007 Meeting of the DHHS Advisory Committee on Blood Safety and Availability, Jerry Holmberg, Ph.D., Executive Secretary, Advisory Committee on Blood Safety and Availability  (15’)


-          Summary of April 25-26, 2007 FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing, Jennifer Scharpf, M.P.H., OBRR, FDA (15’)


-          Summary of August 15, 2007  FDA Workshop on Licensure of Apheresis Blood Products, Lore Fields, DBA, OBRR, FDA (15’)


9:00 a.m.    Informational Presentations:  WHO Biological Standards


A.     Summary of January 29-30, 2007 WHO Meeting with WHO Collaborating Centres for Biological Standards and Standardization to Support the Development of WHO Biological Reference Preparations for Blood Safety-related in vitro Diagnostic Tests, Paul A. Mied, Ph.D., DETTD, OBRR, FDA (20’)


B.     Potency and Safety Standards for Plasma Derivatives, Mei-ying W. Yu, Ph.D., DH, OBRR, FDA (20’)


C.     Joint FDA/WHO minimum potency standards for certain Blood Grouping Reagents,

                          Sheryl Kochman, DBA, OBRR, FDA (20’)


10:00 a.m.    Break


10:15 a.m.    Topic I.  Response to the Office of Blood Research and Review Office Level Site Visit for Research, July 22,                             2005


                     A.  Introduction, Kathryn Carbone, M.D., OD, CBER, FDA (30’)


                      B.  Office Response, Jay Epstein, M.D. and CD Atreya, Ph.D., OBRR, FDA (30’)


11:15 a.m.    Open Public Hearing


11:45 a.m.    Open Committee Discussion


12:15 p.m.   Lunch


1:15 p.m.     Topic II:     Measles Antibody Levels in U.S. Immune Globulin Products


A.     Introduction, Basil Golding, M.D., DH, OBRR, FDA (20’)  

B.   Current Epidemiology of Measles in the U.S., Jane Seward, M.B.B.S., M.P.H., CDC (25’)


C.   Measles Infections and Estimated Protective Titers in Primary Immune Deficiency Diseases and Potential Reemergence of Epidemic Measles in Vaccinated Individuals, William Moss, M.D., M.P.H.,  Johns Hopkins Bloomberg School of Public Health (25’)


D.  Measles Antibody Titers in Plasma Donors, Toby Simon, M.D., CSL Behring (20’)


E.   Measles Antibody Levels over Time in Licensed Immune Globulin Products and Patients with Primary Immune Deficiency Diseases

            i.   Don Baker, Ph.D., Baxter Healthcare Corporation (10')

            ii.  Othmar Zenker, M.D., CSL Behring (20’)


3:15 p.m.    Break


3:30 p.m.    Open Public Hearing                    


4:00 p.m.    Open Committee Discussion


A.     Questions for the Committee

B.     Committee Discussion

5:00 p.m.  Adjournment