BLOOD PRODUCTS ADVISORY COMMITTEE

76th Meeting – March 13-14, 2003

Hilton Gaithersburg, 620 Perry Parkway

Gaithersburg, MD 20877

 

Thursday, March 13, 2003

         

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

 

8:10 a.m.    Committee Updates

 

        CBER Update – Mark Elengold, Deputy Director for Operations, Center for Biologics Evaluation and Research, FDA - 15'

        Medical Device User Fee and Modernization Act (MDUFMA) – Mary Elizabeth Jacobs, PhD – 10'

        CLIA Waiver for the OraQuickฎ Rapid HIV-1 Antibody Test – Elliot Cowan, PhD – 10'

        Trans Net Pilot Program – Alan Williams, PhD – 15'

 

 9:15 a.m.  OPEN PUBLIC HEARING

 

 9:45 a.m.  Open Committee Discussion

                I.      West Nile Virus (WNV) Donor Testing

        A. Introduction and Update of Previous Activities                    – Hira Nakhasi, PhD, Director, Division of                   Emerging and Transfusion Transmitted                           Diseases, OBRR – 15'

                   B. Industry Presentations

                      Update on NAT Testing:

                        1.  Jim Gallarda, PhD, Roche (Whole Blood) –                              10'

                       2.  Cristina Giachetti, PhD, Gen-Probe (Whole                             Blood)-10'

                        3.  Bruce Phelps, PhD, Chiron (supplemental                               test) – 10'

 10:30 a.m. Break

 

 11:00 a.m. Open Committee Discussion

                        4.  Andrew Conrad, PhD, National Genetics                                 Institute (NGI) (Source Plasma) – 10'

                       5.  Chip Stevens, MS, Sanochemia – 10'

                       6.  John Callaghan, MS, Tetracore – 10'

 

 

                        Serological Tests:

                    1.  George Dawson, PhD, Abbott Laboratories –

                            10'

                     2.  Steven Alexander, PhD, Ortho Diagnostics

                            - 10'

                    C.  CDC Update on Investigations of West Nile Virus                        Transfusion Transmitted Cases – Lyle Petersen,                        MD, CDC – 20'

         D.  Donor Serologic Studies of WNV 2002 Outbreak

                         – Susan Stramer, PhD, ARC – 20'

 

12:40 p.m.   Open Committee Discussion

 

         E.  Regulatory Pathway for WNV Testing (FDA Update)                   1.  Guidance for Industry – Martin Ruta, JD,                         PhD – 10'

             2.  Approval Criteria – Robin Biswas, MD – 10'

             3.  Clinical Study Design, Unit and Donor                            Management – Indira Hewlett, PhD – 20'

             4.  Panel Development and In-house Testing –                         Maria Rios, PhD – 10'

            

  1:30 p.m.   LUNCH

 

  2:30 p.m.   Open Committee Discussion    

 

                   F.  Blood Supply Management and Triggers for West                         Nile Virus Testing – Alan Williams, PhD – 20'

                   G.  Testing Source Plasma Donations and Clearance of                       West Nile Virus in Plasma Derived Products

                       – Mahmood Farshid, PhD – 15'

                       - Chris Healy, PPTA Presentation – 20'

 

  3:30 p.m.   OPEN PUBLIC HEARING        

                       

  4:30 p.m.   BREAK

 

  4:45 p.m.   Open Committee Discussion

 

                                 H.  Questions for the Committee

                            I.  Committee Discussion and Recommendations 

                          

 6:00 p.m.   RECESS (until 8:30 a.m. Friday, March 14, 2003)

 

 

 

 

 

Friday, March 14, 2003

 

  8:30 a.m.  Committee Update

 

        Anticoagulants, Irradiation and Freezing of Blood Components –

     Judy Ciaraldi, M.T., (ASCP), Blood and Plasma Branch, DBA, OBRR

        Bar Code Label Requirement For Human Drug Products and Blood – Richard Lewis, PhD

 

 9:00 a.m. OPEN PUBLIC HEARING

 

  9:30 a.m. Open Committee Discussion

 

           II. Discussion on Extension of the Storage Period for                     Pooled Platelets

               A. Introduction and Background – Jaro Vostal, MD, PhD,                   Chief, Laboratory of Cellular Hematology, DH, OBRR

               B. Clinical Performance of Pre-storage Pooled Platelet                   Products – Edward Snyder, MD, Yale University

 

10:15 a.m. BREAK

 

10:45 a.m. Open Committee Discussion

               C. European Experience with Extended Storage of                          Platelet Pools – Ruby Pietersz, MD, PhD

                                    D.     Bacterial Detection in Platelet Products – Mark                      Brecher, MD, University of North Carolina

 

          11:30 a.m.  OPEN PUBLIC HEARING

 

               12:00 Noon  LUNCH

 

           1:00 p.m.  Open Committee Discussion

 

                         E. Questions for the Committee                                        F. Committee Discussion and Recommendations

 

           2:00 p.m.     Update on Particulates in Blood Bags – Informational                   A. Introduction – Richard Lewis, PhD, Deputy Director,                   Office of Blood Research and Review – 10'

                         B. Discovery, ADR Investigation, Conditions of                           Collections Investigation – Peter Page, MD -                          American Red Cross – 15'

                         C. Chronology and Field Overview – Jerome Davis, Office                   of Compliance, CBER – 10'

                         D. Testing

                            - FDA Findings - Division of Hematology, OBRR – 10'

                            – Industry Investigations – Steve Binion, Baxter                        Labs. – 10'

                         E. Follow-up ADR Monitoring

                            - Clinical Studies – Sharyn Orton, PhD, DBA, OBRR –                     10'                

                            - Centers for Disease Control (CDC) and

                              Georgia State Division of Public Health – Matthew                     Kuehnert, MD, CDC – 10'

 

 4:00 p.m. ADJOURNMENT