Revised Draft V5.0 3/11/03
BLOOD PRODUCTS ADVISORY COMMITTEE
76th Meeting March 13-14, 2003
Gaithersburg, MD 20877
Thursday, March 13, 2003
8:00 a.m. Welcome, Statement of Conflict of Interest, Announcements
8:10 a.m. Committee Updates
ท CBER Update Mark Elengold, Deputy Director for Operations, Center for Biologics Evaluation and Research, FDA - 15'
ท Medical Device User Fee and Modernization Act (MDUFMA) Mary Elizabeth Jacobs, PhD 10'
ท CLIA Waiver for the OraQuickฎ Rapid HIV-1 Antibody Test Elliot Cowan, PhD 10'
ท Trans Net Pilot Program Alan Williams, PhD 15'
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'
1. George Dawson, PhD, Abbott Laboratories
2. Steven Alexander, PhD, Ortho Diagnostics
3. Christopher Bentsen, PhD. Bio-Rad 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
ท Anticoagulants, Irradiation and Freezing of Blood Components
Judy Ciaraldi, M.T., (ASCP), Blood and Plasma Branch, DBA, OBRR
ท Bar Code Label Requirement For Human Drug Products and Blood Elizabeth Callaghan, MS
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'
- 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