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
·
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 OraQuick® Rapid HIV-1 Antibody Test – Elliot Cowan, PhD – 10'
·
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'
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