BLOOD PRODUCTS
ADVISORY COMMITTEE
91st Meeting, May 1-2, 2008
Thursday,
May 1, 2008
8:30 a.m. Opening
Remarks, Frederick P. Siegal,
M.D., Medical Director,
Saint Vincent’s
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,
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
C. Age
of Transfused Blood: Short-term Mortality and Long-term Survival after Cardiac
Surgery, Mark Stafford-Smith, M.D. FRCPC.
Professor of Anesthesiology,
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.,
iii.
Clinical Program, Ira Kalfus, M.D., Lev Pharmaceuticals
iv.
Clinical Considerations for Patient Care,
Paula Busse, M.D.,
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