BLOOD PRODUCTS ADVISORY COMMITTEE

82nd Meeting – March 17-18, 2005

Gaithersburg Holiday Inn, 2 Montgomery Village Avenue

Gaithersburg, MD 20877

Thursday, March 17, 2005

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

8:30 a.m. Committee Updates

- Meeting Summary of DHHS Advisory Committee on Blood Safety and Availability – Jerry Holmberg, PhD, Executive Secretary, Advisory Committee on Blood Safety and Availability (15’)

- Summary of TSEAC Meeting – David Asher, MD, OBRR, FDA (15’)

- Update on West Nile Virus Guidance – Alan Williams, PhD, OBRR, FDA (10)

- Critical Path Initiative Workshop Summary

A. CBER Overview - Kathryn Carbone, MD, OD, CBER, FDA (10’)

B. OBRR Summary – Paul Mied, PhD, OBRR, FDA (10’)

C. Clinical Trial Design – Mary Foulkes, PhD., OBE, FDA (10’)

9:40 a.m. Open Committee Discussion

I. Safety of Albumin Revisited

A. Introduction and Background – Laurence Landow, MD, OBRR, FDA (5’)

B. Review of the Cochrane Report – Paul Hebert, MD, Vice Chair of Research, Ottawa Health Research Institute

Ontario, Canada (20’)

C. Review of the SAFE Study - Simon Finfer, MD, Senior Staff Specialist in Intensive Care, University of Sydney, Australia (35’)

10:40 a.m. BREAK

11:00 a.m. OPEN PUBLIC HEARING

12:00 p.m. Open Committee Discussion

D. FDA Perspective and Questions for the Committee

E. Committee Discussion and Recommendations

1:00 p.m. LUNCH

BLOOD PRODUCTS ADVISORY COMMITTEE

Thursday, March 17, 2005 (page 2)

2:00 p.m. Committee Updates

- Update on International Agreements – Mark Weinstein, PhD, OBRR, FDA (15’)

- Sharing Information with the Public – Kathleen Swisher, RN JD, OD, FDA (15’)

2:30 p.m. Open Committee Discussion

II. Review of Standards for Plasma Products for Transfusion

A. Introduction and Review of the Literature - Mark Weinstein, PhD (40’)

B. Presentation (clinical use of plasma) – Irma O. Szymanski, MD. Professor Emerita of Pathology, University of Massachusetts (20’)

3:30 p.m. BREAK

3:50 p.m. OPEN PUBLIC HEARING

4:45 p.m. Open Committee Discussion

C. FDA Perspective and Questions for the Committee

D. Committee Discussion and Recommendations

5:30 p.m. RECESS (until 8:30 a.m. Friday, March 18,2005)

DAY TWO

BLOOD PRODUCTS ADVISORY COMMITTEE

Friday, March 18, 2005

8:30 a.m. Open Committee Discussion

III. Study Design for Abbreviated Uniform Donor History

Questionnaire

A. Background and Introduction - Sharyn Orton, PhD, OBRR FDA (5’)

B. Study Design - Debra Kessler, RN, MS, Donor History Task Force & Director Regional Services, New York Blood Center (40’)

C. Experience with an Abbreviated Donor History Questionnaire - Mary Beth Bassett, BS Medical Technology (ASCP) and Microbiology, Vice President of Quality Assurance & Regulatory Affairs, Blood Systems Inc.(15’)

BLOOD PRODUCTS ADVISORY COMMITTEE

Friday, March 18, 2005 (page 3)

9:30 a.m. OPEN PUBLIC HEARING

10:00 a.m. Open Committee Discussion

D. FDA Perspective and Questions for the Committee

E. Committee Discussion and Recommendations

11:00 a.m. BREAK

11:30 a.m. Open Committee Discussion

IV. Review of Site Visit Report for the Laboratory of Molecular Virology, DETTD

A. Introduction and Background – Hira Nakhasi, PhD, Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR (5’)

B. Overview of Laboratory and Diagnosis and Pathogenesis of HIV variant: a progress report – Indira Hewlett Chief, Laboratory of Molecular Virology OBRR, FDA PhD (15’)

C. The Molecular Biology of HIV Infection of Primary Human Macrophages – Andrew Dayton, MD, PhD, Section Head, LMV, OBRR, FDA (10’)

D. Viral and Host Factors in the Pathogenesis of HIV-1 Infection: an overview – Subhash Dhawan, PhD, Section Head, LMV, OBRR, FDA (10’)

E. West Nile Virus: pathogenesis and diagnostic tools – Maria Rios, Ph.D., Senior Staff Fellow, LMV, OBRR, FDA PhD (10’)

12:30 a.m. LUNCH

1:30 p.m. Closed Committee Discussion

Committee Discussion and Recommendations

2:30 p.m. ADJOURNMENT