DRAFT AGENDA 2/23/2005

 

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