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November 1, 2013 Blood Products Advisory Committee Meeting Draft Agenda

FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
108th Meeting of the Blood Products Advisory Committee
FDA Fishers Lane Building
5630 Fishers Lane, Room 1066
Rockville, Maryland
November 1, 2013

DRAFT AGENDA

Friday, November 1, 2013

  
 8:00 a.m.Call to Order and Opening Remarks Introduction of CommitteeJ. Brooks Jackson, M.D. Chair, BPAC
 Conflict of Interest Statement

Bryan Emery, LCDR
Designated Federal Officer, BPAC

Topic I:  Interpretive Criteria for the MP Diagnostics HTLV Blot 2.4, manufactured by MP Biomedicals, LLC 
 8:05 a.m.IntroductionPradip Akolkar, Ph.D. OBRR, FDA (30’’)
 8:35 a.m.MP Biomedicals Presentations

Matthew Mak
Business Development Director

  

Liane Miller
Director of Clinical Research and Regulatory Affairs (60’’)

9:35 p.m.California Department of Public Health Laboratory HTLV Algorithm 
 9:55 a.m.Data from Blood Industry

Susan Stramer, Ph.D.
American Red Cross (20’’)

  

Michael Busch, M.D., Ph.D. 
Blood Systems Research Institute (20’’)

10:35 a.m.Questions for Speakers           (10’’)
10:45 a.m.Break(15’’)
11:00 a.m.FDA Summary and Questions for the CommitteePradip Akolkar, Ph.D. OBRR, FDA (15’’)
11:15 a.m.Open Public Hearing(30’’)
11:45 a.m.Open Committee Discussion Questions for the Committee(60’’)
12:45 p.m.Lunch(60’’)

Committee Updates

  
1:45 p.m.Summary of April 10-11, 2013 FDA Workshop on Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations*Paul Mied, Ph.D. OBRR, FDA (15’’)
2:00 p.m.Recent FDA Safety Communications: New boxed warnings for immune globulin products and hydroxyethyl starch solutionsHoward Chazin, M.D. OBRR, FDA (15’’)
Topic II:

Review of the Research Programs in the Laboratory of Biochemistry and Vascular Biology, Division of Hematology, OBRR* (TVM:  Dr. Cryer, Site Visit Chair)

 
2:15 p.m.Overview of CBER Research Programs          

Carolyn Wilson, Ph.D. CBER, FDA (15’’)

2:30 p.m.Overview of OBRR Research Programs         

CD Atreya, Ph.D. OBRR, FDA (10’)

 2:40 p.m.Overview of the Division of Hematology Research ProgramBasil Golding, M.D. OBRR, FDA (15’’)
2:55 p.m.Overview of the Laboratory of Biochemistry and  Vascular Biology

Abdu Alayash, Ph.D. OBRR, FDA (40’’)  

 Questions & Answers(10’’)
 3:45 p.m. Open Public Hearing(30’’)
 4:15 p.m.Closed Committee Discussion(30’’)
 4:45 p.m.Adjournment