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U.S. Department of Health and Human Services

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December 14-15, 2010: Blood Products Advisory Committee Meeting Draft Agenda

99th Meeting, December 14-15, 2010

The Hilton Washington DC North/Gaithersburg
620 Perry Parkway
Gaithersburg, MD 20877

Tuesday, December 14, 2010

8:00 a.m.Opening Remarks, Blaine Hollinger, M.D., Chair
Statement of Conflicts of Interest, Announcements
8:10 a.m.

Topic I: Risk of Dengue Virus Infection in Blood Donors

  1. Introduction and Background of Dengue Virus Infection, Deborah Taylor, Ph.D., DETTD, OBRR, FDA (10’)
  2. Dengue Virus Epidemiology in the U.S. and its Territories, Kay Tomashek, M.D., CDC (15’)
  3. Risk Model to Define Rate of Infectious Units During Dengue Virus Outbreaks: Endemic vs. Non-Endemic Areas, Lyle Petersen, M.D., M.P.H., CDC (25’)
  4. Update on Dengue Virus Panel Development, Maria Rios, Ph.D., DETTD, OBRR, FDA (15’)
  5. Overview of Data on Blood Donor Testing and Transfusion Transmission of Dengue Virus, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15’)
  6. Experience with Dengue Virus Antigen Tests, Harold Margolis, CDC (15’)
  7. Recent Experience in Testing Blood Donors in Puerto Rico and Key West, FL, Susan Stramer, Ph.D., American Red Cross (15’)
10:00 a.m.Break
10:15 a.m.Open Public Hearing
11:00 a.m.

Open Committee Discussion
Questions for the Committee

12:00 p.m.Lunch
1:00 p.m.

Topic II: MLV-related Human Retroviruses and Blood Safety

  1. Introduction and Background, Indira Hewlett, Ph.D., DETTD, OBRR, FDA (10’)
  2. Summary of Current Research on MLV-related Human Retroviruses and Disease Association, Jonathan Stoye, Ph.D., NIMR, UK ( 25’)
  3. Recent Studies of Epidemiology of MLV-related Human Retroviruses:
    1. U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA (15’)
    2. U.S. Study. Maureen Hanson, Ph.D., Cornell University (15’)
    3. UK Study, Judy Mikovits, Ph.D. Whitmore Peterson Institute (15’)
  4. Animal Studies: Potential Transfusion Transmission of MLV-related Human Retroviruses, Francois Villinger, Emory University (20’)
  5. Update of Blood XMRV Working Group Activities, Graham Simmons, Ph.D., BSRI (15’)
  6. Prospective and Retrospective U.S. Donor Surveillance Studies, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15’)
  7. Assay Development Efforts on MLV-related Human Retroviruses, Rachel Bagni, Ph.D., National Cancer Institute (20’)
3:30 p.m.Break
3:45 p.m.Open Public Hearing
4:30 p.m.

Open Committee Discussion
Questions for the Committee

5:30 p.m.Adjournment

Wednesday, December 15, 2010

8:00 a.m.

Opening Remarks, Blaine Hollinger, M.D., Chair
Statement of Conflicts of Interest, Announcements

8:10 a.m.

Committee Updates

  • Update from the HHS Advisory Committee on Blood Safety and Availability and Summary of November 4-5, 2010 Meeting, CDR Richard Henry, Deputy Executive Secretary for the Advisory Committee on Blood Safety and Availability(15’)
  • Summary of December 9-10, 2010 Workshop “Product Development Program for Interventions in Patients with Severe Bleeding Due to Trauma or Other Causes,” Jaro Vostal, M.D., Ph.D., DH, OBRR, FDA (15’)
  • FDA Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion, Robert Duncan, Ph.D., DETTD, OBRR, FDA (10’)
  • Update on the Study to Further Define the Incidence of T. cruzi Infection in the U.S. Blood Donor Population, Susan Stramer, Ph.D., American Red Cross (10’)
9:00 a.m.Break
9:15 a.m.

Topic III: Review of the Research Programs in the Laboratories of Hemostasis and Plasma Derivatives, Division of Hematology, OBRR

  1. Overview of CBER Research, Carolyn Wilson, Ph.D., CBER, FDA (15’)
  2. Overview of OBRR Research, C.D. Atreya, Ph.D., OBRR, FDA (15’)
  3. Overview of the Division of Hematology Research Program, Basil Golding, M.D., DH, OBRR, FDA (15’)
  4. Overview of the Laboratory of Hemostasis, Timothy Lee, Ph.D., DH, OBRR, FDA (30’)
    Questions & Answers (15’)
  5. Overview of the Laboratory of Plasma Derivatives, Dorothy Scott, M.D., DH, OBRR (30')
    Questions and Answers (15')
11:30 a.m.Open Public Hearing
12:00 p.m.Closed Committee Discussion
12:45 p.m.Adjournment