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Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA)

Forty-Second Meeting, December 6 & 7, 2012 DRAFT Agenda
NIH Conference Room 5635 Fisher’s Lane, Terrace Level Rockville, MD
Thursday, December 6, 2012
07:30 (30 min)	Doors Open	Open to the Public
08:00 (10 min)	Call to Order	Chairman
08:10 (5 min)	Roll Call	James Berger Executive Secretary HHS, Division of Blood & Tissue Safety
Committee Updates
08:15 (10 min)	HRSA Update Advisory Committee on Transplantation Update	Mark Barr, MD Chair, Advisory Committee on Organ Transplantation, HHS / HRSA
08:25 (10 min)	FDA Update Platelet Product Contamination	Salim Haddad, MD HHS / FDA / CBER / OBRR
08:35 (10 min)	FDA Update Rapid Donor Data Collection for Response to Bioterrorism, Emerging, and Pandemic Agents Threatening Blood Safety	Lou M Gallagher, Ph.D. Senior Risk Assessment Epidemiologist HHS / FDA / CBER / OBE
08:45 (10 min)	FDA Update September BPAC (Hepatitis E Virus and Transfusion Safety)	Robin Biswas, MD Deputy Division Director for Medical Issues & Policy HHS / FDA / CBER / OBRR/DETTTD
08:55 (10 min)	Public Health Service Guidelines Update Draft 2011 Public Health Service (PHS) Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation	Matthew Kuehnert, MD Director, Office of Blood, Organ, & Other Tissues Safety HHS / CDC / OID / NCEZID
Committee Business
09:05 (15 min)	New Members Welcome and Oath	Howard K. Koh, MD, MPH HHS Assistant Secretary for Health
09:20 (20 min)	Assistant Secretary for Health’s Charge to the Committee	Howard K. Koh, MD, MPH HHS Assistant Secretary for Health
09:40	Break (10 min)
Committee Topic: Innovations in Blood & Tissue Products and Emergency Response
Session 1: Considerations for Blood Products Emergency Plans and Use
09:50 (30 min)	Overview of Blood Products for Emergency Response	Harvey Klein, MD Chief, Dept of Transfusion Medicine (DTM) Clinical Center, National Institutes of Health (NIH)
10:20 (15 min)	Overview of Joint BARDA/NIH Blood Products and Cellular Therapies: A Symposium on Emergency Preparedness	Brian Tse, Ph.D. Senior Analyst Biomedical Advanced Research & Development Authority (HHS/BARDA)
10:35 (15 min)	Blood Products – Regulatory Considerations	Ginette Michaud, MD Deputy Director, Office of Blood Regulation & Review U.S. Food & Drug Administration
10:50 (15 min)	Use of Blood Products in an Emergency	Cynthia Kelley, MS Senior Advisor for Counterterrorism Center for Biologics Evaluation & Review U.S. Food & Drug Administration
11:05 (20 min)	AABB Task Force Emergency Plans & Experiences	Karen Shoos, JD CEO, AABB
11:25 (20 min)	America’s Blood Center Emergency Plans & Infrastructure Considerations	Lou Katz, MD Chief Medical Officer America’s Blood Centers (ABC)
11:45 (20 min)	American Red Cross Emergency Plans & Infrastructure Considerations	Richard Benjamin, MD, Ph.D. Chief Medical Officer American Red Cross (ARC)
12:05	Plasma Processing: Challenges for Emergency Preparedness	Toby L. Simon, MD Senior Medical Director, Plasma & Plasma Safety, Global Research and Development/CSL Plasma CSL Behring
12:25 (20 min)	Panel Questions for Day 1 Morning Session	All Morning Speakers (excluding “Updates”)
12:45	Lunch Break (45 min)
Session 2a: System Experiences / Scenario Based Considerations
1:30 (20 min)	New York Blood Center – Emergency Plans & Experiences	Beth Shaz, MD Chief Medical Officer New York Blood Center (NYBC)
1:50 (20 min)	Scenario Case – Radiological/Nuclear Incident	C. Norm Coleman, MD Senior Medical Advisor HHS, Assistant Secretary for Preparedness & Response (HHS/ASPR), OPEO
Session 2b: Platelet Considerations and Blood Product Storage
2:10 (25 min)	Storage, Handling, and Cold Storage	Sherrill Slichter, MD Director, Platelet Transfusion Research Puget Sound Blood Center Professor of Medicine, University of Washington
2:35 (25 min)	Current Status and Future Potential of a Freeze-Dried, Platelet-derived, Hemostatic Agent	G. Michael Fitzpatrick, Ph.D. President, Director of Clinical Research & Development, Cellphire, Inc.
3:00	Break (5 min)
3:05 (25 min)	Innovations to Improve Storage	John Hess, MD Assoc. Director, Univ. of Maryland Medical Center Blood Bank, Professor, Pathology, Univ. of Maryland School of Medicine
3:30 (20 min)	Panel Questions for Day 1 Afternoon Session	All Afternoon Speakers
3:50 (10 min)	Committee Overview of Committee Questions	Session Speakers/Committee
4:00	Adjournment	Committee Chair

Friday December 7, 2012
07:30 (30 min)	Doors Open	Open to the Public
08:00 (5 min)	Call to Order	Committee Chair
08:05 (10 min)	Roll Call	James Berger Executive Secretary
Session 3a: Red Blood Cell & Plasma Innovations
08:15 (15 min)	Blood Pharming Innovations	Lt. Col. Dan Wattendorf, MD Program Manager, DARPA Defense Sciences Office Stewart Abbot, PhD, MSc Executive Director, Stem Cell Research Celgene Therapeutics
08:30 (20 min)	Metabolic changes in stored RBC units	John D. Roback, MD, Ph.D. Associate Professor of Pathology and Laboratory Medicine Director, Center for Transfusion and Cellular Therapies, Emory University School of Medicine
08:50 (20 min)	Innovations: Plasma	Larry Corash, MD Senior Vice President, Chief Medical Officer, Chief Scientific Officer Cerus Corporation
09:10 (20 min)	Blood Bags and Apheresis Supplies	Mark Holmes Vice President, Government & Regulatory Terumo BCT
09:30 (20 min)	Commercial Reagents used in Blood Banking	Ben Marchlewicz, Ph.D. Director, Blood Screening Technical Operations Abbott Diagnostics
09:50	Break (10 min)
Session 3b: Pathogen Reduction, Reagents, and Dept. of Defense Considerations
10:00 (20 min)	Pathogen Reduction	Larry Corash, MD Senior Vice President, Chief Medical Officer, Chief Scientific Officer Cerus Corporation
10:20 (20 min)	Considering the Prospects for Pathogen Reduction of Blood in Emergency Situations	Stephen Wagner, Ph.D. Head, Blood Components Department Holland Laboratory American Red Cross
10:40 (20 min)	Assuring a Safe, Effective and Adequate Supply of Blood Products in Disaster Situations	Ray Goodrich, Ph.D. Vice President, Scientific & Clinical Affairs Chief Science Officer, Blood Bank Technologies Terumo BCT
11:00 (20 min)	U.S. Department of Defense Program: Challenges & Opportunities	Col. Richard McBride Director, Armed Services Blood Program
11:20	Break (10 min)
11:30 (20 min)	Panel Questions for Day 2 Morning Session	All Morning Speakers
11:55	Lunch (50 Minutes)
Session 4: Tissue Product Emergency Use Considerations
12:45 (20 Min)	Tissue Product Considerations	Scott A. Brubaker, CTBS Chief Policy Officer American Association of Tissue Banks
1:05 (20 Min)	Eye Bank Association of America (EBAA)	Patricia Dahl CEO, Eye-Bank for Sight Restoration (EBSR)
1:25 (15 min)	Open Public Hearing (all sessions/considerations)
1:40 (2hr 20 min)	Committee Discussion for Committee Questions & Recommendations	Session Speakers/Committee
4:00	Adjournment	Committee Chair