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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