Richard M. Lewis, Ph.D.

1

• Richard M. Lewis, Ph.D.
• Deputy Director,
• Office of Blood Research and Review
• Center for Biologics
• Evaluation and Research

2
OBRR Strategic Plan to Counter Terrorism

• Actions to Protect the Blood Supply
• Actions to Assure Continued Supply
• Actions to Treat Affected Individuals
• Outreach Activities

3
OBRR Strategic Plan to Counter Terrorism

• Each of the OBRR divisions has been assigned the
  lead on one of these initiatives.
• Division CT efforts reflect these initiatives.

4
OBRR Strategic Plan to Counter Terrorism

• Actions to Protect the Blood Supply
• Research
• Policy and Regulation

5
OBRR Strategic Plan to Counter Terrorism

• Actions to Protect the Blood Supply
• - Research
• In house research has multiple objectives
• Develop new understanding and methods
• Develop expertise for evaluation of industry
  submitted methods
• Transfer technology for industry development
• Lot release testing

6
OBRR Strategic Plan to Counter Terrorism

• Actions to Protect the Blood Supply
• - Research
• Detection and donor screening
• Microarray technology
• Nucleic Acid Testing
• Pathogen Removal/Inactivation
• Blood and Blood products
• Plasma Derivatives
• Filtration methods
• Chemical inativation

7
OBRR Strategic Plan to Counter Terrorism

• Actions to Protect the Blood Supply
• Policy and regulation
• Donor screening/suitability
• Agent exposure
• Emergency release of blood components
• Product Release.
• Exemptions

8
OBRR Strategic Plan to Counter Terrorism

• Actions to Assure Continued Supply
• Development of Emergency Response Procedures
• Identify possible scenarios
• Type
• Biological
• Chemical
• Nuclear
• Extent

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OBRR Strategic Plan to Counter Terrorism

• Actions to Assure Continued Supply
• Develop Methods to Assess Blood Needs Associated
  with an Event
• Immediate
• Short term
• Long term

10
OBRR Strategic Plan to Counter Terrorism

• Actions to Assure Continued Supply
• Determine the need for Strategic Reserves
• Blood
• Test kits
• Supplies

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OBRR Strategic Plan to Counter Terrorism

• Actions to Treat Affected Individuals.
• Develop consistent advice/ reviewer guidance for
  sponsors of investigational products.
• Evaluate prioritization schemes for product use.
• Evaluate the safety of investigational products
  in emergency situations.

12
OBRR Strategic Plan to Counter Terrorism

• Actions to Treat Affected Individuals
• Identify possible therapeutic products.
• Immune globulins
• Botulism
• Anthrax
• Vaccinia

13
OBRR Strategic Plan to Counter Terrorism

• Actions to Treat Affected Individuals.
• Evaluate inactivation methods for manufactured
  products.
• Assure rapid testing and release of licensed
  products.
• Assist in the evaluation of current supplies of
  possible useful products.

14
OBRR Strategic Plan to Counter Terrorism

• Outreach activities.
• Interact with blood organizations to develop
  emergency procedures.
• AABB Taskforce.
• Interact with reagent and supply manufacturers.
• Interact with other government.
• Inter office.
• Inter Agency.
• Address transportation following disaster.
• Reagents.
• Samples.