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Richard M. Lewis, Ph.D. Deputy Director, Office of Blood Research and Review

Richard M. Lewis, Ph.D. Deputy Director, Office of Blood Research and Review Center for Biologics Evaluation and Research. OBRR Strategic Plan to Counter Terrorism. Actions to Protect the Blood Supply Actions to Assure Continued Supply Actions to Treat Affected Individuals

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Richard M. Lewis, Ph.D. Deputy Director, Office of Blood Research and Review

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  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

  9. OBRR Strategic Plan to Counter Terrorism • Actions to Assure Continued Supply • Develop Methods to Assess Blood NeedsAssociated 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

  11. 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.

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