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Critical Path Initiative Workshop: OBRR Summary Paul A. Mied, Ph.D.

Critical Path Initiative Workshop: OBRR Summary Paul A. Mied, Ph.D. Blood Products Advisory Committee, 82 nd Meeting March 17, 2005. The Critical Path Challenge for Blood Products. Enhance Product Safety, Purity and Potency. Avoid Product Shortages & Major Increased Costs. and.

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Critical Path Initiative Workshop: OBRR Summary Paul A. Mied, Ph.D.

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  1. Critical Path Initiative Workshop: OBRR Summary Paul A. Mied, Ph.D. Blood Products Advisory Committee, 82nd Meeting March 17, 2005

  2. The Critical Path Challenge for Blood Products Enhance Product Safety, Purity and Potency Avoid Product Shortages & Major Increased Costs and Critical Path opportunities exist that could improve blood product safety, efficacy and availability while minimizing disruptions to the blood system

  3. Critical Path Initiative Public Workshop: October 7, 2004 “From Concept to Consumer: CBER Working with Stakeholders on Scientific Opportunities for Facilitating the Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies”

  4. Critical Path Initiative Blood and Blood Products Panel Session: Opportunities for FDA and Industry COMMUNICATION • Increase communication with Industry; issue Guidance Documents faster; • Establish a mandate; • Develop consistency with other agencies in regulatory guidelines.

  5. Critical Path Initiative Blood and Blood Products Panel Session: Opportunities for FDA and Industry RESEARCH & DEVELOPMENT • Set standards in advance of product development; • Help with R&D in specific areas; • Help to reduce product development time.

  6. Critical Path Initiative Blood and Blood Products Panel Session: Opportunities for FDA and Industry CLINICAL DEVELOPMENT Set objective, firm approval requirements; Provide more guidance on structure of clinical trials; Make better use of alternatives to clinical trials.

  7. Critical Path Initiative Blood and Blood Products Panel Session: Opportunities for FDA and Industry FDA APPLICATION REVIEW • Accelerate product reviews; • Facilitate introduction of new donor screening tests; • Use alternative measures to validate product or process changes.

  8. Critical Path: Example of Success Donor Screening for West Nile Virus RNA • Issued an alert, call to industry, guidance; • Sponsored a public workshop; • Set standards for development of minipool NAT; • Maintained a dialog with kit manufacturers during development;

  9. Critical Path: Example of Success (Cont.) Donor Screening for West Nile Virus RNA • Approved large-scale studies under IND; • Monitoring epidemiological data and the outcome of nationwide testing; • Developing reference materials and standards; • Animal inoculation studies are ongoing.

  10. Critical Path: Examples of Opportunities • Evaluation of candidate diagnostic and donor screening tests for transmissible spongiform encephalopathies (TSEs) • Development and validation of multiplex NAT to detect bacteria and parasites in blood • Nanotechnology: Novel technology for blood screening and diagnostic use • Development of a valid animal model to predict immunogenecity of factor VIII products • Development of standards for plasma-derived products (e.g., Alpha 1 PI)

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