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Overview Division of Viral Products Office of Vaccines Research and Review

Overview Division of Viral Products Office of Vaccines Research and Review. Laboratory of Hepatitis Viruses Laboratory of Vector-Borne Viral Diseases Site Visit November 6, 2001. Division of Viral Products Office of Vaccines Research and Review. Office of the Director

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Overview Division of Viral Products Office of Vaccines Research and Review

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  1. OverviewDivision of Viral ProductsOffice of Vaccines Research and Review Laboratory of Hepatitis Viruses Laboratory of Vector-Borne Viral Diseases Site Visit November 6, 2001

  2. Division of Viral ProductsOffice of Vaccines Research and Review • Office of the Director • Acting Director, Jerry Weir, PhD. • Acting Deputy Director, Loris McVittie, Ph.D. • Laboratories of DVP • Laboratory of Hepatitis Viruses • Laboratory of Vector-Borne Viral Diseases • Laboratory of Retroviruses • Laboratory of DNA Viruses • Laboratory of Pediatric and Respiratory Diseases • Laboratory of Immunoregulation • Laboratory of Method Development

  3. Division of Viral ProductsMission and Functions • Research Efforts • Viral pathogenesis • Vaccine development & evaluation • Viral vector evaluation • Vaccine safety and efficacy • Review Responsibilities • IND • BLA • Lot release • Post-marketing activities

  4. Division of Viral ProductsStaff and Budget • Current Full-time Staff of approximately 67 • Total staff of approximately 110 • Potential increases in FY02 of >10 full-time staff as a result of counter-bioterrorism initiative • FY02 Budget approximately $1.1M • Increase from a low of ~ $750-800K in FY99-00 • Supplemental funding from outside sources now greater than internal funding • Potential increases in FY02 due to counter-bioterrorism

  5. Division of Viral ProductsLaboratory of Hepatitis • Research Efforts • Immunobiology of Hepatitis C • Strategies for vaccine development • Regulatory Responsibilities • Regulation of hepatitis virus vaccines

  6. Division of Viral ProductsLaboratory of Vector-Borne Viral Diseases • Research Efforts • Mechanisms of replication and pathogenicity of vector-borne viruses • Strategies for vaccine development • Regulatory Responsibilities • Regulation of vaccines for vector-borne virus diseases, HepA, rabies

  7. Site Visit EvaluationNovember 6, 2001 • Committee reviewed the programs of LHV and LVVD • Evaluated individuals in the two laboratory programs • Assessed the future directions of the two laboratory programs

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