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Overview of the Division of Viral Products

Overview of the Division of Viral Products. Site Visit for the Laboratory of Method Development July 26, 2011 Jerry P Weir, Ph.D. Director, DVP. Jerry P. Weir, Ph.D., Director Robin Levis, Ph.D.,Deputy. Laboratory of Retroviruses Hana Golding, Ph.D, Chief.

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Overview of the Division of Viral Products

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  1. Overview of the Division of Viral Products Site Visit for the Laboratory of Method Development July 26, 2011 Jerry P Weir, Ph.D. Director, DVP

  2. Jerry P. Weir, Ph.D., Director Robin Levis, Ph.D.,Deputy Laboratory of Retroviruses Hana Golding, Ph.D, Chief Division of Viral ProductsOffice of Vaccines Research and Review Laboratory of Hepatitis Viruses Steve Feinstone, M.D., Chief Laboratory of Vector-Borne Viral Diseases Lewis Markoff, M.D., Chief Laboratory of DNA Viruses Keith Peden, Ph.D., Chief Laboratory of Respiratory Viral Diseases Jerry Weir, Ph.D., Acting Chief Laboratory of Method Development Konstantin Chumakov, Ph.D., Chief Laboratory of Immunoregulation Ira Berkower, M.D., Chief

  3. Division of Viral ProductsMission and Functions • Regulate viral vaccines and related biological products, ensuring their safety and efficacy for human use • Facilitate the development, evaluation, and licensure of new viral vaccines that positively impact the public health

  4. Division of Viral ProductsMajor Responsibilities • Investigational New Drug (IND) and Biologics License Application (BLA) review, and other pre-marketing activities (e.g., pre-IND) • BLA supplement review, lot release review, and other post-marketing activities (e.g., Biological product deviations) • Manufacturer inspections (pre- and post-licensure) • Consultation with other public health agencies (e.g., WHO, CDC, NIBSC) • Conduct research related to the development, manufacturing, evaluation, and testing of viral vaccines

  5. The Role of Research in the Division of Viral Products • Research and laboratory activities complement the regulatory mission • Address issues related to regulated viral vaccines • Anticipate and address issues related to the development and evaluation of new viral vaccine products • General issues applicable to many products or product classes (e.g., cell substrate issues, improved test methods, etc.) • Specific product issues (correlates of protection necessary for efficacy evaluation, animal models necessary for animal rule implementation, etc.)

  6. Division of Viral ProductsStaff (FTEs) - by Laboratory • DVP IOD – 6 • Lab Respiratory Viruses – 15 • Hepatitis Viruses – 6 • Retrovirus Research – 13 • DNA Viruses – 12 • Vector-borne Viral Diseases – 4 • Method Development – 12 • Immunoregulation – 5

  7. Site Visit Evaluation • Program review • Assessment of progress on projects pursued since previous site visit • Individual review • Consideration for promotion and tenure • Evaluation of future directions

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