Overview of the Division of Viral Products VRBPAC Presentation of the Site Visit Report for the Laboratories of Retrovirus Research, Immunoregulation,

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Overview of the Division of Viral Products VRBPAC Presentation of the Site Visit Report for the Laboratories of Retrovirus Research, Immunoregulation, and Respiratory Viruses - June 11/12, 2009 Jerry P Weir, Ph.D. Director, DVP 12/15/2009

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

Division of Viral Products Mission 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

Division of Viral Products Major 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

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.)

Division of Viral Products Staff – Total FTEs CT FLU

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

Division of Viral Products Budget Internal External Flu

Site Visit Evaluation June 11/12, 2009 Program review of 3 laboratories in DVP – LRR, LIR, and LRV –Assessment of progress on projects pursued since previous site visit Individual review –Consideration for promotion and tenure Evaluation of future directions for each investigator