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Laboratory of Immunobiochemistry

Laboratory of Immunobiochemistry. Ronald L. Rabin, MD Allergenic Products Advisory Committee 12 May 2011. Laboratory of Immunobiochemistry. Ronald L. Rabin, MD - Lab Chief Jay E. Slater, MD – Supervisory Medical Officer Ashraf El Fiky, MD, PhD – Visiting Associate

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Laboratory of Immunobiochemistry

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  1. Laboratory of Immunobiochemistry Ronald L. Rabin, MD Allergenic Products Advisory Committee 12 May 2011

  2. Laboratory of Immunobiochemistry • Ronald L. Rabin, MD - Lab Chief • Jay E. Slater, MD – Supervisory Medical Officer • Ashraf El Fiky, MD, PhD – Visiting Associate • Tarunah Khurana, PhD – Visiting Associate • Philippa Hillyer, PhD – Visiting Associate (July 2011) • Sandra Menzies, MS, Consumer Safety Officer • Katya Dobrovolskaia – Biologist • Mona Febus – Microbiologist • Cherry Valerio – Biologist • Aaron Chen – Biologist • Giulia Fabozzi, PhD • Lynnsie Schramm • Kevin Kirschman • Roger Perreault • Danielle Dougherty • Maggie Collison • Susan Huynh

  3. Division of Bacterial, Parasitic, and Allergenic Products • Jay E. Slater, MD Director • Drusilla Burns, PhD Deputy Director (Acting) • Jennifer Bridgewater, MPH Associate Director for Regulatory Policy Tina Roecklein, MS Regulatory Coordinator

  4. Division of Vaccines and Related Products Applications (DVRPA) • Wellington Sun, MD Director • Paul Richman, PhD Chief, Regulatory Review Branch 1 • CAPT Julienne Vaillancourt, RPh, MPH Team Leader • CDR Colleen Sweeney, MS Regulatory Health Project Coordinator • Nicolette DeVore, PhD Review Scientist • LT Elizabeth Valenti, MPH Regulatory Review Officer

  5. LIB Staff have dual responsibilities Regulatory/review Research

  6. “Routine” regulatory activities Lot release • 2010: 408 Protocols Reviewed Reference distribution • 2010: 4644 vials in 110 shipments sent to manufacturers Reference maintenance • Semi-annual checks • Reference replacement

  7. Lot release protocols submitted

  8. Reference distribution

  9. References replaced in 2010-2011 Extracts • E10-Dp • E5-cat pelt • C14-Ras Sera • S6-Dpf • S2-Cat • S3-Ber

  10. Planned replacements in 2011 • Human serum • S7-Dpf • S5-Grass

  11. How do we manage the inventory? • Semi-annual reference checks • Estimate replacement dates based on expiry and consumption • Monitoring manufacturer requests • Limited distribution for research purposes

  12. Review Responsibilities Investigational New Drug (IND) • Sponsor originated (goal is licensure/market) • Investigator originated (use of extract for purpose other than licensed) • nasal or bronchial challenges • mechanistic studies Biological License Applications (BLA) • Initial License • Supplements • Annual Reports Consultations for other centers • CDER • CDRH

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