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Laboratory of Immunobiochemistry

Laboratory of Immunobiochemistry. Ronald L. Rabin, MD Allergenic Products Advisory Committee 18 March 2009. Laboratory of Immunobiochemistry. Ronald L. Rabin, MD - Lab Chief Jay E. Slater, MD – Supervisory Medical Officer Nicolette deVore, PhD – Staff Fellow

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Laboratory of Immunobiochemistry

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  1. Laboratory of Immunobiochemistry Ronald L. Rabin, MD Allergenic Products Advisory Committee 18 March 2009

  2. Laboratory of Immunobiochemistry • Ronald L. Rabin, MD - Lab Chief • Jay E. Slater, MD – Supervisory Medical Officer • Nicolette deVore, PhD – Staff Fellow • Sandra Menzies, MS, Consumer Safety Officer • Katya Dobrovolskaia – Biologist • Mona Febus – Microbiologist • Cherry Valerio – Biologist • Aaron Chen – Biologist • Viraj Mane, PhD • Zeng Zhao, MD • Philippa Hillyer, PhD • Nataly Raviv • Lynnsie Schramm

  3. Division of Bacterial, Parasitic, and Allergenic Products • Milan Blake, PhD, Director • Jay E. Slater, MD, Deputy Director • 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 • CDR Colleen Sweeney, MS, Regulatory Health Project Coordinator • LCDR Jason Humbert, RN, Regulatory Project Manager • CDR Joseph Temenak, PhD, Regulatory Review Officer • LCDR Michael Smith, PhD, Regulatory Review Officer • LT Elizabeth Valenti, Regulatory Review Officer

  5. CBER Lab Senior Staff have dual responsibilities Regulatory/review Research

  6. “Routine” regulatory activities Lot release • 2008: 390 Protocols Reviewed Reference distribution • 2008: 2480 vials in 132 shipments sent to manufacturers (through 10/07/08) Reference maintenance • semiannual checks • replacement

  7. Lot release protocols submitted

  8. Reference distribution

  9. References replaced in 2008 Extracts • C11-cat • E7-Timothy • E4-cat hair • E8-Dp Sera • S6-Dpf

  10. Planned replacements in 2009 • Sheep serum • S2b-cat • S3-cat

  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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