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

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Presentation transcript:

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

2/12 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

3/12 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

4/12 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

CBER Lab Senior Staff have dual responsibilities Regulatory/review Research

6/12 “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

7/12 Lot release protocols submitted

8/12 Reference distribution

9/12 References replaced in 2008 Extracts C11-cat E7-Timothy E4-cat hair E8-Dp Sera S6-Dpf

10/12 Planned replacements in 2009 Sheep serum S2b-cat S3-cat

11/12 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

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