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Office of Biotechnology Products

Office of Biotechnology Products. July 26, 2007 Advisory Committee Meeting. RESEARCH. REVIEW & REGULATION. Elizabeth (Wendy) Shores Deputy Director, OBP. Center for Drug Evaluation and Research Office of Pharmaceutical Science OBP. OBP: What We Do. Regulatory Review

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Office of Biotechnology Products

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  1. Office of Biotechnology Products July 26, 2007 Advisory Committee Meeting RESEARCH REVIEW & REGULATION Elizabeth (Wendy) Shores Deputy Director, OBP

  2. Center for Drug Evaluation and ResearchOffice of Pharmaceutical ScienceOBP

  3. OBP: What We Do Regulatory Review Scrutinize Submissions from Industry IND, IDE, 5(10)k BLA, NDA (~90 approved), PMA Supplements Inspections (as product reviewer) Guidance Documents Meetings Consults (area of expertise) Bench Research High Quality Mission Relevant

  4. Factors For Biotechnology Products • Variety of Cell Substrates Microbiology (virus, prion), Host Cell Molecules • Heterogeneity Glycosylation, Oxidation, PEGylation • Higher Order Structure : Structure/Function Receptor Interaction and Signaling • Manufacturability Scale-Up, Solubility, Aggregation • Mechanism of Action: Often Unclear Design of Bioactivity Assays • Immunogenicity: Safety and Efficacy Issues • Comparability: Products Rarely Static • Counter Bioterrorism: Animal Rule, Stockpiles

  5. V region CDRs Asn 297 • FcRn • MBL • MR Immunity • Generation and Control of Antibody Responses to Proteins [Ed Max and Ralph Bernstein] • FcgRI,II,III • C1q Jefferis et al. Immunology Letters (2002) 82; 57-65. & PDB 2IG2, 1FC1

  6. Microbiology: Infection • Cytokines and Chemokines in HIV [Michael Norcross and Jinhai Wang] • Characterization of Anthrax Lethal Toxin and Role in Disease [David Frucht]

  7. Innate Immunity & Soluble Mediators • Toll Like Receptor agonists and innate immunity [Serge Beaucage]

  8. Industrialization & Assay Development Oligo Microarray • Improved ODN Synthesis for Diagnostics and Therapeutics [Serge Beaucage]

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