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Strategic Critical Path Research

Strategic Critical Path Research. Keith O. Webber, Ph.D. Acting Director, OBP Office of Pharmaceutical Science ACPS Meeting October 19 th , 2004. Drug Development Path. Discovery Candidate selection Pre-Clinical Studies Clinical Studies Commercialization

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Strategic Critical Path Research

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  1. Strategic Critical Path Research Keith O. Webber, Ph.D. Acting Director, OBP Office of Pharmaceutical Science ACPS Meeting October 19th, 2004

  2. Drug Development Path • Discovery • Candidate selection • Pre-Clinical Studies • Clinical Studies • Commercialization • Post-Approval Manufacturing Optimization • New Indications

  3. Empirical vs. Guided Development Drug Development must be a learning process in order to make intelligent decisions regarding: • Candidate selection • Dosage form and formulation • Clinical indication • Clinical endpoints • Adverse event monitoring • Manufacturing methods

  4. Empirical vs. Guided Development Goal: To establish a knowledge base and the tools necessary to predict the probable success of given products and manufacturing methods and to foster the development of products with a high likelihood of success.

  5. Office of Pharmaceutical Science • Informatics and Computational Safety Analysis Staff • Office of New Drug Chemistry • Office of Generic Drugs • Office of Testing and Research • Office of Biotechnology Products

  6. OPS Critical Path Research • Candidate selection • Dosage form development and evaluation • Toxicity predictions • Bioavailability and bioequivalence prediction • Metabolism prediction • Immunogenicity • Biomarker validity • Mechanism of action • Pharmacogenomics • Manufacturing methodologies

  7. Critical Path Research Strategies Coordinate cooperative research activities: • Predictive modeling based on data from: • Regulatory submissions • FDA laboratory research • Laboratory research from outside collaborators • Published literature

  8. Critical Path Research Strategies Coordinate cooperative research activities: • Laboratory research • OTR • Div. of Applied Pharmacology Research • Div. of Product Quality Research • Div. of Pharmaceutical Analysis • OBP • Div. of Monoclonal Antibodies • Div. of Therapeutic Products • Other FDA Centers • Outside collaborations (Academia, Industry, other Gov’t.)

  9. Utilization of Information • Disseminate to manufacturers via: • Public forums • Guidance documents • Regulatory meetings (pre-IND, pre-NDA, pre-BLA) • Disseminate to reviewers: • Training programs • Mentoring • To enhance the application review process

  10. Questions • Are we focusing on the appropriate Critical Path topics? • Are there others that we should be addressing through our research programs? • How should we identify Critical Path issues in the future and how should we prioritize them?

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