1 / 8

FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee

FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee . Efficient advancement to clinical trials Jack A. Reynolds, DVM Pfizer Central Research PhRMA Drug Safety Subsection. Subcommittee Objectives.

justin
Download Presentation

FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. FDA Advisory Committee for Pharmaceutical ScienceNonclinical Studies Subcommittee Efficient advancement to clinical trials Jack A. Reynolds, DVM Pfizer Central Research PhRMA Drug Safety Subsection

  2. Subcommittee Objectives • Position science of evolving technologies as basis for regulatory guidance • Facilitate drug development • Reduce development time • Retain and build confidence • Safety • Effectiveness Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences

  3. Evolution of Drug Discovery & Development • Genomics, HTS and combinatorial chemistry • Remarkable increase in number of potentially acceptable NCE’s for development • Chronic diseases • Extended development times • Larger efficacy trials • Competition for patients • Complex disease states • Industry consolidation • Increased disease target focus Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences

  4. Current Development Paradigms • Burgeoning number of precisely targeted potential therapies • Cannot build facilities fast enough • Cannot train & hire specialists fast enough • Cannot synthesize bulk material rapid enough • Cannot expand clinical trials broad enough • Take full advantage of our improved decision making/enhancing technologies • Must evolve new paradigms Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences

  5. New Paradigm Utility • Opportunities for efficiency • Time, quality & safety • Achieve proof of concept sooner • Keeping up with pace of discovery • Enhanced selection of clinical drug candidates • “Clinical Discovery” • Getting beneficial therapies to patients sooner • Demonstrate leadership in implementing commercial innovations Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences

  6. Stakeholders in Facilitating Early Entry into Clinical Trials • Appropriate preclinical toxicity studies to underpin low-dose, single-dose human study • Agreements on drug substance specifications and qualification • “minimally characterized drug substance” • Clarify and articulate potential value and benefits of an early clinical program • Understand the clinical opportunities that can be utilized or developed • Importance of communicating examples Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences

  7. Subcommittee ActivitiesNew Technologies Objectives Evaluate potential applications of new technology tools for application in nonclinical and early clinical trials Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences

  8. FDA Advisory Committee for Pharmaceutical ScienceNonclinical Studies Subcommittee Efficient advancement to clinical trials

More Related