December 14, 1999 1 FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee Efficient advancement to clinical trials Jack A.

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December 14, 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

December 14, 1999 Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences J. A. Reynolds 2 Subcommittee Objectives ä Position science of evolving technologies as basis for regulatory guidance Ù Facilitate drug development Ù Reduce development time Ù Retain and build confidence ä Safety ä Effectiveness

December 14, 1999 Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences J. A. Reynolds 3 Evolution of Drug Discovery & Development ä Genomics, HTS and combinatorial chemistry ä Remarkable increase in number of potentially acceptable NCE’s for development ä Chronic diseases ä Extended development times ä Larger efficacy trials ä Competition for patients ä Complex disease states Ù Industry consolidation ä Increased disease target focus

December 14, 1999 Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences J. A. Reynolds 4 Current Development Paradigms ä Burgeoning number of precisely targeted potential therapies Ù Cannot build facilities fast enough Ù Cannot train & hire specialists fast enough Ù Cannot synthesize bulk material rapid enough Ù Cannot expand clinical trials broad enough ä Take full advantage of our improved decision making/enhancing technologies ä Must evolve new paradigms

December 14, 1999 Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences J. A. Reynolds 5 New Paradigm Utility ä Opportunities for efficiency Ù Time, quality & safety ä Achieve proof of concept sooner ä Keeping up with pace of discovery ä Enhanced selection of clinical drug candidates Ù “Clinical Discovery” ä Getting beneficial therapies to patients sooner ä Demonstrate leadership in implementing commercial innovations

December 14, 1999 Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences J. A. Reynolds 6 Stakeholders in Facilitating Early Entry into Clinical Trials ä Appropriate preclinical toxicity studies to underpin low-dose, single-dose human study ä Agreements on drug substance specifications and qualification Ù “minimally characterized drug substance” ä Clarify and articulate potential value and benefits of an early clinical program Ù Understand the clinical opportunities that can be utilized or developed ä Importance of communicating examples

December 14, 1999 Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Sciences J. A. Reynolds 7 New Technologies Subcommittee Activities New Technologies Objectives Evaluate potential applications of new technology tools for application in nonclinical and early clinical trials

December 14, FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee Efficient advancement to clinical trials