Presentation is loading. Please wait.

Presentation is loading. Please wait.

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

Similar presentations


Presentation on theme: "December 14, 1999 1 FDA Advisory Committee for Pharmaceutical Science Nonclinical Studies Subcommittee Efficient advancement to clinical trials Jack A."— Presentation transcript:

1 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

2 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

3 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

4 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

5 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

6 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

7 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

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


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

Similar presentations


Ads by Google