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Enhancing FDA Scientific Collaboration: The Role of the Advisory Committee Subcommittee

This document outlines the proposal for a Pharmaceutical Science Subcommittee within the FDA Science Advisory Board, aimed at facilitating scientific collaboration. It discusses how to optimally leverage resources to capitalize on new scientific opportunities. The proposal details the goals of recommending focus areas, identifying experts, forming expert working groups, and steering collaborative projects. It also explores the history and functions of the Nonclinical Studies Subcommittee, which aims to improve nonclinical drug development and foster collaboration among FDA, industry, academia, and public research institutions.

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Enhancing FDA Scientific Collaboration: The Role of the Advisory Committee Subcommittee

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  1. Advisory Committee Role in Facilitating FDA Scientific CollaborationConcept and Proposal for a Pharmaceutical Science Subcommittee Science Advisory Board to the NCTRJune 11, 2001James T. MacGregor, Ph.D., D.A.B.T.Deputy Director, NCTR Washington OperationsC:\advcomm\nctrsab\jtm61101 c:mydocs\advcomm\ncss\ncsslssp.ppt

  2. How can FDA focus and leverage resources to capitalize on new scientific opportunities? Use Advisory (Sub)Committee Structure to: • Identify and recommend focus areas • Identify experts in focus areas; form expert working groups (EWGs) with nominations from: • Federal Register announcements (Public) • FDA and “Stakeholders” (Collaborators) • Professional Societies • Steer collaborative projects • Convene workshops, symposia • Facilitate reporting & recommendations

  3. History of the Nonclinical Studies Subcommittee, Advisory Committee for Pharmaceutical Science • CDDI Concept (1996-98) • Nonclinical Studies Subcommittee (NCSS), Advisory Committee for Pharmaceutical Science (ACPS) • 8/31/99 Meeting to develop concept • 9/99 ACPS endorsed concept • 12/00 Focus areas selected (accessible biomarkers & noninvasive imaging) • 3/00 Specific EWGs endorsed (cardiotoxicity & vasculitis) • 10/00 Nominations for EWGs received • 1/01 FDA selected EWG members • 5/3-4/2001 NCSS/EWG joint meeting, EWGs begin working

  4. Nonclinical Studies Subcommittee Functions: • To provide advice on improved scientific approaches to nonclinical drug development • To foster scientific collaboration among FDA, industry, academia, and the public

  5. Objectives 1. To recommend approaches and mechanisms to improve: • Nonclinical information for effective drug development • Predictivity of nonclinical tests for human outcomes • Linkage between nonclinical and clinical studies and 2. To facilitate collaborative approaches to advancing the scientific basis of drug development and regulation

  6. Current participants • FDA • CDER • CBER • NCTR • Industry • PhRMA • BIO • Academia • Public Research Institutions • NIH (NIEHS & NTP)

  7. Subcommittee Composition • John Doull, Univ. Kansas (Chair) • Jim MacGregor, NCTR (FDA Coordinator) • Dave Essayan, CBER (CBER Liaison) • Jack Reynolds, PhRMA (DruSafe Chair) • Joy Cavagnaro, BIO • Jack Dean, ACPS (Sanofi-Synthelabo) • Gloria Anderson, ACPS (Morris Brown Univ.) • Jay Goodman, Michigan State University • Raymond Tennant, NIH, NIEHS • Daniel Casciano, NCTR

  8. Future of the Nonclinical Studies Subcommittee? • Focus is on nonclinical safety assessment • NCTR has mandate and structure to lead in this area • FDA Subcommittee Liaison now at NCTR • ICCVAM process for Agency adoption of new methodologies now at NCTR • Should Subcommittee be affiliated with the NCTR SAB? • Is this a good model for implementation in other Advisory Committees?

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