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Advisory Committee Role in Facilitating FDA Scientific Collaboration Concept and Proposal for a Pharmaceutical Science Subcommittee Science Advisory Board to the NCTR June 11, 2001 James T. MacGregor, Ph.D., D.A.B.T. Deputy Director, NCTR Washington Operations C:advcomm<br>ctrsabjtm61101.

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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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