1. Nonclinical Studies Subcommittee John Doull, M.D., Ph.D., Chair Advisory Committee for Pharmaceutical Science November 15, 2000

2. Nonclinical Studies Subcommittee Functions:  To provide advice on improved scientific approaches to nonclinical drug development and regulation  A means to foster collaboration among FDA, industry, academia, and the public

3. Objectives 1. To recommend approaches and mechanisms to improve:  NC information for effective drug development  predictivity of NC tests for human outcomes  linkage between NC and clinical studies and 2. To facilitate collaborative approaches to advancing the science and regulation of drug development

4. Collaborators  FDA  CDER  CBER  NCTR  Industry  PhRMA  BIO  Academia  Public Institutions (NIH)

5. Subcommittee Membership  John Doull, Univ. Kansas (Chair)  James MacGregor, CDER  David Essayan, CBER  Daniel Casciano, NCTR  Jack Reynolds, PhRMA  Joy Cavagnaro  Raymond Tennant, NIH  Jay Goodman, Michigan State University  Jack Dean, Sanofi-Synthelabo  Gloria Anderson, ACPS (Morris Brown Univ.)

6. FY2000 Meetings  12/14/99 Meeting--Identified General Focus  Biomarkers of Toxicity  Noninvasive technologies to link nonclinical and clinical studies  3/9/00--Specific topics for EWGs  Biomarkers of cardiac toxicity  Biomarkers of vasculitis  PET application to small animal studies

7. Subcommittee Role: 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 EWGs identify opportunities for collaborations and define objectives Steering committee to collaborative projects Support workshops and facilitate reports

8. EWG Nominations Requests  FR Notice Published 7/26/00  Letters to Scientific Societies  FDA announcements  Subcommittee contacts  Announcement at public meetings (e.g., Toxicology Forum)

9. EWG Status  Nominations Submission Deadline 9/29/00  Twenty-six nominations received  FDA reviews nominations  Selection of members in process (Nov/Dec)  Joint NCSS/EWG meeting planned  January 2001