ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

Pharmacology Toxicology Subcommittee

June 10, 2003

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

8:30 Call to Order Meryl Karol, Ph.D., Chair

Conflict of Interest Kimberly Topper, Exec. Sec.

8:40 Introduction to Meeting and

Charge to Subcommittee David Jacobson-Kram, Ph.D.

8:50 Topic # 1 Overview of Toxicogenomics at the Drug Development

and Regulatory Interface

Concept of “No Regulatory Impact” for Nonclinical

Pharmacogenomics/Toxicogenomics

Data Submissions to CDER Janet Woodcock, M.D.

Added Value of Toxicogenomics and Biomarker

Signature Development in Pharmaceutical Evaluations Roger Ulrich, Ph.D.

PhRMA Perspective on the Utility and Value of

Expression Profiling Data at the Drug Development

Regulatory Interface and ILSI Experiences with

Cross-platform Comparisons William Pennie, Ph.D.

10:15 Break

10:30 Topic # 2 Toxicogenomic Data Quality and Database Issues

Dealing Effectively with Data Quality Issues,

Platform Differences, and Developing a Database Kurt Jarnigan, Ph.D.

Data Processing, Statistics, and Data Presentation John Quackenbush. Ph.D.

Fluorescent Machine Standards and RNA Reference

Standards (Summary of Results from the NIST Workshop) Krishna Ghosh, Ph.D.

12:00 Open Public Hearing

1:00 Lunch

2:00 Topic # 3 CDER FDA Product Review and Linking Toxicogenomics Data with Toxicology Outcome

CDER IND/NDA Reviews – Guidance, the Common

Technical Document and Good Review Practice John Leighton, Ph.D.

Electronic Submissions-Guidance, CDISC and HL-7 Randy Levin, M.D.

MIAME-Tox William Mattes, Ph.D.

CDER FDA Initiatives Lillian Rosario, Ph.D.

3:30 Break

3:45 Questions to Subcommittee Frank Sistare, Ph.D.

Committee Discussion

4:25 Conclusions and Summary Remarks Meryl Karol, Ph.D.

4:30 Adjourn