Pharmacology Toxicology Subcommittee

June 10, 2003


CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD





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


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