ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
Pharmacology Toxicology Subcommittee
CDER Advisory Committee Conference Room
Call to Order Meryl Karol, Ph.D., Chair
Conflict of Interest Kimberly Topper, Exec. Sec.
Introduction to Meeting and
Charge to Subcommittee David Jacobson-Kram, Ph.D.
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.
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
(Summary of Results from the NIST Workshop)
Open Public Hearing
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.
Questions to Subcommittee Frank Sistare, Ph.D.
Conclusions and Summary Remarks Meryl Karol, Ph.D.