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FDA and Gene Logic initiate research agreement to evaluate toxicogenomics standards

GAITHERSBURG, MD., Aug. 19, 2003 -- Gene Logic announced that it has entered into an agreement to work with the FDA's Center for Drug Evaluation and Research (CDER) to utilize Gene Logic's large collection of gene expression data from control samples (normal and vehicle-treated rats) in order to contribute to the evaluation of RNA performance standards for toxicogenomics data.

The agreement follows FDA Commissioner Dr. Mark McClellan's July statement before the Joint Economic Committee of Congress pledging to evaluate pharmacogenomics as a tool for predicting drug safety and efficacy.

The goal of this agreement is to help the FDA assess data quality in the genomics portion of new drug submissions, with the aim of improving drug safety and efficacy and streamlining the discovery and development process. The results of this research will be publicly available; the Gene Logic data used to generate the results will remain proprietary.

Capt. Frank Sistare, Ph.D., Acting Director, Office of Testing and Research at CDER, stated: "The FDA has been seeking partners to further the assessment program of establishing RNA standards for toxicogenomics data. We determined that Gene Logic was uniquely positioned to help in this effort because of its significant collection of normal control and vehicle-treated rat samples on the Affymetrix GeneChip platform and expertise in gene expression analysis."

Dr. Karol Thompson will be the primary CDER investigator on this project going forward. Looking at potential outcomes, Dr. Thompson said: "We are excited about working closely with Gene Logic scientists in the pursuit of our shared vision of evaluating standards which may become critical for future regulatory submissions. Building on this agreement, we look forward to additional joint research efforts with Gene Logic aimed at increasing the safety and efficacy profile of drugs."

Previous and continuing CDER partnerships in support of this goal have resulted in the identification of genes that are common to several existing microarray platforms and specific to particular organs of interest (liver, brain, kidney and testes) related to assessing toxicity. In the CDER/Gene Logic agreement, both parties will work together to determine which of these genes show the least variation within the same organs of interest.

The FDA will use this information as the proposed basis for establishing a reference standard of the most reliable genes to measure the quality of genomic data. This standard reference set of genes could then potentially be used by pharmaceutical and biotechnology companies as part of the future genomic portions of their investigational drug submissions.

Source: Gene Logic

Posted: August 2003