Gene Logic, FDA Collaborate on Safety/Efficacy Data

Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA’s Critical Path Initiative, an effort to facilitate the use of new scientific and technical methods—such as computer-based predictive models and biomarkers for safety and effectiveness—intended to improve the predictability and efficiency of drug development. There are currently no federal or industry standards in place for assessing the quality of genomic data submissions to the FDA.

Gene Logic obtains and analyzes genomic data in the pharma and biopharma industries and has assembled detailed knowledge bases of gene expression profiles from human tissues and cells. The company has processed more than 200,000 microarrays to obtain genomic data and has developed methods and software to ensure those data are accurate, including more than 40 quality metrics, according to the company.

Donna Mendrick, Ph.D., a Gene Logic scientific fellow and the company’s vice president of toxicogenomics, said, “Industry and FDA consensus is that biomarkers are valuable tools for assessing the safety and efficacy of drug candidates. This collaboration between Gene Logic and the FDA is a step on the path to achieving a common understanding of key microarray QC procedures that may lead to the development of preliminary microarray data standards for the submission of microarray data to the FDA.”

A senior FDA official commented, “Currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future.”