Gene Logic Collaborates with FDA to Explore Genomic Data Quality Metrics Related to Drug Candidate Safety and Effectiveness
News Sep 17, 2007
Gene Logic Inc. has entered into collaboration with the United States Food and Drug Administration (FDA) to share quality control methods and metrics that may be useful in better understanding disparate genomic data sent as part of regulatory submissions.
The collaboration is part of the FDA’s Critical Path Initiative, an effort to stimulate and 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 from laboratory concept to commercially approved medicines.
The results of the collaboration will be released publicly as an early step towards formulating industry-wide standards for genomic data assessment. There are currently no federal or industry standards in place for assessment of the quality of genomic data submissions to the FDA.
The Company has processed more than 200,000 microarrays to obtain genomic data and has developed proprietary methods and software to ensure those data are accurate, including more than 40 quality metrics.
Donna Mendrick, Ph.D., Gene Logic Scientific Fellow and 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 has commented that, “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.”
In treating inflammatory bowel disease (IBD), physicians can have a hard time telling which newly diagnosed patients have a high risk of severe inflammation or what therapies will be most effective. Now researchers report finding an epigenetic signature in patient cells that appears to predict inflammation risk in a serious type of IBD called Crohn’s disease.