FDA News

Ingenuity Systems Delivers Key Milestones in FDA Collaboration to Facilitate Genomic Data Review

(March 26,2008)-- Ingenuity Systems, provider of information solutions for life science researchers, announced it has achieved key milestones in the ongoing Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration. Significant progress has been made in several areas including the curation of new biomarker and toxicology content and the expansion of existing ontological classifications. These developments will advance the FDA towards its goal of rapidly identifying potential genomic 'fingerprints' that could be used to quickly and easily compare genomic data from submissions of drugs in the same class.

Under the terms of the CRADA, Ingenuity Systems and the FDA will expand Ingenuity's content and software solutions to facilitate the research and regulatory review of biomarker, pharmacogenomic, and toxicogenomic data. The collaboration directly relates to the FDA's need to develop better tools for the review of genomic data.

"We are making progress towards the goals outlined in the CRADA," commented Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics. "We are looking forward to this collaboration over the course of
this year so our team can benefit from these tools and information available from them on relationships between drugs and potential mechanism of action and mechanism of toxicity."

"Our collaboration with the FDA was a natural partnership given Ingenuity's close alliance with the industry initiatives and healthcare goals laid out by the Critical Path Initiative," stated Ramon Felciano, Ph.D., CTO and Vice President, Research of Ingenuity Systems. "We are confident that we can leverage Ingenuity's unique capabilities to provide the FDA with a clearer understanding of the biological and chemical relationships embedded in the regulatory data."

Share or bookmarklet this web page at: