Iconix Pharmaceuticals Inc announced an agreement with the U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), to provide CDER with research access to its DrugMatrix system for evaluation purposes. DrugMatrix is the largest private and public reference set of data on the genomic effects of drugs, biochemicals and toxicants.
Conducted by the Office of Testing and Research and led by Acting Director Dr. Frank Sistare, the research project is designed to provide CDER with hands-on experience using chemogenomic data and tools, including the application of molecular toxicology markers to predict drug actions. The FDA group is developing guidance to address the optimal and minimal content and format of gene expression microarray data submissions linked electronically to standard toxicology and pharmacology study results.
The FDA will also use DrugMatrix to evaluate the required skill sets, tools and systems architecture that would be needed to support assessment of chemogenomics data in the drug review process. Iconix will provide training and support in the areas of QA/QC methods associated with gene expression microarray data generation, analysis of data across multiple gene microarray product platforms, and the derivation and validation of markers of toxicity and mechanism from integrated chemogenomic datasets. The FDA group expressed strong interest in developing first-hand experience with a very large set of chemogenomics data linked to traditional toxicology outcomes.
"The power inherent in a chemogenomics-based approach is to look at the entire genomic profile of potential drug candidates -- which is important in identifying new mechanisms of action as well as potential toxicological liabilities," said Jim Neal, CEO of Iconix. "DrugMatrix provides a reference context for the FDA to expand its abilities to interpret the information they are beginning to see from sponsors. We look at this relationship as a tangible way to demonstrate how the private and public research communities can work together to ultimately make the drug discovery, drug development, and drug review process more effective and efficient."