The profiles would better predict how new molecular entities will perform in humans in order to reduce the failure rate in clinical testing.
Specifically, the NIH said it intends to commit around $2 million in fiscal year 2005 to fund four to seven new grants that respond to the RFA. Applicants may request a project period of up to four years and a budget for direct costs up to $250,000 per year.
Examples of preclinical ADME-Tox evaluation tools that will be considered for awards include statistical models developed from preclinical and available clinical data; computational models, including data integration tools that link mRNA levels, protein expression levels, protein activities, and metabolite profiles with chemical scaffolds and ADME-Tox parameters; and identifying novel biomarkers to predict ADME-Tox properties of molecular entities and potential drug interactions.
Letters of intent are due on Dec. 17, and applications are due on
The project, "Novel Preclinical Tools for Predictive ADME-Toxicology," is an NIH Roadmap initiative.