Predictive ADME/Toxicology

The completion of the Human Genome Project and recent advances in our understanding of the molecular mechanisms of diseases have provided increasing numbers of newly defined biological pathways and networks with potential preventive or therapeutic targets. The development of molecular diversity libraries and screening of these libraries have provided tremendous opportunities to discover new chemical and biological agents for the prevention and treatment of diseases. This created the belief that increasing numbers of new molecular entities would enter clinical testing and would receive approval from the Food and Drug Administration (FDA) to treat human disorders. However, this has not occurred. Many candidate agents are failing during clinical testing because of their unfavorable pharmacokinetic properties, unacceptable adverse effects, or major toxicities, as well as the lack of efficacy. The initiative is to support the development, standardization, and validation of novel approaches to obtain comprehensive absorption, distribution, metabolism, excretion (ADME) and toxicological (TOX) profiles that could better predict how new molecular entities will perform in humans to reduce the failure rate in clinical testing. This is an NIH Roadmap initiative. This program explores novel, “high-risk,” and “high-impact” approaches to achieve this goal, rather than incremental technology development that is already supported by current NIH programs.

Data Sharing

As the objectives of each RFA offered on behalf of the Predictive ADME/Toxicology Initiative are unique, so are the particular data sharing plans associated with them. Therefore, interested investigators are strongly encouraged to review the data sharing plans of each RFA in concert with the specific aims of the particular Announcement.

See “Section V” of the Novel Preclinical Tools for Predictive ADME-Toxicology (R21) RFA-RM-04-023.

More Information

For further information about the Predictive ADME/Toxicology Initiative, please see RFA-RM-05-012

Please see the left menu for information on the Predictive ADME/Tox Projects funded for the pilot phase of the Molecular Libraries Initiative.

Note: This predictive ADME/Toxicology Initiative will not continue into the Production Phase of Molecular Libraries, so there are no current funding opportunities available.