De-Risking Therapeutic Development

Preclinical research, which connects basic scientific discoveries with initial testing of therapies in humans, is a failure-prone stage of translation. Innovations in drug discovery and development and management of development programs can substantially reduce the risks, time delays and costs of advancing basic research breakthroughs into treatments, an approach known as “de-risking.”

Preclinical programs at NCATS are designed both to develop new technologies to make this translational stage more predictive and efficient, and also to de-risk targets and disease projects so that they will be more attractive to potential partners. NCATS works with academic, nonprofit and industry investigators and with patient groups to provide preclinical drug development expertise and resources to advance their research and, in addition, assists in generating data needed for regulatory approval.

Using expertise in preclinical drug development, NCATS scientists apply innovative approaches to advance potential treatments to the point of attracting external partners who would be interested in investing in completing clinical development, manufacturing and marketing. NCATS’ goal is to improve success rates in the crucial preclinical stage of development.

NCATS’ Therapeutics for Rare and Neglected Diseases and Bridging Interventional Development Gaps programs aim to de-risk drug development and provide access to NCATS expertise and contract resources to conduct crucial preclinical studies necessary for regulatory approval of first-in-human trials.

Learn more about other translational issues NCATS aims to address: