To bridge the gap that exists in moving scientific discoveries to clinical application, the National Heart, Lung, and Blood Institutes (NHLBI) established and supports a Science Moving towArds Research Translation and Therapy (SMARTT) program for the production and testing of novel therapeutics to treat heart, lung, and blood diseases.
The program serves NHLBI investigators, provides consulting, manufacturing, pharmacology and toxicology testing; preclinical and early phase clinical study design support; and administrative and regulatory expertise.
In November of 2010, the NHLBI awarded four contracts to establish the SMARTT Program infrastructure to provide tailored pharmacology and toxicology testing, manufacturing services, and regulatory support to investigators to expedite the transition of their discoveries to the clinic.
Last week, each of these original contractors were awarded 36-month follow-on SMARTT Program contracts in the following amounts:
The investment into this program by NHLBI is yielding more output in terms of numbers of Investigational New Drugs (INDs) than would occur if investigators had to seek out the necessary IND-enabling services on their own.