Loading...
SMARTT Logo

SMARTT's Mission and Business Model

The mission of the SMARTT program is to accelerate translation of research from demonstration of efficacy in vivo to submission of an investigational new drug application (IND) to the FDA. To accomplish this mission, the SMARTT program provides regulatory support, manufacturing, and pharmacology/toxicology services to qualified projects.

Therapeutic candidates or diagnostic imaging agents that are not intended for treatment of heart, lung, or blood diseases, or for which efficacy in an animal model has not been demonstrated, are not eligible for SMARTT services. Also, medical devices, vectors for gene therapy, and exploratory research aimed at identifying lead therapeutic candidates are not eligible for SMARTT services.

SMARTT accepts requests from academic institutions, non-profit organizations, and small businesses. The process begins with completion of an online application that asks for a general description of the project and services being sought. If the project is deemed eligible, investigators are invited to complete a more detailed Request for Services Application (RSA), which is evaluated by a panel of expert reviewers familiar with the field of study. Successful applicants work with the relevant SMARTT facility to develop a project schedule and budget, which undergoes a final approval step by NHLBI prior to initiation of the work. The application and review process is designed to be completed within three months, assuming all eligibility and scientific merit criteria are met.


SEARCH | SITE INDEX | ACCESSIBILITY | PRIVACY STATEMENT | FOIA | OIG | CONTACT US

National Heart, Lung, and Blood Institute National Institutes of Health Department of Health and Human Services USA.gov