The National Heart, Lung, and Blood Institute (NHLBI) has launched a program to help translate basic discoveries into successful treatments. The Science Moving towArds Research Translation and Therapy program, or SMARTT, will support the transition of potential new therapies for heart, lung, and blood diseases from discovery in the lab to the testing needed to establish their safety and effectiveness in people.
"By offering the SMARTT program to the scientific community, we want to make valuable pre-clinical development resources available to grantees and bring exciting new science to the clinic," said Dr. Sonia Skarlatos, deputy director of the NHLBI's Division of Cardiovascular Diseases.
Pre-clinical development—readying products for testing in humans—is the first step in turning discoveries into cures. All materials must be manufactured consistently, using standard operating procedures and carefully controlled conditions. Materials and data need to comply with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) in order for the U.S. Food and Drug Administration to approve the new therapy. However, these processes can be expensive and are unfamiliar to many academic scientists.
With SMARTT, heart, lung, and blood researchers will be able to apply for services that support the development and testing of their potential therapies. Connecting academic researchers with industry, SMARTT will offer help with manufacturing, pharmacology and toxicology testing, pre-clinical and early-phase clinical study design support, and administrative and regulatory expertise.
SMARTT will provide up to $31.6 million over five years to four facilities across the country:
- A production facility for biologic therapeutics
- Advanced BioScience Laboratories, Inc., Kensington, Md.
- Principal Investigator: Thomas C. VanCott, Ph.D.
- A production facility for non-biologic and small-molecule therapeutics
- SRI International, Menlo Park, Calif.
- Principal Investigator: Mary Price, Ph.D.
- A pharmacology and toxicology center
- SRI International, Menlo Park, Calif.
- Principal Investigator: Hanna Ng, Ph.D.
- A coordinating center
- RTI International, Research Triangle, N.C.
- Principal Investigator: Donald J. Brambilla, Ph.D.
The two production facilities will provide cGMP services needed for drug studies being performed in people for the first time. The pharmacology and toxicology center will conduct GLP testing of potential treatments. The coordinating center will serve as a hub, monitoring and coordinating the organizational and regulatory aspects of the SMARTT program.
Investigators in research areas aligned with the NHLBI's mission are encouraged to take advantage of these resources. Learn more about the SMARTT program by visiting the SMARTT website or sending an email to NHLBISMARTT@nhlbi.nih.gov.
Frequently Asked Questions
Q: Is SMARTT a grant program?
A: No. SMARTT will provide access to pre-clinical development services and resources.
Q: Does SMARTT fund basic research on heart, lung, and blood diseases?
A: No. All SMARTT services will be directed toward obtaining a U.S. FDA Investigational New Drug(IND) Application to be held by the investigator who initiates a request for services.
Q: When will SMARTT services be available?
A: SMARTT services are available now.
Q: How do investigators request services from the SMARTT Program?
A: Interested investigators may request an initial review to determine their eligibility for SMARTT services via an online application.
Q: How will requests be evaluated?
A: Eligible investigators may submit a Request for Services Application that is evaluated by an NHLBI-appointed scientific review board comprised of experts in therapeutics development.
Q: Where can I find more information about SMARTT?
A: Investigators are encouraged to learn more about the SMARTT Program by visiting the SMARTT website or sending an email to NHLBISMARTT@nhlbi.nih.gov.