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About SMARTT

About the SMARTT Program

The National Heart, Lung, and Blood Institute (NHLBI) Offsite icon Science Moving towArds Research Translation and Therapy (SMARTT ) Program supports the translation of novel discoveries into successful new therapies for heart, lung, and blood diseases by providing free, confidential, and rapid preclinical development services to investigators.

Pre-clinical development is the first step in turning discoveries into cures. Nonclinical studies and drug substance manufacturing 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 an Investigational New Drug (IND) application. These processes can be expensive and are unfamiliar to many academic scientists.

The SMARTT Program provides tailored pharmacology and toxicology testing, manufacturing services, and regulatory support to investigators to expedite the transition of their discoveries to the clinic.

More information on how SMARTT supports translational research is available in the form of drug discovery and development figures.

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.

How to request services

Currently, interested investigators may submit an online application to determine their eligibility for SMARTT services.

The SMARTT Program Workflow spans the following main phases: request services, NHLBI approval process, services implementation, translation and therapy.
SMARTT Program Request Lifecycle

Overview of the service request process

  1. Interested investigators submit an online application requesting SMARTT Services.
  2. The NHLBI SMARTT Committee evaluates the request for conformance to the NHLBI mission and SMARTT capabilities.
  3. Upon approval, investigators are invited to submit a more detailed Request for Services application.
  4. Request for Services applications are reviewed by a Scientific Review Board for scientific merit, and feasibility. A summary of the review with recommendations is then submitted to the SMARTT Steering Committee (SC). The SC advises the NHLBI regarding acceptance and prioritization of these applications. The final decision is made by the NHLBI SMARTT Committee.
  5. If approved, the appropriate program resources are engaged and the project is initiated.
  6. After the project has been completed, deliverables are provided to the investigator and service completion reports are submitted.

More information

Marketing Materials, Brochures

Fact Sheet: SMARTT (http://www.nhlbi.nih.gov/new/SMARTT.htm) Offsite icon


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