Bridging Interventional Development Gaps (BrIDGs) was launched under its new name in October 2011. As part of the National Center for Advancing Translational Sciences (NCATS) Division of Pre-Clinical Innovation, BrIDGs makes available, on a competitive basis, certain critical resources needed for the development of new therapeutic agents. Investigators do not receive grant funds through this program. Instead, successful applicants receive access to NIH contractors who conduct preclinical studies at no cost to the investigator. In general, synthesis, formulation, pharmacokinetic and toxicology services in support of investigator-held Investigational New Drug (IND) applications to the Food and Drug Administration are available.
Launched in May 2012, the National Center for Advancing Translational Science's (NCATS) New Therapeutic Uses program helps re-engineer the research pipeline using an innovative strategy to identify new uses for compounds that have undergone significant research and development by industry, including safety testing in humans. The program is designed to develop partnerships between pharmaceutical companies and the biomedical research community to advance therapeutics development.
The TRND program in the National Center for Advancing Translational Sciences (NCATS) Division of Pre-Clinical Innovation aims to encourage and speed the development of new drugs for rare and neglected diseases. TRND collaborations offer an opportunity to partner with TRND researchers and gain access to rare and neglected disease drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. To foster collaborations, TRND uses an application and evaluation process to select collaborators. Selected investigators provide the drug project starting points and ongoing biological/disease expertise throughout the project.
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs are engines of innovation for developing and commercializing novel technologies and products to create life saving technologies and stimulate economic growth. NIH's SBIR and STTR programs provide grant and contract funding opportunities to support small businesses performing research and development on technologies related to the mission of NIH.
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. The program provides regulatory support, manufacturing, and pharmacology/toxicology services to qualified projects. SMARTT accepts requests from academic institutions, non-profit organizations, and small businesses. The process begins with completion of an online application that 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.
NIAID's Interventional Agent Development Services program provides services to facilitate preclinical development of therapeutics and new in vivo diagnostics for infectious disease-causing pathogens and/or toxins, such as imaging and skin test reagents. Services include lead identification and development; chemistry and manufacturing; in vitro and in vivo preclinical safety, toxicology and biokinetics studies; and preclinical development, planning and evaluation services. An investigator may request services if in academia, a not-for-profit organization, industry, or government worldwide. You need not be a grantee of NIAID or another National Institutes of Health Institute or Center. However, you must have appropriate preliminary data to support advancing the product you wish to have studied to the requested stage of the product development pathway.
The NHLBI Gene Therapy Resource Program (GTRP) facilitates the translation of gene therapy research into clinical interventions. The GTRP provides resources for gene therapy research primarily in heart, lung, and blood diseases as reflected in the NHLBI Mission. Requests for resources for gene therapy research that are consistent with the missions of other NIH Institutes may also be considered by the Program. Resources are provided in the form of preclinical and clinical-grade vector production, pharmacology/toxicology testing, immunology testing, clinical trials funding assistance, and regulatory support at no cost to the investigator. Investigators must receive approval of their registration with the program before requesting resources.
The NHLBI program, VITA, is intended to provide funding for early-stage translational development of product candidates in the fields of vascular and lymphatic disorders, thrombotic diseases, and pulmonary hypertension. This may include, but is not limited to, conditions under the Mission of NHLBI such as: peripheral arterial disease, aortic aneurysms and dissections, pulmonary vascular disorders, venous and arterial thrombosis, thromboembolic disorders, and disorders of the lymphatic system. Not included as specific topics in this program are diseases of the coronary and intracranial arteries.
Drug discovery and development projects will enter a National Cancer Institute (NCI) pipeline focused on unmet needs in therapeutics that are not adequately addressed by the private sector. The NCI is committed to moving high-priority discovery and development projects through to proof-of-concept clinical trials. Entry into NExT can occur at any stage of the drug discovery or development pipeline, but depends on favorable review of the applicant's scientific merit. Approved discovery and preclinical development activities may be performed by the NCI Chemical Biology Consortium, a component of NexT.