Drugs, Devices and Diagnostics Development (4D) Grants
We are accepting applications utilizing the Drugs, Devices and Diagnostics Development (4D) Strategic Initiative to further innovation toward an eventual commercial endpoint, being either the launching of a company or licensing to an established company.
Examples of the types of activities these pilot grants can fund:
- Studies to validate the relevance of a biological target, e.g, through the use of small molecules or biologics to demonstrate a defined pharmaceutically relevant outcome
- Validation of primary and secondary, functional assays, i.e., cells, tissues, animals in support of discovering a lead compound in an identified therapeutic area focus
- Validation of a novel drug delivery system through use of known or novel compounds and biological materials, cells, vectors, polymers, animal models, or mechanical and electrical devices
- Studies designed to enhance animal and human toxicologic and drug safety in order to accelerate preclinical to Phase II development
- Validation of novel pharmacogenomics approaches to forecast efficacy and/or safety of drugs in human populations
- Validating a medical device prototype which may include optimization of device parameters, software-hardware integration and design and usability testing
- Validation of in vitro diagnostic (IVD) or laboratory developed test (LDT) in human samples or populations
Submission of a 4D pre-application is mandatory to be considered eligible for 4D Pilot funding. Investigators will be contacted within 5 business days of receipt of the 4D Pre-application.
New requirements for funded pilot grants
The NC TraCS Institute is funded through a CTSA grant from NIH's National Center for Advancing Translational Sciences (NCATS). NCATS recently instituted a new policy requiring the review and approval of all TraCS pilot grants involving human subjects research prior to TraCS funds being released. Therefore, if your proposal is funded and involves human subjects research, TraCS will require additional documentation to send to NCATS. NCATS expects to complete their review in less than 30 days. The NCATS review can occur concurrently with the IRB review; however, final NCATS approval is contingent upon IRB approval.
Submission Due Date
October 10, 2017
Note: Submissions should be received by 5:00 pm on the submission due dates.Submit 4D Consult Request