The CTSI Transformative Funding Agreement provides funding up to $500,000 to address the T1 valley of death: the gulf between novel clinically motivated research and products that show safety and efficacy in humans (Coller BS and Califf RM, 2009). This program seeks to provide funding for development of mature research that if successful will attract significant interest for external partnering. The goal of this program is to enable and accelerate translation of research out of the academic environment (i.e. new company formation, license, or partnership).
Applicants will work toward major milestones (e.g. prototype development, GMP manufacture, GLP toxicology studies, IND submission, completion of Phase I clinical trial) that will enable this translation. Projects selected for funding will be assigned a translational support team for a run-in period of up to six months to deliver a proposed development path, outsourcing plan, and detailed project timeline before funds are released.
Examples of projects responsive to this application might include, but are not limited to, the following:
- A therapeutic agent that has shown efficacy in animal models but needs funding to complete scale up, pharm/tox studies and submit IND needed for clinical trials.
- An alpha prototype device with early proof-of-concept data that needs funding to manufacture devices and conduct clinical trials.
The Primary source of funding is from Duke's Clinical and Translational Science Award (CTSA).
- Letter of Intent (Optional): September 20, 2018
- Application Submission Deadline: November 8, 2018
- Selection of Finalists and Oral Presentations: February 2019
- Final Selection: March 2019
- Project Planning Run-In Period: May – October, 2019
- Funding Period: November 1, 2019 - April 30, 2021 (18 months)
Applicants must have principal investigator status per Duke’s written policy. The proposed project should be innovative, high-risk, and high-impact that if successful will attract significant interest for external partnering. Applicants will work toward major milestones that will enable translation out of the academic environment.
- Applicants are encouraged but not required to bring funding partners, matching discretionary or departmental funds, or commitments from other sources to supplement CTSA support and accelerate research or broaden aims. Applicants must show that they have considered collaboration with other NCATS initiatives including Bridging Interventional Development Gaps (BrIDGs) and Therapeutics for Rare and Neglected Diseases (TRND) to compress timelines and access available expertise.
- Faculty members may not serve as PI concurrently on the Transformative and Translational Duke CTSI awards.
View the RFA for complete submission, selection, and review criteria.
All publications that are the direct result of this funding must reference: “Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002553. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”
Publications must also be registered in PubMed Central.