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CREATE Bio Optimization Track for Biologics (U01)
This Funding Opportunity Announcement (FOA) is part of a suite of complementary programs to encourage the translation of research discoveries into new treatments for disorders that fall under the NINDS mission.
The NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics (CREATE Bio) program is dedicated to biotechnology product- and biologics-based therapies, which broadly include modalities such as peptides, proteins, oligonucleotides, gene therapies, cell therapies and novel emerging modalities. The program includes two tracks: the Optimization Track supports optimization in order to obtain a candidate appropriate for entering the Development Track, and the Development Track supports IND-enabling studies for the candidate.
For entry into the Optimization Track, projects must have strong scientific rationale and demonstrate relevant, rigorous, convincing in vivo data of one or more agent(s) that are sufficiently profiled so that the parameters to be optimized can be quantitatively specified (see entry criteria for details) in the application. At the end of the funding period, a candidate should be identified that has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement (measurement of target binding or proximal downstream effects) with defined minimal and optimal doses, and other favorable properties consistent with the desired clinical application (see Scope below for details).
Projects are funded through the U01 cooperative agreement award mechanism, which involves NINDS Scientific/Research staff's participation in developing the project plan, monitoring research progress, and establishing appropriate milestones. NINDS staff will also provide assistance to academic investigators in guiding them with the therapeutic development process and the criteria needed to advance therapeutic leads to the clinic.
PAR-14-288, UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
PAR-14-289, U44 Small Business Innovation Research (SBIR) Cooperative Agreement-Fast Track
PAR-17-457, U44 Small Business Innovation Research (SBIR) Cooperative, Agreement-Fast Track
- Application Due Date(s): February 13, 2018; July 18, 2018; February 13, 2019; July 18, 2019; February 13, 2020; July 20, 2020 , February 12, 2021
- AIDS Application Due Date(s): May 7, 2018; September 7, 2018; May 7, 2019; September 7, 2019; May 7, 2020; September 7, 2020, May 7, 2021
PAR-17-456 Expiration Date New Date May 8, 2021 per issuance of NOT-NS-20-053. (Original Expiration Date: September 8, 2020 )
Application budgets are not limited but must reflect the actual needs of the proposed project. Budgets for these projects will normally remain under $500,000 in direct costs in any given year and fluctuate over the funding period based on the stage of the project.
The project period may not exceed 5 years