The NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio) program is dedicated to biotechnology product- and biologics-based therapies, which broadly include modalities such as peptides, proteins, oligonucleotides, gene therapies, and cell therapies. The program includes two tracks: the Discovery Track supports lead optimization in order to obtain a candidate appropriate for entering the Development Track, and the Development Track supports IND-enabling studies for the candidate, as well as early-phase clinical trials.
|Purpose||It supports the optimization of therapeutic lead(s) showing convincing proof-of-concept. At the end of the funding period, projects will have identified an optimized candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, and will be ready for entry into the CREATE Bio Development track for further development to enable filing for an IND.||It supports IND-enabling studies for the candidate and early-phase clinical trials. At the end of the funding period, a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum. The program supports early-phase clinical trials, but these are not required components of proposed projects.|
|Entry Criteria||(1) There must be a clear and convincing demonstration of proof-of-concept (e.g., clear dose-response relationship).
(2) Applicants must have one or more therapeutic leads from which a candidate can potentially be derived. The leads must have been sufficiently profiled so that all the essential key parameters to be optimized can be quantitatively specified.
(3) For key in vitro and in vivo assays proposed to optimize the leads, applicants must have pre-existing data demonstrating that the assays are suitable for the proposed purpose and available in either the applicant's or collaborator's laboratories.
|Applicants must have a candidate with the final structure for human testing that minimally satisfies all of the following:
(1) Optimization is finished and final characterization of the candidate, such as structure/identity, selectivity, stability, manufacturability, and other modality-specific characteristics are complete.
(2) For a candidate with sufficient purity, its minimal effective dose, optimal effective dose, time and duration of treatment, have been determined in relevant in vivo assays using clinically relevant functional and/or anatomical outcome measures, and/or in vivo target engagement assays. The in vivo study results should also address the clinically intended route of administration, pharmacokinetics and pharmacodynamics relationship, and bioavailability at the site of action, including blood brain barrier penetration if applicable.
(3) Feasibility for production and reproducible production of the candidate.
|Grant mechanism||Projects are funded up to 4 years through these cooperative agreement mechanisms:
SBIR U44 (PAR-14-287)
|Projects are funded up to 5 years through these cooperative agreement mechanisms:
UH2/UH3 (PAR-14-288)SBIR U44 (PAR-14-289)