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2017 CREATE Bio Program Diagram

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, 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, as well as early-phase clinical trials. 

For a quick look to determine the differences between the CREATE Bio FOA tracks such as grant mechanism, FOA number, purpose, and entry criteria

 Compare the CREATE Bio Optimization and Development Tracks

The CREATE Bio program has contracts for consultants to advise NIH staff and offer investigators assistance on an ad hoc basis.

CREATE Bio Contract Resources/Consultants

Related Resources (see box on this page)

See the Translational section of the Application Support Library for resources to help to successfully apply to the CREATE Bio program such as videos, reference profile tables for each modality, example milestones, example target product profile table, and FAQs.

For stem cell therapy applicants see the stem cell information link.  For instance at the archive link you can find Information such as past workshop on Pluripotent Stem Cells in Translation: Preclinical Considerations.

Since CREATE Bio applicants need to communicate with the FDA, links to quickly find FDA guidance document are provided.