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CREATE Bio Program Overview

CREATE Bio Program Overview 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

Resources and Tools

The CREATE Bio program has contracts for consultants to advise NIH staff and offer investigators assistance on an ad hoc basis. The consultants have expertise in biologic CMC development, regulatory affairs, and statistics.

Knowing therapy development is a challenging process, NINDS asked its biologic consultant contractors to generate educational guidance documents to better prepare investigators. Roadmap to IND for Protein and Peptide Therapies Cell and Gene Therapy Product Development Matrix.

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

The Translational Application Support Library contains 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.

Applicants using stem cells for their therapy should check out NIH Stem Cell Information. For instance at the archive link you can find Information on a past workshop on Pluripotent Stem Cells in Translation: Preclinical Considerations.

List of all current (active) CREATE Bio supported projects available in the NIH RePORTER database, with associated publications.