CREATE Bio: Compare CREATE Bio Optimization and Development Tracks

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 technologies. The program includes two tracks: the Optimization 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.


Comparison of CREATE Bio Optimization Track and Development Track

Use this chart to help you decide which track better suits your needs.

  Optimization Development
Grant mechanism Projects are funded up to 5 years through these cooperative agreement mechanisms:

U01 PAR-17-456

SBIR U44 PAR-17-457

Projects are funded up to 5 years through these cooperative agreement mechanisms:

UH2/UH3 (To be re-issued)

SBIR U44 (To be re-issued)

 
Purpose

This program supports the optimization of potential therapeutic biologics (e.g. peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging modalities) for disorders identified under the NINDS mission.  At the end of the funding period, a successful project should be able to nominate a clinical candidate.
 

This program supports IND-enabling studies for an already identified clinical candidate and the option to conduct a first in human phase I clinical trial.  At a minimum, a successful project should be able to submit an IND application to the U.S. Food and Drug Administration (FDA) at the end of the funding period.
 

 

Entry Criteria

(1) One or more biological agents sufficiently profiled so that the parameters to be optimized can be quantitatively specified.

(2) Demonstrated in vivo efficacy and target engagement using existing agent(s) in relevant animal model(s) to support the scientific premise that the proposed mechanism of action (MOA) and modulation of the target is likely to result in a therapeutic outcome.

(3) Key in vitro and in vivo assays available and suitable to optimize potential therapeutic agents.  

(4) An established and engaged multi-disciplinary project team to execute the proposed pre-clinical

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.