Translational Research Decision Tree

What are you developing?

Are you proposing only clinical work (i.e., your application will not propose pre-clinical studies as part of the project)?

Consider:
NeuroNEXT Clinical Trials Program;
Exploratory Clinical Trials Program or SBIR/STTR Exploratory Clinical Trials Program;
StrokeNet Program

Is the research fundamental basic or applied research that uses existing market-approved devices for their labeled use?

Is the therapeutic device very close to the 'final system'? Is it manufactured using very close to the same manufacturing process that will be scaled for the clinical studies and eventual market manufacture? Is it expected that the changes to the system design informed by the Early Feasibility Study will be minor and not require additional animal testing?

Prior to application can you obtain non-binding FDA Pre-Submission feedback indicating that the pre-clinical plan will support a successful FDA submission for IDE within 2 years (for Non-Significant Risk Studies, preliminary communications with the IRB)?

Consider: CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (UH2/UH3) PAR-14-297. Small Businesses should consider the SBIR version (U44) PAR-14-300.

Is the device on the path to a 510(k) submission?

Prior to application can you obtain non-binding FDA Pre-Submission feedback indicating that the pre-clinical plan will support a successful FDA submission for IDE within 2 years (for Non-Significant Risk Studies, preliminary communications with the IRB)?

Consider: CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (UH2/UH3) PAR-14-295.
Small Businesses should consider the SBIR version (U44) PAR-14-296.

Prior to application can you obtain non-binding FDA Pre-Submission feedback indicating that the pre-clinical plan will support a successful FDA submission for IDE within 5 years (for Non-Significant Risk Studies, preliminary communications with the IRB)?

Consider: CREATE Devices: Translational and Clinical Studies on the Path to PMA or HDE (UH2/UH3) PAR-14-298.
Small Businesses should consider the SBIR version (U44) PAR-14-299.

Do you have a compound that shows promising activity in a disease model?

Can you fill out our Compound Profile Table, with no liabilities?

Are you a small business?

Consider the Blueprint Neurotherapeutics Network SBIR U44 award (PAR-17-201), with entry at the Development stage.
Email Dr. Charles Cywin at Charles.Cywin@nih.gov to confirm.

Do you have assays to conduct a screening campaign?

If your assay is high throughput we recommend that you consider the High Throughput Screening (HTS) to Discover Chemical Probes R01 (PAR-14-284) program.

Do you have assays that can be used or optimized for structure activity relationship (SAR) studies?

Consider the Blueprint Neurotherapeutics Network UG3/UH3 award (PAR-17-205), with entry at the Development stage.
Email Dr. Charles Cywin at Charles.Cywin@nih.gov to confirm.

Consider the translational R21 (PAR-13-023) for small throughput assay development.

Consider the IGNITE Program for small throughput assay development.

Are you a small business?

Consider the Blueprint Neurotherapeutics Network SBIR U44 award (PAR-17-201), with entry at the Discovery stage.
Email Dr. Charles Cywin at Charles.Cywin@nih.gov to confirm.

Consider the Blueprint Neurotherapeutics Network UG3/UH3 award (PAR-17-205), with entry at the Discovery stage.
Email Dr. Charles Cywin at Charles.Cywin@nih.gov to confirm.

Are you developing peptides, proteins, oligonucleotides, gene therapies, and cell therapies?

Do you meet the CREATE Bio Development criteria and align with the purpose of the FOA? (comparison: Optimization and Development Tracks)

 

Consider the UH2/UH3 CREATE Bio Development program (PAR-14-288).
Consider the SBIR CREATE Bio Development program if you are eligible for SBIR (PAR-14-289).
Email Chris.Boshoff@nih.gov regarding pre-application process. Refer to the CREATE Bio pre-application process webpage.

Email Chris.Boshoff@nih.gov to determine if you fit the CREATE Bio program.
Do you want information on other options?

Do you meet the CREATE Bio Optimization criteria align with the purpose of the FOA? (comparison: Optimization and Development Tracks)

Consider the U01 CREATE Bio Optimization program (PAR-17-456).
Consider the SBIR CREATE Bio Optimization program (PAR-17-457) if you are eligible for SBIR.
Email Chris.Boshoff@nih.gov regarding pre-application process. Refer to the CREATE Bio pre-application process webpage.

Consider the SBIR program. You are also eligible for the IGNITE Program.

Are you an SBIR program small business?

Consider the IGNITE Program.