1. How do I know which program to apply for developing therapy?
If you are an academic or small business concern and are not sure which program to apply to for your therapy development refer to the decision tree on the Office of Translational Research home page for assistance. http://www.ninds.nih.gov/funding/areas/translational_research/index.htm
2. Where can I find a quick overview of the CREATE Bio program?
Webinar recording: http://sites.nationalacademies.org/PGA/guirr/PGA_080979#CREATEBio
3. What is the budget for the CREATE Bio programs?
|Discovery Track (U01)||Development Track (UH2/UH3)|
|Non-SBIR||< $500 K/year in direct cost for up to 4 yrs||< $1 M/year in direct cost for UH2 for up to 2 yrs
< $1.5 M/year in direct cost for UH3
Combined UH2+UH3 for up to 5 yrs
|Discovery Track (U44)||Development Track (U44)|
|SBIR||< $700K in total cost in Phase 1 for up to 1 yr
<$4M total cost in Phase II for up to 3 yrs
|< $1M/year in total cost for Phase I for up to 2 yrs
< $1.5M/year in total cost for Phase II for up to 3 yrs
Notice of the Increase in Budget Caps for Applications to PAR-14-287 "NINDS CREATE Bio Discovery Track: Optimization in Preparation for Development of Biotechnology Products and Biologics (U44)” (NOT-NS-16-010)
4. How can an investigator get guidance? Does an applicant have to contact NINDS before they submit?
It is strongly recommended that all potential applicants consult NINDS staff very early in the planning stage and a minimum of 12 weeks before submission of an application is anticipated.
Applicants requesting $500K or more direct costs in any year (excluding consortium F&A) must contact NINDS program staff at least 6 weeks (at least 12 weeks is strongly encouraged) before submitting the application. NINDS program staff are required to get approval from NINDS senior leadership to accept the application for review.
Refer to the CREATE Bio Pre-application Process webpage http://www.ninds.nih.gov/funding/areas/translational_research/CREATE_Bio_Pre-application_Process.htm.
5. What are the entry criteria for the CREATE Bio Discovery and Development track?
See the entry criteria in the CREATE Bio comparison Table:
6. What are appropriate transition activities in the CREATE Bio Discovery UH3 track?
To keep the momentum of projects moving forward projects in the CREATE Bio Discovery track may propose limited initial work for the Development Track, such as starting to identify species for toxicology study or preliminary safety evaluations, preliminary biodistribution study, and piloting formulations. These transitioning activities are generally restricted to the last year of the Discovery Track. Awardees are encouraged to apply to the Development Track FOA as soon as they are eligible, while finishing up these studies in the Discovery Track.
7. Is a team required prior to submitting an application?
NINDS strongly encourages applicants to form multidisciplinary teams before they submit their application. It’s recommended that teams consist of preclinical and clinical scientists, CMC experts, regulatory experts, statisticians, and other academic/industry experts relevant to the therapeutic modality as appropriate. The multidisciplinary team will be able to better define the desired TPP, to design the details of the plans and experiments, inform decision making, and execute the research strategy.
8. Do I have to submit the structure/sequence for my therapeutic in my application? How can I be sure the information in my application will remain confidential?
Enough information on the structure/sequences is required to enable evaluation of the application.
Applications are submitted for evaluation purposes only and are reviewed in closed private (non-public) sessions by reviewers who are under strict confidentiality agreements with the federal government. Therefore, information contained in applications would normally not be considered as a public disclosure and should not affect the applicant’s ability to apply for patents. However, filing patent applications prior to submission of a funding application is something an applicant should consider in conjunction with their legal counsel. Also, it should be noted that the submitted abstract would be published upon award of the grant, so the abstract should be drafted carefully so as not to be considered as an enabling disclosure. You can also mark sections of your application confidential. Please review NIH’s Guide Notice (NOT-OD-14-073) about maintaining confidentiality during review.
9. If I don’t have in vivo efficacy measures that are clinically relevant will in vivo target engagement data satisfy the CREATE Bio discovery track criteria?
Yes, in the absence of preclinical in vivo efficacy measures that are clinically relevant in the field, projects can apply by presenting evidence of in vivo target engagement at the clinically intended site of action. However, if animal models do exist in the field they should be used.
10. Does the CREATE Bio program enable validation of target engagement biomarkers?
Yes, the CREATE Bio program allows the validation of target engagement markers in conjunction with therapeutic development.
11. Is current Good Manufacturing Practices (cGMP) supported in the CREATE Bio program?
The principle is that we support manufacturing of the material that is stage appropriate. Therefore, cGMP that is stage appropriate is supported under the CREATE Bio Development track only depending on the modality. Stand-alone cGMP for clinical studies are not supported. Please contact us for details before you submit your application to make sure your activities are appropriate for the program.
12. What is a TPP and why do I need to include a TPP in the application?
A Target Product Profile (TPP) is a planning tool for therapeutic candidates based on FDA Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool. http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-Bio-Example-TPP.htm. TPP is a good tool to ensure the applicants, the reviewers, and the NINDS program staff are on the same page about the ultimate goal of the projects.
13. How do I write milestones?
Guidance on how to write milestones can be found here: http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-Bio-Example-Milestone.htm
14. Are IND enabling toxicology studies supported in the CREATE Discovery track?
No, they are only supported in the CREATE Bio Development track.
15. If my project does not yet meet the CREATE Bio entry criteria, is there a new feeder program?
The new IGNITE program supports the development of small molecules, as well as peptide, proteins, antibodies, gene therapies, and cell therapies to get you ready for the CREATE Bio program. If you feel the IGNITE Funding Opportunity Announcement does not closely correlates with the therapeutic modality you are developing or you have questions regarding your project fit for the program, please contact NINDS program staff for guidance.
16. Who do we contact if we have questions?
CREATE Bio Project Manager: Chris Boshoff, Ph.D.
Last Modified October 5, 2016