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
The new Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program replaces the Translational R21 (PAR-13-023) announcement with a suite of four funding opportunity announcements that are designed to provide a data package appropriate for entry into NINDS Cooperative Research to Enable and Advance Translational Enterprises (CREATE Bio) program for biologics/biotechnology products or the Blueprint Neurotherapeutics Network (BPN) program for small molecules. This initiative is intended to provide short-term support for well-defined studies that are novel, have clear biological rationale, and relevance for therapy development to obtain missing requisite (or required) the data required for entry of promising therapeutics into the CREATE Bio or BPN programs.
Applicants are strongly encouraged to contact program staff and send them a draft abstract for consultation. Program staff considers both the activities proposed, maturity of the project, and end goal intent of the project when recommending the most appropriate program.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 12 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. NINDS prior approval is required for any applications proposing a budget of $500,000 in direct cost in any year of the project.
Yes, they can be submitted as new applications. Its encouraged that applicants address all past summary statement concerns in the application, however applicants will not be able to specifically include in the Introduction a response to the issues and criticism raised in past summary statements.
The previous U01 Program (PAR-13-022) program supported discovery and development of therapeutics for all therapeutic modalities. The new programs have separate announcements to support the discovery and development of small molecules, devices, and biotechnology products and biologics. Please refer to each modality for details. The previous program went only as far as an IND while the new program supports early clinical trials.
Applicants are advised to contact NINDS program staff at least 12 weeks before a receipt date. As a cooperative agreement, implementation will involve the participation of NINDS program staff in the planning and execution of the therapy-directed projects. Applicants are strongly encouraged to consult with NINDS program staff when planning an application. Consultations will include conference calls with NINDS program staff. Early contact provides an opportunity for NINDS program staff to provide further guidance on program scope, goals, and developing appropriate milestones. Other aspects of an application that are unique to this program will also be discussed. Refer to the CREATE Bio Pre-application Process webpage http://www.ninds.nih.gov/funding/areas/translational_research/CREATE_Bio_Pre-application_Process.htm.
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) are required to contact NINDS program staff at least 12 weeks before submitting the application. NINDS program staff are required to get approval to accept the application for review from senior leadership.
Refer to the CREATE Bio Pre-application Process webpage http://www.ninds.nih.gov/funding/areas/translational_research/CREATE_Bio_Pre-application_Process.htm.
Competing applications for all of these new programs will be reviewed within the NINDS Scientific Review Branch and not at the Center for Scientific Review (CSR). Applications will be assigned to the appropriate review based on the FOA under which they applied. Small business U44 applications will be reviewed in the same review meeting as U01 or UH2/UH3 applications.
Applications from foreign institutions or containing foreign components should apply through the U01 or UH2/UH3 mechanism and not the U44 small business mechanism.
All applicants are strongly encouraged to consult with NINDS program staff when planning an application. Applicants should contact NINDS programs staff at least 12 weeks prior to submitting an application.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. The Acceptance for Review of Unsolicited Applications must be approved 6 weeks prior to receipt date before an application can be submitted. To allow time for NINDS program staff and leadership to consider the request for Acceptance for Review of Unsolicited Applications, we strongly encourage applicants to contact NIH program staff at least 12 weeks before submitting the application.
Yes, 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.
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.
Yes, the CREATE Bio program allows the validation of target engagement markers in conjunction with therapeutic development.
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.
See the entry criteria in the CREATE Bio comparison Table:
One key feature of the Discovery track is that projects need to propose end goals that match the entry criteria for the Development Track, as the intention is to create a contiguous therapeutic pipeline.
The Discovery track end goals are:
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.
At the end of the CREATE Bio Development track a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum with a clinical-ready asset . The program supports early-phase clinical trials, although these are not required.
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
CREATE Bio Discovery track out of scope activities:
CREATE Bio Development track out of scope activities:
Guidance on how to write milestones can be found here: http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-Bio-Example-Milestone.htm
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.
No, they are only supported in the CREATE Bio Development track.
CREATE Program: Hao Wang, Ph.D. CREATEinquiries@mail.nih.gov
Last updated January 29, 2015