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Cooperative Research to Enable and Advance Translational Enterprises (CREATE) Frequently Asked Questions


  1. Can you give me advice on how to apply if I am an academic or small business concern and am not sure which program is appropriate for developing my therapy?
  2. What program replaces the Translational R21 (PAR-13-023) announcement?  What types of applications should submit to the IGNITE program versus the NIH Blueprint Neurotherapeutics Network (BPN) and CREATE programs?
  3. How many years and how much funding can I request in my CREATE Bio Discovery Track (U01 or SBIR U44) application?
  4. How many years and how much funding can I request in my Development Track of CREATE Bio (UH2/UH3, or SBIR U44) application?
  5. Can past applications submitted in response to the Translational U01 program (PAR-13-022) be submitted to either the CREATE Bio Discovery or Development Track?
  6. How do the previous Translational U01 Program (PAR-13-022) relate to the programs?
  7. How can an investigator get guidance on how to write an application for these programs?
  8. Does an applicant have to contact NINDS before they submit?
  9. Where will my application be reviewed?
  10. May foreign work be proposed in an application?
  11. Should I contact NINDS program staff if I want to apply either Discovery or Development Track?
  12. When should I contact NINDS program staff  if I request $500,000 or more in direct costs in any year?
  13. 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?
  14. 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?
  15. Does the CREATE Bio program enable validation of target engagement biomarkers?
  16. Is Current Good Manufacturing Practices (cGMP) supported in the CREATE Bio program?
  17. What are the entry criteria for the CREATE Discovery and Development track?
  18. What are the required end goals of the CREATE Bio Discovery track and how do applicants or grantees of the CREATE Discovery track  know they have the entire data package needed for entry to the CREATE Bio Development track?
  19. What are appropriate transition activities in the CREATE Bio Discovery UH3 track?
  20. What are the required end goals of the CREATE Bio Development track?
  21. What is a TPP?
  22. What is out of scope for the CREATE Bio Discovery track?
  23. What is out of scope for the CREATE Bio Development track?
  24. How do I write milestones?
  25. Is a team required prior to submitting an application?
  26. Are IND enabling toxicology studies supported in the CREATE Discovery track?
  27. Who do we contact if we have questions?

 

  1. Can you give me advice on how to apply if I am an academic or small business concern and am not sure which program is appropriate for developing my 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. What program replaces the Translational R21 (PAR-13-023) announcement?  What types of applications should submit to the IGNITE program versus the NIH Blueprint Neurotherapeutics Network (BPN) and CREATE program?

    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.

  3. How many years and how much funding can I request in my CREATE Bio Discovery Track (U01 or SBIR U44) application?
    • For the U01, the proposed project period is typically 3 years and may not exceed 4 years. Application budgets are not limited but must reflect the actual needs and stage of the proposed project. NINDS anticipates the budget for these projects will normally remain under $500,000 in direct costs in any given year and fluctuate over the funding period based on the stage of the project. For example, the costs during some years may be in the $100,000- $200K in direct cost range. It is strongly recommended that all potential applicants consult NINDS staff about their anticipated project and budget very early in the planning stage a minimum of 12 weeks before submission of an application is anticipated. 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.
    • For the SBIR U44, only Fast-track (combined Phase I and II in one application) or Phase II U44 applications are accepted through the CREATE programs. Direct-to-Phase II is not permitted and any Phase II applications must build off of a previously funded Phase I. Phase I applications that are not part of a Fast-track application are not permitted. NIH has received a waiver from the Small Business Administration (SBA) to exceed the SBIR hard cap for specific topics such as the translational programs CREATE and BPN. Generally, NINDS will not fund SBIR Phase I applications through this program requesting more than $500,000 total funding support or project periods greater than 1 year. In addition, NINDS will not generally fund Phase II applications through this program requesting more than $2M total funding support or project periods greater than 3 years. Additional justification is needed for exceptions. Additional justification is needed for exceptions. Applicants are strongly encouraged to contact program staff before submitting an application.
  4.  How many years and how much funding can I request in my CREATE Bio Development Track (UH2/UH3 or SBIR U44) application?
    • For the UH2/UH3, the proposed project period for the UH2 phase may not exceed 2 years. The total duration of the UH2 and UH3 may not exceed 5 years. Application budgets are not limited but must reflect the actual needs of the proposed project. Applications should rarely exceed $1M in direct costs per year during the UH2 phase and $1.5M in direct costs per year during the UH3 phase. Additional justification is needed for exceptions. It is strongly recommended that all potential applicants consult NINDS staff about their anticipated project and budget very early in the planning stage and a minimum of 12 weeks before submission of an application is anticipated.

    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.

    • For SBIR, only Fast-track (combined Phase I and II) are accepted through the CREATE programs. There is no direct to Phase II option through the CREATE program and Phase I applications that are not part of a Fast-track application are not permitted. NIH has received a waiver from the Small Business Administration (SBA) to exceed the SBIR hard cap for specific topics such as the translational programs CREATE and BPN. Generally, NINDS will not fund SBIR Phase I applications through this program requesting more than $2M total funding support, with no more than $1M total cost in any year or project periods greater than 2 years. In addition, NINDS does not generally fund Phase II applications through this program requesting more than $4.5M total funding support, with no more than $1.5M total cost in any year, or project periods greater than 3 years. Additional justification is needed for exceptions. Applicants are strongly encouraged to contact program staff before submitting an application.
  5. Can past applications submitted in response to the Translational U01 program (PAR-13-022) be submitted to either the CREATE Bio Discovery or Development Track?

    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.

  6. How do the previous Translational U01 Program (PAR-13-022) relate to the programs?

    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.

  7. How can an investigator get guidance on how to write an application for these programs?

    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.

  8. 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) 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.

  9. Where will my application be reviewed?

    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.

  10. May foreign work be proposed in an application?

    Applications from foreign institutions or containing foreign components should apply through the U01 or UH2/UH3 mechanism and not the U44 small business mechanism.

  11. Should I contact NINDS program staff if I want to apply either Discovery or Development Track?

    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.

  12. When should I contact NINDS program staff  if I request $500,000 or more in direct costs in any year?

    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.

  13. 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?

    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.

  14. 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.

  15. 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.

  16. 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. 

  17. What are the entry criteria for the CREATE Bio Discovery and Development track?

    See the entry criteria in the CREATE Bio comparison Table:

    http://www.ninds.nih.gov/funding/areas/translational_research/CREATE_Bio_Comparison_Table.htm

  18. What are the required end goals of the CREATE Bio Discovery track and how do applicants or grantees of the CREATE Discovery track  know they have the entire data package needed for entry to the CREATE Bio Development track?

    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:

    • Optimization is complete: structure, selectivity, stability, manufacturability, etc.
    • Candidate characterization is complete: dose, time and duration of treatment, pharmacokinetics/bioavailability at the relevant site of action, and pharmacokinetics-pharmacodynamics relationship etc.
    • Feasibility for production and reproducible production of the candidate
  19. 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.

  20. What are the required end goals of the CREATE Bio Development 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.

  21. What is a TPP?

    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

  22. What is out of scope for the CREATE Bio Discovery track?

    CREATE Bio Discovery track out of scope activities:

    • Developing animal models
    • Basic research of disease mechanisms
    • Early activities such as target identification and validation
    • Development of risk, detection, diagnostic, prognostic, efficacy prediction biomarkers
    • Manufacture of therapeutics for clinical trials
    • Clinical research and clinical trials involving human subjects except those described in scope to develop and validate target engagement assays
    • Stand-alone studies to identify, validate, or qualify a target engagement marker and other bioanalytical assays
    • Activities already performed utilizing other private or public funds to advance the agent
    • Activities that are supported through the CREATE Bio Development track, with the exception of the transitioning activities designed to enable easy transition from the Discovery to the Development Track
  23. What is out of scope for the CREATE Bio Development track?

    CREATE Bio Development track out of scope activities:

    • Animal model development
    • Basic research and studies of disease mechanisms
    • Early research such as identifying and validating targets and generation of preliminary agents that are not suitable for human testing
    • Development of risk, detection, diagnostic, prognostic, efficacy prediction biomarkers. (NINDS recognizes that target engagement markers developed under the UH2 phase may evolve into predictive markers for treatment trials, but it is not the intent of this FOA to develop predictive biomarkers.)
    • Activities to obtain a candidate that are covered under CREATE Bio Discovery Track
    • Activities already performed utilizing other private or public funds to advance the agent
    • Performance of a clinical trial with the objective of demonstrating clinical efficacy
  24.  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

  25. 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.

  26. Are IND enabling toxicology studies supported in the CREATE Discovery track?

    No, they are only supported  in the CREATE Bio Development track.

  27. Who do we contact if we have questions?

    CREATE Program:  Hao Wang, Ph.D. CREATEinquiries@mail.nih.gov

Last updated January 29, 2015