Pre-Clinical Research Request for Applications

Eligibility

• The Primary Investigator (PI) must have a doctoral degree or equivalent terminal professional degree (e.g. MD, DVM) and must be beyond the postdoctoral level.   
• PIs from academic or private institutions or companies from any country may apply. Industry and academic partnerships are encouraged.
• A single PI must be identified who is responsible for the application, communications, and research conduct.  Sub-investigators are allowed.
• PIs may only submit one application.
• Only one submission will be accepted from the same lab or company.  
• Financial relationships of the PI with a corporate applicant must be disclosed.
• Industry and academic partnerships are encouraged for necessary drug development expertise

Summary

This RFA supports pre-clinical (non-human)) research of new or repurposed drugs and biologics in the areas of neuroprotection, regeneration and plasticity, at the pre-IND or pre-IDE development stage. This RFA does not encompass full drug screens, IND/IDE enabling studies or clinical as the costs are beyond the scope of this RFA.

Suggested areas of focus (applicable areas for drugs, biologics and devices are within the scope of this RFA):

• Pre-clinical in vitro and/or in vivo studies.
• Assay development (including target based assays for drug screening, target engagement and potency assays), lead candidate optimization, studies confirming mechanism of action, evidence of target engagement and selectivity for spinal cord injury relevant mechanisms of action potency, selectivity screens, mechanistic studies, evidence on blood spinal cord penetrance.
• Proof of concept studies validating potential benefits of a therapeutic strategy in pre-clinical spinal cord injury models.
• Dose, timing, non-GLP toxicology, pharmacokinetics and pharmacodynamics, biomarker development in preclinical spinal cord injury studies.
• Medical devices in similar pre-clinical development stages and areas of focus (including benchtop studies).

Phenotypic drug development/targets will be considered if a mechanistic rationale is provided.

Funding/Budget

• Duration: 1-2 years
• Amount: Up to $250,000
• All budgets must be in USD.
• Subcontracting to contract research organizations (CROs) is allowed and encouraged particularly where needed expertise is not otherwise available.  Resources for CROs may be found at the NIH Blueprint website.

The total budget includes direct and indirect costs.  Indirect costs are limited to 10% of the total budget.

Agency Deadlines

• RFA open: October 31, 2024
• Informational Webinar: November 12, 2024, 11AM ET / 9:00 AM MT 
• Letters of intent due: December 12, 2024, 5 PM ET / 3:00 PM MT

Overhead

Limited to 10% of the direct costs.

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

SUBMISSIONS

This RFA will be a two-stage process with an initial LOI submissions and review, followed for an invitation only full grant application process.

All LOIs must be submitted through our online portal at: Pre-clinical RFA online submission portal .  We strongly encourage applicants to view the screens in the online portal system before beginning a LOI.  All communications and correspondence will be sent to the identified PI.

All submissions undergo an administrative and scientific review by individuals under a confidentiality agreement.

Applicants should ensure that submitted proposals fit the goals of the funding program, are clearly and logically written, with sufficient details to ensure that reviewers understand all critical aspects of the proposed project methods and plan.  Given the length of the LOI (approximately two pages) it is not possible to provide the full scope of the methodological details but sufficient detail to assess strategy should be provided.

For questions about the letter of intent application process and the online system please contact Maria Fonseca, Grants Associate at FoundantHelp@Reeve.org. For questions about the scope of the application, please contact Linda Jones, PT, PhD, Reeve Senior Scientific Director Consultant at LJones@Reeve.org. Please note questions must be sent no later than 48 hours prior to the submission deadline.

The following sections are included in the online LOI:

Administrative Section (Required)
Applicant details, high level information on therapeutic, project team and budget summary. See online for details.

Letter of Intent Summary (Required)
Please label each section in the LOI summary section (10,000-character limit) per headings below and address the requested information under each heading.

Impact: Indicate how a successful outcome of the proposed plan would lead to future development efforts, including ultimate goals and estimated timeline for moving the therapeutic into the next stage of development.

Indication:  Describe whether the proposed therapeutic is intended to address neuroprotection, regeneration, and/or plasticity, at what stage of SCI, and in what target SCI population (if known, e.g. severity, level of injury).

Therapeutic: Describe the specific therapeutic being developed, the mode of action, and how the therapeutic was identified. Please identify the strengths and weaknesses of the proposed therapeutic.
Target: Indicate the biological target and hypothesized mechanism and pathway for which you propose to develop a traumatic SCI therapeutic. If available, provide evidence of target engagement.

Stage of Development: Describe the current stage of development of the proposed therapeutic (e.g., high-throughput screening, hit-to-lead, lead optimization, or pre-clinical drug candidate nomination) and discuss relevant data (preclinical and/or clinical) that justifies the progression of the therapeutic to the next development stage (e.g., bioavailability, PK/PD relationships, safety). For drugs, as a guidance, you may refer to the Optional Appendix (Therapeutic Template Profile) Studies to collect gaps in the data can be proposed as part of your application.

Development Plan: Describe and justify the study(ies) you wish to complete to move the proposed therapeutic forward. How do these studies fit into the big picture of developing a therapeutic for persons with SCI?

IP/Competitive Landscape: Describe any intellectual property considerations and/or restrictions that may impact how further development of the proposed therapeutic will proceed (e.g., the existence of competing technologies or legal barriers to commercialization).  Please note that if invited to submit a full grant application (FGA), applicants must describe what data can be shared considering IP.

Additional Requirements

• All applications must be in English with budgets in US dollars.
• Awards will be milestone based and subsequent funding will be contingent upon successful milestone completion.  As drug discovery and development are high-risk, if awarded, milestones and communication will be frequent (no less than every six months) to enable problem solving between the PI and funding agencies and their experts. Continued funding is based on successful achievement of milestones or identification of alternative strategies. However, the Reeve Foundation and Spinal Research will work with applicants and provide expert resources where possible to address challenges that may arise.
• Intellectual property will be held by the grantee/organization undertaking the research.

Informational Webinar

An informational webinar will be held on November 12, 2024 at 11AM ET to clarify and explain the goals of this RFA and answer applicant questions. The webinar will be available to view on-demand after the live air date.

Click here to register.

Invited Applications

• Full grant application invitations: January, 2025 (deadline forthcoming)
• Full grant applications due: March 2025 (deadline forthcoming)
• Anticipated award announcement: June 2025
• Anticipated funding: August 2025

Additional Resources

Using RMS:

RMS: Creating a Pre-Award LOI

RMS: Creating a Pre-Award Application

Support for projects involving Indigenous Research:

Support with the development of your grant application is available internally through the Indigenous Research Support Team (IRST). Applicants can reach out by email to IRST at IRST@ucalgary.ca in advance of the RSO internal deadline. For more information about IRST, please visit the IRST webpage.

Support for Knowledge Engagement:

Support for knowledge mobilization/engagement/translation is available internally through the Knowledge Engagement Team. Applicants can reach out by email to the KE team at knowledge.engagement@ucalgary.ca in advance of the RSO internal deadline. For more information, please visit the KE team webpage.

Support for Research Data Management:

For information on research data management plans, processes, or best practices for your research program, please contact research.data@libanswers.ucalgary.com and/or visit https://libguides.ucalgary.ca/researchdatamanagement.

Support for EDI in Research:

RSO can provide resources and support to research teams on the integration of equitable and inclusive practices in research design and research practice. Contact Erin.OToole@ucalgary.ca for more information.