Pre-Clinical Research RFA Description
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.
Eligibility and Requirements
- 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.
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.
Data Sharing and Publication
- Open access publications are encouraged and funds may be allocated within the budget for this purpose.
- Open data sharing of non-intellectual property is required and a plan for data sharing is part of the application process. If patent protection is being sought, investigators should explain what data may be shared at the time the grant is completed and how data will be shared after filing for patent protection to allow for both further research and the development of commercial products to advance.
- Any data repository may be used as long as FAIR (Findability, Accessibility, Interoperability, Reusability – Wilkinson et al., 2016, DOI: 10.1038/sdata.2016.18) share principals are observed. Investigator are strongly encouraged to set up data in a way that supports data sharing The Open Data Commons for SCI (an option for data sharing) has general guidelines for preparing data for sharing, which can be applied to other data bases.
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.
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