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Home Tomorrow's Cure Biomarker Rfa Biomarker RFA Description

Biomarker RFA Description

A biomarker is defined as a characteristic that is measured as an indicator of a normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions.  There are no FDA qualified biomarkers in SCI, nor any widely accepted/utilized biomarkers.

This RFA supports development and/or validation of biomarkers of any class or type. Classes of biomarkers may include but are not limited to histologic, molecular, biochemical, radiographic, physiologic and digital.   Types of biomarkers relevant to SCI include monitoring, prognostic, predictive, pharmacodynamic/response and safety.  Biomarkers may be relevant for interventions at all stages and severities of SCI, in both non-clinical and clinical studies, and in all body systems.

Potential areas of focus include biomarkers that:

  • Address target engagement at preclinical and/or clinical development stages.
  • Address pathways or mechanism of action.
  • Are conserved across species (pre-clinical and clinical).
  • Address any body system. Consider body systems that are important to people living with SCI but may be understudied (examples include respiratory, sensation, pain, and microbiome).

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.  
  • Applications from junior faculty are encouraged.
  • 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.

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. 

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 – Wilkerson et al., 2016, DOI: 10.1038/sdata.2016.18) share principals are observed. Investigators 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 (https://odc-sci.org/about/tutorials#prepare).

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.  If awarded, communication regarding milestones will be frequent (no less than every six months) to enable problem solving (if needed) 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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