Global RFPs from Academic Investigators Working to Advance Drug Development Projects

Deadline Date: March 31, 2024

Donor Name: Critical Path Institute (C-Path)

Grant Size: $500,000 to $1 million

Critical Path Institute’s (C-Path) Translational Therapeutics Accelerator (TRxA) has announced its 2024 global Request for Proposals for its Breakthrough Research and Innovation in Drug Development Grants, also known as BRIDGe.

These BRIDGe awards are designed to support academic researchers in traversing the drug development valley of death by providing funding and defining optimal strategies for advancing new, cutting-edge therapeutics from the lab to patients.

As a nonprofit drug accelerator, TRxA provides the following for principal investigators who are selected to receive a BRIDGe award:

• Tactical and strategic drug discovery and development expertise, including regulatory science considerations.
• Resources and hands-on guidance, working closely with academic researchers to develop comprehensive data packages for potential drug candidates, a key to garnering interest from biotechnology and pharmaceutical companies to invest in clinical trials.
• Engagement of contract research organizations (CRO) to perform critical discovery phase experiments and/or validate academic studies.

Funds awarded through BRIDGe are provided for the purpose of carrying out research studies directly related to the project as documented in the approved research plan (either at the institution or through a contract research organization).

Funding Levels

• Stage 1
  • Early lead optimization to late lead series. Funding up to $250,000 (direct + indirect costs) for up to 1 year.
• Stage 2
  • Late lead series to selection of clinical candidate. Funding up to $500,000 (direct + indirect costs) for up to 1 year.
• Stage 3
  • Candidate selection through IND enabling studies. Funding up to $1,000,000 (direct + indirect costs) for up to 1 year.

Tools

• Alzheimer’s Pre-dementia Clinical Trial Enrichment Tool
• Alzheimer’s Disease Clinical Trial Simulation Tool
• Early Motor Parkinson’s DAT Clinical Trial Enrichment Tool
• Islet Antibody Clinical Trial Enrichment Tool
• PRO Consortium Measures and Licensing
• Rare Disease Clinical Outcome Assessment Resource

Platforms

• Critical Path for Alzheimer’s Disease Database
• Duchenne Regulatory Science Consortium Database
• Friedreich’s Ataxia Integrated Clinical Database (FA-ICD)
• Integrated Parkinson’s Database
• The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database
• Polycystic Kidney Disease Outcomes Consortium Database
• The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP®)
• TB Platform for the Aggregation of Preclinical Experiments Data (TB-APEX)
• TB Platform for Aggregation of Clinical TB Studies (TB-PACTS)

Who is eligible for TRxA funding?

• Faculty at universities and nonprofit institutions, anywhere around the world.
• Funding is available for projects at academic or non-profit organizations anywhere around the globe.
• Peptidomimetics would qualify for funding, but the molecular weight should be less than around 1000 Dalton.
• Depending on the Stage of projects, they anticipate funding 3-7 projects per year, in the coming years.
• To be eligible for BRIDGe funding and support, investigators need to hold a faculty appointment at a university or non-profit research institution, and intellectual property (IP) associated directly to the project cannot yet have been out-licensed.

Entry Criteria

• Stage 1
  • Project is in early drug lead optimization.
  • Tractable drug leads from multiple chemical series have been identified (demonstration of optimizable structure-activity-relationships [SAR]).
  • Established in vitro pharmacology assays (biochemical and cell-based potency and selectivity).
  • Access to an available or conceived in vivo pharmacodynamic model.
• Stage 2
  • Well defined compound progression pathway with established success criteria.
  • Optimized leads from multiple series (demonstration of optimizable SAR).
    • Characterized in vitro pharmacology properties including cellular activity
    • Characterized ADME properties (in vitro and rodent in vivo)
    • Demonstrated in vivo pharmacology in pharmacodynamic model
  • Access to an available or conceived in vivo efficacy model.
• Stage 3
  • Defined target product profile (TPP).
  • Optimized molecule meeting candidate selection success criteria.
    • Characterized in vitro and in vivo pharmacology properties including demonstrated efficacy in in vivo efficacy model
    • Characterized ADME properties (in vitro and rodent/non-rodent in vivo)
    • Characterized Toxicology properties (in vitro and rodent/non-rodent in vivo)
    • Defined nonclinical formulation
  • Defined good manufacturing practices (GMP) API scale up and characterization plan.

For more information, visit Critical Path Institute (C-Path).