The In vitro Disease Modelling: Type I Diabetes-on-a Chip Platforms for Translational Research RFA directly addresses this need by supporting the validation and refinement of advanced organoid and organ-on-a-chip platforms that integrate human β cells in combination with immune cells, vascular and/or lymphatic elements to model T1D pathogenesis and therapeutic response. Breakthrough T1D encourages applicants to design projects with regulatory relevance in mind, generating data that could support future NAM-based preclinical evaluation. Specifically, projects that contribute to the following FDA-recommended steps will be viewed favorably:
• Mapping critical endpoints: NAM-based models should aim to replicate key human-relevant safety and efficacy outcomes,
such as β-cell toxicity, immune response, engraftment, and pharmacodynamics of cell- or disease-modifying therapies;
• Supporting NAM development: Proposals that refine or validate organoid- or organ-on-chip systems to predict human
response directly contribute to FDA’s roadmap for NAM adoption;
• Establishing validation and qualification pathways: Projects should focus on rigorous benchmarking against clinical data,
demonstrating reproducibility, mechanistic insight, and predictive power, critical elements for potential FDA qualification.
Learn more here
Letter of Intent due: January 28, 2026
Full Proposal due: March 11, 2026
Follow
