California Institute for Regenerative Medicine (CIRM): Preclinical Projects

If you are interested in the following opportunity, please contact Carole King at [email protected].

• Application Due: October 8, 2026
• Amount: $13,000,000
• Project Period: Five years

The California Institute for Regenerative Medicine’s Preclinical Development (PDEV) program funds California-based organizations developing stem cell-based or genetic therapies toward FDA IND clearance and first-in-human trial readiness. Projects may cover Early PDEV activities, such as candidate optimization, preclinical studies, CMC development, and FDA pre-IND preparation, as well as Late PDEV activities, including IND-enabling studies, GMP manufacturing, IND submission, and limited clinical trial startup.

Awards may provide up to $13 million over five years, with up to $5.5 million for Early PDEV and $7.5 million for Late PDEV. CIRM anticipates funding approximately 12–21 awards annually.

A prospective PI should confirm that the project has already demonstrated reproducible disease-modifying activity with a candidate suitable for clinical development. The PI must commit at least 15% effort, the team must include an experienced project manager at 50% effort and a data project manager, and the applicant must serve as the IND sponsor and include at least one California clinical trial site.

Applications will be judged primarily on the therapy’s clinical value, scientific rationale, project plan, team and resources, population impact, patient access strategy, and likelihood of achieving IND clearance within the proposed budget and timeline.