Apply for CIRM's Preclinical Development Stage (PDEV) Research Funding
Accelerating Therapies to the Clinic, Pre-submissions are Due in June
The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world.
CIRM’s Preclinical Development (PDEV) funding program supports completion of preclinical studies, FDA Investigational New Drug (IND) clearance, and clinical trial startup for innovative stem cell-based and genetic therapies.
This partnership model helps applicants navigate key preclinical milestones and maximizes the likelihood of success. This vision is achieved through a critical path approach emphasizing collaboration, knowledge sharing, and strategic alignment with CIRM’s broader goal of advancing 15 to 20 therapies into late-stage clinical trials. The awards may support a range of activities, from candidate optimization to IND-enabling studies and trial startup, ensuring a smooth path toward clinical readiness.
Download the PDEV Program Announcement (PA) for more information on award eligibility, review criteria, and the application process.
Important: All prospective PDEV applicants must first complete a Pre-submission Form.
Download Program Announcement PDF
Expected Outcomes
The expected outcome of all PDEV awards is the clearance of an IND application with the FDA for the stem cell-based or genetic therapy candidate.
To be eligible, applications must meet following list of eligibility requirements:
- The application must propose studies to support submission and clearance of a single IND application with the FDA for the proposed stem cell-based or genetic therapy
- The application must provide data demonstrating that reproducible disease-modifying activity was achieved with the proposed candidate
- The applicant organization must meet CIRM’s definition of a California Organization
Award Amount & Duration
The maximum total funding for a PDEV award is $13 million per award. The maximum award duration is 5 years.
Related Events
