Preclinical Development
CIRM's PDEV program funds preclinical research to advance stem cell and genetic therapies toward FDA IND clearance and clinical trial startup for diseases impacting Californians.
Funder: California Institute for Regenerative Medicine
Due Dates: October 31, 2026: Preclinical Development (PDEV) full application deadline
Funding Amounts: Up to $13 million per award | Maximum project duration: 5 years | Typical stage budgets: $5.5M (Early PDEV, 30 months), $7.5M (Late PDEV, 30 months)
Summary: Supports preclinical development of stem cell and genetic therapies to advance transformative treatments for diseases affecting Californians.
Description
The Preclinical Development (PDEV) program from the California Institute for Regenerative Medicine (CIRM) aims to accelerate the completion of preclinical development, FDA Investigational New Drug (IND) clearance, and clinical trial startup for stem cell-based and genetic therapies. The program is designed to advance innovative therapies for diseases affecting Californians, particularly those that address barriers to patient access and promote equitable delivery of regenerative medicine. The expected outcome of all PDEV awards is FDA IND clearance for the proposed therapy candidate.
CIRM provides not only funding but also expert guidance and access to a network of resources, fostering collaboration and knowledge sharing among awardees. The program emphasizes strategic planning for patient access, robust data sharing, and integration into the CIRM Knowledge Network.
