Preclinical Development (PDEV) Awards
Accelerating Therapies to the Clinic
PDEV Pre-submission forms are now available
Pre-submission forms are due by June 12, 2025
Photo Credit: City of Hope
Preclinical Programs at CIRM
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 program aims to promote therapies addressing unmet medical needs that lack sufficient support from federal or private funding sources.
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.
PDEV Awards: Key Information
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.
Preference Topics
For fiscal year 2025-2026 PDEV cycles, the following project features will be prioritized.
- Pluripotent stem cell-derived therapies
- In vivo genetic therapies
- Therapies using non-viral nucleic acid delivery
- Programs addressing diseases of the brain and CNS
- Programs progression from DISC2 and TRAN1 awards
- Programs in which a pre-IND or INTERACT meeting has been conducted
Funding Allocation
CIRM anticipates funding between 12-21 PDEV awards in FY25-26, contingent on the ratio of Early PDEV and Late PDEV applications recommended for funding.
Project Eligibility
Below is a select list of eligibility requirements for reference. Applications must meet the complete list of eligibility requirements defined in the PDEV PA in order to be considered for CIRM funding.
- 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.
Applicants may request CIRM support for preclinical development activities spanning pre-IND and IND-enabling stages. The maximum overall award amount and duration as well as expected funds requested and duration for each individual stage are described below.
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.
How to Submit a Pre-submission Form:
Log in with your existing CIRM Username and Password. If you do not have a Username, click on the “New User” link and follow the instructions to Create a CIRM Username and password.
Navigate to “Open Programs”. Click on “Start a Pre-submission Form for prospective PDEV applicants”.
Click on the appropriate link and follow the posted instructions. Proposal outline templates can be located and submitted under the “Document Uploads” section.
Click on the “Done with Application” button. The “Done with Application” button will be enabled when all the mandatory sections have been completed.
Note: Once submitted, you can no longer make changes to your application.
Select the tab labeled “Your Applications” and check the table under the section labeled “Your Submitted Applications.” You will see your Pre-submission number and project title listed once the submission process has been completed.
Pre-submission forms for the PDEV Awards will be available on May 13, 2025. Pre-submission forms must be submitted by June 12, 2025.
CIRM Grants Policies, FAQs, and Primers
- Data Sharing and Management Requirements
- Access and Affordability Planning Requirements [link to document]
- Allowable Costs and co-funding FAQ
- Commercialization Rights Primer (IP, Revenue Sharing, Pricing, Access, March-in Rights)
- Grants Administration Policy for Clinical Stage Projects
- CIRM Funding Opportunities: Common Requirements and Definitions
Preclinical Development Resources
PDEV Webinar
CIRM will host a live informational webinar and Q&A session on May 22, 2025 at 11 AM (PST).
PDEV FAQ
The applicant organization must be a California organization per CIRM’s definition. A “California Organization” is a for-profit or non-profit organization or is a California-domiciled wholly owned subsidiary of a non-California organization (any entity that does not qualify as a California Organization) that meets all of the following criteria:
- Employment and Payroll: Employs at least one W-2 employee; and more than 50% of its W-2 employees, whether part-time or full-time, who are paid in any manner (e.g., wage, salary, commission, equity), must be domiciled full-time in California and be required to file California state income taxes due to their employment with the organization.
- Management of Award Activities: The Principal Investigator (PI) must be physically located in California while overseeing all project activities.
- Intellectual Property Rights: In the case of a California-domiciled wholly owned subsidiary of a non-California organization, the subsidiary must retain exclusive rights to any intellectual property arising out of the CIRM-funded project as well as any pre-existing IP rights held by the parent organization.
To ensure that proposals most well-aligned with the funding area preferences, scope, and objective of the program receive an in-depth scientific review by the Grants Working Group (GWG) panel, CIRM has implemented a Pre-submission process for the PDEV Awards. The PDEV Pre-submission must be completed through CIRM’s online grant portal and includes the following sections:
- Online intake section.
- Information on Core Team members, Project Title/Keywords and eligibility certifications.
- Information on the project: project stage, therapeutic candidate, mechanism of action, indication, disease burden, value proposition, disease treatment landscape, major activities, prior regulatory interactions, prior CIRM funding.
- Eligibility: Data and information in support of candidate eligibility and disease modifying activity
Pre-submissions will be evaluated by CIRM staff to assess alignment with program objectives and scope, incorporating funding preferences set annually by the ICOC. Pre-submissions will NOT be evaluated for scientific merit or feasibility. Only selected pre-submissions will be invited to submit a full application.
The maximum total funding for a PDEV award is $13 million per award. The maximum award duration is 5 years.
Early PDEV (Pre-IND) and Late PDEV (IND-enabling) refer to the two stages of preclinical development encompassed by PDEV awards. Projects that meet the candidate readiness eligibility criteria may request CIRM funding for Early and/or Late PDEV activities to achieve the expected outcome of IND clearance with the FDA for the proposed therapy.
Applicants may not request funding solely for Early PDEV activities that won’t achieve the expected award outcome. Applicants may request funding solely for Late PDEV activities if FDA pre-IND feedback has already been obtained for the proposed project.
No. An applicant that meets PDEV eligibility criteria (i.e. candidate readiness) can apply for funding at any point to achieve the expected award outcome of IND clearance.
Programmatic questions regarding this award should be emailed to preclinical@cirm.ca.gov with the subject line “PDEV”. Specific questions related to budget and Grants Administration policies should be emailed to grantsmanagement@cirm.ca.gov with the subject line “PDEV”.
