Preclinical Development (PDEV) Awards is sponsored by California Institute for Regenerative Medicine (CIRM). Supports preclinical studies and FDA Investigational New Drug clearance for stem cell-based and genetic therapies.

Preclinical Development (PDEV) Awards Accelerating Therapies to the Clinic Important Update: New Application Selection Process CIRM is changing the way we review applications to select those that go forward to full review. We will now apply program-specific guiding principles throughout the application process. Updated Program Announcement and application details coming in late May.

Applications for the next PDEV funding cycle will open June/July 2026. The applications will be due October 2026. 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 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 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. 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 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.

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 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 in the PA.

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 PDEV Program Announcement How to Submit a Pre-submission Form: 1.

Go to the Grants Management Portal 2. After logging in, click on the Menu tab Navigate to “Open Programs” . Click on “Start a Pre-submission form for Preclinical Development Program (PDEV)” .

3. Complete each section of the Pre-submission Form Click on the appropriate link and follow the posted instructions. Proposal outline templates can be located and submitted under the “Document Uploads” section.

4. To submit your Pre-submission Form Click on the “Submit PDEV_Pre_Sub-XXXXX” button. The button will be enabled when all the mandatory sections have been completed.

Note: Once submitted, you can no longer make changes to your pre-submission. 5. To confirm submission of your Pre-submission Form 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. PDEV Pre-submission forms are currently closed.

CIRM Grants Policies, FAQs, and Primers Data Sharing and Management Requirements Access and Affordability Planning Requirements Allowable Costs and co-funding FAQ Commercialization Rights Primer (IP, Revenue Sharing, Pricing, Access, March-in Rights) Grants Administration Policy for Clinical Stage Projects Preclinical Development Resources Industry Resource Partner Program CIRM California Academic Cell and Gene Therapy Manufacturing Network CIRM Alpha Clinics Network PDEV Application Resources PDEV Informational Webinar Recording – Recorded May 22, 2025 PDEV Informational Webinar Slide Deck [PDF] PDEV Reference Application Proposal Template [PDF] 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. What is the Pre-Submission process and how does it work?

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: 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.

What is the award amount and duration? The maximum total funding for a PDEV award is $13 million per award. The maximum award duration is 5 years.

Are Early PDEV and Late PDEV two separate awards and can I apply for just one stage of funding? 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. Do I need to have conducted a Pre-IND meeting to apply for PDEV?

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. Who can I contact with any questions about PDEV? 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”.