CIRM PDEV: Preclinical Development Awards for Stem Cell and Genetic Therapies
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Quick Answer
CIRM's Preclinical Development (PDEV) program funds California organizations developing stem cell based or genetic therapies that are ready to move through IND enabling studies toward FDA clearance and a first in human clinical trial. Awards go up to $13,000,000 total cost over as long as 5 years, split into an Early PDEV (Pre IND) stage worth up to $5,500,000 and a Late PDEV (IND Enabling) stage worth up to $7,500,000. Applications must show reproducible disease modifying activity in a relevant preclinical model before CIRM will consider funding. The program recurs once per year, and CIRM anticipates funding between 12 and 21 awards in FY26-27.
Program Overview
CIRM's mission is to accelerate world class regenerative medicine science for the benefit of California patients. Under its Strategic Allocation Framework, CIRM has set a goal of advancing 15 to 20 therapies to late stage clinical trials. PDEV is one of CIRM's core product development programs built to help hit that goal. Unlike many funding mechanisms, PDEV is not a passive check writer. CIRM commits internal staff and an external network of subject matter experts to actively work alongside the awardee team on regulatory strategy, CMC, and clinical planning.
The objective of PDEV is straightforward. Take a therapeutic candidate that already has reproducible disease modifying data, and fund the work needed to clear an IND with the FDA and start a first in human trial. CIRM structures this into two possible stages:
Early PDEV covers Pre IND activities. This includes finishing candidate optimization, conducting a Pre IND meeting with the FDA, and preparing everything needed to enter pivotal IND enabling studies.
Late PDEV covers IND Enabling activities. This includes GLP toxicology and safety studies, CMC and GMP manufacturing scale up, submission and clearance of the IND itself, and clinical trial startup activities to prepare for rapid patient recruitment.
An applicant can request funding for one stage or both in a single application.
Who Should Apply
This opportunity is built for companies and nonprofit research organizations developing a stem cell based therapy or a genetic therapy that already has strong preclinical proof of concept. If your candidate has not yet shown reproducible disease modifying activity in a model relevant to your target indication, you are not ready to apply. CIRM is explicit that it will refuse applications submitted before all eligibility prerequisites are met.
You are a strong fit if:
You are a California organization, nonprofit or for profit, under CIRM's definition of a California Organization.
You have a single, finalized human therapeutic candidate, not multiple candidates under parallel evaluation.
You can name your Principal Investigator, and that person can commit at least 15 percent effort.
You have or can bring on an experienced Project Manager at 50 percent effort and a Data Project Manager to handle data sharing obligations.
Your organization, not an outside partner, will be the IND sponsor of record.
You have at least one clinical trial site in California, or a solid justification for using outside sites.
You can be ready to start funded work within 90 days of award approval.
Funding Allowance
Maximum total award: $13,000,000 in total cost, over a maximum of 5 years (60 months).
Early PDEV (Pre IND) stage: up to $5,500,000, over up to 30 months. That 30 month window includes an optional 6 months specifically for candidate optimization work.
Late PDEV (IND Enabling) stage: up to $7,500,000, over up to 30 months. That window includes an optional 6 months for clinical trial startup activity that follows IND clearance.
Allowable costs include direct project costs, facilities costs, and indirect costs, all governed by the CIRM Grants Administration Policy for Clinical Stage Projects. For profit organizations cannot claim indirect costs. Nonprofit indirect costs are capped at 20 percent of allowable direct research funding, exclusive of equipment, tuition, patient care costs, and large subcontracts over $25,000.
Applicants requesting both stages in one application must budget them separately with no overlap, though CIRM allows up to $1,500,000 of well justified Late PDEV activity that is not dependent on FDA feedback to happen ahead of the Pre IND meeting, such as GMP manufacturing runs at a CDMO.
Co-Funding Requirements
Unpartnered nonprofit applicants: no co-funding required.
Nonprofit applicant with a for profit partner: the for profit partner must commit 20 percent of total allowable project costs.
For profit applicants: must commit 20 percent of total allowable project costs.
Co-funding can be cash based or warrant based. Warrant based co-funding lets a for profit applicant issue equity warrants to CIRM instead of cash, but requires signing a Warrant Term Sheet at the time of application and issuing the warrants at award start.
Eligibility Requirements Snapshot
The application must target a single IND for one stem cell based or genetic therapy candidate.
The candidate must have documented, reproducible disease modifying activity in a relevant preclinical model. If the candidate is manufactured from a single cell source, the exact test article used in that data must be identical to the candidate moving forward. If it comes from multiple cell sources or donors, disease modifying activity must be shown across at least two donor sources or cell lines using comparable manufacturing.
Allogeneic donor cell projects need documented donor consent covering clinical development and commercial sale, plus compliance with Good Tissue Practices under 21 CFR 1271.
The applicant organization must be the named IND sponsor.
The applicant must maintain at least one California clinical trial site.
The applicant organization must meet CIRM's definition of a California Organization, must demonstrate solvency if for profit, and must be in good standing.
What CIRM Will Not Fund
Conducting a clinical trial beyond startup activities.
Patient recruitment, screening, or enrollment.
Costs already covered by a prior, current, or future CIRM award.
Work performed by an out of state organization that would retain independent IP or publication rights over what comes out of the CIRM funded project.
Costs incurred before the date of ICOC board approval.
Timeline
The PDEV program runs once per year. After the application deadline, here is roughly what to expect:
Grants Working Group (GWG) selection happens approximately 60 days after the submission deadline.
GWG discussion of selected applications happens approximately 30 days after selection.
Award approval occurs at the next available Application Review Subcommittee (ARS) meeting of CIRM's governing board.
Awardees must be ready to start work within 90 days of award approval.
How Applications Get Reviewed and Scored
If the volume of submitted applications is too high for the GWG panel to discuss all of them, CIRM runs an initial screening round. Applications get a composite score built from a selection weight (60 percent) and a rank weight (40 percent), based on clinical impact potential, unmet need, and feasibility of patient uptake. Only the top scoring group advances to full GWG discussion.
Applications that make it to full review are scored by 15 outside scientific experts on a 1 to 100 scale. A median score of 85 or higher qualifies the application as having exceptional merit and eligible for funding if funds are available. A median score below 85 is not recommended for funding.
Separately, patient advocate and nurse members of the GWG apply a 1 to 5 Patient Perspective Score. This does not directly change the scientific score, but it can influence discussion and the ARS funding decision.
The five scored review criteria are:
Value Proposition, meaning the clinical improvement the therapy offers over existing options and its potential to address unmet need and improve access.
Rationale, meaning how strong the underlying science and preclinical data are.
Project Plan and Design, meaning whether the proposed activities, budget, and timeline realistically get the project to an active IND.
Project Team and Resources, meaning whether the team has the regulatory, CMC, clinical, and manufacturing expertise and facilities to execute.
Population Impact, meaning how well the applicant understands the demographics and genetic or environmental factors relevant to the target population.
Award Administration After Funding
CIRM disburses funds against Operational Milestones rather than as a lump sum or simple reimbursement schedule. Each milestone releases additional funds once it is achieved. If an awardee misses a milestone by more than four months without resolving it to CIRM's satisfaction, CIRM can cut off disbursements and terminate the award.
Awardees also get access to CIRM's Product Development Expert Network, a group of contracted specialists in CMC, clinical, preclinical, and regulatory strategy who advise on individual projects. Any awardee planning a Pre IND meeting must review their strategy and package with CIRM and this expert network before submitting to the FDA.
Awardees are required to participate in the PDEV Knowledge Network, a pre-competitive knowledge sharing structure across CIRM's portfolio of awardees, and must budget for data management and sharing consistent with FAIR principles.
Frequently Asked Questions
What is the CIRM PDEV program? PDEV is a California Institute for Regenerative Medicine funding opportunity that supports preclinical development of stem cell based and genetic therapies through IND clearance and clinical trial startup, with awards up to $13,000,000.
Who is eligible to apply for a PDEV award? Only California organizations, nonprofit or for profit, that meet CIRM's definition of a California Organization can apply. The applicant must be the IND sponsor, must have a candidate with proven disease modifying activity, and must maintain at least one clinical trial site in California.
How much funding can a PDEV award provide? Up to $13,000,000 total cost over up to 5 years. Early PDEV, the Pre IND stage, caps at $5,500,000 over 30 months. Late PDEV, the IND enabling stage, caps at $7,500,000 over 30 months.
Does PDEV require co-funding or matching funds? Unpartnered nonprofits do not need co-funding. For profit applicants, and nonprofits with a for profit partner, must commit at least 20 percent of total allowable project costs, either in cash or through equity warrants issued to CIRM.
What stage of development does my project need to be at? Your candidate needs reproducible, documented disease modifying activity in a preclinical model relevant to your target indication before you apply. This is a hard eligibility gate, not a scoring preference.
Can I apply for both the Pre IND and IND Enabling stages at once? Yes. Applicants can request funding across both Early PDEV and Late PDEV stages in a single application, though the two stages must be budgeted separately with defined, non-overlapping activities.
How long does the CIRM review process take? Roughly 60 days after the deadline for GWG selection, another 30 days for GWG discussion, then award approval at the next scheduled Application Review Subcommittee meeting. Once approved, awardees must start work within 90 days.
What review score does an application need to get funded? Applications need a median scientific score of 85 or higher out of 100 from the Grants Working Group to be considered to have exceptional merit and be eligible for funding.
Does CIRM fund the actual clinical trial? No. PDEV funds trial startup activities only, meaning protocol development, site preparation, and operational readiness. It does not fund patient recruitment, screening, enrollment, or the conduct of the trial itself.
How many PDEV awards does CIRM expect to fund this cycle? CIRM anticipates funding between 12 and 21 PDEV awards in FY26-27, depending on the mix of Early PDEV and Late PDEV applications recommended for funding.
Who is the IND sponsor under a PDEV award? The CIRM applicant organization itself, or the CIRM Principal Investigator in the case of an investigator sponsored IND. An outside partner cannot serve as the sponsor.
What kind of team does CIRM require on a PDEV application? At minimum a Principal Investigator at 15 percent effort, a Project Manager with relevant preclinical development experience at 50 percent effort, and a Data Project Manager responsible for data handling and sharing obligations.
