CIRM 2.0 FAQ

What is CIRM 2.0?
How does it work?
If the Board rejects our application can we re-apply?
Who can apply?
Why are you doing this?
Will you offer grants or loans to those interested in applying for funding?
Do I have to be in California to apply?
What are the project eligibility requirements?
What are the therapeutic candidate requirements?
What are allowable costs and is there a co-funding requirement?
How much money is allocated for CIRM 2.0 and how much can I ask for?
When did this start?
How can I find out more about applying for funding under CIRM 2.0?

What is CIRM 2.0?

CIRM 2.0 is a new, streamlined process that significantly reduces the amount of time it takes to approve funding for promising stem cell research and potential stem cell therapies. CIRM 2.0 is designed to attract high quality projects that are ready to make progress quickly.

In the past, it could take up to two years to go from an initial application for funding for a clinical stage project to actually getting the money. And if you missed that application cycle, it could be another year before another one came around again. Clearly that’s too long on both counts.

CIRM 2.0 simplifies and accelerates the funding process, cutting that two years down to just four months. And if you miss that deadline for a clinical stage grant application, you only have to wait one month for the next application deadline to come around. For earlier-stage research projects, the application window is approximately every six months. This means that you don’t have to try and rush in an application before you are ready for fear it could be another year before the chance comes around again.

Under CIRM 2.0 you only apply when you have a project that is ready to start within 45 days of it being approved for funding by our Board.

How does it work?

CIRM 2.0 radically changes the way you apply for funding for a clinical trial. Instead of having a single round of funding with one application deadline every, say, 12 months, we will have an open application program with deadlines every month.

Applications will be due by 2pm on the last business day of each month. Once the application is received, our CIRM science team will review it to make sure it meets the requirements as laid out in the Program Announcement (PA).

If it does, it will then be forwarded to an external budget review group, which will assess the project to determine if it has a budget that is appropriate for the level and scope of the work that is being proposed. If the budget review group feels that the project is asking for far more money, or far less money, than the work really needs, they’ll have the ability to re-adjust the budget. The applicant will then have the chance to accept or reject those budget recommendations. If they accept the recommendations, the project moves to the next level. If they reject the recommendations, the project itself is rejected.

The next step is for the project to be reviewed by our Grants Working Group (GWG) an independent panel of experts from around the world. They will assess the scientific merits of the application and give it a score between 0 and 100. Applications are then divided into three tiers based on their scores. Tier 1 applications are recommended for funding. Tier 2 are not recommended for funding as the appliction stands, but the GWG is able to make suggestions on how the applicant can correct problems or improve their proposal. The applicant can revise their application and make their corrections and re-apply for the next funding cycle, or when they're ready. This enables them to increase their chances of being funded. However, if the applicant rejects the corrections, the GWG will vote to either recommend funding or to reject the application. A score of 3 means not recommended for funding. After applications are ranked in one of three tiers, they are then sent on to our governing Board’s Application Review Subcommittee, for a final vote. Both the GWG and the Application Review Subcommittee will meet monthly, usually by conference call.

If the Board rejects our application can we re-apply?

Yes you can. But if you re-apply without making any substantial changes to your application, particularly those recommended by either CIRM Science Officers or the GWG, you may be advised that your application is again likely to fail. And if you re-apply more than once you may be told you are no longer eligible to apply for funding for that particular project.

Who can apply?

Funding is open, as it always has been, to both companies and academic institutions.

The first phase of CIRM 2.0 focused on projects that were either ready to start a clinical trial or were in the advanced stages of preparing to do so. The window for these clinical funding opportunities is always open. Applications simply need to be in by 2pm PST on the last business day of the month. The second phase expanded the accelerated process to include all the other areas of research that we currently fund, namely Discovery and Translational. Applications for these funding opportunities are open approximately every six months. As we add new areas to be covered by CIRM 2.0, we will update our website to let you know what those areas are. 

Regarding eligibility, applicant organizations must be in California to apply for our Discovery and Translational awards. For our Clinical awards, both California and non-California organizations can apply, but non-California organizations will have to have some California connection to be eligible for funding. To qualify as a California organization, you must have more than 50% of your employees located in the state, and you must conduct the activities covered by the award in California.

For non-California organizations applying for our Clinical programs, award money can only be used for allowable expenditures incurred within the state (and those are also subject to our co-funding requirements). And if you are engaged in a clinical trial, then at least one clinical trial site must be in California. Please refer to the Clinical program announcements for more information on allowable costs for non-California organizations.

Why are you doing this?

We have a new, four point plan that we use to assess every thing we do at CIRM:

  • Will it accelerate the development of treatments for patients?
  • Will it increase the likelihood of a successful treatment?
  • Does it target an unmet medical need?
  • Is it efficient?

After a long analysis we felt our old way of funding didn’t meet those four measures. For example, under our current process if you have a program that is ready to start a clinical trial it would take CIRM, on average, 22 months to fund it. Many projects simply cannot wait that long, they need the funding now. In addition, the long cycle time between applying for and getting funding means that much of the data needed for review and for contract agreements is out of date by the time the process is completed. That results in further delays as more up to date information is gathered to help CIRM negotiate an agreement with the applicant. And most importantly it means that if a treatment is ultimately successful it is getting to patients 22 months later than it should.

So we set out to find a new, faster, more effective and efficient way of supporting the best research.

Our goal is not to just reduce the cycle time between applications and attract more applications for funding; we are also trying to attract more high quality applications for funding, ones that have the best possible chance of succeeding. We also wanted to help come up with a process that would accelerate the progression of projects we fund. And we wanted to create a system that was clear and simple to understand, one that better serves our mission.

Will you offer grants or loans to those interested in applying for funding?

This will remain the same as in the past. We will offer both grants and loans.

Do I have to be in California to apply?

You must be in California to apply for our Discovery and Translational programs. For our Clinical programs, you don't have to be in California to apply, but you will have to have some California connection to be eligible for funding. To qualify as a California organization you must have more than 50% of your employees located in the state, and you must conduct the activities covered by the award in California.

If you are not in California you may still apply for funding for our clinical programs but that money can only be used for allowable expenditures incurred within the state (and those are also subject to our co-funding requirements). And if you are engaged in a clinical trial then at least one clinical trial site must be in California. Please refer to the Clinical program announcements for more information on allowable costs for non-California organizations.

Please see California Org and Non California Org Allowable Costs and the Allowable Costs FAQs for more information.

What are the project eligibility requirements?

  • Must be ready to initiate work within 45 days of approval
  • Must propose studies with a single stem cell-based therapeutic candidate*
  • Must demonstrate appropriate stage of readiness
  • Must include a project manager
  • For-profit organizations must demonstrate solvency

What are the therapeutic candidate requirements?

  • A cell therapy where stem or progenitor cells either comprises the therapy or are used to manufacture the therapy.
  • Cord blood or unmodified hematopoietic stem cells – only if it is being developed as a novel method of addressing a rare or unmet need OR is unlikely to receive funding from other sources.
  • A small molecule or biologic that acts on endogenous or cancer stem cells as the primary method of action AND is being developed for a rare or unmet need unlikely to receive funding from other sources.
  • Gene modified T stem cell product is eligible

What are allowable costs and is there a co-funding requirement?

Allowable Project Costs are those costs that: (1) are permitted under CIRM policies and regulations and (2) are for allowable project activities. Allowable Project Costs include both direct, facilities, and indirect costs. The sum of CIRM funds requested plus the co-funding contribution by the applicant make up the total Allowable Project Costs. CIRM has special rules regarding costs outside of California. Please see California Org and Non California Org Allowable Costs and the Allowable Costs FAQs for more information. Co-funding requirements depend on the type of organization and the clinical stage of the project. The co-funding may come from any funding source arranged by the applicant, but may not include “in-kind” or similar types of support. Documentation demonstrating the commitment of funds to cover the proposed co-funding amount must be provided at the time of application submission

Applicant Type

Pre-clinical

Phase 1

Phase 2

Phase 3*

Supplement**

Non-Profit co-funding

None

None

40%

50%

0-50%

For-Profit co-funding

20%

30%

40%

50%

20-50%

* In Phase 3 CIRM's contribution will not exceed $20 million

** Co-funding depends on the phase of activities

How much money is allocated for CIRM 2.0 and how much can I ask for?

There is no cap on awards in Phase 1 or 2 trials. However, each application will be carefully scrutinized by an independent expert budget review panel to determine if the amount requested is appropriate for the work being proposed.

For Phase 3 trials, there is a $20 million cap.

Indirect costs for all research will be capped at 20% for non-profit organizations. For-profit organizations are not eligible for indirect costs.

When did this start?

CIRM 2.0 opened for business on January 1, 2015.

How can I find out more about applying for funding under CIRM 2.0?

On January 21, 2015, CIRM President and CEO at the time, Dr. Randy Mills, held an informational webinar about CIRM 2.0. You can download that presentation here.

If you still have remaining questions, please contact Dr. Gil Sambrano.

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