Maintaining the momentum: a good start but CIRM 2.0 is just the first step

Sir Isaac Newton

Sir Isaac Newton

Newton’s First Law of Physics states that an object either remains at rest or continues to move at a constant velocity unless acted upon by an external force. Well, for the stem cell agency the external force was an exercise in thinking differently about how we do business. That resulted in our governing Board approving CIRM 2.0 yesterday. And we intend to keep that momentum going for as long as we can.

CIRM 2.0 is a streamlined process that will make it easier and faster to apply for funding from the stem cell agency, and is designed to attract high quality clinical stage projects that are ready to start within 45 days of being approved for funding.

As our President and CEO Dr. C. Randal Mills said in a news release:

“Our mission is to accelerate the development of stem cell treatments for patients with unmet medical needs. With many of these diseases, time lost waiting for a treatment means lives lost. We must continue to find new and innovative ways to speed up our process and make it easier to get promising therapies into clinical trials, and to give them all the support they need to be successful. That’s why we undertook this radical overhaul of the way we do business.”

In the past it could take up to two years for a researcher or company to move from applying for funding to getting the money as part of an approved contract. CIRM 2.0 simplifies and accelerates the process, cutting that two years down to just four months. And instead of just one single round of funding with an application deadline every 12-to-18 months, CIRM 2.0 will have an open application process for clinical stage programs with deadlines every month. That means companies and researchers can apply when they are ready and won’t have to try and rush an application in prematurely, for fear it could be another year or more before the chance comes around again.

It’s a big change in the way we work and as Dr. Mills told the Board at yesterday’s meeting, there are bound to be problems:

“There will be bumps in the road, you can’t make radical changes of this nature and scope without running into problems. I know that, my team knows that and we are ready to handle whatever unforeseen consequences come up.”

We plan on monitoring 2.0 as we unveil it, constantly checking to see what’s working and to fix what isn’t. In the short term we will use several measures of how well it’s working such as how many high quality applications we get, how quickly we can move these applications through the approvals process and how long it takes to get successful applicants their money. In the long term the best indication of success will be the quality of the programs we fund and how well they do in completing clinical trials.

This first phase of CIRM 2.0 will cover funding for clinical work but it will later be expanded to include discovery (also known as basic research) and translational research (moving promising discovery research to the clinic). But as Dr. Mills says, even while we are implementing CIRM 2.0 we are already thinking about the next step.

“Soon as this is done we have to start working on how we can improve CIRM 2.0 and keep that sense of urgency and innovation in front of us so that we always look to build a better product and fulfill our mission in a better way. Because there are many sick people out there looking to us for help and until that changes we need to be always looking to improve. Which is why as soon as CIRM 2.0 is done, we’re looking to create CIRM 3.0”

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One thought on “Maintaining the momentum: a good start but CIRM 2.0 is just the first step

  1. If a company had a high quality clinical stage project it could be worth billions of dollars. Why would a company sell their IP to the CIRM for a couple million? We have watched Geron, Stemcells, and bluebird backout of CIRM funding… Could the most advanced trials like Ocata get funding without having to give away their IP?

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