Monday, November 23, 2015

Less Than $1 Billion Left: California Stem Cell Agency Lays Out its Five-Year Bucket List

CIRM's spending plans by area -- CIRM graphic
Three pages on risk of research
Funding ends in 2020
Two new centers proposed, up to $15 million each
Clear pathways to commercialization

The California stem cell agency today unveiled its plan for spending its last $900 million, calling for 50 new clinical trials and an increasingly hard-eyed focus on turning earlier stage research into therapies.

Between now and 2020, the agency’s strategic plan budgeted $620 million for clinical and translational research compared to $170 million for more basic efforts.   

The proposal builds on “radical” changes already underway at the agency and is not without risk. Indeed, the 45-page page plan devotes three pages to the subject of “risk.” Sherry Lansing, a longtime board member and former chair of the University of California regents, said in a press release,

“It’s an ambitious plan, but you never achieve anything worthwhile by playing it safe.”

Jonathan Thomas, chair of the agency’s governing board, said the strategic plan “began with us throwing out all our preconceived notions of what we do, and instead focused on what was possible with the time and money we have left.”

The California Institute for Regenerative Medicine (CIRM), as the $3 billion agency is formally known, is projected to run out of funds for new awards in 2020. It is unclear what if any cash can be raised from either public or private sources. However, Thomas is scheduled to discuss future funding prospects at the board’s Dec. 17 meeting in Los Angeles.

Much of the plan has been revealed in the past six months as Randy Mills, CEO of CIRM, briefed the governing board on its developing direction. Mills joined the agency in May 2014 after a career in the biotech business. The thrust of the strategic plan reflects his business background and a strong emphasis on measurable benchmarks and organizational clarity.  He launched an effort called CIRM 2.0 earlier this year in an effort to speed funds to clinical efforts and improve the quality of applications. (See here and here for earlier stories on the strategic plan.)

New to the spending plan -- at least in any kind of detail -- were two proposals slated for $12 million to $15 million each. One was dubbed a “translating center.” The other was called an “accelerating center.”

The translating center will be located at a single enterprise and be charged with development of cGMP compliant cell manufacturing processes, providing “core services” leading to FDA investigational new drug applications and coordinating with the FDA and the accelerating center.

The accelerating center will also be located a single enterprise that has stem cell-specific regulatory expertise. It will provide support for clinical trials in an effort to accelerate the regulatory process and conduct of clinical trials.

Over the past six months or so, Mill has repeatedly made the case for capturing promising early research and ensuring that it has a clear pathway to clinical trials and ultimately into the market.  

Under his strategic plan, “every program will be integrated into and coordinated with the overall effort” to fulfill the CIRM mission: “To accelerate stem cell therapies to patients with unmet needs.”

The plan additionally sets concrete standards for measuring the agency’s performance as well as each team’s performance within the agency, including such specifics as the percent of application reviews held as scheduled and percent of projects that advance to the next stage.

The proposal is set for discussion and action at the directors’ Science Subcommittee meeting next Monday and goes to the full board on Dec. 17 for final approval. The meeting will be based at CIRM's new headquarters in Oakland with remote, teleconference locations for the public in San Diego and Los Angeles. Specific addresses are on the agenda.

While the plan is called a draft, it is not likely to undergo significant changes. However, interested parties can weigh in with comments by emailing them to CIRM at this email address by 5 p.m. Dec. 3.
CIRM's goals for the next five years -- CIRM graphic

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