Calif. stem cell agency poised to approve ambitious strategic plan

The governing board of California’s stem-cell agency gathers in Los Angeles Thursday for a critical meeting: It will vote on an ambitious plan to sharply accelerate the agency's productivity over the next five years.

The California Institute for Regenerative Medicine was launched in 2005, after California voters approved a $3 billion bond measure to create it. 

But a decade and $2 billion later, only 15 Institute-funded clinical trials are underway and the agency has yet to bring a stem cell therapy to market. That's frustrated those who expected faster results. 

"There wasn’t a full understanding of the exceedingly slow nature of scientific research and how long it takes to get into the clinic," says David Jensen,  a journalist who regularly writes about the agency in his blog, "California Stem Cell Report."  

Enter Institute President C. Randall Mills, who is leading a push to greatly speed up the process of developing new therapies. After taking over last year, Mills, who previously headed a biotech company that brought the world’s first approved stem cell treatment to market (in Canada and New Zealand), led an overhaul of the agency’s research and development processes.

The result:  five of the 15 agency-funded human trials started this year, which the strategic plan hopes to increase to 65 by 2020.  

Mills says the new approach "placed a lot of emphasis on urgency and systems and efficiency and most importantly patients." 

The agency has already reduced the amount of time it takes to process and approve projects for clinical trials - from about 22 months to "about 100 days," he says.  

The proposal before the board also includes hiring experts skilled at moving stem cell research into human trials; and, Mills says, it calls for working with the U.S. Food and Drug Administration to ease regulatory rules that the Institute considers burdensome.

"Being able to demonstrate effectiveness and safety in humans is what ultimately is going to bring about the cures that people want," Mills says.

But doing that will require investment from the private sector, which so far has been unwilling to make substantial investments in stem cell research.

To spur that interest,  the strategic plan proposes offering a $75 million grant to a firm willing to partner with the Institute and invest $75 million of its own money to create a stem cell company. Mills says that investor would then have its pick of some of the Institute's most promising research.

"It's a very good, cutting edge, California kind of idea where we can blend the best of what the state is able to do with what the best of what the private sector is able to do," he says.

Jensen says showing more success by 2020 is also critical to the agency’s long-term survival. The Institute has $890 million research dollars remaining in its coffers, and "in five years, by its own projections, it’s expected to run out of money for new rewards," he says. Unless it can raise additional public and/or private funding, "the agency is going to dwindle away."

The Institute is working to avoid that fate. This week the agency announced it had received $7 million dollars in pledges in private grants that it will use to leverage more funding for its work beyond 2020.