Ten years in, California's stem cell program is getting a reboot

Turning 10 years old may not quite mark adolescence for a human child, but for a major government research effort such as California's stem cell program, it's well past middle age.

So it's a little strange to hear C. Randal Mills, the new president and chief executive of the program known formally as the California Institute for Regenerative Medicine, say it's time to instill in CIRM "a clear sense of mission."

But that's what Mills is planning for the coming year, as he launches CIRM 2.0, a comprehensive reboot of the program.

Mills, a former biotech company chief executive, took over as CIRM's president last May. His first task, he told me, was to "take a step back and look broadly at how we do our business." He reached the conclusion that "there was a lot of room for improvement."

That's a striking admission for a program that already has allocated roughly two-thirds of its original $3-billion endowment.

Biomedical researchers are sure to find a lot to like about CIRM 2.0, especially Mills' commitment to streamline the program's grant and loan approval process for projects aimed at clinical trials of potential therapies. Reviews of applications take about 22 months on average; Mills hopes to cut that to about three months. The process can be made more efficient without sacrificing science: "We need to do it quickly and also focus on quality," he says in a videotaped presentation on the CIRM website. The CIRM board last month approved a six-month, $50-million round of funding under the new system, all to be aimed at testing new therapies.

Yet the focus on drug development shows that CIRM remains a prisoner of the politics that brought it into existence. The Proposition 71 campaign in 2004 employed inflated promises of cures for Parkinson's disease, Alzheimer's, diabetes and other therapy-resistant conditions to goad California voters into approving the $3-billion bond issue ($6 billion with interest) for stem cell research.

CIRM says it has funded clinical trials of 10 therapies and has backed an additional 87 projects "in the later stages of moving toward clinical trials." In scientific terms that's progress, but it may fall short of the public expectations of "cures" stoked by the initiative's promoters 10 years ago.

And that poses a political problem. At its current rate of grant and loan approvals of about $190 million a year, CIRM has enough funding to last until 2020. What happens after that is an open question, but any campaign to seek new public funding may depend on CIRM's having a successful therapy to show off to voters.

Mills says winning approval for more public funding isn't the goal of CIRM 2.0. "It's not our job at CIRM to extend the life of CIRM," he told me. Instead, he couches the need for urgency in terms of serving patients. As chief executive of Maryland-based Osiris Therapeutics, where he worked before joining CIRM, he says, he had "a firsthand view into the significance of stem cell treatment, and of how important urgency is in this game." Osiris received approval from the Food and Drug Administration and Canadian regulators for a stem cell drug to treat children with severe complications from bone marrow and other blood transplants.

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Ten years in, California's stem cell program is getting a reboot