The state of California is preparing to make a bet of up to $40 million on a fast-moving field that promises to revolutionize medicine and ultimately lead to personalized stem cell treatments that can be tailored for a patient’s genetic makeup.
Directors of the California stem cell agency are meeting in Berkeley on Wednesday to create one or two stem cell genomic centers that they predict will make the state a world leader in the new field. Scientists and businesses from biotech centers in the Bay Area, San Diego and elsewhere are competing for the money.
The move into genomics comes as the $3 billion agency struggles to fulfill the promises of the ballot initiative campaign of 2004, when voters approved its creation with a total of $6 billion in state spending, including the interest on bonds sold to finance the endeavor. So far, no therapies or cures have emerged from the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. It will run out of cash for new awards in less than three years and needs some high-profile results to raise more money.
Scientists and biotech businesses say they hope that genomics, the study of genes and their relationships, can lead to a catalog of disease genes and pave the way for new therapies that are tailored to individual needs. Linking stem cell treatments, which also promise extraordinary results, could provide even more effective treatments. UC Davis stem cell researcher and blogger Paul Knoepfler describes the stem cell genome effort as part of a “revolution.”
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“Genomics is going to become a key part of all of our lives whether you like it to be or not,” he says on his blog.
“Right now, in a lot of ways, doctors are making educated guesses as to how to treat us patients more generally,” Knoepfler says. “By knowing our genomic information, our genotype – the information tucked away in our genomes –they could be making far more educated choices about treatments, and we could be making far more informed decisions about our health.”
The National Institutes of Health says that genes play a role in nine out of the 10 leading causes of death in this country. “Genomics is helping researchers discover why some people get sick from certain infections, environmental factors and behaviors, while others do not,” the institute says.
The nascent field is not without controversy. The U.S. Food and Drug Administration recently cracked down on the Google-backed genetics firm 23andMe of Mountain View, saying that it had failed to show that its testing produced accurate results. The company last month said it would stop providing health information with its tests. The danger to the public, say some medical experts, is that people might act on inaccurate or poorly understood genetic information and unnecessarily undergo drastic or harmful procedures intended to ward off future disease.
Such concerns haven’t slowed growth in the genomics industry, however. Various studies say that the current annual sales of genomic products exceed $3 billion and peg the annual growth rate at anywhere from 10 percent to 17 percent.
The stem cell agency two years ago this month sized up the situation and decided it was time to jump in. The agency’s governing board gave the go-ahead – on a voice vote with virtually no discussion – to the concept behind this week’s awards. CIRM directors had already been primed at the time by a presentation by Craig Venter, head of the La Jolla Institute bearing his name and internationally famed for his genomics work. Venter told the CIRM board that “there will not be any clinical stem cell applications without understanding genomics.”
Venter said genomics is needed to tell whether a particular stem cell therapy will cause more harm than good. Venter also told the board that he already had embarked on a stem cell genome effort. He is believed to be competing for the CIRM funding, and his talk raised eyebrows among some researchers because it was so closely tied to the board action.
The agency opened the door to applications from researchers and institutions in October 2012, eight months after the talk by Venter, who appeared at the agency’s invitation. The review of those applications and the identities of the applicants are cloaked in secrecy, which is the traditional way scientific grants are awarded in this country even when they involve public funds.
A combination of out-of-state scientists and six CIRM board members scores the grants and makes its decisions. The full, 29-member CIRM board will have the final say in a public meeting in Berkeley on Wednesday, but it almost never departs from the recommendations for approval by its reviewers. CIRM announces only the names of the winners and does not release the names of rejected applicants because it might embarrass them.
Last week, CIRM President Alan Trounson and his staff recommended funding only one of the applications – for $33 million – although reviewers had approved four, according to documents at the CIRM website. No public explanation was immediately provided, except that CIRM spokesman Kevin McCormack said the reviewers actually “did not recommend funding all of the applications,” although that was clearly stated on the website, as has been the practice on the review of thousands of previous applications.
The funding round is budgeted for $40 million, but could be more or less depending on the wishes of the board.
A number of the major educational institutions in the state are likely to be involved in this week’s awards. Stanford University’s name surfaced last year when a conflict-of-interest violation in the initial grant review was reported by the California Stem Cell Report. CIRM grant reviewer Lee Hood of Seattle, renowned internationally for his genomics work, acknowledged that he had failed to disclose his conflict in connection with a $24 million application involving Irv Weissman, director of Stanford’s Institute for Stem Cell Biology and Regenerative Medicine. Weissman and Hood are longtime friends and own property together in Montana.
The closed-door review also marked the first time in CIRM’s history that reviewers, all from out of state, failed to finish with a decision supporting any of the proposals, according to CIRM. Reviewers’ comments were sent back to applicants, who resubmitted their proposals for review in November in another closed-door session. This time, Hood did not participate.
In addition to Stanford, California enterprises that have a strong interest in genomics and that are possibly involved in the competition include: Illumina and Sequenom of San Diego, Life Technologies of Carlsbad, CombiMatrix of Irvine, Pacific Biosciences of Menlo Park and Complete Genomics of Mountain View, which is owned by BGI, a Chinese business that is the largest genomics sequencing firm in the world. Others include Scripps, the San Diego Supercomputer Center at UC San Diego, the Novartis Genomics Institute and Fate Therapeutics, both of San Diego, and UC Santa Cruz.
UC Davis has just begun an $18 million genome operation in partnership with BGI, but Richard Michelmore, director of the Davis Genome Center, said it was not involved in any of the CIRM applications. (Ken Burtis, who is a member of the faculty of the Davis Genome Center, is a member of the CIRM governing board.)
The expected winner of the $33 million award is a group headed by Stanford University’s Michael Snyder, director of its Center for Genomics and Personalized Medicine, based on documents posted Friday on the stem cell agency’s website.