Sustainability Study to Begin: 'Existential Reality' Confronts $12 Billion California Stem Cell/Gene Therapy Agency
SOUTH SAN FRANCISCO -- The chairman of California’s $12 billion stem cell and gene therapy agency announced a new effort yesterday to devise a plan to confront the “existential reality” that hangs over the agency.
The financial extinction of the California Institute for Regenerative Medicine (CIRM) is assured by state law unless its supporters come up with additional billions for the agency. Outside evaluators of CIRM have long recommended that it tackle its sustainability problem.
Vito Imbasciani, the full-time chair of the 35-member CIRM board, told the directors it is necessary to secure a “reliable funding stream” in order to continue searching for cures for afflictions that affect, according to its backers, half the families in California.
By one estimate, CIRM would need to mount another ballot campaign for funding as early as 2028 if it wants the best chance of winning more billions.
Since its birth 20 years ago via a ballot initiative, CIRM has awarded $4 billion to about 1,500 researchers in California. However, it has yet to finance a stem cell therapy that is widely available to the public.
Its only source of funding is money that the state borrows. CIRM has $3.8 billion left to spend but is burning cash at a rate of about half a billion dollars a year. The initiative allows CIRM to receive only $540 million a year. Once the bond financing runs out, there is no more.
Another bond initiative has been deemed in the past by CIRM as the only viable option to generate more cash.
“This (sustainability) project will investigate all possible avenues,” Imbasciani said, “to secure sufficient additional funding that will afford CIRM the opportunity to extend its useful existence past 2032 for an additional and as yet undefined period of years.
“The scope of this project will identify and align stakeholders, create viable courses of action and secure the necessary resources for CIRM to achieve financial, operational and scientific sustainability.
“This will allow CIRM to continue advancing regenerative medicine research, sponsor clinical trials and bring cures to address unmet medical needs to the people of California and the world.”
Imbasciani also said, “Approximately $3.8 billion will last, assuming a typical annual burn rate of $450 million, from six up to eight years with sufficient funds reserved for four additional years so CIRM can see already funded projects through to their conclusion.”
The figures are rough estimates and will need to be refined under various scenarios.
Those scenarios could involve mounting a new ballot initiative, slowing the pace of awards, reducing awards in certain areas and seeking outside private funding, an effort that has failed in the past. A new initiative would likely require developing a therapy that resonates with voters and involves late-stage clinical trial funding, which is much more expensive than basic research.
Imbasciani announced the plan for a sustainability study at the beginning of yesterday’s board meeting, but there was no discussion initially. However, a few comments came much later, following a presentation about CIRM’s communications efforts.
CIRM board member Kim Barrett, vice dean of research at UC Davis' medical school, stressed the need for continued support of basic research. “It’s really our seed corn,” she said. The public may not understand its importance, she added, a matter that CIRM communications need to address.
CIRM CEO Jonathan Thomas said, “I will just say that any sort of notion of sustainability derives from a program that's generating ongoing success…to prove to the ...taxpayers of California, who voted twice to fund CIRM, that we are making progress. Progress is defined variously in many different ways.”
Thomas said that one measure of success is the therapies that reach the public. “But you can go all the way back to basic research, which discovers biomarkers or other targets or whatever that set the table for the translational and clinical work to develop therapies years down the road.”
He said CIRM is “100 percent committed” to continuing funding basic research and has already awarded $1 billion in that area.
Because of CIRM’s unique nature, however, the agency's financing goes well beyond science. It depends on voter approval to secure funding, a dependency that raises political considerations about motivating voters and the favorable timing of another initiative.
Below are a few articles dealing with CIRM’s sustainability problem. It is the only state agency that effectively faces a voter referendum to continue its existence. State law requires CIRM to formulate a transition plan for when its funds run out.
How Long Does the California Stem Cell Agency Have to Live?
The financial guillotine could fall as soon as four years from now
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How Long Will the California Institute for Regenerative Medicine Survive?
(An article from Biopolitical Times)
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Pluses and Minuses: How 17,000 Words Shape a $12 Billion Stem Cell and Gene Therapy Program
California's "Christmas Tree" research effort -- from affordability to mental health