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California stem-cell agency shifts toward clinical work

Posted on behalf of Monya Baker.

The California Institute of Regenerative Medicine (CIRM) voted on 24 May to accept a new strategic plan which shrinks or eliminates support for basic research, facilities and training, while funneling more of its funds toward clinical development. “The first stage of CIRM was really exploring the field,” said Ellen Feigal, senior vice president of R&D. “The next five years should be one of more focus.” By July 2013, the agency hopes to have two programmes approved for clinical trials in the United States.

During the past five years, nearly half of the approximately $1.3 billion awarded by the agency went toward building new research facilities and training and career development. Looking ahead, of the approximately $840 million to be awarded  over the next five years, about three fifths is slotted to go toward development research,  preparing stem cell-based therapeutics for clinical testing, with much of the rest devoted to translational and basic research. (An additional $650 million has been approved but not awarded; allocation is roughly an average between previously awarded funds and future plans.)

No one spoke during a call for comments from the general public, and the plan was approved by a voice vote with no objections. Board member Jeff Sheehy voiced concerns about cutting off training and basic research. CIRM president Alan Trounson and Ellen Feigal said that the exact allocations could be determined at future meetings. There was general acknowledgement that difficult funding decisions are ahead. “We are now in the realm of trade-offs,” said Sheehy.

Also today, CIRM announced $69 million of grants for translational research. “With these new awards, the agency now has 52 projects in 33 diseases at varying stages of working toward clinical trials,” said Jonathan Thomas, governing board chair, said in a statement.

“I think it’s a natural evolution of the institution,” says Deepak Srivastava, a cardiovascular researcher at the Gladstone Institute in San Francisco. “With their stated goals of getting cures into people, it’s appropriate to shift the balance.” Srivastava was awarded a $6.3 million grant from the agency today, one of about twenty investigators to receive funds for translational programs.

CIRM officials held several sessions in October last year to get public input on the new plan. The agency has also found itself under criticism for not producing new therapeutics. When stem-cell funding agency was funded by a ballot initiative in 2003, campaigners described the proposition as a vote for cures.

Already, CIRM had been emphasizing clinical applications, awarding grants for translational medicine and for “disease teams,” charged with preparing the Investigational New Drug Application required for clinical trials in the US.

The 2012 strategic plan sets a five-year goal to have at least ten therapies in early clinical trials, with 20 CIRM funded programs also receiving outside capital for clinical development. CIRM, which is scheduled to run out of funds around 2017, set itself a one-year goal to obtain $50-million in outside funding.

CIRM adopted a strategic plan in 2006 and updated it in 2009

All but one of the 5-year scientific goals in the 2012 strategic plan are modeled on the 10-year goals from the 2006 plan. The new goal is for CIRM to broaden efforts to “educate and engage” Californians about CIRM’s work. This goal will be assessed by counting the number of ‘online engagements’ with the agency.

 

Comments

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    Don Gibbons said:

    Neither potential future funding scenario presented to our board yesterday eliminated funding for basic research, an area the agency is firmly committed to supporting. What was eliminated in one scenario was funding for training and career development. In one scenario basic research would get 16 percent of future grant rounds and in the other it would get 13 percent. The board will deliberate on this issue at a future meeting.

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