Sacramento, Calif., March 11 – In a move that will speed the path of bringing stem cell-based therapies to the people of California, the Governing Board of the California Institute for Regenerative Medicine, the state stem cell agency created by Proposition 71, approved a concept proposal for funding the development of new stem cell therapies.
The Targeted Clinical Development Awards provide critical funding for early clinical development including early stage trials testing therapies derived from pluripotent stem cells and activities that support those trials, such as manufacturing the potential therapeutic. This funding will help speed the pace of moving these potential therapies through clinical trials and, if those trials prove successful, into doctor’s offices. The awards will provide the lesser of $25 million or 50% of the project cost to fund the completion of early stage clinical trials in less than three years.
Clinical development often runs into barriers when funding sources such as pharmaceutical companies or venture capital firms deem early clinical development too risky of an investment. “Helping to bring candidate therapeutics into the clinic CIRM is fulfilling the desires of California voters who supported Proposition 71’s mission of developing novel therapies for incurable diseases,” said Robert Klein, chair of the CIRM Governing Board. “The Clinical Development Awards will provide critically needed support for the earliest and hardest-to-fund stage of clinical research. These therapies should provide healthcare cost savings and create new tax revenues for California when chronically ill people and their caregivers are able to return to work.”
CIRM expects to release the RFA this spring, with applications due in July. Funding recommendations from the independent grants working group will come before the Governing Board for final approval in December. Funds will be dispersed as grants to non-profit organizations or as loans to for-profit organizations.
The board also voted to support recommendations from its Legislative Subcommittee expressing concerns about SB1064, introduced by Sen. Elaine Kontominas Alquist of San Jose. In an open letter to Senator Alquist regarding SB1064, Klein and co-vice chairs Senator Art Torres (Ret.) and Duane Roth wrote: “We wish to express our individual concerns regarding the bill’s potential economic impact on the state’s new tax revenues and new jobs created by CIRM. More importantly, we are concerned about the bill’s potential impact on finding treatments and cures for diseases and traumas that Californians struggle with everyday.”
The full text of the letter is available here: /board-and-meetings/letter-senator-alquist-regarding-sb-1064
The committee did not recommend opposing or supporting the bill, but rather recommended seeking a vote in the legislature to move the bill to “interim study.” That move would provide an opportunity for CIRM to update the legislature on the agency’s progress. It also allows the committee chair to call a hearing after the legislature adjourns to review the progress that CIRM has made on all the issues raised by the Little Hoover Commission and the Controller’s Financial Accountability Committee and to verify the transparency the Board is on record supporting. While welcoming legislative oversight, the Board indicated it was looking forward to the outside scientific assessment that President Trounson has been putting together for later this year as mandated by CIRM’s 2006 and 2009 strategic plans.
The board also supported the recommendation of its subcommittee to seek further analysis of the impact of AB52, introduced by Assemblyman Anthony Portantino of Pasadena. That bill would move from the Department of Public Health to CIRM the previously legislated authority to receive fee surcharges from birth certificates to fund the collection and oversight of public banking of umbilical cord blood in California. This study would be internal with the CIRM management directed to look at issues around the science, logistics and liabilities of such a service with the help of appropriate outside experts.
At the same meeting the board approved a resolution thanking Stuart Orkin, former Chair of the grants working group, for his hard work and exceptional service on the committee. The resolution states, “Stuart Orkin dedicated special effort leading, as Founding Chair, the California Institute for Regenerative Medicine’s Grants Working Group and striving to maintain the integrity of the review process.”
About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 328 research and facility grants totaling more than $1 billion, making CIRM the largest source of funding for human embryonic stem cell research in the world. Estimates suggest that these grants already awarded will generate tens of thousands of job-years of employment in the state.