California Institute for Regenerative Medicine
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The California Institute for Regenerative Medicine (CIRM) was created in 2004 after 59% of California voters approved California Proposition 71 (2004: The California Stem Cell Research and Cures Initiative. The passing of Proposition 71 established a 29-member Independent Citizens Oversight Committee (ICOC) that governs the allocation of the $3 billion authorized to fund stem cell research in California. The agency was authorized to distribute the money in grants, funded by bonds, over a ten-year period to institutions and scientists throughout California that focused on advancing stem cell research and regenerative medicine. The mission of CIRM is: To support and advance stem cell research and regenerative medicine under the highest ethical and medical standards for the discovery and development of cures, therapies, diagnostics and research technologies to relieve human suffering from chronic disease injury.
Implementation of Proposition 71 was delayed when opponents filed two lawsuits that challenged the constitutionality of California Proposition 71 (2004). Opponents argued that the initiative created a taxpayer-funded entity not under state control, that the ICOC had a conflict of interest with representatives being eligible for grant money, and that the initiative violated the single-subject requirement of initiatives by funding areas beyond stem cell research. In May 2007, the Supreme Court of California declined to review the two lower court decisions, thereby upholding Proposition 71 as constitutional and permitting CIRM to fund stem cell research in California.
During the litigation delay, CIRM focused on logistical and administrative procedures. In December 2004, CIRM held their first meeting to discuss the hiring of their first president, the location of their headquarters and established three working groups that would advise the board. The three working groups included: Scientific and Medical Research Funding, Scientific and Medical Research Facilities, and Scientific and Medical Accountability Standards. In 2005, the agency moved their headquarters to San Francisco, California and CIRM issued its first grants in 2006.
CIRM Funding Process
CIRM’s funding process occurs in several steps. It begins with the science staff evaluating current stem cell research and determining the type of funding that is most likely to advance the field. This decision marks a new round of funding focused on a specific goal. The agency then issues a request for applications (RFA) and scientists and organizations in California organize and submit proposals relating to the specific goals of CIRM. The proposals are evaluated by an international group of independent experts in stem cell research, therapy development and the biotech industry. None of the experts are located in California. The expert panel reviews each application and makes recommendations to CIRM’s governing board as to those applications that should receive funding. The CIRM governing board considers the experts’ recommendations and then votes on the applications that will receive funding.
What Does CIRM Fund?
CIRM provides funding in three general areas: research, training and facilities. The earliest rounds of funding focused on the development of facilities, lab spaces and training. When CIRM first started in 2004, scientists in California interested in stem cell research struggled with a lack of specialized research facilities and access to essential research equipment.
A majority of the funding (69%) is allocated to various areas of stem cell research. The first research grants focused specifically on basic science to help build knowledge and understanding of stem cells. CIRM has provided funding for research that involves all types of stem cells with the most commonly funded being embryonic stem cells, induced pluripotent stem cells (iPSC) and adult stem cells.
Developing a more comprehensive understanding of stem cells has enabled scientists to expand their research and explore the potential application of stem cells to regenerative medicine. In 2008 and 2009, CIRM began to expand their focus from basic research and allocated money to small teams of scientists that explored how the basic research could translate into therapeutic applications. CIRM now funds research that focuses on stem cell derived treatments for a variety of diseases with the four most funded areas being neurological disorders, cardiovascular disease, blood and immune disorders and cancer.
CIRM has provided funding for 87 therapy-focused studies totaling approximately $600 million and this funding has resulted in 10 therapeutic clinical trials. Specific examples of such funding include:
- In 2009, CIRM awarded $67 million in early translational grants that was allocated to 13 nonprofit organizations and two for-profit organizations, BioTime and Novocell. The grants focused on advancing basic research towards patient application by enhancing the development of drugs for various diseases.
- In 2012, two biotech companies, ViaCyte and Bluebird Bio received a total of $20 million in grants that supported their work in developing therapies for diabetes mellitus and blood disorders.
- In 2013, Cellular Dynamics of Madison, Wisconsin was awarded $16 million from CIRM to create three iPSC lines using tissue samples from both healthy and diseased individuals  CIRM also awarded the Coriell Institute for Medical Research $10 million to establish and manage a biobank in California for the iPSC lines created by Cellular Dynamics.
Over the past few years, the developments in stem cell research and therapeutic application have been reflected in the allocation of CIRM funding. Up until 2009, awards were applied to research space, training and discovery research. Since 2009, CIRM has continually increased the funds committed to clinical research from approximately $200,000.00 to $600,000.00.
Evaluations of CIRM
In 2008 the Little Hoover Commission evaluated CIRM at the request of California Senators Sheila Kuehl and George Runner. The Commission commented specifically on the structure of the CIRM governance board and the need for greater transparency and accountability. The Commission provided suggestions on how to improve the structure and enhance the functioning of the CIRM board some of which included: decreasing the size of the ICOC from 29 to 15 members with four having no affiliations with CIRM-funded organizations; allow board members to serve a maximum of four years; and eliminating the overlapping responsibilities of the agency chair and the board president. In addition, the Commission recommended that CIRM also allow outside experts to evaluate grant proposals.
In December 2012, the Institute of Medicine (IOM) released a report, “The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures”, that evaluated CIRM programs and operations since its start in 2004. The IOM committee made recommendations similar to those made in the Little Hoover Commission. In general, the IOM recommended that the ICOC separate their responsibilities as executor and overseer and noted potential conflicts of interest among the CIRM board members. Several active CIRM board members also represented organizations that currently received or benefited from CIRM grants. The IOM committee also recommended that CIRM organize a single Scientific Advisory Board with experts in stem cell biology and cell-based therapies.
Most recently, the integrity of CIRM's grant review process was challenged in February 2014 after CIRM awarded a Stanford-led consortium $40 million stem cell genomics award, making it the largest CIRM research grant. In February 2013, CIRM reviewers evaluated applications for genomics awards but, for the first time, declined to send any grant proposals to the board for a final decision. Comments were sent back to the researchers and re-submissions were accepted in Fall 2013. During the Fall 2013 review, CIRM reviewers sent all four genomic award proposals to the CIRM board, recommending that all four projects receive funding despite the projects exceeding the budget of $40 million. The CIRM President, Alan Trounson became involved in the selection process and the final decision was to fund the Stanford project only, totaling $40 million. The CIRM grant review and scoring process and the role of President Trounson have been questioned, especially by those that did not receive funding like Jeanne Loring from the stem cell program at Scripps Research Institute.
The Future of CIRM
It is expected that the $3 billion initially funded to CIRM through Proposition 71 will end by 2017. Therefore, discussion continues to increase regarding how and if CIRM will continue funding current and future stem cell research projects. In February 2014, Robert Klein, a leader in the initial campaign for Proposition 71 and former CIRM Board Chair, presented a proposal at the UC San Diego Moores Cancer Center to extend CIRM funding. If the public supports the proposal, Klein and other backers have said they would work to get an initiative on the 2016 ballot that would provide an additional $5 billion in funding to CIRM and stem cell research. The other option discussed is for CIRM to become a private, non-profit organization that would rely solely on outside funding.
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- California Family Bioethics v. California Institute for Regenerative Medicine, 55 Cal Rptr 3d 272 (Cal App 1 Dist 2007).
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- CIRM Press Release (25 October 2012). "Stem Cell Agency Awards Almost $20 million to Companies Developing Therapies for Diabetes and a Potentially Deadly Blood Disorder". Retrieved 24 March 2014.
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- Jenson, David. "California's $40 Million Stem Cell Genomics Award: irregularities, Complaints and Integrity". Retrieved 8 April 2014.
- Jensen, David (10 February 2014). "Amid Allegations of Unfairness, California's Stem Cell Agency Begins Examinations of $40 million Genomics Award Round". Retrieved 8 April 2014.
- Fikes, Bradley (20 February 2014). "$5B initiative proposed for stem cell research". The San Diego Union-Tribune. Retrieved 8 April 2014.
- "The Case for CIRM 2.0: Continuing California's Stem Cell Leadership". Knoepfler Lab Stem Cell Blog. 31 October 2013. Retrieved 8 April 2014.