The California Institute for Regenerative Medicine Science, Governance, and the Pursuit of Cures (2013) / Chapter Skim
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to distribute $3 billion in state funds for stem cell research. The passage of Proposition 71 by the voters of California occurred at a time when federal funding for research involving human embryonic stem cells was uncertain, given the ethical questions raised by such research.
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Its principal aims are to accelerate certain critical aspects of the science of regenerative medicine and its translation into treatments for a spectrum of currently intractable human diseases. Research on stem cells is an important area of biomedical research because of the promise it holds for developing new and more effective treatments for a wide variety of diseases.
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What has been the economic impact of CIRM's research and facilities awards and grants? • CIRM's intellectual property policies -- What are the strengths and weaknesses of CIRM's policy for sharing revenue generated by intellectual property?
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In the short term, CIRM's expenditures are supporting approximately 3,400 jobs, and its innovative efforts have also attracted substantial additional private and institutional resources to this research arena in California. CIRM's long-term impact on such critical aspects of the California economy as state tax revenues and health care costs beyond the shorter-term and temporary impact of its direct expenditures cannot be reliably estimated at this point in CIRM's history.
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Any such plan should address such key strategic areas as how CIRM intends to obtain funding after bond proceeds have been spent, how the venture philanthropy fund proposed in the 2012 Strategic Plan will interface with CIRM, and impacts of any new funding models on the role and structure of the ICOC.3 GOVERNANCE OF CIRM Assembling the broad coalition of citizens and institutions that were united in their enthusiasm for stem cell research, but had somewhat different perspectives, had implications not only for the design of Proposition 71 but also for CIRM's ongoing programs and operations. While CIRM's restrictions on amending the administrative structure established in Proposition 71 had the advantage of protecting the Institute's ongoing operations from outside interference in an ethically controversial arena, they also made it difficult to modify the organization's structure in response to experience and/or changing circumstances.
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The committee believes good governance requires that the board delegate more authority and responsibility for day-to-day affairs to the president and senior management. The Little Hoover Commission recommended that CIRM and the legislature eliminate overlapping authority between the chair and president and improve the clarity and accountability of each.
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CIRM should put systems in place to restructure the board to have a majority of independent members, with out increasing the size of the board. It should include representatives of the diverse constituencies with interests in stem cell research, but no institution or organization should be guaranteed a seat on the board.
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CIRM should revise its definitions of conflict of interest to recog nize conflicts arising from nonfinancial interests, such as the potential for conflict arising from an individual's interest in a specific disease, and should reassess its policies for managing conflict of interest in light of this broader definition. An important theme of the committee's governance recommendations is for CIRM to transition from the governance structure initially outlined in Proposition 71 to one the committee believes would better serve the interests of the citizens of California and the field of regenerative medicine.
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THE SCIENTIFIC PROGRAM The ICOC adopted its first scientific strategic plan in December 2006. The goals during this initial phase were to develop appropriate laboratory facilities for stem cell research, to fund basic research in stem cell biology, to invest in programs focused directly on research on a broad range of diseases, and to establish a long-term foundation for California's leadership in stem cell research and development.
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Nonetheless, based on the consensus of both academic and industrial stem cell experts who provided comments to the committee, and given both the lengthy time frame generally required for development of new therapies and the high failure rate of clinical trials at Phase 1 or 2, the committee believes the translational goals enumerated in the 2012 strategic plan are unrealistic. Instead of focusing purely on quantitative measures, such as numbers of trials and disease areas, CIRM should also focus on fundamental biological mechanisms that ultimately determine the success or failure of a specific disease intervention and on the careful design of translational studies to make them maximally informative even in the absence of any demonstrable clinical benefit.
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Most of CIRM's ethics and public policy spending has focused on intramural funding for public outreach and education and the internal development of technical, instrumental, and procedural policy frameworks for basic stem cell research. Also lacking are proposals that would prepare academic institutions in California for collaboration with the private biotechnology or large pharmaceutical sectors.
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The committee has considerable concern about the role of the ICOC with regard to management versus oversight of CIRM activities, particularly for the grant-making process. The ICOC may move applications from one tier to another before taking a final vote.
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. 7 Proposition 71 divides responsibility for CIRM's intellectual property policies among the ICOC, which is assigned to "establish policies regarding intellectual property rights arising from research funded by the institute"; the chairperson, whose responsibilities include "to lead negotiations for intellectual property agreements, policies, and contract terms"; and the president, whose responsibilities include "to manage and execute all intellectual property agreements and any other contracts pertaining to the institute or research it funds." Codified at California Health and Safety Code § 125290.40.
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Perhaps the most controversial aspect of CIRM's intellectual property provisions is the requirement that grantees and their exclusive licensees submit to CIRM "access plans" that will afford access to any drug resulting from CIRM-funded research to "Californians who have no other means to purchase the drug."9 Federal law and other state-funded stem cell programs have no comparable provisions. Uncertainty about how the system will work could make industry cautious about licensing and investing in CIRM-funded inventions, especially if they have the option of turning to other sponsors that do not impose similar requirements.
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As other sources of funding for stem cell research become available and as the field of regenerative medicine advances from the laboratory to the clinic, the ICOC should reconsider whether its goal of developing cures would be better served by harmonizing CIRM's intellectual property policies wherever possible with the more familiar policies of the Bayh-Dole Act. CONCLUSION The creation of CIRM resulted from the initiative, imagination, and hard work of a broad group of stakeholders in California.
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The committee is aware that its recommendations come at a time when CIRM may well be faced with pressing challenges resulting from the expiration of Proposition 71 funding and/or dynamic changes in the field of regenerative medicine. The committee hopes its recommendations will be considered not only now, but also in the future as decisions are made.
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