The California Institute for Regenerative Medicine Science, Governance, and the Pursuit of Cures (2013) / Chapter Skim
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2 CIRM's Initial Processes and Funding Model
2 CIRM's Initial Processes and Funding Model
Pages 29-50
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From page 29... ...
This chapter reviews the origins of CIRM and the committee's assessment of the implications of those origins for the Institute's ongoing work. The chapter then examines the funding model that supports CIRM's work, the impact of this economic investment, and the consequences of CIRM's funding model for the broader scientific enterprise.
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From page 30... ...
In adopting Proposition 71 in the 2004 general election, the voters of California approved an amendment to the state constitution making it a constitutional right for California residents to engage in stem cell research, including research using hES cells, and requiring the state to devote considerable resources to such efforts and to the field of regenerative medicine more generally. Once again, it is important to stress that this was accomplished at a time in the nation's history when, as outlined in Chapter 1, the ethics of research using hES cells was the focus of serious disagreement in Washington, DC, and elsewhere; when future federal funding for research in this arena was highly uncertain; and when additional methods of creating 1 California Stem Cell Research and Cures Initiative, Proposition 71 (2004)
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From page 31... ...
All stakeholders understood that achieving these objectives would require significant progress on the scientific frontier; nonetheless, as stem cell research developed rapidly in California and elsewhere, these varied interests conflicted at times, creating some friction in the process of deciding about the allocation of CIRM funds among various priorities or particular aspects of the frontier in this aspect of regenerative medicine (Adelson and Weinberg, 2010)
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From page 32... ...
While this profile of the ICOC was understandably designed to include representatives of a broad range of stakeholders most concerned and most knowledgeable about the future of regenerative medicine, they were also the constituency expected to benefit most directly and immediately from CIRM's grants. Detail on the Institute's governance structure and the committee's assessment of its effectiveness and challenges is presented in Chapter 3.
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From page 33... ...
Thus while the availability of funds for the field of regenerative medicine as a whole enjoyed a certain stability in California, there were no such guarantees for individual researchers or research teams. Moreover, 3 General obligation bonds are a form of long-term borrowing in which the state issues municipal securities and pledges its full faith and credit to their repayment.
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From page 34... ...
In any case, if the best efforts in stem cell research in California and elsewhere were not to yield clinical or other benefits to the next generation, that generation would bear a cost burden not offset by any corresponding clinical benefit or any longterm economic benefits to the state.6 In many ways, investments in research and development appear to be analogous to more prosaic infrastructure investments in, for example, roads, bridges, and power networks, which often are financed through the issuance of long-term bonds. Perhaps the most significant difference, however, is the uncertainty surrounding investments in the biomedical enterprise and the precise nature and timing of the benefits expected to accrue.
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From page 35... ...
Although the relative stability CIRM offered the field of regenerative medicine in California was a notable improvement over the uncertain prospects for federal funding, especially for hES cell research, the roughly 10- to 15-year period for expending the agency's initial bond funding, as noted above, is not a long time in which to realize the full benefits of basic or clinical biomedical research. Thus, the creation of CIRM and the development of its programs almost immediately raised questions about its long-term future and the impact of the expiration of its funding on the full career path of scientists recruited to the field or the state.
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From page 36... ...
It is clear, however, that CIRM's perceived success did not go unnoticed by other states, which responded in some cases with initiatives and models of their own in the area of regenerative medicine and/ or in the broader biomedical arena, some of which are discussed below. Economic Impact of the Investment in CIRM California's substantial investment in CIRM quite naturally raises the question of the actual economic benefits generated by this investment and just how these benefits relate to the costs of the program.8 Although overall investments in science and technology have transformed society and yielded enormous economic dividends, this does not mean that all investments in science and technology produce substantial economic dividends (Maddison, 2007)
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From page 37... ...
To put this estimate in context, however, total employment in California is roughly 16 million, and NIH alone provides more than $3.5 billion per year to California research institutions. In conclusion, measuring the economic impact of biomedical research, especially work in a specific arena such as regenerative medicine, remains a difficult and complex task.
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From page 38... ...
These are substantial achievements, but assessing their longer-term economic impact is simply not possible with the information currently available. Consequences of CIRM's Funding Model for the Broader Scientific Enterprise Although Proposition 71 clearly increased significantly the total national and international level of resources devoted to this area of regenerative medicine, any prior constraints on how local resources can be allocated entail at least some modest costs for the global enterprise.
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From page 39... ...
. The creation of CIRM by California voters and the agency's focus on advancing stem cell science and the field of regenerative medicine fall squarely within these larger trends.
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From page 40... ...
CIRM's research leadership grants, which provide funding to recruit leading stem cell scientists to California, fall within the tradition of these programs. The value and impact of these state programs designed to fund research grants or to recruit scientists should be assessed in the broader context of a state's support for its overall research and development enterprise, including, for example, its research universities.
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From page 41... ...
It is important to note that the committee is not evaluating these programs, but reviewing some of their key characteristics to provide additional perspective on CIRM. Given CIRM's focus on stem cell research and regenerative medicine, the committee's comparison concentrated on other state programs specific to these fields.
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From page 42... ...
The initial act creating the program appropriated $20 million for grants supporting embryonic or adult stem cell research and specified that an additional $10 million should be dispersed from the state's Tobacco Settlement Fund for the following 8 fiscal years (through the fiscal year ending June 30, 2015)
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From page 43... ...
The MSCRF requires that funded grants include human stem cell research but imposes no requirements on the specific type of human stem cells studied. In early 2012, Maryland issued a new RFA focused on preclinical and clinical research, which specifically targets for-profit companies conducting stem cell research in the state.
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From page 44... ...
44 TABLE 2-1 Characteristics of CIRM and Comparable Funding Programs California New York Connecticut Maryland Texas Origin Voter initiative Legislature Legislature Legislature Voter initiative Financial commitment $3 billion $600 million $100 million Not specified $3 billion Funding mechanism Bonds Annual appropriations Annual appropriations Annual appropriations Bonds (tobacco settlement funds) Awards announced to ~$1.6 billion ~$221 million ~$69 million ~$91 million ~$760 million date Approximate duration 10 years 11 years 10 years Open-ended 10 years First awards 2006 2008 2006 2007 2009 NOTE: Funding totals as of August 2012.
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From page 45... ...
Its initial efforts to establish human and physical capital certainly are necessary steps toward the development of a scientific environment for regenerative medicine in California that is conducive to establishing and sustaining leadership in this area of medical research and to eventual clinical success. Moreover, the work of CIRM-sponsored researchers continues to enrich regenerative medicine everywhere, just as CIRM's efforts continue to benefit from and be inspired by many exciting new developments in regenerative medicine taking place both within and outside of California.
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From page 46... ...
As a result, the costs of these contemporary investments in the science of regenerative medicine have been transferred to future cohorts of taxpayers, who were presumed to be the principal beneficiaries of CIRM's programs. • The stability offered by the terms of Proposition 71 to critical aspects of the field of regenerative medicine in California has allowed CIRM to engage in long-term planning; develop a compre hensive long-term funding strategy, including support for training, infrastructure, and research; attract significant private funding to its capital projects; and recruit scientists to the state.
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From page 47... ...
The committee believes that in this process, it will be important for CIRM to give increased attention to industry inputs since the latter are crucial to a fuller understanding of what it will take to attract the much larger sums required to take laboratory findings to the "bedside." As part of its 2012 Strategic Plan, CIRM set forth plans to establish a platform to enable grantees, and industry, among others, to continue their pursuit of CIRM's mission after the Institute's bond funding expires (CIRM, 2012b)
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From page 48... ...
• ow any new funding models would impact the role and structure H of the ICOC. The next three chapters contain the committee's principal findings, conclusions, and recommendations on the implementation and operations 11 In the committee's view, this recommendation can be carried out by CIRM without legislative action.
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From page 49... ...
2004. Economic impact analysis: Proposition 71 California stem cell research and cures initiative.
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From page 50... ...
. YESon71 (The California stem Cell Research and Cures Initiative)
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