Monday, October 18, 2010

How Fast Should the Stem Cell Agency Spend its Remaining $1.6 Billion?

Directors of the California stem cell agency will give away more than $80 million this week and wrestle with the question of what to do with their remaining $1.6 billion and how fast to spend it.

The $1.6 billion is a new figure for the public. Previously it was assumed the agency had $2 billion left, having committed $1 billion in awards. However, $2 billion figure did not include operational expenses, such as interest, legal costs and $180 million for administration through 2016.

The CIRM board is not likely to make a final decision on its strategic spending plan at the meeting Wednesday and Thursday in Los Angeles and at UCLA. Directors will have more information to work with in December when they consider the report of CIRM's external review panel, which conducted three days of hearings last week. The public was barred from most of those proceedings, and there are few clues concerning the direction of the blue-ribbon panel's recommendations.

Here are links to key documents on CIRM's future spending scenarios: Projected cash flow, memo on cash flow and more projections.

Also before the board are applications for $80 million for early translational research. Three applicants whose proposals were rejected by reviewers have filed petitions seeking to reverse the decisions. They are Sophie Deng of the Jules Stein Eye Institute at UCLA, Leif Havton, also of UCLA and Frederick Meyers and Kit Lam of UC Davis. (You can find their appeals by clicking on their names.)

The appeal process itself, which has troubled the board for several years, may also be modified this week. A proposal that would formalize a process for sending grants back to reviewers for additional examination is on the table. The staff information on the plan said,
“When a material dispute of fact exists and the Board is unable to resolve the issue at the meeting at which the application is considered, the Board may conditionally deny funding for the application, subject to a limited analysis of the factual issue or issues identified by the Board. The option for additional analysis is not a reconsideration of the application as a whole, but is limited to consideration of the issue or issues identified by the Board. This option should be reserved only for those circumstances in which the Board is unable to reach a decision at meeting at which the application is presented because of the factual dispute or question. Programmatic issues, such as whether the agency’s portfolio is well-balanced among diseases, should not be a justification for additional analysis, nor should clear errors in the review of an application that have been identified by staff and presented to the Board during the meeting at which the application is considered.”
Also before the board is CIRM's second recruiting grant to a scientist, as yet unidentified. It would provide $4.9 million to the “mid-career neuroscientist” in addition to incentives provided by the recruiting institution. The reviewer summary said,
“Reviewers characterized the PI’s research vision and plans as truly innovative, novel, ambitious, and important. The research focus on devastating and currently incurable blinding diseases was viewed as highly significant, with a potential to revolutionize the field. Reviewers were confident that the PI’s research would contribute to both the critical basic science and preclinical advances that will underlie novel therapies.”
Other items before the board include a proposal to spend $600,000 to provide seed money for an online, open-access journal for translational stem cell research, and changes in the loan administration policy. Most of the changes appear to be a straight-forward clarification of language that removes questions by business, which is the target of the loan program that was once described as a $500 million effort.

Missing from the proposed changes is one dealing with automatic forgiveness of loans to businesses under specified conditions. It appears to be connected to an application from iPierian, Inc., in the early translational round. However, the changes would apply to all loans to businesses and remove financial ambiguity that could be a stumbling block for some enterprises.

The changes came before the Finance Subcommittee last week, but some board members raised questions about them. Plus the panel did not have a quorum and could not legally act. The Finance Subcommittee has scheduled a meeting for Oct. 26 to consider the proposal again. It would then go to a special teleconference meeting in the board, if necessary.

CIRM has not provided a link to the loan forgiveness changes in the Oct. 26 agenda, but they can be found in a document here.

The public will be able to participate in the CIRM board meeting this week at teleconference locations in Washington, D.C., and Pleasanton in Northern California. The meeting can be heard on the Internet as well, but that audiocast does not permit participation.

Specific locations and instructions for the audiocast can be found on the agenda.

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