Wednesday, November 24, 2010

New Directions for CIRM? Closer Links with Industry, Aggressive Search for Innovation, Better Communication

The $3 billion California stem cell agency has done an “extraordinary” job so far, a blue-ribbon review panel said today, and should expand its efforts internationally, create closer ties with the biotech industry and perform triage on its existing portfolio of research grants.

The panel's 19-page report said that the agency now stands at a critical point as its first and only chairman, Robert Klein, is departing, and as it moves more aggressively into development of clinical applications.

The panel encouraged CIRM to seek out innovative projects, even from out-of-state and bring them to California, instead of merely posting requests for grant applications. Industry needs to play a much larger role in funding, the panel said, and it urged changing grant review processes to meet industry needs. “Considerable obstacles to industry engagement remain,” echoing a view stated by biotech firms for past several years. (See here and here.)

The eight-member panel was recruited by CIRM and conducted three days of mostly closed door hearings orchestrated by the agency in San Francisco in October. It was convened as part of the agency's strategic planning process. The panel was not asked to measure CIRM's current results against the campaign promises made in 2004 when voters created the program.

The 29-member CIRM board will discuss the report at its meeting Dec. 8 in Irvine. The subject could come up as early as next Wednesday at a meeting of the directors' Governance Committee.

One recommendation dealt directly with the board itself and the overlapping responsibilities of the chairman and president of the agency, which have been troublesome in the past. Noting that the board has had a “very hands-on approach” during the past six years, the panel's report said.
“We believe this is an appropriate time for the Governing Board to examine its role and composition, mindful of the legal reporting, fiduciary and accountability requirements of the state of California. With the imminent stepping down of the founding Governing Board Chair and CIRM visionary Mr. Robert Klein, it is imperative that the roles and responsibilities of the Governing Board Chair and CEO positions remain distinct but complementary to ensure the continued positive, collaborative partnership between these two key individuals. There should be clarity of the roles and responsibilities of the Governing Board Chair and CEO as it pertains to CIRM’s strategic directions, its policies, international partnerships, funding decisions, public communications and oversight.”
The panel also recommended improvements in CIRM's public relations and education efforts. The panel said,
"(It) strongly encourages CIRM to significantly increase both the quality and breadth of its community outreach and education programs. The objective should be to ensure state-wide visibility and awareness of the contributions that California is making to the global research effort and to create opportunities for Californians to be informed about advances in the research, and to engage in dialogue with the scientific and clinical community about the benefits, limits and resulting guidelines for this exciting area of biomedicine."
Such an effort is all the more important if CIRM is to win approval of the  new, multibillion dollar bond measure that Klein is touting.

The panel had strong praise for CIRM's program so far, particularly since the agency was operating with a staff of less than 50. “Remarkable” and “extraordinary” were a couple of the adjectives. The report said,
“CIRM has built significant additional research capacity in the state, has attracted scores of talented young people to stem cell research, and has catalyzed large and important stem cell projects across the state. The (panel) was most impressed with this rapid start up, the overall quality of the scientists and projects that have been funded, the development of major buildings and other facilities for stem cell research, the forging of several important international partnerships and the innovative training programs that are in place.”
The panel warned that some patient advocate groups might have to lower their expectations as the result of the grant triage, which it called “portfolio prioritization.” The report said,
“While the (the panel) appreciates the natural wishes of disease groups to move forward on particular diseases or conditions, CIRM’s Governing Board, guided by management and external advisors, must begin the difficult process of focusing the number of disease areas to those that it believes have the greatest chance of development progress and clinical success, given reasonable timelines and budget. Attempting to move forward across too broad a front might compromise moving forward on any disease. Undoubtedly, these will be difficult decisions....”
Backers of basic science might also find some reason to be concerned about the emphasis on funding development of clinical applications. However, the report said,
"We strongly encourage CIRM to continue to invest in the research programs, intellectual infrastructure, training and development necessary to advance the understanding of stem cells."
On the international front, the panel said CIRM's efforts should be expanded into non-stem cell areas that could support CIRM's mandate. The agency should "sharpen the focus on meaningful, targeted excellence required for global leadership in the development of innovative treatments based on regenerative medicine."

You can find a list of all the reports recommendations here.

The California Stem Cell Report is interested in hearing from readers about their views on the panel's recommendations and conclusions. You can post them directly by clicking on the word “comments” or you can email them to djensen@californiastemcellreport.com. We will post them verbatim. We encourage writers to identify themselves but anonymous comments are permitted.

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