Sunday, October 06, 2013

Scientific Advisors Take First Look at $3 Billion California Stem Cell Agency

Directors of the California stem cell agency on Wednesday will hear the first recommendations from a newly formed scientific advisory board, created to provide “cohesive” advice that a blue-ribbon study said has been lacking at the agency.

Formation of the panel was recommended last December by the prestigious Institute of Medicine (IOM) in its $700,000 report on the performance­ of the stem cell agency. The IOM said a scientific advisory board would be invaluable in helping the agency to “make fundamental decisions about dealing with challenges that cut across particular diseases, decide which discoveries should progress toward the clinic and determine how best to engage industry partners in developing new therapies.”

The report from the eight-member panel is not yet available to the public although only two business days remain before the agency's governing board meeting in Burlingame, Ca.

The panel was created last July and has held at least one meeting, which was not noticed publicly. The members include only one Californian, Corey Goodman, co-founder of venBio, a San Francisco biotech venture capital firm. According to an article by Bernadette Tansey on Xconomy, his current advice to biotech industry executives is:
 “Don’t do what I did. That worked then—it won’t work now.”
The other scientific advisors are: Sir John Bell, Oxford University, Great Britain; Christine Mummery, Leiden University Medical Center, The Netherlands; Sean Morrison, Children’s Research Institute at UTSW, Texas; Stu Orkin, Harvard Medical School, Dana Farber Cancer Institute, Mass., and also a member of the IOM panel that studied CIRM; Fiona Watt, Centre for Stem Cells and Regenerative Medicine, King's College London; John Wagner, University of Minnesota Stem Cell Institute,who is also a member of the CIRM standards group, and Maria Grazia Roncarolo, San Raffaele-Telethon Institute for Gene Therapy (TIGET).
(More information on each member is available by clicking on their names.)

In response to queries from the California Stem Cell Report, Kevin McCormack, senior director of public communications, said that the members of the board will not receive compensation but will be reimbursed for their expenses. McCormack said that they have been screened for conflicts of interest.

CIRM, as the $3 billion stem cell agency is known, has not yet prepared a written description of its new advisors' duties. McCormack instead referred to the IOM's description of what the board should be doing.

The IOM recommended formation of “a single Scientific Advisory Board, as opposed to multiple advisory boards as proposed in the 2012 strategic plan, (that) would provide cohesive, longitudinal, and integrated advice to the president regarding strategic priorities, which is lacking in the current CIRM organizational structure."

At its July 25 meeting, the CIRM governing board was told by President Alan Trounson that the scientific advisory board “may or may not be supportive completely of our strategic plan, but it will be a recommendation we'll bring to the board for further discussions about how we orient ourselves.”

The IOM cited several areas where CIRM has “made strategic decisions that resulted in the omission of some important areas.” They included “addressing the novel ethical and regulatory aspects of clinical applications of potential stem cell therapies” and preparation of “academic institutions in California for collaboration with the private biotechnology or large pharmaceutical sectors.”

The IOM report said,
“(T)he notable absence of industry representatives on most disease teams demonstrates the inadequate emphasis of CIRM’s translational/development RFAs on what is needed to enable regulatory approval for cell-based therapies.”
Also scheduled for Wednesday's governing board meeting is a review of its translational grant portfolio. That report is also not yet available publicly. In the past, such reports were often limited to a Power Point outline and not available to the public until their presentations were underway during the board meeting.

Here is the text of the IOM's summary of its recommendation for creation of the scientific advisory board.
“CIRM proposes to create a Clinical Advisory Panel and Industry Advisory Board. Although the committee supports CIRM’s intent to establish advisory boards, it recommends that one Scientific Advisory Board be established. Striking the proper balance in research across the portfolio of basic, translational, and clinical studies will require that CIRM solicit broad input in executing its strategic plan. The committee believes the proposed Scientific Advisory Board could serve an invaluable role in this process.
“Recommendation 4-1. Establish a Scientific Advisory Board. CIRM should establish a single Scientific Advisory Board comprising individuals with expertise in the scientific, clinical, ethical, industry, and regulatory aspects of stem cell biology and cell-based therapies. A single Scientific Advisory Board, as opposed to multiple advisory boards as proposed in the 2012 strategic plan, would provide cohesive, longitudinal, and integrated advice to the president regarding strategic priorities, which is lacking in the current CIRM organizational structure. The majority of the members of the Scientific Advisory Board should be external to California, appointed by and reporting to the CIRM president. Such an external board would be invaluable in vetting ideas for new RFAs, suggesting RFAs that otherwise would not have been considered, and helping CIRM maintain an appropriate balance in its research portfolio. Input from this board would help CIRM make fundamental decisions about dealing with challenges that cut across particular diseases, decide which discoveries should progress toward the clinic, and determine how best to engage industry partners in developing new therapies. The board’s reports and the president’s response to those reports should be delivered to the ICOC(the CIRM board) and discussed in sessions open to the public.”
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