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.”
