The California stem cell agency's $40
million genomics round seems to be turning into a bit of a muddle.
The agency's Web site said this week that four
applications were approved for funding by CIRM's prestigious grant reviewers, whose recommendations go to the agency's governing board next week. However, CIRM President Alan Trounson and his staff are
recommending that only one of those applications, a $33 million
proposal, be approved by the board. Those other
recommendations from reviewers, the agency said today, are not really recommendations.
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| Alan Trounson CIRM photo |
The move by Trounson, who announced
last fall that he is leaving the agency, reflects the most aggressive
action taken by the staff on grant applications since they began
making recommendations on them last year.
As of this writing, the CIRM Web site
has yet to offer a rationale for the staff's recommendations. The review summaries of the applications said simply,
"CIRM Staff Recommendation: Do not fund"
So the
California Stem Cell Report queried the agency this morning about the
matter.
Kevin McCormack, CIRM's senior director for
communications, replied that the reviewers actually “did not
recommend funding” the three out of the four applications despite
what the agency officially says on its Web site. The language and graphic on the Web site, however, conform to the agency's
practice involving thousands of applications over the last nine
years. Its governing board has been exquisitely careful to heed the positive recommendations of its reviewers.
The unusual situation – not to mention the dollars at stake
-- seems certain to trigger public presentations by rejected
applicants at the governing board's meeting next Wednesday in Berkeley. The board can override both staff and reviewer
recommendations as well as increase or decrease the money available
for the genomics round.
To fully understand the muddle, it is necessary to understand some details of
the CIRM grant review process. The CIRM Grants Working Group -- composed of six voting CIRM board members, and a long list of
out-of-state scientists plus other experts from time to time, or some subset of the group -- examines the applications behind closed doors. The scientific members
score the grants and then they are voted on by the full panel. The
results of the reviewer decisions are presented to the public in
tiers. Tier one is invariably funded by the board with no discussion
at the later public board meetings. In the history of CIRM, only one or two
applications have been downgraded from tier one. The definition of
tier two has varied, but these basically are wobblers –
applications with some merit but not quite enough to win approval
from reviewers. Occasionally the board reaches into tier two to
approve an application. Tier three applications are not recommended
for funding by reviewers.
Four applications for funding to create
stem cell genomics centers were placed in tier one, according to
documents on the CIRM Web site this week. Their scientific scores
range from 88 to 75. A fifth application was scored at 70 and placed
in tier two. The names of the applicants were withheld in keeping
with CIRM's practice. The agency only announces the names of winners.
CIRM says it withholds the names of rejected applicants to avoid
embarrassing them.
Here is McCormack's full explanation
for the variation between the longstanding practice of the agency and
what has happened in the genomics round.
“Tier 1 in this case really means 'fundable' as in adequate for funding. Assignment to this tier was based solely on scores from scientific review. Reviewers understood that only one or possibly two centers would be funded (that was clearly stated in the RFA) and did not recommend funding all of the applications.”
McCormack is correct that the RFA said one or two. Most CIRM RFAs have similar language. The RFA for the basic biology round, also to be considered on Wednesday, for example, says that as many as 30 grants may be awarded. It could be less, and it could
be more depending on the board's druthers.
In the past, CIRM staff has offered the
board a brief written statement supporting their recommendations on
applications. Presumably that will be posted on the CIRM Web site
soon.
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| Craig Venter Venter Institute photo |
The latest situation is not the first
unusual event in the genomics round, which began publicly two years
ago this month at a CIRM board meeting in San Diego. It was then that
the board approved the concept for the $40 million round on a voice
vote with almost no debate. The CIRM directors had already been primed by 30-minute
presentation by Craig Venter, the famed genomics expert who heads the San Diego area institute bearing his name. Venter, who was invited to
appear by the agency, built a case for the importance of genomics and said he had already begun a stem cell genomics effort. He is believed
to be one of the competitors for next week's funding for CIRM. His
presentation raised eyebrows among some scientists because of its
close tie to the board vote on the plan.
The genomics round was also marked by a conflict-of-interest violation last year involving eminent Stanford
stem cell researcher Irv Weissman and Lee Hood of Seattle, renowned
internationally for his genomics work. Hood had been recruited by Trounson to be a reviewer in the round. However,
at the review session, Hood failed to disclose his relationship to
Weissman, who was involved in a $24 million application from
Stanford. They are longtime friends and own property together in
Montana.
Reviewers at that session were unable
to come up with recommendations for funding. It was the first time in
CIRM history that has occurred. The reviewer comments were
subsequently sent back to applicants who resubmitted their proposals
for review last November.
As for the $33 million proposal
recommended by Trounson and his staff, the review summary says it
involves seven major academic and nonprofit institutions. The review
said the applicants are offering “very substantial matching funds.”
The institutions are also widely
scattered. The review summary said,
“Although some reviewers expressed minor concerns that the multiple, geographically separated components of this large and interdependent program could pose an administrative challenge, overall, reviewers expressed much confidence in the demonstrated abilities and collaborative experience of the program leaders for achieving a shared vision.”
The study of genomics also requires
manipulation of massive amounts of data, a matter of importance to reviewers. The review summary said that aspect
of the proposal was a “major strength.” The summary said,
“The leader of this center component is a pioneer in the field and has an outstanding track record in the proposed activities.”
During its public discussion of grant proposals, the
CIRM board is not told the name of the applicants. It only works from
the public summary of the proposal and does not see the actual
application. Board members with conflicts of interest are prohibited
from engaging in the discussion or voting.
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