Thursday, January 23, 2014

California's Stem Cell Genomics Awards: An Untidy Affair

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.

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.

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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