Monday, July 30, 2007

Stem Cell Lab Building Plan Heads for Approval Next Week

The California stem cell agency Monday moved forward on its largest single grant effort – a $220 million proposal for new research labs – with hopes that some construction could begin as early as next January.

The Facilities Working Group of the California Institute for Regenerative Medicine (CIRM) sent criteria, evaluation standards and grant review procedures for the lab grants to the agency's Oversight Committee for approval when it meets Aug. 8 in San Francisco.

Major universities and research institutions in California, ranging from Stanford to UC San Diego, are lining up for the money. Some have been planning since November 2004 when Prop. 71 created CIRM and provided it with $3 billion in funding, the largest single financial source for human embryonic stem cell research in the world.

The group did not settle on a firm timetable, but Robert Klein, chairman of the Oversight Committee, said he expected to see initial approval of the grants in early January. He said that would mean that some institutions could begin construction shortly thereafter.

That would be possible under a new, two-step grant review process approved by the working group Monday. It calls for the scientific component of the proposals to be approved first via the scientific grants group with facilities group action later. Klein said high rankings at the first stage of approval (at a yet to be scheduled Oversight meeting early in January) would permit some ambitious institutions to begin work. Jeff Sheehy, a member of the Oversight Committee and the facilities group, said the new process could speed up final approval by at least a month compared to the smaller, shared lab grant review completed earlier this year.

The facilities group also indirectly addressed the ticklish question of dividing the grant money between smaller, less-established institutions and the heavyweights of stem cell research. The proposed grant rules call for applicants to choose as many as three scientific areas where they believe they have strength: basic and discovery research, preclinical research, preclinical development and clinical research. The areas were dubbed, respectively, Element X, Element Y and Element Z.

If a university identifies itself as having strength in all three elements (XYZ), it will compete against other similar XYZ institutions as a “CIRM Institute.” If it has strength in two elements, it will compete as “CIRM Center of Excellence.” If strength is in one area, the competition will be among other single-strength “CIRM Special Programs.”

The grant process places emphasis on value, leverage and urgency, which account for 70 out of 100 possible points. The urgency component (20 points) requires a two-year construction timetable with financial penalties for failing to meet deadlines. The value component( 25 points) calls for a “good return to the taxpayer,” among other things. The leverage component (also 25 points) is aimed at forcing the institutions to come up with major financial support for their proposals in addition to CIRM funding.

Several times the discussion focused on ambiguities in the criteria such as “facility assets,” “enhanced capability” and “reasonable and necessary.” Some of these are likely to be refined as a final RFA is developed. But Klein told the small audience at today's meeting at CIRM headquarters in San Francisco, “We're going to make a lot of subjective decisions.” It was a refrain he came back to several times.

Following the meeting, when we asked him about the difficulties posed for applicants by ambiguous terms, he said they do create challenges. But he said the criteria is designed to “accommodate the creativity” that California institutions have. He and others on the facilities group said they wanted to provide ample opportunity for imaginative approaches to lab construction, management and collaboration.

The facilities group also approved a rule aimed at preventing double-dipping in the grant process. It permits only one application per institution with funding for a single project on a single site. This means, for example, that if a legally constituted consortium applies for a grant, members of that consortium cannot apply for another grant separately.

John M. Simpson, stem cell project director of the Foundation for Consumer and Taxpayer Rights and a longtime attendee at CIRM sessions, praised the overall process for the lab grants. Often a critic of CIRM and the grant process at one point, he said the facilities group meetings benefited both the agency and applicants, generating a higher participation from the applicants/public compared to many other CIRM sessions. That “enhances the output,” he said.

Simpson is correct about the larger turnout, but even that is small, ranging from 30 to 40 persons at its peak during the recent round of meetings. What surprised us is the fact that some potential applicants did not regularly attend the sessions. That means they will miss important nuances that are not available via online transcripts and Power Point presentations. As for attendance by the general public, nobody bothered, but that is not much different than public proceedings at any other state agency.

To see more specifics of what the facilities group considered, see this location. The document is likely to be reposted in several days with changes from today's meeting as part of the Oversight Committee agenda.

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