The new president of the California
stem cell agency -- even before his appointment last week --
participated in handing out more than $640 million in awards from the
agency to businesses and academic researchers.
Perhaps more importantly, all of those
awards involved advanced stages of research leading to clinical
trials, the current focus of the Golden State's research enterprise.
The participation of Randy Mills, the
former CEO of Osiris Therapeutics, in the approval of the grants and
loans came during the closed-door review of their applications. He
was a member of the panel of out-of-state reviewers used in eight
CIRM award rounds. The panel of scientist is large, but each award round uses only a small subset of the total group.
Mills' five years as a reviewer gives him a special
insight that is not even shared by most of the members of the CIRM
governing board. Only seven members of the 29-member CIRM board sit on the review panel.
CIRM Chairman Jonathan Thomas, who is a non-voting member of the grant review panel, last week said that Mills demonstrated "a sharp intellect and a keen analytical mind" during grant reviews.
The grant reviewers make the de facto
decisions on the vast majority of grant applications. The governing
board has almost never overturned a positive decision by the
reviewers. The full board receives only the review summaries that are
available to the public, with the exception of proprietary
information. Indeed, board members have complained over the years
about not having enough information to make decisions when faced with
appeals from rejected applicants.
The reviewer sessions are where the
scientific merit of the proposed research is scrutinized and
criticized in detail and scored. Until recently, other issues were
considered as well, what the agency calls “programmatic” review,
which covers nearly everything.
The role of the president of the agency
during the closed-door review is not clear, although he does not have
a vote. Alan Trounson, the current president of the agency, was
believed by some California researchers to be active during the
closed-door process, injecting comments and likely affecting
decisions by reviewers at least on some occasions. However, the
agency does not release transcripts or minutes from the review
sessions.
Late last year, the CIRM president was
authorized to make public recommendations to the full board
concerning applications. That process is new, but stirred controversy in January in the $40 million stem cell genomics round.
Here are the award rounds involving
Mills and the dollar amount that was budgeted for each: Strategic partnership I, $30 million; strategic partnership II, $40 million;
strategic partnership III, $80 million; disease team II, $240
million; disease team III, $100 million, early translational II, $80
million, and early translational IV, $70 million. A specific amount
for the 8th round, disease team II planning, was not available at
this writing on the CIRM Web site, but that round was relatively small, $1 million or so
or less.