StemCell Therapy

All $69 million in last month's
translational research round went to 21 academic and nonprofit insitutions. No business received an award. One firm, Eclipse
Therapeutics of San Diego, appealed to the agency's governing board but was not successful despite having a higher scientific score
than at least two winners.

The miniscule amount of funding for
commercial enterprises – less than 4 percent of $1.4 billion handed
out so far – has been a matter of concern for some time for both
industry and some members of the CIRM governing board. Most
recently, industry executives complained at an April hearing of the
Institute of Medicine panel looking into CIRM's operations.
Even a 2010 review commissioned by CIRM said the agency needed to do
better by business.

The question of funding goes beyond a
simple matter of fairness or "good science," as CIRM
describes its funding goal. Without efforts by industry to turn
research into cures, CIRM will not be able to fulfill promises to
voters in 2004 when they approved creation of the stem cell agency.
CIRM last month approved a set of five-year goals that push more
aggressively for development of commercial products, but the goals
lacked such things as a financing round devoted solely to business
applicants.

In last month's translational round,
applicants went through a three-step process, which is conducted
primarily behind closed doors. First came what CIRM calls
pre-applications. Those were reviewed by CIRM staff with the help of
outside advisors if necessary. Applicants who cleared that hurdle were allowed to apply for the full, peer-reviewed round. During that
process, the CIRM Grants Working Group reviews applications,
makes decisions and sends them to the full CIRM board for
ratification and possible changes. The board almost never has
rejected a grant approved by reviewers. But the board has ultimate
authority and sometimes funds applications that reviewers have
rejected. The applicants' names are withheld from the board and the
public during the process, although some of the board discussion and
the final vote is conducted in public. CIRM does not release the
names of rejected applicants unless they appeal.

In the translational round, a total of 42
pre-applications out of 167 were approved by staff, according to
CIRM. Thirty-eight came from nonprofits and academics out of the 153
such institutions that applied. Four out of 14 business
pre-applications advanced to full applications but none made the
final cut. All of the winning applications were linked to
institutions that have representatives on the CIRM governing board.
Those representatives are not allowed to vote on or take part in
discussion involving applications to their institutions.

The primary decision tool used by the
grant review group is a scientific score. In last month's round,
scores of approved grants ranged from 88 to 53. However, eight grants
that were ranked above 53 were rejected by the board. One of those
higher-ranking applications came from San Diego's Eclipse
Therapeutics, which scored 58. The low-ranking grants were approved
for what CIRM describes as "programmatic" reasons.

More than three weeks ago, the
California Stem Cell Report asked CIRM for figures on the
numbers of applications in the translational round, including those
for business. CIRM said the figures had not been compiled and would
not be available until after the awards were made on May 24. The
numbers were finally supplied yesterday.

Our take: The number of applicants, and
their breakdown, is basic information that should be part of board's
decision-making process. The statistics should be routinely available
well in advance of the board's meeting. Indeed, the agency in its
earlier days used to routinely publish the figures. It may be now
that generating them is more time-consuming than necessary. The
recent performance evaluation of the agency said CIRM needs to make
major improvements in how it handles critical information needed for
its top management and board.

Whatever the reason, given CIRM's poor
track record with business, the agency's directors should diligently
track industry's success rate on applications. If proposals ranked as
low as 53 are approved while higher ranking applications from
business are bypassed, it warrants more than cursory examination.