This is a big week for
Randy Mills, the man who took control
of the $3 billion California stem cell agency
just seven months ago.
It all comes under the rubric of
“CIRM 2.0,” a phrase coined
by
UC Davis stem cell researcher
Paul Knoepfler and adopted by Mills after he
became president of the
California Institute for Regenerative Medicine (CIRM),
as the agency is formally known.
How important are the changes? Important enough for the
agency to tout their mere outline
in a press release out of last October’s board meeting
instead of focusing on the hard news of the approval of its much-ballyhooed Alpha stem cell
clinic program.
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Randy Mills
CIRM photo -- Todd Dubnicoff |
Mills has made his career in business, serving as 10 years
as the CEO of
Osiris Therapeutics of Maryland. He managed to make
Prochymal
the world's first government-approved stem cell drug approved for use on an
off-the-shelf basis. Mills likes to move fast, which is largely the point of CIRM 2.0, and says that he wants to make the agency “radically more effective
and efficient.”
The agency’s news release in October quoted Mills as saying,
“Right now it can take almost two years for a promising idea
to go from the application to the final funding stage. That’s just
unacceptable. We are going to shorten that to just 120 days.”
He also told directors at their October meeting,
“We are in the
business of trying to save people’s lives….We have to behave with the
appropriate sense of urgency.”
Mills knows that stem cell companies can’t sit around
waiting two years for cash. Most operate on a short financial leash and are
perpetually having to raise money. Mills also knows that researchers with
non-profit institutions cannot wait for whenever it is convenient
for the agency to bless them with greenbacks. Those researchers want to be
first with their findings. And they need cash to meet payrolls and to satisfy
their sponsoring institutions.
So Mills says,
“We’re not just making it faster, we’re also making it
easier for companies or institutions with a therapy that is ready to go into
clinical trials to be able to get funding for their project when they need it.
Under this new system they will be able to apply anytime, and not have to try
and shoehorn their needs into our application process.”
At the end of January, the agency will begin
accepting grant applications related to clinical trials on a monthly basis. The
promise is for quick decisions and quick cash. Rejected researchers will – if
their thinking has CIRM potential – be coached and guided into preparing a
fundable project. Accepted researchers will find themselves working more
closely than ever with CIRM staffers to develop something that will emerge as a
marketable product.
Mills is convinced that CIRM 2.0 will also improve
applications, generating more proposals that will be scored at 95 out of 100 by
scientific reviewers instead of the many applications scored at 75 that have
been regularly approved.
All of the details of the plan are still not clear. But $50
million will be set aside for the first six months of next year. Applicants can
ask for whatever amount they want, but budgets will be scrutinized before they
even get to the scientific reviewers. Appeals will not be allowed. Milestones must be met or the cash dries up.
The whole process sounds a bit like a venture capital
operation minus face-to-face pitch meetings.
New rules dealing with conflicts-of-interest on the part of
reviewers will be in place. They will allow applicants to seek to disqualify up to
three reviewers
for almost any reason. However, applicants will not be told who
is reviewing their applications behind closed doors. They will have to guess by
ferreting out reviewer names from CIRM’s list of more than 100.
Little public criticism of the plan has been heard at the
two initial briefings that Mills has given board members. It is clear that there
will be hiccups or worse, like any new process. One question involves
transparency. Will the public or other scientists know which applications have
been rejected along with the subject of their research, as they do currently. Another question
involves board involvement. Currently seven members of governing board sit on the
review committee. How will they participate on a monthly basis?
Coaching rejected applicants can lead to better or more
targeted proposals. But is that something that researchers will readily accept?
Does the whole process move the board farther away from the grant-making
process. Already the directors have turned over what once were public appeals
by rejected applicants to agency staff to be handled behind closed doors.
However, applicants can still speak directly to the board on their own on any subject
under a state law that CIRM cannot change.
But none has been successful recently in winning grant approval through that
route.
Mills says
his reorganization plan for CIRM staff – he
prefers the word “team” – will create “organizational clarity and operational
efficiency.” It will certainly help to break
up ossified structures that may have grown up during the tenure of former President
Alan Trounson, who was not known for his managerial or organizational skills.
The plan also would seem to have some impact on the
controversial dual executive arrangement involving the president and the
chairman of the agency, Jonathan Thomas, who is also salaried. On the surface, the
reorganization would seem to remove some responsibilities from the chairman and
cost him some of his staff. However, the agency has not responded to questions
concerning that area.
Kevin McCormack, senior director of communications for CIRM
and who is also one of the top executives at the agency, will no longer be
reporting, for example, to both the chairman and the president. That shared
reporting was insisted on by former Chairman Robert Klein when the position
that McCormack came to occupy was created.
The dual executive arrangement, which is enshrined in state
law, has been criticized
for minimizing accountability at the agency. It has
also
led to tussles between Klein and other executives, although no serious
disputes have surfaced in public for several years.
CIRM 2.0 holds great promise. It also depends mightily on
Mills' leadership and managerial skills in a considerably different environment
than he has previously experienced. Will CIRM 2.0 make a favorable impression in the
scientific community and with the public? That depends, of course, on the
outcome of the research it generates. So far, CIRM 2.0 is barely visible in
the stem cell community -- at least
according to an item on the blog of UC
Davis researcher Knoepfler. His readers were recently asked to vote on the top
stem cell story of 2014. CIRM 2.0 came in last with 0.44 percent of the vote.
That sort of response does not discourage Mills. He said, in an item on Knoepfer’s blog prior
to the 0.44 percent showing:
“We think the more
the word gets out about this and all of the other great features of CIRM 2.0,
the more high quality interest we will see from industry and academia alike.”
The details of the plan were approved yesterday by the
Governance Subcommittee of the CIRM governing board. The plan will come before
the full board at its meeting Thursday in Berkeley, with teleconference
locations in Los Angeles, San Francisco and Sacramento and is virtually certain
to be approved.
(Here are links to
the CIRM blog item on the 2.0 plan and
to Mills’ slides that he presented to
CIRM directors nearly two months ago. The transcript of that meeting has not
yet been posted by the agency. Perhaps Mills can add posting of transcripts to
his fast-track efforts.)
