SAN FRANCISCO – A 42-year-old former
business executive from Maryland is expected to slip his spanking new
card key into a slot this morning outside of the third-floor offices
here of the California stem cell agency.
It will open the door to a $3 billion
adventure into scientific research, California politics and
government and one of the riskier areas of the biotech industry –
one that is also filled with visions of nearly miraculous cures and
revolutionary changes in medicine.
Randy Mills Osiris photo |
C. Randal Mills, more commonly known as
Randy, begins his first day on the job today as CEO of the state's
nearly 10-year-old stem cell research effort, the California
Institute for Regenerative Medicine (CIRM). It is an enterprise that
has been praised for its contributions to science but now
faces
financial extinction unless it develops new sources of funding. The
borrowed money that finances the agency's new grants will run out in
2017, leaving CIRM with only the task of winding down existing
research.
Mills, the former CEO of Osiris Therapeutics of Maryland, embodies changes already underway
at the agency, which is pushing hard to commercialize stem cell
research. With the arrival of Mills, the three top executives are
all more tied to industry than academia. Ellen Feigal, the No. 2
person at the agency, was with Amgen prior to joining CIRM. Elona
Baum, general counsel and vice president for development, was with Genentech.
Mills has given no public clue about
whether he is planning major changes at the agency. In a very brief
comment April 30, when he was named to the post, he said only that
patients were his top priority. In announcing the appointment, CIRM
Chairman Jonathan Thomas said Mills will take a “fresh look” at
the agency and will “evaluate what we are doing right and what we
can do better.”
It is clear that Mills, who has a Ph.D. in drug development from the University of Florida, will bring a
definite business mindset to CIRM, which has been
dominated by a culture closer to academia than industry. In 2009, he told PharmExec.com,
“When I came to Osiris in 2004, Osiris was what I called Osiris University. It was highly academic, brilliant people doing great science, but there was no commercial focus. That's changed nicely over the last four years....”
The previous two presidents of CIRM,
Zach Hall and Alan Trounson, came from largely academic and
non-business backgrounds. Mills' career has been spent in business,
including an eight-year slog to drive the stem cell product Prochymal
into the market. In 2012, Prochymal became the world's first
government-approved stem cell drug approved for use on an off-the-shelf
basis. That occurred in Canada. However, the drug is currently only
available in the United States under special, limited access
standards set by the FDA. Prochymal was sold last fall to Mesoblast
of Australia in deal that could reach $100 million.
Mills, as might be expected, has
remained mum on any personnel changes he may have in mind. He may have something to say about the five positions that were
eliminated by Trounson in his proposed budget, which is due to be
presented to the CIRM board May 29.
The elimination of the positions did
not involve firing any employees. They involved jobs vacated by departures or ones that had not been filled. Nonetheless, the five
slots represent nearly 10 percent of the existing 56 employees. Mills
may want to have the ability to hire some additional staff on his own
in an effort to implement matters he considers important. But any
action he might take would be limited by the budget cap imposed by
state law on CIRM.
Decisions are likely to come faster
under Mills. Trounson was almost fabled for his globe-trotting
absences which tended to delay things at CIRM. Under his tenure, CIRM
had a host of lingering management problems that were cited in a 2012
performance audit that was required by state law. The agency says it
is addressing those deficiencies. Along with faster decisions may come a turn away from consensus-driven action, a slow and cumbersome process that many business executives avoid, believing it is impossible to make everyone happy.
Some of the decisions for Mills could involve as much as $400 million. CIRM has only about $600 million in
uncommitted funds. However, that figure does not include board-approved conceptual plans for handing out the $400 million. No
RFAs have yet been posted for those rounds. If Mills is looking for
new directions or would like to pour more money into an existing
effort, such as those aimed at later stage clinical trials with
businesses, he could either slow the release of specific RFAs or
go back to the board to ask it to reconsider the efforts.
The 29-member board is unlikely to turn
down requests from their new CEO. Rejection of a Mills' proposal
would be interpreted as a sign of a lack of confidence in him.
At least initially, Mills is also
likely to have a smooth road in connection with the controversial and much
criticized dual executive arrangement at the agency. Under
Proposition 71, which created the $3 billion agency in 2004, the chairman and the
president have overlapping responsibilities. That has led to public
tensions in the past, particularly with the first agency chairman,
Robert Klein. However, under Trounson, public airing of those
problems has subsided. Plus current chairman Thomas has a much
different management style than Klein.
Thomas has main responsibility for
finding new sources of funding for the agency and is talking about
some sort of private-public partnership. Mills' role in the
fund-raising is not publicly well defined. But Thomas has praised
Mills' ability in raising $160 million for Osiris. Thomas may want to
harness Mills' presentation and persuasion talents.
As CEO of CIRM, Mills will be the
person responsible for generating the type of research results that
will resonate with potential private investors as well as the public.
One advantage he has is that the agency is little known to the vast
majority of the California population. In such situations, public
opinion is more easily shaped.
Nonetheless, the San Francisco
Chronicle recently took the occasion of Mills appointment to say that
CIRM has not lived up to its hype. The newspaper's editorial said the
agency should not expect more public funding.
The biotech industry is likely to be
pleased with the appointment of one of their fellows as president of
CIRM. The industry has been critical of the agency in the past,
although it is currently dancing closer to business. The key
issue has been the meager amount of awards to industry. According to
CIRM calculations, only about 7 percent of the $1.7 billion in awards
has gone to business, up from about 4 percent calculated by the
California Stem Cell Report a few years ago. More cash has trickled
down via subcontractors hired by grant recipients.
The increasing coziness with industry
is necessary to develop an actual FDA-certified product that can be
used to treat patients. But ties to industry also raise
conflict-of-interest issues. CIRM has been dogged by conflict questions since its inception because of the nature of its board,
which was dictated by Proposition 71. Roughly 90 percent of dollar
value of the awards has gone to institutions with links to past and
present members of CIRM's governing board, according to calculations
by the California Stem Cell Report. (See here and here.)
In 2010 in the New England Journal of
Medicine, Bernie Lo of UC San Francisco, chairman of the CIRM
Standards Group and who also led an Institute of Medicine(IOM) study
on conflicts of interest, warned that "irreconcilable differences" exist involving medical research and the private
sector because of sharply divergent priorities.
"Despite their benefits, relationships with industry create conflicts of interest that can undermine the primary goals of medical research. Where there are conflicts, legitimate and serious concerns can be raised about the openness of research and potential bias in the design, conduct, and reporting of research "
Mills' left Osiris in December of last
year for what were reported as “personal reasons.” At 42, he has
a long career ahead of him. Carrying on well at CIRM, which is facing
its financial demise, could be a springboard to a large leap forward
for Mills in a few years into another position in the biotech
industry, as well elsewhere.
More lies coming out of California,,State number six to pass physician assisted suicide. Prop 71 was passed in 2004 then tied up in court for years while millions died waiting for a stem-cell treatment. The FDA issues 'Investigational New Drug Permits" designed for approval within 24 hours after the permit is needed to save a patients life. The permit includes stem-cells. Not too many MD's ever stick their neck out for a patient , so this is more bullshit, pretending that they care ! "Too risky" what a lie that is ,, yet they will help you commit suicide. No,,nothing will improve and update,,we are stuck with giant factory style hospitals , drive by nurses and hit & run doctors along with big pharma driving up prices. Blame the FDA or take years to pass a regrow act while millions die ! Oh we are waiting for the regrow act to pass,,have to keep you safe , in the meantime you die or they certainly can help you die ! read more on my mini-website,,,,www.nomoreparalysis.com
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