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Amid Uncertain Future, State's Stem Cell Agency Loses Transformative Leader

THE SAN DIEGO UNION-TRIBUNE
http://www.sandiegouniontribune.com/business/biotech/sd-me-cirm-president-20170503-story.html

California’s stem cell agency is on the hunt for a new president and CEO after the surprise announcement this week that C. Randal Mills will be departing the California Institute for Regenerative Medicine. He will leave at the end of June.

Mills, who has headed the agency for three years, will become the next president and CEO of the National Marrow Donor Program. CIRM is replacing him on an interim basis with Maria Millan, M.D., the agency’s vice president of therapeutics.

The state agency will soon begin a search for a permanent replacement, said Jonathan Thomas, CIRM’s chairman. Millan is a candidate to fill that position, with Mills’ strong endorsement.

His initiative, called CIRM 2.0, was a response to criticism that the agency, funded with $3 billion in California bond money in 2004, has been too slow in getting treatments to patients. ($6 billion will be repaid, including $3 billion in interest)

Agency-supported treatments are now being tested in medical centers throughout the state, including San Diego County. Most prominently, CIRM has established an “alpha” stem cell clinic at UC San Diego. It is the cell therapy arm of UCSD’s Sanford Stem Cell Clinical Center.

Mills said he decided to leave because the National Marrow Donor Program, which he was familiar with, resonated with his own goals of making personal connections with patients.

Before joining CIRM in 2014, Mills was president and CEO of Osiris Therapeutics, developer of a pediatric stem cell drug called Prochymal, used to treat a complication of bone marrow transplants called graft vs. host disease.

“If you look at my office, the walls are covered with pictures of the children that we treated who went through bone marrow transplantation,” Mills said. “Getting to know them, and getting to know their families … that had a tremendous effect.”

The unexpected announcement drew surprise and concern from stem cell researchers and observers. As admirers of CIRM 2.0, they expressed uncertainty about what direction the agency would take. And with the $3 billion beginning to run out, looking for a new source of funding will be a top concern of Mills’ successor.

Confidence

But Mills said Wednesday the agency will do well.

“If me leaving CIRM is a problem, then I didn’t do a good job at CIRM,” Mills said. “Whether it’s because I’m going to be the head of the National Marrow Donor Program or I get hit by a car, the success of this organization, or any organization that’s healthy and functional, should never pivot on one person,” Mills said. “I’ve assembled a team at CIRM that I have absolute, absolute confidence in.”

Mills said he would be surprised if Millan didn’t turn out to be the agency board’s overwhelming choice to be his permanent successor. She assisted in developing the agency’s strategic plan and helped it run smoothly, he said.

In 2015, Mills named Millan as senior director of medical affairs and stem cell centers, one of three appointments to CIRM’s leadership team. Before joining CIRM, she was vice president and acting chief medical officer at StemCells, Inc. Before that, Millan was director of the Pediatric Liver and Kidney Transplant Program at Stanford University School of Medicine.

Millan said the agency’s strategic plan is working, and taking the agency where it needs to go. That plan was developed to guide researchers, doctors and companies over the predictable hurdles they encounter in translating basic research into therapies testable in the clinic — and that companies would want to commercialize.

“We’ve already done the challenging piece of identifying the how — how to get to the mission, which is to accelerate these stem cell treatments to those with unmet medical needs,” Millan said. “Team members are all aligned in accomplishing these goals … One can’t help but be more energized and motivated to execute on the strategic plan.”

About 30 stem cell clinical trials are under way that the agency has funded at one stage or another in research and development.

Jonathan Thomas, the CIRM chairman, said Mills has done what he promised when joining CIRM, and the agency is operating “markedly better,” in productivity, speed and efficiency.

“He has made it, through CIRM 2.0 and beyond, a humming machine that is operating on all cylinders,” Thomas said. “In doing that, he’s worked extensively and highly collaboratively with Maria (Millan) and the rest of the team. That has made CIRM an even better operation than it ever was. So we are in extremely good shape right now to go forward.”

Goals accomplished

Jeanne Loring, a CIRM-funded stem cell scientist at The Scripps Research Institute, said Mills made the agency friendlier and more predictable for the scientists it funds.

“The first and most dramatic thing he did was to end the process of independent grants,” Loring said. Under that process, each grant proposal was considered on its own, with no consideration for success under a previous grant for an earlier stage of the research.

“It was always very troubling to people, I think, that they could do very well with CIRM money on an early-stage grant, and that would earn them nothing in a further application to continue the work,” Loring said.

As part of CIRM 2.0, Mills emphasized that once projects were accepted for funding, CIRM would become a partner with the scientists to help them accelerate research and development, and ultimately commercialization.

Loring leads a team researching the use of stem cells for Parkinson’s therapy. The cells are collected from the patients to be treated, making them a genetic match. They are then genetically reprogrammed to resemble embryonic stem cells, and then matured into the brain cells destroyed in Parkinson’s.

Loring’s team was awarded $2.4 million in 2016 from CIRM to advance its research. A next-stage grant to translate the research to a clinically ready approach would need about $7 million, Loring said. The work is part of Summit for Stem Cell, a nonprofit alliance of scientists, doctors, patients and Parkinson’s disease community supporters.

Veteran stem cell watcher David Jensen praised Mills on his blog, California Stem Cell Report.

"Dr. Mills made substantial contributions to the agency during his tenure, improving both efficiency of the grant making process and transparency of CIRM's operations,” Jensen quoted stem cell observer John M. Simpson of Consumer Watchdog as saying.

Simpson added that as CIRM draws down the rest of its $3 billion with no new funding in sight, it’s not surprising that Mills would accept another job.

Paul Knoepfler, a CIRM-funded stem cell scientist and blogger, wrote Tuesday that Mills “had a big positive impact on CIRM and helped it go to the next level.”’

“About the only thing I wasn’t a fan of in terms of his leadership was my perception of his negativity toward the FDA and toward FDA oversight of stem cells, and how that manifested at CIRM during his time there,” Knoepfler wrote. “But good people can strongly disagree on policy.”

 

bradley.fikes@sduniontribune.com

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