[Updated 5/2/17, 7:30 p.m. ET. See below.] The head of California’s stem-cell agency is stepping down after three years on the job. C. Randall Mills, known as Randy, is leaving the agency to run a nonprofit bone marrow donor matching program as of July 1, according to CIRM.
Mills joined CIRM, which stands for California Institute for Regenerative Medicine, in April 2014 and made no secret of the agency’s need to show results from the billions of dollars taxpayers had bestowed upon it. Mills had previously been CEO of the for-profit Osiris Therapeutics, a developer of adult stem cell products. Mills immediately outlined reforms to review proposals faster and move projects quickly into clinical trials. He and his team branded the effort “CIRM 2.0.”
“Mills had a big positive impact on CIRM and helped it go to the next level,” writes Paul Knoepfler, a stem-cell researcher at the University of California, Davis, and close chronicler of regenerative medicine science and policy at his blog The Niche.
CIRM has funded nearly 30 clinical trials, by its own count, and several other programs have entered the clinic after earlier support from CIRM.
Knoepfler praised Mills on his blog this morning, writing that his only criticism was what he saw as his “negativity toward the FDA” and its oversight of stem cell work.
Another observer of the agency, David Jensen of the California Stem Cell Report, recently described as “encouraging” the results from two mid-stage clinical trials funded by CIRM. One study is testing a drug from Asterias Biotherapeutics (NYSEMKT: AST) for spinal cord injury; the other involves a Duchenne muscular dystrophy treatment from Capricor Therapeutics (NASDAQ: CAPR).
Via his independent blog Jensen frequently breaks news, such as the Mills resignation, and takes a skeptical view of the agency.
CIRM was created in 2004 when Californians, in a backlash against the George W. Bush administration’s restricted funding for embryonic stem cell research, voted for a $3 billion bond—a cost of $6 billion with interest payments. As of early 2015, more than $1.5 billion had gone toward new facilities at the state’s top universities, education and training of researchers, and preclinical research.
After a decade, only a handful of CIRM-funded projects had reached clinical studies. Scientifically, slow progress was understandable. Politically, the agency was under fire for the slow pace. In the public eye, it had overpromised and under-delivered. It had also tripped itself up with instances of what seemed like self-dealing, earning a rebuke from the Institute of Medicine of the National Academies (as well as praise for its overall mission).
None of the apparent conflicts were more brazen than Mills’s predecessor Alan Trounson leaving CIRM and quickly joining the board of a Bay Area company that CIRM had generously funded. That company, StemCells, shut down in 2016 after multiple failures.
[Updated with clinical trial information.] One CIRM-funded study underway is at privately held Forty Seven, which spun out of Stanford University last year with lavish venture backing. More than $30 million in CIRM funding helped Stanford researchers, led by Irv Weissman, push their cancer drug into clinical studies. Forty Seven will owe money back to California taxpayers as it begins to earn revenues.
Another closely watched study will be run by the University of California, Los Angeles, to treat a form of severe combined immunodeficiency, or SCID, sometimes called the “bubble baby” disease. CIRM has pledged $19 million for the trial, which could lead to an approval if all goes well.
Mills is leaving to run NMDP/Be The Match, an international bone marrow donor registry based in Minneapolis. The nonprofit’s R&D group just made an investment in privately held Magenta Therapeutics and agreed to collaborate with Magenta on new bone marrow transplant related therapies.
Upon Mills’ departure, CIRM’s interim CEO and president will be Maria Millan, who is currently the agency’s vice president of therapeutics. She worked for years as a pediatric transplant specialist at Stanford. In its press release, CIRM did not note that Millan also spent six years, from 2006 to 2012, as an executive at StemCells.
CIRM’s original $3 billion will run out in 2020, and the agency has $650 million left to spend. Millan and whoever succeeds her will seek money to keep the agency going in some form, perhaps from another public bond, perhaps from private donations; or wind it down, risking that many of its funded projects in the pipeline will lose support.
CIRM chairman John Thomas told Nature recently that “the majority of our projects will not be ripe for interest from big pharma and the venture-capitalist community by the time we run out of funds.”