CA stem cell program CEO abruptly resigns

The chief executive officer of California’s $12 billion stem cell and gene therapy program, Maria T. Millan, resigned abruptly this week, leaving what is the largest such state research effort in the nation without even an interim leader.

Millan gave no reason for her departure nor did the agency itself. Her last day at work will be next week, Nov. 17.

Millan has led the California Institute for Regenerative Medicine (CIRM), as the agency is officially known, as CEO and president for the past six years and as a vice president for five.

In its announcement Tuesday of her departure, CIRM said its 35-person governing board would seek to find an interim CEO to serve during the search for a replacement. CIRM did not say whether the interim executive would come from the current management team.

Millan’s departure comes as the agency faces major challenges. They include expansion of an embryonic effort to assure the affordability of CIRM’s potential treatments that could cost millions of dollars. Some of the directors are also behind a move to sharpen its focus and reset its priorities.

CIRM currently describes itself as the world’s largest institution dedicated to regenerative medicine. It was created in 2004 through the ballot initiative process and funded with $3 billion in state bond funding. When it ran out of money in 2020, it was refinanced with $5.5 billion in bonds through another ballot initiative. Interest on the bonds pushes the total cost to $12 billion or more, according to state estimates. Its funding could run out again in nine years or perhaps less, depending on the agency’s rate of spending.

Millan’s departure comes as the agency faces major challenges. They include expansion of an embryonic effort to assure the affordability of CIRM’s potential treatments that could cost millions of dollars.

CIRM has not developed a plan to stave off the situation that occurred prior to 2020. It was then set to begin closing its doors in 2021. About half of its roughly 65 employees left for more secure employment. The development of a financial sustainability plan will be a major challenge facing any new CEO as well as its large board.

In the news release announcing her departure, Millan did not comment on her plans. ““My eleven years at CIRM have been fulfilling and rewarding,” she said. Millan said that CIRM’s work has driven “unimaginable progress and growth of the regenerative medicine field.”

Vito Imbasciani, chair of the CIRM board since last March, said, “Her vision, passion and tireless efforts have set a standard of excellence that will continue to inspire us at CIRM.”

While neither commented on the reasons behind her resignation the CIRM board began a formal evaluation of her work earlier this year. At the last full board meeting Sept. 28, directors met behind closed doors for nearly three hours to consider her work.

Many of the board members are relatively new, having served only since 2020 when the refinancing initiative expanded the board from 29 to 35 persons. The size of the board, its role and the agency’s management structure have been the subject of much criticism in the past, including in a $700,000 study commissioned by CIRM itself.

The report by the prestigious National Academy of Medicine recommended a major overhaul of the board, substantially reducing its involvement in grant approval and administrative matters.

The search for a new president is likely to take months. In the past, CIRM has struggled to find suitable candidates to fill the CEO post, which has a top salary of $632,000 annually. (CIRM did not respond to a request Tuesday for Millan’s specific salary.)

While the agency is small in terms of employees — only in the mid-60s currently — its award programs are complex. They include an effort to create a public-private manufacturing process and education and training programs to support industry.

The 2020 ballot measure, Proposition 14, also charged CIRM with new, major tasks, including the affordability effort. Some of the therapies that CIRM is helping to finance could cost as much as $3 million or more. The agency is not alone in wrestling with the astronomical costs. They are a matter of concern nationally and internationally with regulators and other enterprises, public and private, that are developing revolutionary gene therapies.

Another new and ongoing mandate involves planning on how to spend $1.5 billion on neuro diseases, such as dementia and stroke, an approach that is beginning to encompass all of CIRM’s spending priorities.

At the same time, CIRM is yet to fulfill the expectations of voters in 2004, who were led to believe during the ballot campaign that nearly miraculous stem cell treatments were right around the corner. None of the research CIRM has helped to finance has led yet to a stem cell therapy that is available to the general public.

CIRM has helped to finance 96 clinical trials, which are the last stage before a therapy is approved for widespread use. However, nine out of 10 proposed, conventional treatments that enter clinical trials do not emerge successfully. Gene and stem cell therapies are not conventional.

In the past, CIRM has relied on the directors’ Governance Subcommittee to lead searches for presidential candidates. Typically the effort begins with an attempt to agree on specific attributes of a new president, which can require several public meetings. A search firm is likely to be hired, a process that may require a couple of months.

One longtime observer of CIRM, who asked not to be identified in order to speak candidly, said the process could extend into the summer of next year before a new CEO is in place at CIRM’s South San Francisco headquarters.

Jensen is a retired newsman and has covered CIRM for 18 years on his newsletter, the California Stem Cell Report. He authored the book, “California’s Great Stem Cell Experiment,” in 2020.