California researchers vie for millions in stem cell dollars

Nine California research organizations will vie behind closed doors this week as the state’s stem cell agency scores their bids to kick off what would be a first-in-the-nation, $80 million manufacturing network to speed the development of revolutionary medical therapies.

The effort is aimed at breaking down production bottlenecks and linking academia with business to “advance California as the world-class hub of cell and gene therapy manufacturing.”

“‘Because these therapies are ‘living medicines,’” the agency says, “they are complex and costly to produce” and present a major challenge to industry.

The state’s $12 billion stem cell and gene therapy agency, officially known as the California Institute for Regenerative Medicine (CIRM), is financing the proposed network. Earlier this year, it sought grant applications from research organizations. CIRM’s grant reviewers, who are from out-of-state, will make their decisions in private during a two-day session on Thursday and Friday.

No other state in the nation has a taxpayer-financed manufacturing stem cell network on the scale proposed by CIRM, which was created by Proposition 71 in 2004 and refinanced by Proposition 14 in 2020.

The initial campaign 18 years ago raised voter expectations that “miraculous” therapies were virtually around the corner. However, CIRM is yet to finance a stem cell therapy that is available to the general public, but it has invested in 88 clinical trials.

The agency, as is its practice, is withholding the names of the applicants. But it is a good bet that none of them will be rejected. CIRM has allocated $20 million for the initial network round, with a cap on each award of $2 million over two years.

The immediate beneficiaries are likely California academic institutions that could include five University of California campuses (Davis, Irvine, UCLA, San Diego and San Francisco) along with Stanford, University of Southern California/Childrens Hospital and Cedars-Sinai and City of Hope, both in the Los Angeles area.

CIRM has allocated $20 million for the initial network round, with a cap on each award of $2 million over two years.

A basic requirement for selection is that applicants have a Good Manufacturing Practices facility already in place. All of the nine above institutions have such a facility, which meets federal standards for the production of such things as stem cells.

The identities of the winning applicants are not scheduled to be officially disclosed until after the formal ratification of reviewers’ decisions this summer by the full CIRM board.

All of the institutions mentioned above have or had representatives on the 35-member CIRM board. Roughly 80 percent of CIRM’s funds have gone to institutions that have ties to members of its governing board over the last 18 years, according to a Capitol Weekly analysis.

CIRM has come under fire for conflicts of interest, including from the National Academy of Medicine in a $700,000 study commissioned by CIRM itself.

The identities of the 15 reviewers are not disclosed by CIRM, and they are not required to disclose publicly their personal or professional interests. However, CIRM says it examines those interests for possible conflicts.

The second phase of the network is expected to cost $60 million and begin in about two years. It would bring in private businesses in a major way. Private enterprises could become involved this year as a source of the matching funds – 20 percent of the award – that CIRM is requiring from academic applicants.

In this year’s round, applicants are also required to have a plan for addressing the needs of underserved communities. CIRM additionally requires applicants to develop a plan for “maintaining sustainability beyond the immediate project period.”

Members of the public can file comments on the manufacturing network effort with CIRM by sending them to [email protected].

Jensen is a retired newsman. He has written since 2005 about the stem cell agency on his newsletter, The California Stem Cell Report, and published in 2020 a history of CIRM’s earlier days