Going Dark for the Holidays

 The California Stem Cell Report will be dark for the holidays until about Jan. 4. If you have last-minute gifts to give, don't forget "California's Great Stem Cell Experiment," a great gift for anybody above age 13 and some below that the age, even many of our dear readers. 😉

California's Quest for Stem Cell Therapies: $5.5 Billion Reboot Kicked Off Today

California's ambitious stem cell agency today launched itself on a new, $5.5 billion journey, approving a plan to hand out $182 million to researchers by the middle of next year and beefing up its efforts to bring equality to therapies and scientific labs.

The moves came courtesy of Proposition 14, the ballot initiative that saved the financial life of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known.  Just 12 months ago, CIRM was dealing with its possible demise as it was running out of the $3 billion that voters gave it in 2004. 

Proposition 14 sets the agency, which currently has only 33 employees, on a sweeping course that extends its work into areas such as mental health and "aging as a pathology." The agency's new, 17,000-word charter also provides up to $155 million for work dealing with affordability and access to possible stem cell therapies. 

CIRM was created 16 years ago by another ballot initiative following a campaign that raised voter expectations that stem cell therapies were right around the corner. The agency has yet to help finance a stem cell therapy that is approved for widespread use by the federal government, although CIRM is backing 68 clinical trials, a number that was considered unimaginable in 2004, the year the agency was born. 

During its online meeting today, the agency's governing board approved, as expected, a $182 million plan to make 36 awards during the next six months. It calls for $100 million for clinical work, $22 million for basic research and $60 million for translational research, which involves attempts to move discoveries into the clinical stage, the last stop before they are approved for general distribution. 

A call for applications is expected to be posted soon. 

The board took its first step to address the affordability and access issues identified by Proposition 14. Eight persons were named to CIRM's new Affordability and Access committee. It will be led by CIRM's vice chair, Art Torres, a former state legislator and who also serves on the board of Covered California, a state body designed to deal with affordability issues in connection with the federal Affordable Care Act. More persons are expected to be named to the affordability committee next month. 

The CIRM board approved changes in how it evaluates applications for awards to require scientists to specifically address diversity and equity issues. Under its new rules, applications will be scored on how well the research deals with underserved communities. Applicants will also be scored on the diversity of their research teams. 

The agency's new operational budget calls for the hiring of 10 more employees between now and the end of June, ranging from a vice president for science to an administrative assistant. Job listings are expected to be posted soon. 

CIRM Chairman Jonathan Thomas laid out some details for crafting a new strategic plan for the next five years. It includes action on the plan by the end of June, which will mean that requests for applications will be issued soon thereafter.  The June date has been moved up from later in the summer.

The public and researchers will be able to weigh in with comments and suggestions during the development of the plan. 

Today's session stood in sharp contrast to the agency's first meeting this month in 2004, just after the voter approval of the ballot measure that created CIRM.  The fledgling agency did not have a single employee. It had no bank account, no offices and no phones. Spectators, interested parties and news reporters, nonetheless, crowded into the CIRM board's first meeting. Major stories appeared in the media throughout the state. 

Today, CIRM's online session was watched by only about 30 to 40 persons, most of whom were likely associated with the agency itself. And the meeting drew virtually no media attention.

More Information Available This Morning on Future Direction of $12 Billion, California Stem Cell Program

California's $12 billion stem cell research program, which is embarking on a major new pathway, has posted additional information online that provides some clues to its direction for the next five years. 

The information comes in the form of 33 pages of slides to be used today at a daylong, public meeting of the agency's governing board. The slides were created by Maria Millan, president of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, and other top executives of the enterprise. 

While the slides need considerable explanation, which will be forthcoming later today, they provide a start for those seeking to understand how the 16-year-old agency is planning to spend $5.5 billion in the Golden State over the next decade or so. 

Beyond the 33 pages of slides, other information is being offered as well that deals with a $182 million awards budget for the next six months and new requirements for sharing research data and increasing diversity.  

Still missing is information on the launch of the agency's new effort at dealing with affordability and access questions involving stem cell treatments, a new task created by Proposition 14, the ballot initiative that saved CIRM's financial life. 

The agenda for Monday's meeting contains instructions for participating in the online meeting. Written comments are always useful as well as oral presentations. Written material can provide needed backup for the briefer oral comments and are directly in front of CIRM directors and staff. Comments should be emailed to kmccormack@cirm.ca.gov.

The session starts at 9 a.m. PST today.

Needs of the Underserved: California Scientists Seeking Millions for Stem Cell Research Will Need to Measure Up

Directors of California's $12 billion stem cell agency tomorrow are expected to require scientists seeking hundreds of millions in research dollars to specifically address the needs of underserved communities.

If the researchers fail to do so, their applications will receive a score that reflects that shortfall. The immediate impact will fall on scientists who apply for funding from the $182 million expected to be handed out during the next six months.

Below is language from a "concept plan" before the board. This particular version comes from the plan that applies to basic research applications. Nearly identical language is also contained in plans for the translational and clinical rounds.

All of the concept plans can be found on agenda for the meeting, which also contains instructions for participating in the online meeting, which is open to the public. Written comments are always useful as well as oral presentations. Written material can offer needed backup for the briefer oral comments and are directly in front of CIRM directors and staff. Comments should be emailed to kmccormack@cirm.ca.gov.

The new language is in red. The strike-throughs indicate language to be removed. 

“Addressing the Needs of Underserved Communities

in CIRM-Funded Projects

“All applicants for the DISC2 program will be required to provide a statement describing how their overall study plan and design has considered the influence of race, ethnicity, sex and gender diversity. 

"Applicants should discuss the limitations, advantages and/or challenges of their research proposal in developing a product or tool that addresses the unmet medical needs of the diverse California population, including underserved racial/ethnic communities. Examples include use of models and tools that account for population diversity (e.g. HLA types, gender, genomics data, cell models). 

"Applicants should also address how the research team has or will incorporate diverse and inclusive perspectives and experience in the implementation of the research project. 

"The GWG and CIRM’s governing board will evaluate consider these statements as a review criterion in their evaluations and in making funding recommendations. Priority will be given to projects with the highest quality plans in this regard."

Quote of The Day

 "The first COVID-19 vaccine is not expected to be ready for clinical trials before the end of the year." From the journal Infection, Genetics and Evolution, April 19, 2020.