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. 😉
Thursday, December 24, 2020
Monday, December 21, 2020
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
The session starts at 9 a.m. PST today.
Sunday, December 20, 2020
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 email@example.com.
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."
Friday, December 18, 2020
One of the excellent features of California's $12 billion stem cell program has little to do directly with science. The feature does not deal with petri dishes, genetic manipulation or microscopes.
It has a lot to do, however, with the stem cell agency's responsiveness to the public. It involves the persons behind the test tubes and even the Big Pharma companies that are the key to bringing stem cell therapies into widespread use.
What we are talking about is fundamental to building trust in the California Institute of Regenerative Medicine (CIRM), as the stem cell agency is officially known, and whether CIRM can sustain itself beyond the date when its money runs out again in a decade or so.
On the surface, it's a simple matter: the ability of the public, scientists and businesses to weigh in on how CIRM spends its next $5.5 billion -- the amount that the people of California are borrowing to pay for the agency's forays.
Next Monday represents a first-rate opportunity for the public and the myriad interested parties to show up and speak up, both to the board that governs CIRM and its top executives. Some of the matters on the table at Monday's CIRM directors' meeting are, in one form or another:
- Should CIRM spend $100 million for clinical work over the next six months and only $22 million on basic research?
- Should it change its diversity requirements to require more awards to a more diverse group of scientists?
- Should it require wider research data sharing to improve the quality of work across the field or should it cosset CIRM-financed findings to shield intellectual property?
- How should the state spend up to $155 million to improve stem cell treatment affordability and patient access to therapies and clinical trials? Does such an effort actually represent an unnecessary subsidy to the businesses involved?
Anybody who desires to do so can participate in the CIRM board meeting, which will be online. Questions can be asked. Suggestions can be made. Complaints can be aired.
The session represents the first big step into CIRM's new world of Proposition 14, the ballot initiative the provided the new, $5.5 billion in bond funding. The measure also set CIRM on a wider course that offers fresh opportunities that are not without challenges.
Deciding how to spend $5.5 billion is not a minor matter. It is tiny, however, compared to the dense processes used by another government research organization -- the 27 branches of the National Institutes of Health and their multitude of advisory bodies. In contrast, California's stem cell program is wide open, transparent and accessible to the people most affected.
What happens beginning Monday and over the next year will fundamentally shape the success or failure of California's stem cell program, the largest such state effort in the nation and the first in California's history.
CIRM stands open to influence -- for better or worse -- by patients, the general public, researchers and companies that have received nearly $3 billion over the last 16 years. It is now up to all those folks and more to speak up and help CIRM in its efforts to bring to market the much-heralded stem cell therapies and to be a first-rate steward of the people's money. Plus, speaking out is in the best personal and professional interests of those involved.
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 firstname.lastname@example.org.
The session starts at 9 a.m. PST Monday. Don't miss an opportunity to help shape the course of California's program to cure untreatable diseases and to lead the way globally on stem cell research.
Wednesday, December 16, 2020
|The enormous cost of stem cell therapies is |
a fresh target for CIRM.
Proposition 14, California's $5.5 billion stem cell ballot initiative, is coming home to roost, so to speak.
"Proposition 14 would launch a hefty effort to make stem cell therapies more affordable and accessible. The cash behind that drive could run as high as $155 million. And that’s not necessarily going for patients.
"The intent is to create and build support for financial models for health insurance companies. CIRM would also be charged with helping to implement them. Such models would justify the cost of the theoretically one-time cures by demonstrating that they would actually save money — ending the need to treat patients in what currently seems to be an endless and expensive cycle.
"Proposition 14 speaks of covering patients and, importantly, their caregivers for medical expenses, lodging, meals and travel. That would help provide access to clinical trials that are located in prohibitively expensive urban areas, which poses financial barriers for persons who live some distance away. The added coverage would additionally help researchers and companies recruit enough trial participants, which can be a problem in some disease areas.
"The affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.
"The extraordinary cost of stem cell treatments involves something called 'reimbursement,' a biomedical industry euphemism for how companies cover the high costs of the research and still make a profit. If money is not to be made, businesses are not likely to be motivated to turn CIRM research into cures.
"Proposition 14 creates a 17-member, CIRM affordability committee to drive all this. It would work with industry and the federal government to win their support. The committee would be backed by as many as 15 CIRM staffers. The ballot allows as much as $55 million for their compensation over 10 or so years.
"But if 15 is not enough, more employees could be hired beyond the nominal cap on CIRM employees of 70 if they are compensated through the use of private cash.
"The measure additionally allows the new affordability panel to hire consultants, capping that expense at about $105 million.
"The affordability effort involves important public policy, industry and research issues that concern patient groups and industry. However, the affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.
"Votes by the committee, however, would have to be taken in public.
"Members of the panel would not be required to disclose publicly their economic or professional interests. The committee would be exempt from the state public records act except for material specifically submitted to the CIRM board."
No. 1 Read: A 'Deep Dive' Into the Sweeping Changes Made in California's $12 Billion Stem Cell Program
|Capitol Weekly's Twitter item on its most|
read story of 2020
Capitol Weekly, the respected online news service devoted to state government and politics, this week reported that its most-read story of the year is an article headlined "Proposition 14: There’s much, much more than meets the eye."
The Aug. 31 article was drawn from my new book, "California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures." The book is a product of 15 years of coverage of the stem cell agency and posting of more than 5,000 items on its activities on the California Stem Cell Report."Proposition 14, the fall ballot measure to save California’s stem cell agency from financial extinction, contains much, much more than the $5.5 billion that it is seeking from the state’s voters.
"Added to the agency’s charter would be research involving mental health, 'therapy delivery,' personalized medicine and 'aging as a pathology.' That is not to mention a greater emphasis on supporting 'vital research opportunities' that are not stem cell-related.
"The measure would enlarge the board from 29 to 35 members. Even at 29, the board has been much criticized for its large size, which creates more possibilities for conflicts of interest, a long-standing issue for the agency.
"Proposition 14 would ban royalties generated by state-backed stem cell inventions from being used for such things as prisons and schools, isolating the funds from tinkering by lawmakers."
"Our mission is to inform, enlighten and educate Californians about public policy and state governance, and to provide a platform for engagement with public officials, advocates and political interests. To meet this goal, Open California publishes continuing, in-depth, nonpartisan coverage of current policy and political issues, and hosts regular forums for public discussion of policy and California politics."
Monday, December 14, 2020
The state stem cell agency, which is now into everything from "aging as a pathology" to mental health, is looking to hire 10 persons to fill posts ranging vice president of science to administrative assistant.
While the positions are yet to be officially posted online, here is the list of expected openings, according to the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known.
- Senior Executive Assistant
- Senior Science Officer, Review
- Project Manager, Review
- Vice President of Science
- General Counsel
- Grants Management Specialist
- Administrative Assistant
- Director of Finance
- Business Services Officer
- Senior Science Officer
Official postings for the positions could come as early as late this month. They will appear on this CIRM web page.
CIRM currently has 33 employees. Proposition 14 contains a nominal cap of 70 but also permits the number to grow substantially if the employees are compensated through cash that is not part of the agency's official state bond funding.
Friday, December 11, 2020
California's newly rejuvenated stem cell program today kicked off its fresh spending plans with a $182 million effort that focuses heavily on awards that could lead more quickly to actual treatments.
The plan was approved by the Science Committee of the governing board of the California Institute for Regenerative Medicine (CIRM), as the $12 billion agency is formally known. CIRM was running out of money until voters this fall approved Proposition 14 and rescued the agency from financial oblivion.
The $182 million plan for the first half of next year represents CIRM's first major dip into its new, $5.5 billion bucket that was created by narrow voter approval of Proposition 14. The full board is expected to approve the new research budget at its Dec. 21 meeting.
The program allots $100 million for possibly 10 clinical awards in the next six months. Translational research will receive $60 million (11 awards). "Quest" research is allotted $22 million for 15 awards. Quest awards involve early stage, basic research while translational research involves attempts to move basic research into the clinical level.
Clinical trials are the last hurdle to clear before a treatment can be approved by the federal government for widespread use. No CIRM-financed stem cell treatments have yet received that approval since the agency began its work 16 years ago. CIRM, however, has helped to fund 68 ongoing clinical trials.
The Science Committee has 10 members, at least six of whom are linked to institutions or businesses that could apply for CIRM funding. While members of the 35-member CIRM board can vote on the overall research budget and also "concept" plans for such things as Quest and clinical research, they are barred from voting on specific applications from institutions that they are connected to.
The Science Committee also approved changes aimed at increasing diversity in CIRM-related research and requiring greater data sharing by scientists. The committee strengthened the staff-proposed diversity language by also proposing scoring applications on how they beef up diversity among researchers. Details on that are yet to be worked out and will be presented to the full board on Dec. 21.
A call for more diversity among researchers was aired last month at a meeting of the only state entity charged with reviewing CIRM's financial affairs.
The data-sharing requirement triggered some concern about whether it would be a disincentive to some researchers who feared losing control over their intellectual property. However, CIRM CEO Maria Millan said the agency was treading carefully to take those concerns into consideration.
Researchers will be able to apply for the awards shortly after Jan. 1 when detailed program announcements will be released by CIRM.
Tuesday, December 08, 2020
The California stem cell agency this morning moved to boost its annual operations budget to $15.3 million, up from the $12.3 million spending plan approved last June.
The increase came as a result of the passage of Proposition 14, which saved the agency from financial extinction and provides $5.5 billion in state bonds over the next decade or so. The amount brings to $12 billion the expected cost of the agency before it again runs out of cash.
The 2020-21 budget originally stood at $12.3 million because it anticipated the possible phase-out of the agency, known officially as the California Institute for Regenerative Medicine (CIRM).
The increases approved today by the CIRM directors' Finance Committee were aimed mainly at hiring additional staff. The agency currently has 33 employees and never has had more than 62. The budget provides for up to 10 new employees, directors were told.
More are expected to be needed as the agency moves into the new, expanded role authorized by Proposition 14, which provides for more than 85 employees for CIRM.
Other increases were generated by the cost of a triennial, performance audit required by state law, which has run about $230,000, although the audit is barred from evaluating the agency's scientific performance. Legal and related expenses will be increasing by about $318,000. Currently, CIRM has one lawyer on staff with other legal services provided under an outside contract. The general counsel position is vacant.
Cash for the new budget will come from the agency's existing funds. Proposition 14 funds will not be available until next year.
The operations budget is relatively minor compared to the amount to be awarded for research grants. That budget is being revised for the first half of next year. The directors Science Committee is scheduled to consider that topic on Friday but has not yet publicly disclosed the staff recommendations.
(After this item was posted, the stem cell agency added documents to the Friday agenda that dealt with changes in the basic, translational and clinical awards programs, which should be of considerable interest to applicants, among others. See link in the preceding paragraph.)
The Friday meeting is public, as are nearly all CIRM meetings, and can be seen online. The public, including researchers, may comment on each item and address the board as well on any subject at the end of the meeting.
During the first half of 2021, CIRM directors will be drafting a revised strategic plan that will determine allocations for such areas as basic and translational research and clinical work over the next five years. Also on the table will be a number of new areas for research and significant work on accessibility and affordability issues related to possible stem cell treatments.
The next meeting of the CIRM board is scheduled for Dec. 21 at which it is expected to ratify today's action.
With no votes left uncounted, the ballot initiative that saved the financial life of California's now $12 billion stem cell program has topped out at 51.1 percent approval compared to 48.9 against.
The count reflects the most recent state election figures from late Friday. None of California's 58 counties is reporting that it has ballots yet to count.
The raw numbers are 8,588,156 for Proposition 14 and 8,221,692 against. The measure provides $5.5 billion that the state will borrow over the next decade to fund the operations of the California Institute for Regenerative Medicine (CIRM).
Official certification of the election results is required by Friday.
CIRM was created by another ballot initiative in 2004 with $3 billion in state bonds. That money has nearly run out, and the agency was set to close its doors beginning this month. However, the passage of Proposition 14 saved CIRM.
The measure provides no additional funding beyond the $5.5 billion. It will run out in 11 or so years, unless the agency slows its expected rate of spending. Because the money is borrowed, interest adds to the cost of the research and to the cost to taxpayers, bringing the estimated total expense to $12 billion.
Monday, December 07, 2020
The Californian who is slated to head the vast federal agency that includes the National Institutes of Health (NIH) and the Federal Drug Administration (FDA) got his start in politics with the man who is now the vice chair of the California stem cell research program.
Photo: Lucy Nicholson, Reuters
Becerra was reared in Sacramento by Mexican immigrants, went off to Stanford as an undergraduate and also received a law degree from the Palo Alto university in 1984. Later, he went to work for then State Sen. Art Torres, now vice chair of the stem cell agency, and in 1986 moved to Los Angeles to direct Torres' district office. Torres, former state Democratic party chairman, and Becerra continue to have close political ties, we understand.
Becerra was elected to the state legislature and Congress with the support of Torres. Becerra served from 1993 to 2017 in the House of Representatives, a period that included top leadership positions. He will have his hands full in Washington. Some Republicans are opposing his nomination because of his stand on abortion and his work on the Affordable Care Act. The Los Angeles Times editorial board labelled Becerra as President-elect Biden's Obamacare "fix-it guy."the California Health Care Foundation."Reyes is recognized nationwide for her career-long efforts to improve the care of women with high-risk pregnancies — especially those in medically underserved communities," the foundation says.
Thursday, December 03, 2020
|Is the stork bringing stem cell billions?|
The article in the Times, written by columnist Sandy Banks, was not really about CIRM per se. But it was a story that might not have been told without a $13 million check from CIRM.
"As a child, (Junior) grew accustomed to frequent hospital stays. But the disease got progressively worse as he moved through his teens; the bone pain was so disabling, he often had to be sedated with heavy-duty opioids."Banks continued,
"At one point, the bones in both his legs were so damaged by the disease, doctors thought he might not ever walk normally again. Junior battled back."Banks wrote,
“'I want to be cured of this disease,' he said. 'And I wish the world was more understanding about the people who are struggling with it.'”Junior is a patient in a UCLA clinical trial led by Donald Kohn, whose research has been supported by a total of $52 million from the stem cell agency -- a figure not noted in the story.
The stem cell agency comes into the story ever so briefly at paragraph 21. "The trial is funded by the California Institute for Regenerative Medicine (CIRM), the stem cell agency created by voters in 2004 and infused with $5.5 billion in new research money by voters who narrowly approved Proposition 14 this fall," the Times reported.
That is the first and last mention of California's stem cell program in the Times' story. However, that is better treatment of CIRM than is found in most stories in the media over the last few years -- the ones that deal with accomplishments tied to the agency's cash. (See here and also here.) The articles rarely mention where the money comes from. It could be flown in by stork, for all the readers know.
Proposition 14 saved the agency from financial extinction. But the measure was a squeaker, and it set the stage for another life-or-death ballot initiative. The money from Proposition 14 runs out in about 11 years. No other source of funding is provided. If CIRM goes to the ballot again in less than a decade or so, it will need a strong base of support from California voters, 8.2 million of whom voted last month to cut off funding for CIRM.
Building a solid base takes years. It also requires something of a change involving the scientific community and science journalism, which is a big ask. The tradition in scientific journals regarding funding is to relegate mention of the sources of money to a tiny footnote as if it were not the lifeblood of research.
Science writers -- the few that now exist in the mainstream media -- follow that ancient and tired public tradition of ignoring what makes research happen. They focus on "exciting" results from the bench and clinic -- not the "filthy lucre" that pays scientists, their institutions, the post-docs who labor behind the microscopes, the equipment suppliers and keeps the lights on.
Like most state agencies, CIRM is ignored by the media with only occasional exceptions. Its activities are not well known. That is not likely to change over the next decade despite the best efforts of CIRM's tiny staff. The exception would be a major or even minor scandal or development of a major breakthrough that would resonate with the people of California.
The folks in the media have a vast array of topics to cover, all of which CIRM competes with for attention. The news industry is, in fact, overwhelmed by matters that need public scrutiny: schooling for children, jobs for parents, affordability for housing, vaccines for Covid-19, homelessness, climate change, wildfires and much, much more. Meanwhile, the industry is struggling with its own sustainability issues, laying off thousands of reporters, closing outlets and desperately searching for new business models.
Breaking through this wall of issues to generate favorable, regular coverage of the stem cell agency's good works is a herculean task. And so far, the reality is that CIRM's good works are quite minor in terms of how they affect the lives of the vast majority of the people in California.
The CIRM team, from top to bottom, has provided a prodigious amount of positive information that can resonate with the public. Building positive relationships with voters, however, is a long-term task that requires commitments that go well beyond CIRM's stalwart staffers, who currently weigh in at only 33 for a multibillion dollar program.
CIRM has major budget and legal limitations, courtesy of Proposition 14. Its outreach team is small, again an outgrowth of ballot initiatives. Nonetheless, CIRM has a potential army of more than 900 available plus more in the future, given the agency's expansive, new responsibilities authorized by Proposition 14. And that doesn't count the patient advocates or their allied organizations.