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Sunday, January 24, 2021
Friday, January 22, 2021
California Stem Cell Conflicts of Interest and Their Regulation Rise Next Week
Proposition 14 left the state stem cell agency with $5.5 billion plus a significant and wide range of new issues. One involves creation of “advisory task forces,” which were not formally enabled in the ballot initiative that created CIRM 16 years ago.
Advisory/working groups to CIRM have played a significant role in the past and may play an even greater role under the agency’s new charter. They are likely to be the venue where major new issues are hashed over and policies developed that are adopted by the full board with little change.
Those policies are likely to have an impact on businesses developing stem cell therapies and their affordability and accessibility not to mention researchers.
Next Thursday the agency's governing board takes on conflict-of-interest rules for those new entities as its directors push into the new territory of Proposition 14. Conflicts, however, have been a bugaboo for the agency for years.
Advisory/working groups to CIRM have played a significant role in the past and may play an even greater role under the agency’s new charter. They are likely to be the venue where major new issues are hashed over and policies developed that are adopted by the full board with little change.
Those policies are likely to have an impact on businesses developing stem cell therapies and their affordability and accessibility not to mention researchers.
Read all about it in an item posted today on a new platform for this blog, the California Stem Cell Report (CSCR), the only independent, news and information source devoted solely to the Golden State's 16-year-old research program, the first of its kind in state history.
This blog's migration to a new platform is aimed at improving service to readers and helping to bring a new focus to our coverage, which began in January 2005 and which has resulted in 5,000 items since then.
Tuesday, January 19, 2021
California Stem Cell Board Faces its Future in Late January Meeting
Directors of the $12 billion California stem cell agency will meet on Jan. 28 to examine the new and sweeping scope of their changing enterprise, now remodeled in a major way by voters as a result of the last fall's election.
Affordability, mental health and "aging as a pathology" are all part of the new charter for the California Institute for Regenerative Medicine(CIRM). Its governing board has scheduled a four-hour online session on the 28th that is open to public comment, questions and criticism.
Read about the meeting in an item posted this morning on a new platform for this blog, the California Stem Cell Report (CSCR), the only independent information source devoted solely to the Golden State's 16-year-old research program, the first of its kind in state history.
The blog's migration to a new platform is aimed at improving service to readers and helping to bring a new focus to our coverage, which began in January 2005 and which has resulted in 5,000 items since then.
Tuesday, January 12, 2021
California's $12 Billion Stem Cell Agency and Fresh Ruckus over Conflicts of Interest
The appointment of a new member to the governing board of California's $12 billion stem cell research program triggered additional comment and criticism today concerning conflicts of interest at the agency.
The matter involves Larry Goldstein, a well-known scientist at UC San Diego, who has received $22 million from the California Institute for Regenerative Medicine (CIRM), the formal name for the stem cell agency. Goldstein's employer has received $232 million.
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| Marcia Darnovsky CGS photo |
"Proposition 14, which just last fall gave CIRM another $5.5 billion of public funding, should have been a chance for the agency to turn over a new leaf, but it made none of the changes that could have addressed the agency's built-in conflicts or other structural problems.
"Now CIRM has accepted a board member who has personally received some $22 million in CIRM grants, and whose institution has received far more. It appears that CIRM will continue to flout basic principles of good governance, despite being a public agency wholly funded by public dollars. This is a real and ongoing problem."
Last September, Capitol Weekly, California's respected government and political news service, carried an analysis of CIRM awards and their relationship to board members. It showed that 80 percent of the $2.7 billion awarded by CIRM has gone to institutions with links to past and present members of the CIRM board.
The agency's 35 directors are barred from voting on specific awards to their institutions. However, they set the rules, scope and direction for the awards.
UC Davis stem cell scientist and blogger Paul Knoepfler, who supports the stem
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| Paul Knoepfler UCD photo |
"I'm sure that Larry will do an excellent job on the board, and he brings a unique depth of knowledge on stem cell research. However, along the lines of what Aaron said as quoted in the piece, at the very least the appointment presents some challenges of perception of the agency."
Knoepfler's reference is to Aaron Levine, a Georgia Tech biomedical research policy expert who served on the IOM panel that conducted a $700,000 study of CIRM and recommended major changes in its governance and conflict of interest procedures. Levine told the California Stem Cell Report,
“Larry Goldstein is, in many ways, an inspired choice for the CIRM board. He is a well-regarded stem cell scientist and former CIRM grantee with administrative experience and demonstrated interest in public policy. On the other hand, CIRM has, at the very least, a perception problem with conflicts-of-interest and appointing a former grantee to the board so soon after the passage of Proposition 14 seems to suggest that this challenge will persist.”
“More broadly, conflict of interest concerns reflect the structure of the CIRM Board dating back to Proposition 71 in 2004 and the broader challenge facing many organizations of recruiting interested, qualified, and independent board members. CIRM has taken a number of steps to help address conflicts of interest since the IOM report was published many years ago, but I would have liked to see the board structure adjusted as part of Proposition 14 to introduce more independence into the oversight structure and further address these concerns.”
CIRM was running out of money last year and was set to close its doors until voters approved Proposition 14, which provided $5.5 billion more and significantly expanded the scope of the agency.
CIRM had an opportunity to deal with conflict of interest concerns during the formulation of the ballot measure in discussions with the sponsor of the measure, Robert Klein, a millionaire developer in Palo Alto. Klein also directed the writing of Proposition 71 in 2004 and served as CIRM's first chairman after writing into the initiative qualifications for the chair that applied uniquely to him.
The California Stem Cell Report asked Klein this morning whether he had made a recommendation to any party that Goldstein, who is co-chair of a scientific advisory panel to Klein's stem cell advocacy group, be appointed to the CIRM board. Klein replied in an email this morning:
"No. I learned of the appointment after the fact. Dr. Goldstein will be an outstanding board member. Given that he has closed his lab at UC San Diego and he is no longer conducting stem cell research, his extraordinary research record on neurodegenerative diseases and his experience in previously competing for CIRM grants will provide the board with important insights in advancing the search for therapies that are devastating to the brain, the body’s neurological system, and many other disease areas."The State of California’s stem cell therapy development efforts and science generally will benefit greatly by Dr. Goldstein’s sacrifice of the remaining years he could have conducted scientific research, in favor of this new commitment to public service on the CIRM board, that will benefit patients everywhere."
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| Lawrence Goldstein in lab at Sanford Consortium, UCSD photo |
(Update: CIRM told the California Stem Cell Report on Monday that it was speaking for Goldstein in its comments. Goldstein confirmed that in an email and did not respond otherwise.)
It is technically possible today to make changes in the law dealing with conflicts at CIRM and the composition of its board. However, those would require a super, super-majority vote (70 percent) of both houses of the legislature and the signature of the governor, a politically difficult task.
Monday, January 11, 2021
Recipient of $22 Million from California's Stem Cell Program Named to Its Board
Larry Goldstein, UC San Diego video
It was the first time in the history of the 16-year-old agency that a scientist who has received agency awards has been appointed to the board of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known.
Goldstein's appointment raises once again questions involving conflicts of interest at the agency. Since its inception, CIRM has awarded $2.7 billion to California researchers and enterprises, including UC San Diego. Eight out of every ten dollars has gone to institutions with links to past or present CIRM board members, according to an analysis by the California Stem Cell Report.
Conflict of interest issues have dogged the agency since before voters created it in 2004. In a report in 2012 commissioned at a cost of $700,000 by CIRM itself, the prestigious Institute of Medicine (IOM) said,
“Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of (the CIRM governing board), introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board.”
The IOM said the composition of the board, which is called the Independent Citizens Oversight Committee (ICOC) makes it neither “independent” nor capable of “oversight.”
In response to a question, Kevin McCormack, senior director of CIRM communications, said,
"Larry is no longer involved in any active CIRM awards and has stepped away from his research work, with the exception of one project for which he does not intend to seek CIRM funds.
"He brings a wealth of knowledge to the board and a different perspective as a leading stem cell scientist and former CIRM-funded researcher. As for conflicts, he is precluded from voting on any applications and cannot even participate in the discussion of applications submitted by UCSD."
While members of the CIRM board cannot vote on specific applications involving their institutions, they set the rules for the grant competition and approve "concept plans" for new grant rounds. Those rounds can and do benefit board members' institutions. UC San Diego has received $232 million in total funding from the agency, making the campus the third-largest recipient.
CIRM provided $43 million to help create the Sanford Consortium for Regenerative Medicine in La Jolla, which involved UC San Diego and other research institutions, all of which have been represented on the CIRM board. Goldstein was the founding scientific director of the consortium.
Goldstein, as a member of the CIRM board, is barred from applying for additional funding, CIRM said in response to a question.
Queried by email, Aaron Levine, a member of the IOM panel that studied the stem cell agency and an expert in biomedical research policy at Georgia Tech, said,
A longtime observer of the agency and supporter of stem cell research, who must remain anonymous, was "quite
distressed" by the Goldstein appointment. "Don't they have any sense of what's appropriate," the person said. "He has benefitted in so many ways and is so intertwined with Bob Klein."
Reports filed by Goldstein on his research can be found on this CIRM web page and by clicking on the description of each award. He was appointed by UC San Diego Chancellor Pradeep Khosla and replaces David Brenner, dean of the UC San Diego Medical School, who has served two terms on the CIRM board. .
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| Aaron Levine Georgia Tech photo |
“Larry Goldstein is, in many ways, an inspired choice for the CIRM Board. He is a well-regarded stem cell scientist and former CIRM grantee with administrative experience and demonstrated interest in public policy. On the other hand, CIRM has, at the very least, a perception problem with conflicts-of-interest and appointing a former grantee to the Board so soon after the passage of Proposition 14 seems to suggest that this challenge will persist.”
“More broadly, conflict of interest concerns reflect the structure of the CIRM Board dating back to Proposition 71 in 2004 and the broader challenge facing many organizations of recruiting interested, qualified, and independent board members. CIRM has taken a number of steps to help address conflicts of interest since the IOM report was published many years ago, but I would have liked to see the board structure adjusted as part of Proposition 14 to introduce more independence into the oversight structure and further address these concerns.”
Proposition 71 is the ballot initiative that created CIRM in 2004 with $3 billion in state bonds. When the money ran out last year, voters approved Proposition 14, which saved the agency with $5.5 billion more. The total cost of the agency by the time the money runs out again is estimated to be $12 billion because of the interest expense of the bonds.
Proposition 14 also expanded the board from 29 to 35 members, creating an increased likelihood of conflicts of interest.
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| Bob Klein California Stem Cell Report photo |
distressed" by the Goldstein appointment. "Don't they have any sense of what's appropriate," the person said. "He has benefitted in so many ways and is so intertwined with Bob Klein."
Klein is the Palo Alto developer who crafted Proposition 14 and 71 and contributed millions to the ballot campaigns. Goldstein serves as co-chair of the scientific advisory board of Klein's stem cell advocacy group, Americans for Cures.
In its news release, CIRM Chairman Jonathan Thomas said,
“I have known Larry for many years and have nothing but the highest regard for him as a scientist, a leader, and a great champion of stem cell research. He is also an innovative thinker and that will be invaluable to us as we move into a second chapter in the life of CIRM.”
Friday, January 08, 2021
Hundreds of California Scientists Eyeing $182 Million from Golden State Taxpayers
Hundreds of California stem cell researchers this week took part in an online exploration of the new, $182 million research plans of the state's newly refinanced efforts to develop therapies for afflictions ranging from cancer to incontinence.
Their questions ranged from the quite technical to how to comment during the formulation of a new strategic plan for the California Institute for Regenerative Medicine (CIRM), the official name of the stem cell agency.
CIRM is in the process of figuring out how to spend a total of $5.5 billion approved by voters last fall. The cash will fuel research for about another 11 years. At that point, CIRM funding will terminate unless another source of financing is developed.
The agency was created in 2004 by voters who allotted it $3 billion in borrowed money. By the time the money runs out, CIRM will have cost taxpayers an estimated $12 billion, which includes interest on the state bonds.
This week's webinar dealt with the agency's plans to award $182 million -- the first bite into the new $5.5 billion -- over the next six months for basic, translational and clinical research. On Thursday, Gil Sambrano, vice president of portfolio development review, laid out the plans that were approved last month by the CIRM governing board. He answered a number of questions during the session, which was viewed by more than 350 participants. Since then, the recording of the session has attracted an additional, 50-plus viewers. (To see the session, click on this sentence.)
CIRM began making awards in September of 2005, and it has delivered cash to more than 900 recipients. Many have received more than one award.
The first deadline for clinical applications in the latest round of funding is the last business day of this month. The deadline for translational applications is 2 p.m. PST Feb. 18. The deadline for the basic research "Quest" round is 2 p.m. PST March 18.
Monday, January 04, 2021
Looking for Some Research Cash? $182 Million on Table in California; Briefing Thursday on How to Get It
California's $12 billion stem cell program is entering a new phase that will affect patients and researchers alike, and it is planning a show-and-tell this Thursday for the curious.
"With the voter approval of Proposition 14 CIRM is about to start a new chapter in its life. Because we are always trying to improve the way we operate, always trying to be better, there are going to be changes in the way we do things. Some of those changes are in the way we fund research, and the kinds of projects we are going to fund," the agency said in an announcement last week.
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| Gil Sambrano, CIRM photo |
vice president of portfolio and review. Sambrano has been at CIRM (the California Institute for Regenerative Medicine) for years. He is in charge of the application review process, among other things. (Update: Here is a link to a video of the presentation.)
The CIRM session is aimed primarily at researchers and is expected to deal with some changes dealing with making CIRM-funded data more open along with the new diversity requirements in applications dealing with both potential patient populations and lab/research staffing.
CIRM plans to award $182 million in the next six months. Based on discussions and action last month by the CIRM board, it would behoove applicants to be well-informed about the details of the new requirements and how they will affect the scoring of grant applications.
Here are links to the specifics on the changes: discovery/basic research, translational and clinical.
Here are CIRM instructions for joining the webinar that begins at noon PST on Thursday. The Zoom address is https://cirm-ca.zoom.us/s/
Other methods: Phone one-tap, US: +16699006833,,92287515387# or +13462487799,,92287515387#, or join by telephone (for higher quality, dial a number based on your current location) US : +1 669 900 6833 or +1 346 248 7799 or +1 253 215 8782 or +1 301 715 8592 or +1 312 626 6799 or +1 929 205 6099; Webinar ID 922 8751 5387, passcode 210107.
Thursday, December 24, 2020
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. 😉
Monday, December 21, 2020
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.
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 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.
Friday, December 18, 2020
Speak Up: Time to Help Shape California's $12 Billion Stem Cell Future
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 kmccormack@cirm.ca.gov.
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
California's New Task: A $155 Million Drive to Make Stem Cell Therapies Affordable and Accessible
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| 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.
Next Monday, the governing board of the state stem cell agency is scheduled to begin to settle in under the new measure, which does much more than save the agency's financial life.
One of the agency's biggest, new challenges involves the accessibility and affordability of the staggering expense of potential stem cell therapies. On the agenda is the creation of a legally mandated "working group" to deal with the treatment cost issues.
Details of the proposed appointments to the group and its initial steps are not yet available from the California Institute of Regenerative Medicine (CIRM), as the agency is formally known. But the 17,000-word Proposition 14 has plenty to say about the new program. Here is a rundown drawn from my new book, "California's Great Stem Cell Experiment," which deals with the first 16 years of the agency's life, policies and financial times.
"The new playing field for CIRM encompasses particularly critical areas of costs to patients and profits for companies. Stem cell therapies are expected to be enormously expensive — $1 million or more in many cases. That’s a figure that makes health insurance companies balk and Medicare blanch.
"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."
The day-long meeting is open to the public, including scientists, who can also comment and ask questions. Comments are limited to three minutes. Lengthier comments should be emailed to the board via this address: kmccormack@cirm.ca.gov
No. 1 Read: A 'Deep Dive' Into the Sweeping Changes Made in California's $12 Billion Stem Cell Program
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| 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 piece was written by yours truly and dealt with the successful ballot initiative that saved the state stem cell agency from financial oblivion with a $5.5 billion infusion of borrowed money.
The 17,000-word measure, however, also involved a sweeping expansion of the scope of the agency and made a host of consequential changes. The freelance piece began:
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."
Other stories in Capitol Weekly's top ten, most-read articles include the governor's plans for a stricter Covid lockdown, the tough sell facing California ballot measures and Capitol Weekly's list of the state's 100, top unelected political power players.
Capitol Weekly has been around for decades, originally as a print publication. It is now part of Open California, a nonprofit that helps to fill a gap left by diminishing coverage of state issues by the mainstream media.
On its website, Open California says,
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Monday, December 14, 2020
Need Work? California's Stem Cell Agency Looking to Hire Ten
Looking for a job with an exciting and unique $12 billion stem cell research funding organization in the Golden State of California.?
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.
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.
(Update: On Jan. 2, applications for seven of these positions were available on the CIRM web site.)
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.
- 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.
CIRM is currently based in Oakland, Ca.
Friday, December 11, 2020
California Stem Cell Agency Set to Fund $182 Million in Research in Next Six Months
Click on the above to see a recording of today's online meeting of the CIRM Science Committee
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.
Here are links to the changes approved for the Quest program, the translational program and the clinical programs.
Tuesday, December 08, 2020
California Stem Cell Agency Beefs Up Budget with Plans to Hire 10 More Persons
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.
(Here are links to today's documents prepared by Jennifer Lewis, acting finance director, dealing with the agency's operational budget: finance presentation, finance appendix.)
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.
Vote Count on $5.5 Billion Stem Cell Measure Nearing its Official End
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
Ties, Politics and Stem Cells: The Becerra Nomination
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.
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| Xavier Becerra 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 $12 billion state stem cell agency has been working with the NIH and FDA to expedite approval of stem cell therapies that the agency has helped to finance. The agency points to its sickle cell initiative with the NIH as an example of federal-state cooperation.
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