Tuesday, January 26, 2021

CIRM Lays Out New Path: Funding More Buildings, More Research and Into New Territories (Personalized Medicine, Therapy Delivery)

California’s stem cell agency has for the first time laid out in some detail its view of the sweeping scope of its new charter -- approved by voters last fall and which directs the program into areas such as personalized medicine and therapy delivery over the next decade or so. 

The agency’s perspective will be discussed in public Thursday morning before its 35-member governing board. The new path is charted in the form of 17 pages of slides plus annotations on a 17,000-word ballot initiative, which is more than twice as long as the U.S. Constitution.

The documents were posted online by CIRM yesterday afternoon, two and a half days before this week’s meeting.... 

You can read the full item here on the new platform for the California Stem Cell Report, the only independent, news and information source devoted solely to the Golden State's stem cell 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 carried in 5,000 items since then.

Monday, January 25, 2021

Plus and Minuses: The Proposition 14 "Christmas Tree" and its Implications


From the exploration of mental health to "aging as a pathology," Proposition 14 launched the California stem cell agency on a course that will take it far afield from its founding charter of 2004. 

Directors of the agency will receive a briefing Thursday on the details of the 17,000-word, "Christmas tree" ballot initiative. The California Stem Cell Report has prepared a deep look at many of the features of the measure, including how it could be altered if CIRM desires to take on that difficult task. Below is an excerpt from the full item, which can be found on the new platform for this blog.

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Proposition 14, last fall’s ballot measure to save California’s stem cell agency from financial extinction, contains much, much more than the $5.5 billion it sought from the state’s voters.

Added to the agency’s charter is 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 enlarged the board from 29 to 35 members — seats not yet filled as of this writing. But 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 bans royalties that are generated by state-backed stem cell inventions from being used for such things as prisons and schools, isolating the funds from tinkering by lawmakers....

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The California Stem Cell Report is the only independent, news and information source devoted solely to the Golden State's stem cell 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 carried in 5,000 items since then.

Sunday, January 24, 2021

New Home for California Stem Cell Report -- Don't Miss an Item

The California Stem Cell Report is in the process of migrating to a different platform. To be sure that you have the latest news and information concerning the California stem cell agency, please go to this location. 


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.  

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. 

Marcia Darnovsky
CGS photo
"Conflicts of interest at CIRM have been a major concern since the agency was founded, as pointed out by observers including the Institute of Medicine (IOM) and the Little Hoover Commission, California's independent oversight organization," said Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, Ca., which has long opposed CIRM.  

"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

Paul Knoepfler
UCD photo
cell agency, said in a comment this morning carried on the first item on this subject on the California Stem Cell Report 

"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." 
Lawrence Goldstein in lab at Sanford
Consortium, UCSD photo
Goldstein is barred by CIRM rules from applying for grants. The agency said yesterday that Goldstein has stepped away from his research with the exception of one project. 

(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

Larry Goldstein, a well-known stem cell researcher at the University of California, San Diego who has received nearly $22 million in awards from the California stem cell agency, today was named to its governing board.

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.  

Aaron Levine
Georgia Tech photo
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 Techsaid, 

“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. 

Bob Klein
California Stem Cell Report photo
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." 

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.”
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. . 

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. 

Gil Sambrano, CIRM photo
Addressing many of those matters will be Gil Sambranothe stem cell agency's
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/92287515387

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.

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