California Stem Cell Report

The California Stem Cell Report Has Moved

2022-03-04T17:13:00.000-08:00

Looking for the latest information and news about California's $12 billion stem cell and gene therapy research agency? We have moved to this new platform.

Check out these recent developments.

It's a Tale of Ticking Clocks and Risky Endeavors

The bubble baby treatment, Orchard and CIRM's future

More than 100 CRISPR Patents 'Wiped Off the Face of the Earth'

Impact on California stem cell agency awardees yet to emerge

Pace of State Spending in California on Cell/Gene Therapy? $38K an Hour

2021-12-17T17:33:00.002-08:00

Read the latest news about the California stem cell agency on our new platform. The link below will take you there. You can subscribe free today by clicking on the button at the end of the article below. Don't miss any of the latest doings at the $12 billion California Institute for Regenerative Medicine (CIRM). The Los Angeles Times says the California Stem Cell Report is "indispensable" reading. More than 3 million page views can't be wrong.

$38,000 an Hour: The Current Pace at the California Stem Cell Agency

From broke to $5.5 billion in riches; the story of the last 12 months

Life After Proposition 14: California Stem Cell Agency's Take on Its First Year with $5.5 Billion

Text of what CIRM has to say

Bluebird bio's $1.8 Million Setback on Gene Therapy: Is It a Growing Sign of Rejection of Reimbursement Profit Models?

2021-08-13T18:44:00.000-07:00

"Some bad news about a $1.8 million gene therapy echoed across the Atlantic Ocean this week and carries implications for California’s state stem cell agency, which also is engaged in developing so-called “one-and-done” therapies.

" The matter involves bluebird bio of Cambridge, Mass., and its proposed Zynteglo therapy for the rare blood disorder beta thalassemia. The European Union last week refused to go along with bluebird’s price for the treatment -- $1.8 million.

"Bluebird, which spells its name in all lowercase, said it would fold up its European operations...." "This news (about bluebird) plus Orchard's departure demonstrates urgency around affordability that needs to be addressed, especially when likely sickle cell disease therapies come to fruition,” said an observer who has followed CIRM (the state stem cell agency) for years, but declined to be identified publicly.

“The technology is similar to proven therapies in X-linked SCID and beta thalassemia that are languishing. Serious consideration needs to take place around utilizing ‘march-in’ rights built into CIRM's IP (intellectual property) policies to force the provision of these therapies in an affordable manner...."

Subscribe Free Today to the California Stem Cell Report -- - The Most Comprehensive Source for the Ins and Outs of California's $12 Billion Stem Cell Program

2021-06-13T09:19:00.005-07:00

Don't miss important fresh news and information about California's $12 billion stem cell research agency. It is charting a new course with new opportunities and significant changes in direction, including a greater emphasis on the fast-growing gene therapy field.

The changes already mean a lot for patients, researchers and policymakers and will have an even greater impact in the next several years. Tracking the agency's affairs is not easy, but you can find what you need on the The California Stem Cell Report.

Dubbed "indispensable" and "authoritative" in the Los Angeles Times, the Report is the only regular, independent source of news and information dealing with the California Institute for Regenerative Medicine (CIRM).

It is news that can be found nowhere else. Plus it is comprehensive. More than 5,000 items have been published since CIRM was created in 2004.

You can subscribe free to the California Stem Cell Report on its new platform by clicking on the "Subscribe Today!" box on the upper right of this page. Or just go to one of the following recent stories and click on the subscribe button.

California Stem Cell Agency Withholds $5.8 Million from Orchard in Bubble-Baby Flap; Money to Go to New Effort Involving Compassionate Use

California to Spend $41,000 an Hour on Stem Cell Research

'Boiling the Ocean:' California Wrestles with Billion-Dollar Decisions and Stem Cell Research

Feds Crack Down on Rogue Stem Cell Clinics; California Remains Unhurried; Expensive treatments are harming patients

Read All About It: Bubble Babies Hit by Suspension of Trial for Genetic Cure; California Taxpayers Paying for Trial

2021-05-24T11:33:00.003-07:00

"Indispensable" is what the Los Angeles Times this morning called this blog, the California Stem Cell Report.

The comment came in a story that was triggered by our coverage of the Orchard-CIRM-UCLA bubble baby clinical trial, which was shoved aside by Orchard Therapeutics for financial reasons. That leaves a bunch of children out in the cold as far as the genetic treatment is concerned.

UCLA says the treatment has saved the lives of more than 50 persons.

Below is a list of the Orchard stories that we have carried on our new platform since we unearthed the issue on May 11. You can subscribe free to articles on our new home by clicking on the subscribe button in stories on the new platform. Subscribe today.

Here is the list.

Wicked' Problems, Orchard Therapeutics and Bubble Babies: A California Stem Cell Story

CaliforniaStem Cell Agency Pledges to Do "Everything" to Salvage Cure for Bubble Baby Disease

Can a California 'March-In' Save Terminally Ill 'Bubble Babies?'

Orchard's Suspension of Bubble Baby Disease Trial Earns Sharp Rebuke

Bubble Baby Cancellation Story Draws Attention in California's Largest Newspaper

Essential Reading on California's Ground-Breaking, $12 Billion, Stem Cell/Gene Therapy Research Program

2021-04-04T07:51:00.002-07:00

Don't miss out on news and information on the $12 billion California stem cell agency.

Its activities affect the lives of thousands of people and have the potential to affect the lives of millions of more. Not to mention that it is venturing into new areas of health policy and research.

Subscribe today to the California Stem Cell Report on its new platform. You can do so by clicking here and tapping the subscribe button. Plus it's free.

Cited as “indispensable” in the Los Angeles Times, the California Stem Cell Report is the only independent voice regularly reporting on the activities of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known. In 2012, the Institute of Medicine invited the publisher of this site to testify during its $700,000 evaluation of CIRM.

This report has covered CIRM since its inception in 2004 and has published more than 5,000 items and attracted more than 3 million page views.

It is essential reading if you have something at stake in what CIRM does and how it spends its money.

Here are links to recent articles on the California Stem Cell Report's new platform.

California's Sickle Cell Surge: Researchers Tackle Disease with First-Ever, Gene-Editing Clinical Trial

How Does a CIRM Work? California's Stem Cell Agency Offers Up Trail Guide to Its Ambitious $12 Billion Program

What Do California Voters Want from Their Stem Cell Agency’s Multibillion-Dollar Smorgasbord?

2021-03-26T09:31:00.003-07:00

Boiling the Ocean:' California Wrestles with Billion-Dollar Decisions and Stem Cell Research

What Does 'Unlikely' Mean?

Photo: License Dashboard

The talk at the California stem cell agency this week was of ”boiling the ocean,” the meaning of “unlikely” and “DEI.” All of which involves how $5.5 billion in taxpayer dollars will be used over the next decade or so....

Read all about it on the new platform for the California Stem Cell Report. And please subscribe on the new site to keep seeing the most complete and independent source of information on the doings at the state's $12 billion therapy development enterprise.

The Latest: Deciding who Decides Who Gets California's Stem Cell Billions

2021-03-18T07:22:00.000-07:00

CIRM directors tomorrow take up the matter of how the agency chooses the judges of applications for billions of California stem cell research dollars. You can read more about what's in store on the new platform of the California Stem Cell Report.

You can also make sure you don't miss any of the news by subscribing free. It's easy. Just click on the subscribe button when you go to the link below.

Who Should be a Stem Cell Judge for California's $12 Billion Research Agency?

Looking at how scientists are chosen to score grant applications

The California stem cell agency has released its plans to revise the process of choosing the folks who make the de facto decisions on billions of dollars in research awards.

The revisions grew out of a meeting last month of the governing board of the $12 billion agency, officially called the California Institute for Regenerative Medicine (CIRM).

Some directors sought more diversity among as many as 300 scientists who are tapped to review applications for awards. One director sought assurances that the process would lead to the selection of the most talented scientists, ones who also could be counted on work positively with others during the review process....

Subscribe Today to the Leading Source of Information on a $12 Billion Source of Stem Cell Research Funding

2021-03-13T07:50:00.003-08:00

It's time to subscribe -- free! -- to the California Stem Cell Report, which has moved to a new platform.

Don't miss news and information concerning critical developments at the $12 billion California stem cell agency. It is the leading, independent and reliable source for all that happens at the California Institute for Regenerative Medicine (CIRM).

With more than 3 million page views and more than 5,000 items during the last 16 years, the Report's readers range from researchers throughout California to across the nation. Not to mention policymakers and entrepreneurs in the burgeoning stem cell field. "Indispensable" is how the Los Angeles Times described the California Stem Cell Report.

You can subscribe on the blog's new platform while reading the latest CIRM news. Please do it today. Here are recent links and excerpts that will take you to the location where you can subscribe with just one click.

Telling the California Stem Cell Story: A Matter of Billions of Dollars

Building a Base of Voter Support

David Jensen

23 hr ago

Can the stork be relied on to bring stem cell cash?

The respected California news service Capitol Weekly this week brought the exploits of the state’s $12 billion stem cell agency to a much wider audience than normal -- one that includes policymakers, lobbyists, lawmakers and even some information-hungry folks in the general public.

The case in point involves the $17 million provided by the stem cell agency to help finance the world’s first clinical trial to treat spina bifida in the womb. ....

Bulldogs and Babies: World's First Trial to Treat Spina Bifida in the Womb

UC Davis Research Began More than 10 Years Ago

David Jensen

Mar 10

Bulldog pups were tested earlier in the spina bifida research and came out lively. UCD video

Backed by $17 million in cash from California’s stem cell agency, researchers at UC Davis this month are launching “the world’s first clinical trial using stem cells to treat spina bifida before the child is born.”...

California Stem Cell Flashback: When CIRM Was Homeless and Without an HQ

2021-03-08T08:16:00.000-08:00

CIRM is now based in Oakland. Here is what it looked like prior to a CIRM board
meeting in 2019. The view from the 16th floor includes the San Francisco Bay.
Photo: California Stem Cell Report

Editor’s note: Sixteen years ago California’s stem cell program was basically homeless. It had barely come into being. It had no way to pay its bills or even employees. This link will take you to an item from Jan. 25, 2005, on the California Stem Cell Report that captures a slice of what it was like back then. It also comments on today's situation at the agency's headquarters in Oakland, where space needs appear to be changing.

Speaking of changes, the California Stem Cell Report has moved to a new platform. Be sure to subscribe free on the new site so that you don't miss out on information that goes to researchers and policy makers throughout the state.

$165 Million for Stem Cell Education and Training in California

2021-02-26T16:24:00.002-08:00

California's ambitious stem cell agency is in the midst of determining how it is going to spend $5.5 billion over the next decade or so. Its decisions are likely to affect millions of patients desperate for therapies and cures for afflictions ranging from cancer to diabetes. That is not to mention the agency's impact on health care policy and the thousands of scientists, technicians and others in their California laboratories.

The go-to source for independent information about the programs of the stem cell agency is this blog, which has readers in every major stem cell research organization in the Golden State, the National Institutes of Health and the Food and Drug Administration.

Over the last 16 years, the California Stem Cell Report has brought its readers exclusive information and news that can be found nowhere else. It has chronicled CIRM's accomplishments and its missteps over the years. And it is essential reading as CIRM wades into gene therapy, affordability efforts, personalized medicine and much more.

Here are links and excerpts from this week's California Stem Cell Report, which has moved to a new platform as it chronicles the latest chapters in the life of the agency known officially as the California Institute for Regenerative Medicine (CIRM). Subscribe to the "new" version of this blog through the "subscribe" buttons that can be found on its new platform at Substack. Three-million "views" of the site can't be wrong.

California Approves $165 Million for Stem Cell Training and Education

Relaunches Touted Programs at Academic Institutions

California’s stem cell agency today pumped an additional $165 million into its efforts to beef up the Golden State’s stem cell workforce, but not without a rumpus involving the actual cost of each additional worker, who range from technicians to physicians.

The agency and many of its 35-board members have touted the programs, which have been underway for a number of years. But earlier versions of the program, as well as the latest proposal, have not included a price tag for each of what the agency calls “ready-to-start” professionals.

That led to a contentious discussion among governing board members during which a variety of high-level figures surfaced. One calculation by a board member generated a cost of $1 million per person per year (video at end of this item).

"Hotel California" for Golden State Stem Cell Research? Plus the Bad Tidings on a $16 Million Clinical Trial Investment

2021-02-23T18:05:00.001-08:00

Here are links and excerpts from items this morning on the California Stem Cell Report, which has moved to a new platform. Don't miss the exclusive and news about California's $12 billion stem cell/gene therapy program, including information that can be found nowhere else. Subscribe to the "semi-new" version of this blog through the "subscribe" buttons that can be found on the new site. Three-million "views" of the site can't be wrong.

CIRM 'Hotel California' for Stem Cell Research? But Bad News in a California Stem Cell Trial

Stem cell researchers yesterday discussed a possible facility in California to aid in stem cell research that was dubbed a stem-cell Hotel California after the famed Baja retreat.

California’s rejuvenated stem cell program yesterday received bad news about a $16 million clinical trial investment but also heard glowing praise from stem cell researchers who suggested ways to spend $5.5 billion more.

It all happened during a nearly five-hour session Monday morning devoted to crafting a new, five-year strategic plan for the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. The meeting came in the wake of voter passage last fall of Proposition 14, which saved the agency from death by a lack of dollars.....

Text of Statement by Amander Clark of UCLA on Future Direction of California's Stem Cell Program

Clark's Talk was Aimed at Needs in Basic Research

Looking for Work? California's Stem Cell Agency Needs 11 Good People

2021-02-09T08:40:00.001-08:00

California’s ambitious stem cell research agency is now hiring as part of its renewed search for treatments and therapies, fueled by a fresh infusion of $5.5 billion courtesy of the people of the Golden State.

You can read all about the new jobs on the California Stem Cell Report's new platform. The article includes links to job descriptions, salaries and much more. Here is an excerpt:

“'Our team of highly trained and experienced professionals,' the agency says, 'actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell and regenerative medicine technologies.'

"The Oakland, Ca.-based agency is officially known as the California Institute for Regenerative Medicine (CIRM). It says it 'is the world’s largest institution dedicated to helping people by bringing the promise of regenerative medicine closer to reality.'

"At last report, the 16-year-old agency had 32 employees, down from a peak of more than 60 a few years back. But it has new and expanded responsibilities under Proposition 14....."

Don't Miss Critical Information and News about California's $12 Billion Stem Cell Program

2021-02-04T18:18:00.000-08:00

The California Stem Cell Report has moved to another platform, but you can still subscribe free to the latest news and information about the Golden State's $12 billion stem cell research program.

For more than 16 years, the report has brought to its readers an independent perspective unfettered by government and industry ties. Read the California Stem Cell Report if you want to know what is going on at the state stem cell program, which operates with no legislative or gubernatorial oversight.

The California Stem Cell Report is essential reading for policy makers, stem cell company executives, scientists and patient advocates. Subscribe now.

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

2021-01-26T14:03:00.001-08:00

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.

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

2021-01-25T10:59:00.003-08:00

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.

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

2021-01-24T07:00:00.001-08:00

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.

California Stem Cell Conflicts of Interest and Their Regulation Rise Next Week

2021-01-22T17:54:00.000-08:00

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.

California Stem Cell Board Faces its Future in Late January Meeting

2021-01-19T11:54:00.004-08:00

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.

California's $12 Billion Stem Cell Agency and Fresh Ruckus over Conflicts of Interest

2021-01-12T11:28:00.006-08:00

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.

Recipient of $22 Million from California's Stem Cell Program Named to Its Board

2021-01-11T15:50:00.001-08:00

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 Tech, said,

“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. .

Hundreds of California Scientists Eyeing $182 Million from Golden State Taxpayers

2021-01-08T14:24:00.006-08:00

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.

Looking for Some Research Cash? $182 Million on Table in California; Briefing Thursday on How to Get It

2021-01-04T08:18:00.005-08:00

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 Sambrano, the 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.

Going Dark for the Holidays

2020-12-24T10:25:00.000-08:00

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

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

2020-12-21T14:37:00.002-08:00

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.