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. 

8,588,156

51.1%

8,221,692

48.9%

California Pumps $5 Million into Search for Stem Cell Treatment for Covid-19

Coronavirus

California's stem cell agency, in an emergency action, has allocated $5 million for research into treatments for Covid-19 and set the deadline for the first applications for one week from today. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), approved the funding last Friday during an emergency meeting of its governing board. 

In an item yesterday on the CIRM blog, Maria Millan, CEO and president, said,

"California researchers have made us aware that they are pursuing potential stem cell based approaches to the Covid-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."

The agency set accelerated timetables for action, both by the agency and applicants. It said it would expect winning applicants to begin work within 30 days of being approved. 

CIRM's move comes as itself is facing a mortal financial threat. It was created by voters CIRM in 2004 with $3 billion. It is now down to its last $27 million and is hoping voters will approve $5.5 billion more via a proposal that is yet to qualify for the November ballot. Otherwise CIRM's doors will begin to close in the fall. 

Presumably, billions of private and public dollars are already pouring globally into the search for various aspects of Covid-19, so the $5 million is a relatively tiny amount. CIRM has developed a speedy process, however, for bringing funds to bear on research and is acting to accelerate that even further. 

Jonathan Thomas, chairman of the CIRM board, said, 

"The coronavirus is creating an unprecedented threat to all of us and, as one of the leading players in regenerative medicine, we are committed to doing all we can to develop the tools and promote the research that will help us respond to that threat." 

The campaign to qualify the $5.5 billion initiative for the ballot released a statement heralding the action by CIRM. Robert Klein, the Palo Alto real estate developer behind both the original ballot measure and this year's funding initiative for CIRM, said, 

"The investment by California’s stem cell institute to combat Covid-19 highlights the remarkable potential of this research and therapy development to impact the lives of every Californian. ...We urge Californians to think back on this moment, when they decide the fate of future life-saving stem cell discoveries and treatments come November."

The campaign said 10 days ago that it has suspended the gathering of signatures. It is not clear whether it has enough to qualify for the fall ballot. More than 600,000 valid signatures are required. 

Here are links to additional CIRM information on its Covid-19 program:

• Concept statement
• Application information and timetables
• Presentation slides from last week's meeting
• CIRM's news release

California's $250 Million Stem Cell 'Claw Back:' Recycling Research Cash

CIRM's recovery of cash is not common practice in government research
iStock image

California's stem cell agency, which critics have sometimes labelled a boondoggle, has managed to "claw back" $250 million during its 15-year life, an achievement that it attributes to diligent financial stewardship.

The cash includes $30.3 million last year with a high of $41.9 million in 2017.

The funds were recovered through a number of means including the cancellation of research awards when they failed to meet milestones. The terminations have left some scientists less than happy.

Termination of awards is not common in the world of government-funded science. In contrast to California, the National Institutes of the Health (NIH) do not generally engage in the practice, according to The Scientist magazine.   

The size of the two organizations, however, is much different. The NIH makes about 50,000 awards a year. The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, has made only 1,031 awards during its lifetime. Its awards now total $2.7 billion for research into everything from cancer to incontinence. 

CIRM compiled its cash recovery figures in response to a request by the California Stem Cell Report. The request for the figures was prompted by CIRM board action this month to recycle $1.8 million in recovered funds into more research. The recovery practice is akin to what is known in Wall Street parlance as a "claw back."

Kevin McCormack, senior director of communications, said in a statement,

"The total amount of recovered funds collected since 2005 is $250 million which averages to an estimated $16.6 million per year. Although we cannot break this number down by year, recovered funds were significantly smaller in the early days of CIRM as we began launching awards and then increased over time as the portfolio grew.  Since implementation of operational milestones in 2016, recovered funds have totaled to the following:

• "2016 - $30 million

• "2017 - $41.9 million

• "2018 - $25.85 million

• "2019 - $30.3 million

"The number of awards cancelled is 32 and the total amount for that category is $122.3 million."

The financial stewardship of the California stem cell agency is a matter that has come under intermittent scrutiny during CIRM's short life. Its performance, however, will draw considerably more attention from its foes during the next eight months as CIRM backers seek to win voter approval of a ballot initiative for $5.5 billion more.

One of the agency's opponents is Republican state Sen. John Moorlach of Costa Mesa, Ca., who produced a video in 2017 denouncing CIRM as a boondoggle, ineffective and unaccountable. 

Termination of awards by CIRM began in 2009 and was first reported by the California Stem Cell Report. At the time, the cancellations led to some ill will in segments of the scientific community more comfortable with the easy ways of the NIH.

But one of the researchers who lost an award said at the time:

“I think that it is very important for CIRM to closely monitor its grantees. As a California taxpayer, I want to know that state revenues supporting the CIRM effort are well utilized. Furthermore, CIRM (and its grantees) need to make good on the promise of translating the science of stem cell biology into novel therapies.”

It was a statement that agreed with the agency's position. McCormack said, 

"Right from the very beginning CIRM has always tried to be good stewards of taxpayer’s dollars so we have always had processes and policies in place that ensured we were closely managing our awards which has resulted in recovered funds."  

Not all of the "claw back" came from failure to meet milestones. McCormack said, 

"Cancelled awards are a portion of the funds returned, but recovered funds also include unspent funds at the end of an award; reductions during contracting due to rebudgeting, unallowable costs, or inaccurate facilities rates; or a failure to meet a particular a condition of the milestones such as target patient enrollment which results in an award reduction.

"Awards can be canceled for not meeting milestones, changing the scope approved by the GWG, or other non-compliance issues."

(The full text of McCormack's comments can be found here.)

The agency is now down to its last $27 million for awards. Come the morning of Wednesday Nov. 4 the day after the election, CIRM will either start to shutter its operations at its Oakland headquarters or gear up for even more extensive forays into biomedicine.

California Stem Cell Agency Chalks Up its 60th Clinical Trial as Funds Dwindle

OAKLAND, Ca. -- The California stem cell agency last week awarded about $54 million for research into afflictions ranging  from eye disease to epilepsy as it edged increasingly closer to running out of cash.

Nine applications were approved including more clinical trials -- the last stage before therapies are approved for widespread use. The actions bring to 60 the number of clinical trials that the 15-year-old agency is helping to finance.

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known,  has about $27 million left, plus any additional funds that the agency might recover when awards are cut short as research fails to meet required milestones. The $27 million, however, is earmarked for sickle cell research in a partnership with the federal government.

In some past years, CIRM handed out as much as $300 million a year.

The agency's sole source of significant funding has been $3 billion in state bonds. It is pinning its hopes for the future on voter approval of a $5.5 billion ballot initiative in November 2020.  Playing a role in that effort is likely to be a CIRM-financed, economic study from USC that bolsters the argument that the economic benefits of the agency more than justify renewing its funding.

Dana Goldman, a professor of public policy, pharmacy and economics at USC and who directed the study, said that the private sector is not going to make the types of investments that CIRM has made in developing new treatments. He told the board last week that it would take only small improvement in success rates in such areas as stroke therapy to more than cover the cost of CIRM's activities. (Here is a link to his slides for the presentation.)

CIRM was created in 2004 by voters but has yet to invest in research that has resulted in a widely available therapy.

Maria Millan, CEO of CIRM. said in a news release:

“Programs, such as those funded today, that were novel stem cell or gene therapy approaches addressing a small number of patients, often have difficulty attracting early investment and funding. CIRM’s role is to de-risk these novel regenerative medicine approaches that are based on rigorous science and have the potential to address unmet medical needs. By de-risking programs, CIRM has enabled our portfolio programs to gain significant downstream industry funding and partnership."

Below is a list of the awards with links to the official summaries of the review of the applications, which can be found by clicking on the application number. Letters by applicants to the board can be found by clicking on the applicant's name. Additional letters of support for the research can be found on the agenda for the meeting. 

Here is the UCLA news release on the awards to three UCLA researchers.

Application Number	Amount  (in millions)	Institution	PI	Target
CLIN1-11591	$5.5	Stanford	Rosa Bacchetta	IPEX
CLIN1-11472	$6.6	UC Irvine/jCyte	Henry Klassen	Retinitis pigmentosa
CLIN2-11620	$10.5	Cedars-Sinai	Clive Svendsen	Retinitis pigmentosa
CLIN2-11661	$5.5	Brain Neurotherapy Bio	Krystof S. Bankiewicz	Parkinson’s Disease
CLIN2-11650	$10.3	UCLA	Sophia Deng	Limbal stem cell deficiency
TRAN1-11536	$4.9	UCLA	Caroline Y. Kuo	Immune deficiency
TRAN1-11555	$3.2	UCLA	Yvonne Y. Chen	Myeloma
TRAN1-11544	$2.9	City of Hope	Karen Aboody	Ovarian cancer
TRAN1-11611	$4.8	Neurona Therapeutics	Nicholas Corey (no letter posted)	Epilepsy

California Stem Cell Agency Posts $54 Million in Good News for Eight Researchers

Eight California researchers may be able to breathe a sigh of relief this morning with the news that the California stem cell agency has enough cash on hand to fund their applications to develop therapies for afflictions ranging from Parkinson's to eye diseases.

All eight of the applications have been approved already by the agency's reviewers. The agency's  governing board very rarely reverses the reviewers' actions. 

Until a day ago, it was uncertain whether the agency had the money to fund all the proposals. The good news for the scientists came in the form of a posting late yesterday on the web site of the agency, formally known as the California Institute for Regenerative Medicine (CIRM). The posting said that the agency has $54.2 million available for new awards as of Wednesday of this week (Oct. 23). The total for the eight application is about $52 million. 

Of course, it is possible that the board could move in a different direction based on considerations not readily apparent from the agenda for its meeting next Thursday. 

If the agency has $2 million or so left after next week's meeting, it is also unclear what it will do with the cash. One possibility is that it could retain the cash for awhile and combine it with funds that might be recovered from awards that have not met milestones.  So far this year, the agency has recovered $30.3 million.

CIRM has expected to run out of cash this year for new awards after dispensing $2.7 billion over the last 15 years to 1,017 recipients. It is hoping voters will approve $5.5 billion more via a ballot initiative in November 2020. 

Thursday's meeting does have another financial fillip. Listed on the agenda is a line that says a report will be made on private donations. That could be good news or not-so-good news depending on how successful its private funding efforts have been over the last couple of years. Results of that drive are yet to be publicly announced. 

(Editor's note for careful readers: The CIRM document that contains the $54.2 million figure also lists $57.2 million in applications. One of those applications, a $5 million proposal, was not approved by reviewers, however.) 

California Stem Cell Researchers Compete Next Week for $52 Million in Awards

Directors of the California stem cell agency will make yes-or-no decisions next week  on eight applications for $52 million to seek cures for afflictions ranging from Parkinson's to an incurable eye disease called retinitis pigmentosa.

All eight have been approved behind closed doors by the agency's grant reviewers, but it is yet to be determined whether the agency has enough cash to ratify that action.

Prior to voting on the applications, the 29-member board is scheduled to discuss how the agency's final funding will be parceled out. The agency expects to run out of cash for new awards at the end of the Oct. 31 meeting. However, also on its agenda are a few words promising a report on the status of its search for private donations. 

Below is a table on the applications. It includes links to the review summaries prepared by the agency, which is formally known as the California Institute for Regenerative Medicine. Links to the review summary can be found on the application numbers.

Some of the applicants have filed additional letters with the board seeking to bolster their pitches. The letters can be found by clicking on the researcher's name. Some of the applicants are expected to address the board personally Oct. 31 in Oakland.

The agency has a non-embarrassment policy of not disclosing the names of applicants and their institutions until a vote by its board.  However, when they write the board, their names become a public record. The names of applicants who fail to win approval are never disclosed by the agency.

Look for more stories in the upcoming days from the California Stem Cell Report on the agency's Halloween meeting.

Application Number	Amount In millions	Institution	Principal  Investigator	Target
CLIN1-11591	$5.5	Stanford	Rosa Bacchetta	IPEX
CLIN1-11472	$6.6	Not disclosed	Not disclosed	Retinitis pigmentosa
CLIN2-11620	$10.5	Not disclosed	Not disclosed	Retinitis pigmentosa
CLIN2-11661	$8.0	Brain Neurotherapy Bio	Krystof S. Bankiewicz	Parkinson’s Disease
CLIN2-11650	$10.3	UCLA	Sophia Deng	Limbal stem cell deficiency
TRAN1-11536	$4.9	UCLA	Caroline Y. Kuo	Immune deficiency
TRAN1-11555	$3.2	UCLA	Yvonne Y. Chen	Myeloma
TRAN1-11544	$2.9	Not disclosed	Not disclosed	Ovarian cancer

Meeting Delays and the California Stem Cell Agency: A Matter of Many Millions of Dollars

For the second time in two months, the governing board of the $3 billion California stem cell agency has postponed important meetings which had been expected to deal with its final research awards and its declining finances. 

The latest postponement involved a Sept. 25 meeting. On the table would have been redirection of tens of millions of dollars and the question of financing awards already approved by the agency's reviewers.

Last month, an Aug. 22 session involving major awards was  cancelled. As of today, the next meeting of the agency's board will not come until Oct. 31.

The governing board of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), has before it far more reviewer-recommended awards than it can fund. Agency officials hoped that funds received from cancelled research projects would help fill the gap.

CIRM is financed with $3 billion in state bonds but has no source of significant cash beyond that. It expects to run out of money for new awards -- most likely by the end of next month -- depending on how it deals with the applications in its award pipeline. Those decisions are now likely to be made at the meeting currently scheduled for Oct. 31. 

Queried about the reason for delaying this month's meeting, Maria Bonneville, executive director of the board,  replied, 

"There were some scheduling issues and, as you know, getting the whole board together isn’t easy. (The) soonest I could get a quorum was Oct 31."

CIRM's future depends on a proposed, $5.5 billion ballot measure in November 2020 that would allow it to continue at the pace of the last 14 years. The agency also has been engaged for some time in an effort to raise privately more than $200 million to bridge the funding gap between now and the 2020 election. 

No specific progress has been publicly announced concerning that effort. However, the financial plight of the agency has received more public attention in recent months. That attention may have generated the loosening of the purse strings of some potential donors. 

The agency also may well have made a pitch to California Gov. Gavin Newsom for some sort of interim funding, possibly payable back with 2020 bond proceeds. Newsom was an important supporter of the agency in 2004-05 and engineered a $17 million package to lure its then headquarters to San Francisco when he was mayor of that city.

California Stem Cell Agency Backs Breast/Ovarian Cancer, Brain Injury Research and More with $29 Million; $71 Million Left

Saul Priceman of the City of Hope. Priceman received $9.3 million last month from CIRM for a clinical trial for breast cancer. City of Hope video.

The California stem cell agency last month handed out $29 million to finance efforts to develop treatments for traumatic brain injury, ovarian cancer and more, leaving it with about $71 million for new research awards before its cash runs out. 

The nearly 15-year-old agency, known formally as the California Institute for Regenerative Medicine (CIRM), is hoping that a yet-to-be written ballot initiative for the November 2020 ballot will give it a $5.5 billion infusion. The agency began its life in 2004 with $3 billion. 

Fresh figures from the agency show that it has about $43 million available for new awards, not including those involved in a sickle cell anemia effort with the National Institutes of Health.  CIRM's contribution to that program totals about $28 million. The agency is still accepting applications in that program. 

The amount of funds available overall to CIRM could rise as funds come back to the agency as the result of termination of unsuccessful research.

In last month's two-hour meeting, CIRM's board approved five grant applications, but not without more public discussion than has occurred in some past years when the agency was flush with cash. 

Directors talked about priorities, CIRM's portfolio and the vagaries of the scoring process, which is done behind closed doors by out-of-state researchers/reviewers who do not have to publicly disclose their professional or financial conflicts of interest. 

But the meeting also led to a reflection by CIRM board member Jeff Sheehy on the value that CIRM has brought to the field and California. Sheehy is a patient advocate of the 29-member panel. He has been on the board since its first meeting in December 2004 and leads the board's public discussion during ratification of funding decisions by reviewers.

Sheehy told his fellow board members that he had lost his mother to ovarian cancer and knew the "incredibly painful, difficult road" that she walked.  He said that CIRM is providing a new path to a better future for cancer patients and others with dreadful diseases and urged diligence in supporting renewed funding for the agency.  

In formal action, the board approved a $9.3 million investment in a clinical trial for a treatment of breast cancer, the second most common cancer in women. The trial is the 56th in which the agency is involved. The award went to Saul Priceman of the City of Hope. The review summary of his application (CLIN2-11574) can be found here. 

The CIRM panel also approved awards to the following researchers and institutions. The review summaries for all, including applications not approved, can be found here. 

Mark Tuszynski, $6.2 million, UC San Diego, spinal cord injury (no UCSD news release)
Evan Snyder, $4.9 million, Sanford Burnham, ischemic brain injury (no Sanford news release)
Brian Cummings, $4.8 million, UC Irvine, traumatic brain injury (UCI news release)
Mark Humayun, $3.7 million, USC, age-related macular degeneration (no USC news release)

The CIRM news release on the July meeting and awards can be found here. The transcript of the meeting can be found here. 

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