Monday, December 14, 2020

Need Work? California's Stem Cell Agency Looking to Hire Ten

Looking for a job with an exciting and unique $12 billion stem cell research funding organization in the Golden State of California.?

The state stem cell agency, which is now into everything from "aging as a pathology" to mental health, is looking to hire 10 persons to fill posts ranging vice president of science to administrative assistant.

While the positions are yet to be officially posted online, here is the list of expected openings, according to the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known. 

(Update: On Jan. 2, applications for seven of these positions were available on the CIRM web site.)
  • Senior Executive Assistant
  • Senior Science Officer, Review
  • Project Manager, Review
  • Vice President of Science
  • General Counsel
  • Grants Management Specialist
  • Administrative Assistant
  • Director of Finance
  • Business Services Officer
  • Senior Science Officer
Here is a link to the pay schedule at CIRM. Here is a link to a document dealing with the agency's compensation program as of today.

Official postings for the positions could come as early as late this month. They will appear on this CIRM web page.

CIRM currently has 33 employees. Proposition 14 contains a nominal cap of 70 but also permits the number to grow substantially if the employees are compensated through cash that is not part of the agency's official state bond funding. 

CIRM is currently based in Oakland, Ca. 

Friday, December 11, 2020

California Stem Cell Agency Set to Fund $182 Million in Research in Next Six Months

Click on the above to see a recording of today's online meeting of the CIRM Science Committee

California's newly rejuvenated stem cell program today kicked off its fresh spending plans with a $182 million effort that focuses heavily on awards that could lead more quickly to actual treatments.

The plan was approved by the Science Committee of the governing board of the California Institute for Regenerative Medicine (CIRM), as the $12 billion agency is formally known. CIRM was running out of money until voters this fall approved Proposition 14 and rescued the agency from financial oblivion. 

The $182 million plan for the first half of next year represents CIRM's first major dip into its new, $5.5 billion bucket that was created by narrow voter approval of Proposition 14. The full board is expected to approve the new research budget at its Dec. 21 meeting

The program allots $100 million for possibly 10 clinical awards in the next six months. Translational research will receive $60 million (11 awards). "Quest" research is allotted $22 million for 15 awards. Quest awards involve early stage, basic research while translational research involves attempts to move basic research into the clinical level. 

Clinical trials are the last hurdle to clear before a treatment can be approved by the federal government for widespread use. No CIRM-financed stem cell treatments have yet received that approval since the agency began its work 16 years ago. CIRM, however, has helped to fund 68 ongoing clinical trials. 

The Science Committee has 10 members, at least six of whom are linked to institutions or businesses that could apply for CIRM funding.  While members of the 35-member CIRM board can vote on the overall research budget and also "concept" plans for such things as Quest and clinical research, they are barred from voting on specific applications from institutions that they are connected to.  

The Science Committee also approved changes aimed at increasing diversity in CIRM-related research and requiring greater data sharing by scientists. The committee strengthened the staff-proposed diversity language by also proposing scoring applications on how they beef up diversity among researchers. Details on that are yet to be worked out and will be presented to the full board on Dec. 21. 

A call for more diversity among researchers was aired last month at a meeting of the only state entity charged with reviewing CIRM's financial affairs. 

The data-sharing requirement triggered some concern about whether it would be a disincentive to some researchers who feared losing control over their intellectual property.  However, CIRM CEO Maria Millan said the agency was treading carefully to take those concerns into consideration. 

Researchers will be able to apply for the awards shortly after Jan. 1 when detailed program announcements will be released by CIRM. 

Here are links to the changes approved for the Quest program, the translational program and the clinical programs. 

Tuesday, December 08, 2020

California Stem Cell Agency Beefs Up Budget with Plans to Hire 10 More Persons

The California stem cell agency this morning moved to boost its annual operations budget to $15.3 million, up from the $12.3 million spending plan approved last June. 

The increase came as a result of the passage of Proposition 14, which saved the agency from financial extinction and provides $5.5 billion in state bonds over the next decade or so. The amount brings to $12 billion the expected cost of the agency before it again runs out of cash. 

The 2020-21 budget originally stood at $12.3 million because it anticipated the possible phase-out of the agency, known officially as the California Institute for Regenerative Medicine (CIRM). 

The increases approved today by the CIRM directors' Finance Committee were aimed mainly at hiring additional staff. The agency currently has 33 employees and never has had more than 62. The budget provides for up to 10 new employees, directors were told. 

More are expected to be needed as the agency moves into the new, expanded role authorized by Proposition 14, which provides for more than 85 employees for CIRM.

Other increases were generated by the cost of a triennial, performance audit required by state law, which has run about $230,000, although the audit is barred from evaluating the agency's scientific performance. Legal and related expenses will be increasing by about $318,000. Currently, CIRM has one lawyer on staff with other legal services provided under an outside contract. The general counsel position is vacant. 

Cash for the new budget will come from the agency's existing funds. Proposition 14 funds will not be available until next year. 

(Here are links to today's documents prepared by Jennifer Lewis, acting finance director, dealing with the agency's operational budget: finance presentationfinance 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. 

8,588,15651.1%8,221,69248.9%


Monday, December 07, 2020

Ties, Politics and Stem Cells: The Becerra Nomination

The Californian who is slated to head the vast federal agency that includes the National Institutes of Health (NIH) and the Federal Drug Administration (FDA)  got his start in politics with the man who is now the vice chair of the California stem cell research program. 

Xavier Becerra
Photo: Lucy Nicholson, Reuters
California Attorney General Xavier Becerra was nominated this week to lead the Department of Health and Human Services after a long career as a congressman and leader of the Democratic Caucus in the House of Representatives.  

Becerra was reared in Sacramento by Mexican immigrants, went off to Stanford as an undergraduate and also received a law degree from the Palo Alto university in 1984. Later, he went to work for then State Sen. Art Torres, now vice chair of the stem cell agency, and in 1986 moved to Los Angeles to direct Torres' district office. Torres, former state Democratic party chairman, and Becerra continue to have close political ties, we understand.

Becerra was elected to the state legislature and Congress with the support of Torres. Becerra served from 1993 to 2017 in the House of Representatives, a period that included top leadership positions. He will have his hands full in Washington. Some Republicans are opposing his nomination because of his stand on abortion and his work on the Affordable Care Act. The Los Angeles Times editorial board labelled Becerra as President-elect Biden's Obamacare "fix-it guy." 

While Becerra's professional life has largely been in politics, he does have a spousal, medical tie. His wife, Carolina Reyes, is a physician, educated at Stanford with an M.D. from Harvard. She is a maternal-fetal medicine specialist, has taught at USC and has been active in a wide range of professional and community activities. Currently she is a member of the governing board of the California Health Care Foundation.

"Reyes is recognized nationwide for her career-long efforts to improve the care of women with high-risk pregnancies — especially those in medically underserved communities," the foundation says

The $12 billion state stem cell agency has been working with the NIH and FDA to expedite approval of stem cell therapies that the agency has helped to finance. The agency points to its sickle cell initiative with the NIH as an example of federal-state cooperation. 

Thursday, December 03, 2020

Save the Goose: California's Stem Cell Story and the 'Army of 900'

Is the stork bringing stem cell billions?



More post-election coverage is trickling out regarding the activities of the $12 billion California stem cell agency, including a lengthy and compelling piece in the Los Angeles Times, the state's largest circulation newspaper. 

The hitch is that the Times piece does not mention the stem cell agency until the 21st paragraph, a fact that carries more weight than the 40 words in the paragraph itself. 

The article in the Times, written by columnist Sandy Banks, was not really about CIRM per se. But it was a story that might not have been told without a $13 million check from CIRM. 

The piece dealt with sickle cell disease. Banks' entry point was a patient named Evie Junior, whose harrowing experiences are certain to resonate with nearly all the paper's readers. 

Banks wrote,
"As a child, (Junior) grew accustomed to frequent hospital stays. But the disease got progressively worse as he moved through his teens; the bone pain was so disabling, he often had to be sedated with heavy-duty opioids."
Banks continued,
"At one point, the bones in both his legs were so damaged by the disease, doctors thought he might not ever walk normally again. Junior battled back."
Banks wrote,
“'I want to be cured of this disease,' he said. 'And I wish the world was more understanding about the people who are struggling with it.'”
Junior is a patient in a UCLA clinical trial led by Donald Kohn, whose research has been supported by a total of $52 million from the stem cell agency -- a figure not noted in the story. 

The stem cell agency comes into the story ever so briefly at paragraph 21. "The trial is funded by the California Institute for Regenerative Medicine (CIRM), the stem cell agency created by voters in 2004 and infused with $5.5 billion in new research money by voters who narrowly approved Proposition 14 this fall," the Times reported.

That is the first and last mention of California's stem cell program in the Times' story. However, that is better treatment of CIRM than is found in most stories in the media over the last few years -- the ones that deal with accomplishments tied to the agency's cash. (See here and also here.) The articles rarely mention where the money comes from. It could be flown in by stork, for all the readers know. 

Why is this important? The answer has to do with CIRM's reliance on tenuous, ballot-box financing and the sustainability of the California stem cell program.  The situation should be of interest to a little known state entity, which is the only state panel that has a legal charge to review the stem cell program.  

The panel is the Citizens Financial Accountability and Oversight Committee (CFAOC). It was created by the same ballot initiative that established the stem cell agency 16 years ago. Last month, at the CFAOC's once-a-year meeting, its members urged the agency to make itself better known. 

Proposition 14 saved the agency from financial extinction. But the measure was a squeaker, and it set the stage for another life-or-death ballot initiative. The money from Proposition 14 runs out in about 11 years. No other source of funding is provided. If CIRM goes to the ballot again in less than a decade or so, it will need a strong base of support from California voters, 8.2 million of whom voted last month to cut off funding for CIRM.

Building a solid base takes years. It also requires something of a change involving the scientific community and science journalism, which is a big ask. The tradition in scientific journals regarding funding is to relegate mention of the sources of money to a tiny footnote as if it were not the lifeblood of research.

Science writers -- the few that now exist in the mainstream media -- follow that ancient and tired public tradition of ignoring what makes research happen. They focus on "exciting" results from the bench and clinic -- not the "filthy lucre" that pays scientists, their institutions, the post-docs who labor behind the microscopes, the equipment suppliers and keeps the lights on.

Recipient institutions write the news releases -- the starting point for most journalists -- without mentioning the many, many billions that taxpayers (state and federal) have provided. Even the stem cell agency itself does not mention dollar amounts in its blog items dealing with significant results from CIRM research. (For an example, see this item from the agency's blog on the UCLA/Kohn sickle cell trial, which CIRM is funding with $13.1 million. That figure is not directly revealed in the blog item.)

Like most state agencies, CIRM is ignored by the media with only occasional exceptions. Its activities are not well known. That is not likely to change over the next decade despite the best efforts of CIRM's tiny staff. The exception would be a major or even minor scandal or development of a major breakthrough that would resonate with the people of California.

The folks in the media have a vast array of topics to cover, all of which CIRM competes with for attention. The news industry is, in fact, overwhelmed by matters that need public scrutiny: schooling for children, jobs for parents, affordability for housing, vaccines for Covid-19, homelessness, climate change, wildfires and much, much more. Meanwhile, the industry is
 struggling with its own sustainability issues, laying off thousands of reporters, closing outlets and desperately searching for new business models.

Breaking through this wall of issues to generate favorable, regular coverage of the stem cell agency's good works is a herculean task. And so far, the reality is that CIRM's good works are quite minor in terms of how they affect the lives of the vast majority of the people in California. 

The CIRM team, from top to bottom, has provided 
a prodigious amount of positive information that can resonate with the public. Building positive relationships with voters, however, is a long-term task that requires commitments that go well beyond CIRM's stalwart staffers, who currently weigh in at only 33 for a multibillion dollar program. 

CIRM has major budget and legal limitations, courtesy of Proposition 14. Its outreach team is small, again an outgrowth of ballot initiatives. Nonetheless, CIRM has a potential army of more than 900 available plus more in the future, given the agency's expansive, new responsibilities authorized by Proposition 14. And that doesn't count the patient advocates or their allied organizations.

The army of 900 consists of the researchers and institutions that have received cash from CIRM -- all potential missionaries who can carry the CIRM message from Yreka in the north to Calexico in the south. 

The institutions could highlight CIRM funding in their news releases, instead of burying or omitting it. Researchers could reach out regularly to the various affected communities to help keep the cash flowing. Grantees could pony up $2,000 each and send it off to a new, broad-based nonprofit that might be called something like "Friends of CIRM."

But more immediately, the army of 900 could -- one by one -- resolve to make six new contacts in 2021 with the public or media to tell the CIRM story. Doing so would serve science and CIRM not to mention themselves.

The next statewide election best suited for approval of another bond measure is fast approaching. It is only eight years away. That is much less time than it takes to complete the preclinical work and clinical trials needed for a federally approved stem cell treatment, which is, ultimately, the only thing that voters really want. 

If the army of 900 needs an inspirational motto, it could be something like "Save The Goose."  You know, the one that lays the Golden Eggs. It is better than relying on the stork. 

Wednesday, November 25, 2020

Post Election Media on What's Next for $12 Billion California Stem Cell Program

Passage of Proposition 14 has generated a handful of articles recently dealing with the direction of the California stem cell agency over the next decade or so, including pieces carried by Bond Buyer and Calmatters, a respected online news service dealing with state government and politics.

Barbara Feder Ostrov wrote a Nov. 24 article for Calmatters, which quoted  Jonathan Thomas, chair of the California Institute for Regenerative Medicine (CIRM), as saying,
“California has always had a frontier mentality and a love for the cutting edge, and the work that CIRM has done has put it on the very forefront of regenerative medicine.”
Proposition 14 saved CIRM from financial extinction by requiring the state to borrow an additional $5.5 billion for the 16-year-old program, which was originally funded with $3 billion in state bonds in 2004. Total cost of the program is expected to hit about $12 billion before the money runs out again in 10 to 15 years.

Ostrov also quoted Paul Knoepfler, a UC Davis stem cell researcher and blogger, on new areas of research for CIRM that are authorized by Proposition 14. He said,
“Stem cells are interesting and important, but there are going to be a lot of new therapies in the next 10 years that are not stem-cell centric."
In the article, CIRM board member Ysabel Duron addressed the need for improvement of diversity in terms of developing therapies for underserved segments of the population. She said,
“We need to keep researchers’ feet to the fire. They need to show us a plan and we need to reward them.”
Ostrov quoted this writer on some of the issues facing CIRM, including the question of what happens when the latest $5.5 billion is exhausted:
“The sustainability issue is important and it’s hard to address.… The money doesn’t last forever.”
Bond Buyer's Keeley Webster's article noted that the agency will be rewriting its budget now that Proposition 14 has passed. The measure alters CIRM's budgeting rules, shifting some significant costs around. 

Webster quoted state Controller Betty Yee on the agency's $5 million Covid round from last spring. Yee said,
“The $5 million didn’t buy a lot, but it did help get information out to underserved communities. And it put a model out there of how CIRM has been able to accelerate research projects.”
In a piece by Andrew Sheeler, The Sacramento Bee quoted Robert Klein, a Palo real estate developer and sponsor of Proposition 14. Klein poured millions of dollars into the ballot campaign. He said, 
“We had a big obstacle because we had to communicate to voters not only the potential to change the nature of treatments ... but we also had to inform voters of how the state could afford this....It was a citizen’s initiative in the truest sense.”

Monday, November 23, 2020

California's Stem Cell Research Program: How $3 Billion is Growing to $12 Billion

California's 16-year-old stem cell research program is a prodigious enterprise that is helping to finance 68 clinical trials and that has funded hundreds of California scientists for their work in an embryonic field, so to speak. 

The scope and importance of the program and its cost, however, are not necessarily apparent to most Californians. The program is not high on the radar of most people and certainly not the subject of breakfast table conversations in the overwhelming majority of the state's households. 

Over the past 16 years, the California Stem Cell Report has regularly described the stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM), as a $3 billion effort. But the use of that number did not make it clear that the cost ran significantly higher. 

When CIRM was created through a ballot initiative in 2004, the state Legislative Analyst estimated it could cost taxpayers $6 billion because of the interest on the money that the state borrowed to finance it. The figure has turned out to be closer to $4 billion because of unusually low-interest rates over the last decade or so. 

Under Proposition 14, the agency will receive an additional $5.5 billion from state bonds to spend on research and other new programs. The state legislative analyst has estimated the total cost will run about $7.8 billion because of -- once again -- interest costs. 

The Proposition 14 funding brings the total estimated cost of CIRM to nearly $12 billion.  And that is the figure that the California Stem Cell Report will use going forward to describe the program, unless someone can convince this writer otherwise. 

Referring to CIRM as a $12 billion enterprise immediately tells the reader that it is a significant effort. The number helps to draw readers into stories about CIRM. It is also more accurate than using a smaller figure, which would tend to minimize the cost and mislead taxpayers. Describing CIRM only as a $8.5 billion ($3 billion plus $5.5 billion) agency tends to conceal its true cost to the people of California. (In retrospect, this website should have used the 2004, $6 billion figure to describe CIRM over the last 16 years.)

CIRM is a rare bird among state agencies for a number of reasons. In this case, we know that its funding will cease at some point. Nearly all state departments do not live with that sort of financial guillotine.  

The 17,000-word ballot initiative, crafted by Robert Klein, a Palo Alto real estate developer, limits CIRM's annual CIRM bond sales to $540 million. Based on the experience under the previous initiative -- Proposition 71 of 2004, which created CIRM -- the agency is not likely to hit the $540 million cap each year. That could extend CIRM's possible life for another 15 years or so unless it becomes unusually tight-fisted.

As for the $12 billion figure, this writer is open to arguments for using another number, but I will have to be convinced. I am prepared to air those arguments (their full text) on this website. So if a reader thinks another figure is more appropriate, please let me know the reasons why either by filing a comment using the comment function at the end of this item or by sending me an email at djensen@californiastemcellreport.com.

Friday, November 20, 2020

Praise and Advice Given in Review of California's Stem Cell Research Program

The California stem cell agency today received both kudos and advice from the small state panel that is charged by law with reviewing its financial practices and is the only such state entity with that unique task. 

The panel is the Citizens Financial Accountability and Oversight Committee (CFAOC), which was created in 2004 as part of the ballot initiative that also created the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. 

While it reviews the financial affairs of the agency, the CFAOC has no authority to require changes. CIRM's programs will cost state taxpayers an estimated $11.8 billion dollars before funds run out in 10 to 15 years. 

Betty Yee
Controller photo
State Controller Betty Yee is by law the chair of the CFAOC. It also has four other members, one of whom was sworn in just this morning. Yee and the others were liberal in their praise of the agency's work. In addition to the usual financial information, Maria Millan, CEO of the agency, presented the CIRM programs and their successes. 

Millan's presentation was greeted with praise by all the CFAOC members, including Yee. Towards the end of the meeting, Yee said that she and other members would like to be kept up-to-date regularly on CIRM matters since the CFAOC is required to meet only once a year. 

Yee said, "Numbers have lots of stories behind them. I think really to understand them fully, it is about exactly what we learned today."  She  said she hoped that part of the revision of CIRM's strategic plan next year will involve "how do we tell our story better."  Yee said she thought the agency was doing "great" but there was so much to be told. 

Catherine Sarkisian
UCLA photo

The new member of the CFAOC is Catherine Sarkisian, a UCLA physician who specializes in geriatric medicine, an area that Proposition 14 identified as a new target for CIRM.

Sarkisian raised a question about the need for diversity among recipients of  CIRM grants. CIRM officials pointed to existing training programs for high school and college students. Sarkisian said that those were important "pipelines" but that CIRM should consider creation of "on-ramps" to build up diversity among awardees. 

During the meeting, CIRM officials disclosed that the new strategic plan is expected to be approved next summer by the Independent Citizens Oversight Committee (ICOC), as the CIRM governing board is known. Work on it is already underway. Researchers and other members of the public can weigh in on what they would like to see funded over the next five years by emailing their comments to info@cirm.ca.gov.   

CIRM will be operating under a new, 17,000-word statute -- Proposition 14 -- that significantly expands the agency's scope and increases the ICOC size from 29 to 35. 

The new course of the agency is also likely to come up at a Dec. 21 meeting of the CIRM board. The public can address the board online or email comments. The agenda is legally required to be posted Dec. 11. It will contain instructions for online access to the meeting. 

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