Update on the Search for New Execs at the California Stem Cell Agency

California’s $3 billion stem agency no longer lists on the Internet job openings for a director of medical affairs and director of administration but reports that the positions remain vacant.

The new, top level posts were created in a reorganization of the enterprise, which has less than 60 employees, by its president Randy Mills, who took over last May. He made the move as part of his CIRM 2.0 effort.

In the initial postings last month, the agency said the positions would remain open until they were filled. Three other openings for directors in the areas of blood and cancer, neuro/ocular and organ systems continue to remain up on the CIRM Web site.

No explanation was offered for removal of the medical affairs and administration openings. Kevin McCormack, a spokesman for the agency, said the positions have not been filled.

Here are job posting documents as they originally appeared.

   Director of Administration, California Stem Cell Agency

   Director Medical Affairs, California Stem Cell Agency

Crossing the One-Million Mark: A Decade's Worth of Stem Cell Readership

Google message on page views from last Friday.

The California Stem Cell Report last week chalked up its one millionth page view, a large and fancy readership score that came after more than 10 years of writing about the Golden State’s $3 billion stem cell research program.

Google reported the seven-digit figure at 10:50 a.m. PST on Friday.  No bells rang, however, and no whistles sounded. The tumbler on “dashboard” of the blog just simply and silently clicked over from 999,999.

For those not familiar with Internet terms, a page view is recorded by Google each time a person opens his or her Internet browser on a particular page. It is an industry standard that it is used to help define readership, something akin to circulation numbers for newspaper.

The one-million figure is both large and small. It is tiny in comparison to most general news sites, which may gather millions of page views in a week. It is large in comparison to the potential audience. This writer estimates that no more than 3,000 or 4,000 persons worldwide are deeply interested in stem cells. Considerably fewer are deeply interested in the affairs of the California stem cell agency.

There is also the “so what” question that comes up when evaluating readership. Have any of the more than 4,000 items published since January 2005 had a significant impact? That is always hard to judge, but bumps in readership tend to indicate that certain themes are resonating.  The scope of the audience also indicates that many individuals find frequent value in what is carried here. 

Regular readers of the California Stem Cell Report range from the general public to the folks at the National Institutes of Health. Readers check in from Harvard, UC San Francisco, Stanford, UCLA, UC San Diego, France, Germany, Russia, the United Kingdom and many other locations. Occasionally, a member of the stem cell agency governing board will comment favorably and privately about the value of the blog. Journalists read it, using it as a springboard for their own stories.

The article with the highest views by far deals with the potential cost of stem cell therapies and discussed a report from Japan that contained the figure $512,000.  Earlier today, the item recorded 10,303 page views since it was published less than two years ago. Also today, the article ranked No. 6 out of 2.5 million results in a Google search using the term “stem cell therapy cost.” The piece seems to have attracted a great deal of interest from the public with many onetime hits, probably coming from people who are considering such a treatment.

The second most read item on the California Stem Cell Report is a 2009 item headlined, “Controller Calls for Online Posting of Financial Holdings of CIRM Officials.” It had 2,748 page views. Third is a “pay-for-eggs” item from 2013 that hit 2,487.  That piece involved a commentary in Forbes, which undoubtedly generated abnormally high traffic for the subject.

Our continuing intent has been to delve deeply into a single subject, the California stem cell agency. It is an important experiment in stem cell research funding. Its work has already had a major impact on the field in California. The agency’s success or failure could have major implications for the field and is worthy of considerable attention.

The California Stem Cell Report brings an independent focus to information about the agency. The Report is the only news site devoted exclusively to coverage of the agency and related matters, including analysis and commentary.  The blog provides on-the-scene coverage of the agency's most important public events, either via the Internet or from the sites of the sessions. The blog also explores in more depth California stem cell issues ignored by both the scientific press and the mainstream media. It provides information that can be nowhere else. 

The Internet is well-designed for such a relatively narrowly focused effort as opposed to the mainstream media, which must pursue mass audiences.  Blogs are especially useful in dealing with narrow subjects because of their relatively low production costs, timeliness and lack of space limitations. Newspapers and other mass media, on the other hand, have high costs and extraordinary space limitations as to do all print products. Timeliness can also be issue with some Web sites associated with print.

As for our costs, this blog is produced by one person, David Jensen (yours truly). He is a retired journalist who finances it personally and who has no financial ties to biotech academia or industry,
or the agency. Google does place ads on the site, which generate about $150 every six months or so based on the number of people who click on an ad.

But beginning today this blog is boosting its efforts to cover the costs of the California Stem Cell Report and adding a way to contribute directly to the effort. On this page, you can find a PayPal “donate” button in upper left hand corner. Donate today. It is a way to help keep independent, California stem cell news flowing vigorously. As the California stem cell agency noted last week, “Money matters.”

And thanks to all who are moved to contribute.

A California Stem Cell Plus: Cash Counts on Research Publications

“Money matters,” says the $3 billion California stem cell agency. And it is right.

The agency was commenting yesterday on a study published this week that indicated that the Golden State has “over-performed”in terms of publication of research findings as the result of the agency’s efforts.

The comment appeared on The Stem Cellar, the agency’s blog. Kevin McCormack, senior director of communications, wrote,

“The question the researchers posed was; have the states that fund stem cell research seen an increase in their share of scientific publications in the field? The answer, at least in California’s case, is absolutely yes.” 

The study by Aaron Levine of Georgia Tech said its findings “suggested” that the increase was due to 667 awards totaling $1.9 billion made by the stem cell agency over the last 10 years.

As Levine’s article noted, many other factors need to be examined to determine whether the agency has met the goals of the 2004 ballot campaign that created the stem cell research effort. But for now, the piece by Levine is a significant plus for the California Institute for Regenerative (CIRM), as the agency is formally known. And it comes from an independent source, one that is not financed by the agency, as some other studies have been.

The California Stem Cell Agency and "Over-Performance' -- Study Cites Hefty Publication Record

The trajectory of CIRM-funded research publications in two areas: The blue
line involves U.S. hESC research articles, green represents iPSC. The black
 and grey lines involve non-CIRM funded research from California in cancer
and RNAi. The vertical bars indicate the general date when each of the four
 states studied began their state-funded efforts. Levine chart.

A study by a Georgia Tech researcher today indicated that California state funding has “played an important role” in creating “over-performance” in the Golden State’s stem cell research efforts.

The article in Cell Stem Cell by Aaron Levine, an associate professor of at Georgia Tech’s School of Public Policy,  was titled "Assessing State Stem Cell Programs in the United States: How Has State Funding Affected Publication Trends?"

It dealt with publication of human embryonic (hESC) and induced pluripotent stem cell (iPSC) research from 2006 to 2013 from four states with stem cell programs. He and his students counted the frequency of articles that cited some funding from each of the state agencies involved.  

Levine wrote,

“In both California and Connecticut, state funding programs appear to have contributed to over-performance in the field.”

 He also said,

“Between 2010 and 2013, approximately 55 % of hESC-related articles published with at least one California author acknowledged state funding, suggesting that this funding program played an important role as California maintained and built upon its early leadership in the field.” 

Levine noted that other measures are important in assessing the impact of the state efforts, including New York and Maryland. In an email, he said,

“There are many possible measures of impact. These could include measures of research output (i.e. publications or patents), research quality (i.e. citations to publications or patents or measures of journal quality), scientist training, scientist recruitment, commercialization of research, etc.  The hope for this article is to provide one data point in an ongoing effort to better understand the impact of CIRM and other state stem cell funding programs.  It's always hard to know how a research program will unfold, but I certainly hope to conduct additional analyses of state funding efforts and contribute to our understanding of the impact these programs have had on the field.” 

Levine examined hESC articles because that area of research was critical to California voter approval of Proposition 71 in 2004. The ballot measure created the $3 billion California Institute for Regenerative Medicine (CIRM), the formal name of the stem cell agency. The initiative was mounted in response to the Bush Administration’s restrictions on hESC research.

The agency says that about 240 of its 667 awards involve human embryonic stem cells. A little more than 100 involve iPSC. CIRM has awarded $1.9 billion so far and is expected to run out of money in 2020 at the current pace.

Aaron Levine
Georgia Tech photo

Levine, who served on the Institute of Medicine panel that evaluated the California agency, also published a piece in 2010 that said through 2009 only 18 percent of California's dollars went for grants that were "clearly" not eligible for federal funding.

Here are some excerpts from Levine’s article today.

“After the California Institute for Regenerative Medicine (CIRM) issued its first grants in April 2006, the share of articles acknowledging California funding increased rapidly from approximately 3% in 2006 to 2007 to more than 20% in 2010 to 2011 and 2012 to 2013. 

“Overall, California state funding was acknowledged in nearly 19% of all hESC-related articles in our data set published between 2006 and 2013, compared with 1.8% of articles in a comparable set of RNAi-related research (t test, p < 0.01). 45% of the hESC-related articles published between 2006 and 2013 in our data set with at least one author from California acknowledged funding from the state.”
 “Our comparative analysis provides some of the first evidence that the distribution of stem-cell-related publications in the United States differs from the distribution of publications in fields not targeted by specific state funding policies, and our analysis of the funding sources acknowledged in many of these articles strongly suggests that state funding is responsible, in part, for these differences.

"The share of hESC-and iPSC-related publications produced in each of the four states examined depends on a variety of considerations, including the size, strengths, and interests of the scientific community and the specifics of the policy itself (i.e., its timing, its size, and its focus). In addition, it depends on the competitive environment within the United States, as over-performance in one state must be balanced by under-performance in others. In both California and Connecticut, state funding programs appear to have contributed to over-performance in the field. In California’s case, the state was already a strong performer in hESC related research before its state funding policy was adopted in 2004, and funding began flowing in 2006. This may reflect a generally supportive state environment or a first-mover advantage, as Geron Corporation, a key funder of early hESC research, is based in the state.

“Following passage of Proposition 71 in November 2004 and the creation of CIRM in the ensuing years, the state’s share of hESC-related research grew from approximately 25% in 2002 to 2003 to more than 40%, and the state maintained this position of strength in both hESC-and iPSC-related research from 2008 through the end of our data in 2013. Between 2010 and 2013, approximately 55% of hESC related articles published with at least one California author acknowledged state funding, suggesting that this funding program played an important role as California maintained and built upon its early leadership in the field." 

“In addition, publications are only one measure of the impact of state science funding programs, and examining other outcomes (e.g., patents awarded, clinical trials initiated, etc.) is an important topic for future investigation. Indeed, more thorough efforts to evaluate these state stem cell programs, ideally drawing on the initial goals of the programs and a wide range of relevant outcomes, would be an important step to help assess their impact on the field and the value of field specific state science funding programs more generally.”

The students listed on the article include Hillary Alberta, Albert Cheng, Emily L. Jackson and Matthew Pjecha.

Trounson Named as Advisor to California Cord Blood Firm

A California cord blood firm yesterday appointed Alan Trounson, the former president of the $3 billion California stem cell agency, to its newly formed scientific advisory board.

Cord Blood Registry of San Bruno, which says it is the largest “family bank” in the world, announced yesterday that Trounson is one of four members of its science board. It said the panel would help expand the scope of therapies that it is developing.

Alan Trounson, UCSD photo

Trounson last year left his post as president of the agency, formally known as the California Institute for Regenerative Medicine(CIRM). Seven days later, he joined the governing board of StemCells, Inc., a firm that had received $19.3 million in funding from CIRM. The move surprised the agency and generated a flap over revolving-door conflicts of interest.

Cord Blood Registry has not received any funding from the stem cell agency. In response to a question, Kevin McCormack, senior director for CIRM communications, said today the firm has “no connections whatsoever” with the agency.

It is not clear whether the firm plans to seek financing from CIRM in the future. Cord Blood announced last month that it is involved in an effort with a CIRM-funded, Cellular Dynamics International of Madison, Wisc., to reprogram cord blood and umbilical tissue into reprogrammed pluripotent cells.

Cellular Dynamics, founded by famed researcher Jamie Thomson, has a a facility in Novato, Ca., and was awarded more than $16 million from CIRM in 2013.

Heather Brown, vice president of scientific and medical affairs at Cord Blood (CBR), said in a press release,

"The (scientific board) will provide strategic guidance on current issues that will contribute greatly to CBR's continued progress in research and clinical development."

The company’s press release said,

“CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with leading research institutions to establish FDA-regulated clinical trials, requiring CBR processed cord blood….” 

The company has been in business since 1992 but yesterday’s announcement marked the formation of its first scientific advisory board. It is headquartered in the San Francisco Bay Area, but it stores its cord blood in an 80,000-square-foot facility in Arizona.

Last month, Geoffrey Crouse, CEO of the firm, told Karen Garloch of the Charlotte Observer that some private cord blood banks have“overstated the state of the research” involving cord blood.

He made the comment in connection with the formation of the national Cord Blood Association. He said that he expects the association to “bring the industry to a higher standard.”

According to an April 25, 2014, article in the Wall Street Journal, the blood cord banking business globally runs about $4 billion a year and has had its share of problems. The piece by Dionne Searcy and Christopher Stewart said,

“A Wall Street Journal analysis of government inspections and a review of lawsuits in the U.S. found problems in the loosely regulated cord-blood-banking business, including dirty storage conditions, leaky blood samples and firms going out of business. 

“Some private cord-blood banks are essentially marketing websites that lure customers, collect fees, then outsource the processing and storage of what is touted as biological life insurance for children.”

California's Stem Cell Agency Receives Two Applications in Kick-off of Fast-track Program

The California stem cell agency said today that its new, $50 million CIRM 2.0 program has attracted two applications from businesses for funding of clinical stage work.

The $3 billion agency refused to reveal any further information about the applications, which are part of a radical overhaul of its grant-making efforts.

The next applications in the round are due on Feb. 27.  End-of-the month, rolling deadlines for applications will continue through the middle of this year. The agency did not expect to see a rush of applicants last month because the new, rolling deadlines allow researchers greater flexibility on when they can seek financing.

The goal of the CIRM 2.0 program, which was devised by Randy Mills, president of the agency, is to fast-track funds to researchers and improve the quality of applications.

If the applications that were filed last Friday are approved, the companies should receive their cash before the beginning of May. That compares to an average of about 22 months under former agency President Alan Trounson.

The agency, formally known as the California Institute for Regenerative Medicine or CIRM, has yet to officially promulgate the rules for the grant rules as well as revised loan policies.

Both items were on tap for last week’s board meeting. They were put off until the March meeting while unspecified revisions are being made. A draft is available for the new grant administrative process.

The agency has declined to disclose the draft of the new loan regulations. The loans have been attractive to businesses in the past because they are forgivable if no commercial product results. It is not clear whether the agency intends to continue with that policy.

The California Stem Cell Report has asked the agency for the amount being sought on each application, the general nature of the research being proposed and which of the three CIRM 2.0 programs the applications address.

Correction

The Stem Cellar item on Saturday said that Anne Holden wrote the piece in question on the CIRM blog. It was actually written by Don Gibbons. The attribution to Holden was based on information on the CIRM blog item that incorrectly indicated she wrote it.

Ethics and Stem Cell Research Symposium Feb. 12: Gordie Howe to Right to Try

The public and other interested parties are invited to a UC Davis bioethics symposium Feb. 12 that is likely to deal with some high profile issues involving stem cell research.

Davis researcher Paul Knoepfler is helping to organize the event which he said will include stem cell tourism (think former hockey great Gordie Howe), Right to Try laws and much more. The panelists include Timothy Caulfield of the University of Alberta and Leigh Turner of the University of Minnesota.

A blogger by the name of HappyAnise wrote on the StemcellPromise blog,

“What it makes this so exciting is that they’re apparently going to be talking about some REAL, GENUINE ethical issues. To wit… what on earth are we going to do about all of those stem cell clinics popping up in various and assorted countries? You know, the ones with the weird, dubious, expensive treatments that the FDA would never approve in a gazillion years? And while we’re on the subject, when is the FDA going to do anything about regulating, say, $10,000 stem cell creams? And what about those “Right to Try” laws? They passed in four states in November, but what is the federal government going to do, if anything? What should they do?”

You can register with at 916-734-6181 or julie.bechtel@ucdmc.ucdavis.edu.

California's New, Fast-Track Stem Cell Program Draws Applications But Details Missing

California’s new and ambitious effort to speed stem cell therapies into widespread use drew “multiple” applications as it closed out its first round on Friday.

January is the first month of what the agency calls a radical move in its grant-making. Its initial foray is a $50 million clinical stage round that will be accepting applications for funding at the end of each month until the middle of the year.

The promise for those filing Friday is to put money in their hands in roughly four to five months. That compares to an average of 22 months under the agency’s previous grant rounds.

Randy Mills, the president of the agency, devised the fast-track effort and dubbed it CIRM 2.0. He told agency directors on Thursday that “multiple applications” had been received. (See here and here for more on CIRM 2.0.)

The California Stem Cell Report on Thursday and Friday asked for the specific number that Mills referred to. The agency, formally known as the California Institute for Regenerative Medicine(CIRM), however, did not provide a figure. 

The requests from the California Stem Cell Report also sought the following, all of which is public information: the total number of applications, the number from academic institutions, number from nonprofits, number from businesses, figures on the amount being sought on each application and the general nature of the research proposed.

Applications were due by 5 p.m. PST Friday. Presumably the agency will have the complete information assembled by early Monday and will provide it then. 

The Stem Cellar: California Stem Cell Agency on Gordie Howe and Human Tissue Donations

The Stem Cellar is the blog of the California stem cell agency, and it is consistently worthy of attention.

For the most part it deals with scientific issues, only occasionally touching on other matters. Of course, it does serve as a vehicle for selling the agency’s programs and informing readers about their benefits.

On Friday, the Stem Cellar dealt once again with the Gordie Howe stem cell treatment situation, which received a fair amount of attention over the holidays in December.

The case involved a San Diego firm and treatment of the famed hockey star in Tijuana. Most of the coverage in the mainstream media has largely accepted the claims that the treatment has been wildly successful.  

Don Gibbons, senior science and education officer, wrote on Friday, 

“Finally some healthy skepticism has arrived. Hockey legend Gordie Howe’s recovery from a pair of strokes just before the holidays was treated by the general media as a true Christmas miracle. The scientific press tried to layer the coverage with some questions of what we don’t know about his case but not the mainstream media. The one exception I saw was Brad Fikes in the San Diego Union Tribune who had to rely on a couple of scientists who were openly speaking out at the time. We wrote about their concerns then as well.

"Now two major outlets have raised questions in long pieces back-to-back yesterday and this morning. The Star in hockey-crazed Canada wrote the first piece and New York Magazine wrote today’s. Both raise serious questions about whether stem cells could have been the cause of Howe’s recovery and are valuable additions to the coverage."

Gibbons also wrote on another subject.

“A University of Michigan study suggests most folks don’t care how you use body tissue they donate for research if you ask them about research generically. But their attitudes change when you ask about specific research, with positive responses increasing for only one type of research: stem cell research.

“On the generic question, 69 percent said go for it, but when you mentioned the possibility of abortion research more than half said no and if told the cells might lead to commercial products 45 percent said nix. The team published their work in the Journal of the American Medical Association and HealthCanal picked up the university’s press release that quoted the lead researcher, Tom Tomlinson, on why paying attention to donor preference is so critical:

“'Biobanks are becoming more and more important to health research, so it’s important to understand these concerns and how transparent these facilities need to be in the research they support.'

“CIRM has begun building a bank of iPS-type stem cells made from tissue donated by people with one of 11 diseases. We went through a very detailed process to develop uniform informed consent forms to make sure the donors for our cell bank knew exactly how their cells could be used. Read more about the consent process here.” 

We should also note that The Stem Cellar is several notches above what the agency used to produce several years ago for a blog. It is informative, explanatory and accessible and improving.

(Editor's note: An earlier version attributed The Stem Cellar item to Anne Holden based on incorrect information on the CIRM blog that indicated that she had written the piece.) 

Winners Revealed for $30 Million in California Stem Cell Awards

The California stem cell agency today revealed the identities of the winners of $30 million in awards aimed at removing bottlenecks in stem cell research.

The 20 names were added to the news release posted yesterday afternoon on the agency’s Web site. All the recipients work at institutions that have representatives on the agency’s governing board. Those representatives are not allowed to vote on the applications from their institutions, but they set the rules for and the scope of the research that is being funded.

Today’s posting of the names is a departure from past practices. Previously the agency would release the names on the day when the agency board approved the grants. Yesterday, the agency moved quickly to publish the main body of the news release on the action, minus the names.

The list contains the number of each application, but without a link to the summary of reviewer comments on the proposals.  The reviewer comments cannot be found by searching on the application number on the CIRM Web site.

Instead, a search on application numbers on the CIRM Web site will turn up only an abstract and statement of public benefit prepared by the researcher.

The review summary, which contains more details and something of a critique, can only be found in a 162-page, omnibus document given to board members and posted on the meeting agenda. It encompasses all the application review summaries along with scores and staff comments.  That document, which is much more valuable to the public and the scientific community than the abstract and benefit statement, can be found here.  

(Editor's note: Following publication of this item, Kevin McCormack, senior director of communications for CIRM, sent the following concerning the statement that representatives of institutions receiving awards are not allowed to vote on applications from their institutions.

("That's not quite right. In fact, it's not right at all. Representatives of institutions are not allowed to vote on any applications at all, not just those that involve their own institutions. They can't vote on any funding or award.")

Evaluation of California's Stem Cell CEO Caps Today's Board Meeting

Directors of the California stem cell agency have gone into executive session to discuss evaluation of its new president, Randy Mills, who has been on the job since last May. No major additional action is expected from the board. The California Stem Cell Report does not expect to file additional items later today. But check the articles below for earlier board action today on $30 million in grants, sweeping proposed rules for stem cell grants and termination of the $131 million CIRM scholars program.

From Fraud Checks to Unspent Funds: California's Proposed Rules for Stem Cell Researchers

The California stem cell agency today put off adoption of  new rules for the way it will hand out its last $1 billion, speeding the money to researchers and attempting to improve the quality of research proposals.

The agency's staff deferred action on the proposal in order to spend more time refining it prior to action in March. The interim grant administration rules are designed to implement the CIRM 2.0 plan laid out by agency president Randy Mills, who has been on the job since last May. 

The rules will apply to the initial phase of CIRM 2.0, which closes the first of its new, rolling application rounds tomorrow, and is subject to adjustment. CIRM (the California Institute for Regenerative Medicine) expects to extend the new rules in one form or another to all upcoming award rounds.

The agency calls the fast-track effort a radical change from previous years. It is certain to have a major impact on many scientists.

The agency is funded by money that the state borrows (bonds). It has handed out roughly $2 billion and figures its remaining $1 billion will last until about 2020 when it will need additional financing.

The new regulations talk about such things as “real-time course corrections,” background fraud checks, early and stringent budget review, restrictions on appeals by rejected applicants and elimination of paper work.

Here are some excerpts from an agency memo identified as coming from the “legal team.”  It unfortunately does not contain a marked-up version showing language that has been deleted from the previous grant administration policy along with the new language.

Money

“Prior to CIRM 2.0, payments to grantees were made primarily based on the calendar – disbursements keyed off the start date of the project and were periodically made based on some given period of time following that date. Under the proposed GAP(grant administration policy), however, for clinical stage projects, CIRM will shift to a milestone-based payment schedule. Thus, this section of the GAP describes the importance of the milestones and how payments on the grant will only be made upon successful completion of the milestones.

“Additionally, in many circumstances the grantee will be allowed to keep unspent CIRM funds upon successful completion of the project, to be spent on any other project of the grantee’s that is consistent with advancing CIRM’s mission. This new process will incentivize grantees to advance the project in the most efficient and shortest time possible, fulfilling CIRM’s goal to accelerate such projects.”

Background checks

“The eligibility section has been drafted to reflect that applicants will undergo a background check to ensure no prior or pending records of fraud or misuse of funds.” 

Budgets

“This new review will examine the proposed budget to identify where proposed costs diverge from established market rates and where opportunities for budget tightening may be found. To incentivize efficient budgeting, where CIRM determines that a budget differs significantly from market rates, conforming adjustments will have to be made before the application will be brought forward for review by the GWG (the grant review group).” 

Fast-track

“Rather than require submission of extensive documentation regarding compliance with myriad protocols and processes – some CIRM-imposed and others external – the proposed process will rely on certification of compliance by the applicant, with the ability for CIRM to request supporting documentation if cause to do so arises.” 

Elimination of paper work

“Because most prior approval requests were routinely granted, and therefore added little value to the process, prior approval requests for rebudgeting and carryforward have been eliminated. We have also eliminated prior approval requests for no-cost extensions because our new CIRM awards will have project end dates that will be extended automatically as needed to complete the final Operational Milestone. CIRM intends to increase the latitude for grantees to pursue their research, while maintaining visibility into and approval of any changes to key components of clinical trials, manufacturing processes, or any other activities that meaningfully impact milestones or suspension events.” 

Clinical advisory panels (CAP)  for each award

“CAPs will provide real-time course correction and will focus more on acceleration opportunities than pure evaluation. CAPs will be tailored for the needs of each project and will consist of CIRM and external members, more nimbly sized than prior CDAP panels. CAPs will meet on a quarterly basis (instead of annually with CDAP) and examine all relevant information regarding project progression, possible roadblocks, and avenues for progression.” 

Appeals from rejected applicants

“Finally, in light of the rolling nature of the programs which will allow unsuccessful applicants in many instances to reapply with improvements to their applications, CIRM will limit the grounds for appeal of Scientific Review to those based on demonstrable conflicts of interest (as defined in the conflict of interest policy applicable to GWG members).”

Stem Cell Research Training Program Terminated by California

The California stem cell agency today scuttled its first grant program, a $131 million effort to train stem cell scholars at time when researchers were backing away from the field.

The 29-member governing board voted, 14-5, to end the program that began in 2005 as an effort to demonstrate that the research effort was still kicking while legal challenges threatened its existence. The vote came on a recommendation by the agency's staff.

Arlene Chiu, who is now with the City of Hope, was the chief scientific officer for the agency when the program was launched. She told agency directors said it was time to rethink the program, which was aimed at bringing more scientists into the field. She said,

"Its success has removed its necessity."

Chiu said stem cell research is currently attracting a growing wave of interest among younger scientists. The agency said some training would be included in future research programs.

(Editor's note: The chart on the training program was added to this item after it was initially posted.)

CIRM Press Release on $30 Million in Awards

The California stem cell agency has posted a news release on approval of $30 million for 20 projects to clear out roadblocks hampering the development of stem cell cures. A list of recipients will be forthcoming later, the agency said.

California Okays $30 Million in Awards to Help Remove Stem Cell Roadblocks

Directors of the California stem cell agency today approved $30 million to help eliminate bottlenecks in turning stem cell research into cures.

The action gave the go-ahead to awards that were backed by either its blue-ribbon reviewers from outside of California or the agency’s own staff, plus three additional proposals moved forward by the board.  The agency has already spent $52 million to develop stem cell research tools. Today's round was originally budgeted for $35 million.

After a brief discussion, the 29-member board approved, 9-2, an award to UC Davis researchers who had appealed rejection of a $1.8 million proposal by the staff of the California Institute for Regenerative Medicine (CIRM), as the $3 billion agency is formally known.

The agency did not immediately release the names of the winners. It keeps the names of all applicants secret until after the board ratifies the actions of its reviewers, who make the de facto award decisions for the agency behind closed doors.  The agency is expected to issue a press release on the awards later today. (Here is the link to the press release. It does not include a list of recipients.)

The board did not vote on two applications on which appeals were filed involving material misstatement of facts. Those were deferred  until the March board meeting. The final four numbers of those applications are 7836 and 7678.

Here is a link to the document on this "tools and technology" round submitted to the board by its staff. Summaries of the reviews can be found with the document along with the scores on the winners.

Discussion Underway in $35 Million in California Stem Cell Grant Round

Directors of the California stem cell agency have begun discussion of awards in a $35 million round to remove bottlenecks in stem cell research. Here is a CIRM list of board members that have conflicts on specific applications. Those board members are not allowed to discuss those applications or vote on them.

  Voting Conflict List CIRM Board Meeting 1-29-15 by DavidJensen

California Stem Cell Directors Open Meeting Today in California

Directors of the California stem cell agency opened their meeting today in Burlingame, Ca., at 9 a.m. PST with introduction of new board members.

Former Top Exec at Stem Cell Agency Appointed President of Huntington Medical

The former chief scientific officer of the California stem cell agency, Marie Csete, yesterday was named the president of the $53 million Huntington Medical Research Institutes in Pasadena, Ca.

Marie Csete, Huntington photo

Csete left the stem cell agency in 2009, after serving for a little more than a year. Her departure involved tension between her and former agency President Alan Trounson.  She told the journal Nature,

"When it became clear to me that my considered clinical advice was not respected, I concluded that it made no sense for me to stay at CIRM.”

Csete was the last person to hold the position of chief scientific officer at the agency. Trounson left the agency in July last year.

Huntington reported assets of $53 million in late 2013 and funds a wide variety of research. 

California Stem Cell Appeal: $1.8 Million Needed for Removing Bone Replacement Bottleneck

A UC Davis researcher is making a strong pitch to the California stem cell agency to finance a $1.8 million effort to “resolve bottlenecks in engineering replacement bone and cartilage.”

J. Kent Leach, UC Davis photo

J. Kent Leach, an associate professor in the departments of biomedical engineering and orthopedic surgery, said his proposal addresses “a major hurdle in regenerative medicine of the musculoskeletal system (that) impairs the inherent personalized medicine component of stem cell-based methods.”

In a letter to the agency’s board for its meeting tomorrow, Leach said the research team involved is “arguably the most qualified team in the nation to conduct these studies.” 

Other scientists participating are Laura Marcu and Kyriacos Athanasiou.

Kyriacos Athanasiou
UC Davis photo

Reviewers for the $3 billion agency, who make the de facto decisions on awards, scored the application at 72 and did not approve it for funding. The agency’s staff also nixed the proposal, declaring,

“There is another application recommended for funding in Tier 1 that proposes to optimize and apply the same imaging technology platform to a different test system. In addition, the scientific leadership of the two applications is the same.”

Leach said,

“The co-PI (Dr. Marcu) of this proposal is also PI (principal investigator) on RT3-07879, which is focused on assessing stem cell repopulation and remodeling of engineered vascular tissue constructs. 

Laura Marcu, UC Davis photo

"However, the use of this technology for monitoring the maturation of engineered bone and cartilage, tissues composed of dense matrix reflective of the differentiation of contributing stem cell populations, is substantially different from cardiovascular applications. Of course, both applications involve instrumentation based on optical spectroscopy and ultrasound principles, but the implementation and subsequent commercial hurdles for this technology is very different.”

 (For the summary of reviewer and staff comments, see application RT3-07981 in this document.)

Leach noted that another competing application in the round received an identical 72 score and was approved by the agency’s staff.

The grant round was budgeted for as much as $35 million. Reviewers and CIRM staff recommended approval of awards totaling $29.2 million.

Scientists making appeals directly to the board have not been successful in the last 12 months or so. The board has been more reticent about overturning reviewer and staff recommendations since it changed review and appeal procedures in 2013.

Follow Complete Coverage of Tomorrow's California Stem Cell Meeting

Keep track of all the “thrills and chills” at tomorrow’s meeting of the governing board of the $3 billion California stem cell agency with gavel-to-gavel coverage from the California Stem Cell Report.

This blog will monitor the session via the Internet from our perch in Banderas Bay in Mexico and file stories as warranted. On tap is as much as $35 million in awards. Reviewers and agency staff have approved only $29 million. But three UC Davis researchers are seeking another $1.8 million.  

Also up for action are major changes in the administration of grants – all part of the CIRM 2.0 effort designed to fast-track cash and beef up the quality of applications.

The session, scheduled for eight hours, can also be heard via a listen-only audiocast and Webcast for the slides being used.  Teleconference locations where the public can attend and comment are also available in Sacramento, Irvine and two in La Jolla.  Specific locations and directions for the Internet access are available on the agenda.  

The meeting begins at 9 a.m. PST in Burlingame.

Bump on CIRM 2.0 Speedway: California's Missing Stem Cell Loan Rules

When the applications come in this Friday for the California stem cell agency’s new, $50 million stem cell research round, business applicants will not be seeing a substantial portion of key financial rules for the awards.  

Missing will be the terms of loans that the agency expects to offer to for-profit enterprises. Loans -- rather than grants -- have been the favored method of businesses for receiving awards. The reason is that the agency’s loans have been forgivable if the research does not generate an appropriate amount of cash for the company. Grants, on the other hand, carry requirements for royalty payments. (None have been generated.)

Under the terms of the fast-track, CIRM 2.0 applications, businesses will have the choice of grants or loans. New grant terms are expected to be approved at Thursday’s meeting of the governing board of the $3 billion agency, one day before the deadline for applications for the first round of CIRM 2.0.

Action on new loan rules was originally scheduled for this week but postponed a few days ago after the agenda was posted Jan. 17. The specific reasons are not entirely clear.  The California Stem Cell Report yesterday asked about the delay and for a copy of the latest loan proposal. Kevin McCormack, senior director for communications, replied, 

“We are in the process of revising the (loan policy) and nAeeded additional time to ensure alignment with CIRM 2.0 and the other policy changes so we postponed the meeting.  It will be rescheduled before the March board meeting.
 “And as we are still working on the loan policy it would be premature to share that with you right now, it's still a work in progress.”  

Given that businesses have amounted to a tiny percentage of awards in the past, the delay in the loan rules question may not be significant. But this round is aimed at clinical stage projects, which are more likely to involve businesses and could generate more applications from the private sector.

Some time is available to adopt new rules before CIRM board action on the awards, possibly during an April 23 telephonic meeting. But one of the main points of CIRM 2.0 is to put cash in the hands of recipients significantly faster than in the past. This is especially important for stem cell companies, which are always pretty much cash starved.

Delays in any portion of the aggressive timetable for CIRM 2.0 could mean delays in handing out money.

It is not surprising that some difficulties have arisen in the new award procedures. Randy Mills, CEO of the stem cell agency, last week told an Internet audience of about 200 there would be “some bumps.” He said,

“This is going to be one wild ride.”  

To help smooth it out for both the agency and applicants, it would behoove the agency to post the proposed loan terms in a timely fashion. That means that they should be available to the public when a meeting agenda involving the rules – be it for a subcommittee or full board meeting -- is posted on the CIRM Web site. That is normally 10 calendar days ahead of the session.  The agency, which is costing taxpayers $6 billion including interest, doesn’t need any more mysteries.

$131 Million and 887 Papers: Demise of California's First Stem Cell Grant Program

The $3 billion California stem cell agency on Thursday is expected to put to rest its oldest grant program – an effort that was begun with bravado in 2005 but minus the cash to back it.

It was a matter -- at the time -- of showing the Golden State’s stem cell flag despite legal challenges that had stalled the progress of the agency.  The grants were the agency’s first and came on a late summer day in Sacramento during a governing board meeting marked by confusion and frustration.

David Baltimore
PasadenaNow photo

Board members complained they did not have enough information to make good judgments on the awards. 

Nobel Prize winner David Baltimore, a board member and president of Caltech, objected to what he considered loose standards in evaluating the applications for millions of dollars.

At one point, a crusty reporter from The Associated Press, Paul Elias, jumped up and demanded to know exactly what was going on.

The headline on the story the next day in the California Stem Cell Report said, 

“CIRM Hands Out $39 Million (sort of)….”

The awards created a training program for stem cell scientists. It was aimed at attracting more researchers into a field that was atrophying because of the Bush administration’s restrictions on stem cell research funding. 

Without adequate financial resources, the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, appealed to the recipient institutions to advance the funds with the expectation they would be reimbursed later.

Zach Hall, who was appointed president of the agency the same day, called the awards “historic.” Robert Klein, the chairman of the CIRM board, said he was thrilled by the program.

One of the major goals of the board action was to show that the agency and that its tiny staff (something less than 20) was still kicking despite the legal dispute that blocked issuance of the bonds that provide funding for the agency. 

In that regard, CIRM was more than successful.  The meeting was well-covered by major newspapers in the state, a far cry from the situation today. The message in the stories was largely favorable. The California Stem Cell Report wrote on Sept.11, 2005,

“Subordinated was the reality that the agency does not yet have the money. Even more deeply subordinated were complaints about the grant process from critics.”

The initial awards ultimately grew into a nine-year, $131 million effort. In a Jan. 20 memo to the CIRM board, the agency’s current president, Randy Mills, said,

“The programs have trained 859 CIRM Scholars. These trainees have worked in 436 different laboratories on a broad range of research projects, with the majority focused on basic research. CIRM Scholars have been authors on 887 scientific publications.”

The average cost for each “scholar” was about $152,000, Mills reported. The California Stem Cell Report calculated an average expense of about $148,000 for each scientific article, although such articles usually have more than one author. Mills said 34 percent of the recipients were graduate students, 48 percent post-doctoral and 18 percent clinical fellows.

Not noted by Mills was the fact that nearly all the awards went to institutions linked to members of the agency’s governing board. Virtually no other institutions existed, however, in California that could provide the training.

In December 2013, the board asked the agency staff to prepare a new version of the training program, a task that was not completed before the board hired Mills last spring.

In his memo last week, Mills said that “the CIRM team determined that a new training grant program is no longer an optimal method of supporting the education and training of stem cell scientists.” He continued,

“CIRM believes that supporting the training of new stem cell scientists is best accomplished by bolstering funding for our research grants programs, particularly the earlier discovery and translational phases where each program can be individually evaluated for its merit and contribution to CIRM’s mission.”

Mills said he will present concept plans for new discovery and translation rounds, including training within them, during the next six months. And he asked the board to approve his recommendation to drop the plans continue the old, once-hailed training program.

A California Stem Cell Mystery is Solved

The California stem cell agency today cleared up one of the mysteries involving next Thursday’s meeting of its governing board and likely action on a training program.

The agency last Saturday posted the agenda for the meeting that included a cryptic description that appeared to involve the abolition of one of its several training program. The agency did not respond to a query last Monday about exactly what was meant by the agenda item, making it nearly impossible for affected parties to respond in an appropriate and timely fashion.

Following the posting yesterday on this blog of an item describing the situation -- "The California Stem Cell Agency and Its Unnecessary Mysteries" -- the agency added a memo early today from CIRM President Randy Mills to the Thursday agenda. The memo explained that what was involved was the CIRM Scholars Program.  

Look for an item on this Web site early Monday on the expected end to the program.

The California Stem Cell Agency and Its Unnecessary Mysteries

For the second month in a row, the California stem cell agency, which sits on top of $3 billion in taxpayer cash, is playing a mystery game with the public.

Coming up next Thursday is a meeting of the 29-member board of the agency. These sessions are the most important public events involving the agency, which operates outside of normal state oversight. They deserve full transparency.

Without it, affected parties -- not to mention the people who pay the $6 billion total bill (including interest) for the stem cell research – do not have a genuine opportunity to comment and make suggestions about matters that involve their livelihoods and organizations.   

The latest problem primarily involves a cryptic agenda item for next week's board meeting that says only “consideration of the CIRM team’s determination not to present concept proposal for training program at this time.”

The agenda containing the item was posted last Saturday on the agency's Web site. The agency has not posted anything further on the matter and has not responded to a query five days ago seeking more information.

Training issues have been a subject of considerable concern and interest in the stem cell community, both at the state college level, which has received little of the agency’s cash, and universities and research institutions.

Backed by 11 top researchers, Jeanne Loring, head of the stem cell program at Scripps, has said the “Bridges” shared laboratory and training program has “provided the infrastructure upon which California’s reputation as the center of the stem cell universe was built.” (See also here.) 

Susan Baxter, executive director of the California State University’s system-wide program for biotechnology, said,

“Despite the Great Recession, Bridges graduates have succeeded in landing jobs and gaining admittance to graduate and medical schools at much higher rates than peer groups.” 

Does the training agenda item refer to the concerns of Baxter, Loring and the others? It could be a reference to the agency's high school training effort or something else entirely. It is totally unclear and unnecessarily so.

If the agency is fulfill its promise of maximum transparency, it should post ample background material on matters to be discussed when it posts the agenda 10 calendar days ahead of upcoming meetings. In the absence of that, however, it would have taken only five minutes or less to write a line specifying which training programs are up for consideration.

  

In addition to the mystery about the training programs, not to be found is information about proposed changes in the agency’s loan program. Those are scheduled to be approved next Thursday, only three business days from today. The changes likely will have a significant impact on businesses.  A board subcommittee was scheduled to consider them on Monday, but that meeting has been cancelled for unknown reasons. The agency has not responded to a query on when the session will be rescheduled, but presumably it will happen before the board meeting on Thursday.

Last month, the agency also created a similar mystery. It involved what turned out to be a $50 million program that deserved more timely attention from affected parties and the public.

In years past, the agency was infamous for failing to post material for its meetings in a timely fashion. Even board members sometimes complained about not having information. Sometimes meetings were postponed.

Since Jonathan Thomas became chairman in 2011, the situation has improved.  Randy Mills, the new president of the agency, is stressing "clarity" in what the agency does. However, the mysteries of the past two months do not auger well. The agency can and should do better. 

Webinar Now Available on Fast-Track Plan to Hand Out $1 Billion in California Stem Cell Cash

The ins-and-outs of CIRM 2.0 – at least some of them – are explained by the CEO of the California stem cell agency, Randy Mills, in a Webinar now available on the agency’s Web site.

The Webinar includes presentation slides and a Q&A. About 200 persons logged in for the session earlier this week on the new, fast-track effort to unload the agency’s next $1 billion. Kevin McCormack, senior director for communications, said after the Webinar,

"Of the 234 people who registered and, at some point tuned in today (Jan. 21), 108 were industry. Over the course of the 50 minute webinar some tuned in and dropped out so there was a rolling audience with 200 being the most tuned in at any one time."

If you are one of those who would like some cash from CIRM, this is must viewing. The 51-minute session can also be downloaded for later consumption.

Faster Cash but Tougher Competition for California Stem Cell Researchers

A slide from today's Webinar on CIRM 2.0

Randy Mills, who has led California’s $3 billion stem cell agency just since last May, today told a cyberspace audience that his agency will finance only the “absolute best” proposals under his new “2.0” version of the research effort.

Mills addressed about 200 persons who logged into a Webinar to learn more about the radical changes that began this month at the California Institute of Regenerative Medicine (CIRM), as the agency is formally known. Mills has dubbed the new direction CIRM 2.0.  And he said,

“CIRM 2.0 is going to be highly, highly competitive.”

It was a theme that the CIRM CEO came back to several times. He advised listeners that the competition will be tougher than in the past and that the agency will be more discerning.

CIRM 2.0 is aimed at both improving the quality of applications and at speeding money into the hands of researchers, cutting the time from application to funding from an average of 22 months to four months.   Mills intends to extend the new process to basic research and translational research later this year. 

Mills, the former CEO of Osiris Therapeutics in Maryland, said,

“We’re in the time business at CIRM.”

Mills said he expects the quality of applications to improve as the agency becomes more engaged in working with researchers to build proposals that will meet the agency’s needs.  CIRM will additionally become a partner with successful applicants and provide outside, expert help to overcome such things as logjams involving possibly the FDA or manufacturing problems, Mills said.

One of the major changes in CIRM 2.0 involves timing of grant rounds. Instead of rounds a year or more apart, Mills said,

“The application window is always open.”

The agency kicked off the new program this month with clinical stage programs. The deadline for filing applications is a week from this Friday(Jan. 30). No applications have been filed as of today.  No worries, Mills basically said. Applications will be accepted again next month with a deadline of Feb. 28 and every month thereafter with the deadline falling on the last business day of each month.

The agency has strict legal requirements to limit its spending to California operations. But in a Q&A session during the Webinar, Mills made it clear that a foreign-based company was eligible to seek funding for research activities that were being conducted with the Golden State.

In a brief telephone interview later, Mills said today's session was part of a "massive" effort on the part of the agency to spread the word about research funding opportunities involving CIRM.  He said he has been surprised about the lack of awareness -- outside of a relatively small circle in California -- of the availability of CIRM cash for biotech enterprises that traditionally have been struggling for funding.  

During the Webinar, Mills also acknowledged that CIRM 2.0 is new and is likely to encounter “some bumps” that he said the agency will work to solve. Nonetheless he told the researchers,

“This is going to be one wild ride.”

Mills’ Webinar on CIRM 2.0 is expected to be posted on the CIRM Web site either later today or tomorrow.

A Show-and-Tell Tomorrow on Handing Out California's Next $1 Billion for Stem Cell Research

Want to know more – from the horse’s mouth, so to speak -- about how California’s stem cell agency plans to give away its next $1 billion?

The public and researchers have a chance to hear directly tomorrow, via the Internet, from the agency concerning its plans for CIRM 2.0, the name of its new fast-track plan for handing out cash.

Registration is required, however, for the Webinar, which is scheduled for 12 p.m. PST.  CIRM says,

“Questions may be submitted in advance of the Webinar via email to cschaffer@cirm.ca.gov or via Webex registration.  During the webinar questions may be submitted via the Webex Q&A functionality.”

CIRM 2.0 was initiated by CIRM President Randy Mills as part of his efforts after he was appointed last spring. Mills will be personally presenting the proposal for the Webinar.

The agency says the plan is intended to put money in the hands of researchers with greater alacrity and improve the quality of grant applications. The agency describes the changes in the award process as radical.  Read more about it here, here and here. 

California to Pump $35 Million into Removing Stem Cell Therapy Roadblocks

California is set to give away as much as $35 million later this month to create tools and technology to help researchers develop the stem cell therapies that were promised to voters 11 years ago.

The idea behind the awards is to eliminate bottlenecks that block commercialization of research. California’s $3 billion stem cell program was created by voters late in 2004 with the expectation that it would quickly lead to stem cell cures.  It has spent about $1.9 billion so far but no therapies have reached the marketplace.

The latest, $35 million round is budgeted for as many as 20 awards of up to $1.2 million each to be distributed over a period as long as three years.  The $1.2 million is for "direct" research costs. CIRM would also pay for "indirect" costs that raise the total substantially.

Applications were sought last year from both academics and businesses with possible collaboration involving out-of-state partners, including China, Australia, Germany and Brazil.  Non-California enterprises would not receive funding from the state agency.

Action on the applications is part of the agenda for the Jan. 29 meeting of the 29-member governing board of the California Institute for Regenerative Medicine (CIRM), the formal name of the stem cell agency.  

The round is not part of the new fast-track program, CIRM 2.0, initiated by CIRM President Randy Mills. The “tools” effort contains different timetables, among other things. The work must begin within six months of approval of the awards, considerably longer than the 45 days specified under CIRM 2.0, which began just this month.  The old process also contained a pre-application review that has been eliminated.

The board is additionally expected to approve new rules for CIRM 2.0 awards, including loans to businesses.  Given that the deadline for applying for the first round of CIRM 2.0 is Jan. 31, potential applicants would be well-served to scrutinize the proposed new regulations. Interested parties can make comments or suggestions in advance of the board meeting and the related sessions of the board’s Science Subcommittee on Tuesday and the Intellectual Property (IP) Subcommittee on Jan. 26.  

The grant rules can be found on the Science panel agenda. The new loan rules have not yet been posted on the IP agenda. Comments can be sent by email to mbonneville@cirm.ca.gov or made at one of the public meeting sites. 

Public teleconference sites for the Science Subcommittee session Tuesday include San Francisco, Oakland, Irvine, Duarte, La Jolla and Sacramento. Addresses are on the agenda.  The only public site listed currently for the IP subcommittee is San Francisco.

The Jan. 29 full board meeting will be held in Burlingame but remote teleconference locations are also available where the public can participate. They currently include locations in Irvine and La Jolla, but that could change prior to the meeting.  Addresses are available on the agenda.