Text of Tobacco Tax Initiative to be Posted on this Web Site

The text of the proposed tobacco tax initiative that would fund the California stem cell agency has vanished from its location last week on the attorney general's Web site. We are attempting to query the attorney general's office about the matter. We will also post the full text on this Web site shortly. 

Tobacco Taxes and Stem Cells: Backers Still Not Talking, Questions Raised

Backers of a proposal that could rescue the $3 billion California stem cell agency from financial oblivion remained mum today as questions arose about the viability of the possible ballot measure.

The plan would raise roughly $700 million annually by increasing tobacco taxes, channeling about $200 million to the stem cell agency through a ballot initiative that would have to be approved California voters. The stem cell agency is scheduled to run out of cash for new awards in 2017 and is casting about for new sources of funding.

However, CIRM, as the agency is known, was largely caught by surprise last week by the release of the details of the proposal, which was filed by prominent Orange County attorney Frank Barbaro, former chairman of the county's Democratic Party.

Barbaro has not responded to email requests for more information about the backers of the plan and their financial commitment to an electoral campaign. Backers of a similar proposal that was narrowly defeated in 2012, Prop. 29, said they knew nothing about the effort.

The latest measure could go on the November ballot this year or the general election ballot in 2016 if it qualifies. The timeline for November is daunting. Responding to a query from the California Stem Cell Report, Sacramento political consultant Jeff Raimundo said in an email,

“Sounds like most people didn’t know this was coming. An Orange County attorney filing an initiative with no known backers?  Hmmm…formula for failure? 

“If stem cell agency folks didn’t know about it (and there’s no real reason to believe they did) and the cancer-fighting community had no knowledge, it’s hard to figure out how proponents are going to muster support from voters who only two years ago rejected a similar proposal from a more transparent and credible group. Prop. 29 barely failed, but it had a big push from advocacy organizations. 

“Too many questions right now to get a good handle on how effective such a campaign might be  -- who the REAL sponsors are, who would put up the money for the campaign, whether the OC attorney is a shill for someone else, whether those who back CIRM and its research role can be persuaded to back a new proposition. Many more initiative proposals are filed than are ever circulated. And many more are circulated than ever actually make the ballot in Californa. They’ve got a long way to go and not a lot of time to get there.”

The agency said last week that it has not endorsed the plan. Directors have not yet had a chance to consider it during a public meeting.

But CIRM Director Francisco Prieto, a Sacramento physician, told the California Stem Cell Report,

“I wasn’t aware of the tie-in to CIRM funding before (Friday). I don’t think they asked us first, but I’d be happy to see it pass, of course. I’m in favor of so-called 'sin taxes' – including those I pay when I support California’s wine industry. Raising the price of tobacco is one of the single most effective things that we can do to reduce smoking rates, especially among young people who are the most price sensitive. As the guy who has to sign the death certificates, I’m in favor of anything we can do to reduce smoking.”

Another CIRM director who responded to our queries, Jeff Sheehy, a communications manager at UC San Francisco, said that conceptually the proposal could make sense.

 "It's a better source of funds.  However, it does create a well-funded opposition campaign.  Still trying to  figure out if this is a good thing or not," Sheehy said.

Other board members as well said they had no advance knowledge of details of the measure.

Robert Klein, the former chairman of the agency, also responded, saying that that he was not involved in the proposal. He said he questioned the structure and funding approach but declined to elaborate.

Earlier last month we asked Klein about talk in the California stem cell community that he was involved in another bond measure effort for CIRM. Bonds are the current source of funding for the agency.

A spokeswoman for Klein replied,

“There is no campaign. We have done a single one scientific briefing on the progress of Proposition 71(the measure that created CIRM in 2004). It is strictly informational and does not constitute a campaign. We will decide in late 2015 what the next steps will be based on the scientific research at that time.”

Our take: In terms of the financial structure, Barbaro's tobacco tax proposal has at least one downside for CIRM. If the measure is successful in its goal of reducing smoking, the amount of money it raises from tobacco consumption will decrease. That, of course, would mean a dwindling amount of cash for the agency.

Launching a campaign for next fall's ballot would require a prodigious effort at this late stage even if some of the millions needed are already nailed down. The groups that backed the measure in 2012 are not likely to jump aboard immediately given their surprise at the latest proposal. They also may have other priorities as well at this point. Organizationally, work would have to begin now even though there is the possibility that not enough signatures could be gathered by the end of May to qualify for the fall ballot.

Opposition from the tobacco industry would be fierce. It raised $47 million in 2012 for its campaign compared to $12.3 million from the backers of the tobacco tax.

Nine Years on the California Stem Trail: A Look Behind the Curtain

Back in November 2004, the re-election of President George Bush dominated the news throughout the nation. But out in California, there was talk of a new gold rush, triggered by a measure buried deep on the ballot that month.

The latter-day argonauts were not expected, however, to be scratching out nuggets. Instead they would be fiddling with stem cells, particularly human embryonic stem cells. It all looked like big bucks for the biotech industry -- $3 billion from a new state agency.

That was when the idea for this blog began to percolate. A few weeks later -- nine years ago this month  -- the first item appeared on the California Stem Cell Report. It now seems a likely occasion to reflect on the scope and purpose of what appears here and to discuss readership and other matters.

David Jensen
Editor California Stem Cell Report

First, to answer an oft-heard question: Why am I am writing about this particular agency, formally known as the California Institute for Regenerative Medicine(CIRM)? The simple answer is that it is interesting, at least to some, and important. The agency – created by Proposition 71 of 2004 – is an exceptional and unprecedented state effort. Nothing like it has existed in
California history. It operates with unusual autonomy. The governor and the legislature cannot touch its funding or direct its research. It survives on $3 billion borrowed by the state, which will roughly double the cost of the research to $6 billion or so because of the interest on the borrowing. It also marks another first with its use of California state debt to pay for scientific research.

At one point, CIRM was the world's largest single source of funding for human embryonic stem cell research. The agency has lured top researchers from other states and countries. And it represents a unique mash-up of government, politics, big business, big science, big academia, morality, ethics, life and death and even sex.

Since 2005, the California Stem Cell Report has been read by researchers, policy makers and other interested parties around the world. They log in from Singapore and Great Britain, Canada and Korea as well as institutions ranging from the NIH and Harvard to Stanford, UC San Francisco, Scripps and Sanford Burnham and more.

I estimate that only a few thousand persons around the world are deeply interested on a regular basis in stem cell research, making the potential audience for this Web site rather small. But Google reports that as of today 729,841 page views have been registered during the life of the blog. (I have posted 3,608 items.) Last month, which was slow because of the holiday, the California Stem Cell Report chalked up 16,878 page views, which are the basic Internet standard for measuring readership.

The items that seem to grab the most attention involve individuals as opposed to the nuts and bolts of either science or policy. When CIRM directors considered election of a new chairman in 2011, readership jumped. Machinations involving selection of new presidents at the agency draw readers. Of course, reports about dubious activities or problems also are of significant interest. The lure of stories about people nonetheless is not much different than seen in the mainstream media, based on my 35 or so years in the news business.

Another matter that has drawn an extraordinary amount of interest involves money: specifically the expected cost of stem cell therapies. In 2010, I posted on Scribd a study financed by CIRM -- one that the agency was not trumpeting -- that examined the issue of costs. Since then, it has been read 14,096 times, the most of any document that I have posted on the Scribd service, which provides a way to mount documents and link to them via the blog.

In its initial years, the blog primarily surveyed California media reporting on the stem cell agency, providing links and commentary with some original reporting. But today the focus is mostly on original reporting with analysis and commentary. The agency and its doings have slipped off the radar of the mainstream media, where they probably will remain short of a major scandal or a massive PR effort by the agency.

One of my goals was to provide detailed information, news and analysis about California's unusual research effort – far more than could be done by print media. The idea was to exploit one of the unique characteristics of the Internet-- the capability of publishing nearly unlimited amounts of information. Newspapers constantly cut, squeeze and trim stories because of both cost and their desire to publish a large number of articles about many different subjects. With the Internet, there is virtually no limit on the amount of content, a feature that is both good and not-so-good. Another goal was to go beyond the official handouts and to provide a guide to where useful information can be found.

The California Stem Cell Report differs from the mainstream media in another regard. The blog carries the remarks of representatives of the agency and other interested parties VERBATIM, even when they sometimes involve harsh attacks on the conduct of the blog. Major media almost never allow such access.

I have a couple of biases that underpin what I do. One is the assumption that it is beneficial generally for the government to fund scientific research. The other and more important principle is that government agencies should operate with maximum openness and transparency and that their first obligation is to the people – not the researchers that they fund or the institutions that have something at stake.

While readers can judge for themselves the success of the blog, the scope of the readership from the NIH to California's biotech hot spots suggests it is well-received. Mainstream media reporters as well as science writers often use the California Stem Cell Report as a reference and starting point. The blog has also served as a springboard for acceptance of my own occasional freelance articles in such places as The Sacramento Bee and Wired News. And in 2012, I testified before the Institute of Medicine, at its invitation, during preparation of its $700,000 report on the stem cell agency.

As for how the work is done, the writing and reporting are performed largely from a sailboat in Mexico and Central America, on which my wife and I live full-time. Sometimes that has presented difficulties, but as cellphone and Internet service has improved over the years, the task has become easier. We make visits back to California regularly during which I meet with agency officials and others and attend CIRM's public meetings.

I have focused largely on the policy and business aspects of the agency because that is where my knowledge and background lies. During my career, I have covered and edited stories from the state Capitol for United Press International and spent 10 years as the business editor of The Sacramento Bee along with editing prize-winning investigative projects, including the 1992 Pulitzer Prize-winning series, “The Monkey Wars,” by Deborah Blum, who now teaches at the University of Wisconsin. I also served two years and one week with Jerry Brown during his 1974 campaign for governor and into his first term.

As for my financial interests, my wife and I have never had any investments in any enterprise that could benefit financially from the activities of the stem cell agency except for possibly through index-based mutual funds over which I have no control. But like most of world, my family has suffered from conditions that theoretically could benefit from development of stem cell therapies. 

I am always interested in thoughts and comments from readers, critical or otherwise. My skin is reasonably thick. I have always told reporters who have worked for me that if you perform your act in a public place you should be prepared for any sort of reaction. I welcome suggestions for stories and improvements.

Feel free to contact me at djensen@californiastemcell.com. Or if you prefer to withhold your identity, you can leave a comment anonymously via the “comment” function at the end of each item.  

Irv Weissman and Reader Comment

Stanford researcher Irv Weissman was mentioned in a comment on Jan. 3 on the California Stem Cell Report on the "Growing Stem Cells..." item.

It is the practice of this Web site to inform people who are mentioned in comments that something has been said about them and making it clear that they have an opportunity to add to the dialogue.

In this case, Weissman had difficulty in filing his comment directly via the “comment” function on the blog, so we are filing it here.

Among other things, the anonymous reader said, “Is it not clear that Irv Weissman is CIRM's puppet master?”

Weissman's response via email: “Anonymous need not remain anonymous.”

Stem Cell Agency Financing Proposal a Mystery to Some

A proposed ballot measure that could mean the financial survival of the $3 billion California stem cell agency was little known to the agency itself until early this week and is a mystery to backers of a similar tobacco tax proposal in 2012.

Kevin McCormack, senior director for communications at the agency, said,

“Individuals at CIRM did hear about the possibility of another tobacco tax measure but did not know any of the details, including the 30 percent provision for us, until the initiative was filed on Tuesday.” 

He told the California Stem Cell Report in an email, 

“As for being in support of the plan, the board has not yet had a chance to consider this measure and therefore we do not have any position on it.”

Some of the agency's board members also indicated that they were not involved with the proposal and learned of it only today.

Jim Knox, vice president for advocacy of the American Cancer Society Cancer Action Network in Sacramento, said in a telephone interview that none of the groups that backed the unsuccessful Prop. 29 in 2012 was involved in the latest effort.

The proposed initiative was filed Monday by Santa Ana attorney Frank Barbaro, the former chairman of the Orange County Democratic Party. It would impose a $1.00-a-pack tax on cigarettes to fund brain research and related illnesses, raising roughly $700 million annually. Thirty percent would be routed directly to the stem cell agency, which will run out of money for new grants in 2017.

Barbaro has not yet responded to a request for comment. 

Knox, who was involved in the 2012 campaign, described the situation involving the latest initiative as bit of a mystery and “strange.” He said “no one has heard” about the proposal. He said the language, however, was clearly adopted from the Prop. 29 initiative. "They stole all our language," he said.

Knox said the proposal was filed very late to qualify for the November 2014 ballot. He said Barbaro will not get his proposal back from the attorney general's office until February sometime, leaving him a very short period to gather signatures by the end of May. That is the usual deadline for qualifying measures for the November ballot.

Knox said it is possible that signatures could be gathered in time but that it would be expensive. Roughly one million signatures are needed at a cost that could run as high as $5 or so.

Knox said the Barbaro initiative could be held until the November 2016 general election.

Tobacco Tax Looms as Financial Rescue for California Stem Cell Agency

California's stem cell agency, which is facing near financial death in 2017, could be rescued by a proposed ballot initiative that could channel roughly $200 million a year to the research effort.

Frank Barbaro
OC Register photo

The measure was filed this week with state officials by attorney Frank Barbaro of Santa Ana, a major figure in Orange County Democratic politics. It appeared to be modeled after a 2012 ballot initiative to raise tobacco taxes to fund cancer research that was very narrowly defeated.

The latest proposal would increase taxes on cigarettes by about $1 a pack and raise roughly $700 million a year, based on estimates for the 2012 initiative, Prop. 29. Barbaro's proposal would set aside 30 percent of that revenue to flow directly to the stem cell agency for research into a wide range of brain disorders and “dysfunctional conditions,” including spinal cord injury, heart disease, stroke, autism, cancer and much more.

Fifty percent of the funds would go to a new California Brain Research Citizen's Oversight Committee (CBRCOC), which would consist of 11 members, of whom four would be appointed by the governor. The others would be top executives of the University of California and its campuses. The new brain research operation would be similar to that of the state stem cell agency and would be able to award grants and loans and fund buildings and equipment.

Barbaro submitted the 14-page initiative to the state attorney general's office on Monday for preparation of a title and summary. The immediate hurdle for the measure is to collect roughly 1 million signatures to qualify it for the ballot, presumably November of this year. In 2012, hiring persons to collect signatures cost anywhere from $1 for each signature to as much as $5 to $6.

The California Stem Cell Report has queried Barbaro via email for additional comment on the measure, its backers and sources of funding. We will carry his comments when they are received.

The $3 billion California stem cell agency, which subsists on money borrowed by the state, is slated to run out of cash in 2017 for new awards. It has been considering some sort of public-private effort to generate additional funding.

The 2012 tobacco tax initiative was rejected by voters by an exceedingly slim margin, 50.3 percent to 49.7 percent, a difference of less than 30,000 votes. Political gamblers are likely to bet that the latest measure would win approval next fall, although the tobacco industry is likely to mount a tough fight.

California Gov. Brown's State Stem Cell Spending Figures

California Gov. Jerry Brown's proposed budget contains numbers for the state's stem cell agency although he can do nothing legally about its spending, even if he wanted to.

That's because the agency was created in such a manner that neither the governor or the legislature can get their fingers on stem cell research dollars. The idea was to protect research from politics. So Prop. 71, the 10,000-word ballot initiative that created the agency, made changes in both the state constitution and state law that gave the California Institute for Regenerative Medicine (CIRM) unique autonomy.

Brown's proposed budget does cast CIRM spending in a different light than seen in the agency's budget presentations. It shows that CIRM spending is expected to rise from $213 million in 2012-13 to $293 million in 2014-15, nearly all of which goes for research awards. The agency has legal authority to tap $300 million a year from money that the state borrows and that goes directly to the agency.

The proposed budget also projects 59.5 employees at the San Francisco-based agency in 2014-15 compared to 56.7 in 2012-13. Projected operating expenses amount to $15.6 million for 2014-15, compared to a $13.8 million in 2012-13. 

Both figures are interesting in light of CIRM's figures that show that its operational budget for the current fiscal year exceeds $17 million. No reason for the discrepancy was immediately available, but we suspect it is probably a case of different methods of accounting or perhaps off-the-mark figures from the stem cell agency to the state Department of Finance, which compiles the state spending plan.

The agency operates under a spending cap of 6 percent of its total expenditures, also imposed by Prop. 71. It will run out of cash for awards in 2017 and is currently trying to devise a way to finance its future operations. Another bond issue, which requires voter approval, has not been ruled out, but most of the discussion focuses on some sort of public-private partnership at a level much diminished from $300 million annually.

While Brown cannot chip away at CIRM spending by the usual state process, the agency does take notice of his desire for sharp-eyed budgeting. A few years ago, the agency cut back on out-of-state travel after Brown announced restrictions for other state agencies.

Knoepfler and Capricor Score Big This Week

Capricor's stock price has soared since Monday.
Chart from Google Finance

With the new year hardly begun, UC Davis stem cell researcher and blogger Paul Knoepfler has fulfilled one of his 10 predictions for the stem cell world in 2014.

On Dec. 29, Knoepfler predicted a “big announcement from Big Pharma” in 2014. He did not have to wait long to add some shine to his crystal ball.

On Monday, he wrote about the news that Johnson&Johnson was pumping $12.5 million into Capricor Therapeutics' stem cell therapy for heart disease. Capricor could see another $325 million from J&J if all goes well in its stage two clinical trial, which is being supported by $20 million from the California stem cell agency.

“I'd call that big money,” Knoepfler wrote. He also noted in his blog he has no financial interest in either company.

Investors liked the news as well. Capricor's stock closed at $7.05 today, more than double its $3.40 close on Friday, the business day just prior to J&J announcement. 

Big Pharma's J&J Buys Into California Stem Cell Therapy Research for Heart Disease

California's $27 million investment involving a Beverly Hills stem cell firm is paying off once again as the business attracted a major, financial vote of confidence from Big Pharma's Johnson&Johnson.

The firm, Capricor Therapeutics, last month received approval for a phase two clinical trial for its heart disease therapy. Yesterday, it announced that the Janssen Biotech arm of Johnson&Johnson was immediately pumping $12.5 million into the product with the potential of $325 million more, depending on the outcome of the phase two trial.

Linda Marban
Capricor photo

John Carroll of Fierce Biotech wrote that the move marked a “rare Big Pharma gamble on a field that is trying hard to mount a comeback.” The California stem cell agency, which is funding the phase two trial, said the news was “heartening”and a represented a “very good start” to the year for Capricor.

Linda Marban, CEO of Capricor, told Fierce Biotech that J&J had been probing Capricor for a year. She said, 

“One of the reasons why I was motivated to work on this deal is because of the statement it makes in the field. It says, OK, somebody very large and powerful is taking a look at this technology and saying there's something there, and that's the most exciting thing for me."

Interest from the “large and powerful” is of major importance not only to Capricor but to the stem cell agency, which runs out of state money for new research grants in 2017. It is slowly trying to develop other sources of revenue, and it has yet to bring a therapy to market despite promises to voters during the 2004 ballot campaign that created the agency. Votes of confidence from Big Pharma will go a long way in encouraging investment in the agency and the stem cell field generally.

Investors indeed were more than encouraged by the yesterday's news, which sent Capricor's stock soaring 48 percent. It closed at $5.06 yesterday, up from $3.40 on Friday. Marban has said the firm hopes to be profitable by 2018.

Johnson&Johnson's investment is not the first tied to a key executive at Capricor, Frank Litvack, who is executive chairman of the firm. Litvack, who unsuccessfully ran in 2011 against Jonathan Thomas for the chairmanship of the stem cell agency, sold Conor MedSystems to J&J for $1.6 billion in 2006.

Bradley Fikes of the San Diego U-T discussed the Capricor research late last month in some detail. One of the phase one trial sites was at Scripps Health. Fikes wrote,

“Mark Athens received Capricor’s treatment on Sept. 25, about a month after having a moderate heart attack. The Encinitas resident was the last treated under Phase 1, said Scripps cardiologist Richard Schatz, who performed the procedure. It will take about six months to know whether the treatment worked, Schatz said.”

Fikes continued,

“'All their previous work showed that the scar got smaller and the muscle tissue around it got more robust,' Schatz said. 'So two things happened: The viable tissue got bigger and the scar got smaller. And that should translate into some sort of clinical benefit down the road.'”

Here are links to the press release from Capricor and other stories in story Genetic Engineering and Biotechnology News and PharmaTimes.

Bloomberg Reports on the WARF hESC Patent Challenge

The California-based challenge to the WARF patents involving hESC research drew national media coverage this week on Bloomberg News.

Susan Decker of Bloomberg described the heart of the matter as a dispute over who profits from stem cell research. She wrote,

“'What we’re asking the government to do is say WARF has no right' to the patent, said Dan Ravicher, executive director Public Patent Foundation in New York, which is handling the challenge for Consumer Watchdog(of Santa Monica, Ca.) 'It’s like the government sent a check to WARF they didn’t deserve.'”

Dan Ravicher and Jeanne Loring at Post Office
when they filed the patent challenge July 17,
2006.  The photo was taken by an anonymous
 woman at the Post Office with Loring's camera. 

The challenge to the patents was filed by Consumer Watchdog and researcher Jeanne Loring of Scripps seven years ago. They contend that the patents are “too similar to earlier research” to be valid and that they hinder scientific research. They also contend that the Myriad decision by the U.S. Supreme Court that limits the right of ownership of human genes should also apply to stem cells. Ravicher successfully argued the Myriad case before the high court.

Decker said the issue is no small matter and involves major developments in medicine. She reported,

“'The next paradigm shift in medicine will be advances in cell therapy -- it’s under way,' said Jason Kolbert, senior biotechnology analyst with Maxim Group LLC in New York. He said pharmaceutical makers such as Teva Pharmaceutical Industries Ltd. (TEVA) of Petach Tikva, Israel, and Pfizer (PFE) Inc. of New York are working with stem-cell researchers on new therapies.”

Decker reported that written arguments from the U.S. Patent Office are scheduled to be delivered Jan. 17 to the federal district court of appeals in Washington, D.C.

Growing Stem Cells and Raising Cash in California

California's nearly 10-year-old effort to develop therapies from stem cells is riding a technology wave that some folks are saying will pick up considerable momentum this year.

That is good news for the state's $3 billion stem cell agency, the California Institute of Regenerative Medicine, which will run out of cash for new grants in 2017 and which is looking for new sources of revenue from the private sector.

The latest outlook for regenerative medicine was posted on re/code, a new technology Web site led by a couple of well-known refugees from the Wall Street Journal, Walt Mossberg and Kara Swisher. One of their writers, James Temple, weighed in with a piece on Jan. 1 about technology forecasts for 2014.

He said “five clear themes emerged” and one involved regenerative medicine. Temple, a former San Francisco Chronicle columnist, quoted James Canton, CEO of the Institute for Global Futures, as saying “major strides” are in the offing for 2014. In an email to Temple, Canton said,

“The most significant trends and breakthroughs in 2014 will be in regenerative medicine: The use of human stem cells to grow new organs, repair tissues (and) heal patients with numerous cardiovascular and autoimmune diseases.”

Another one of Temple's “futurists,” David Houle, author of “The Shift Age,” said that “sometime between now and 2020, 'our replacement parts will be superior to the parts we are born with.'”

Temple yesterday looked back to 2013 via a report by the National Venture Capital Association and Thomson Reuters. It said that the biotech industry accounted for 42 out of 82 venture-backed initial public offereings last year. The figure was five times more than the biotech sector offerings in the last five years.

Temple's pieces followed other stem cell forecasts from UC Davis researcher and blogger Paul Knoepfler, who is also optimistic. Knoepfler even predicted a “big announcement from Big Pharma” on stem cells or regenerative medicine.

Whether the forecasts are correct or whether the IPO trend will continue is a bit beside the point for the stem cell agency. What they can profit from is the fact that this kind of news generates excitement among investors and among those who might be willing to make a major bet on the Golden State's stem cell agency. Fund-raising becomes easier when the public rhetoric is more than optimistic. The band wagon effect takes hold. The visions of hope that entranced 59 percent of California voters in 2004 when they created the stem cell agency seem much closer to reality.

Catching this wave, however, is no easy matter, and the agency's 29 directors stalled last month when faced with a plan for a new financial future. Whether they can act with dispatch on this issue remains to be seen.

Job Opportunities at the California Stem Cell Agency

The $3 billion California stem cell agency has begun the year looking for several good people to help turn stem cells into cures.

On the top of the list, of course, is the position of president, which pays up to $561,959 annually. The impending vacancy has been known for some time, but the agency recently posted the official job opening on its Web site.

The agency is also looking for a senior medical officer to “manage a portfolio of grants, loans and contracts primarily focused on IND enabling and clinical development projects.” This is a key position that requires an M.D. or Ph.D. in biomedical science and substantial experience. The job pays up to $232,891.

Newly open is the position of communications manager for the agency's Web site and social media efforts, which are the chief public faces of the agency. Amy Adams held the position for several years, but has returned to Stanford to help with their science PR efforts. That position has a top salary of $136,306.

Additionally open is the job of grants management officer, who supervises management of the agency grants. Amy Lewis has left the post to become deputy to the chairman of the agency for public finance and governance. The top salary for the position is $153,316. Helping out the grants management officer will be a new grants management specialist with a top salary of $99,887.

The agency currently has only 57 employees to oversee its research portfolio and to initiate new rounds of awards for research. Additional employment information can be found here.

Golden State Milestone: Stem Cell Agency Announces its First Phase Two Clinical Trial

The California stem cell agency today scored a first with the announcement that one of its projects – a heart disease therapy -- has now advanced to a phase two clinical trial after successfully completing a phase one safety trial.

In a press release, Jonathan Thomas, chairman of the $3 billion research effort, hailed the Allstar trial by Capricor Therapeutics, Inc., of Beverly Hills. He declared,

"This is a highly significant announcement for us at CIRM as it's the first time we have funded a therapy into a Phase 2 clinical trial.

"Heart disease claims around 600,000 American lives every year, so clearly there is a huge need for new approaches and more effective therapies. We are hopeful this is the first of many treatments to turn the tide against this disease, and that this will be the first of many projects we are funding to get to a Phase 2 trial."

The adult stem cell therapy “uses unrelated donor-derived stem cells, called cardiosphere-derived cells, that are then infused into a patient’s artery with the aim of reducing scarring caused by heart attacks,” CIRM said.

Capricor Therapeutics, which has its roots in Cedars-Sinai in Los Angeles, describes itself as as “a diversified heart failure biotechnology company.” It came into being last summer as the result of the merger of Capricor and Niles Therapeutics. The company has benefited from about $27 million in support from the stem cell agency, including $6.9 million for early work by one of its founders Eduardo Marbán at Cedars-Sinai.

The company's stock price closed at $2.48 today, down 17 cents. Its 52-week range is from $2.48 to $2.65.

The firm's CEO, Linda Marbán, said the move into phase two was a “giant leap” for the firm and the heart therapy field.

The executive chairman of the firm is Frank Litvack, a heart surgeon who was the only other candidate for chairmanship of the stem cell agency when Thomas won the job in 2011.

The announcement today is a milestone for the stem cell agency, which is aggressively seeking results that will help to generate financial support after 2017, when its current state funding runs out.

The CIRM news release said,

“The next phase will involve an estimated 300 patients who have had heart attacks, and they will be evaluated in a double-blind, randomized, placebo-controlled trial.  This will be further broken down into two groups: one will include patients 30-90 days post attack, the second will be 91 days to one year after the incident.”

The phase two trial is to determine the therapy's effectiveness and further study its safety. If successful, it can move into a phase three trial to confirm its effectiveness, monitor side effects, compare it to common treatments and collect information that will allow the drug or treatment to be used safely.

Here is a CIRM video in which Eduardo Marbán discusses some of the issues involved in the therapy. Here is a link to a 2011 presentation to the CIRM governing board about the early research – a presentation that generated some excitement on the board.

Cost-saving Stem Cell Cuts Puzzle California Scientists

Jeanne Loring, the head of the Scripps stem cell program, reflected last week on the move by the $3 billion California stem cell agency to scuttle a program that she and other scientists believe is critical to the research effort.

Writing on ipscell.com, she discussed the effort to save the “shared” labs program at 17 institutions around the state. Continuation of the program was axed by directors last week in a cost-saving move. The agency is down to its last $600 million or so, and the governing board was feeling the pressure last week of having to deal with competing interests.

The board has 29 members, but only six in attendance could vote on the program because of the board's longstanding conflict-of-interest problems. Four approved the recommendation by CIRM staff and its Scientific Advisory Board to halt the lab program. That was all it took – the votes of four directors out of 29.

Loring and 11 other scientists attended last week's board meeting in an unsuccessful effort to the save the labs. She later wrote,

“We are back home now, but still puzzled about why CIRM would destroy one of its most successful programs.  The irony is that the board would like to continue to support training.  The training is done in the shared labs.  There are no more courses without the shared labs. 

“We aren’t giving up; we’re just taking some time to think.  Meanwhile, the positive side:  we did an amazing thing:  we are normally very competitive with each other, but on Wednesday we came together from all over California to support a single cause that is dear to our hearts.  That will remain a high point for me, even though I also feel a profound sense of loss.”

Bad Link Repaired

A bad link in the "$61 Million" item has been fixed, thanks to an anonymous reader who called it to our attention. The link is to the list of all the applications in that round.

Wish List on Criteria for New President of $3 Billion California Stem Cell Agency

Directors of the $3 billion California stem cell agency today moved closer to possibly selecting a non-scientist as the new president of the nine-year-old research enterprise.

On a unanimous voice vote with no discussion, they approved criteria that did not make it mandatory that a scientist fill the position being vacated by Alan Trounson, a noted IVF researcher who is returning to Australia.

Instead, the governing board decided that candidates should have “experience with and personal commitment to medical and scientific research including familiarity with stem cell research.”

In terms of academic credentials, the criteria state that the new president have either or both an M.D. or Ph.D. degree or “equivalent industry experience or similar body of knowledge developed in professional roles.”

The criteria that was approved was not available to the public today on the CIRM Web site prior to board action. It had been altered on Tuesday night from an earlier version that was posted on the Web site.

Here is the text of what appear to be the only alterations (all additions) in the new criteria.

• "Comfort working in the public sector, including an awareness of the need to comply with the laws that govern them, such as transparency, conflict of interest, and public accountability laws." 
• "Experience dealing with, and commitment to, diversity and gender equality in the workplace."

It is ironic that the addition of the need for awareness of the need for transparency was added but the document was not available to the public prior to board approval.

CIRM Chairman Jonathan Thomas said yesterday that the agency is on verge of signing a contract with a search firm, Korn Ferry, to help in finding the new president. Directors have been emphatic about the need for speed in finding the new president.

Trounson has agreed to stay on for an unspecified period, but he could leave at any point. If he leaves before a new president is chosen, presumably Ellen Feigal, senior vice president at the agency, would pick up his duties temporarily, as she did earlier this year for three months.

She is also likely to be a candidate for the top spot, and if she is not selected after serving again on an interim basis, she might well decide to look for opportunities elsewhere.

California Stem Cell Agency Board Quits for the Day

The governing board of the California stem cell agency adjourned its two-day meeting in Los Angeles at 2:40 p.m. PST today. We will have an item coming up shortly on approval of the criteria for selection of the new president. The board approved a revised criteria that was not available to the public prior to board action. It is unclear whether any of the changes were substantive.

Stem Cell Agency Identifies Grant Recipients

The California stem cell agency has posted its press release on this week's meeting of its governing board. The press release includes the identities of the grant recipients. All of the recipients are affiliated with institutions represented on the CIRM board. Here is a link to the press release.

$61 Million Approved for Stem Cell Clinical Trials

Directors of the California stem cell agency today handed out $61 million in its ambitious disease team program that is designed to push stem cell research into clinical trials.

Action on the six awards followed yesterday's move by the board to set aside $200 million to beef up its efforts for stage one and two clinical trials. The agency is focusing ever more intently on commercializing its research.

The $3 billion program is expected to run out of cash for new grants in 2017. Its efforts to develop a new stream of funding depend a great deal on showing results that resonate with the public and possible funding sources.

This grant round was originally budgeted for $100 million, but directors today were loath to approve additional funding. They noted that the agency is now living an era of financial limits.

Today's awards are aimed at cancer (three grants), sickle cell anemia, macular degeneration and severe airway obstruction. Size of the awards ranges from $20 million to $4.4 million. Terms range up to four years.

The agency did not immediately release the names of the winners, in keeping with its policy of secrecy until after the board votes. However, the names of the applicants could be determined by a knowledgeable person searching articles in the various fields. A CIRM news release is expected shortly with the names of the researchers and institutions. (Here is a link to the press release. All of the recipients are employed at institutions represented on the governing board.)

Thirteen applications, including one from a business, were considered by reviewers.

Here are links to the information provided by CIRM staff on the grant applications: summaries of the grant reviews, staff justification for funding tier two applications, Power Point presentations to be made to directors on the applications, including the range of scores on individual applications. However, the range of scores on the rejected applications was not provided.

Stem Cell Board Nixes $13.4 Million to Help Cure Cartilage Disorders

Directors of the California stem cell agency today rejected a $13.4 million proposal that would have been the first disease team research that it has backed that would deal with cartilage disorders.

The project would have built on earlier research funded by CIRM. The agency staff cited work at UC Davis  by Kyriacos Athanasiou and at Scripps by Peter Schultz. Funding of the application was supported by the CIRM staff, which did not identify the applicant.

However,  the governing board, however, went along, on a 10-1 vote, with arguments by Director Jeff Sheehy and others that the agency had finite resources and had to make difficult decisions. He noted that many alternative treatments exist for cartilage problems. Sheehy said,

"We are here to make progress on serious diseases and conditions."  

Former Chairman Robert Klein, in an unusual appearance as a member of the public, urged approval of the grant. He said that it would address conditions "very prevalent in the older population."  Klein told the board that the research would be a "very important milestone that will help you get more money in the future."

While Klein did not mention it, older persons participate in elections to a much greater degree than younger persons. They would be an important group in winning support for another bond issue to fund CIRM, which runs out of cash for new grants in 2017.