California's Stem Cell Research Spending Up for Review Next Week

If you are interested in how the state of California is going to spend its final $800 million or so on stem cell research, you should catch a key meeting next Tuesday in Oakland, which also can be heard online.

The session involves the 29-member, governing board of the $3 billion California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is formally known.

The agency was created by California voters in 2004 with voters' expectation that stem cell therapies were all but just around the corner. So far, no therapies have been developed by the agency that are available for widespread use.

Nonetheless, the agency, which runs out of money in 2020, is pushing hard. It has more than 20 clinical trials underway, which is the last step in bringing a therapy to market. However, those trials can take years with no guarantee that a proposed product will emerge successfully.

On tap on Tuesday will be a look at the agency's research plans for the next three years with a review of how it has performed so far in 2016. The agency's proposal for research spending in 2017 is likely to have a significant impact on the hundreds of stem cell researchers in California. The proposal is not yet available online, however, with only two business days left before the meeting.

CIRM is also hinting that there will be some surprises at the meeting, but it is unlikely that a product announcement will be forthcoming.

Additionally on tap are applications for a total of $14.9 million for two early-stage clinical trials. One is for $6.7 million (CLIN2-09439) to test using stem cells and T cells to eliminate the life-long need for immunosuppresive drugs by kidney transplant recipients. The other (CLIN2-09698) is for $8.3 million for a mid-stage trial (2b) for a therapy for retinitis pigmentosa.

The applications were approved for funding by the agency's grant reviewers, who meet behind closed doors and do not publicly disclose their economic or professional interests. Ratification of the reviewer decisions is a formality for the agency. although the names of the recipients are not generally disclosed prior to board action.

The board is expected to re-elect Jonathan Thomas as chairman of the panel. Thomas was elected to the position in 2011. He has sent a  two-page letter to the board detailing his work during the last five years. Also scheduled to be re-elected is Art Torres as vice chairman.

Thomas receives $400,000 annually for his "80 percent effort" in the part-time position. Torres, a former state lawmaker, receives $225,000, also for an "80 percent effort."

Instructions for listening to the meeting online can be found on the agenda. In addition to main meeting site in Oakland, public telephonic locations exist in San Diego and La Jolla. Specific addresses can be found on the agenda.

Multi-Billion Dollar Ballot Measure for California Stem Cell Agency in 2018?

California's $3 billion stem cell research effort is scheduled to run out of cash in three short years, but the likelihood seems to be increasing that voters will be asked again to come up with additional billions for the state's stem cell agency.

In fact, the chairman of the stem cell agency, Jonathan Thomas, is saying flatly this week that his predecessor, real investment investment banker Bob Klein, intends to place a funding measure on the November 2018 ballot.

Klein led the ballot initiative campaign in 2004 that created the unusual -- for a state -- stem cell research program, officially called the California Institute for Regenerative Medicine (CIRM). The agency is financed with cash that the state is borrowing. increasing total costs to roughly $6 billion because of the interest expense.

Jonathan Thomas, left, with Don Reed,
vice president of public policy, Americans
for Cures, Klein's advocacy group --
CIRM photo

Thomas' statement was contained in a letter to the governing board that recapped his work since he was elected by the board in 2011 to replace Klein. One section of the letter dealt with funding of the agency.

Thomas wrote,

"Bob has already announced that he intends to put a measure on the November 2018 ballot. We keep him updated on CIRM's progress so that he is fully informed."

Thomas added that he and two key CIRM staffers have "initiated discussions with a number of philanthropists and foundations interested in medical research who could be potential sources of funds to keep CIRM going in the event Bob's measure is not successful."

The California Stem Cell Report has queried Klein about his plans. The full text of his response will be carried when it is received.

Robert Klein, Americans for Cures
photo

Klein has publicly mentioned a possible bond measure in the past, most recently in 2014, including a figure as high as $5 billion. It is unclear whether he has spoken more specifically on the matter since then.

Klein maintains a stem cell advocacy group, Americans for Cures, which has an active web site and an impressive list of scientific advisors, including Irv Weissman of Stanford, Rusty Gage of the Salk Institute and Owen Witte of UCLA.

Klein's 2004 stem cell campaign cost $34 million to convince California voters that the state needed to begin its own human embryonic stem cell (hESC) research effort in the wake of then President Bush's restrictions on federal funding in that area. The campaign created the impression that cures were close at hand, according to opponents and media observers. The agency is yet to back a therapy that is available for widespread use.

The election of Donald Trump as president is widely expected to trigger new, Bush-like restrictions on human embryonic stem cell research that could create the same sort of climate that helped lead to the success of the 2004 ballot initiative in California. 

Champion of Stem Cell Research: Nancy Reagan Hailed by California Stem Cell Leader

The chairman of California’s $3 billion stem cell research effort yesterday weighed in with a tribute to Nancy Reagan and her support for human embryonic stem cell research.

Jonathan Thomas said,

“With the passing of former first lady Nancy Reagan the California Institute for Regenerative Medicine has lost a good friend and a champion of stem cell research. Mrs. Reagan was an advocate for stem cell research for many years and her voice was an important one in helping ensure the passage of Proposition 71. Her call to protect the ability of scientists to ‘pursue medical miracle possibilities’ echoed the feelings of millions of Americans looking to stem cell research for help in battling deadly diseases. We, and patients everywhere, were fortunate to have such a great champion for the work that we do.”

Nancy Reagan’s backing of hESC research began in the spring of 2004 with an unsuccessful effort to convince former President Bush to rescind his restrictions on federal funding of hESC research.

An Associated Press story said at the time,

"'It's hard to overstate or overestimate the power of her impassioned plea for the Bush administration to reform its stem cell policy,' said Daniel Perry, president of the Coalition for the Advancement of Medical Research. "She's given permission for very conservative, anti-abortion Republicans to disagree with Bush. It's a courageous stance against a president of her own party."

Newsweek magazine also carried a piece about her efforts.

The Klein Legacy: Vestiges of California's Stem Cell Past to be Scrubbed This Week

No doubt exists that Bob Klein left his mark on the $3 billion California stem cell agency. Sometimes he is described as the father of the agency. He was its first chairman and led the drive to win voter approval of the research effort in 2004.

Bob Klein, Elie Dolgin photo

The agency has been under new leadership since 2011. And this Thursday some of the marks left by Klein are going to be erased.

Minor stuff now, but they recall some of the issues that rumbled through the agency in earlier days.

For example, the agency’s rules currently restrict to 12 the number of employees in the chairman’s office out of an agency total now of 55-56. The restriction is almost certainly to be removed on Thursday by the agency’s governing board. A memo by agency general counsel James Harrison said mildly that “disagreements” existed during the Klein regime about staff resources, leading to the limitation.

Those disagreements were actually sufficiently harsh that the stem cell board at one point in 2007 felt compelled to strip six employees from Klein’s office of chair, limiting him to four.

During Klein’s tenure, he also scheduled board meetings with jam-packed agendas that often took two days. The lengthy sessions tested the patience of board members, some of whom fled for the doors in an effort to catch their flights home as the hours wore on. The result was that the supermajority, legally required quorums required to do business were lost.. (See here and here for
more on quorum problems at the agency.)

To help avoid those unseemly situations, rules allowing telephonic attendance by key members of the board were enacted. Nowadays, the meetings proceed with dispatch, often ending early, much to the satisfaction of board.

So the board on Thursday plans to expand the use of telephonic meetings, which could well be a plus and a minus. The move will increase the number of offsite locations where members of the public and researchers can weigh in remotely with comments during meetings, a feature that has been lightly used. On the other hand, there will be less face-to-face contact between members of the board, something that is an important aid in finding solutions to touchy problems.

California Stem Cell Agency Symposium: 'Vague Fears' vs. Potential Genetic Alteration of Human Race

California’s $3 billion stem cell agency has called a high-level meeting for next fall to examine a
"red-hot" issue that many prominent researchers say could lead ultimately to alteration of the human race.

The topic is a technique that makes it much easier to alter the genetic make-up of individuals in a way that can be inherited by their offspring.

In April, scientists in China reported genetically modifying human embryos in what was regarded as a “world first.” (See here and here.)

That came after a group of leading scientists in March called for a global moratorium on the genome-editing practice, stating that the therapeutic benefits were tenuous.

More recently Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, wrote on May 28 about how the subject was viewed at a meeting called, “Biotech and the Ethical Imagination: A Global Summit.”

Steven Pinker

“The far end of techno-enthusiastic perspectives, both on human germline modification specifically and on biotech in general, was represented by Harvard experimental psychologist and popular science writer Steven Pinker. In his opening remarks, Pinker counseled bioethicists to ‘stay out of the way of progress.’ In his closing comments, he cast ‘vague fears’ as standing in the way of saving millions of lives. In between, he epitomized the ‘bad boy scientism’ that too frequently characterizes the biotech field.” 

Jonathan Thomas, chairman of the stem cell agency, and Geoff Lomax, the agency’s main person on bioethics, wrote on June 1 about the matter and the upcoming meeting. In an item on the agency’s Stem Cellar blog, they said,

“Given CIRM’s support for research activities where genome editing may be employed, we believe it is important to have effective policies to guide our future funding decisions. Therefore, we have charged the CIRM Medical and Ethical Standards Working Group with convening a public workshop to elucidate the scientific and policy considerations surrounding genome editing in the context of CIRM supported research. This workshop is a first step in evaluating whether CIRM should make changes to its existing policies governing stem cell research.”

 CIRM’s standards group consists of some of the top bioethicists in the country. Early on, they developed the agency’s rules for research on stem cells, which were the most advanced in the country at the time. The chairman of the group is Bernie Lo of UC San Francisco.

The genome-editing issue to be discussed in November was originally scheduled to be brought up at an April meeting of the standards group. However, it was put off for a variety of reasons. Thomas subsequently called the meeting for next fall.

At the April meeting, Ted Peters of the Pacific Lutheran Theological Seminary and a member of the stem cell standards group, said the issue was “red hot.”  Jeff Sheehy, a member of the agency board and a communications manager at UC San Francisco, said the agency needed to clarify where it stood.  

Robert Taylor of the Emory School of Medicine and also a member of the standards group, said,

“There are companies that are offering to do this for your cell line, so it's really out there.”

Lo said,

“I think Jeff has raised a really important, complex and breaking topic. I think the idea of having a symposium to deal with both the science, and the ethics policy could be a really important thing to do.” 

 Suggestions regarding the meeting can be sent to Lomax at glomax@cirm.ca.gov. 

Chairman of $3 Billion California Stem Cell Effort Up for Evaluation Next Week

One week from today, a select panel of the directors of the $3 billion California stem cell agency will meet for the first time to assess the performance of its chairman, Jonathan Thomas, during his nearly four years in office.

Thomas, a Los Angeles bond financier, was elected as chairman of the agency in June 2011 on a 14-11 vote of the 29-member agency board. (See here and here.) He is paid $400,000 annually for his part-time work (80 percent), according to a Sacramento Bee database. His salary has remained unchanged since he took office.

Left to right, Robert Klein, Art Torres and Jonathan Thomas (2009 photo)

Thomas succeeded Robert Klein as chairman of the agency. Klein was elected in December 2004 after shepherding the ballot campaign that year to pass Proposition 71, which created the agency and funded it with state government borrowing.

The agenda for next week’s meeting gave no clue to the reason for calling this particular evaluation session. But good personnel practices would seem to require regular evaluations, perhaps even more often than every four years.

In 2012, then outside counsel to the board, James Harrison, prepared a memo for the subcommittee discussing evaluation procedures. In the memo, Harrison, now general counsel to the agency but still an independent contractor, summarized procedures that called for Thomas to submit his job goals for 2012-13.

Also to be evaluated, according to the memo,  was Art Torres, vice chairman of the board. Torres was also elected by the board and works part-time (80 percent) at an annual salary of $225,000. The subcommittee has not scheduled a meeting to evaluate Torres’ performance. Torres has been paid $225,000 annually during the last two years. However, his pay ran up to $247,000 in 2012, $239,000 in 2011 and $230,000 in 2010, according to The Bee database, which is drawn from public records.

(In response to a question, the stem cell agency said later today that the money paid to Torres in those three years was for unused vacation time. Earlier versions of this item did not contain that response.)

The Evaluation Subcommittee has six members, including Thomas and Torres. However, Thomas is not likely to be sitting in on his own evaluation next week. Chairman of the panel is Francisco Prieto, a Sacramento physician. The others are Stephen Juelsgaard, former executive vice president of Genentech; Sherry Lansing, former head of a Hollywood studio and a University of California regent, and Jeff Sheehy, a communications manager at UC San Francisco.

The subcommittee has met six times since Thomas was elected. All of those meetings dealt with assessment of Alan Trounson, former president of the stem cell agency, according to agendas.

Next Friday’s meeting will be almost entirely behind closed doors, but the public does have an opportunity to comment.  Two locations for the public exist in San Francisco and one each in Los Angeles, Calistoga and Napa. Specific addresses can be found on the agenda.

Ten Year Performance of Stem Cell Agency: Top Execs' Comments

Here is the text of what Jonathan Thomas, chairman of the California stem cell agency, and Randy Mills, president of the agency, had to say about its performance over the last 10 years.

Their remarks came after the agency was asked for comments from them for an article that appeared in The Sacramento Bee Nov. 16, 2014. The piece was written by David Jensen, publisher of this blog.   

The agency was told that it was likely that their comments would be severely limited in the piece in The Bee because of the space limitations of the print media. They and others queried were also told that the full text of their comments would be carried on this Web site.

Here are the comments from Jonathan Thomas: 

"In just a few short years we have helped accelerate the pace of research in California so that we are now funding ten projects that have moved out of the lab and into clinical trials in patients. These include trials in heart disease and diabetes, cancer and blindness, HIV/AIDS and sickle cell disease. By any standards this is a remarkable achievement. But this is really only the start. We have a pipeline of other truly promising therapies that we hope to  move into clinical trials in people in the next few years." 

 "We are a long way from running out of money. We have almost one billion dollars left to award to researchers. At our current rate of spending we'll be able to continue funding new projects until 2020, and we are already working on developing new sources of income to help us keep funding the most promising projects long after that. Without us, without our support, many of the most promising stem cell research projects in California could come to a stop. Those projects are far too important to the millions of people suffering from a wide range of deadly diseases and disorders. We don't intend to let that happen.”

"In ten years and more than 660 grants there have only been a handful of cases where there have been concerns about a conflict of interest and those were all acted upon quickly to remove even the perception of any conflict. The changes we made in response to the IOM report further strengthened the integrity of our process and demonstrated just how seriously we take these matters."  

Here is the comment from Randy Mills: 

"Everything we do centers around the patients, about developing successful therapies for people in need. Our first ten years laid the groundwork and now we are making changes to speed up the way we work, to make it easier for the most promising projects to get the funds they need when they need them, to accelerate the development of effective therapies and to do everything possible to ensure that we live up to the faith the people of California showed in us when they created the stem cell agency.”

California Stem Cell Agency: Comparing the Critiques

State Controller John Chiang has posted a useful, side-by-side comparison of critiques of the $3 billion California stem cell agency, including the Institute of Medicine(IOM) study, along with the responses from the agency.

Chiang, the state's top fiscal officer, has additionally posted the initial remarks Jan. 23 by CIRM Chairman Jonathan Thomas before the stem cell agency governing board on his plan to deal with the sweeping recommendations of the IOM.

Regardless of one's opinion of the board's response to the IOM, Thomas adroitly handled the discussion and vote, not a small accomplishment given the size of the board (29 members) and the legal restrictions involving public meetings. Under state law, Thomas could not lobby significant numbers of the board in advance of the meeting. He was restricted to engineering the approval in a public session, which can easily take on a life of its own given the unwieldy size of the board and the necessity for public comment.

As for the documents posted by Chiang, he is chairman of the Citizens Financial Accountability and Oversight Committee, the only state body specifically charged with oversight of the agency and its board. The web site for the committee is the only location on the Internet where Thomas' prepared remarks and the comparison can be found.

Chiang's comparison chart includes not only the IOM study, but last year's performance audit and the Little Hoover Commission study in 2009. Missing, however, is the state auditor's report in 2007 and its recommendation that the agency seek an attorney general's opinion on whether scientific grant reviewers must file a public financial disclosure form.

Here are links to the various documents: Thomas' prepared comments, Power Point chart used by Thomas, comparison chart of various studies and the transcript of the Jan. 23 meeting during which the governing board approved its response.

CIRM's Thomas: Conflicts 'Put to Bed' at Stem Cell Agency

The chairman of the $3 billion California stem cell agency, Jonathan Thomas, today hailed board action last week as putting “to bed once and for all” questions about financial conflicts of interest by members of the agency's governing board.

Writing on the agency's blog, Thomas pointed to board approval of a new policy that would bar 13 of the 29 members of the governing board from voting on any grants whatsoever. The 13 are the members who are “appointed from an institution that is eligible to receive money.” Three other board members have ties to institutions that receive money. Two are employees of the institutions and one is the chair of the University of California board of regents, Sherry Lansing. All three are appointed as patient advocate members of the board. Currently all 16 are barred individually from voting on grants to their institutions, but they can vote for awards to other institutions.

Thomas proposed the plan last week to the governing board, which approved it on a 23-0 vote with one abstention. Thomas advanced the proposal in response to the recommendations of a 17-month study by the Institute of Medicine(IOM). CIRM paid $700,000 for the blue-ribbon report, hoping that it would serve as the basis for continued financing of the agency beyond 2017, when funds for new grants run out.

The IOM's far-reaching recommendations included creation of a majority of independent members on the board, which would mean some current members of the board would lose their seats. No institutions would be guaranteed seats on the board. Currently five members are appointed from the University of California. The Thomas plan does not deal with those recommendations.

The IOM said “far too many” members of the board have ties to institutions that receive funds from CIRM. Compilations by the California Stem Cell Report show that about 90 percent of the $1.7 billion that the board has awarded has gone to institutions linked to directors.

Thomas said that the board last week “endorsed a framework of proposals that would dramatically change the way the board works, and directly addresses the concerns and recommendations of the IOM, in particular their feeling that the way our Board works could create a perception of conflict of interest.”

Concerning the change in voting for the 13 board members, Thomas wrote,

“It was not an easy change to propose and certainly not an easy one for our board members to approve. They all care deeply about our mission and devote a great deal of thought, time and energy to helping us do our work. So for 13 of them to agree to abstain from a key aspect of their work was difficult to say the least. And yet they did it because they felt it was important for the overall goal of the agency.”

Thomas continued,

“So why did we take this approach? It's simple. We want people to focus on the great work we do, on the groundbreaking research we fund, and the impact we are having on the field of regenerative medicine not just in California but throughout the U.S. and around the world. As long as there are perceptions of conflict of interest hanging over the Board, this will continue to be difficult.”

Thomas said,

“This puts the economic conflicts issue to bed once and for all.”

Thomas' Plan to Meet the the Recommendations of the IOM

Jonathan Thomas, chairman of the California stem cell agency, presented the following plan today to the governing board of the agency to deal with recommendations of the Institute of Medicine. 

  IOM proposal by the chairman of the California stem cell agency by  

Stem Cell Agency Chairman Says IOM Report 'Quite Complimentary'

Jonathan Thomas
CIRM Photo

Jonathan Thomas, the Los Angeles bond financier who is chairman of the $3 billion California stem cell agency, has weighed in at more length on the sweeping recommendations from the Institute of Medicine for changes at the agency.

He wrote a piece for the agency's blog that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press release yesterday that said the IOM “praises the agency as a 'bold social innovation.'”

Thomas did acknowledge that the report “highlighted some areas and made some recommendations about where and how we might improve our performance.” 

Thomas concluded by saying the agency takes the report seriously and will, over the next few months, consider how best to respond.

Nearly needless to say, other observers of the agency differ with Thomas' characterization of the report as “quite complimentary.(See here and here.)

Stem Cell Awards of the Year: From Geron to iPS 'Warts'

The end of the year is a traditional time for the media to come up with lists of both the dubious and meritorious events and personages of the year. This year's nominations from a California stem cell researcher include Geron, Roman Reed and the new chairman of the California stem cell agency.

Paul Knoepfler, a stem cell scientist at UC Davis and one of the few stem cell scientists who blogs regularly, today revealed his awards for 2011. They ranged from the political cartoon of the year to the stem cell scientific issue of the year.

Geron was named in the "misstep of the year." Knoepfler wrote,

"You guys really screwed up by dropping your stem cell program in this manner. I believe this bordered on the unethical. I commend the actual stem cell scientists at Geron, but the person(s) who as leaders pulled the trigger on killing the stem cell program did wrong."

Roman Reed was named "stem cell activist of the year." Reed is the man who came up with the CIRM motto several years ago, "Turning stem cells into cures." He has long been active on stem cell issues, along with his equally hard-working father, Don Reed.

Jonathan Thomas, the relatively new chairman of the stem cell agency, was named "stem cell leader of the year." Thomas was elected chairman of the agency in June, replacing Bob Klein, who stepped down. Knoepfler wrote that Thomas "has impressed the stem cell community and made some very positive changes at CIRM to make an awesome organization even better."

Knoepfler has much more,  including the stem cell biotech of the year –
Advanced Cell Technology of Santa Monica, Ca. – which Knoepfler said has two hESC trials on track and an "impressive scientific leadership." Not to be overlooked is the stem cell scientific issue of the year – "warts" or genetic changes -- at least possible ones involving iPS cells. Knoepfler points out that the subject has drawn a vast number of citations in journal articles.

We should not forget the stem cell blog of the year, which came in as a tie between Stem Cell Network of Canada and Stem Cell Assays by William Gunn of San Diego and Alexey Berseney of Philadelphia. Knoepfler also mentioned the CIRM Research Blog, overseen by Amy Adams, and the California Stem Cell Report. Knoepfler said the California Stem Cell Report "is read by a who’s who of the stem cell world, and is a source of important information about CIRM," although Knoepfler said he wished the blog was more balanced "in terms of positive and critical stories." However, Knoepfler did note that several more positive items have appeared recently, but this analyst warns of the perils of excessive exuberance.

CIRM's Thomas Blogs on Geron and the Stem Cell Business

The chairman of the $3 billion California stem cell agency has made his second entry into the blogosphere, this time adding a bit more on Geron's abandonment of what would have been its historic hESC clinical trial.

Jonathan Thomas, a Los Angeles bond financier, wrote yesterday on the CIRM research blog, which has recently been the site of more spritely and relevant items.

Geron's action has particular relevance for CIRM, which awarded the company a $25 million loan last May to help with the clinical trial.

Thomas said CIRM's "immediate concern" when officials heard the surprise news was for the patients and the families involved in the trials. Thomas continued,

"However, Geron is a business. The company decided that their cancer therapies were farther along than the stem cell trial and when they held the stem cell program against the prism of economic reality they made a business decision to end the trial."

Thomas also minimized the importance of Geron to CIRM. He said,

"CIRM’s award to Geron was just one of the 44 projects in 26 disease areas that are in various stages of working toward clinical trials."

It was a somewhat different story last May when former stem cell agency chairman Robert Klein said in a widely distributed CIRM news release,

"Supporting the Geron trial is a landmark step for CIRM."

Regardless of the spin on Geron from either CIRM or others who are more skeptical, Thomas' entry into the world of electronic media is to be applauded as is what appears to be a new direction in the research blog.

The CIRM blog is now newsier, more lively with more variety and more voices. All of which should redound, albeit modestly, to CIRM efforts to improve its communications with the public and opinion makers. The difficult thing about blogs, however, is the time and effort required to sustain them, and the task could be something of a communications test for CIRM. Blogs constantly need to be fed. Indeed, blogs are voracious, sort of like the carnivorous plant called Seymour in "The Little Shop of Horrors." As many of you may recall, Seymour had a simple but insistent refrain, "Feed me, feed me, feed me."

California Stem Cell Agency Takes Initiative in PR 'War'

Jonathan Thomas, chairman of the $3 billion California stem cell agency, took to the blogosphere today with an item promoting CIRM's progress, declaring that it is a record of which Californians can be proud.

In his debut performance as a blogger, Thomas declared that the agency has 43 research projects that are in various stages of moving towards clinical trials. He wrote on CIRM's research blog,

"Given that it normally takes a decade or longer for a basic science discovery to reach clinical trials, 43 projects seemed to me like quite an achievement – an achievement that the people of California should take pride in supporting. Not only is CIRM driving stem cell science in our state, but through our national and international collaborations California has become a stem cell hub that accelerates stem cell progress worldwide."

Thomas, a Los Angeles bond financier, pointed to a new document from CIRM, titled "Funding therapies: Fueling Hope." It summarizes some of the agency's work and touts the "incredible potential" of stem cells.

The document also explains the laborious process for creating a therapy before it can be brought to market and actually used to treat patients. The document said,

"Altogether, carrying out the basic research, translational work and preclinical data leading up to a clinical trial can take a decade or longer, and that's just to start the clinical trial. CIRM’s funding approach speeds that timeline by providing stable funding that eliminates pauses in the research to raise new funds, by strategically funding areas thought to be barriers to the clinic and by forming teams of researchers who work in parallel rather than sequentially to reach clinical trials faster."

When Thomas was elected chairman of the agency last June, he told directors that the agency was in a "communications war" in which its record was not fully appreciated by the public. He made telling the CIRM story one of his top priorities.

Today's blog posting by Thomas and, more particularly the "Fueling Hope" document, will be useful to CIRM in dealing with the overblown expectations of rapid cures that were generated by the hype of the 2004 ballot initiative campaign that created the stem cell research program.

The campaign generated impressions among voters that cures – specifically human embryonic stem cell cures – were just around the corner and that the Bush Administration, with its restrictions on hESC research, was the only thing standing in the way. Indeed, without George Bush, there would be no state stem cell agency  since his stand against hESC created an apparent need for alternative funding. For voters who expected instant cures, however, CIRM must be a sad disappointment since it has developed no therapy that is being used to treat people.

Managing expectations is a critical task for CIRM, which will run out of funds in 2017 and which is expected to be asking voters for another multibillion dollar bond measure sometime in the next few years.

CIRM Chairman on Geron: Agency in for the Long Haul

Commenting on Geron's decision to abandon hESC research, the chairman of the California stem cell agency, Jonathan Thomas, says the agency knew "the road to new therapies would be arduous, and that for each success, there would be setbacks as well."

In a memo Monday to the agency's 29 board members, Thomas reiterated that Geron maintains the decision had nothing to do with safety concerns. He said the company's action underscores the agency's commitment to long-term development of stem cell therapies.

Thomas also said the $3 billion agency will retain the stock warrants it received from Geron, but did not disclose their numbers. We have queried CIRM for more details. CIRM loaned Geron $25 million, which was paid back by Geron on Monday.

A copy of the Thomas memo was provided to the California Stem Cell Report. Here is the full text.

"Dear Board Members:

"Earlier this afternoon, we learned that Geron made a decision to discontinue its stem cell research program, including the CIRM-funded clinical trial involving spinal cord injury. Geron made this decision in order to shift its focus to its oncology program. Geron has assured us that its decision to discontinue the trial had nothing to do with safety concerns; the cells have been well-tolerated and the patients have experienced no adverse effects. Geron will continue to follow all enrolled patients and has committed to accrue data and update the FDA and the medical community regarding the patients’ progress.

"In addition, Geron has returned CIRM’s funds, with accrued interest. CIRM will maintain the warrants it received.

"Of course, we remain committed to funding clinical development of stem cell therapies. We have always recognized that the road to new therapies would be arduous, and that for each success, there would be setbacks as well. We also know that companies make decisions for business reasons, and that it is not unusual for a company to pursue a new strategy, as Geron has done. CIRM, by contrast, is focused on its long-term goal of delivering therapies and cure to patients, and today’s events underscore the importance of CIRM’s long-term commitment to funding therapy development.

"This trial represented the first-ever clinical trial of human embryonic stem cells and we expected that it would be challenging. We share the frustration of all the patients for whom this trial offered great hope. I spoke personally with both Don and Roman Reed to express my commitment to the on-going search for therapies.

"Although we are deeply disappointed by Geron’s decision, we are grateful that Geron has established a regulatory pathway for human embryonic stem cell therapies and we are confident in the potential of stem cells to treat patients suffering from chronic disease and injury.

"Here is a link to CIRM’s press release: http://www.cirm.ca.gov/PressRelease_2011-11-14"

Stem Cell Agency PR/Communications Not Up to Snuff, CIRM-funded Report Says

The communications/public relations efforts of the $3 billion California stem cell agency have fallen short, damaged its own public image and led to organizational "dysfunction," according to a CIRM-commissioned study.

The report by the Sacramento firm of Townsend Raimundo Besler and Usher cited "less than satisfactory results" and CIRM's failure to keep pace with the need to communicate with many different audiences. The political consulting and PR firm wrote,

"(A) lack of coordination and systematic organization has led at times to dysfunction, and, while the Institute may be respected and well-known in the scientific world, it is far less of either among other critical audiences."

(Disclosure note: The author of this item on the California Stem Cell Report and Jeff Raimundo, one of the principals of the Townsend firm, worked together at The Sacramento Bee two decades ago.)

The report, to be acted on tomorrow night and on Wednesday by CIRM directors, cited some measureable PR successes. But it said CIRM "lives in two worlds – the high-level domain of advanced scientific research and the secular world of politics and public opinion."

The Townsend firm recommended a number of changes to improve matters, including "rebranding" the California Institute for Regenerative Medicine, the official name of the agency, as the "Stem Cell Institute." Townsend said the agency's formal name "has proven not particularly effective in helping the public" understand its work.

Townsend also recommended centralizing communications management, reorganizing existing communcations staff, creating an annual communications/PR plan and developing a set of messages that will generate public support. Also recommended were polling and focus groups to help formulate needed strategies along with specific ways of measuring the success of CIRM's communications plans.

Townsend cited the need to go beyond traditional scientific as well as mainstream media. The report said that the while public has traditionally "gotten their information from mainstream news media, that is no longer true. Much of the flow of information to the public is through interactive and electronic media today, particularly blogs and websites."

The report indirectly referred to former Chairman Robert Klein, who stepped down in June. Townsend said,

"Virtually since its inception and until recently, the Institute has been led by a high-profile, articulate and charismatic individual who assumed much of the responsibility for communicating with many if not most of CIRM's audiences. Although that situation helped keep messages simple and focused, it did not keep pace with the demands of the Institute to communicate at many different levels and with many different audiences."

CIRM commissioned the study following the June election of Jonathan Thomas, a Los Angeles bond financier, to replace Klein, who is a Palo Alto real estate investment banker.

At the time of Thomas' election, he told directors that the agency is in a "communications war." He said the world is focused on "internal issues" at CIRM instead of "the grand, big picture. "  He also discussed CIRM's financial situation. Its bond funding will run out in roughly 2017. And prior to his departure, Klein expressed the need to seek another multibillion dollar bond measure sometime in the next few years. Such a ballot measure would seem certain to be rejected today, given the state's current financial crisis and the lack of the cures that were touted in the 2004 election campaign that created CIRM and that was headed by Klein.

Earlier this year, directors approved an organizational change that created a senior level director of public communications in the office of the CIRM chairman to market the stem cell agency to the public. The agency is currently in the process of hiring that person. However, the three-person communications staff remains within the president's office.

Accompanying the Townsend report was a document from CIRM President Alan Trounson detailing responsibilities for the new hire and declaring that he "fully supports" the new communications effort. Under Trounson's structure, the PR chief would report to Art Torres, the co-vice chairman of CIRM, and Ellen Feigal, vice president for research and development. Trounson's statement does not specifically delineate who reports to the new PR person but places responsibility for virtually all of the agency's communications efforts in the hands of that person.

The Townsend study also says that CIRM is understaffed for its communications tasks although it did not specifically recommend new hires.

The Townsend report was posted on the CIRM website sometime during the weekend, only two business days before it is to be considered, making it nearly impossible for the public or interested parties to prepare thoughtful comments.

The California Stem Cell Report asked CIRM earlier for the cost of the Townsend report as well as a copy of the contract, both of which are a public record. Neither piece of information has been forthcoming.

Biotech Industry Alert: California Stem Cell Agency Moves Ahead with Industry-Friendly Efforts

The newly elected chairman of the $3 billion California stem cell agency is pushing forward with efforts to engage industry more deeply in state efforts to develop commercial stem cell therapies.

Industry has long been unhappy with its meager share of CIRM grants – 7 percent of $1.25 billion. A blue-ribbon panel commissioned by CIRM last year recommended major improvements.

Duane Roth

The latest action by Jonathan Thomas, the Los Angeles bond financier who was elected in June to head the agency, comes in the form of a thrust to be led by CIRM co-Vice Chair Duane Roth, a San Diego businessman.

Thomas' plan for engagement of industry will be discussed this evening at Stanford at the first meeting of the board's new eight-member Intellectual Property Subcommittee.

Thomas' proposal, posted only early today on the CIRM web site, would expand the panel's current jurisdiction. The document said,

Stephen Juelsgaard

"In light of CIRM’s desire to engage industry in its mission to deliver therapies and cures to patients who suffer from chronic disease and injury and the overlap between industry-related issues and the current jurisdiction of the subcommittee, Chairman Thomas, with the concurrence of Subcommittee Chair (Stephen) Juelsgaard, proposes to expand the jurisdiction of the subcommittee to include industry-related issues, such as: (1) participation by representatives of industry as members of the Grants Working Group; (2) the development and refinement of programs to incorporate industry into CIRM’s research programs; (3) financing issues relating to industry involvement with CIRM; (4) evaluation of barriers to industry engagement in CIRM-related or funded activities; (5) addressing means of encouraging industry interaction and involvement, especially in the areas of development, regulatory compliance, manufacturing and commercialization, with CIRM-funded research organizations that have identified potential promising therapies and (6) consideration and refinement of CIRM’s loan program."

Juelsgaard, former executive vice president of Genentech and currently a lecturer at Stanford Law School, was appointed to the board last May by Lt. Gov. Gavin Newsom. Juelsgaard once was reported as being considered as a possible candidate for chair of the agency.

Thomas said Roth would be named co-chair of the IP Subcommittee with responsibility for industry relations. Juelsgaard will deal more generally with IP issues, including "developing a program to assist CIRM grantees in protecting intellectual property generated from CIRM-funded research and to ensure that the state has an opportunity to share in the revenues arising out of CIRM-funded research." That topic is on the agenda of this evening's meeting.

Also to be discussed is another industry-friendly effort: A $30 million "Opportunity Fund" to "enhance the likelihood that CIRM funded projects will obtain funding for Phase III clinical trials (e.g. follow-on financing), (ii) provide a potential source of co-funding in the earlier stages of clinical development, and (iii) provide CIRM funded projects with access to pharma and large biotech partners that can provide valuable expertise in the areas of regulatory, clinical trial design and manufacturing process development."

New Stem Cell Agency Chair Discloses More than $3 Million in Investments

The new chairman of the California stem cell agency, Jonathan Thomas, last week reported that he has more than $3 million in investments, including holdings in an enterprise that invests in "distressed debt" and in a consulting firm that teaches businesses how to "out-behave the competition."

Thomas' statement of economic interests -- required by state law – disclosed that the bond financier has more than $1 million invested in Saybrook Capital of Santa Monica, Ca., a firm that he co-founded. Thomas is currently a partner in the firm, which deals with "distressed debt," including government bonds. He has said he will continue to be involved with the business while he also serves the part-time (80 percent) chairman of CIRM at a salary of $400,000.

In his statement, Thomas also reported that as of taking office on June 23 he had a more than $1 million investment in the Saybrook Opportunity Fund and another $1 million-plus holding in LRN, a Los Angeles-based firm that provides "legal/ethical" consulting.

LRN was founded in 1994 by Dov Seidman, an attorney and author of the book "How." On the firm's web site, Seidman said he started LRN "with a powerful vision that the world would be a better place if more people did the right thing." Since then, the firm says it has consulted with 500 companies including Pfizer, Johnson & Johnson, eBay, 3M and Walt Disney.

We asked Thomas about he came to be involved in LRN. Scott Tocher, counsel to the CIRM chair, replied via email that Thomas "knew the gentlemen who founded the company and thought it was a very interesting business model and on that basis made his investment."

Thomas' holdings also include shares in 71 different companies for a total that could range from $206,000 to $1.4 million. Most of the holdings were less than $10,000 each. Eight ranged between $10,001 and $100,000. The state disclosure law requires reporting of investment values only in broad ranges.

Thomas disclosed holdings in four pharmaceutical companies: Allergan, Gilead Sciences, Pfzer and Watson Pharmaceuticals. The investments ranged from $2,000 to $10,000. A similar investment was reported in Thermo Fisher Scientific, which makes stem cell research equipment.

Pfizer is deeply involved in stem cell research, including a $100 million commitment in the United Kingdom. The Pfizer effort includes a collaboration with Peter Coffey at University College of London. Last fall, CIRM directors awarded Coffey $4.9 million to lure him to UC Santa Barbara. Coffey is also involved in a joint $24 million research program backed by CIRM and the UK.

Thomas reported income of between $10,001 and $100,000 each from Saybrook and CSI Management Limited. Tocher said CSI is the contracting affiliate for CSIP Group of Los Angeles, a private equity firm with a primary focus on China.

Thomas' statement shows that he had a more than $100,000 share in the gross income of Saybrook Capital. Tocher said that state law required the disclosure "regardless of whether or not JT actually received any income. As is typical of private equity firms, not all income is distributed for a variety of reasons (reserves, co-investment, etc.)."

The statement also disclosed Thomas' $3,239 investment in Advanced Cell Technology of Santa Monica, Ca., a human embryonic stem cell research firm. Thomas last month sold the ACT stock at what he said was a "significant loss."

All CIRM board members are required to file economic disclosure statements, which are used to help determine whether they can vote on matters that come before the governing board or even take part in discussion. The disclosure statements for board members and top executives at CIRM can be found here. The agency began posting them on its web site just this spring. Thomas' statement is not yet posted but you can find it below. Jonathan Thomas Statement of Economic Interests

California Stem Cell Agency Chair Sells Interest in Advanced Cell Technology

Jonathan Thomas, at right, at his first CIRM board meeting in June.  Outgoing
Chairman Robert Klein is at left and co-Vice Chairman Art Torres in center. 

The new chairman of the $3 billion California stem cell agency, Jonathan Thomas, has sold "at a significant loss" the 17,046 shares he held in a California-based stem cell firm.

In response to a query from the California Stem Cell Report, Thomas, a bond financier in Los Angeles, said that his stock in Advanced Cell Technology of Santa Monica, Ca., was sold recently at 19 cents a share or a total of $3,239. Over the last 12 months the stock price of ACT has ranged from four cents to 27 cents. Thomas did not disclose size of the loss he took on his investment.

Thomas additionally said the firm in which he is a partner, Saybrook Capital, also of Santa Monica, sold all 11,364 shares it held in ACT at $0.1856 a share. Thomas said in an email,

"To put the sales in context from a volume standpoint, ACT has had a three month average daily trading volume of over 4.9 million shares. With these sales, I have no remaining investment of any kind in ACT stock. All sales were at a significant loss."

Thomas will remain a partner at Saybrook while serving as the part-time (80 percent) chairman of CIRM.

Prior to his election as chairman of CIRM, Thomas publicly disclosed his interest in ACT, which is only one of two companies in the United States with a clinical trial underway involving a human embryonic stem cell therapy(see here, here and here). He said in a statement to CIRM directors last spring,

"As I proceeded through my career in law and finance, I took particular interest in stem cell research and looked for a company to work with in that arena. In 2000, I began tracking Advanced Cell Technology (or "ACT"), a then fledgling-company pursuing therapeutic products from embryonic stem cell research. After extensive review of their intellectual property portfolio and lengthy due diligence, I led an early round financing to cover the company’s operating expenses. I have tracked ACT over the years and am familiar through it with the ups and downs typical of the biotechnology industry. Now, 11 years later, ACT has two of the three products derived from embryonic stem cell research currently in clinical trials. It will be interesting to see how things play out."

ACT moved its official headquarters to California after passage in 2004 of Prop. 71, the ballot measure that created the state's stem cell research effort. ACT has applied for grants from the stem cell agency, but never received one. At one point, an ACT researcher publicly complained about conflicts of interest in the grant review process. CIRM, however, gave short shrift to the complaint.

ACT reportedly applied for a loan from CIRM in its recent $50 million clinical trial round. But the company was not identified as a winner when directors approved a loan to Geron in May. However, ACT is reportedly in line for an award later this year from CIRM, according to industry scuttlebutt.

Under state law, Thomas is required to file a statement of his economic interests within 30 days of assuming his position. Thomas was sworn in on June 22. He told the California Stem Cell Report on Saturday that he is "just finishing up getting all the data together. It will be good to go in the next few days."

LA Times Editorial on New CIRM Chair: Tin Ears and Extinction

The Los Angeles Times said this morning that it suspects that the election of Jonathan Thomas as chairman of the $3 billion California stem cell agency "will go a long way toward assuring the institute's extinction."

In an editorial, the state's largest circulation newspaper said,

"It always annoys voters to discover that government workers make more than they do, but what especially rankles about Thomas' big paycheck is that his hiring comes at a time when most state agencies are making radical cutbacks and when the institute itself is considering a ballot measure to ask voters for billions in new funding."

The editorial is the latest in several negative pieces in the mainstream media about the choice of Thomas, a Los Angeles bond financier, to become chairman. The articles focus primarily on Thomas' $400,000, part-time (80 percent) salary.

The Times wrote,

"The new head of California's stem cell research agency, which has a staff of 50, not only makes more money than the governor, he makes twice as much as the chief of the National Institutes of Health, which has 17,000 employees. Does that make him overpaid? Not necessarily. But it does make the board that hired him remarkably tin-eared about politics."

The editorial did note that "it's possible" that Thomas "could earn his big bucks," given his background in finance, if CIRM is forced to try to sell state bonds privately.

The selection of Thomas also drew attention this week in the San Francisco Bay Area in a commentary by San Francisco Chronicle columnist Phil Matier in a report on KCBS television station.

The station picked up the LA Times news story on Thomas' salary, adding that it was one of the highest in state government. Matier said during the news story that it was all part of the "birth of a bureaucracy." He said voters shouldn't expect a stem cell breakthrough for another 10 years. He also called CIRM the "high speed rail of medicine." For non-Californians, that is a reference to another multibillion dollar California bond program that is staggering under heavy public criticism.

In another commentary on a blog called Secondhand Smoke, Wesley J. Smith, author and bioethicist, posted a video of the song "Hey Big Spender." Smith wrote,

"The state is sinking financially.  Cutbacks are being forced across the board.  But not at the CIRM....

"These people live in a different world of 'entitlement' (there’s another word) and 'luxury.'  This is just another reason for the people of California to turn off the borrowing money spigot in 2014."

Prior to the LA Times salary story, Pete Shanks of the Center for Genetics and Society of Berkeley, Ca., on June 29 wrapped up the election of Thomas on its Biopolitical Times blog, quoting John M. Simpson of Consumer Watchdog of Santa Monica, Ca. Simpson said that the selection of Thomas is "a public relations disaster from which the stem cell agency will never recover."

For other articles on the Thomas election and the situation at CIRM, see here, here, here, here and here.