California Stem Cell Report

Magazine Survey on CIRM Shows Mixed Results

2012-01-26T18:00:00.001-05:00

The magazine GEN this week produced two relatively lengthy articles dealing with the current state of affairs and the future of the $3 billion California stem cell agency.

Much of the material is familiar to readers of the California Stem Cell Report, but GEN, which says it reaches "221,035 biotech and life science professionals, also produced an online survey that asked its readers: "How helpful has CIRM been in advancing stem cell science?"

At the time of this writing, the results showed that 40.9 of respondents said CIRM was "very helpful." An identical percentage said "not very" or were undecided. The survey showed 18.2 percent as ranking the agency "somewhat" helpful. The number of respondents was not disclosed.

The two articles (see here and here)by Alex Philippidis also discussed the possibility of a bond issue in a "few years," before CIRM runs out of cash in 2017. Philippidis wrote,

"By then CIRM hopes to have won what ICOC (the CIRM governing board) chairman Jonathan Thomas, Ph.D., has called the 'communications war' the agency is fighting with California newspapers and the CIRM-focused blog California Stem Cell Report. Both have criticized the agency over a host of governance and pay issues."

For the record, the California Stem Cell Report has not criticized the agency in connection with the level of its executive pay. We have pointed out that many California voters have a highly negative and visceral reaction to high public salaries, which is a matter that CIRM must deal with in connection with retention of public confidence. We have also noted that the salaries represent a tiny, tiny fraction of CIRM spending.

IOM Panel Ends California Visit With No Mainstream Media Coverage

2012-01-25T23:59:00.005-05:00

The blue-ribbon Institute of Medicine panel examining the performance of the $3 billion California stem cell agency has quietly concluded its first public hearing in California without so much as a smidgen of daily coverage in the mainstream media.

Instead, the big state news in California yesterday was a lawsuit filed by lawmakers against the state's top fiscal officer to prevent him from cutting their pay again when they fail to pass a balanced budget.

It would have been extremely unlikely, however, to have seen any daily coverage of the IOM session. The mainstream media generally ignores the affairs of the California stem cell agency.

Other than what has appeared on the California Stem Cell Report, the most comprehensive look at the $700,000, IOM examination of CIRM was provided on Tuesday by Marcy Darnovsky of the Center for Genetics and Society, which has followed CIRM, and the ballot measure that created it, since 2004.

Darnovsky brought her readers on the Biopolitical Times up to speed on CIRM matters. She noted that CIRM will need more cash in a few years when its bond funding runs out. She concluded,

"But ballot measure or no ballot measure, CIRM will continue to disperse the public money it controls - another billion and a half dollars. This is a public agency spending increasingly scarce public resources. It is funding a field of research in which we place great hopes for medical and scientific advances. These factors make it all the more crucial that CIRM follow the basics of good governance and public accountability, and eschew the hyperbole and exaggerated promises that have tainted stem cell research for so long."

The California Stem Cell Report emailed a 1,370-word statement to the panel. The study director of the IOM panel said the statement would be placed in the panel's record.

The document provided perspective on the formation of CIRM, the political context in which it operates and discussed some of the potential pitfalls of CIRM's necessary but delicate courting of industry. Suggestions were offered for changes to ease potential conflicts of interest and to open to the public the statements of the economic interests of the grant reviewers who make the de facto decisions on CIRM's funding.

Here is the full statement from the California Stem Cell Report.
CSCR Statement to IOM-CIRM Performance Inquiry

The California Stem Cell Agency and the ACT Opportunity

2012-01-25T13:02:00.000-05:00

A promising, positive story on stem cell research in California popped up in the news this week, involving improvements in vision as the result of the only hESC clinical trial in the nation.

The story came after Jonathan Thomas, chairman of the $3 billion California stem cell agency, said in the San Francisco Business Times that what he likes least about his job is that "the coverage in the press chooses to focus on items besides the extraordinary work that our scientists are doing."

The good news about the eye research appeared in the New York Times, Los Angeles Times and across the nation. However, it did not involve work at the stem cell agency, probably for reasons that likely have to do in good part with CIRM. The research involves a firm headquartered in Santa Monica, Ca., Advanced Cell Technology, that moved its base to the Golden State in hopes of securing CIRM funding. ACT has applied more than once for CIRM cash but has never received a grant. And it is one of the rare companies that has complained publicly to the CIRM governing board about a conflict of interest on the part of a CIRM reviewer. In ACT's case, its complaints received a public brushoff at a CIRM board meeting in 2008.

ACT's results in its clinical trial are quite tentative. They involve only two persons. One of the UCLA scientists involved said part of the results could have been the result of a placebo effect. Nonetheless, the reports carried the kind of story line that CIRM yearns for. Indeed, Thomas stressed the need for positive news when he told CIRM directors last June that the agency is in a "communications war" that is tied to its ultimate fate. (The agency runs out of cash in 2017.)

The New York Times' Andy Pollock wrote,

"Both patients, who were legally blind, said in interviews that they had gains in eyesight that were meaningful for them. One said she could see colors better and was able to thread a needle and sew on a button for the first time in years. The other said she was able to navigate a shopping mall by herself."

On its research blog, CIRM described the ACT results as a "milestone." CIRM's Amy Adams wrote,

"It’s the first published paper showing that—at least in this small number of patients for the first few months—the cells are safe."

She quoted Hank Greely of Stanford as saying that the news from ACT is "at least, a little exciting – and in a field that saw its first approved clinical trial stopped two months ago, even a little exciting news is very welcome."

Greely's reference, of course, was to Geron's sudden abandonment in November of its hESC trial, only three months after CIRM gave the firm a $25 million loan. It was widely believed that ACT was one of the initial applicants in the round that provided funding for Geron, although CIRM does not release the names of non-funded applicants.

Last week, CIRM directors spent a fair amount of time discussing the agency's future. The talk was of priorities, hard choices and generating results that would resonate with the people of California.

This week's news from a company that was not funded by CIRM will give them more to ponder.

LA Times: Deck Stacked at the IOM Hearing

2012-01-21T21:36:00.000-05:00

The Los Angeles Times web site today carried a sharply worded piece about the upcoming Institute of Medicine hearing on the performance of the $3 billion California stem cell agency.

Written by Pulitzer-prize winning columnist Michael Hiltzik, the item was headlined,

"Stacking the deck on the stem cell program."

The piece referred to Tuesday's meeting of the Institute of Medicine panel looking into the stem cell agency's affairs. The Times article was based largely on a piece yesterday on the California Stem Cell Report that reported that six of the 11 witnesses at the IOM hearing were coming from institutions that had received $418 million from CIRM. The item also reported that the only other witnesses were either CIRM employees or on its governing board.

Hiltzik wrote,

"The insular character of the stem-cell research community always has made objective evaluations of CIRM difficult -- most of the experts in the field are in a position to seek grants from the program or work with it on grant review. The IOM study could have been a counterbalance to that. But that doesn't look like it's about to happen."

State Controller to Hold Hearing on Stem Cell Agency Finances

2012-01-21T21:29:00.000-05:00

The only state body specifically charged with oversight of the $3 billion California stem cell agency and its board will meet next Friday in Los Angeles for a look at the enterprise's financial affairs.

The group is the Citizens Financial Accountability and Oversight Committee, chaired by the state's top fiscal officer, Controller John Chiang. It was created by Proposition 71, the ballot initiative that established the stem cell research effort.

The agenda is a tad shy of details on what is likely to be brought up although it does mention a briefing by CIRM on "CIRM’s financial performance, current budget,update of grants awarded and grant process."

CIRM Chairman Jonathan Thomas is expected to attend along with the agency's new and first chief financial officer, Matt Plunkett.

Orkin Appointed to IOM-CIRM Performance Review Group

2012-01-20T21:55:00.001-05:00

Scientist Stuart Orkin of Harvard, who headed the grant review group of the California stem cell agency for three years, today was named as a member of the blue-ribbon Institute of Medicine panel conducting an examination of the perfomance of the $3 billion enterprise.

Orkin left the grant review group in November of 2008. The IOM posted information about Orkin today but did not mention his earlier connection to CIRM. The grant review group makes the de facto decisions on grants by the stem cell agency.

During Orkin's tenure, the agency began to come under fire from businesses for what they said were deficiencies in the grant review process.

Orkin replaces David Scadden, also of Harvard, who resigned from the IOM-CIRM panel in December month because of his ties to Fate Therapeutics of San Diego, which lists him as a scientific founder.

Performance Review of California Stem Cell Agency Dominated by $418 Million Worth of Friendly Witnesses

2012-01-20T14:56:00.002-05:00

The Institute of Medicine opens its inquiry in San Francisco next week into the performance of the $3 billion California stem cell agency with testimony from representatives of enterprises that have received $418 million from the agency. No independent witnesses are scheduled to appear.

The IOM is being paid $700,000 by the stem cell agency to conduct the study, which was authorized by the CIRM board in 2010, with the hope that the findings would bolster voter support for another multibillion dollar bond measure for the agency.

So far the IOM-CIRM panel has held one day of public hearings in Washington, D.C., only involving CIRM representatives. Next week's session will be one of two days of public hearings in California before the inquiry is concluded. Another one-day public session is scheduled for Washington. So far the IOM-CIRM panel has not publicly heard any independent analysis of CIRM operations.

Earlier this week, the California Stem Cell Report asked Harold Shapiro, chairman of the IOM-CIRM panel, whether the IOM actually expected to receive forthright assessments of CIRM from individuals linked to institutions that have received hundreds of millions of dollars from the agency.

Shapiro did not reply but referred the inquiry to a public relations person at the IOM, Christine Stencel. She said that next week's meeting is one of "several means" by which the panel will gather information. She pointed to a short note on the IOM website linking to survey forms for others who may be interested in communicating with the panel.

Eleven witnessesses are scheduled for next Tuesday's meeting. Five are CIRM employees or members of the CIRM governing board. The remaining six come from institutions that have received $418 million from CIRM: Stanford ($193 million), UC San Francisco ($115 million), UC Davis($62 million) and UC Berkeley ($48 million). Five of the witnesses have received grants directly from CIRM: Alice Tarantal of UC Davis($5 million), Howard Chang of Stanford ($3.2 million), Irina Conboy of UC Berkeley ($2.2 million), Helen Blau of Stanford ($1.4 million) and John Murnane of UC San Francisco ($1 million).

We asked Shapiro how the witnesses for next week were selected. Stencel replied,

"The list of presenters and topics you see on the agenda reflect information and insights that the committee considered useful at this point in its work."

We asked,

"Why weren't representatives from other well-informed California organizations invited, such as the Little Hoover Commission, which performed a lengthy study of CIRM, and the Center for Genetics and Society, which has followed CIRM since 2004.? Are there any plans to seek them out for public comment?"

The IOM did not respond directly but made the general statement about using "several means" to gather information.

We also asked,

"Why is 50 percent of (next week's) meeting being held behind closed doors? Who is expected to testify? What will be the nature of the business to be discussed? CIRM is a public enterprise, engaged in spending $6 billion (including interest) of taxpayer funds. It would seem that almost nothing that it does should be barred from public scrutiny."

Stencel replied,

"The closed portion of the meeting will be devoted to internal committee discussions; there will be no presentations. This is per the National Academies study process."

(The National Academies are the parent organization of the IOM.)

Two members and the study director of the IOM-CIRM panel also made an unannounced trip to California last year, visiting Stanford and UC San Francisco in addition to CIRM offices. The IOM did not respond directly to questions from the California Stem Cell Report about whether the trip was at the invitation of CIRM and whether the traveling members met with any representatives of institutions or groups that have not received CIRM funds. Stencel said the trip was undertaken to gain a "better understanding" of the task before the panel.

The text of the questions asked by the California Stem Cell Report and the IOM response can be found here.

Text of IOM Responses to Questions About Selection of Its CIRM Witnesses

2012-01-20T14:55:00.000-05:00

Here is the text of the questions posed this week by the California Stem Cell Report to the Institute of Medicine concerning its performance assessment of the $3 billion California stem cell agency and the IOM hearing Jan. 24 in San Francisco.

Also included is the text of the responses from the IOM, which is being paid $700,000 by the agency to conduct the study. The initial question was addressed to Harold Shapiro, chairman of the IOM-CIRM panel. Christine Stencel, senior media relations officer for the IOM, replied. The second question was addressed directly to Stencel.

Here are the questions sent Jan. 16 to Shapiro.

"Dr. Shapiro --

"I am working on an article dealing with the upcoming meeting of the CIRM IOM panel Jan. 24. It will discuss the topics to be discussed and the witnesses. I would like your comments particularly in regard to the selection of the witnesses.

"Other than CIRM-connected individuals and media representatives(based on the agenda as of Jan. 16), they come from institutions that have received $356 million from the stem cell agency. Several of them have personally received grants. (UC Davis representatives were later added to the agenda, boosting the figure from $356 million to $418 million.)

"My questions:
"How were these witnesses selected? Does the IOM actually expect to receive forthright assessments of CIRM from individuals that have received hundreds of millions of dollars from the agency?

"Why weren't representatives from other well-informed California organizations invited, such as the Little Hoover Commission, which performed a lengthy study of CIRM, and the Center for Genetics and Society, which has followed CIRM since 2004.? Are there any plans to seek them out for public comment?

"Why is 50 percent of the meeting being held behind closed doors? Who is expected to testify? What will be the nature of the business to be discussed? CIRM is a public enterprise, engaged in spending $6 billion (including interest) of taxpayer funds. It would seem that almost nothing that it does should be barred from public scrutiny.

"Finally, who is Larry Fisher? He is listed on the IOM agenda as having a connection with the Los Angeles Times. However, an employee of the Times tells me that Fisher is not listed in any of the directories that he has access to.

"Dr. Shapiro, I will carry any comments that you make verbatim on the California Stem Cell Report. If you would like to add more than responses to the questions, I would welcome your thoughts."

Here is the response Jan. 17 from Stencel.

"Dr. Shapiro forwarded your query to the IOM for response. Our offices were closed yesterday for the MLK holiday, so we are catching up on all the correspondence we’ve received. The upcoming meeting is one of several means by which the committee will gather information and perspectives to inform its deliberations. The list of presenters and topics you see on the agenda reflect information and insights that the committee considered useful at this point in its work. This meeting is not the sole means by which committee members will gather information. For example, you will note that there are links to surveys posted on the project page (http://www.iom.edu/Activities/Research/CIRMReview.aspx) on the IOM website that request information from a variety of sources. The committee has also requested specific data from CIRM; a list of what was requested is in the Public Access File for this study, which is accessible via the Public Access Records Office. In addition, the committee expects to hold another information gathering meeting in California later this year.

"To your query about the extent to which the meeting is open, the committee is holding a day-long open meeting to gather information on Jan. 24. The closed portion of the meeting will be devoted to internal committee discussions; there will be no presentations. This is per the National Academies study process. Please see Stage 3 in the explanation of the National Academies study process on this webpage: http://www.nationalacademies.org/studyprocess/index.html.

"To your question about Mr. Fisher, due to an oversight in drafting the agenda, he is misidentified as being affiliated with the LA Times. As the agenda you last saw indicated, he was an invited speaker, but since he has not responded, he will not be speaking at the meeting and is being removed from the agenda.

"Thank you for your ongoing interest in this IOM review."

Here are the California Stem Cell Report questions Jan. 17 to Stencel:

"I understand that some members of the CIRM - IOM panel made a publicly unannounced trip to California to visit some recipient institutions. What was the purpose of the trip? Who went? How long did it last? What institutions were visited? Who put together the agenda for the visit? Was it at the invitation of CIRM and facilitated by CIRM? Did the traveling members of the panel meet with any representatives of institutions or groups that have not received CIRM funds? Please feel free to add any other thoughts on this subject if you wish. Thank you."

Here is Stencel's response:

"Harold Shapiro and Terry Magnuson, who had been asked to serve as chair and vice chair of the committee, visited CIRM and two universities conducting stem cell research in September 2011 before the full committee was assembled. Drs. Shapiro and Magnuson wanted to visit CIRM to gain a better understanding of the task that their committee, when formed, would be undertaking given the many questions being posed (per Statement of Task) and the limited timeframe to complete the review. They also met with leaders of Stanford and the University of California, San Francisco and toured laboratories on the two campuses to get a better feel for the type of stem cell research supported by CIRM. IOM study director Adrienne Stith Butler accompanied them."

In Rare Negative Vote, CIRM Directors Nix $6.3 Million Grant Application

2012-01-17T18:51:00.000-05:00

Directors of the California stem cell agency today rejected a $6.3 million grant to recruit an unidentified researcher to the Buck Institute after some of CIRM's grant reviewers raised questions about his/her research, achievements and experience.

The CIRM governing board voted 3-16 with two abstentions on the grant, which scored 76 out of 100 during a closed-door session of reviewers earlier this month. Directors were told that the grants review group voted 11-6 to approve the application.

The CIRM board almost never rejects a recommendation from grant reviewers.

During the board's discussions, several directors raised questions about whether CIRM would be paying -- with the grant -- for research that did not fit within its objectives. Others said the intent of the agency's recruitment grant program was to attract the best scientists to California.

The research proposal was the subject of an unusual, dissenting minority report by reviewers. The CIRM staff-prepared review summary said,

"A motion to recommend the application for funding carried with a majority vote. Because the motion was opposed by more than 35% of members, opponents have exercised their right to have that position reported to the ICOC(the CIRM governing board). The GWG(grant review group) members raised three main opposing points. First, some GWG members were not convinced that the research program proposed by the candidate, despite its scientific merits in a simple model organism (the fruitfly Drosophila), would be translated effectively to mammalian models and human studies. Thus, they questioned whether the work would have significant impact on CIRM's mission of advancing stem cell research toward therapies. Second, some GWG members felt that the candidate's research vision did not extend far beyond significant discoveries to which the candidate has already contributed, and was, therefore, solid and safe but not venturesome or compelling. Third, although the candidate is clearly a rising star, some GWG members were concerned that the candidate's achievements and experience were not yet sufficiently mature for the leadership position expected under this award."

However, the review summary also said,

"The goal of the proposed research is to expand the study of molecular pathways mediating stem cell aging and to extend these investigations into mammalian cells....The proposed studies will investigate the regulation of stem cell activity and aging in response to nutritional conditions and environmental stress. These efforts could yield new insights into a range of chronic diseases and lead to therapeutic approaches to maintain or restore adult stem cell function in humans. "

"The candidate’s emerging leadership and recognition by the field has been reflected in numerous invitations to speak at major meetings and to contribute reviews and commentaries to leading journals. The PI (applicant) was lauded in outstanding letters from leaders in the field of stem cell aging research. They described the candidate as a highly energetic, innovative, and focused scientist who is recognized internationally as a critical thought leader making fundamental contributions to the understanding of aging mechanisms."

Normally the names of institutions connected to grant applications are not disclosed prior to board approval. However, the name of the Buck Institute was mentioned during the discussion about the application. Votes by the grants review group are also not normally disclosed during board discussions.

The award would have been the fourth in CIRM's $44 million programt to help recruit stem cell researchers to California.

California to Spend $40 Million for Two Stem Cell Genomic Centers

2012-01-17T17:34:00.001-05:00

The California stem cell agency plans to spend $40 million to create two stem cell genomic research centers, including possibly one at a for-profit research enterprise.

The proposal was approved today by CIRM directors on a vote by show of hands.

CIRM said the objective of the effort is "to transformatively advance the stem cell field." The grant program was touted by CIRM President Alan Trounson as a way for California to gain a "firm and lasting grip" on global stem cell leadership.

Writing in the January issue of Nature Biotechnology, Trounson and CIRM scientists Natalie DeWitt and Michael Yaffe said an "urgent need" exists "to ramp up efforts to establish stem cells as a leading model system for understanding human biology and disease states and ultimately to accelerate progress toward clinical translation."

They continued,

"For California to take a firm and lasting grip on leadership in stem-cell research—and, as stated in Proposition 71,'advance the biotech industry in California to world leadership as an economic engine for California’s future'— its scientists must have access to these technologies and moreover create a coordinated international enterprise to maximize the reach and impact of stem cell genomics. Genomics is creating a sea change in biomedical research and medicine, and accordingly, the California Institute for Regenerative Medicine (CIRM; San Francisco) can create a process through which stem-cell research can participate and even provide leadership in a new era of medicine."

The stem cell agency staff proposal to directors said,

"Genomics technologies and the data sets they yield are fast becoming the currency of biology and medicine. The cost of genome sequencing is dropping exponentially, a trend that will soon make genome-scale characterization a practical tool for fundamental studies of stem cell biology and for advancing therapeutic applications. Meanwhile, cell therapeutics are advancing toward clinical trials, and hES and hiPS cells have become the gold standard for studying human cell biology, tissue and organ development and repair, and disease. Combining genomic technologies with stem cell research will accelerate fundamental understanding of human biology, disease mechanisms, tissue engineering and cell therapies...."

Awards for the centers of up to $20 million each are scheduled to be awarded next winter.

Here is a link to the CIRM press release on the proposal.

CIRM Board Meeting About to Resume

2012-01-17T14:07:00.002-05:00

Directors of the California stem cell agency are about to resume their meeting with a discussion of future directions and financing.

CIRM Directors to Take Up Future Funding and Direction of Stem Cell Agency

2012-01-17T13:57:00.000-05:00

The meeting of the CIRM board has recessed for five minutes. When it resumes directors will begin discussing their desires for future direction of CIRM and the "transition plan" for the agency as it loses its funding in about five years.

Two Potential Buyers Eyeing Geron's hESC Business

2012-01-17T13:17:00.002-05:00

Geron has two interested potential buyers for its human embryonic stem cell business, the president of the California stem cell agency said today.

Alan Trounson told CIRM directors that at one point four parties had expressed interest but two have backed out. He did not disclose the names of any of the parties.

Last fall, Geron announced it was giving up its hESC work because of financial concerns about what once was the first clinical trial of a human embryonic stem therapy. Last summer CIRM loaned Geron $25 million for the trial, which has been repaid with interest. Following Geron's announcement, Trounson said he was working to help find a buyer for Geron's hESC business.

However, today he said he was "suddenly distanced" from the process a few days ago. CIRM director Sherry Lansing, who once headed a Hollywood film studio, asked Trounson whether there was anything that directors could do to help find a buyer for Geron's hESC business. She asked about the amount of money needed by Geron and whether patient advocates could help generate other momentum.

Trounson suggested that the discussion should be continued privately. He did say that CIRM has prepared a document that outlines what would be necessary for the agency to resume funding of the hESC trial.

Trounson told directors that Geron's departure from hESC research has had "a very strong negative influence internationally."

Geron, which is based in Menlo Park in California, said last week it has hired Stifel Nicolaus & Co. to help sell the hESC business. .

California Stem Cell Agency Slated for More Bond Funding This Spring

2012-01-17T12:28:00.000-05:00

The California stem cell agency is slated to secure additional bond funding this spring when the financially troubled Golden State initiates a new round of borrowing.

CIRM Chairman Jonathan Thomas told directors today that the $3 billion agency will be involved in the upcoming round. He did not specify the amount that CIRM would receive or the timing of the bond issue.

The agency's only significant funding comes from state bonds, whose funds flow directly to CIRM. The governor and legislature cannot touch the CIRM funds under the terms of the ballot measure that created the research effort in 2004.

Last year at this time, the state suspended bond sales. At the time, CIRM had sufficient funds to meet its commitments until about June of this year. Late last year, Thomas worked out a temporary funding arrangement with the governor's financial aides to cover any possible shortfall.

Thomas made the announcement at the beginning of today's CIRM board meeting in San Diego.

Currently CIRM President Alan Trounson is reviewing new stem cell research that has been published recently.

Stem Cell Agency Shying Away From Another Multibillion-dollar Bond Proposal

2012-01-16T14:38:00.001-05:00

The $3 billion California stem cell agency, which is expected to run out of cash in five years, is backing away from an attempt to win voter approval of another multibillion dollar bond measure to finance its research efforts.

The agency disclosed its new position in a document posted in connection with the meeting tomorrow of its governing board in San Diego. CIRM said,

"Although additional funding could be a possibility in the future, it would be premature even to consider another bond measure at this time. Instead, CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work."

The statement is a sharp departure from previous discussion of mounting a ballot campaign for a $4 billion to $5 billion bond measure on behalf of CIRM.

The only significant source of cash for the agency currently is the $3 billion in bonds approved by voters in 2004. Nearly half of that is committed. The latest financial report from CIRM shows its funding of research peaking in 2017-18.

During the last year or so, former CIRM Chairman Robert Klein has repeatedly discussed another bond measure and has even more recently expressed his desire to raise funds for a new electoral campaign. Klein resigned from his post last June. The CIRM board elected Jonathan Thomas, a Los Angeles bond financier, to replace Klein, who was the agency's first chairman and who led the 2004 ballot campaign.

In 2010, the CIRM board approved spending $700,000 for an Institute of Medicine study of CIRM with the expectation that its findings would enhance the likelihood of approval of more bond funding.

The IOM study is currently underway. The blue-ribbon panel is scheduled to hold a two-day public meeting in San Francisco Jan. 24-25 as part of its assessment of CIRM performance.

CIRM largely functions below the news media's radar, but talk of a new pitch for money has triggered negative commentary. Last month, the San Jose Mercury News said in an editorial that the agency should close its doors when its cash runs out because another bond measure would siphon off much-needed money for education and other critical services already "starved" by state budget cuts.

Backing away from another bond measure could benefit CIRM by helping to remove the likelihood that its actions will be judged in the context of an electoral campaign. But the action also raises the possibility that some of CIRM's best employees may leave for better prospects given that they may not have much of a future at an agency that would appear to be going out of business – at least at its current robust level.

The CIRM document dealing with the bond measure is dubbed a "transition plan" and is required by state law.

Instead of seeking to borrow more billions, the document said,

"CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work. Through its funding of state of the art research facilities, collaborative funding agreements, and industry engagement, CIRM has already made progress in creating this platform."

The document also raised the possibility of creation of a nonprofit organization to carry on CIRM's stem cell research, a proposal that has floated quietly for some years. Such an effort could involve raising funds from the biotech industry, which CIRM is currently trying to engage in a more friendly way.

At the top of CIRM's list of transition plan activities is creation -- both nationally and internationally -- of "Alpha Stem Cell Clinics" for delivery of therapies to patients. The clinics also would foster clinical trials and evaluate cell therapies. Additionally included are efforts to drive "follow-on funding" for CIRM projects and strengthened efforts to support industry.

Directors could alter the CIRM transition plan at their meeting tomorrow. But it was placed on the agenda by Chairman Thomas and is unlikely to see major revisions.

IOM Holding Hearings on California Stem Cell Agency in San Francisco Jan. 24-25

2012-01-05T17:47:00.000-05:00

The California Stem Cell Report will be mostly dark during the next two weeks since its editor, yours truly, will be out of Internet range sailing in the Perlas islands south of Panama.

However, we want to let you know that a meeting of the governing board of the California stem cell agency is scheduled for Jan. 17 in San Diego. Also, the Institute of Medicine later this month will hold one of its two public sessions in California to assess the performance of the $3 billion stem cell research effort. The agenda for the Jan. 24-25 meeting in San Francisco had not been posted at the time of this writing. But the IOM said it will be available at least 10 days ahead of the meeting.

The IOM also has not yet filled the spot on the CIRM study panel vacated by David Scadden of Harvard when he resigned last month because of a conflict of interest involving Fate Therapeutics of San Diego.

If you are eager to delve into the details of what the CIRM governing board is up to, you can find the agenda and perhaps additional background information at this location on the CIRM web site when it is posted, probably by Jan. 7. While the meeting is scheduled for San Diego, usually one or two remote locations around the state are available where interested parties can participate. The California Stem Cell Report does plan to cover the meeting live via the Internet audiocast and file reports as warranted.

$40 Million Genomic Research Effort Planned by California Stem Cell Agency

2012-01-05T08:04:00.001-05:00

The California stem cell agency is proposing a $40 million program to set up two stem cell genomic research centers, including possibly one at a for-profit research enterprise.

The plan would augment an existing program in genomics or bioinformatics, according to a CIRM document. The goal is to rapidly build "an effective stem cell genomics infrastructure that will provide a new platform for the application of genomics tools to stem cell biology and regenerative medicine."

The proposal is scheduled to be considered at a meeting of the CIRM directors Science Subcommittee next Wednesday. It will then go to the full CIRM board at its Jan. 17 meeting.

The stem cell agency's proposal said,

"Genomics technologies and the data sets they yield are fast becoming the currency of biology and medicine. The cost of genome sequencing is dropping exponentially, a trend that will soon make genome-scale characterization a practical tool for fundamental studies of stem cell biology and for advancing therapeutic applications. Meanwhile, cell therapeutics are advancing toward clinical trials, and hES and hiPS cells have become the gold standard for studying human cell biology, tissue and organ development and repair, and disease. Combining genomic technologies with stem cell research will accelerate fundamental understanding of human biology, disease mechanisms, tissue engineering and cell therapies...."

The RFA for the proposal would be released in May with board approval of applications in the winter of 2013.

Interested parties can participate in the meeting at locations in San Francisco, Irvine, Oakland, Pleasanton, Duarte, Los Angeles (2), Stanford, Healdsburg and Irvine. Addresses can be found on the agenda for the meeting.

Golden State Stem Cell Agency to Give Away $42,237 an Hour This Year

2012-01-05T05:32:00.009-05:00

The California stem cell agency plans to hand out $370 million this year, including a whopping $240 million in what it calls its disease team round.

That amounts to $42,237 every hour of every day of 2012.

Amy Adams, CIRM's communications manager, reported the $370 million figure in the CIRM research blog, which she edits. The other rounds of funding for 2012, Adams wrote, include $95 million for early translational research, $35 million for basic biology and $2.2 million for stem cell research by high school students. Those funds would be routed through universities.

So far CIRM has handed out $1.2 billion to 454 recipients in the seven years it has been in business. It is expected to run out of its $3 billion in about 2017 unless it secures voter approval of more bond funding or some other source of revenue.

Adams' item on the funding expected to be approved this year is part of CIRM's efforts to make its research blog more lively and newsy. Indeed, unless we are mistaken, it is the first time in the history of the agency that it has laid out its funding plans for a forthcoming year in a single public document.

In her item, Adams also pointed to various locations on the CIRM web site where interested parties can track the agency's affairs.

The changes in the blog are a step in the right direction, laying out not only more information but also racheting up the interest level.

A Stem Cell Word Cloud: Slicing and Dicing CIRM Grants

2012-01-04T20:01:00.000-05:00

The $3 billion California stem cell agency has handed out 454 grants since its inception in 2004 but what does it all mean?

Stem cell researcher Paul Knoepfler took a crack at an unusual analysis a couple of days ago, generating a word cloud from the titles of all the CIRM grants.

Writing on his blog, the UC Davis scientist and CIRM grant recipient said he was surprised by some of the results, including how small the word "induced" was in the cloud considering the hooha over induced pluripotent cells. Knoepfler also wrote,

"I found it fascinating that the next top word was 'differentiation.' As much as we all focus on stem cells in their native state, clearly the differentiation of stem cells is critically important."

Knoepfler used a free, word-cloud forming utility(Wordle) to generate the results, which Amy Adams, CIRM's communications manager, called "cool."

San Jose Merc to California Stem Cell Agency: Time to Bow Out

2011-12-19T21:11:00.001-05:00

The $3 billion California stem cell agency should shut its doors when its cash runs out in about six years and turn over development of stem cell therapies to industry and academe, the San Jose Mercury News said in an editorial on Saturday.

The piece in the leading newspaper in California's Silicon Valley was headlined, "Stem Cell Institute Should Take a Bow (Out)."

The newspaper wrote,

"This state is in financial crisis with no full recovery in sight. Bankrolling the next phase of research would come at the expense of other critical state services, including public education, that are state government's core mission and already are starved by budget cuts. It would be a mistake to pile more debt onto the state's already heavy bond obligations, which are paid off from the same general fund that pays for schools and other services. Medical research is important, but it is not at the heart of state government's mission. Bond measures now need to deal with water supplies and other looming crises."

The editorial said CIRM has provided a "strong foundation from which universities and companies can move toward cures."

But the newspaper concluded,

"Cures remain elusive -- there is never a guarantee with scientific research -- but the 10-year start voters approved was meant to be just that. The promise of stem cell treatments now must be kept alive with funding from industry, academic institutions and private foundations and philanthropists."

The editorial comes as the seven-year-old agency is driving to turn research into therapies that can actually be used in treatments. At the same time, CIRM is considering asking California voters to approve another multibillion bond measure in the next few years, a proposal that seems to be fresh news to many in the media.

The San Jose newspaper covered the stem cell agency with some detail in its first year of operation. In the last few years, however, the paper's coverage has been all but non-existent, like most of the news media in California.

Earlier this month, the paper published an overview of the agency, which highlighted the discussions by former CIRM Chairman Bob Klein about another bond issue, along with the fact that the cures promised by the campaign of 2004 have not materialized. The proposed bond issue is old news for most persons who have followed CIRM; the plan has been around publicly for more than a year. But the call for more cash comes a surprise to many of in the media. And to the public. So it is likely to pop up again as other news outlets re-visit the agency from time to time.

The presence of another electoral campaign also imposes a different sort of burden on CIRM – something quite removed from such matters as the basic biology of stem cells. It means that the stem cell agency's endeavors are being evaluated in a political context, which involves such questions as whether its actions are designed to generate the millions in campaign contributions necessary to win a statewide election or whether it is neglecting valuable research for something that will instead generate a high profile result for the benefit of the campaign but not add much to the science.

It is all part of tactics and strategy involved in the "communications war" that CIRM Chairman Jonathan Thomas discussed with CIRM board members last June in his bid to win election to his post.

ACT and CIRM: Fresh Life in a Troubled California Stem Cell Courtship?

2011-12-18T22:12:00.001-05:00

Advanced Cell Technology, which has unsuccessfully sought funding several times from the $3 billion California stem cell agency, drew some attention today in a piece in a Massachusetts newspaper.

The Worcester Telegram took a look at the firm, headquartered in Santa Monica, Ca., with labs in Marlboro, Mass., in the wake of Geron's departure from hESC research. The move left ACT as the only firm in the country with an hESC trial and perhaps with a better shot at CIRM funding.

Reporter Lisa Eckelbecker wrote,

"Advanced Cell, publicly traded since 2005, has spent years developing its technologies. The company brings in little revenue and has an accumulated deficit of $180.9 million. About 1.6 billion shares of Advanced Cell common stock is outstanding, a result of numerous financings over the years. It trades for about 10 cents a share on the Over-the-Counter Bulletin Board, an electronic exchange for small companies. No analysts from major Wall Street banks report on the company.

"The company's treatment for Stargardt's macular dystrophy and dry age-related macular degeneration — the treatment that required (a) mountain of paperwork before the FDA — first went into the eyes of patients in July in Los Angeles. The retinal pigment epithelial cells, generated from embryonic stem cells, were developed to slow the progression of the eye disorders, which can lead to blindness."

ACT moved its headquarters to California following the passage of Prop. 71 in 2004, the ballot initiative that created the California stem cell agency. The company said at the time it expected to "gain significant momentum by being able to take advantage of a favorable environment for funding."

ACT initially landed in Alameda, Ca., but has since moved to Southern California. Its official opening in 2006 in Alameda was attended by the state treasurer and at least one CIRM official, according to the company. The firm has never secured funding from the stem cell agency, which does not release the names of rejected applicants. However, the California Stem Cell Report carried an item in 2008 that pointed out that a researcher for ACT complained publicly about a reviewer's conflict of interest in connection with an ACT application(see here and here). At the time, Robert Klein, then CIRM chairman, brushed off the complaint. The journal Nature has also reported that ACT has applied unsuccessfully several times for CIRM awards.

It is a fair bet that ACT was an initial applicant in the round that provided funding to Geron last spring. However, by the time Geron's application went to the full CIRM board, the other applicants had withdrawn – the first time such an event had occurred at CIRM.

Since Geron pulled out of the hESC business last month, it is likely that ACT and CIRM have opened fresh discussions, given their mutual interest in producing a stem cell therapy. CIRM also has a new chairman who is familiar with ACT. After Geron was awarded its $25 million loan from CIRM last May, the agency's board elected as chairman a Los Angeles bond financier, Jonathan Thomas, who led an early round of financing for ACT in 2000. Thomas last summer sold his remaining 17,046 shares in ACT for $3,239. Thomas said he had a "significant loss" on the sale but did not disclose the amount.

Geron's flight from hESC and ACT's perserverance come as the stem cell agency is pushing aggressively to drive research into the clinic. Plus CIRM needs tangible results that voters can understand if CIRM is win ballot-box approval for continued funding in the next few years. The agency will run out of cash in about 2017 and is considering mounting a campaign for another multibillion bond issue.

IOM Looking for New Member for Its CIRM Performance Panel

2011-12-15T10:43:00.001-05:00

If you want to serve on the Institute of Medicine panel examining the $3 billion California stem cell agency, you have a chance during the next few weeks.

The panel has lost a member because of a conflict of interest and is now engaged in the process of replacing him. The IOM will consider both expressions of interest and suggestions for candidates. Currently, the panel has no member from California, which leaves it minus an important perspective.

Christine Stencel, senior media relations officer for the IOM, told the California Stem Cell Report that the IOM expects to fill vacancy by its meeting Jan. 24 in California.

David Scadden of Harvard resigned from the IOM/CIRM panel earlier this month because of his ties to Fate Therapeutics of San Diego, which lists him as a scientific founder.

Persons interested in serving or nominating candidates can email Adrienne Stith at Astith@nas.edu.

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

2011-12-14T19:08:00.000-05:00

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.

New Multibillion Dollar Stem Cell Bond Measure Wins Endorsement with a Caveat

2011-12-12T15:23:00.000-05:00

A blogger on the web site of Los Angeles television station KNBC today supported a new multibillion bond measure for the California stem cell agency but with an interesting qualification.

Joe Mathews, author and a senior fellow at the New America Foundation, said the new bonds should be backed by a tax on the people and companies involved in the business of health care. He wrote,

"New stem cell moneys can't come out of funds that would otherwise go to other programs."

Mathews said voters "probably" shouldn't approve another multibillion dollar bond measure for CIRM that is paid back through the state's general fund. He wrote, however,

"(T)hat doesn't necessarily mean there shouldn't be another stem cell bond. California's major universities have invested in stem cell research, with help from the agency.

"Major researchers have relocated to the state. And the unknown nature of stem cell research's promise, while frustrating efforts to justify the research dollar for dollar, argues for doing more to learn more.

"What the state budget picture does require is that any stem cell bond should have a clear funding mechanism -- a specific tax or new revenue source (some sort of levy on companies and people involved in the business of health care) -- that would be more than enough to pay back any bond."

Mathews is co-author of "California Crackup: How Reform Broke the Golden State and How We Can Fix It," which declares that the initiative process is one of major fault points in California government. The initiative was used to create the $3 billion stem cell agency in 2004, making it immune from normal state government accountability and locking in funding that cannot be touched by the legislature or government despite any other financial needs of the state.

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

2011-12-10T21:25:00.001-05:00

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."