Thursday, June 30, 2011

CIRM's New Chair to Sell Stem Cell Stocks Shortly but Continue Link with Bond Firm

The new chairman of the $3 billion California stem cell agency, Jonathan Thomas, says he will soon sell his interests in a California stem cell company but will retain his financial ties to a bond investment firm, pending a double-check with the agency's outside counsel.

As part of his pitch for the $400,000 post as the chair of CIRM, Thomas, a bond financier and partner in Saybrook Capital of Santa Monica, Ca., said he led an earlier round of financing for Advanced Cell Technology, also of Santa Monica, Ca. He said he still owned a "small portion" of the company's stock and was prepared to liquidate it to avoid any conflicts. He also said he has no other "actual or potential conflicts."

The California Stem Cell Report queried Thomas via email concerning the timing of the sale and also his relationship with Saybrook. The firm posted a news release this week congratulating Thomas and declaring that it was looking forward to a continuing and flourishing relationship with him.

In response to our query, Thomas, who is being paid $400,000 a year for 4/5 time by CIRM, said,
"With respect to ACT, I will be selling my interests very shortly.  Re Saybrook, we don't buy or underwrite (nor have ever bought or underwritten) any State of California GO's (state general obligation bonds).  No conflict of any kind there.  Re severing ties with Saybrook, I have been previously advised that there are no conflicts maintaining affiliations with the firm.  Just to get additional input on both issues, though, I will check again with (the CIRM) Board counsel and advise."
(Thomas later said that no conflicts existed with Saybrook and indicated he was continuing his financial relationship with the firm.)

Advanced Cell Technology reportedly applied for a loan in the $50 million CIRM clinical trial round this spring. No action was reported on the application, but financial scuttlebutt has it that ACT is line for a CIRM loan later this year.

As for the California state bonds, the stem cell agency relies on the state to borrow money for its funding and has no other real source of cash. Saybrook specializes in distressed government bonds. Currently California has the lowest bond rankings of any state in the nation.

Prior to the election for chairman, we asked the CIRM board counsel, James Harrison of Remcho Johansen & Purcell of San Leandro, Ca., whether the board required the chair candidates, including Thomas, to file a written disclosure of financial interest. Harrison said,
"We have discussed the state's disclosure and disqualification rules with both candidates."
But he said no written disclosure was required in advance of board action.

As of this year, the stem cell agency has begun posting the state-required financial disclosure forms of its board members and top officials. Thomas is required to file his within 30 days of assuming office, which would be July 23.

As chair, Thomas will be working with the office of state Treasurer Bill Lockyer, who controls the sale of state bonds. One of the mechanisms Thomas will operate through is the California Stem Cell Research and Cures Finance Committee, a six-member body created by Prop. 71, which also created the stem cell agency. The committee determines whether it is "necessary or desirable" to sell bonds for CIRM. In addition to sitting on the committee, Thomas can appoint two members. The other members are the state treasurer, state controller and state director of finance.

In its press release on Thomas, Saybrook said,
"'JT (Jon Thomas) is the best man for the job. I’ve known him since our high school tennis days and he brings an impressive skill set to the position,' said Jon Schotz, partner at Saybrook Capital, LLC and Jon Thomas’s graduate school roommate at Yale.

"Jonathan Rosenthal, also a partner at Saybrook Capital, LLC says: 'I couldn’t be happier for JT. We’ve had a wonderful partnership and friendship for the past 20 years and expect that it will continue to flourish.'"
Sphere: Related Content

Fix on Bad Link to San Diego Editorial

We had a bad link to an editorial in the San Diego Union-Tribune in the media coverage item yesterday. You can the piece here. Sphere: Related Content

Wednesday, June 29, 2011

CIRM Media Coverage: PR Problems, Salary Issues and Bond Election

The California stem cell agency has picked up additional media coverage this week, including a Q & A on Nature magazine's web site in which CIRM's new chairman stressed the need for better PR.

Also appearing this morning was an editorial in the San Diego Union-Tribune and, earlier this week, an item in a political column in the San Francisco Chronicle.

But first the piece in Nature, written by Erika Check Hayden. It consisted of questions and answers from Jonathan Thomas, who was elected chairman last week.

Here is the first question and answer:
"Name one thing that needs to change at CIRM and one thing that the agency is doing well.

"The agency is doing a fantastic job of developing projects that are on the cutting edge of science, and going after a wide range of currently incurable diseases. The science side is a huge success.

"But the public-communication and information efforts need to be dramatically improved. The agency has done a very good job of informing the scientific media about the projects that it has funded, but I don't think it has given sufficient attention to educating the public or the elected officials that oversee the agency. So I am starting a robust public-communication programme."
Hayden also asked about Thomas' $400,000 salary, which is part of the public relations problem facing CIRM. Nature wrote,
"You will be paid US$400,000 a year. Why do you deserve a higher salary than the governor of California or the director of the National Institutes of Health?

"The voters approved the maximum salary for the position to be a little over $500,000. (clarification: Proposition 71 did not state a salary for the CIRM chair; it directed the board to set the chair's salary. The board did this 2008. See 'Salary for CIRM head despite deficit') The board felt that it was a job that would take up 80% of the incumbent's time. My feeling is that if there's somebody that you really want in the position, that somebody should be paid commensurate with what the voters approved. So 80% of $500,000 is $400,000, and I believe that salary is in keeping with voter intent."
The parenthetical clarification is from Nature – not the California Stem Cell Report – but it is an accurate description of how salaries are set at CIRM. If a $500,000 salary had been included in the ballot measure, it probably would have doomed the initiative's chances at the polls.

Thomas also discussed a possible bond election, perhaps as much as $5 billion, to provide more funds for CIRM. He also briefly discussed creation of a nonprofit organization to help reduce the size of the proposed bond issue. CIRM will be making its last grants in just four years or so, depending on its burn rate.

The San Diego editorial said that the stem cell agency is "at its most critical stage since its creation." The newspaper wrote,
"And it is our guess that many who have followed CIRM would agree that the institute’s awkward overlapping management structure, the controversies over conflicts of interest, its internal and external politicking, and the lack of legislative oversight were not what they bargained for when they voted for it."
The editorial concluded,
"Stem cell research remains one of the most exciting and important fields in medicine. With a new era beginning at CIRM, it is our hope that headlines to come can highlight the scientific successes and not the managerial failings."
 The San Francisco Chronicle's Matier and Ross column on Monday reported the election of Thomas. The column said Thomas' salary will include $250,000 in private funds, which is incorrect. The funds are public. They were donated to the state some years ago by private individuals to be used as the agency wished. Outgoing Chairman Robert Klein and the CIRM board are trying to avoid public outrage at the salary by using the funds from the donors and portraying them as non-public. Sphere: Related Content

Monday, June 27, 2011

Stem Cell Agency Seeking High Level PR Person; Salary Could Top $200,000

The California stem cell agency is seeking to hire a public relations person at a salary of up to $208,250 to peddle the good news about its efforts and pave the way for voter approval of a $3 billion to $5 billion state bond issue.

The CIRM board approved the position last week. It was promptly posted yesterday on the CIRM web site.

The job description does not mention the bond measure, but that is clearly in the minds of the board. Last week, they chose a man to head the $3 billion agency who says it is in "communications war." Jonathan Thomas, a Los Angeles bond financier, said he is embarking on a misssion to tell CIRM's "great story" and assure its continued financing.

The new PR person will work under the direction of Thomas and Co-vice Chairman Art Torres, a former longtime state legislator and head of the state Democratic Party. Torres himself has a better-than-average understanding of PR and what it takes to win elections. Torres is also chair of the CIRM board's Communications Subcommittee.

The salary for the new position, with a range from $139,048 to $208,520, is likely raise some eyebrows. It could exceed that of the head of the NIH, who earns $200,000 and oversees a $40 billion budget, but who is obviously underpaid. It is certain to exceed that of the media director for the University of California system, who earned $110,437 in 2009 and that of the communications chief at UCLA, who was paid $156,180 in 2009.  The chief communications officer at CIRM was paid $194,409 in 2010, but the new person is virtually certain to be paid more. (The salary figures were reported by The Sacramento Bee's state salary database.)

Significantly, the position – director of public communications -- is within the chairman's office and not the office of the president of CIRM, Alan Trounson. Left within Trounson's purview, perhaps only nominally in terms of its strategic direction, is scientific communications. The California Stem Cell Report has commented earlier on the difficulty of running a PR operation with a bifurcated structure.


The job description makes it clear that the new PR person will be contracting with an outside firm for additional help. The description also indicated that CIRM expects to see "quantitative and qualitative growth" in media coverage of the stem cell research effort. Sphere: Related Content

Sacramento Bee: 'CIRM Is In Trouble'

The Sacramento Bee today editorialized on the election of Jonathan Thomas as chairman of the $3 billion California stem cell agency in a commentary headlined "Salary for new CIRM chief does not bode well."

The Bee said,
"Although Thomas comes with an impressive background in the financing world, his salary adds to a management overhead that already is excessive at CIRM. Moreover, it perpetuates a dual-executive arrangement at CIRM that is unusual for a scientific institute and inevitably create conflicts."
The Bee said,
"Robert Klein II, chairman and initiative kingpin of California's stem-cell research agency, has stepped down. Given our assessment of Klein's imperious operating style, you might think that champagne corks would be flying. That is not the case.

"Although Klein no longer is acting in an official capacity, the oversight board of the California Institute for Regenerative Medicine decided last week to choose a successor with ties to Klein. To make matters worse, this new chairman – Los Angeles bond financier Jonathan Thomas – will be paid nearly $400,000 for the job."
The Bee continued,
"CIRM is in trouble. It has poured billions into research grants, but is running out of money and has shown itself to be inept at basic governmental functions. Oversight board members are frustrated that basic information about grants and board decisions can't get posted on the institute's website in a timely manner. Members of the public are even more frustrated.
Can Thomas bring a new culture to CIRM? If he can, it might – just might – justify his salary."
As of about 9 a.m. today, the editorial had drawn eight comments from Bee readers. None reflected favorably on CIRM. Sphere: Related Content

Stem Cell Agency's New Chief Heads for BIO

Jon Thomas (right) presided briefly at the end of the CIRM board meeting last week on a resolution
 honoring outgoing Chairman Robert Klein (left). Co-vice
Chairman Art Torres is in the center of the photo. 
SAN DIEGO, Ca. – The newly minted chairman of the $3 billion California stem cell agency kicks off his first full week today with a trip to the mammoth BIO convention in Washington, D.C., to spread the word about CIRM and learn about the latest the biotech industry has to offer.

Jonathan Thomas, who won his $400,000-a-year post on a 14-11 vote by the CIRM board here last week, told the California Stem Cell Report last Thursday that for the next couple of weeks he will be "generally setting up shop." The Los Angeles bond financier expects to spend some time at CIRM headquarters in San Francisco following the BIO meeting.

Once past the initial stages, he estimated that he would be spending one to two days a week in San Francisco and more as needed. He said there is "no substitute for a personal presence."

One of his priorities, he said, will be trying to "get the facts out to the public" about CIRM. In a statement to the CIRM board last Wednesday, he said the agency is engaged in "a communications war." He said CIRM's successes are not well-known.

As for the BIO convention, it is the premier biotech industry event of the year with about 15,000 attendees and 17,000 "business partnering meetings." Presumably other CIRM executives will be attending the session in addition to Thomas. Sphere: Related Content

Sunday, June 26, 2011

'A Critical Crossroads:' California Stem Cell Agency's Finances and 'Communications War'

The new chairman of the California stem cell agency, Jonathan Thomas, last week spoke more forthrightly in public about the financial condition of the research effort than we have heard from other CIRM officials.

Thomas also addressed the "communications war" involving the $3 billion research endeavor along with the dual executive arrangement at CIRM. In a conversation at last week's meeting of the CIRM board, he took issue with the coverage of the management structure by the California Stem Cell Report.  Thomas said his prepared statement would more clearly represent his position on the much-criticized arrangement.

Here are excerpts from his remarks dealing with those three areas. The full text of his remarks, which he provided at the request of this blog, can be found at the end of this item.

Thomas summarized the "huge success" story of CIRM and then said,
"Having said all that, CIRM is at a critical crossroads in its history. As the events of the past week continue to remind us, California is in a state of full-out fiscal crisis. No one knows when it will end or how it will ultimately play out. As a result, the agency faces the real possibility that it will not have timely access to the amount of bond proceeds it expected and may be forced to look elsewhere in very short order to the full funding required to meet its projected short term needs or to evaluate how to push grants out or otherwise modify expenses if that becomes necessary. And let's not kid ourselves – this problem could last for a long time. As a result the medium and long term funding questions are no less profound. As the agency enters a translation phase with the goal of getting more and more products into clinical trials, will CIRM be able to help its grantee and loan recipients get the money they need to cover this most expensive part of therapy development? Will CIRM be able to line up funding to sustain it beyond the target last award in 2017? These are huge questions. 
"On other fronts, the agency is in the middle of a communications war. In spite of its great story, the world seems to be focused on internal issues instead of the grand, big picture. These negative impressions distract from CIRM's mission and unnecessarily create adversaries where there would be many fewer if the true story were known. For that reason, CIRM must mount a robust public communications and information effort to get the message out. Front and center in any public communications stragetgy must be the patient advocates and their vast networks. These are the people that it's all about. When you tell their stories, you put a real life face on the marvelous science and cannot help but compel public enthusiasm and compassion."
On the subject of the shared responsibilities of the chair and the president, Thomas said,
"On reading the statute (Prop. 71), the positions of chair and president are designed to be complementary, not overlapping. When carried out as defined in a collaborative and respectful manner, they should together provide 100 percent of what the agency needs to be effective.

"On this latter point, some have decried having two chief executives. I couldn't agree more. If elected, I would attend to my many responsibilities and would expect (CIRM President) Alan (Trounson) to do the same. I would not look to micromanage but would instead empower Alan to handle his considerable job duties. He and I spoke on Sunday on this very issue and agreed that a complimentary, highly collaborative relationship was the best way to bring the agency towards fulfilling its goals."
Here is the full text of Thomas' remarks.
Statement by Jonathan Thomas to CIRM governing board 6-22-11
Sphere: Related Content

Nature Magazine's Brief Take on CIRM Chair Election

A Nature magazine blog has carried a brief item on the California stem cell agency's new chairman with the headline reading "Bond king elected as new CIRM chief."

The three-paragraph story by Elie Dolgin was routine although it did point out that Jonathan Thomas' parttime (80 percent) salary of around $400,000 is well above that of the $173,987 for California Gov. Jerry Brown.

The story ran June 23 on Spoonful of Medicine June 23. Sphere: Related Content

Friday, June 24, 2011

NY Times and San Diego UT on New CIRM Chair; LA Times and SF Chron Ignore Election

The New York Times and the San Diego Union-Tribune have published the most comprehensive stories on the election of Jonathan Thomas as chairman of the California stem cell agency, including brief updates on CIRM's progress.

The Times article was posted yesterday on its web site. Andrew Pollack wrote that Thomas was "taking over at a time when the state's fiscal crisis could jeopardize financing for the effort." Pollack wrote that Thomas' financial experience
"... including dealing with government bond issues, seemed to appeal to the (agency's) board. The stem cell effort is financed through bond sales so it has actually been quite well insulated from the budget deficits that have forced huge cuts to many other state programs, including the University of California system.

"Still, the state’s fiscal crisis is now impeding the ability of the state to sell new bonds. That could eventually leave the stem cell agency short of funds, though probably not until next year."
Pollack also mentioned differences between Thomas and Frank Litvack, the other candidate for CIRM chair and a Los Angeles cardiologist, concerning the dual executive arrangement at CIRM. Litvack said the chair's job should be parttime and concerned mainly with oversight. Pollack continued,
"But Mr. Thomas said there was enough work for the chairman to do full time, without conflict with the role of the president."
Pollack's story summarized the current state of CIRM's efforts with three paragraphs:
"Scientifically, it is still too early to determine how successful the program will be. Certainly, it has not yet produced the cures for various diseases that were promised to voters, but realistically it is too early to expect that.

"But from a governance point of view the agency has been criticized by consumer groups, a state commission and newspaper editorials for lack of accountability, an unwieldy structure and conflicts of interest. Many members of the board represent universities and hospitals that receive funding from the agency, though members are not allowed to vote on items that concern their employer.

"The agency is now shifting its emphasis from basic research toward testing potential new therapies in clinical trials, which means it will be giving more of its money to biotechnology companies in the future."
Darce's piece covered more of the debate about the chairmanship. Additionally, Darce wrote:
"The new chairman said he also will try to clean up the institute’s image by launching a public relations campaign focusing on the scientists who have received state funding and the work they have produced.

"'If the true nature of what CIRM does became common knowledge, then the people of California would see this as the amazing success story that it is,' Thomas said. 'They would be very proud to know that California has become the largest center for stem cell research in the world.'"
The Los Angeles Times, the state's largest circulation newspaper, and the San Francisco Chronicle (CIRM's headquarters is in San Francisco) so far have not published any stories on Thomas' election.

Science magazine has carried a brief item by Greg Miller on the election.

Here is CIRM's press release on the election. It does not mention Thomas' $400,000 salary or the actual vote, which is not unexpected for a press release, but which is basic information for a news story.

The Sacramento Bee's story yesterday has triggered 44 comments as of this morning, mostly hostile because of Thomas' salary. But the number of comments is modest compared to other, more high profile stories. Sphere: Related Content

Thursday, June 23, 2011

Public Already Commenting Negatively on $400,000 Salary for New CIRM Chair

Initial mainstream media reports about the $400,000 salary of the new chairman of the California stem cell agency, Jonathan Thomas, today promptly triggered compaints from the public.

By late afternoon, the story on The Sacramento Bee website had attracted 39 comments, many of which remarked quite unfavorably on the pay. Torey Van Oot wrote The Bee story.

One anonymous reader said, "'We' the tax payer getting screwed again with this high salary."

Also posting a story on the election of Thomas was Katie Worth of the San Francisco Examiner. Sphere: Related Content

Hand-Off at The Top

Jonathan Thomas takes oath of office. (left to right, Robert Klein, Thomas, Melissa King, executive
director of  CIRM board, James Harrison, outside board counsel)

It was a statement that could be taken in more ways than one.

It came from outgoing CIRM Chairman Robert Klein today as he swore in his successor, Jonathan Thomas, a Los Angeles bond financier.

Thomas read the prescribed oath for all state employees. Then Klein shook his hand and said,
"I congratulate you on a journey that you will never forget."
Klein said one reason he is leaving his post is to spend more time
 with his wife and family.
 (left to right, Klein and his wife, Danielle, and Thomas, following the swearing in. 

Sphere: Related Content

CIRM Directors Adjourn Meeting

CIRM directors just concluded their meeting in San Diego this afternoon with the swearing-in of newly elected Chair Jonathan Thomas. His first responsibility was to preside over the unanimous approval of a resolution honoring Robert Klein for his work and then adjourn the meeting. Sphere: Related Content

Consumer Watchdog: $400,000 CIRM Chair Salary Will Incense Public

Consumer Watchdog's John Simpson, a longtime observer of the California stem cell agency, today said that the public will be outraged by the salary of its new chairman, damaging the prospects of a new multibillion dollar bond measure for stem cell research.

Simpson, stem cell project director for the Santa Monica, Ca., organization, supported the candidacy of Frank Litvack, writing an op-ed piece May 31 in The Sacramento Bee. Jonathan Thomas, a Los Angeles bond financier, was elected last night on a 14-11 vote.

Asked for comment on the outcome of the election, Simpson said in an email,
"The election of Bob Klein's successor was an opportunity for the board to end the dysfunctional dual executive model that has plagued CIRM since its launch and move to a structure where the chair serves in an oversight capacity. All outside evaluators have advocated this.

"Instead, after considerable arm-twisting from some of the state's top Democrats, the board picked a $400,000-a year candidate, Jonathan Thomas, who plans to be deeply involved in the agency's day-to-day operations. CIRM already has one executive who makes a half-million-dollar salary, President Alan Trounson. It's pure folly to spend nearly that much again so that two overly paid executives can trip over each other in a 50-person state agency.

"By comparison Dr. Francis S. Collins, director of the National Institutes of Health, gets a salary of $199,700, according to the NIH Department of Human Resources.

"The public outrage that will result from hiring a $400,000-a-year chairman will prove to be a public relations disaster from which the stem cell agency will never recover. Those contemplating going to the public in the future to seek another bond issue should have considered the negative impact such a salary will have. Opponents of a bond initiative will have a field day.

"The board had the chance to correct CIRM's management structure and put the agency on the right track for the future. They squandered that opportunity, opting instead to select the candidate with the best political connections, and did so at considerable unnecessary expense to the public."
Sphere: Related Content

More Info on Roll Call on New CIRM Chair

We have added the following information to the earlier item today on the roll call vote on the new chair of the California stem cell agency.

Absent last night were CIRM directors Leeza Gibbons, Eugene Washington, Marcy Feit and Sam Hawgood. Feit attended the meeting this morning and said she would have voted for Thomas. She said had planned to be available to vote from a teleconference location, but could not reach it because of a transportation hang-up. Sphere: Related Content

CIRM Board Puts Off Changes in Review of Big Ticket Grants

Directors of the California stem cell agency this morning put off major proposed changes in the review process for high profile grant applications in clinical trial and disease team rounds.

Director Jeff Sheehy, chair of the directors' Science Subcommittee, sought the delay because, saying that the leadership of the committee and CIRM staff had not been able to reach a consensus on the language. There was no discussion on the matter.

Earlier this month, CIRM staff indicated some urgency existed concerning implementation of the plan. Sphere: Related Content

Trounson's Report Available Online

The California stem cell agency this morning posted the presentation of CIRM President Alan Trounson. In it, Trounson reviews recent stem cell research and briefs the board on his current priorities. During the meeting, board member Jon Shestack noted the importance of posting the material and its importance in communicating about CIRM's direction. Sphere: Related Content

Roll Call on Election of New CIRM Chair

Here is the roll call on the 14-11 vote last night electing Jonathan Thomas as the new chair of the California stem cell agency. All members who were available voted. There were no abstentions.

Voting for Thomas were Floyd Bloom, Jacob Levin (alternate for Sue Bryant), Michael Friedman, Michael Goldberg, Philip Pizzo, Stephen Juelsgaard, Robert Klein, Sherry Lansing, Robert Quint, David Serrano Sewell, Jeff Sheehy, Jon Shestack, Oswald Stewart, Art Torres.

Voting for Frank Litvack: Robert Price (alternate for Robert Birgeneau), David Brenner, Ted Love, Bert Lubin, Sholmo Melmed, Claire Pomeroy, Francisco Prieto, Carmen Puliafito, Duane Roth, Joan Samuelson, Kristina Vuori

Absent were Leeza Gibbons, Eugene Washington, Marcy Feit and Sam Hawgood. Feit attended the meeting this morning and said she would have voted for Thomas. She said had planned to be available to vote from a teleconference location, but could not reach it because of a transportation hang-up. Sphere: Related Content

Stem Cell Directors Resume Meeting in San Diego

Directors of the California stem cell agency  resumed their meeting this morning in San Diego with a presentation by CIRM President Alan Trounson on his priorities and review of recent research. He began with a report on a a piece in Nature Biotech about public perceptions of stem cell research, which shows strong support for the endeavor. Robert Klein is conducting the meeting. Newly elected Chair Jonathan Thomas is seated at the directors' tables. Klein's resignation does not officially take effect until tomorrow. Sphere: Related Content

Thomas Reacts to Vote News

Jonathan Thomas was not in the room late last night when directors of the California stem cell agency voted to elect him to a six-year term as chairman of the $3 billion research endeavor. He was elsewhere in the hotel in San Diego. Directors went on to some minor business as they waited for his return. Shortly after he and his wife were seated in the audience, outgoing Chairman Robert Klein reiterated the vote and Thomas received a standing ovation. In this photo, Thomas is applauding in return. His wife is seated. In the background is Frank Litvack(with glasses), who lost the election for the chairmanship. Sphere: Related Content

Race for the Chair: Political and Financial Pressure Help Thomas Win CIRM Chairmanship

SAN DIEGO, Ca. –- Directors of the $3 billion California stem cell agency late yesterday evening elected Los Angeles bond financier Jonathan Thomas as chairman of the unprecedented research enterprise as it strives to fulfill seven-year-old campaign promises to turn stem cells into cures.

The board voted 14-11 to choose Thomas over Frank Litvack, a cardiologist/businessman, also from Los Angeles. The vote came with no debate following a three-hour closed session. Each candidate appeared separately in private, followed by a discussion among board members, also in private. Only one member of the public spoke out on the election during the public portion of tonight's meeting, during which each candidate read a statement.

The California Stem Cell Report was told that Gov. Jerry Brown's office called six members of the CIRM board during the past two days and managed to switch some members from Litvack to Thomas. The governor's office did not respond to queries about the matter.

Outgoing Chairman Robert Klein said the key factor in the vote was the state's current financial crisis and its possible negative impact on CIRM, which depends solely on state bonds for cash. Earlier Thomas sounded an alarm about CIRM finances, telling directors it was necessary to move to assure financial stability. CIRM faces both short and long term financing problems. Thomas could be the last chairman of CIRM unless he and the board devise a way to finance it beyond 2018, roughly the date when the agency runs out of money.  (For more on Thomas' remarks, see here.)

Klein told the California Stem Cell Report that Thomas would be paid something in the range of $390,000 to $395,000 annually for 80 percent time on the job. (The agency later said the correct figure is $400,008.)

Thomas is chairman and co-founder of Saybrook Capital of Santa Monica, Ca. The firm specializes in distressed government bonds. The current state budget crisis in California has left the state with the worst bond rankings of any state in the nation. State Treasurer Bill Lockyer, who controls the sale of state bonds, and the governor and lieutenant governor all nominated Thomas.

On Monday Lockyer sent a strong letter to his five appointees to the CIRM board urging them to vote for Thomas. He said the bond financier was the only candidate with a "complete toolkit" for the job. Lockyer stressed Thomas' background in bond financing.

Unless CIRM receives funds from a fresh bond sale, it will run out of cash in the middle of next year. However, the state is limiting its bond sales because of its budget crisis. CIRM will face tough competition to have its bonds placed in the two sales rounds expected to come up in the next 12 months. .

Some observers interpreted Lockyer's letter as a veiled warning to the entire 29-member board to approve Thomas, with the letter implicitly raising the possibility that the agency could come up short in the next bond rounds.

Longer term, CIRM has only about $1.4 billion or so to hand out for grants or loans. Klein has touted a $3 billion to $5 billion bond measure that would be presented to voters sometime during the next few years. To win support of the proposal, the agency will need a record of substantial accomplishment that resonates with the public.

During Thomas' six-year term, the agency will also have increasing responsibilities for monitoring its massive and growing grant portfolio. The task will become more challenging with larger and more complex grants and loans that have achievement benchmarks that must be met. If not, CIRM is supposed to withdraw its cash. At the same time, the agency continues to wrestle with its computerized grant management system.

To accomplish its goals, CIRM is working ever more closely with the biotech industry. Some industry executives have been dismayed at the tiny fraction of funding that has gone to businesses. A blue-ribbon review panel last fall cited the need to bolster funding for industry. At the same time, the taxpayer-funded agency must assure that the state receives full value for its dollar.

Litvack also had a blue-ribbon business resume along with a record of scientific accomplishment. One description calls him a "serial entrepreneur." He was CEO of Conor MedSystems of Menlo Park, Ca., when it was sold a few years go to Johnson &  Johnson for $1.4 billion. More recently he has been involved with Pervasis Pharmaceuticals and Capricor, Inc.

Litvack touted his scientific and business experience in developing new products and running the FDA gauntlet. State Controller John Chiang, who recently gained national attention for cutting off the pay of California legislators because they failed to pass a balanced budget, nominated Litvack. Chiang said,
"Litvack knows from personal experience what it takes to develop new medical technologies and move them through the regulatory process to adoption in the market place."
Sphere: Related Content

Wednesday, June 22, 2011

Thomas Elected New Chairman of CIRM

Jon Thomas was elected chairman of CIRM on a 14-11 vote. More to come. Sphere: Related Content

Board Resumes Public Session

The CIRM board just came back into public wsession after about three hours of meeting in private. Sphere: Related Content

CIRM Directors Still Mulling Chair Selection Privately

The two candidates for the chairmanship of the California stem cell agency appeared separately and in private before the organization's directors tonight. Their appearances have concluded. Directors have now been huddled behind closed doors for about two hours. The staff and and the two candidates are all gathered in the public  meeting room, chatting in small groups.. Sphere: Related Content

CIRM Board Goes Behind Closed Doors

The CIRM  board has gone into executive session following presentations by the two candidates for chair. It is unclear when the public session will resume. Sphere: Related Content

Thomas Stresses His Bond Expertise, Cites State's Dicey Financial Condition

Jonathan  Thomas, a candidate for chair of the $3 billion California stem cell agency, tonight hammered away at the value of his bond financing experience and what it could bring to the survival of the research enterprise. 

Speaking to the CIRM board, Thomas, a Los Angeles bond financier, hit on many of the themes sounded by state Treasurer Bill Lockyer in his letter on Monday. Lockyer nominated Thomas for the post. In his letter, he said Thomas was the only candidate who had a "complete toolkit" for the job. 

In his comments, Thomas repeatedly said he had "all" the qualifications for the job. Lockyer, in fact,  underlined all in his letter when he referred to Thomas' qualifications.. 

Thomas spoke candidly about CIRM's financial condition. He asked whether CIRM will have funds available after 2017, a reference to CIRM projections that its $3 billion will run out about then. Thomas said the state is in a "full out fiscal crisis." As a result, a "real possibility" exists that CIRM will not have "timely access to the funds it needs."  He said the the agency may have to look to other sources of funding.  

"Let's not kid ourselves. This problem could last for a long time," Thomas said. 

The board has not heard that sort of candid public comment about its finances recently, although the warning signs have been there for some time. 

Thomas also addressed the dual executive issue. He said the CIRM chairman and president should have complementary positions -- not overlapping. He said he spoke with CIRM President Alan Trounson on Sunday and would expect to have a complementary, highly collaborative arrangement with him. 

Thomas brought up the statement by Frank Litvack, the other candidate for chair, that he would serve in a parttime role. Thomas said the position demands more time than that offered by Litvack. 

We have asked Thomas for a copy of his remarks. He said his only copy was marked up and said he would provide one tomorrow. 


Sphere: Related Content

Text of Litvack's Statement to CIRM Board June 22, 2011

Here is the text of Frank Litvack's remarks this afternoon to the directors of the California stem cell agency. Litvack is a candidate for chair of the agency.
Litvack statement to CIRM board June 22, 2011 Sphere: Related Content

Race for the Chair: Litvack Discusses "Black Box" of Bond Financing

SAN DIEGO, Ca. – Los Angeles cardiologist and businessman Frank Litvack tonight made a final pitch to directors of the California stem cell agency to become the next chairman of the $3 billion research effort.

In remarks prepared for delivery, Litvack stressed his business experience during which he said he raised hundreds of millions of dollars. He noted that his enterprises were all high risk ventures and were not "back-stopped by the faith and credit of the state of California," a reference to the state bond funding behind CIRM.

He also reviewed his work in developing new products and his dealings with the federal agencies that regulate them.

Litvack reiterated much of what he has told the board previously, including his commitment to serve as more of an oversight chairman rather the engaging in day-to-day management. Prop. 71, which created the stem cell effort, set up a much-criticized dual executive arrangement with overlapping responsibilities for the chairman and president.

Litvack also addressed the "black box" issues raised by state Treasurer Bill Lockyer and others concerning the need for bond financing experience. (See here and here.)

Litvack said,
"In the spectrum of financial instruments, state bonds are not considered complicated. In fact, they are among the most simple."
He reviewed the current state financial situation and how state bonds work. Come next spring, Litvack said,
"Should the unthinkable happen, as it occasionally does, and there is no (state) budget by next year, then CIRM will need to assume the mentality of a start-up venture and get creative....One might consider a private placement (of bonds) if permitted. As with any form of financing, it is not the mechanics that is rate-limiting. Rather it is the ability to clearly articulate the vision to the prospective investors."
Other new proposals surfacing in Litvack's remarks included:
  • CIRM-sponsored meetings between venture capitalists and promising stem cell companies to help generate much-needed funding for the businesses.
  • Possibly selling industrial development bonds, which are aimed at building businesses in a particular region, to help finance clinical trials.
For more on Litvack's background and previous statements, see here and here and here. Sphere: Related Content

CIRM Directors Approve $27 Million Training Effort at State and Community Colleges

Directors of the California stem cell agency this afternoon approved a $27 million extension of a training program at California state and community colleges. CIRM staff said the program supports 160 trainees a year at 16 institutions. The extension will cover a three year period. The vote was 7-0.. Nineteen of the 29 CIRM directors were not able to vote or participate in discussion of the proposal because of conflicts of interest. Sphere: Related Content

$47 Million Training Extension Approved

On a 6-0 vote, directors of the California stem cell agency this afternoon approved a $47 million extension of a scientific training program at the state's universities and research institutions.  Only seven members present at the meeting were eligible to vote on the matter. The board has 29 members. The others were disqualified because of conflicts of interest. Sphere: Related Content

An Example of Conflict of Interest Issues at CIRM

The $47 million training program extension now being debated by the directors of the California represents a good example of the conflicts built into the California stem cell agency.

The board has 29 members. Twenty are barred from participating in the debate or voting  because of conflicts of interest. Here is a list of the institutions that stand to receive funding under the extension. Sphere: Related Content

CIRM Directors Start Chair Election Meeting

SAN DIEGO -- Directors of the California stem cell agency began their meeting this afternoon with a discussion of a $47 million extension of a training program. The meeting is well-attended by board members but probably has less than 10 members of the public in attendance. I chatted briefly with Jonathan Thomas, a candidate for the position of chair, briefly prior to the beginning of the meeting. He said the California Stem Cell Report has not reported his position accurately concerning the responsibilities of the chair and the president. We have described the structure as a dual executive with overlapping responsibilities for the chair and president and said that Thomas supports that sort of arrangement. We did not have time to cover the subject properly before the start of the meeting.  Thomas said he will address the structure in his presentation to the board later this afternoon or evening. Sphere: Related Content

Live Coverage of CIRM Chair Election Tonight

The California Stem Cell Report will provide live coverage tonight from San Diego of the election of a new chairman for the $3 billion California stem cell agency. The two candidates are scheduled to make presentations about 5 p.m., but that could change.  The public can tune into the discussions via the Internet. Directions for the link can be found on the meeting agenda. Public teleconference locations can be found in Pleasanton and Los Angeles. Specific addresses are on the agenda. The teleconference locations can be used by the public to make comments to the board. The Internet audiocast is listen only. Sphere: Related Content

Race for the Chair: Blowback, Politics and CIRM Financing

A strongly worded letter from California state treasurer Bill Lockyer concerning this week's election of a new chairman of the state's $3 billion stem cell agency could be triggering a bit of blowback for the candidate backed by Lockyer.

The letter advised all five of Lockyer's appointees that he is a vigorous supporter of Jonathan Thomas, a Los Angeles bond financier who was nominated for the chairmanship by Lockyer, the governor and lieutenant governor, all Democrats. The only other candidate is Frank Litvack, a Los Angeles cardiologist and businessman, who was nominated by the state controller, also a Democrat. The 29-member CIRM board meets late this afternoon in San Diego to choose between Litvack and Thomas.

Lockyer's preferences carry more than normal weight for the entire CIRM board because he is the gatekeeper on the sale of state bonds, the only real source of cash for CIRM. Lockyer becomes even more important since the agency will need a fresh dose of funding by next spring. The state plans to limit its bond sales during the next 12 months because of its ongoing financial crisis. CIRM is likely to face stiff competition for being placed in the bond rounds when they do occur.

Lockyer's letter disturbed or angered some CIRM board members, based on what the California Stem Cell Report has learned from a variety of sources. But none of the five Lockyer appointees responded to queries.

Political inteference – and nasty at that – was one reaction. Is Lockyer trying to tell the board that CIRM financing would be endangered if his candidate is not approved, wondered another board member.

One thought Klein engineered the letter. However, Klein and Lockyer are not on the best of terms, we understand. Another thought CIRM co-vice chair Art Torres, who is close to Lockyer, could have had a hand in it. Our own speculation is that Lockyer, like any successful politician, wants to see his candidate win and is willing to do what he thinks it takes to produce a victory. Other factors as well could have entered into it.

While the letter has triggered strong negative reaction, it is not clear whether it has changed the positions of fence-sitters. It could have a reverse effect for Lockyer, given the reaction of some board members in the past to other efforts at what they regard as outside intrusions into CIRM affairs.

Rumblings persist that CIRM Chairman Robert Klein, a real estate investment banker, continues to work on behalf of Thomas. However, CIRM's outside counsel, James Harrison, has strongly denied that on behalf of the outgoing chairman. Klein, however, is reportedly once again talking about the private placement of CIRM bonds and the need to have a chairman who could do that.

One board member reflected on Klein's unsuccessful attempt last fall to engineer the selection of his own successor. The pitch then was "science science science." The CIRM director said,
"Now it is bonds bonds bonds, legal legal legal. Full time is the only way possible and paid paid paid, and the only way CIRM can be governed is as it was written in the gospel of Prop. 71."
The reference to fulltime and paid is to Thomas' reported desire for a salary in the range of $400,000-plus, working at 80 percent or more time. Litvack says he would work parttime for a salary around $137,000. Another separation point on the men is Thomas' apparent support for continuing the much-criticized dual executive arrangement at CIRM while Litvack has indicated he sees the chairmanship as much more of an oversight function. Of the two, Litvack has a stronger scientific background while Thomas has more experience in bond financing.

One question arose about the public nature of Lockyer's letter with more than one board member saying the treasurer could have delivered the same message to his appointees privately with a phone call, letter or email. Copies of the letters were emailed Monday to the California Stem Cell Report by the treasurer's office. We have a standing request into the treasurer's office and others for any information regarding the chair election.

As for the politics in the matter, Thomas is reportedly being backed by by former California state Treasurer Kathleen Brown, who is now chair of investment banking for the Midwest for Goldman Sachs. She is also sister of California Gov. Jerry Brown and a personal friend of the candidate. The governor nominated Thomas for the post in a terse, 56-word letter. Thomas also reportedly has the support of Congressman Howard Berman, a longtime West Los Angeles Democratic politician.

Klein, who controls the CIRM board agenda, has allotted only 30 minutes for public presentations and public comments by the candidates beginning about 5 p.m. tomorrow. Then comes an executive session, allotted about 60 minutes, after which the formal public vote would be swiftly taken. The CIRM board agendas are always full, but the one for the meeting this week is especially jammed with major items. Several board members are not pleased with the tight schedule and wonder whether it is part of an effort by Klein to limit discussion and ensure favorable action on Thomas. Sphere: Related Content

Tuesday, June 21, 2011

CIRM's Trounson Has Month-Long Gig in Australia in July 2012

The Australian Centre for NanoMedicine has announced that the president of the $3 billion California stem cell agency, Alan Trounson, will be spending July 2012 as its "visiting professor."

The announcement apparently came as a surprise to some directors of the state's research program, which paid Trounson $490,118 in 2010. There was no date on the announcement but it appears to have been placed on the Internet sometime this spring.

The center is part of the University of New South Wales and was formed in April 2010. Trounson, who emigrated from Australia to take the CIRM post, is the second visiting professor in the program.

The center's announcement did not specify whether Trounson would be paid for his stint in Australia next year. Nor did it explain his exact duties. The center has at least one very slight connection to CIRM. Geoff Symonds, a longtime Australian researcher and chief scientific officer of Calimmune of Tucson, Az., made a presentation at the center's international conference last June 30-July 2. Calimmune, whose founders include former CIRM director, Nobel Laureate David Baltimore, shares in a $20 million grant with Irvin Chen of UCLA.

For more on Calimmune, see here and here.

We are querying CIRM for more information on Trounson's commitments in July 2012. Sphere: Related Content

Election Night Coverage Planned for CIRM Chair Balloting

The California Stem Cell Report will provide live coverage tomorrow and Thursday of the election of a new chairman for the $3 billion California stem cell agency. The election is scheduled for Wednesday evening with the two candidates to make presentations about 5 p.m., but that could change.  The public can tune into the discussions via the Internet. Directions for the link can be found on the meeting agenda. Public teleconference locations can be found in Pleasanton and Los Angeles. Specific addresses are on the agenda. The teleconference locations can be used by the public to make comments to the board. The Internet audiocast is listen only. Sphere: Related Content

Monday, June 20, 2011

State Treasurer Boosts CIRM Chair Candidate with Strong Letter of Support

California State Treasurer Bill Lockyer today urged his five appointees to the board of the $3 billion state stem cell agency to vote this week for a Los Angeles bond investor as the new chairman of the research enterprise.

In a robustly worded letter, Lockyer said Jonathan Thomas, chairman of Saybrook Capital of Santa Monica, Ca., is the only candidate to have the "complete 'toolkit'" to meet the legal and other criteria for the job.

Lockyer, who holds the key to CIRM's financing, and two other state officials nominated Thomas in May. In his letter, Lockyer particularly stressed Thomas' background in state bond financing. California state bonds are the only real source of cash for the agency. Thomas' firm specializes in distressed government bonds. California's bond rating is the worst of any state in the nation.

The other candidate to replace outgoing Chairman Robert Klein is Frank Litvack, a Los Angeles cardiologist and businessman. Litvack was CEO of Conor MedSystems of Menlo Park, Ca., when it was sold in 2006 for $1.4 billion. Litvack, who has been described as a serial entrepreneuer, says he has raised tens of millions of dollars for various companies.

The election for the new chair is scheduled to be held Wednesday evening at the meeting of the 29-member CIRM board in San Diego.

If this were a normal political situation, Lockyer's letter would be considered a direct order to his appointees. Failure to comply could mean a request that the appointee resign. However, this is only the second election for CIRM chair. And the research enterprise is quite removed from the normal political environment.

Lockyer, however, runs the sale of state bonds, which are CIRM's life blood. The stem cell agency will need a fresh fund transfusion no later than next spring.

Lockyer said in his letter (see the full text below) that all – and he underlined all – the legal criteria should be given full consideration. Lockyer specifically mentioned "direct knowledge and experience in bond financing," which he also underlined and parenthetically noted "emphasis mine."

Lockyer said that the legal requirements "must govern" the selection of the chair. If the criteria are missing, Lockyer said that the chairman "simply cannot independently fulfill the oversight responsibilities of the position, much less the very significant responsibilities" of dealing with bond financing and government relations.

The state treasurer told his appointees that his letter was the first time he had contacted his appointees to board. He said he did so today only because he felt so strongly about Thomas.

Here is the text of the letters to all five CIRM board members appointed by Lockyer: Michael Goldberg, Michael Friedman, Francisco Prieto , Floyd Bloom and Robert Quint.
Lockyer Letter to ICOC Appointees Supporting Thomas 06-20-11 Sphere: Related Content

Coming Up This Week

The California Stem Cell Report will be providing live coverage Wednesday and Thursday of the election of a new chairman for the $3 billion California stem cell agency. We will also have comprehensive coverage of additional issues from the meeting site in San Diego. The public can tune into the discussions via the Internet. Directions for the link can be found on the meeting agenda. Public teleconference locations can be found in Pleasanton and Los Angeles. Specific addresses are on the agenda. The teleconference locations can be used by the public to make comments to the board. The Internet audiocast is listen only. Sphere: Related Content

Sunday, June 19, 2011

Right Medicine for CIRM: Front Page Paean to Stem Cell Research

The California stem cell agency scored another PR plus a couple of days ago with a glowing, front page story in the San Francisco Chronicle that basically left readers thinking stem cells are the fountain of youth.

It is the type of coverage that the agency needs to persuade California voters to borrow another $3 billion to $5 billion and place it the hands of the small band at CIRM HQ on King Street in San Francisco to give to researchers.

The story had all the earmarks of being generated by CIRM. If it wasn't, it should have been. It was a nifty paean to the virtues of all manner of stem cell research. It included a solid quote from CIRM President Alan Trounson. And all four of the researchers named in the article are recipients of CIRM grants.

Written by Chronicle reporter Erin Allday, the article's first paragraph said,
 "It may not be as sexy as curing cancer or repairing devastating spinal cord injuries, but the science of aging — and what researchers might be able to do to slow down or even reverse some of the worst effects of getting older — is taking off in the stem cell industry."
The piece cited research by Thomas Rando of Stanford and said,
Stanford's Thomas Rando -- stitching old and young together
"Even if stem cells don’t add decades to human life, they might give people many more productive years in their 70s, 80s and beyond, Rando and other scientists say. 'With aging, there are a lot of systems that start to become less efficient or break down or be more inclined to diseases. We may work out ways to provide stem cells that would enable people to remain vigorous,' said Alan Trounson, president of the California Institute for Regenerative Medicine. "
The story continued,
"'The idea has always been there, the fountain of youth you could get at if you were constantly replacing old cells with new cells,' said Dr. Deepak Srivastava, head of cardiovascular and stem cell research at the Gladstone Institutes in San Francisco."
This paragraph caught our eye and conjured up an amazing image when we thought about its direct application to humans.
"In 2005, (Rando) stitched together two mice — one young, one old — to join their circulatory systems. After awhile, the stem cells in the old mouse were healthier and more active, leading scientists to believe that the younger blood and tissue from the young mouse were invigorating the stem cells in the old one."
In 2008, Amy Adams, then of the Stanford PR staff but now with CIRM, also wrote about the implications of Rando's research in a piece in Stanford Medicine magazine. She explored more of the scientific implications and limitations about sharing blood via stitching or otherwise. A sidebar to her main piece said,
"A lack of scientific grounding won't thwart anti-aging hucksters, says David Magnus, director of the Stanford Center for Biomedical Ethics. 'I can easily imagine a company starting up in another country based on Rando's findings,' Magnus says."
In fact, dubious stem cell marketing pitches are already well underway. We encountered one advertising on Google while doing research for this story. It was from a company in the Phillipines that offers treatments for breast augmentation and erectile dysfunction.  Our readers may even find ads like that on this blog, placed there by Google's automated system.

One downside to the impact of Chronicle story: It is behind a paywall and hasn't shown up in ordinary Google searches or alerts. We are in debt to Wesley J. Smith, whose blog post on the Chronicle story called it to our attention.

Smith, an attorney and author, is no friend of CIRM. His item yesterday described the $3 billion agency as "arrogantly managed and wildly expensive." Smith wrote,
"I suspect that the CIRM and its supporters are gearing up for a very expensive–pull out all the stops–PR drive to resell stem cells as the  cure all, as the once Golden State turns to pyrite.  Since they don’t have any real cures to point to, they plan to seduce with vaguely timed promises that stem cells will allow us to run marathons when we are eighty and make love at 90 like we were 25 and hormonal–the old quest for a fountain of youth updated for the scientific age."
Nonetheless, stories like one in the Chronicle are the right medicine for CIRM if it wants to live to a ripe old age. Sphere: Related Content

Saturday, June 18, 2011

CIRM Director Samuelson on Laggard Information: 'It's crazy. It isn't professional. It bugs me.'

Failure of the $3 billion California stem cell agency to make information available this month in a timely fashion led one of its directors to vote against major changes in its grant review procedures and abstain on another $30 million grant proposal.

Joan Samuelson
The director involved is Joan Samuelson of Healdsburg, Ca., an attorney and patient advocate member of the 29-member board. The occasion was the June 6 meeting of the directors' Science Subcommittee. Ironically,  one of the proposals involved would mandate greater advance notice to some grant applicants about issues on their applications than the advance notice that the CIRM board itself receives on matters it is considering. The other item  would create a new, $30 million "opportunity fund."

Both proposals were not made available to the public until Saturday June 4 for a meeting Monday June 6. Members of the Science Subcommittee apparently did not receive information about the matters any sooner than the public. Samuelson's reaction to the laggard performance was stronger, but not isolated from complaints heard in the past from some directors about late information. (See here for a discussion of problems with CIRM openness.)

Here are excerpts of what Samuelson, other directors and CIRM staff had to say June 6, according to the transcript, which was posted two days ago with little notice -- standard policy for CIRM.
Samuelson: "This is going to feel like the bad kid at the birthday party. I think we have to go back to the beginning and just acknowledge that we didn't have time to reflect on this stuff. The beginnings of the agenda came on Friday, and there wasn't -- at the end of the day and then we were getting stuff just a few hours ago.

"So I'm hoping we're not going to make any permanent decisions or recommendations to the (governing board) until we've had some time to reflect on it. And in part that's because it seems to me there's some questions about whether this changes programmatic review, whether it changes the nature of the (grant review group), and the way that the patient advocates are involved in it. It excludes them from participation in at least one place."
Outgoing CIRM Chairman Robert Klein pressed for action on the matter. He said a "number of board members" asked that it come to the full board in June.

Ellen Feigal, CIRM vice president for research and development, responded, generating the following exchange:
Feigal: "Frankly, we're not going to be able to try this out until next year."

Samuelson: "Then, for goodness sakes, let's wait till the next board meeting."

Feigal: "Well, we don't need to wait. I think --"

Samuelson: "If it was in such a rush, why didn't we get the material earlier? We should have some kind of timetable."

Feigal: "I think what we're trying to do is be responsive to the board and to -- at our last review group meeting, we had told people that we were going to do this in due diligence, and we tried to pass this forward. So just let us know how --"

Samuelson: "I'd like two weeks notice for any changes in the process."

Jeff Sheehy(chair of the committee): "I have a motion on the floor, and I'd like to get a second, and then I'm going to take public comment."
The discussion continued with more comment about how some board members wanted to consider the proposal while the problems with the clinical trial round were fresh in their minds.

Feigal then said that the proposal would have to go out to affected parties before this fall.
Feigal: "If we don't present it (to the board)in June, we don't have much time.

Samuelson: "I'm going to have to vote against it, and I don't want to do that. I just feel like in good conscience, I need to feel like the process was deliberative enough, and I just don't feel that way."
CIRM President Alan Trounson said he had brought the matter up a year ago and has been talking about it to board members for a "long time."
Samuelson said: "Jeff, could you add to the agenda a discussion of the timetable for bringing materials to the subcommittee?"

Sheehy: "I take responsibility for the delay in getting materials for it, Joan."

Samuelson: "We're going to in a minute be voting on something that I didn't have any time to look at at all because it arrived about an hour ago."

Sheehy: "I understand. I understand. we're trying. all of us –"

Samuelson: "I'm not complaining as long as I'm not obligated to make decisions on it in real time. It's crazy. It isn't professional. It bugs me. so I think -- if we can't be sure that staff will get it to us, then we've got to set a time frame."

Sheehy: "I think it's something we can discuss at the next subcommittee meeting."
Pat Olson, executive director of scientific activities, subsequently addressed the matter, declaring:
"Joan, I do apologize for the delay in getting the materials out. That was actually my fault. I'm not going to let Jeff take the blame for that. And I apologize because I've been working on getting an RFA out. So there is a lot of things going on right now. So that's wholly my problem, and I take full responsibility for it. Nonetheless, I think that the dialogue here should be helpful in essentially clarifying things."
Sphere: Related Content

CIRM Posts Details of Change in Big Ticket Grant Reviews

The California stem cell agency has added substantial amounts of additional information to its agenda for its board meeting next week, including a proposal that will make significant changes in the reviews for its important clinical trials and disease team rounds.

The additional material was posted late yesterday, only two business days before the meeting that begins next week in San Diego. As we noted yesterday, the dilatory postings do not serve the public, the California stem cell community, the agency or its directors well. One CIRM director, Joan Samuelson,  says laggard postings at CIRM are "crazy" and unprofessional.

"It bugs me," she told other directors earlier this month.

The new review procedures would involve grants or loans in the roughly $20 million and up range. They would provide an opportunity for applicants to comment on reviewer questions in advance of the formal peer review meeting. They would also allow reviewers to question applicants by telephone on the day of the review. The procedures grew out dissatisfaction by some board members with the process in which Geron was loaned $25 million in May.

The Geron funding represents CIRM's first entry into clinical trials. The agency is expected to be involved in more clinical trials as it tries to push stem cell therapies into the marketplace. The agency is seeking to produce results that would persuade voters to approve another bond measure – perhaps as large as $5 billion – to continue CIRM's efforts.

Ellen Feigal, CIRM's new vice president for research and development, told a panel of CIRM directors earlier this month that the new procedure is aimed at "making sure we have complete information in real time about the research grant." She said the changes are designed "to make sure that the investigators, the applicant, actually feel that they have an opportunity to address some of the difficult questions that could arise during the review process."

Her comments were made at the directors' Science Subcommittee meeting June 6. The transcript of the session, which is worthy of review by all potential CIRM applicants, was released two days ago with little notice, which is standard procedure for CIRM.

The review changes call for scientific reviewers to complete their initial review of applications 14 days in advance of a review meeting along with a list of key questions. The questions, plus any additional issues that CIRM staff has, would be go to applicants 10 days ahead of the review to give them time to respond. Applicants would be asked to be available by phone on the day of the review for any additional questions.

The discussion at the committee meeting largely involved details in execution of the plan and whether reviewers would pose questions directly to applicants. The answer was no, that some other person would pose the questions to avoid possible identification of scientific reviewers, whose identities are kept secret by CIRM.

Also discussed was the nature of the questions – whether they would involve nuanced matters or matters that could be addressed with a yes or no. From the committee's discussion, it was clear that this initial effort will be a testing ground to work out exactly how the new procedure will be implemented.

Other information freshly available on the agenda for next week's meeting involves:

  • An $80 million grant program, beginning next year, for physician scientists to conduct research that will translate into possible applications.
  • A $30 million "opportunity fund," controlled initially by the CIRM president, to accelerate development of therapies and implement a recommendation of last fall's blue-ribbon external review panel and assist industry.
  • A $27 million, three-year extension of a training program involving California state colleges(but not the University of California) and community colleges.
  • A job description for CIRM's new director of public communications, who apparently would run the agency's PR efforts from the chair's office as opposed to the president's. The post is part of a reorganization of CIRM management.
(Editor's note: An earlier version of this item did not contain the comments from Joan Samuelson.)
Sphere: Related Content

Friday, June 17, 2011

Openness Failure – Public Stiffed on Major California Stem Cell Matters

With only two business days remaining before a critical directors' meeting of the $3 billion California stem cell agency, the research institute has failed to provide basic background information to the public and the California stem cell community on many of the issues to be decided.

The CIRM openness failure makes it nearly impossible for researchers and biotech business executives and the public to make thoughtful suggestions or raise questions before the matters will be approved at the meeting next Wednesday in San Diego. The failure is not a onetime breakdown. It is the latest in a years-long demonstration of mismanagement of what should be a routine task. The dearth of information additionally damages CIRM's ability to generate the kind of positive news stories about its efforts that directors increasingly desire. 

The matters involved next week are not picayune. One involves major changes in the peer review process on applications for big-ticket, high profile grants ($20 million or so) on which CIRM is staking its future as well as the actual clinical development of stem cell therapies. The proposal will immerse CIRM ever more deeply in the earliest stages of grant applications. Some candidates will benefit. Others will lose out. But no details are available via the board meeting agenda about what exactly is under consideration.

Another matter with missing information involves creation of a $25 million "opportunity fund" that would be controlled by CIRM President Alan Trounson – not the CIRM board. Another involves extension of a $90 million training program. Still another involves a new, $180,000 federal lobbying campaign – a subject that generated some controversy two years ago.

Persons who understand the murky navigational nuances of the CIRM web site might be able to ferret out some outdated information dealing with the issues. But one cannot assume that two- and three-week-old memos, some of which are quite scanty, represent exactly what will be presented to CIRM directors next week.

This is not a problem for the public alone. Some CIRM directors have complained that they have received documents too late to examine them carefully. It is clearly unreasonable to expect the 29 persons (business executives, medical school deans, physicians and so forth) who serve on the board to push aside all their other concerns to perform a last minute study of material that should have been provided days earlier.

The responsibility for this sad state of affairs rests clearly with CIRM Chairman Robert Klein and CIRM President Alan Trounson. Klein controls the board agenda. Trounson is responsible for the staff work necessary to generate most of information. Klein's staff generates the rest.

One can only hope that the election of a new chair next week and revision of the CIRM management structure will also mean a major improvement in a critical interface between a $3 billion enterprise and the people who are paying for it – not to mention Californa's entire stem cell research community.  
Sphere: Related Content

Race for the Chair: A Reading List on Selection of a New Chairman of the $3 Billion California Stem Cell Agency

Jonathan Thomas (left) and Frank Litvack
Here are links to information concerning the selection of a new chairman of the $3 billion California stem cell agency, including items on the California Stem Cell Report and documents posted by the state's stem cell agency. It is not a complete compendium, however, of all news coverage or CIRM documents. Links within the articles will take you to additional information, including primary source material. The links to items on the California Stem Cell Report are excerpts and headlines from the actual item. (This list was updated June 22.)

Criteria for the chairmanship

March 22, 2010
Trounson's Criteria for New CIRM Chairman
CIRM President Alan Trounson has offered in writing his thoughts on the qualities that should be reflected in a person who may succeed Robert Klein as chairman of the $3 billion stem cell research effort next December.

March 4, 2011 -- Outgoing Chair Robert Klein's lengthy memo on the role of the chair.

March 10, 2011
CIRM Directors Move to Alter Role of Chair of $3 Billion Stem Cell Program
Directors of the California stem cell agency, in sharply divided moves, today said that its next chairman should serve in a part-time capacity in largely an oversight role.


Candidate Statements
The June 5 and June 6 items below carry verbatim statements from the two candidates that can only be found on the California Stem Cell Report.

June 5, 2011
Litvack Envisions Oversight Role for CIRM Chair, Shoring Up 'Messaging' and Industry Ties
Los Angeles cardiologist/businessman Frank Litvack, a candidate for chair of the $3 billion California stem cell agency, says he regards the job as part-time and says that the chair should not be involved in day-to-day management.

June 6, 2011
The CIRM Chair Race: Candidate Thomas Touts His Public Finance Experience
In his first appearance before directors of the $3 billion California stem cell agency, bond financier Jonathan Thomas, a candidate for the chairmanship of the agency, stressed his professional background as an investment banker and attorney and his service on government boards.

June 2, 2011
The Candidate's Letters: What Thomas and Litvack Have to Say
Here is a brief look at the letters of interest submitted to the board of the $3 billion California stem cell agency by two men in pursuit of a six-year appointment as its new chairman. First the item on Jonathan Thomas, then Frank Litvack. CIRM directors begin evaluating the men on Monday.


News Coverage of the Nomination Process

May 24, 2011
Nature Says CIRM Faces 'Stark Choice" in New Chairman
Nature magazine today weighed in with its story on the nominations for the new chairman of the $3 billion California stem cell agency.

Minimal News Coverage on CIRM Chair Nominees
The latest news coverage of selection of a new leader for California's $3 billion stem cell agency is meager, to say the least.

May 23, 2011
Litvack vs. Thomas for Chair of the $3 Billion Stem Cell Agency
California State Controller John Chiang today nominated Frank Litvack, a "serial entrepreneur" and cardiologist, to become the new chairman of the $3 billion California stem cell agency.

Southern California Investor Nominated for Chair of the State's Stem Cell Agency
California Gov. Jerry Brown and the state's treasurer, Bill Lockyer, today nominated the head of a Southern California bond investment firm, Jonathan Thomas, as a candidate to become the new chairman of the $3 billion California stem cell agency.

May 18, 2011
Southern California Investor Identified as Possible Candidate for CIRM Chair
Robert Klein, chairman of the $3 billion California Institute for Regenerative Medicine, is backing the head of a Southern California investment firm to succeed him at the helm of CIRM as it pushes aggressively to bring stem cell therapies into the marketplace, according to a reliable source. However, James Harrison, outside counsel to the CIRM board, flatly denied that Klein has endorsed any candidate.

May 19, 2011
Cardiologist/Entrepreneur Eyed for Stem Cell Agency Chair
A Los Angeles cardiologist who is also described as a "serial entrepreneuer" is under consideration as a possible candidate for chairman of the $3 billion California stem cell agency.

June 20, 2011
State Treasurer Boosts Chair Candidate with Strong Letter of Support

California State Treasurer Bill Lockyer today urged his five appointees to the board of the $3 billion state stem cell agency to vote this week for a Los Angeles bond investor as the new chairman of the research enterprise.

June 22, 2011
Race for the Chair: Blowback, Politics and CIRM Financing
A strongly worded letter from California state treasurer Bill Lockyer concerning this week's election of a new chairman of the state's $3 billion stem cell agency could be triggering a bit of blowback for the candidate backed by Lockyer.

Endorsements

May 31, 2011
Litvack Picks Up Public Support for Bid to Become Chair of Stem Cell Agency
The Consumer Watchdog organization today endorsed a Los Angeles cardiologist as the new chairman of the $3 billion California stem cell agency, declaring that it is time to "correct the agency's dysfunctional management structure."

Endorsement letter from the president of the Genetics Policy Institute supporting Litvack

CIRM executive structure

June 12, 2011
CIRM Directors Tackle Touchy Management Issues
Key leaders of the California stem cell agency have scheduled a 60-minute meeting tomorrow to decide long-standing, thorny matters at the $3 billion enterprise, ranging from the province of the new chairman and the current president to just exactly who is a senior officer of CIRM.

June 14, 2011, CIRM memo summarizing changes in management structure

June 14, 2011, text of new management structure/internal governance policy

Chair Salary

April 2, 2011
Sacramento Bee Whacks Pay Plan for New CIRM Chair
In case you missed it, The Sacramento Bee editorialized last week about the $3 billion California stem cell agency, deploring its much-criticized, dual-CEO structure and the possibility of a $400,000 salary for a new, part-time chairman.

March 24, 2011
Papering over the Pay Problem at CIRM: When is a $400,000 Salary Not $400,000?
Three top leaders of the California stem cell agency have come up with a plan that they hope will allow CIRM to avoid the wrath of the public when its new chairman is paid a salary that could be seven times the income of an entire, typical California household.

2010 attempt to find a new chair

Dec. 13, 2010, letter from state Controller John Chiang, who said the process was "fundamentally flawed."

Dec. 15, 2010
Klein Given New, Six-Month Term as Chairman; Board to Examine Criteria for Replacement
Directors of the California stem cell agency today re-elected Robert Klein as chairman of the $3 billion enterprise, culminating a weeks-long flap that included closed-door dealings, allegations of “sleazy” conduct and dubious, last minute financial warnings about CIRM's financial condition.

Dec. 16, 2010
Nature Magazine Says Bernstein Is Still A Possibility for CIRM Chair
Canadian scientist Alan Bernstein is not necessarily off the table as a candidate to become the next chairman of the $3 billion California stem cell agency, Nature magazine's Web site is reporting today.

Dec. 5, 2010
The Biopolitical Times Recounts the "Sordid" Saga at CIRM
The Center for Genetics and Society, which has not written much recently about the California stem cell agency, has posted its perspective on the latest events involving the election of a new chair at the $3 billion enterprise.

Dec. 6, 2010
Read This Item to See What CIRM Has Expunged From Its Web Site
With one day left before Wednesday's meeting of the directors of the California stem cell agency, the public can find much to mull over by reviewing the agenda for the session. But no one will find anything on three matters that have been expunged from CIRM's Web site. They deal with the less than artful attempt by CIRM Chairman Robert Klein to engineer the selection of his successor.

Dec. 5, 2010
Klein's Maneuvers, CIRM's Reputation and Bernstein's
A Canadian scientist yesterday pretty much identified a bottom line on the attempt by CIRM Chairman Robert Klein to hand pick his successor at the $3 billion public research agency. In an interview with the Toronto Globe and Mail, Alan Bernstein said the publicity about the machinations “compromises his international reputation and the reputation of the [California] agency.” Sphere: Related Content