Wednesday, June 22, 2011

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..

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.

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. 


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

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.

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.

$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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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."

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.)

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.  

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.”

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