IOM Study of California Stem Cell Agency Still Pending

Back in August, directors of the California stem cell agency authorized a $615,000 study of their $3 billion enterprise by the prestigious Institute of Medicine at the National Academies of Science.

As of last week, a contract for the work had not been signed, although the two-year study was originally scheduled to be completed by September 2012 -- in time for a ballot measure campaign for an additional $3 billion-$5 billion in bond funding for CIRM.

According to the agency's press release on the study, the IOM study would be aimed at demonstrating "public accountability" and would provide "an independent evaluation of the performance and standards" at CIRM. Some CIRM directors have also expressed hope that the findings would help generate support for the ballot measure for more cash.

In response to a question about the status of the effort, Don Gibbons, chief communications officer for CIRM, said the contract is still being negotiated but provided no further details.

Last summer, CIRM directors approved the project on a voice vote with only one dissent. The study would cover virtually all of CIRM's activities, including areas that were examined closely last fall by CIRM's external review committee. When directors approved the IOM study, they also specified that IOM examine the "output of awarded grants, including their economic impact."

The IOM effort would be the third in a series of recent reports on CIRM. This year, the agency is also required, under a new state law, to commission the first-ever performance audit of its activities.

Duane Roth, co- vice chairman of CIRM and a San Diego businessman, cast the lone no vote. He raised questions about the staff time needed for the report (the external review took at least 2,000 hours). Roth also told directors,

"I would just caution that the outcome on something like this can cut both ways. And to go in just sort of blind trust that they're going reach the conclusion you want them to reach, I don't think is a foregone conclusion. So you at least ought to think about the downside of a rather critical one."

Directors specified that "donor funds" be used to pay for the study as opposed to "taxpayer funds," meaning cash from state bond sales, which is the only major funding available to CIRM. Some private donors have contributed money (now roughly $3.5 million) to CIRM. Once the money is in the hands of CIRM, however, it all belongs to the taxpayers, although the donor funds may be used for purposes that are barred for bond funds. Spending the donor cash on a study also means that the funds will not be available for research or some other purpose.

The IOM has proposed that a panel of 14 persons prepare the report. It would meet four times. Two public workshops would be held in California. The report would be subject to a peer review process and "appropriate institutional review procedures." The final report would be delivered to CIRM after 12 to 13 months and at least 10 days prior to its public release.

You can read what was proposed in August below.
Proposed IOM study of California stem cell agency Aug. 2010

CIRM Stingy with Info on Matters Before Directors This Week

With less than three business days left before Thursday's meeting of the directors of the $3 billion stem cell agency, CIRM has not yet produced details for the public on three significant matters that are to be considered.

The agency's failure to provide the information for the biotech industry, researchers, patient advocates, policy makers and the public via the directors' agenda is not a onetime event. It is part of a pattern -- a de facto policy -- that reflects poorly on CIRM. Withholding information about board matters effectively stifles participation by the public and discourages coverage by the media.  It also fails to meet the pledge of CIRM Chairman Robert Klein to adhere to the highest standards of openness and transparency.

However, more information on two items is now available. One involves a $6.6 million, visiting faculty program. Another deals with selection of grant reviewers, something of a sorepoint within the biotech industry.

The CIRM faculty plan states:

"The CIRM Visiting Faculty Award will operate through supplemental awards to existing CIRM-funded research grants, all of which have been peer reviewed and approved by the ICOC. The funds will enable a sabbatical researcher (Visiting Scientist) to work on an existing CIRM-funded research project for 6-12 months. The supplemental CIRM funds will cover up to 50% of the Visiting Scientist's salary and fringe benefits costs, with the remainder being paid by the Visiting Scientist’s home institution."

Applications would be submitted by the recipient of an existing research grant – who would be known as the "host scientist." The proposal envisions up to 30 awards with decisions on awards being made by CIRM staff.

Also before directors are eight proposed new alternate scientific members of the grants review group. None appear to have significant biotech industry experience. The agency has drawn fire from industry for its lack of grant reviewers who have a business background. CIRM's own external review panel said last fall,

"The majority of granting processes are designed on academic models. These processes do not necessarily fit the needs or timelines of industry and/or the realities of managing industry projects. Granting processes and funding criteria could be clarified and streamlined from an industry perspective and timelines for decision-making could be aligned with industry norms."

Regarding the review's sweeping recommendations themselves, CIRM President Alan Trounson said in early December that he would report on how they should be implemented. His report is not on the board's agenda for this month. The next CIRM board meeting is scheduled for March 9-10.

As for the previously mentioned three agenda items lacking information, one is a proposal to subsidize trips to Toronto in June for perhaps hundreds of persons to attend an international stem cell conference. The proposal contains no cost estimate nor does it indicate how many persons would be involved. We calculated a very rough estimate of $3,000 a person, depending on a number of variables. This may be worthwhile effort. We are inclined to think there is considerable value for scientists at such meetings. But so far CIRM has failed to do even a poor job of making the case for the subsidy program.

Another item needs much more explanation about why it is being considered this week. Only 22 words are devoted to it on the agenda although it is an unusual exception to the normal grant approval process. The item concerns an application for $4 million by Fred Gage of the Salk Institute in the early translational round. Decisions on that round were made last October by CIRM directors. Scientific reviewers did not approve the Gage application for funding, but it was set aside by the directors for additional consideration.

This week's agenda provides no hint concerning that background and no clue about why the application is still around. Its history can be unearthed from CIRM documents, although virtually all ordinary users of the CIRM web site would find the task daunting if not impossible. Here is a brief synopsis of the story:

At the Oct. 21, 2010, CIRM board meeting, CIRM Director Joan Samuelson, a patient advocate for Parkinson's and who also is living with the disease, moved to have directors override the negative decision by reviewers. During the discussion at the October meeting, CIRM Director Jeff Sheehy, also a patient advocate and member of the grants review committee, said in support,

"One of the key factors that was very motivating was the stature of the scientist and paucity of people working in Parkinson's in California. Eminent neurologists within the room said we campaigned (in 2004 for Prop. 71) -- we had Michael J. Fox on TV -- we talked about Parkinson's as a target. But one of the problems in our ability to fund this in California is that there's a lack of a sufficient number of outstanding Parkinson's (researchers) -- other diseases are more or better represented, at least this is what is stated, and the opportunity to get this particular eminent scientist into this arena was a value in and of itself."

The discussion at the October board meeting went beyond the specific grant and into procedures of the board and the grant review process, including discussion how of exceptions are made.

Ultimately the board asked CIRM President Trounson to look into the grant and report back on his views.

Researchers, patient advocates and others interested in CIRM funding would be well-advised to read the discussion, which covers about 17 pages of the transcript beginning on p. 144. Also of interest at the Thursday meeting concerning funding is an appeal by a Stanford researcher, Stefan Heller, in the tools and technology round that is before directors.

The third matter that is shy of information involves changes in the agency's biotech loan program and its payback provisions. We wrote earlier about what those might involve. Our take can be found here.

CIRM Beefs Up Technology: More Info and Better Service for Applicants, Grantees Promised

The California stem cell agency is reporting technology improvements that they will hope will aid researchers and the public as well.

Amy Adams, CIRM communications manager and who deals with the agency's web site, wrote last Friday on the CIRM research blog:

"As of our most recently posted RFA (Disease Team Therapy Development Awards) we’re all electronic. Grantees fill out an application online. If their application gets funded, the grantee can manage that grant online. Progress reports? Well, they still have to pull together the data, but it can be submitted online. Publications? Report them online. New applications? They go into your user account and you can manage all those grants from the same place. Time to submit a new form? No problem, CIRM makes sure there’s a notice in your account. Less time battling forms means more time doing research, which is good news for all people eager for new stem cell therapies.

"I’m not a grantee, so these miracles are all a bit abstract. However, I do know people inside CIRM are looking forward to not taking angry calls from grantees who are frustrated with our forms. And they are looking forward to having that data automatically in our database rather than needing to import it from PDF.

"The public will start seeing the benefit of these electronic developments over the next few months. Information that’s in our database can also be displayed on our website. I’m excited to start posting progress information and publications as part of our grant summaries. Stay tuned."

On the Science of Being Wrong

A tidbit that caught my eye from an article by David Brooks in the Jan. 17, 2011, issue of the New Yorker.

"Human beings are overconfidence machines. Paul J. H. Schoemaker and J. Edward Russo gave questionnaires to more than two thousand executives in order to measure how much they knew about their industries. Managers in the advertising industry gave answers that they were ninety-per-cent confident were correct. In fact, their answers were wrong sixty-one per cent of the time. People in the computer industry gave answers they thought had a ninety-five per cent chance of being right; in fact, eighty per cent of them were wrong. Ninety-nine per cent of the respondents overestimated their success."

Four Researchers Appeal Grant Reviewer Decisions; Stanford Scientist Cites Broader Concerns

Four scientists from UCLA and Stanford are seeking next week to overturn negative decisions by CIRM's scientific grant reviewers on their bids for close to $2 million each. One Stanford researcher is raising important policy questions that go well beyond the scientific merit of the proposed research.

The appeals to the full board of the California stem cell agency come in the $40 millon tools and technology round, which is aimed at addressing "technical bottlenecks and (enabling) novel translational approaches." The awards are scheduled to be given out by the agency's directors Thursday in Burlingame.

The researchers who appealing directly to the CIRM board are Guoping Fan and Martin G. Martin, both of UCLA, who are seeking $1.8 million each, and Craig Levin and Stefan Heller, both of Stanford, who are seeking $1.9 million each.

Most of the appeals to the CIRM board focused heavily on science issues, but the letter by Heller addressed additional, broader issues.

Stefan Heller
Stanford Photo

Heller, who has financial ties to a San Diego firm dealing with hearing disorders, already holds a $2.5 million grant from CIRM that was awarded in 2007. Heller used the funds for research dealing with potential cures for deafness through human embryonic stem cells. Both he and CIRM reviewers say he is one of the few scientists working in that area, although some 3.5 million Californians suffer from debilitating hearing problems.

Heller's pitch to the CIRM board defended his science but also implicitly raised questions about the quality of CIRM's grant oversight. And he said that without additional funding, CIRM's initial $2.5 million investment could well be damaged. Heller wrote,

"Now is the time to build on this asset and not to stop the funding and to disperse the researchers."

He argued that hearing losses are a widespread affliction and deserve more attention. He said his research could create jobs in California, an economic argument that CIRM has been touting widely as justification for its efforts.

According to the CIRM review summary, Heller's application was denied "due to strong concerns regarding feasibility of developing an adequate hESC-derived otic cell model, especially because little progress was reported despite an ongoing CIRM-funded effort in this laboratory, reviewers were doubtful that technical hurdles would be overcome." Heller rejected the contention that he had made "little progress." CIRM monitors the progress of its grantees and has pulled grants from three recipients.

Heller said,

"We believe that the reviewers were not appropriately calibrated with respect to the state of the science in our field, which consists of only a few laboratories – compared to larger fields with many well-funded laboratories. On the other hand, successful development of novel therapies for hearing loss and balance disorders would affect the lives of millions of patients. Therefore, research activity in our field clearly remains disproportionate to the major medical need."

He continued,

"The Heller lab is CIRM funded for 3 1/2 years and we have had several publications arising from CIRM funding including a major recent one in the journal Cell on mouse ESC guidance. The main results of our human ESC study are unpublished, we agree with this critique, but this does not mean that we have not made progress....Our ongoing CIRM comprehensive research grant has been funded based on a specific time plan and our current progress is very much in line with the original time plan."

Heller wrote,

"We are one of less than five laboratories working on stem cell related approaches to find treatments for hearing loss. We strongly believe that our science has to be exemplary as one of the few representative laboratories of the field."

Heller said,

"Our research group is an asset for CIRM in a small and specialized field with a high medical need. We have established a working and productive CIRM-funded group of people that joined us from outside the inner ear field that now, after 3 years, has reached a level of competence and productivity that comes close to groups working in much larger fields with more depth in basic science, as well as a much larger pool of personnel that readily joins these laboratories. Without the investment from CIRM, this group would not exist! Now is the time to build on this asset and not to stop the funding and to disperse the researchers. There are few laboratories in our field and progress is carried by a much smaller group of people than some of the larger fields that are well-supported by CIRM. Yet, a larger field much easier absorbs a major individual funding gap, whereas lack of sufficient funds will most certainly substantially hamper any progress in the hearing loss treatment field because we will lose the best and brightest coworkers of our laboratory. Our inner ear hESC group at Stanford would be in danger of dissolving, and research on the topic would have to start all over again, possibly severely slowing down the translation of hESC technology into the hearing loss field, thereby affecting millions of patients."

In his job creation argument, Heller said his application

"...directly deals with removing the only existing bottleneck preventing the development of the first high-throughput drug discovery screens in the hearing space. We have been extensively talking with potential investors as well as with multiple big pharmaceutical corporations about feasibility of our approach particularly with respect of using the assay as asset for a new biotech firm. We have been meeting with high-throughput screening experts from two out of the top ten big pharmaceutical companies and have discussed our planned hESC-based screening assays with them. Removal of the existing bottleneck, the main topic of our grant application, will directly expedite the founding of a new drug-discovery company in the hearing field locally in the SF Bay area."

Stanford's web site shows that Heller has financial links with Otonomy, Inc., a San Diego company "developing novel drug therapies for disorders of the inner and middle ear." According to Otonomy's web site,

"This field represents a large opportunity as there are no approved drug treatments for the nearly 30 million Americans facing debilitating hearing and balance disorders such as Ménière's disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment, and tinnitus."

Heller reported that he receives more than $5,000 in consulting fees from the company and has more than $5,000 in equity in the firm. He also serves on the company's advisory board.

Here are links to the other appeal petitions and review summaries.

Fan appeal, review summary; Levin appeal, review summary; Martin appeal, review summary.

Minimal Coverage of New VP Appointment at CIRM

The San Francisco Business Times and a blog by Nature magazine appear to be the only media to run stories on the appointment of a new vice president of research and development, Ellen Feigal, at the California stem cell agency.

The stories were routine, but Ron Leuty of the Times reported,

"CIRM interviewed at least 14 candidates, but some pulled out after considering the cost of housing in the Bay Area, the post’s salary and the public nature of CIRM’s work."

Here is a link to the Nature piece by Erika Check Hayden.

CIRM Clarifies Directors' Pay Proposal

Directors of the California stem cell agency next week are expected to approve a plan to compensate some members of its board up to $15,000 a year, but confusion about the pay rate has arisen because of a footnote in the proposal.

The plan would affect six patient advocate members of the 29-member CIRM governing board. The proposal posted on the CIRM web site for the board's Jan. 27 meeting in Burlingame states:

"A regular Patient Advocate member of the Grants Working Group would be eligible to receive 75% of the daily compensation paid to a regular Scientific member of the Grants Working Group and the Patient Advocate Vice Chairs would be eligible to receive 75% of the daily compensation paid to the Review Chair."

The compensation for a scientific member of the group is $750 a day. Seventy-five percent of that is $562.50.

However, CIRM says the formula in the footnote does not exactly represent what is being proposed.

James Harrison, outside counsel to the board, said in an email,

"First, the footnote has understandably caused confusion -- we plan to delete it and repost.

"Second, under the policy, the rate of the stipend would be the same for the regular Patient Advocate members and for the Patient Advocate Vice Chairs -- $562.50 per day. The variable is the number of days required for preparation and participation in a particular review session.

"If the Board were to adopt the policy, the Chair of the Board would consult with the Scientific Staff regarding the volume and complexity of applications for a particular review session and their expectation regarding the number of days required for the scientific members of the Working Group for that session. The Chair would then determine the number of days required for the regular Patient Advocate members and for the Patient Advocate Vice Chairs. The Chair could determine that the Vice Chairs will require additional preparation time, so the total amount paid to the Vice Chairs could be different than the total amount paid to the regular Patient Advocate members for a particular review session."

Regarding the deletion, we would recommend that CIRM note on the document that it has been altered since its first public posting. Given that it is an official government document and part of the public record, it is important that an accurate record of its history be maintained.

For additional background on the plan, see this item.

Feigal Salary

In response to a query, CIRM said this afternoon that the new vice president of research and development, Ellen Feigal, would be paid $332,000. You can find the full story on her appointment here, with the updated salary information.  

Amgen Exec Named to New VP Post at California Stem Cell Agency

The California stem cell agency today named Ellen Feigal, an executive at Amgen, Inc., to the new position of vice president for research and development.

Feigal(left) with Claire Pomeroy, dean of
 the  UC Davis School of Medicine in 2007
 at an awards ceremony involving Feigal.
 Pomeroy is also a member of the
CIRM board of directors.

She will begin work at the $3 billion research enterprise Jan. 31, leaving her current post as executive medical director for global development at Amgen, which is based in Thousand Oaks, Ca., north of Los Angeles.

Feigal will fill a position that has been vacant since the summer of 2009, basically the No. 2 spot at CIRM. CIRM President Alan Trounson created the post in the wake of the departure of Marie Csete as chief scientific officer. The VP position replaces the chief scientific officer position.

The vice president's position has a salary range that runs from $286,000 to $529,100. It is the same range as for chairman or president of CIRM. In response to a query, Don Gibbons, the agency's chief of communications, said Feigal would be paid $332.000.

CIRM's press release said,

"Feigal will report to Trounson and will work closely with other CIRM executives to build and manage the pre-clinical and clinical programs, both within California and with CIRM’s international collaborators, as well as interactions with the NIH, FDA and other regulatory bodies. She will also manage the assembly and oversight of CIRM’s clinical advisory committee that will assess project progress, milestones and go/no-go decisions. A key aspect of her portfolio will be working with the biotechnology, pharmaceutical and investment sectors as well as academia to enable and enhance development of clinical applications from CIRM’s science portfolio."

Trounson said,

“As CIRM matured and moved more of its resources into translational and clinical science, we saw the need to formalize a role for a vice president for research and development, and Ellen’s career trajectory and experience fill our vision for that role perfectly."

The CIRM press release said,

"Feigal distinguished herself in many positions in academia, the federal government, non-profit research organizations, small pharma and large biotech companies. She has focused on assessing novel therapies, training young investigators in how to assess novel therapies, and in building partnerships and coalitions to enhance translational research. In her position at Amgen she also led the scientific/clinical interface with patient advocacy organizations and formalized the company’s policy on expanded access to therapies for those with limited or no treatment options."

The news release continued,

"In addition to her work at Amgen, Feigal currently serves as Adjunct Professor and Director of the American Course on Drug Development and Regulatory Sciences at the University of California, San Francisco. The course, developed under her leadership in collaboration with the FDA, UCSF’s Department of Bioengineering and Therapeutic Sciences, its Center for Drug Development Sciences and the European Center of Pharmaceutical Medicine at the University of Basel, was launched in 2007. It is taught over two years, with six sessions, each four days in length in Washington, D.C. and a separate parallel course in San Francisco. Feigal will step down as course director and adjunct professor as she takes on this new position at CIRM."

In 2007, Feigal received UC Davis Health System's first-ever "Transformational Leadership Award," which honors someone who has “enhanced the profession, improved the welfare of the general public, provided for personal distinction and brought honor to our university.”

UC Davis said,

"Her collaborative work with organizations such as the Food and Drug Administration, National Cancer Institute, Translational Genomics Institute and Critical Path Institute are helping to cut through red tape and bring life-saving drugs to patients as quickly and safely as possible."

CIRM Directors to Consider Plan to Pay Some Board Members up to $15,000 Annually

The California stem cell agency has released more information on issues coming before its directors next week, including a plan to pay some of the patient advocate members on its board up to $15,000 a year for their work.

Ten patient advocate members sit on the 29-member CIRM board of directors. The proposal would apply to six, those who serve on the Grants Working Group and the vice chair and co-chair of the Facilities and Standards Working groups. Barred from the compensation plan would be the chairman and statutory vice chairman of the agency, Robert Klein and Art Torres respectively, who are also patient advocate members. They already are paid for their work.

The new pay plan -- to be considered next Thursday in Burlingame -- would establish a daily rate of $562.50 for patient advocates who sit on the groups as regular members. Patient advocates serving as vice chair or co-chair would be entitled  to that rate plus an additional, unspecified amount.  A cap of $15,000 would be placed on the pay.

The rate is 75 percent of what CIRM pays its outside scientific reviewers, whose expenses are also covered by CIRM. The patient advocate compensation would be in addition to their expenses as well.

The chairman of the CIRM board would determine the total compensation for each advocate based on the number of days required for "preparation and participation" in grant reviews as well as for meetings of the facilities and standards groups. (Our comment: The plan would give the chairman additional leverage on some board members. It may be more appropriate to require that the compensation decision be made by the chairman and the two vice chairmen of the board.)

Currently members of the board receive per diem of $114 per day and $14 an hour for attendance at meetings and preparation time, plus expenses.

The CIRM information about the plan did not contain an estimate on the total cost of the compensation. It also does not fully explain the justification for the pay. However, patient advocate members sometimes lose salary from their regular jobs when they take time off to participate in CIRM activities. Their attendance is also more critical because other board members often have legal conflicts of interest that prevent them voting on some matters. CIRM directors who are not patient advocates and who hold top executive positions may not lose salary, depending on the polices of their employers. Such members additionally can often use the staff of their institutions to perform work in connection with CIRM activities.

Some of the patient advocate members may decline the new compensation. Here is a list of those who would be affected, based on information posted on the CIRM web site but not on the agenda: Sherry Lansing, former Hollywood studio chief, co-chair of the standards group and member of the grants group; Jeff Sheehy, a communications manager at UC San Francisco, a member of the standards, facilities and grants groups; Jonathan Shestack, a Hollywood film producer, member of the standards group and grants group; Marcy Feit, CEO of ValleyCare Health System, member of the standards, grants and facilities group; Joan Samuelson, founder of the Parkinson's Action Network, vice chair of the grants group, member of the standards and facilities groups, and David Serrano Sewell, a San Francisco deputy city attorney, vice chair of the facilities group, member of grants group.

Other information posted by CIRM on its web site for the directors meeting includes the grant reviewers' summaries of the 56 applications submitted for the $40 million tools and technology round. In response to a question, Gibbons said seven businesses applied for grants. However, CIRM refused to provide a breakdown between non-profit research institutions and academic applicants because, Gibbons said, the non-profits "have always had an academic component." Five of the 56 applicants have German collaborators, who will receive their funding from non-CIRM sources.

The top ranked grant was given a scientific score of 90. The lowest ranked grant approved by reviewers was scored at 62. Fourteen grants that appear to be ranked above 62 were rejected by reviewers. The summary of the reviewer comments indicated that a portion of the grant was recommended for funding because of "programmatic" reasons. That portion of the review said,

"The proposed materials may offer some advantages over competing materials in the current marketplace for soft tissue reconstruction. Reviewers discussed the emergence of clinical data for utility of hASC and agreed that there might be potential for nearer term translation of formulations as proposed in Aim 1."

So far we have not seen any appeals from researchers whose grants were rejected by CIRM reviewers.

The directors agenda also now has links to information concerning the determination of the criteria for the person who is elected in June to succeed CIRM Chairman Klein, who has said he will step down then.

(Editor's note: An earlier version of this item incorrectly characterized the amount of compensation for the co-chairs and vice chairs, based on inaccurate information provided by CIRM. For more details on the error, see this item.)

CIRM Directors to Hand Out $40 Million Next Week; Meeting Details Not Available to Public

Directors of the California stem cell agency meet one week from tomorrow to give away $40 million and move forward on electing a new chairman of the $3 billion enterprise come next June.

With six business days left before the meeting, however, few details of what is to be considered are available to the public via the directors' agenda on the CIRM web site. That is in keeping with the agency's practice of not making such material accessible until very shortly before its board meetings. The de facto policy effectively suppresses public involvement in CIRM affairs.

Some information on the matters before directors on Jan. 27 is available elsewhere on the agency's web site, although it may have changed and be out-of-date. Less than avid users of the web site would have considerable difficulty in locating the information on their own. Nonetheless, the California Stem Cell Report has ferreted out some background on what is likely to be discussed next week by CIRM directors.

Item 8 before directors is only described as "consideration of recommendations from Grants Working Group regarding applications submitted in response to RFA 10-02: CIRM Tools and Technology Awards II." What that means is that directors are virtually certain to give away $40 million to 20 lucky scientists. The board almost always ratifies all the recommendations of its grant reviewers when the reviewers approve funding for applications. Summaries of the reviewers' recommendations were not available at the time of this writing.

Scientists from Germany are collaborating on some of the applications, but their funding will not come from CIRM. The purpose of the grant round is to "develop such tools and techniques that address technical bottlenecks and enable novel translational approaches." Some information on the program can be found here.

CIRM directors are also scheduled to deal with the criteria for a new chair to replace Robert Klein, whose latest retirement date comes in June. The evening before the directors meet, their Governance Subcommittee will discuss the matter and make recommendations to the full board. In contrast to the meeting of the full board, the committee posted all the relevant material well in advance of its meeting. However, that information cannot be found via the agenda for the directors' meeting. But you can find it here and via an item on the California Stem Cell Report.

The CIRM board will also be asked to subsidize trips in June to Toronto for perhaps hundreds of persons for the annual convention of the International Society for Stem Cell Research, the largest such organization in the world. The agenda says subsidies would go to "patient advocates, CIRM Bridges Scholars and other CIRM funded early career scientists." No information was provided via the agenda on the number of persons involved or the total cost of the effort. We could not find such details elsewhere on the CIRM web site.

Information on the ISSCR web site, however, shows that non-member registration for the convention can run as high as $1095 for the four-day session. Then there are hotel, eating and travel expenses. Discounted rooms for single and double occupancy are going for $227 US at the convention hotel, the Fairmount Royal York, which, at 28 stories, once was the tallest building in the British Commonwealth and featured a 50-ton pipe organ. Round trip air fares for June from San Francisco to Toronto were running about $500 to $700 if booked today. No one from CIRM is on the program when we checked. Our ballpark calculations show a very rough cost of $3,000 per person, depending on such variables as the actual cost of registration and flight reservations.

Biotech firms should have considerable interest in a proposal involving the CIRM loan program and "proposed regulatory language/process for multiple payback alternative to warrant coverage for loans." The agency provided no further clue to the specifics although the item probably refers to this Nov. 29 proposal, which could be out-of-date.

In all, CIRM directors have nine matters of considerable importance before them next week. But the public, scientists, the biotech industry, policy makers and others are left in the dark by CIRM if they depend on the agenda that the agency posts.

The directors meetings are the most important public events involving the agency, which is consuming $6 billion(including interest) in taxpayer funds. Giving stakeholders and the public easy access to matters before the  board is a simple and straight-forward task. It would seem to be very much in CIRM's best interests to keep all the interested parties well-informed about its activities.

Oversight Panel to Review CIRM Finances Later This Month

The only state panel specifically charged with financial oversight of California $3 billion stem cell research effort meets later this month to examine its budget and review last fall's external review of CIRM's operations.

The Citizens Financial Accountability Oversight Committee is scheduled to convene in Los Angeles on Jan. 28, two days after a key panel of CIRM directors is expected to take up part of the committee's 12-month-old request to improve openness and transparency at CIRM.

The financial committee was created as part of Prop. 71, the ballot initiative that also created the stem cell research program. It is chaired by the state's top fiscal office, Controller John Chiang. CIRM is exempt by provisions of Prop. 71 from the normal oversight of the governor and the legislature.

While the committee is a sister to CIRM, the agency has distanced itself from the panel. CIRM successfully lobbied last year to remove from legislation a Chiang-supported provision that would have required the panel to commission a performance audit of the agency. Last February, shortly after the committee unanimously recommended more openness, CIRM President Alan Trounson described the committee's discussion of CIRM as a “strange critique” and “irrational attack.”  (See page 132 of the transcript of the board of directors meeting.)

Among the financial committee's recommendations was a proposal that CIRM post on its web site the statements of economic interests of its directors along with expense claims from directors and top staff. The proposal is to be taken up by the CIRM directors' Governance Subcommittee on Jan. 26 in Burlingame.

Also tap for the Jan. 28 financial committee meeting is discussion of a new law that removed the 50-person cap on CIRM staff. The change was made after Trounson said the quality of its work will suffer without more help. Currently CIRM has more than $1 billion committed to nearly 400 recipients. It has nearly another $2 billion go hand out.

Fresh Approach Urged on CIRM Chair Selection, Self-evaluation of CIRM Board Included

Directors of the California stem cell agency are being asked to make a "clean start" in their effort to elect a new chair of the $3 billion enterprise – an effort that would also include a self-assessment of the board itself.

The appeal is being made by Claire Pomeroy, a CIRM director and dean of the UC Davis School of Medicine and is scheduled to be considered at a Jan. 26 meeting of the CIRM directors' Governance Subcommittee. The full board will take up the panel's recommendations the next day.

In an email to Sherry Lansing, chair of the Governance panel, Pomeroy said,

"In the spirit of a clean start and an open process, I would suggest that the Governance Committee consider proactively attaining input from all the board members in two areas:
"1. Self-assessment of board performance/function to date
"2. Desired attributes of board chair"

In her email, Pomeroy noted an article last month in Science magazine, headlined "CIRM: The Good, the Bad And the Ugly." Pomeroy said her recommendations would help to "to ensure an open process free of conflict of interest and personal agendas." She said,

"This is our chance to emphasize the mission over in-fighting and can define what kind of organization CIRM and the board will be."

Asked for a comment., John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said that Pomeroy's suggestions sound "like exactly the right approach."

Pomeroy's proposal and other important background material were posted on the CIRM web site on Saturday, 11 days in advance of the meeting. CIRM has had considerable difficulty in posting such material in a timely fashion. But the postings for the Jan. 26 session represent a substantial improvement and offer the public and interested parties an opportunity to make thoughtful comments in time for the meeting or to make plans to attend.

Pomeroy said she borrowed the self-assessment plan from another organization on whose board she serves. The plan would involve a series of questions for all 29 board members with "Yes/Sometimes/No answers" and a section for free-form comments.

Some of the questions proposed by Pomeroy:

• "Board focuses on the appropriate strategic, fiduciary, and generative issues that guide the work of the organization
• "Board attends to policy related activities that guide the work of management staff
• "Board is composed of a diverse group of individuals with a variety of skills to consider the interests of the organization's broad constituencies
• "Board avoids getting into administrative/management details
• "Board members offer a diversity of opinions and addresses issues in a respectful manner
• "Board is too influenced by the views of the president and/or other management staff

Another section would deal with individual board members. Some proposed questions:

• "I understand my responsibilities as a board member
• "I come to the board meetings fully prepared to participate
• "I receive adequate information, presented in a concise and focused manner, on matters that come to the board in a timely manner
• "At board meetings, I feel comfortable raising and discussing dissenting or contrary opinions
• "I think about the work of the organization (CIRM) between board calls and meetings
• "I understand the issue of conflict of interest and have no conflicts other than those disclosed in writing
• "I receive personal satisfaction from my role as board member."/li>
  

On the subject of desired attributes of a new chair, Pomeroy said,

"It seems to me that we don't always hear from all the board members about their thoughts on this issue and as a committee we should know the ideas of all the (board) members."

She proposed a survey of all board members asking such things as:

• "Desired attributes of a chair (e.g. collaborative, etc)- list top 3
• "Desired skill sets of a chair (e.g. advocacy, financial, etc)- list top 3
• "Desired background/experience of a chair (e.g. academics, patient advocate, industry experience, etc)- list top 3
• "Recommended time commitment of chair (e.g. full time, 1 day a week, attendance at meetings and availability by phone in between, etc)
• "Recommended financial compensation for chair (e.g. salary range)"

Included on the agenda for the Governance meeting in Burlingame is a memo on the legal criteria for the CIRM chair.

 Another issue dealing with openness and transparency is also on the committee's agenda. It consists of a request from the Citizens Financial Accountability Oversight Committee that CIRM post on its web site the statements of economic interests and travel expense claims by the CIRM board and executive staff. The committee, which reviews the financial operations of CIRM, made the request nearly a year ago.

The panel is chaired by the state's top fiscal officer, Controller John Chiang, one of four state officials who makes nominations for the CIRM chair. Chiang's office posts the economic interest statements and expense claims of its top staff on its web site, as did former Gov. Arnold Schwarznegger. It is unclear whether Gov. Jerry Brown will follow the practice.

(Editor's note: An earlier version of this story did not mention that the Governance Subcommittee's recommendations will be taken up by the full board of directors on Jan. 27.)

Correction

The "Nature Medicine" item on Jan. 14, 2011, incorrectly said that Alan Bernstein, according to Nature Medicine, was not necessarily off the table as a candidate for president of CIRM. The article should have said he was not off the table as a candidate for chairman of CIRM.

Nature Medicine on CIRM Chair Election

The botched bid by Robert Klein, chairman of the California stem cell agency, to hand pick his successor was revisited in the January issue of Nature Medicine.

The article is a briefer version of what Elie Dolgin filed last month on the Internet. The headline on the magazine article reads, "Nomination bungle leaves CIRM leadership in limbo."

Dolgin again reported that the Alan Bernstein, executive director of Global HIV Vaccine Enterprise, is "not necessarily off the table" as a candidate for chairman.

Bernstein withdrew from consideration following a flap over Klein's attempt to have him chosen as the new chairman of CIRM.

Klein's first term expired last month, but on Dec. 15 the board re-elected him for six months at no pay.

The CIRM directors also opened the door to a broader and more publicly accessible process for setting the criteria for electing a new chair. That process is scheduled to be completed by about Feb. 15, but the directors have made no announcements about how they specifically intend to proceed. We are querying Sherry Lansing, chair of the directors' Governance Subcommittee, concerning the process.

The Nature Medicine article is behind a subscription barrier. If you would like a copy of it, please send an email to djensen@californiastemcellreport.com.

(Editor's note: An earlier version of this item incorrectly said Bernstein was not off the table for president as opposed to chairman.)

Three Bidders Seek California State Funds for Online Stem Cell Journal

The California stem cell agency is about ready to jump into the publishing business.

The $3 billion, taxpayer-financed enterprise on Monday received three responses to its proposal to spend $600,000 over the next three years to start a new, online stem cell research journal. The enterprises seeking the seed money are AlphaMed Press of Durham, N.C., the International Society for Stem Cell Research (ISSCR) of Deerfield, Ill., and the information conglomerate Elsevier, which is based in Amsterdam.

CIRM wants to kick off a new peer-reviewed, open-access journal to accelerate “the entire field as knowledge is aggregated and shared more readily” and encourage collaboration between stem cell biologists, clinicians and engineers, according to CIRM's plan. (See the RFP below and CIRM President Alan Trounson's proposal here.)

The journal would focus on translational aspects of stem cell science, stem cell-based regenerative medicine and tissue engineering, stem cell-based predictive toxicology and cancer stem cell investigation. The journal would be independent of CIRM but the agency would, “with agreement from the editors,” provide “periodic short articles on translational stem cell research.”

The CIRM seed money would amount to $200,000 a year for three years with the journal becoming self-sustaining at the end of the period. Preference will go to publishers "committed to California-based editorial offices." The award date is scheduled for Jan. 24.

Of the three bidders, the ISSCR seems to have the least publishing experience. It is an international organization of stem cell scientists. The ISSCR web site does not list any publications other than the organization's newsletter. CIRM sponsored its convention last year in San Francisco. Trounson served on its board of directors in 2008.

AlphaMed publishes Stem Cells, which it says “is the oldest journal in the fast-paced area of stem cells and regenerative medicine." The organization added, "Not only is it the first journal to be devoted to this promising research, it remains at the top tier of peer-reviewed monthly journals for this discipline.” Trounson sits on Stem Cells' editorial board.

Elsevier touts “a global community of 7,000 journal editors, 70,000 editorial board members, 300,000 reviewers and 600,000 authors.” It has a publishing tradition that stretches back to 1580 and has been embroiled in the controversy concerning the debate over open access to the research in its publications.

Elsevier publishes Cell Stem Cell and Stem Cell Research, whose editorial board also includes Trounson.

The Public Library of Science, whose international headquarters are within walking distance of CIRM in San Francisco, did not submit a bid. The organization is “a nonprofit organization of scientists and physicians committed to making the world's scientific and medical literature a public resource.” It has a roster of publications ranging from biology to neglected tropical diseases.

We have asked CIRM for copies of the bids submitted by the three groups. We will bring them to you when we receive them.

Here is the CIRM RFP.CIRM RFP for Online Stem Cell Journal

California Stem Cell Agency Says It Unaffected by Suspension of State Bond Sales

Suspension of California bond sales because of the state's budget crisis will not have an “immediate impact” on the state's stem cell agency, whose only real source of cash is state bonds.

James Harrison, outside counsel for the CIRM board, said that the agency “has cash reserves to cover its current needs and it does not need to issue bonds in the spring.” As recently as December, other CIRM staff members had also said that the agency had funding to cover its programs to about June 2012.

However, on Dec. 14, CIRM Chairman Robert Klein told agency directors that the reliability of the agency's funding needed “immediate attention” because of a notice that his office had “just” received from the state treasurer. Klein also said that “our collaborative funding partner nations” early this year will require “assurances of our future performance.” His warning came on the eve of his successful bid for re-election as chair and was much different than a rosy assessment he offered 12 days earlier. .

Here is the text of Harrison's response to our query to Don Gibbons, CIRM's communications chief, concerning the impact of the bond sale delay on CIRM. In his comment, Harrison refers to earlier items on the California Stem Cell Report about Klein's changing positions on the state of CIRM's bond financing. Some of those items can be found here, here and here.

Harrison's statement:

“As we have stated in the past, we disagree with your characterization of Chairman Klein's comments to the Board.  At the time of the Treasurer's request, CIRM had no authority for the Treasurer to issue bonds on CIRM's behalf.  The Chairman therefore considered it a priority to respond to the Treasurer's request in light of CIRM's projected need for additional bond funding for the 2011/2012 fiscal year.  You are confusing the Chairman’s desire to get a required authorization approved (before he left the agency) that could cover any bonds sold in 2011 or 2012.  As the Chairman previously reported, the agency has cash reserves to cover its current needs and it does not need to issue bonds in the spring. CIRM therefore did not request bond funding as part of a Spring 2011 bond sale, and as a result, the Treasurer's decision not to go to the market in Spring 2011 does not have an immediate impact on CIRM.”

For those interested in more details about CIRM's borrowing, as of last November, the state owed about $2 billion on stem cell bonds, including $1 billion in principal and about the same amount in interest, according to the state treasurer's office. Payments on the interest come out of the state budget each year and affect the amount of cash available for other state expenses, ranging from education to health services for the poor.

Prop. 71, which created CIRM in 2004, authorized $3 billion in bonds that flow directly to CIRM and cannot be touched by the governor or the legislature. The borrowing is expected to cost another $3 billion to $4 billion over the lifetime of the bonds.

A special, six-person committee, the California Stem Cell Research and Cures Finance Committee, is charged with determining by majority vote whether it is “necessary or desirable” to issue bonds for stem cell research. Three members of the CIRM board of directors, including Klein, sit on the committee. The other three members are the state treasurer(who is the chairman), the state controller and the state finance director.

California Suspends Bond Sales: Potential Impact on Stem Cell Agency

The state of California, dogged by a mammoth financial crisis, is postponing the sale of state bonds this year, raising questions about the move's impact on the state's stem cell research effort, which is funded solely through the borrowed money.

State Treasurer Bill Lockyer said yesterday the delay in selling state bonds until later this year would save the state $248 million. It would be the first time that the state has not sold bonds in the first half of the year since 1988, according to Bloomberg News. Lockyer's action came as part of the stringent state budget proposed yesterday by Gov. Jerry Brown.

On Dec. 14, Robert Klein, chairman of the $3 billion California stem cell agency, told its directors that the reliability of the agency's funding needed “immediate attention” because of a notice that his office had “just” received from the state treasurer. Klein declared,

“Recent applications for clinical trial rounds and the acceleration of our funding commitments on our other programs require an immediate focus on this issue, given there may not be another opportunity until late 2011 to authorize additional bond funding.”

Klein also said that early this year “our collaborative funding partner nations” will require “assurances of our future performance.”

Klein's warning came on the eve of his successful bid to be re-elected as chairman of the agency. The notice from the treasurer did not carry the urgency that Klein indicated and was nearly two weeks old by the time he told directors about it. It also arrived in Klein's office the day before he gave a rosy financial assessment to the directors' Finance Subcommittee and said no problems existed with its bond financing.

We have queried CIRM concerning its view of the impact of the suspension of state bond sales. In the past, CIRM officials have said it has enough cash on hand to operate and award grants to about June 2012.

According to the Bloomberg article by Michael Marois and Alison Vekshin, California has about $69 billion in securities outstanding as of the end of June. Another $100 billion in debt has been authorized by voters but has not been issued.

The article said that debt service, including the interest on stem cell bonds, will cost the state nearly $5 billion in the next fiscal year, even after the moratorium.

Science Magazine Assesses CIRM: 'The Good, Bad and Ugly'

Science magazine examined California's $3 billion stem cell research effort in a piece published during the holidays, and the third paragraph of the story began with this quote,

“It's the usual CIRM circus.”

Whether one thinks the comment was well-deserved or not, it falls far short of the type of publicity that the agency needs, especially as it considers mounting a bid to secure an additional $5 billion from California voters.

Overall, the two-page article was pretty much a straight-forward overview of where CIRM stands at the beginning of 2011. The story began, however, with a look at the shenanigans of CIRM Chairman Robert Klein as he tried unsuccessfully last year to hand pick his successor. And that was what triggered the “CIRM circus” comment from Marie Csete, former chief scientific officer for CIRM.

The piece by Greg Miller was entitled, “CIRM: The Good, the Bad And the Ugly” – another less-than-felicitous phrase concerning the public agency. The article covered the basics: dollars handed out, labs built, concerns about high salaries and conflicts of interest and the recent external review report. It noted that many scientists view CIRM as a “tremendous success.” But it also reported that patient advocates “are tired of waiting for stem cell cures.” Miller's article continued,

“...(E)ven CIRM supporters say the institute has to improve its relationships with industry if it hopes to fulfill its mandate: generating stem cell therapies that help people suffering from conditions like diabetes and Parkinson’s disease. A recent report by a panel of external scientists convened by the CIRM board said translating basic science into therapies should be a major priority going forward.”

Miller wrote,

“Not surprisingly, CIRM grantees are not complaining. 'I just moved into a spectacular new building,' says Arnold Kriegstein, the director of the new Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California, San Francisco (UCSF). CIRM kicked in $35 million for the new facility, about a third of its cost.”

(Editor's note: UCSF has received $111 million in grants. The dean of its medical school sits on the CIRM board of directors, as do several other medical school deans whose institutions have received hundreds of million dollars.)

The article continued,

“Several California biotech leaders say they have been frustrated by their interactions with CIRM. 'In the past, there’s been a lack of recognition that it takes a company to actually take a treatment forward from the bench top into the clinic,' says Chris Airriess, chief operating officer of California Stem Cell Inc. in Irvine. Airriess says his company has twice applied, unsuccessfully, for CIRM money. He and others place much of the blame on the review process, which he says is structured too much like the NIH review process for academic research grants. CIRM reviewers criticized his company’s applications for the lack of new science, but Airriess says that misses the point. 'Companies are trying to stabilize a technology and commercialize it rather than push the bleeding edge,' he says.

“Even companies that have succeeded say it hasn’t been easy. Earlier this year, San Francisco–based iPierian won a $6 million early translation award and a $1.5 million basic biology award. 'We put a ton of effort into understanding what was being asked for,' says CEO Michael Venuti.”

Science magazine concluded,

“CIRM President Alan Trounson says he is sensitive to these (industry) concerns but doesn’t think the review process is problematic: 'Companies that have put in well-formed proposals have done very well.' But he acknowledges that CIRM has had difficulty attracting proposals, particularly from larger companies. He’d like to set up an industry advisory board to help improve industry relations.

“In the coming months, he and others will be waiting anxiously to see who succeeds Klein as chair. Patient advocates want an advocate at the helm. Scientists would prefer a scientist. Trounson, who may have to work most closely with the new boss, says he’s hoping for someone with expertise in the delivery stage of therapeutic development. 'The basic science, as long as we look after it, will take care of itself,' he says. The real challenge for CIRM, he says, is getting the science into the clinic. 'We need more help on how to make it all happen.'”

In terms of the negative information in the piece, one thing helpful to CIRM is that the article is tucked away behind a subscription barrier, so it is not likely to be available to mainstream journalists (whose employers are notoriously cheap) as they do research on the agency. Nonetheless, the article is likely to be checked by most scientists interested in CIRM affairs and quite possibly by any potential, major contributors to an election campaign for more billions for the agency.

But the real problem is not with the publicity or the slant of the article – it is with the actions of Klein and the agency. There would have been little dubious to write about concerning the choice of a new chair if Klein had not tried to engineer the selection of his successor in a closed-door process that raised charges of conflict of interest. And as far as issues with the biotech industry go, those have been apparent for several years, but little has been done to deal with them.

(If you are interested in receiving the entire article, please email a request to djensen@californiastemcellreport.com, and I will send it to you.)

Klein Ballyhoos Stem Cell Effort as 'Forever Changing the Future of Human Suffering'

The chairman of the California stem cell ageny, Robert Klein, recently wrote an op-ed piece for the San Jose Business Journal replete with superlatives about the significance of the state's $3 billion research effort.

It represented the type of publicity that the agency will need to convince California voters to approve the roughly $5 billion, new bond issue that Klein is touting.

Klein is a man who loves effusive prose, and plenty was in evidence in his piece. “Far-reaching,” “huge difference,” “stem cell revolution” and a promise that the work of the California stem cell researchers “will begin to mature (in five to seven years), forever changing the future of human suffering” – all were part of the op-ed article.

Klein also trotted out some economic statistics that he has used before, but again with no source for the data. They may have come from a $300,000 economic impact study commissioned in 2009 by CIRM with orders that it “execute a vibrant and aggressive strategy to support the goals and initiatives of CIRM.” (See here and here and here..) The final report was originally scheduled for April 2010, but has never been released publicly. Don Gibbons, chief communications officer for CIRM, said yesterday that the agency is now “shooting for later this month.”

The contract is held by LECG of Devon, Pa. As of last August (the most recent information available), the firm had been paid $75,000 on its contract, which was scheduled to terminate last Oct. 6.

Klein also cited a clinical trial involving UC San Diego with the clear implication that it was the result of CIRM-funded research.

Here is what John M. Simpson of Consumer Watchdog said about the claim in 2008.

“California’s stem cell agency overstated and hyped the importance of its funding in enabling clinical trials for a drug to treat a severe blood disorder...seriously undercutting the agency’s credibility and alienating those who support publicly funded stem cell research.”

His report followed our item on the research that quoted a scientist as saying that CIRM wrongly took credit for the research.

The field of stem cell science has been criticized for the hyperbole the surrounds it, much of which was evident in the 2004 election campaign that created the California stem cell agency. While some license is expected in any campaign, dubious claims can blow back on those who utter them as voters detect the flim-flam.

Did Klein go too far in his piece last week? Is CIRM creating a record of rhetorical excesses that will backfire?  Time will tell, but the agency can rest assured that those to want to block stem cell research will be parsing the agency's PR with considerable diligence.

California Stem Cell Agency Expanding Staff, Looking for a Few New Hires

Beginning Jan. 1, the California stem cell agency is expected to start bringing aboard a number of new employees as the 50-person cap on staff is lifted by a new state law.

One of those persons is expected to be a special projects coordinator who reports directly to CIRM President Alan Trounson. The post has a salary that that tops out at $224,536.

The new position has a wide range of duties including: development of new initiatives for CIRM, meetings with the biotech industry, academia and government officials, writing strategic documents and white papers on key initiatives, negotiations on critical projects, preparation of documents for the public and monitoring scientific developments.

One of the specific projects mentioned in the job description seems to be linked to a recommendation this fall from a blue-ribbon panel that called for CIRM to reach out to find promising, out-of-state endeavors that could be lured to California. The description described one project for the new hire like this:

“Identification of international new and rapidly evolving basic and applied research programs that may be linked to or introduced into the CIRM Californian biotech and academic research environment.”

Trounson is looking for someone with a Ph.D. in a biomedical science with a preference for some who also has a law degree and/or an MBA.

CIRM has additionally posted openings for science officers and grants management specialists. Still open is the new position of vice president for research and development, although that job description is not posted on CIRM's Web site. The job has been vacant for about 18 months.

CIRM Directors Move Towards Wider Public Access in Chair Selection

Directors of the California stem cell agency this week opened the door to a broader and more open way of determining who should lead the $3 billion enterprise for the next six years.

They set in motion a process in which the directors will publicly establish criteria that they would like to see in a person who would succeed Robert Klein as chairman come next June. No details were forthcoming and undoubtedly not yet developed, but the process is scheduled to be completed by about Feb. 15.

The timeline may be unrealistic given that the board has only one scheduled meeting between now and then. Nonetheless the new effort will provide the public with a chance to offer suggestions and comments. The vehicle for determining criteria for the new chairman is the CIRM directors' Governance Subcommittee, chaired by Sherry Lansing, a highly regarded former Hollywood studio chief. The subcommittee is supposed to complete its work within 60 days and develop criteria that will go beyond the legal qualifications for the chair.

CIRM directors now have an excellent opportunity to reach out and engage both the public at large and CIRM's special constituencies. Reach out is the operative phrase. Passive posting of information a day or two ahead of a meeting someplace on the CIRM Web site will not draw in comments. An email and phone effort, with follow-up, would be far more successful in generating thoughtful suggestions from both the public and specific, important stakeholder groups. To be useful, background material should be available prominently on the CIRM Web site at least two weeks ahead of the first subcommittee meeting. Indeed, it is not too early for the public to file suggestions and thoughts with the agency this week and next.

Some questions for the public to consider: Does the chair need to be a nationally known scientist? Does the post require experience in the biotech industry? Must the person have extensive experience in hands-on administration? Should the person be skilled in conciliation and negotiation?

One starting point for those interested in the election is the official rundown on how the nominations and election are supposed to work.

The information was offered up yesterday on the agency's Web site for the CIRM board of directors meeting.

Written by CIRM's outside counsel, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., the memo, however, is a bit outdated. It was prepared last August but not widely publicized by CIRM. It is also not clear that the process, even with a change of dates, will be followed exactly for the election of new chair by next June, Klein's retirement date.

The earliest meeting date for the Governance Subcommittee is likely to be sometime in January, given the upcoming holiday season. The CIRM board is scheduled to meet Jan. 26-27 in San Francisco. The subcommittee may want to tackle the issue before that meeting in order to present a tentative proposal to the full board for suggestions and possible revisions for final adoption in March 9-10 in Sacramento.

The board has a relatively light schedule during the first half of the year, only four meetings between now and August. Presumably the election for the chair would occur June 22-23 at the board meeting scheduled for San Diego. The only other meeting scheduled in the first half of the year is May 3-4 in Los Angeles.

Correction

An item today concerning an article on Nature magazine's Web site dealing with the re-election of Robert Klein as chairman of CIRM said that the reporter interviewed Klein yesterday. In fact, Klein was interviewed earlier.

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.

His name popped up in a piece by Elie Dolgin about the re-election of Bob Klein for a term of six months as chair  at the agency as he and the CIRM board search for his replacement.

Dolgin had interviewed Klein prior to yesterday's vote and reported that Klein would “like someone with industry experience who has worked with U.S. drug regulators in the past.” Previously Klein, a real estate investment banker, said he thought a nationally known scientist was necessary to replace him as chair. The CIRM board, which chooses the chair, has not specified the criteria it desires, but is scheduled to do so over the next 60 days.

Dolgin continued,

“Notably, Bernstein’s name is not necessarily off the table. According to Klein, California’s attorney general-elect Kamala Harris will look into the legality of a 1978 attorney general decision ruling that the requirement of citizenship for holding public office is unconstitutional.”

Dolgin's story was one of only two that we have seen thus far concerning Klein's re-election. The board specified yesterday that he should serve no more than six months. Klein said he hoped to leave sooner because of family reasons. He was receiving a half-time $150,000 salary but will receive no pay during his new service.

We reported earlier on the other story on the election by Ron Leuty in the San Francisco Business Times. It noted that the next nominees for chair will come from four state officials, all Democrats, including the newly elected governor and lieutenant governor, Jerry Brown and Gavin Newsom respectively. That is a good situation for Art Torres, co-vice chair of CIRM, and who is likely to be a candidate again for chair. Torres was head of the state Democratic Party and a longtime state legislator. He knows all the nominating officials. Torres was nominated by the state controller this month but withdrew his name in favor of Klein.

During its public session, the board expressed no displeasure with Klein's attempts to engineer the selection of his successor.  Sherry Lansing, chair of the directors' Governance Subcommittee, said nothing illegal or incorrect occurred.  But Dolgin wrote,

"Not everyone was happy with this scenario. In a strongly-worded letter sent two days ago, state Controller John Chiang urged the CIRM board members to delay their decision and start anew with fresh nominees. 'It is clear that the current selection process is fundamentally flawed,' Chiang wrote. 'The taxpayers who provide the funds for CIRM must be assured that the chair and vice chair are selected in an open, transparent process — not through a backroom deal or by default because a deal has fallen apart.'

"'This path that they’ve gone down is a face-saving path for Klein who screwed up this election by trying to manipulate it and tap his own successor,' says John M. Simpson, stem cell project director of the Santa Monica-based advocacy group Consumer Watchdog. “He needs to let go and let the board step up and exercise its oversight responsibilities without constantly trying to pull the strings.'"

As for Klein's mention of the possibility that Bernstein's name would come up again, that would appear to be extremely unlikely. Bernstein told the Toronto Globe and Mail that the ruckus surrounding Klein's maneuvers damaged his (Bernstein's) reputation and that of the California stem cell agency.

As for the citizenship issue, it is difficult to understand why Klein is raising the matter again, except to note that he earlier misrepresented the attorney general's opinion as the reason for Bernstein being compelled to drop out of consideration.

(Editor's note: An earlier version of this item said that Dolgin interviewed Klein yesterday.)

UCSD's Goldstein Says His CIRM Grants Not All Basic Research

In an item carried Dec. 13 called “Eleven Top Stem Cell Researchers Back Klein for Re-Election,” we wrote,

“All but one of them have tens of millions of dollars at stake in grants from the stem cell agency and are heavily invested in basic research, as opposed to translational efforts to push research into the clinic.”

One of those mentioned by name was Larry Goldstein of UC San Diego, who has $14 million in grants from CIRM. Goldstein emailed us today, pointing out that his $11 million grant is not basic research. He said,

“For what it's worth, this grant, which constitutes the bulk of my CIRM funding is not basic research, it is translational with the goal of launching a clinical trial. Many of the statements about my research funding being only basic are incorrect as a result.”

Brown and Newsom to Nominate Two of the Next CIRM Chair Candidates

One news article on the re-election of Robert Klein as head of the California stem cell agency surfaced quickly tonight with an interesting reminder.

Reporter Ron Leuty's piece in the San Francisco Business Times was straight-forward. But it also refreshed readers on the nomination process for CIRM chair. It noted that two of the next nominees for chair will come from two new state officials, incoming Gov. Jerry Brown and Lt. Gov. Gavin Newsom, both Democrats.

Klein was nominated by the sitting governor and lieutenant governor, both Republicans.

Brown's choice could be interesting. However, he has been known to dally on filling vacancies in his own administration, much less enterprises outside the scope of his influence, such as CIRM. He also has a penchant for sometimes unusual appointments. Brown and CIRM vice Chair Art Torres, former longtime state legislator,also have known each for for decades.

Two other Democratic state officials, Treasurer Bill Lockyer and Controller John Chiang, also will make nominations for the new chair. Chiang had previously nominated Torres. Lockyer and Torres are old friends and colleagues. Lockyer did not nominate this month for chair, but nominated Torres for vice chair.

CIRM also produced a routine news release on the re-election tonight. You can find it here.

Torres and Roth Re-elected as CIRM Vice Chairs

Directors of the California stem cell agency today routinely re-elected Art Torres and Duane Roth as co-vice chairman of the $3 billion research effort.

Neither faced active opposition. Jeff Sheehy had been nominated for vice chair against Torres, but told the board he was not seeking the post.

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.

Klein said he would serve for no more than six months and would prefer a shorter term. He is expected to serve without a salary. The directors also instructed its Governance Subcommittee to examine the criteria for a replacement and report back to the full board in 60 days.

The vote on Klein was not entirely audible on the Internet audiocast but it appeared nearly unanimous with the exception of Jeff Sheehy, who abstained.

Sherry Lansing, chair of the Governance Subcommittee and a former Hollywood studio chief, supported Klein's re-election and defended the election process. She said,

"Nothing was done that was not correct."

She said all actions taken were in the best interests of CIRM's mission.

Klein had been publicly telling the board and others for months that he would not seek re-election to a six-year term. Behind the scenes, he began to attempt to engineer the selection of his successor, a Canadian scientist, Alan Bernstein, who chaired the recent “external review” of CIRM's programs.

Klein's effort began to fall apart after Bernstein's name surfaced publicly in an item Nov. 29 on the California Stem Cell Report.

A spate of articles dealing with the issue appeared in a number of publications, including the Los Angeles Times, the San Francisco Business Times, Nature magazine's Web site, the Biopolitical Times, the Toronto Globe and Mail and The Sacramento Bee as well as here. The various articles detailed the reports of backroom dealings and issues with Klein's conduct.

On Monday, the state's top fiscal officer, John Chiang, who has a special role in connection with the agency, urged cancellation of this week's election, declaring that the process was fundamentally flawed. Sheehy read Chiang's letter to the board and said he agreed with it.  No other CIRM directors publicly raised questions about the election flap.

Klein has been chairman of the California Institute for Regenerative Medicine, as the agency is formally known, since voters approved its creation in 2004 through Prop. 71. Klein and a handful of associates wrote the measure, which included a detailed legal list of qualifications that fit only one person in the state – Klein. The move so angered one early major backer of Prop. 71 that he now refuses to speak to Klein, according to Nature magazine.

Klein has been the dominate force at the stem cell agency since he was elected by the 29-member board to his first six-year term. He also has angered at least some members of the CIRM board and clashed with its first president, Zach Hall. Prop. 71 gave overlapping executive responsibilities to the chairman and president of the agency.

As of this week, CIRM has approved $1.1 billion in grants, 90 percent of which has gone to institutions that have representation on the CIRM board of directors. The board is making larger awards currently, and Klein is looking for more cash. His plans include another bond measure, perhaps as high as $5 billion, before voters possibly in 2012 or 2014.

Klein Re-elected

Robert Klein today was re-elected as chairman of the $3 billion California stem cell agency.

He said he will only serve for no more than six months. More on this shortly.

Bad Link Fixed

A bad link in an item today concerning the Biopolitical Times story on the election of the CIRM chairman has  been repaired. If you wish, you can find the story directly here.

CIRM Directors Convene Behind Closed Doors to Consider Election of Chairman

Directors of the California stem cell agency met briefly this afternoon in public but immediately went into a closed-door executive session to consider the election of a new chairman for the agency.

Chairman Robert Klein, who is seeking re-election, said the directors had a “very limited” time to consider the matter because some would have to leave soon. That would mean that the panel could lose its quorum and its ability to act legally.

Based on the Internet audiocast of the meeting, it was impossible to determine how many of the 29 members of the board answered the roll call. But the executive director of the board, Melissa King, reported a “healthy quorum.”

Among those responding as present was Sherry Lansing, who had previously reported in her letter endorsing Klein that she would be unable to attend. Lansing is former Hollywood studio executive and chair of the CIRM Governance Committee, which deals with such matters as election of the chair.

CIRM Board Attorney Challenges Assessment of Klein's Financial Warning

James Harrison, outside counsel to the CIRM board of directors, this afternoon took issue with our item yesterday that reported that CIRM Chairman Robert Klein issued an “urgent, financial alarm” concerning the agency's bond funding as part of his bid for re-election.

We are carrying the message from Harrison, of Remcho, Johansen & Purcell of San Leandro, Ca., verbatim. Our assessment of it follows his remarks. For the original items, see here and here.

Harrision's remarks:

“I write in response to your recent blog postings regarding CIRM’s financial condition and in appreciation for the additional information provided by the Treasurer’s Office.

“First, Bob Klein did not issue 'an urgent, financial alarm' in his candidate statement as you suggest.  Rather, he made the Board aware of an issue that he intends to “immediately focus” on if the Board were to re-elect him as Chair.  Currently, CIRM has no authority for the Treasurer to issue additional bonds on CIRM’s behalf.  Given CIRM’s expectation that the disbursement of funds will accelerate in 2011, it important that this authorization occur in the first quarter while CIRM’s existing Board members and staff who are familiar with the process are in place.

“In an email communication to CIRM on December 2, 2010, the Treasurer’s Office informed CIRM that the Treasurer’s Office only had “December and January available for finance committee meetings since we could issue bonds as early as February 2011.”  Based on this exchange, staff believed that it was a priority for Bob to work with them to prepare the internal projections that are essential for the meeting.  It is important to obtain an additional authorization even though Bob believes that it is not necessary to obtain bond funds in the immediate future.  We welcome the additional information from Tom Dresslar, the Treasurer’s spokesperson, but don’t perceive a significant difference between what the Treasurer’s Office has said and what Bob Klein said in his statement.  Furthermore, even if the California Stem Cell Research and Cures Finance Committee meeting were to occur in February or March, Bob would like to ensure that all of the background work that is necessary to provide additional authority to issue bonds on CIRM’s behalf is completed in the first quarter of 2011, including updated projections for 2011 and 2012 that are generally required by the Department of Finance.  Given that Bob has stated that he only has 90 to 180 days available to serve as Chair, he would like to focus on this immediately.”

Obviously our characterization of Klein's remarks is our opinion. But given the nature of his choice of words – such as “just informed,” “immediate,” “essential” and “there may not be another opportunity” – plus the election-eve timing of the statement, ample evidence exists to conclude that Klein was sounding an urgent alarm aimed at generating concern among CIRM board members. And the point of the concern was to demonstrate Klein's indispensability to directors.

Upcoming

We plan to provide live coverage of this afternoon's meeting of the board of the California stem cell agency and its deliberations on the matter of a new chair, based on the audiocast of the proceedings on the Internet. The meeting is likely to involve one or more executive sessions of unknown length. If you would like to listen to the audiocast, instructions can be found on the agenda. The meeting is scheduled to begin at 4 p.m. PST.