Peril and the CIRM Presidential Search

Attempting to understand the presidential search of the California stem cell agency certainly meets the definition of a task fraught with peril. It is a process that is being conducted behind closed doors and whose participants are sworn to secrecy on any significant details. All of which is entirely appropriate.

Nonetheless the search is fundamentally important to the current and future health of the $3 billion effort and is worthy of some public scrutiny.

We wrote earlier this week about the process, and today another piece of ours appeared on Wired.com.

To summarize: compensation, personal chemistry, structural management issues all are complicating the recruitment effort. But there are others, one of which is the desire for a blue ribbon scientist to run the agency. But the new president would also be expected to give up his lab and research work. The first search in 2005 apparently brought forth some scientists/presidential candidates who wanted to continue their lab work. This time around that seems to have been ruled out by the Oversight Committee. So that narrows the field.

Former president Zach Hall earlier this year suggested to CIRM directors that a new president could do very well without having a high-toned scientific pedigree. But when we talked to Oversight Committee member Jeff Sheehy last week, he said candidates with a good scientific vision were the ones that excited him. Of course, Sheehy is but one of 29 members of the committee.

Hall also said in an interview last month that the Oversight Committee “must be willing to enable a new president to take a strong leadership role.” It was a comment based on the ticklish relationship between him and California stem cell chairman Robert Klein, which was exacerbated by Prop. 71's unnecessary dabblings in management minutia. Those are now locked in state law and virtually immutable.

Finally come comments from John Simpson of the Foundation for Taxpayer and Consumers Rights. He is a longtime observer of CIRM and reasonably fair-minded. We asked him for his thoughts on the search. Here is the text of what he sent us:

"The selection of CIRM's president is undoubtedly the ICOC's single most important task. He or she will be the chief executive of an enterprise that is costing California taxpayers $6 billion.

"Zach Hall helped define the president's role and deserves credit for getting the fledgling agency off the ground. The new president faces the daunting task of moving forward from entrepreneurial, adrenaline-filled days of a start-up mode to maintaining an established agency where the routine is, indeed, routine.

"He or she must be seen to do the public's business in public and will need vision to move the agency forward.

"A thick skin and diplomatic skills will be a necessary in dealing with some of the oversized egos on the ICOC as well as the various members of the public who take an interest in the agency.

"Judging from hints dropped by ICOC Chairman Bob Klein, the new president will have to deal with a new board chairman within a year; Klein will likely step down in 2008. That could make the new president's job easier.

"The average California probably won't pay much attention to the agency even though $6 billion of taxpayer money is at stake unless something goes terribly wrong, or incredibly right -- meaning a significant scientific breakthrough results from California's efforts.

"The most likely scenario is the middle ground. Incremental advances, but no flashy breakthroughs.

"If the ICOC can pick the perfect person, however, Californians will ultimately take notice because the president will actually deliver on the wild promises made during the campaign to pass Proposition 71."

One caveat to Simpson's remarks. While Klein did speak last December about stepping down next year, it is not a done deal.

Time for More Openness in $220 Million Grant Program

The California Stem Cell Report today formally called on directors of the California stem cell agency to open up the $220 million lab grant process by making the names of applicants and other related information a matter of public record.

In a letter to California stem cell Chairman Robert Klein, David Jensen, publisher of the report, said such action would conform to the letter and spirit of the California Constitution, which guarantees the public a broadly construed right of access to information about “the conduct of the people's business.” He also said opening up the information would help to preserve public confidence in embryonic stem cell research.

Here is the text of the letter:

"This letter is to request that the Oversight Committee -- as part of the RFA to be considered for major labs at the Aug,. 8 meeting -- stipulate that the names of the applying institutions, their letters of intent and applications are a public record when they are received by the California Institute for Regenerative Medicine.

"Such action by the ICOC would serve the best interests of CIRM and its goal of adherence to the highest standards of openness and transparency. It would also comply with the letter and spirit of the California Constitution, which declares that the people of California have “the right of access to information concerning the conduct of the people’s business” -- a right that is to be “broadly construed.” As you know, 83 percent of voters approved that constitutional right of access in November 2004 when they passed Prop. 59.

"In many ways, the California Institute for Regenerative Medicine is very open, which is a tribute to the Oversight Committee's commitment to transparency.

"But now, as the agency embarks on its single largest round of grants, it is time to take another step to protect the public interest and the agency itself as well. Fifteen members of the Oversight Committee have ties of one sort or another to institutions that may well seek funds in this round of lab grants. The entire University of California system is represented on the board, along with Stanford University, the Burnham Institute and other well-regarded institutions. On Aug. 8, the board will set the rules under which employers of many of its members stand to benefit by tens of millions of dollars. Combine all that with the critically important but closed-door, scientific review of the applications, and you have an information void that can only lead to the worst sort of speculation. Making the applicant names and other information public goes a long way in helping to prevent such a situation.

"In the past, CIRM has made a case for privacy on research grant applications from individual scientists. But applications from government and nonprofit institutions are fundamentally different. They are not subject to the same concerns that individual researchers might have regarding their reputations or work.

"We urge you to act in the public's best interest and open up the $220 million lab grant process by making public the names, letters of intent and applications from all institutions seeking funds. Such a move will enhance CIRM's reputation and help to maintain public confidence in embryonic stem cell research."

A Wired Look at CIRM Presidential Search

Wired.com has a piece by yours truly on the effort to find a new president for the California Institute for Regenerative Medicine. We will carry more a few more details on the effort later on Friday. You can find the Wired article here.

Corn, Ham and the Women of CIRM

From Hollywood's Sherry Lansing to Davis' Claire Pomeroy, patient advocate Don Reed covered them all. Wonder Women, he called them.

Reed is the irrepressible patient advocate who doggedly attends almost every meeting involving the California stem cell agency and then goes on to fight the stem cell fight nationwide via the Internet.

On his blog – stemcellbattles.com – the July 31 posting involved the women on CIRM's Oversight Committee. Reed did not mention the women who staff the agency, including the two who are now in charge of the effort. But he probably will.

With Lansing, Reed reached into the past and rented a movie, Rio Lobo, in which she appeared with John Wayne. Lansing's heart-of-gold character did away with a bad guy who had done her wrong, but then helped Wayne to walk again.

Reed himself is a goodhearted fellow. Some people might think his writing style a little corny, but I once had a high school speech teacher who constantly reminded me, “Corn is better than ham any day of the week.”

A $100 Million Collaborative Effort

CIRM Oversight Committee members Ed Penhoet and Claire Pomeroy enjoyed a $100 million day earlier this week in Sacramento.

The occasion was the announcement that the Gordon and Betty Moore Foundation was giving the money to UC Davis to establish a nursing school. Penhoet is president of the foundation. Pomeroy is dean of the medical school at UC Davis.

The Moore donation is the largest ever made to UC Davis and one of the largest ever for the University of California system.

Gordon Moore is one of the founders of Intel. His son, Ken, was present for the announcement. A story written by Bill Lindelof and Dorsey Griffith reported the following:

"He (Ken) said a nurse came into his mother's room and told her it was time for a shot. Betty Moore balked, but the nurse insisted.

"'Turns out she got the insulin shot that should have gone to the patient in the neighboring bed,' said Ken Moore. 'They nearly had two deaths out of one medical error. That was the start of her really being interested in nursing care.'"

Sharon Stello of the Davis Enterprise reported:

"UCD spokeswoman Lisa Lapin said initial connections between the foundation and the Davis campus were made between Claire Pomeroy, UCD vice chancellor for human health sciences and dean of the medical school, and Penhoet, both of whom serve on the California Stem Cell Commission(sic). They started talking about mutual visions for nursing education, and the conversation evolved into the grant."

CIRM Director Nova Taking Her Firm Public

Tina Nova, a director of the California stem cell agency, is looking for a big payday when the company she heads, Genoptix, goes public, seeking to raise $86 million.

The Carlsbad, Ca., firm has filed documents with the federal government announcing its plans for an initial public offering. Genoptix, which reported its first quarterly profit this year, provides laboratory and diagnostic services to hematologists and oncologists. It is backed by venture capitalists including
Enterprise Partners, Chicago Growth Partners, William Blair Capital Partners, Alliance Technology Ventures, Tullis-Dickerson, Excelsior Venture Partners and others.

Nova is one of 29 members of the Oversight Committee for CIRM. The IPO filing, which has lots of interesting business details, can be found here.

CIRM, Entropy and the Presidential Search

The California stem cell agency entered its fourth month today without a permanent president, although its directors knew last December that the post would be vacant by summer.

On Monday, Robert Klein, chairman of the agency's Oversight Committee, told the California Stem Cell Report that he expected the search to move forward “in a material way” at next Wednesday's meeting of CIRM directors. However, he did not predict a decision on either a candidate or a new salary for the president.

Klein said he was “committed to getting absolutely the right person.” He said the search is not taking long when compared 12 to 18 month efforts to find top academic or university executives.

The Oversight Committee met three times in unusual, teleconference meetings between the end of June and the end of July to consider candidates and compensation. But those meetings, conducted mainly in private, ended with no public action.

The presidential search is not on the public portion of the Oversight Committee's agenda Wednesday, but the matter can be taken up during the group's scheduled personnel session, which also will be behind closed doors.

Following last week's meeting of the CIRM standards group, Jeff Sheehy, a member of the Oversight Committee, said in an interview that compensation is a significant factor in the search, which apparently involves candidates from academe. He noted that CIRM cannot provide special housing allowances that are often part of the compensation mix in academic recruitment efforts. Nor can the institute provide loans to its employees. Academic employment also can provide tenure and other financial opportunities that would not be available to a CIRM president.

Since the beginning of May, two capable CIRM staffers have picked former president Zach Hall's responsibilities on an interim basis. But earlier this year, we pointed out that organizations with lame duck CEOs and interim presidents can easily slip into drift. No one wants to make a decision that would tie the hands of a new president. Hiring new staffers can also be difficult. While it is hard to quantify the impact, it can be quite harmful. More than one director has voiced that concern.

As far back as last January, Oversight Committee member Michael Goldberg warned fellow directors against complacency. Goldberg has more than a nodding acquaintance with such issues as a venture capitalist who directs life science investments for Mohr Davidow Ventures of Menlo Park, Ca.

He said,

"There's a whole organization there that's been charged with an enormous responsibility of administering the research apparatus of the CIRM, and it's leaderless. I don't like working for an organization that's leaderless. I say leaderless, I don't mean that in the sense it doesn't have a chair engaged and vice chair engaged and (outgoing president Zach Hall's) engagement, but it's not the same as an organization that's moving forward.

"There's entropy in my experience at this stage of an organization's life with a leader who's announced his departure....That should give us actually an increased sense of urgency, if anything. so I'd like to do everything we can to fast track the process without sacrificing any of the transparency and engagement with stakeholders that I think we're all committed to."

CIRM Directors to Address Business IP and Lab Grants

Directors of the California stem cell agency meet next Wednesday with a $220 million matter foremost in their minds, but other issues, such as intellectual property rules for grants to businesses, also are up for action.

Criteria and procedures for the $220 million lab grant RFA – the largest single grant effort by CIRM – are likely to dominate the discussion. The meeting is expected to be the last stop before grant applications are sought. California stem cell Chairman Robert Klein is talking about approving the first stage of the grants in January(see item below).

Proposed payback requirements for businesses that receive grants from CIRM, which are part of the IP regulations, are up for possible action. The agenda is vague, but if I were a business interested in having a voice on what could be a multimillion dollar matter, I would want to be present for the Wednesday meeting in San Francisco.

The agenda also includes a proposal for pre-approval of certain Japanese stem cell lines in CIRM-funded research and changes aimed at making it easier to do research in California on reprogramming of somatic cells.

One cryptic agenda item lists consideration of an unspecified proposal from the California State University system. No details were available on the agenda at the time of this writing, but we are attempting to find out more.

Stem Cell Lab Building Plan Heads for Approval Next Week

The California stem cell agency Monday moved forward on its largest single grant effort – a $220 million proposal for new research labs – with hopes that some construction could begin as early as next January.

The Facilities Working Group of the California Institute for Regenerative Medicine (CIRM) sent criteria, evaluation standards and grant review procedures for the lab grants to the agency's Oversight Committee for approval when it meets Aug. 8 in San Francisco.

Major universities and research institutions in California, ranging from Stanford to UC San Diego, are lining up for the money. Some have been planning since November 2004 when Prop. 71 created CIRM and provided it with $3 billion in funding, the largest single financial source for human embryonic stem cell research in the world.

The group did not settle on a firm timetable, but Robert Klein, chairman of the Oversight Committee, said he expected to see initial approval of the grants in early January. He said that would mean that some institutions could begin construction shortly thereafter.

That would be possible under a new, two-step grant review process approved by the working group Monday. It calls for the scientific component of the proposals to be approved first via the scientific grants group with facilities group action later. Klein said high rankings at the first stage of approval (at a yet to be scheduled Oversight meeting early in January) would permit some ambitious institutions to begin work. Jeff Sheehy, a member of the Oversight Committee and the facilities group, said the new process could speed up final approval by at least a month compared to the smaller, shared lab grant review completed earlier this year.

The facilities group also indirectly addressed the ticklish question of dividing the grant money between smaller, less-established institutions and the heavyweights of stem cell research. The proposed grant rules call for applicants to choose as many as three scientific areas where they believe they have strength: basic and discovery research, preclinical research, preclinical development and clinical research. The areas were dubbed, respectively, Element X, Element Y and Element Z.

If a university identifies itself as having strength in all three elements (XYZ), it will compete against other similar XYZ institutions as a “CIRM Institute.” If it has strength in two elements, it will compete as “CIRM Center of Excellence.” If strength is in one area, the competition will be among other single-strength “CIRM Special Programs.”

The grant process places emphasis on value, leverage and urgency, which account for 70 out of 100 possible points. The urgency component (20 points) requires a two-year construction timetable with financial penalties for failing to meet deadlines. The value component( 25 points) calls for a “good return to the taxpayer,” among other things. The leverage component (also 25 points) is aimed at forcing the institutions to come up with major financial support for their proposals in addition to CIRM funding.

Several times the discussion focused on ambiguities in the criteria such as “facility assets,” “enhanced capability” and “reasonable and necessary.” Some of these are likely to be refined as a final RFA is developed. But Klein told the small audience at today's meeting at CIRM headquarters in San Francisco, “We're going to make a lot of subjective decisions.” It was a refrain he came back to several times.

Following the meeting, when we asked him about the difficulties posed for applicants by ambiguous terms, he said they do create challenges. But he said the criteria is designed to “accommodate the creativity” that California institutions have. He and others on the facilities group said they wanted to provide ample opportunity for imaginative approaches to lab construction, management and collaboration.

The facilities group also approved a rule aimed at preventing double-dipping in the grant process. It permits only one application per institution with funding for a single project on a single site. This means, for example, that if a legally constituted consortium applies for a grant, members of that consortium cannot apply for another grant separately.

John M. Simpson, stem cell project director of the Foundation for Consumer and Taxpayer Rights and a longtime attendee at CIRM sessions, praised the overall process for the lab grants. Often a critic of CIRM and the grant process at one point, he said the facilities group meetings benefited both the agency and applicants, generating a higher participation from the applicants/public compared to many other CIRM sessions. That “enhances the output,” he said.

Simpson is correct about the larger turnout, but even that is small, ranging from 30 to 40 persons at its peak during the recent round of meetings. What surprised us is the fact that some potential applicants did not regularly attend the sessions. That means they will miss important nuances that are not available via online transcripts and Power Point presentations. As for attendance by the general public, nobody bothered, but that is not much different than public proceedings at any other state agency.

To see more specifics of what the facilities group considered, see this location. The document is likely to be reposted in several days with changes from today's meeting as part of the Oversight Committee agenda.

Golden Eggs on The Stem Cell Blog

Time to move off this channel briefly and visit The Stem Cell Blog (published by Chris Scott of Stanford) to read a guest posting from this writer on the $220 million lab grant program at the California stem cell agency. It begins:

“You could call it a stem cell variation of the chicken and egg question.

“But in this case, it involves edifices – not eggs. And researchers – not roosters. Which is more important?”

A little later this afternoon we will have an update right here on this site concerning this morning's developments at CIRM. The Facilities Working Group modified the rules for making the lab grants and moved them along to the full Oversight Committee for consideration Aug. 8. The intention is to see at least some institutions begin construction on their approved facilities in January.

ACT, NIH and No Go Federal Funding

Despite all the hoopla on the Potomac about stem cell research, don't expect the federal situation to change any time soon and eliminate the justification for California's own $3 billion stem cell research effort.

The latest evidence for that came in a piece Sunday by Rick Weiss of the Washington Post. It demonstrated the hidebound nature of the NIH as well as the constraints it faces. The piece did not have to mention NIH's tight financial situation.

Here are the first few paragraphs of Weiss' story:

"With the active encouragement of the Bush administration, U.S. scientists in the past year have developed several methods for creating embryonic stem cells without having to destroy human embryos.

"But some who now wish to test their alternatively derived cells have found themselves stymied by an unexpected barrier: President Bush's stem cell policy.

"The 2001 policy says that federal funds may not be used to study embryonic stem cells created after Aug. 9 of that year. It is based on the assumption that the only way to make the cells is by destroying human embryos -- a truism in 2001 but not any longer.

"As a result, the National Institutes of Health recently refused to consider a grant application for what would have been the first federal study to compare several of the new, less politically contentious stem cell lines.

"'This is not the way to make good health policy,'" said Robert Lanza, the frustrated vice president for research and scientific development at Advanced Cell Technology (ACT) in Worcester(see editor's note below), Mass. Lanza submitted the study proposal with stem cell experts from several major research labs."

Even with a change of administration in 2009 and a Democratic Congress, it will take a considerable amount of bureaucratic shuffling to chart a new NIH and federal course on embryonic stem cell research. Then additional funds would have to become available or be taken from existing research – an effort that would be strongly resisted. Some would argue at that point that states are already handsomely financing ESC research, and more is not needed from the feds. Even if funds become become available, then the NIH has to go through another lengthy award process.

(Editor's note: ACT is headquartered in Alameda, California – not in Massachusetts. Why is it in the Golden State? Because that is where the money is. We should also note that a public relations agency for ACT is sending copies of the Weiss story to various interested parties, probably throughout the country. Nothing wrong with that. If you have a drum, you probably should beat it.)

Stanford's Chris Scott and His New Stem Cell Blog

A snappy new blog on stem cell issues has popped up at Stanford University, complete with a reading list and podcasts.

Called "The Stem Cell Blog," it is published by Chris Scott, director of Stanford's Program on Stem Cells in Society and author of the book, "Stem Cell Now." (You can find a picture of Scott here.)

The first post dates back to June 26 with a graphic account about research with live pigs. More recently, the blog has a post based on work by Susan Stayn, Stanford's state stem cell legal expert. Called “What Color is Your State?” it begins like this:

"Taking a cue from Homeland Security, we’ll periodically publish a color-coded ranking of American states and their legislative positions on embryonic stem cell research."

You can also download the state rankings in a PDF file.

We have added The Stem Cell Blog to our links on the left of this site.

Weekend Reading: Guide to a $220 Million Giveaway

For all of you stem cell lab hopefuls, the California stem cell agency has posted 29 pages of Power Point presentations that will be used during Monday's meeting on the $220 million program.

It includes the latest thinking from the “interested parties” meeting earlier this week as well as other fresh developments. We have not yet digested the material, which is a bit complex. But if you have a horse in this race, check it out. Monday's meeting is the last before the massive program comes up at the full Oversight Committee session Aug. 8.

Here is the link to the documents.

CIRM Group Gives Nod to Japanese Cell Lines

The California stem cell agency Friday moved to add some Japanese stem cell lines to two already approved foreign lines and to make it easier for California researchers to engage in experiments to reprogram somatic stem cells.

Meeting in San Francisco in a national teleconference session, the Standards Working Group made positive recommendations in both areas that will be taken up Aug. 8 by the agency's Oversight Committee.

The Japanese lines are ones that are derived under the “Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells.” Geoff Lomax, senior CIRM officer for the standards group, said researchers are seeking as many lines as possible. He also said a delegation of Japanese scientists had requested inclusion of the lines. UK and Canadian stem cell lines already enjoy pre-approval.

The group also discussed the question of varying deadlines for using embryos for derivation of stem cells. Prop. 71 sets a deadline of 12 days after cell division. The Japanese deadline is 14, as is the UK, according to testimony. Bernie Lo, chairman of the standards group, noted that it is not currently
actually possible to derive embryonic stem cells beyond 12 days.

After some discussion, Lo asked CIRM staff to research the issues involved so that CIRM can act quickly when derivations can occur after 12 days.

The group additionally recommended that CIRM permit reprogramming experiments on existing somatic stem cells that do not necessarily meet the informed consent requirements intended to be used for new cell lines. Ann James, senior university counsel for Stanford University, said researchers at her school wanted maximum flexibility.

Kevin Eggan of Harvard, a member of the CIRM group, said such cell lines have been in use for perhaps as long as a decade and represented a valuable starting point for research into how to reprogram adult cells into pluripotent ones – the characteristic that makes human embryonic stem cells so valuable. Others noted that it would be all but impossible to replicate today's informed consent requirements for those older lines.

Patricia Olson, scientific program officer at CIRM, said permitting use of the older lines would only allow CIRM-funded researchers to do what others already do outside of California.

Background material from CIRM on these issues can be found here.

Thomson Report Carried by Nature, Chronicle of Higher Education

Nature magazine and the Chronicle of Higher Education have picked up a report from this blog on Jamie Thomson's ties to UC Santa Barbara.

The report in Nature briefly discussed the flap involving the Wisconsin Alumni Research Foundation's ownership on patents originating from Thomson's work on human embryonic stem cells.

The Chronicle's story on its news blog cited the Nature item as its source. Both publications also mentioned this blogger's report, noting that the Thomson connection helped UCSB win a $2.3 million grant from CIRM.

CIRM Grants: Checks Not in the Mail, Squeaky Clean Review Underway

Directors of the California stem cell agency have approved $170 million in grants so far this year, but none of the money has yet reached researchers, universities or other recipients.

In early June, directors were told that the first wave of the funds -- $45 million approved five months ago -- was likely to receive the administrative go-ahead before the beginning of July. But that schedule has gone by the boards, and it is not clear exactly when the checks will ultimately be sent.

At the heart of the issue is the review of the details of the grants that occurs following their approval by the Oversight Committee.

Arlene Chiu, interim chief scientific officer for CIRM, told the committee last month, "We strive to be good stewards of the public's money."

Each one of the 117 proposals is examined by CIRM staff for compliance with its rules and state law. Slowing the process are the newness of the procedures, the small size of the CIRM staff(about 25)and even the speed at which the recipient institutions respond to requests for additional information. It is fair to say that universities do not necessarily act speedily even when millions of revenue are on the line.

CIRM has also been without a permanent president since the beginning of May, raising the possibility that the process might be moving faster with a permanent CEO in place. However, Dale Carlson, chief communications officer for CIRM, said, "I’ll tell you categorically that’s not a factor."

We asked Carlson about the funding process. Here is his reply verbatim:

"The length of time reflects several factors. First, we are looking at a large number of approved grant applications, particularly relative to the staff available to conduct the administrative review.

"Second, the requested costs on every application need to be carefully reviewed to ensure that they are accurate and in keeping with our policies. Facilities and indirect cost reimbursement rates also need to be checked, verified, and may need to be adjusted to fall in line with prevailing rates from other national grant-making institutions.

"This too is proving more time-consuming than we'd originally estimated.

"Third, some institutions are more prompt than others in responding to requests for documentation.

"This is still a new exercise for us. We're being very careful and thorough to ensure we get it right. It should go faster in the future.

"Fortunately, the recipient institutions understand that we are working with a new and small staff, and are by and large being very patient with our process. I think they share our interest in seeing this exercise properly completed, as it should generate efficiencies down the road.

"We are making every effort to send out all the notices of grant award (NGAs) in the coming weeks. The release of funds by the State Controller's Office follows the return of signed certification statements, and we obviously have no control over how quickly institutions turn those around."

Caution and care are to be commended in the case of this review. CIRM is still an infant organization. Laying a good groundwork for the future remains paramount. Plus financial foulups are viewed harshly in the media. Witness the stories earlier this spring about expensive lunches by some CIRM directors, a trivial expense that some reporters focused on in their stories about a state audit of CIRM. Bigger numbers would generate bigger and more unfavorable stories with a negative impact on CIRM's reputation.

CIRM Presidential Search: No Announcement Yet

Directors of the California stem cell agency failed to take public action today for the third time in the last month in their seven month search for a new president.

No announcement was made following the closed door session of the Oversight Committee. The last words – "progress is being made" – came from stem cell chairman Robert Klein on July 12. Klein had expected to fill the position by June.

Lab Grant Evaluation Standards

The evaluation standards for the $220 million lab grant program have now been posted on the CIRM website and are available here.

Upcoming This Week: Japanese Stem Cell Lines, Lab Grants and Presidential Search

From $220 million in lab grants and Japanese stem cell lines to the latest chapter in the search for a CEO, the California stem cell agency is set for a busy week.

We want to point out the background material prepared for the Standards Working Group meeting on Friday. Posted last week well before the meeting, the paper neatly summarized the history behind the matters being considered, touched on the issues involved and offered up draft language to deal with the problem in two cases. It was a good example of staff work that improves the decision-making process.

The standards group, which regulates CIRM-funded research, will consider whether to include some Japanese stem cell lines as "approved" for study. They would join some lines from Great Britain and Canada as ready to use. That means that research using them does not have to go through a more lengthy review process. Specifically, the Japanese lines being considered are ones derived under the "Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells."

The group is also scheduled to consider a problem in connection with informed consent requirements and research involving somatic cell lines. The agency's regulations created a situation in which "existing somatic cell lines obtained with informed consent may not be available for reprogramming experiments unless consent was obtained in accordance with the exact requirements of section 100100 (of CIRM regulations)."

The staff report said,

"The SWG might consider a more flexible standard for use of somatic cells. Interviews with leading researchers suggest the inability to utilize commonly available commercial somatic cells (non-covered stem cell lines) lines would limit CIRM-funded researchers from attempting to replicate studies."

On Wednesday, CIRM will conduct a session for "interested parties" on the $220 million lab grant effort. Proposed evaluation standards are scheduled to be posted Monday on the CIRM web site. Earlier, the agency posted the criteria and scoring. On July 30, the Facilities Working Group will wrestle with the subject once again, but the ball is rolling faster, so you applicants should pay close attention. Don't be shy about communicating with the agency if you can't be at the meetings.

On Tuesday, the Oversight Committee will convene for the third time in a month for a special, teleconference meeting to consider presidential compensation and candidates. They are legally equipped to come to a decision in their seven-month effort. But our bet is that no new president will be announced.

Nature Magazine Trumpets California 'Upstart'

The California stem cell agency's $85 million faculty awards program received some attention today on the website of Nature magazine.

A brief piece by Monya Baker noted that the program had been announced by "an upstart state-funded initiative to make California a stem-cell research hub."

She wrote:

"US biomedics moving from postdoc to independent research often struggle to find stable sources of funding. New investigators receive only 6% of US National Institutes of Health (NIH) R01 awards, the multi-year grants that US universities rely on. Similar to R01, the CIRM grants will fund direct project costs of $300,000 for academics and $400,000 for clinicians. Worries over money hamper long-term thinking, says Xianmin Zeng of the Buck Institute in Novato, California, who plans to apply. Many foundations give only small amounts of money over one or two years, she says. 'For young investigators to get a stable environment, they need a stable foundation,' Zeng says."

Klein Rebuffed in Lobbying Effort for New Stem Cell Nonprofit

California stem cell Chairman Robert Klein -- and associates -- Tuesday failed in their initial efforts to secure a land use change that would have swapped Northern California farmland for a new, nonprofit stem cell research institute that Klein would have chaired.

The proposal was put off by Yolo County supervisors during an angry meeting, reported Mary Lynne Vellinga of The Sacramento Bee. However, the proposal is not likely to vanish. Its chief backer, developer Angelo Tsakopoulos, is a persistent businessman. The stem cell proposal was one of three land use proposals that the supervisors were considering. Vellinga wrote:

"Tuesday's vote shelves -- at least for now -- a proposal by Sacramento developer Angelo K. Tsakopoulos to build an incubator for stem cell research just south of Interstate 80 outside Davis, and to fund it with profits from the construction of an unspecified number of homes.

"The county has been considering inclusion of some 1,500 acres, about 60 percent of the land owned by Tsakopoulos, for an 'innovation corridor' targeting life science and biotechnolgy.

"A bevy of stem cell experts, researchers and accident victims in wheelchairs -- including Ms. Wheelchair California -- turned out Tuesday to support the idea.

"'With your approval, the suffering people would have hope,' said Roman Reed, who was paralyzed when he broke his neck playing football. A state law named after Reed sets aside money for paralysis research.

Robert Klein, chairman of the state-funded California Institute for Regenerative Medicine, also made an appearance. He has been working with Tsakopoulos to promote the idea of a center, which he plans to head.

The supervisors took pains to stress that they would love to see a stem cell research center built in Yolo County but don't support the idea of building housing on the valuable farmland next to the Yolo Bypass. “'The money (for the center) comes from building the houses; that's not something I can support in that area, no matter how much I care,' Thomson said.”

For more on this issue, see the Yolo item below. Searching on the label Yolo will also turn up additional items.

Correction

The item below incorrectly said CIRM is scheduled to approve grants at a rate of $54,000 an hour this year. The correct figure is $29,000 an hour. The $54,000 rate included the major lab grants, which do not appear likely to be approved this year.

Klein, Chimeras and the Yolo Land Deal

In the eyes of some, the unusual lobbying by the chairman of the $3 billion California stem cell agency on behalf of an effort to swap farmland for a new, nonprofit stem cell research institute is not necessarily unethical or inappropriate.

No public hue or cry has erupted over the issue. Yes, two stem cell agency watchdogs have expressed dismay or outrage. One newspaper said Robert Klein should give up his state post if he continues to pursue the lobbying effort. But another good government advocate privately said he did not detect illegal or even unethical conduct.

So what's at stake here? One question centers on whether Klein has something to gain that conflicts or appears to conflict with his role as a state employee. Another question involves whether he is using inappropriately his position as chairman of the CIRM. Would he have been asked to lobby for the land deal if he were not overseeing the agency?

The answer to that question is: Probably not. Klein would be little more than another Darrell Issa if he were not the chair of CIRM's Oversight Committee. “Darrell who?” you might ask. Issa, like Klein, played a major role into a ballot measure that has had an enormous impact on California. In Issa's case, he financed, with $1.7 million of his own money, the effort that placed the gubernatorial recall on the 2003 ballot and sent Arnold Schwarzenegger to the state house. Issa was widely believed to be considering a run for governor. But today he remains an obscure California congressman.

Klein would have lapsed into similar obscurity without his high visibility post at CIRM. He now travels to Australia and Korea to hobnob with international stem cell scientists. He is profiled by Fortune magazine. He is an articulate, aggressive global salesman for human embryonic stem cell research.

But that is almost totally due to his state post. He heads his own private, national stem cell lobbying group in California, but that does not provide the prestige and power that accrues as the result of heading a concern that is giving away money this year at the rate of $29,000 an hour.

Tomorrow(7/12), Klein plans to bring his state-endowed prestige and power to bear on five Yolo County supervisors, some of whom have greater political ambitions and need to raise funds. Failure to act favorably on the 2,800-acre land use change could dry up some potential sources of funding, some of whom may well have ties to Klein, who is a prodigious fundraiser. Those considerations will certainly be going through the minds of supervisors as they hear him speak.

A spokeswoman says that Klein will not benefit financially from the deal that would make farmland along Interstate 80 between Sacramento and UC Davis available for development. In return, Yolo County, one of the top tomato producers in the nation, would be home to a stem cell research center with a $300 million or so endowment. Klein would chair the new institute. The Sacramento Bee reported that Klein is “cagey” about whether he would hold his state position at the same time. However, the proposed nonprofit would certainly look to CIRM for funding of at least some of its activities. Even if Klein has left CIRM by the time those grants are sought, he will still enjoy considerable, residual clout as the result of his CIRM connections. The situation is akin to those Pentagon officials who leave the government and go to work for enterprises seeking lucrative Defense Department contracts.

Klein is a multimillionaire real estate investment banker, who continues to operate his own business. He and Angelo Tsakopolous, the Sacramento developer and major political contributor seeking the land use change, go back a few years, but Klein's aides say they have never done business together. Klein's association with Tsakopolous has already proved beneficial. The developer's firm, AKT, gave $125,000 to Klein's lobbying group, Americans for Stem Cell Therapies and Cures, last April. If the Yolo deal is successful, it could lead to joint real estate work in the future. Tsakopoulos is a firm believer in building good relationships.

From Klein's point of view, he believes more research is better. To fail to bend his best efforts to promote the field and develop more resources would be to short change a campaign he has already devoted years to. Should he remain aloof from an ambitious project because of the tender sensitivities of some? No, he would answer. That's not the way to bring cures to millions of suffering people.

In stem cell circles, scientists talk of the “yuck factor” and chimeras, the mythological beasts composed of more than one animal. Some say that if a stem cell experiment creates such a creature and generates a “yuck” response, the experiment should be dropped.

Klein, who is a man of many parts, generates a “yuck” for his Yolo lobbying, his harshest critics say. We do not entirely disagree. His multiple roles raise questions about his primary priority. Serving as chairman of CIRM was perceived under Prop. 71 as a fulltime position complete with a $412,500 salary (which Klein to his credit does not take). Klein wrote substantial portions of that law. It is now time for him to respect its intent.

(Correction: An earlier version of this said CIRM was scheduled to approve grants at a rate of $54,000 an hour this year.)

Fresh Comment

Christopher Scott, executive director of Stanford's Stem Cells in Society program, has posted a comment on the Thomson item below, raising some interesting questions regarding Thomson's affiliation with UCSB.

Proposed Criteria for Major CIRM Lab Grants

Here is the text of the proposed criteria for the $220 million in lab grants scheduled to be given out later this year. The text was provided by CIRM.

Criteria, Definitions & Scoring
Recommended by the Facilities Working Group for RFA 07-03

Value (Special Features, Innovation/Sustainability
Costs)
Definition:
The investment represents a good return to the
taxpayer while considering costs, quality, geographic
location, and benefits of the project. The facility has
innovative elements that encourage conservation and
renewable resources. The project costs are reasonable
and necessary.
Scoring: 25


Leverage

Definition:
The CIRM investment prompts additional investments
that are consistent with the CIRM objectives; these
investments are additional capital funding for the
project. These costs include project cash expenditures
prior to the Notice of Grant Award and may include
(1) the purchase of land and/or a building at the
documented cost to the institution and (2) other
capitalized project cost. The project leverage
attributable to internal project overhead and
architectural and engineering costs will be no more
than 10% of the total project costs.
Scoring: 25

Urgency

Definition:
Places a high priority on completion of the project
within two years; and the delivery of projects on an
expedited scheduled. The institution, the team and
approach has a historic and proven track record of
delivering capital projects on an expedited schedule.
Start Date: Notice of Grant Award
End Date: The base building is available for
occupancy and/or installation of equipment.
Scoring: 20

Shared Resources

Definition:
The project benefits from facility assets at the
applicant site or collaborating institutions that reduce
the cost and increase the value for the mission.
Scoring: 15

Functionality
Definition:
The planned space design for the base building and
tenant improvements is consistent with the CIRM
objectives of meeting current programmatic needs and
expanding regenerative medicine research capacity
and capabilities. The facility provides for long term
flexibility while meeting scientific objectives.
Scoring: 15

Adopted on July 12, 2007

Thomson's New Lab Under Construction In Santa Barbara

Ever so quietly, eminent stem cell researcher Jamie Thomson is coming to California – at least part-time.

The move has attracted little public notice. The news has oozed out, much as tar seeps onto the sandy beaches of Santa Barbara, where Thomson's new lab is under construction on a bluff overlooking the Pacific Ocean.

His appointment as an unpaid adjunct professor at the University of California campus there has definitely produced something less than big headlines.

But Thomson's impending presence did play an indirect role in helping to secure a $2.3 million grant for the campus from the California stem cell agency.

The CIRM review of the UCSB grant repeatedly referred to Thomson, who works fulltime at the University of Wisconsin, without naming him. It noted that UCSB, which has five Nobel Laureates, came up with $1 million to establish Thomson's lab. The review said “that the close proximity of the recently-recruited PI will keep the effort (meaning management of CIRM-funded research) state-of-the-art.”

The review continued:

“There was continued discussion on the nature of the interactions with the newly-recruited PI (Thomson). The letter from this PI describes the establishment of a satellite lab at the home institution and four collaborations, three of which have been initiated (including one with the PD), and one of which is to be initiated. This new PI offers experience in growing cells in serum-free, feeder-free conditions. How this PI will work out the situation with a satellite lab is unclear, but s/he suggests that 5-8 people will be working on-site at the applicant institution. It was noted that this PI will provide advice and consultation but there was no percent effort commitment nor any indication of how much time s/he would spend at the institution.”

We should note that the grant was not for Thomson's work.

The only California story we have seen on Thomson's appointment is a five-paragraph article by Nick Welsh in the Independent, a free weekly newspaper in Santa Barbara. Welsh quoted Dale Carlson, chief communications officer for CIRM, as saying:

"This is a great coup for Santa Barbara. He is one of the finest, if not the very finest, researcher in the field."

Correction

The “Lab Criteria” item below did not include the name of Janet Wright as one of the CIRM Oversight Committee members attending the Facilities Group meeting.

Scientists and Their PR Responsibilities

Good advice on the role of scientists in the ongoing debate about embryonic stem cell research can be found on Nature's new blog on stem cell issues.

Monya Baker, San Francisco news editor for the magazine, commented on the recent testimony that the Bush administration squashed dissenting view among its appointees, which we should note happens with almost any powerful presidential administration, or for that matter, gubernatorial(see stories about how Arnold appears to be micromanaging the state's smog board).

Baker said it was important for scientists to be publicly engaged lest Luddites carry the day. She wrote:

"To be part of the solution, scientists must spend time away from the lab bench. The scientific community should get its views (and the evidence for them) into the public sphere, writing letters to editors and politicians, speaking to schools and gatherings.

"When scientists do so, they balance enthusiasm with caution, caveats with imagination. They should be able to tell personal anecdotes without fear of being mocked by their peers. To maintain credibility, not to mention civility, scientists should understand opposition to stem-cell research and describe which opinions are backed by data, which are not, and which exist independent of data.

"Consistent efforts can help turn a raucous debate into a reasoned one."

We add that it takes repetition, repetition and more repetition to have an impact.

CIRM Panel Sets Lab Criteria, Nitty Gritty Still Pending

Much work remains to be done on the details for the criteria for $220 million in stem cell research lab grants to California universities and research institutions, but “great progress” was achieved earlier this week, according to one long longtime observer.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said the lengthy session “accomplished a lot.” He wrote in an email that the

"CIRM staff needs to fill in major details with draft language now that broad policy objectives have been set. It was a long meeting, but a necessary one if the public is to have faith in the mechanism of doling out $220 million in building grants."

Simpson, who was a newspaper editor for many years prior to his current position, offered this account of this week's events.

The Facilities Working Group during a marathon seven-hour meeting Thursday unanimously decided to require that the 20 percent matching requirement necessary under Prop. 71 to receive a facilities grant be made in cash.

The eight FWG members present also agreed to refer to amounts contributed to a project beyond the 20 percent threshold as "leverage."

The panel selected five criteria to use in making the awards and the points
that would be awarded to each of the criteria. Assuming that an applicant
could receive 100 points, the criteria and and possible value are:

--Urgency (20 points)
--Value (25 points)
-- Leverage (25 points)
--Functionality (15 points)
-- Shared resources (15 points)

The members considered the possibility of using a scale with more total
points as long as the ratio among the criteria remained the same and
suggested CIRM staff give that further thought.

All agreed that if CIRM is to maximize its impact on stem cell research
facilities across California, it will be necessary to encourage institutions
to bring as much "leverage", that is cash, to building projects as possible.

"We'll have to get substantial cash leverage," said Bob Klein, ICOC
chairman.

All of the procedures and criteria developed by the FWG for the proposed
$220 million in facilities grants must be approved by the ICOC.

The FWG also voted to recommend that grant recipients be required to use
buildings financed with CIRM money for regenerative medicine for a definite
period of time, perhaps 10 or 20 years. They decided to leave the exact time
requirement to be determined by the ICOC.

The panel also developed definitions for each of the criteria. The next step
is for the CIRM staff to propose draft language for standards to evaluate
each of the criteria. The proposals will be discussed at a meeting of
"interested parties" (representatives of institutions likely to seek money)
on July 25.

The FWG will is expected to meet July 30 to complete its recommendations so
they can be forwarded to the ICOC for its August meeting.

Arlene Chiu, acting chief scientific officer, outlined a proposal to consider a two-step process to review the facilities grants. They would be reviewed first by the Scientific Working Group for scientific merit and then be forwarded to the ICOC. After ICOC review, the proposals would go to the
Facilities Working Group for review and recommendation to the ICOC.

The FWG did not act on that proposal because by that point in the meeting it
was short of a quorum, Joan Samuelson and Stuart Laff, having departed around 6 pm. The consensus appeared to be that the staff recommendation made sense.

Other committee members attending were: David Lichtenger, chairman; Klein; Edward Kashian; David Serano Sewell; Janet Wright and Jeff Sheehy. Around 20 people, mostly representatives of institution seeking money, attended.

(Editor's note: An earlier version of this item did not include Janet Wright as one of the committee members attending the Facilities Group meeing.)

The Bee Calls for Klein Resignation If He Continues to Lobby on Land Deal

The Sacramento Bee said today that California stem cell Chairman Robert Klein should resign from his post at the $3 billion state institute if he continues to lobby on behalf of a controversial Northern California deal that would swap favorable land use decisions for a private stem cell research facility.

The editorial noted that Klein's stem lobbying group, Americans for Stem Cell Therapies and Cures, earlier this spring received $125,000 from the Angelo Tsakopolous' land development company, which is seeking to convert farmland to commercial development. In return, a $200 millon stem cell nonprofit institute would be created at the location. The more than 2,000 acres is located on Interstate 80 between Sacramento and UC Davis.

The Bee wrote in an editorial:

"Klein says there's no connection between his efforts to retire campaign debt (owed by his lobbying group) and his support for the Yolo project, but it nonetheless creates an appearance of paycheck politics. If Klein wants to continue to promote the Yolo project or any project that could overlap with his duties as a state official, he needs to resign from CIRM. The sooner the better."

The newspaper said that Klein makes a "compelling case" for the type of research facility that would be built at the site by a nonprofit institute that would be headed by Klein. The Bee wrote,

"But if the case is strong, the multiple hats that Klein is wearing with this project are troublesome....He is cagey when asked if he would also continue to chair CIRM. There's the potential that the industries and researchers who would be part of this Yolo research center would also seek funding from the California institute, which would put Klein in a serious conflict of interest."

Fresh Comment

Jesse Reynolds of the Center for Genetics and Society makes an interesting point in a comment on the Lansing item below. He notes that Jeff Sheehy, who serves as a patient advocate and is on the Facilities Group, is employed by UC San Francisco.

Sherry Lansing Resigns from Lab Grant Group; Conflicts of Interest Cited

University of California Regent Sherry Lansing today resigned from the group that is setting criteria for the California stem cell agency's $220 million lab grant program. 

California stem cell Chairman Robert Klein announced Lansing's resignation at the beginning of the meeting of the Facilities Working Group. 

He said Lansing, who is in Portugal, was leaving the group because she "wants things to go forward and because she sees possible conflicts with her role as a UC regent and the working group's work," according to John M. Simpson, of the Foundation for Taxpayer and Consumers Rights. 

Simpson is attending the meeting in the San Francisco area this afternoon. A number of UC campuses are expected to seek building funds under the program. The facilities group makes funding criteria recommendations to the full Oversight Committee, on which Lansing also has a seat. 

That committee will make the final decision on the rules for receiving the grants. Many of its members are employed by or have links to institutions that are likely to apply for funds. 

With the resignation of Lansing, none of those institutions have seats on the 10-member facilities group. The only members of the Oversight Committee now on the panel are five patient advocates. The other members come from the private sector or, in one case, the state Department of Corrections.

More On the Presidential Search, Plus Lab Grants and ICOC Vacancies

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, offered the following observations on today's CIRM events, including this afternoon's meeting on the criteria for $220 million in lab construction grants and vacancies on the Oversight Committee.

Simpson, who has followed the agency closely for about two years, was present for this morning's meeting of the Oversight Committee concerning its attempts to find a new president. Simpson said in an email:

"'Steady progress' is being made toward selecting a president and chief executive of CIRM, Robert Klein, ICOC chairman, said this morning after an early morning executive session of the board. He declined, however,...to be specific about a time table to complete the selection. He said selecting the right candidate was the most important issue, not the schedule."

Simpson said board went into executive session about 7:15 a.m. Klein predicted a 15 to 30 minute meeting.

Simpson continued:

"The board resumed public session at approximately 8:15 am with Klein commenting that he should have offered a more realistic prediction of the length of the meeting given the board's proclivity for full discussion of
issues.

"'There were a lot of thoughtful comments,' Klein said."

Simpson said that he complained to the Oversight Committee about the failure of the Facilities Working Group to post background documents on the lab grant criteria well in advance of this afternoon's critical meeting. Simpson said the documents were vital to understanding the largest grant package CIRM has offered so far. He said he wanted to the full board to be aware of the situation.

Concerning the vacancies on the board, Simpson said,

"After the meeting in conversation with Tamar Pachter, General Counsel, and James Harrison, outside counsel, it emerged that both David Baltimore, former president of Caltech and Richard Murphy, former president of the Salk Institute, have resigned from the board. They had their ICOC positions by virtue of their jobs before recently retiring.

"With the vacancy created by the death ofLeon Thal, the ICOC has 26 members instead of the full compliment of 29. This means that a quorum -- something the board frequently has had difficulty mustering -- is now 17 members rather than 18."

The CIRM quorum requirement is large and is written into state law by Prop. 71. It cannot be changed by the Oversight Committee, only by an unlikely revision in the law. In contrast, other government entities often need only a simple majority of their members to take legal action. Large quorum requirements mean that a minority on a board can block action simply by not being present at a meeting.

CIRM Directors Still Looking for New President

Directors of the California stem cell agency this morning met again behind closed doors to discuss candidates to head the $3 billion research effort but adjourned without announcing a decision.

The search is now into its seven month. CIRM's first president, Zach Hall, announced his plans to leave early last December. The agency has been without a permanent president since the beginning of May, when Hall departed.

The Oversight Committee could have acted this morning. The matter of presidential compensation and candidates was properly noticed on its agenda. But virtually the entire teleconference meeting, which included a link to one director in Portugal, was in executive session, and no announcements were made during the public segment.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, asked during the public portion whether a new president would be named prior to the directors meeting in August.

Chair Robert Klein replied that artificial timelines could not be imposed and and that the search must focus on finding a president with the right scientific vision for the agency, according to CIRM officials. Previously the Oversight Committee had expected to fill the position in June.

Klein may call another presidential meeting within the next 10 or 15 days.

Stem Cell Snippets: Pachter, Kessler and Google

CIRM General Counsel – Jessica Jones has a brief Q&A on law.com with CIRM's new general counsel, Tamar Pachter. Among other things, Pachter was asked what is like working for a controversial agency. Her reply, "Is there a state agency that isn't controversial (laughs). It really doesn't affect my work all that much."

Egg Concerns – Anna Salleh for ABC Online reports concern in Australia about international trafficking in human eggs for stem cell research. Catherine Waldby of the University of Sydney is quoted as saying there are already problems in eastern Europe. Waldby's research is to be published in the New Genetics and Society Journal.


Kessler and Google Health Committee – CIRM Oversight Committee member David Kessler has been named to Google's Health Advisory Council. Kessler is also dean of the UC San Francisco medical school. The Google council is aimed at understanding health issues and providing "feedback on product ideas and development." Sergey Brin, co-founder of Google, contributed at least $100,000 to the Prop.71 campaign.

Poultry and CIRM's Oversight Committee

The California stem cell agency has two lame ducks on its board and another vacancy that has remained unfilled as the result of gubernatorial inaction since last February.

The vacancy on the Oversight Committee is the seat formerly held by Leon Thal, who died in a plane crash on Feb. 3.

Thal was appointed to the board by Gov. Arnold Schwarzenegger. State law requires him to fill the vacancy within 30 days. We asked the governor's office today when the post would be filled. Sabrina Lockhart, a spokeswoman, replied:

"Gov. Schwarzenegger is proud of California's leadership in stem cell research - which has placed our state on the cutting-edge of this potentially life-saving science. Because stem cell research is such an important priority for the Governor, he will fill the vacancy as soon as he finds an ideal candidate to fill the position."

It is not uncommon for governors to flout deadlines such as the one created by Prop. 71 for filling vacancies.

The lame ducks on the board are David Baltimore, former president of Caltech, and Richard Murphy, who retired earlier this month from his position as head of the Salk Institute.

Both hold their seats on the 29-member Oversight Committee as the result of their former professional positions. Both are expected to continue to serve at least for some time, which appears to be permissible under Prop. 71.

More Fresh Comments

Anonymous weighs in with more on the "cronyism" business related to the "90 Percent" item below. We have posted an answer to the question of why only 27 biographical sketches are found on the CIRM website for the 29-member Oversight Committee.

Fresh Comments

An anonymous comment has been posted on the "90 percent" item below, which raises a question about the significance of the item. We have posted a reply. "Faye" also had a comment about the terms of Oversight Committee members and whether they can be rotated out. We have posted additional information in response to her query. You can find all of this by going to the "90 percent" item and looking at comments at the end of the item.

New Lab Proposal Info Now Available

The California stem cell agency this afternoon posted 58 Power Point slides for the meeting of the Facilities Working Group Thursday afternoon. The slides summarize comments made at four earlier hearings, identify some questions that should be answered at this week's session and outline steps to be taken before the proposal is presented to the Oversight Committee Aug. 8 in San Francisco for approval.

While obviously sketchy, they are useful -- in fact mandatory reading -- for anyone interested in the subject of giving away $220 million for construction of new stem cell research labs in California.

Five-hour Research Lab Meeting: A Mockery?

The California stem cell agency Thursday afternoon is going to attempt to set criteria in five hours for handing out $220 million in research lab grants in a process that one watchdog likens to a "public relations sham."

No proposed criteria will be available prior to the public meeting. They may not be available at the beginning of the meeting either. Instead, the only advance, online offerings are likely to be marginally useful, Power Point presentations that will summarize issues and suggestions presented during previous four public sessions of the Facilities Working Group.

John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumer Rights, Monday said in an email to California stem cell Chairman Robert Klein,

"This facilities RFA is one of the most important and potentially contentious RFAs that CIRM will issue. It's supposed to be based on the input of four public hearings held around the state.

"The ICOC is to be commended for authorizing those hearings to gather public input about the policies.

"However, not making a draft of the policies to be discussed available with ample time for review by the public so they can make intelligent comments at the meeting makes a mockery of the entire process. It forces one to conclude that there was no real interest in meaningful public input and that your process was nothing more than a public relations sham."

Simpson added that not having the information in advance also makes it difficult for members of the working group to take intelligent action.

The only documents available online until late Monday afternoon were two facilities group transcripts from May 31 and June 4. Transcripts from hearings June 11 and June 19 were not available until Simpson called -- in his email to Klein -- for them to be posted forthwith.

The failure to post important material well in advance harkens back to earlier days of CIRM, when even members of its Oversight Committee complained publicly about not getting background material in advance. Some of that can be chalked up to growing pains.

But problem is obviously continuing. It has been compounded by not allowing enough time at meetings -- called by Klein or other committee chairs -- to cover all the necessary ground. In this case, for example, 11 persons sit on the Facilities Working Group. If each took only 10 minutes asking questions or making comments, that would consume nearly two hours. Then there is a staff presentation, questions and comments from representatives of California universities and institutions as well as from the general public. All with no draft criteria to actually read and study ahead of time.

Encumbering the process of handing out research lab grants fits with what one might call a modified stonewall strategy. CIRM does not have to make grants for lab construction. If it did not, CIRM would would have more money for research, which seems to be a priority of patient advocates on the Oversight Committee. On the other hand, executives from institutions represented on the committee could understandably take a different view although grants for their researchers are certainly important to them.

Whatever the case, the facilities group's hearings on the research lab criteria have been one of CIRM's more heavily attended series of events – mainly by folks from universities and nonprofit institutions.

It is a disservice to them, the public and CIRM itself not to provide a better opportunity for comment as well as thoughtful consideration by the working group.

Conflicts at CIRM: The 90 Percent Test

About ninety percent of the $209 million handed out so far by the California stem cell agency has gone to institutions that have "representatives" on the board that approves the funding.

The grants have gone for training new stem cell scientists, funding research and remodeling laboratories.

The group that approves the money is the 29-member Oversight Committee. Fourteen members of that committee have close links to the institutions that have received about $190 million in grants.

None of this is illegal but it illuminates the nature of the built-in conflicts of interest on the board. Prop. 71 created the situation. Nearly all the institutions in California that could be suitable recipients of stem cell research have some sort of representation on the decision-making board. The measure spelled out, for example, that five executive officers from University of California medical schools have seats on the board. It also stipulated that four executive officers from California research institutions sit on the Oversight Committee. The group would be hard pressed to come up with a long list of other institutions that would make suitable candidates for hefty stem cell funding.

Members of the Oversight Committee are barred from voting on grants to their institutions, and CIRM goes to considerable lengths to make sure that does not happen. However, all members of the committee can vote on the rules and standards for making the grants. And this week, a working group of CIRM is scheduled to devise rules for $220 million in grants for major labs at California institutions. Those standards will help establish, among other things, whether the money will be accessible to smaller institutions and spread geographically around the state or even whether that is a good idea.

While some have deplored the conflicts on the board, the situation is not likely to change soon. Prop. 71 can only be modified by another vote of the people or by a super, supermajority vote in the legislature and approval of the governor.

In the absence of a change, the Oversight Committee's structure and actions make it even clearer that CIRM should operate with a maximum of disclosure and openness, something the committee sometimes feels uncomfortable with.

Here are the names of the members of the Oversight Committee with links to institutions that have received grants and the size of the grants. Some members directly represent their institutions, such as the deans. Others, such as Sherry Lansing, have close links to an institution but serve as the result of some other designation. Lansing is a University of California regent, but serves on the board as a patient advocate.

David Baltimore, president emeritus Caltech, $2 million; Robert Birgeneau, chancellor UC Berkeley, $5.5 million; David Brenner, dean UC San Diego medical school, $17.7 million; Susan V. Bryant, dean School of Biological Science UC Irvine, $17.5 million; Michael A. Friedman, president City of Hope, $357,978; Brian E. Henderson, dean USC medical school, $9 million; David A. Kessler, dean UC San Francisco medical school, $30 million; Sherry Lansing, UC regent, 10 UC campuses have received grants; Gerald S. Levey, dean UCLA medical school, $15.8 million; Richard A. Murphy, president Salk Institute, $8.9 million; Philip Pizzo, dean Stanford medical school, $31 million; Claire Pomeroy, dean UC Davis medical school, $11 million; John C. Reed, president Burnham Institute, $17 million, and Oswald Steward, chair of the Reeve, Irvine Research Center, UC Irvine, as noted under Bryant, the campus has received $17. 5 million.

The amounts could be larger, for example, if we included the $8 million in grants to Children's Hospital of Los Angeles, which has close ties with USC. Or the $10 million to the Gladstone Institute, which has ties to UC San Francisco.

Short biographies of members of the Oversight Committee can be found here. More specifics on the size and nature of the grants can be found here(see the list at the end of the press release.

UC Davis Tightens Rules on Industry Influence

Efforts to control the influence of the medical industry in academia received more support recently at the UC Davis medical school, whose dean sits on the Oversight Committee for the $3 billion California stem cell agency.

Reporter Dorsey Griffith of The Sacramento Bee wrote earlier this week:

"UC Davis' ban against drug industry gifts, lunches and samples has expanded to include a prohibition of freebies from any company that markets its wares to the large health system.

"University of California, Davis, officials Monday announced the expanded new policy, which took effect Sunday.

"'There was consensus that we really needed to make sure that all our policies ensure that our behavior is totally transparent and ethical,' said Dr. Claire Pomeroy, vice chancellor and dean of the UC Davis School of Medicine. 'I think it's consistent with our values here of really being focused on the patient.'"

Pomeroy is one of 29 members of the Oversight Committee, which has its own set of issues dealing with conflicts of interests.

Stanford and UCLA, whose medical school deans also sit on the Oversight Committee, have similar rules, along with Kaiser Permanente Northern California, Yale and the University of Pennsylvania.

Yolo Stem Cell Proposal Attracts More Attention

A "farmland war," "unethical" – two of the descriptions emerging today in a fresh story about the Northern California land development/stem cell research project involving the head of the state's $3 billion stem cell agency.

CIRM Chair Robert Klein and Angelo Tsakopolous, a Sacramento area land developer, are lobbying for a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million. Earlier this spring, Klein's private lobbying organization received a $125,000 contribution from Tsakopolous' company. Klein would chair the proposed nonprofit.

In a story written by reporter Ralph Brave, the Sacramento News & Review today painted a bucolic picture of the development's location, which is hard on a very busy freeway just west of Sacramento. Brave wrote:

"This acreage has become the latest battleground in the ongoing war over the fate of Yolo County’s distinctive dedication to preserving farmland and open space. Although it’s just commenced, this particular battle’s mix of the area’s most powerful real-estate magnate, the head of the state’s stem-cell oversight committee, the re-evaluation of Yolo County’s General Plan governing development, and next year’s elections promises a prolonged, intense struggle that could determine much about the county’s and the region’s future."

The election issue involves at least the chair of the Yolo supervisors, a locally elected official who is seeking a seat in the California legislature. The dispute was characterized as a "farmland war" in a caption on a photo of a portion of the site.

Brave continued:

"Environmental attorney James Pachl told SN&R that Tsakopoulos’ 'proposal is an attempt to bribe the supervisors by offering to contribute to a fashionable charity in exchange for approval of AKT’s development project(AKT is Tsakopolous' company). Perhaps legal, but too unethical for most public officials to consider. The AKT property is valuable farmland, wildlife habitat and open space that should continue to be farmed.' A supporter of stem-cell research, Pachl expressed concern that 'the proposal will create a local political firestorm that will likely stop the project and damage the credibility of stem-cell researchers.'"

The newspaper also brought into its coverage another CIRM official, Claire Pomeroy, a member of the Oversight Committee and dean of the UC Davis School of Medicine.

Brave wrote that attendees at one dinner promoting the project included two Yolo supervisors, Klein and Pomeroy.

Brave said Pomeroy later told him that "it would not be 'appropriate to involve myself in land-use decisions.'"

Last Saturday, reporter Luke Gianni of the Woodland Daily Democrat quoted Pomeroy as saying,

"The concept of a research center for stem cells is a good one and something I support. A new research park in this region, in addition to the stem cell facilities we're currently building in Sacramento, could help complement the promising work our scientists are now doing in regenerative medicine."

Brave's story contained more details on financing the stem cell research facility, provided by Amy Daly, executive director of the Klein lobbying group, Americans for Stem Cell Therapies and Cures.

"Upon approval for residential and commercial development for some portion of the Tsakopoulos 2,800-acre property, 200 acres would be donated to a new nonprofit called Bridge to Cures. One hundred of those acres would be taken to a bank and used as collateral for a loan to finance the building of the research center and its labs. Part of the profits from the residential and commercial development would go into an endowment, to be used as loans, grants and other financing for biotech companies to advance stem cell and other biomedical discoveries into clinical applications."

Daly said the center's labs would be leased to for-profit companies. Earlier, she told the California Stem Cell Report that Klein would chair Bridge To Cures.

Size of the endowment has ranged from $50 to $400 million, depending on the size of the development that might be approved.

To see all the items on this subject, click on the label "yolo" below.

Recent Comments

Yvonne Perry, author of "Right to Recover, Winning the Political and Religious Wars over Stem Cell Research in America," has posted comments on the "Internet radio program" and the "TV coverage" items below.

News Coverage of Monday's WARF Stem Cell Matters

The latest developments in the WARF stem cell patent case received light coverage today among mainstream newspapers.

Stories appeared in three newspapers – the San Diego Union-Tribune, Milwaukee Journal Sentinel and the Wisconsin State Journal.

Coverage was straight forward. Wisconsin State Journal reporter David Walhlberg had this item concerning scientist James Thomson and his stem cell discoveries in 1998.

"...(T)he challengers added a new twist. They said Thomson had 'unique access' to an Israeli scientist who provided him with human embryos and enviable funding from the biotech firm Geron.

"'Had other scientists in the field been given the same access to those limited resources, they, too, would have been able to make the same accomplishment Dr. Thomson did,' the challengers wrote.

"Thomson did not respond to a request for comment Monday. In an e-mail interview last year, he said, "Some very good, simple ideas only seem obvious afterwards.'

"Andy Cohn, WARF spokesman, called the new filing 'a minor step in a long process.'"

Terri Somers of the San Diego Union-Tribune noted this case is a long way from being resolved and could wind up in court following the patent challenge.

No Aussie Location for July 12 Presidential Meeting

The folks down under are not going to have a chance to comment on the selection process for the next president of the $3 billion California stem cell agency.

Australia will be dropped from the list of remote locations for the teleconference meeting of the Oversight Committee on July 12. The site in Australia was listed on the agenda because California stem cell chairman Robert Klein was visiting the country. However, he will return on July 8. We are told that listing the Australian location was an error.

CIRM Takes Another Whack at Hiring President

In another attempt at hiring a new president for the California stem cell agency, directors of the $3 billion effort have scheduled their second unusual teleconference meeting in the last few weeks to consider compensation for the post and candidates for the position.

This one is for July 12. The last such meeting was held on June 26 and ended with no public action. The directors have sealed off any public comment after an embarrassing information leak earlier this year.

In order to act on candidates and compensation, state law requires that advance notice be given. Posting such a notice could just be a hopeful contingency measure in case a deal can be concluded by the meeting date. Nonetheless, a decision must be quite close.

One of the sticking points in the recruitment process has been the $400,000 salary for the position, which apparently has been too low for some. For more details on that see the "ticklish" item posted earlier.

Members of the Oversight Committee are calling in from 14 locations in California, according to the agenda, and one in Australia, where California stem cell Chairman Robert Klein is visiting. Members of the public can listen in at those locations during the public portions of the meeting and speak out as well. The June 26 meeting was almost entirely in executive session.

Twenty-nine persons sit on the Oversight Committee. Presumably more locations will be added as the meeting approaches. Otherwise, there may not be enough members on the teleconference to take legal action.

Melton, Cowan and Trounson Beef Up WARF Challenge

Three prominent stem cell scientists – two from Harvard and one from Australia – have bolstered a challenge to the embryonic stem cell patents held by the Wisconsin Alumni Research Foundation.

They are Douglas Melton and Chad Cowan, both of Harvard, and Alan Trounson of Monash University in Australia. Previously Jeanne Loring of the Burnham Institute had filed statements in support of the challenge to the patents of the discoveries by James Thomson of the University of Wisconsin.

Melton said,

"I very much believe Dr. Thomson deserves the scientific and public recognition he has received. However, he deserves that recognition because he undertook the arduous and timely task of getting fresh and high quality embryos to use as starting material for his work, and sufficient funding for such research, not because he did anything that was inventive... His perseverance and commitment deserve recognition and accolades. But I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious."

Melton's statement was released today by the Foundation for Taxpayer and Consumers Rights and the Public Patent Foundation. They filed the challenge last year in the wake of complaints in the scientific and commercial stem cell community about the restrictions and costs involving the WARF patents. The challenge won favorable preliminary ruling from the federal government, which WARF has responded to.

Carl Gulbrandsen, managing director of WARF, said earlier in a news release that:

"...the patents and publications the (Patent and Trademark Office) relied upon were not relevant to the isolation and proliferation of human embryonic stem cells. Gulbrandsen's comments were echoed by Dr. Colin Stewart, a leading stem cell researcher at the Institute of Medical Biology in Singapore, who submitted a declaration in support of the Thomson patents that emphasized the differences between mouse stem cells, which were prominent in the PTO's rejections, and the human embryonic stem cells that were isolated and characterized by Thomson."

More on the WARF response can be found at this site.

FTCR also has additional material, including the declarations from Trounson, Cowan and Loring, on its site.

The PTO now takes the arguments under submission. It is not expected to render a judgment for many months, perhaps as a long as a year.