Economic Woes: California, the Stem Cell Biz and CIRM

In a story that circulated today nationally and perhaps internationally, The Associated Press has painted a bleak picture for the stem cell industry despite the election of a president who is a friend of the cause.

The news came on top of the even more unpleasant news that California is facing a $28 billion budget shortfall. The state's leaders are now in a position of holding out a tin cup to the federal government, enviously eying the $700 billion bailout for the private sector.

California Assembly Speaker Karen Bass, the state's second most powerful elected official, did not exactly say, "Please, sir, can I have some," but her words were close.

All this as the $3 billion California stem cell agency, which is constitutionally protected from budget woes, is looking to hand out tens of millions of more dollars in December and create a $500 million "bank," financed at taxpayer expense, to help struggling biotech companies. All of which may be good, but could lead to a ticklish image problem.

What the PR and policy problem boils down to is this: The state slashes medical assistance to the poorest Californians while millions and millions flow unfettered to CIRM-funded researchers.

First, the news from Associated Press reporter Matthew Perrone, writing out of Washington, D.C., He said that despite the election of a friendly president,

"Experts say struggling stem cell developers will face a new, equally daunting obstacle: an investment climate devastated by the financial crisis."

Perrone quoted WBB Securities analyst Stephen Brozak as saying,

"The good news is there will finally be freedom to operate, the bad news is there will be no more venture capital, which is the real freedom."

The AP story also said that investment in early stage stem cell companies was slumping even before this fall's financial meltdown.

"Venture capital investment in biotech startups — which includes stem cell developers — has fallen more than 65 percent to $443 million in the most recent quarter, from a high of $1.3 billion in late 1999."

According to Perrone, analyst Bill Tanner of Leerink Swann was even more pessimistic on hESC companies. Tanner said,

"Even if one of these companies was going to be successful, I doubt you'd have a new embryonic stem cell product on the market in the next 20 years."

The AP story appeared as California's Legislative Analyst posted a new estimate of California's budget shortfall -- $28 billion over the next 20 months. One recommendation from the analyst was for no new state borrowing, which could strike at CIRM's revenue source, California state bonds. Even before the new figure was released, State Treasurer Bill Lockyer said that the state will not be able to issue new bonds until 2009 because investors want to see how the state copes with its financial crisis.

The fiscal mess is so bad that Jim Sanders of The Sacramento Bee quoted Assembly Speaker Bass as saying "can we have $5 or $6 (billion?)" from the federal government.

The state's stem cell agency is all but immune from the California crisis because Prop. 71 locked in its funding sources and made it impossible for the governor or the legislature to cut its budget. However, if Lockyer refuses to issue bonds well into 2009, CIRM funding might hit a hard spot.

It is not clear what CIRM's current financial status is, although its chairman, Robert Klein, told directors on Sept. 25 that CIRM's cash situation at that point guaranteed "that this critical work to reduce human suffering and advance medical science is able to move forward."

He continued,

"The scientists and clinicians and patients counting on our progress need not be concerned about our work being interrupted."

Klein said that earlier this year he anticipated a troubled bond market and arranged for money from the state's "pooled money investment fund" that should be sufficient until late spring. But he noted,

"Maybe I should have drawn down three years of money."

There is no doubt that research cannot be done without a reliable source of funding. Nonetheless, CIRM must carefully consider how its operations, with salary ranges that exceed $500,000 annually and huge outside contracts, may be perceived by the public or elected officials. It is a time to tread with great care.

As for the $500 million biotech loan program, one could argue that it is needed now more than ever. At the same time, some might look askance at lending taxpayer funds to extremely risky ventures – ones that could not even find financing under the best of circumstances – while Californians who can least afford it will see health care, education and other vital services slashed.

The lending program will not make the slightest dent in the state's economic travails. As we have noted before, CIRM's activities currently have an infinitesimal, immediate impact on California jobs and businesses. CIRM's annual giveaway does not even exceed the $356 million budgeted for a new "condemned inmate complex" at San Quentin prison. That said, the lending program, which is yet to be fully explained, could well be a good idea.

We will know more after Nov. 19 when the CIRM Finance Committee will discuss it in greater depth.

Fresh Comment

Bradley Fikes has identified himself as the "anonymous" author of the comment mentioned in the post below.

Fresh Comment and Link to CIRM Penhoet Release

"Anonymous" has posted a comment on the "CIRM Board Changes?" item with a link to a posting by reporter Brad Fikes of the North County Times on Garamendi's news release on Penhoet. CIRM's news release has now been posted and can be found here.

Penhoet Resigns as Vice Chairman of CIRM

The vice chairman of the $3 billion California stem cell agency, Ed Penhoet, has resigned from his post, but CIRM announced Monday afternoon that he will remain as one of the 29 members of the board of directors.

The statement by CIRM came only hours after the California Stem Cell Report said that Penhoet "denied scuttlebutt in the California stem cell community that he is leaving the board." However, the item also said incorrectly that he denied he "is stepping down as its vice chairman." That item was based on a one-sentence response from Penhoet that did not address all the questions we asked him on Saturday. (More on that below.)

We also queried CIRM early this morning on the matter, asking Don Gibbons, chief communications officer, for comment on reports that Penhoet was stepping down. No response was forthcoming from Gibbons on the matter.

CIRM's press release, which has not yet been posted on its website, said Penhoet was stepping down because of "the time constraints of this leadership position."

CIRM said:

"However, Penhoet has accepted the appointment by Lieutenant Governor John Garamendi to one of the board’s member positions designated for the life sciences commercial sector."

Penhoet was not quoted in the CIRM press release on the leadership change, which said that the co-founder of Chiron will continue to head the CIRM IP Task Force.

The move clears the way for nomination of a new vice chair by the state's constitutional officers, such as governor and lieutenant governor. It is likely that CIRM Chairman Robert Klein will make suggestions for possible nominees. Former CIRM board member Tina Nova has been mentioned as a candidate, but she said earlier today that no one has approached her about serving in that capacity. She also said she has "no plans to return to the CIRM board."

The full CIRM board must vote on the vice chair, selecting from the nominees. The post carries a salary of up to $332,000 annually. Penhoet did not accept a salary, raising a question whether the next vice chair will. If so, it also raises the possibility that Klein, who also has not accepted pay, will seek the $508,750 salary for which he is eligible. He has repeatedly said he may seek a salary at some point.

Some of you may wonder about some of the details involved in preparing our original item below that reported incorrectly that Penhoet said he was not stepping down. Our email query to Penhoet on Saturday said,

"I am planning on writing an item that will say that California stem cell scuttlebutt has it that you are resigning as vice chair of the ICOC. Is that correct?"

Penhoet's response:

"I have no intention of leaving the board, David."

We then asked,

"I may be parsing this too finely, but do you intend to imply that you would remain on the board but give up the vice chair position? Thanks."

Penhoet did not respond to that question. We notified him early this afternoon that our original item had been posted but have received no further communications.

CIRM was queried at 7:35 a.m. California time today about the subject but has not responded to us as of this writing.

Changes on CIRM Board? Penhoet, Nova Say No

Ed Penhoet, one of the co-founders of Chiron, has denied scuttlebutt in the California stem cell community that he is leaving the board of the $3 billion California stem cell agency and is stepping down as its vice chairman.

Penhoet's statement came in response to a query from the California Stem Cell Report concerning the talk about changes in the CIRM board. He said,

"I have no intention of leaving the board."

If Penhoet (see photo) were to resign as vice chairman, CIRM Chairman Robert Klein would like to replace him with Tina Nova(see photo), president and CEO of Genoptix, Inc., of Carlsbad, Ca., according to the scuttlebutt. However, Nova resigned in September from the CIRM board of directors, citing demands of her business.

Responding this morning to our question, Nova said she is not interested in resuming service with CIRM. She said,

"I have no plans to return to the CIRM board. My business is demanding all of my time, that is why I resigned.  I have not been approached about the vice chair position, and I have not spoken to Ed Penhoet for over three months."

CIRM has not responded to an inquiry on the Penhoet/Nova matter. We will carry its response when we receive it.

Given the firm denials from both Penhoet and Nova, one can only wonder how the subject came to surface publicly. Such talk usually has some sort of basis in fact, although it can become distorted as it passes around. It could also represent some sort of trial balloon on the part of persons interested in seeing changes made.

As far as the mechanics of selection of board members are concerned, Klein does not have legal authority to either appoint or re-appoint board members or select a vice chair. Klein is also elected by the board.

The vice chair and chair, who serve for a term of six years, are elected by the full board of directors from nominees offered by California constitutional officers, such as the governor and state treasurer.

Penhoet has been on CIRM's board since its first meeting in December 2004. He heads the task force that worked out the difficult issues of intellectual property concerning CIRM grants, bringing his broad background as a scientist and businessman into play.

2009 CGS Forecast: Petri Dishes -- Not Stem Cell Therapies

The usual season for prognostications for the coming year is the end of December. But Jesse Reynolds of the Center for Genetics and Society in Oakland, Ca., weighed in last week with a couple.

Writing on his group's Biopolitical Times, Reynolds said,

"With the end of stem cell research as a political vehicle, its advocates are likely to temper expectations. They'll not just move out the goalposts on the timeline towards treatments, but the touted uses of stem cells will shift from potential cellular therapies to models of human diseases in Petri dishes and better drug testing methods. These new purposes will win fewer votes than "your own personal biological repair kit," but they are also much more realistic."

Reynolds also predicted there will be no outpouring of federal cash for hESC in the near future. He made a different case than we did in our item below. He said,

"Even when President-elect Obama removes the Bush restrictions, federal funds will be available only to work with embryonic stem cell lines, not to create new ones. Grants for the latter are restricted by the Dickey-Wicker amendment, which would be left in place by both the repeatedly-vetoed stem cell bill and Obama's platform."

Reynolds also made his case for the death of hESC research as a political vehicle. He said,

"...(T)he real message from this election cycle is the end of embryonic stem cell research as a relevant political issue. It was huge in 2004, present but marginal in 2006, and seemed comatose with the 2007's failure of New Jersey's stem cell funding initiative. In this cycle, the topic made barely a peep.

"Hopefully now work can proceed in concert with a level-headed conversation about the true potential of stem cell research and the real challenges posed by human reproductive and genetic biotechnologies."

Waiting For Barack: Don't Hold Your Breath on Stem Cell Cash

Signals are emerging from the Obama team that the president-elect will move quickly to overturn President Bush's restrictions on federal funding for human embryonic stem cell research. However, that may not necessarily translate to a rush of big dollars at the national level.

On Sunday, the leader of Obama's transition team, John Podesta, indicated that the president-elect would move quickly with executive orders that do not require Congressional action, which can drag on for months if not years.

Podesta mentioned stem cell research specifically as one area that Obama could move on immediately.

Podesta's comments followed something along the same lines last week from Obama's chief of staff, Rahm Emanuel. In an interview with the Wall Street Journal, he enunciated a credo for the new administration:

"Do what you got elected to do."

He said "bucket No. 1" for the Obama administration would be children's health care. Second comes ending restrictions on stem cell research. Third is an economic recovery package.

Earlier this year, CIRM Chairman Robert Klein speculated that the Obama administration, beset by a host of enormous issues, would be slow to act on stem cell research. Klein suggested that Congressional action would be needed.

While that does not appear to be the case at this point, transition teams sometimes have trouble getting their act together and priorities can change.

What is certain is that the NIH is suffering from a financial squeeze. Until that squeeze is relieved and the necessary bureaucratic grant-making procedures are completed, don't expect to see large sums flowing into human embryonic stem cell research from the feds. Plus, other worthy scientific research will be fighting for the dollars that might go to the stem cell cause.

Indeed, the existence of such programs as California's $3 billion stem cell research effort could serve as a justification for the feds to hold back on beefed-up hESC research funding at the national level.

CIRM Quorum Solution Stalled

Today's attempt to deal with the perennial problem of attendance at meetings of directors of the $3 billion California stem cell agency was postponed Sunday on short notice.

A special teleconference meeting had been scheduled for today on the issue, but late Sunday the agency said the session had been postponed. No reason was given for the delay. No date was set for a future meeting.

The cancellation notice followed a closed-door meeting of the directors' Governance Subcommittee on Sunday afternoon. It was the Governance panel that had come up with a proposal to to help solve the attendance issues, which have made it difficult to maintain the supermajority quorum needed to do business legally. The plan would allow, on a limited basis, participation of directors via telephone.

However, the only item on the Governance agenda Sunday afternoon dealt with personnel matters. It was not clear whether the cancellation of today's directors meeting, which also included a personnel session, had anything to do with the meeting of the Governance committee Sunday afternoon. The agency released no announcement of actions by the Governance panel.

Potholes in Freeways vs. Therapies in the Clinic

"Where are the cures?" is the headline on the piece in the Nov. 10 issue of Newsweek.

The article by science columnist Sharon Begley virtually cried out for a sidebar on California.

Begley wrote about the "valley of death," translational research and the need for industrial skills that can make the production of stem cell therapies economic.

She quoted Hans Kierstead of UC Irvine, mentioned Geron of Menlo Park, Ca., as well as a proposal to create a "center for cures" at the NIH. Along the way, she noted that scientists involved in basic research are wary of the "center" proposal – a feeling that has surfaced indirectly at the California stem cell agency.

But Begley said:

"The existence of such a center would free scientists to go back to making important discoveries, not figuring out large-scale pipetting, for goodness' sake."

All of what Begley wrote about is on the $3 billion plate at the California stem cell agency. And some of the CIRM actions are coming quite soon. The "valley of death," for example, is scheduled to be dealt with next month through a $500 million lending program. Waiting for action from the new presidential administration is not good enough for CIRM Chairman Robert Klein and company.

As Begley concluded:

"There is lots of talk these days about increasing the nation's spending on infrastructure, such as roads and bridges, to lift the economy out of its doldrums. Me, I'd be willing to put up with potholes in exchange for a new administration spending serious money to take the discoveries taxpayers have paid for and turn them into cures."

Conflicts of Interest, CIRM and Transparency

Do conflicts of interest exist among the scientists who make the de facto decisions on hundreds of millions of dollars in California grants for research related to embryonic stem cells?

The answer? Yes.

Even the California stem cell agency acknowledges that fact. Because of conflicts, the agency regularly excuses some of the scientists who review the grant applications from participating in specific cases.

But CIRM stoutly maintains that the financial and professional interests of reviewers are not suitable for release to the public or applicants. The agency contends the reviewers are only making recommendations. However, the reviewers' decisions are almost never rejected by CIRM's board of directors. The agency also has turned down a recommendation by the state auditor that it seek an opinion from the state attorney general on whether it should publicly disclose the reviewers' interests.

Trust us, the agency says. We will police the conflicts and assure that no abuses occur.

Rarely do rejected applicants raise conflict issues publicly. No one wants to offend the world's largest source of funding for human embryonic stem cell research. In August, however, one scientist brought up the question of conflicts at a meeting of the CIRM board of directors.

Steven Kessler, a scientific director at Advanced Cell Technology of Los Angeles, was not happy with the response he received from CIRM staff on a letter he wrote concerning what he said was a conflict of interest on the part of a unnamed reviewer.

According to the transcript of the meeting, here's how Kessler summarized his position for CIRM directors:

"If a grant reviewer has a financial relationship with company "X"...that is, he's receiving funding from that organization or he's expecting royalty income from some company by virtue of having licensed technology to that company and that reviewer is sitting in on reviews from other for-profit organizations...and doesn't recommend those for funding, to us, from a business perspective, that's a conflict of interest."

Kessler said he had cited "numerous instances" of conflicts on the part of the reviewer, where there would be "every incentive to help impede the competition for the company that he has a relationship with.".

Kessler said,

"I was told that the way CIRM interprets its own conflict of interest policy, the example I gave you was not a conflict of interest."

At that point CIRM Chairman Robert Klein cut off Kessler, declaring that the directors needed to discuss the names for CIRM-funded labs before going to lunch.

Kessler's comments followed a discussion in which Klein and other directors expressed concern about reviewers quitting if they were subject to public complaints.

Klein said,

"To the extent that (applicants) are criticizing peer reviewers, which is sometimes common, we're going to lose our peer reviewers."

On Sept. 14, we asked CIRM for a copy of Kessler's conflict-of-interest letter. On Oct. 22, more than five weeks later and after repeated follow-up queries, the agency declined to release the letter.

Initially, Don Gibbons, chief communications officer for CIRM, said there was a question of redaction of material from the letter. Then he said our inquiry was lost by CIRM's interim general counsel. Ultimately, on Oct. 22, Gibbons said,

"Our interim general counsel has determined that the Kessler letter is part of the grant application process and as such is not a public document."

We asked for the legal reasoning behind that statement. On Oct. 29, Gibbons quoted interim counsel Ian Sweedler as saying,

"Applicants need to know that they can contact CIRM with information about potential conflicts, and that they can do that without leveling public allegations against a professional colleague."

Obviously conflicts of interest can at times involve judgment calls. CIRM also places a burden on its reviewers, all of whom come from out-of-state and cannot apply for CIRM grants. Marie Csete, now CIRM's chief scientific officer, commented last year on the situation when she was a reviewer prior to her employment at CIRM. Among other things, she said that she and the other reviewers were being asked to fund the work of their competitors.

CIRM's overriding concern has been the care and feeding of reviewers. We acknowledge that they need considerable attention. However, the main issue here is the stewardship of public funds and the integrity of a state government process involving billions of dollars. From its birth, CIRM has wrestled with problems spawned by the ballot initiative that created the research program. CIRM was deliberately cobbled together with built-in conflicts starting at the very top. The chief beneficiaries of CIRM's largess sit on its board of directors and set the rules for grants and control the process.

The bounty from CIRM is huge. Here is a list of CIRM recipient institutions (with grant totals) which have or had employees or representatives on the CIRM board of directors: Stanford, $94 million; UC San Francisco, $82 million; UCLA, $51 million; UC Irvine, $51 million; USC, $48 million; Sanford (San Diego) Consortium, $43 million; UC Davis, $36 million; UC San Diego, $33 million; UC Berkeley, $29 million; UC Santa Cruz, $17 million; Burnham, $18 million; Salk Institute, $16 million; Scripps, $9 million; UC Merced, $8 million; UC Santa Barbara, $7 million; UC Riverside, $6 million; Caltech, $2 million, and City of Hope, $2 million.

The built-in conflicts at CIRM are not likely to change, short of another ballot measure. They are enshrined in the state Constitution, a move by Prop. 71 writers who wanted to make CIRM immune to normal government oversight.

However, handing out billions behind closed doors with no outside scrutiny is a recipe for abuse. State ethics officials are already looking into the attempt by one CIRM director to influence CIRM staff on behalf of his institution. Should a major scandal erupt, it would ill serve the agency, the people of California and the cause of science.

If only to protect itself, the agency should comply with its repeated promise to adhere to the highest standards of openness and transparency and publicly release the statements of the economic and professional interests of its reviewers.

(Further note: Kessler also declined to release his letter to us. The CIRM grant review committee meets next Wednesday and Thursday in San Francisco to review applications for $66 million in public funds. The review sessions are closed but the public may comment on Wednesday morning.)

Sunday Afternoon with CIRM: A Personnel Matter

The Governance Subcommittee of the $3 billion California stem cell agency has an interesting little meeting scheduled for this weekend.

Interesting in the sense that the meeting of the group of CIRM directors poses more questions than answers.

Only one substantive item is on the agenda, a closed-door personnel session. Both the narrow scope of the meeting and the unusual Sunday afternoon timing made us wonder what exactly was going on.

We asked Don Gibbons, chief communications officer for CIRM, to illuminate the subject matter further and explain the Sunday timing. His one-sentence response:

"It is because of the chair of the subcommittee’s busy schedule."

The chair is Sherry Lansing(see photo), a former Hollywood studio head (think "Titanic"and "Forrest Gump")and now head of the charitable foundation bearing her name. She is indeed a busy woman and has her fingers in several major pies, including the board of regents of the University of California.

The responsibilities of the eight-member, directors' governance committee include such things as CIRM internal controls, ethics, outside contracting as well as monitoring management goals. One could speculate that the meeting's timing reflects a certain urgency and importance, although its recommendations generally must be approved by the full board of directors. That 29-member group meets on Monday.

Closed-door personnel sessions are permitted under state law. If the committee takes any action, it must be reported following the private session. However, the public will have a chance to speak out during the meeting at six different locations in California, if they choose to do so. The teleconference sites include San Francisco, Los Angeles, La Jolla, Palo Alto, Sacramento and Laguna Beach. The street addresses can be found on the agenda.

Rare Teleconference Session of CIRM Directors on Monday

Californians will have an unusual opportunity next Monday to tell the directors of the $3 billion California stem cell agency what they think and listen to them attempt to solve a problem that has nagged them since 2005.

The occasion is a meeting of the directors, who are officially known as the Independent Citizens Oversight Committee. Virtually all of their meetings have been held under circumstances that require the physical presence of interested parties who might want to observe or comment.

However, on Monday, the meeting will be conducted via teleconference arrangements from locations throughout the state, from Healdsburg to La Jolla. One site in San Antonio, Tx, is included. Apparently one director will be staying at the Grand Hyatt there.

All the locations are public for the purposes of this meeting. The agenda includes only one item – a plan to solve the problem of meeting the board's super-quorum requirement of 65 percent at meetings of the 29-member group. The requirement is enshrined in state law courtesy of Prop. 71 and is politically nearly impossible to alter. Instead, the plan to help provide better director attendance provides for the telephonic participation of a limited number of directors on a limited basis for regular meetings.

Monday's meeting also provides an opportunity for the public to comment on any issue, although the board is legally restricted to action only on agenda items.

Here is the current list of teleconference locations in California other than Healdsburg and La Jolla(two sites): San Francisco(two sites), Sacramento, Los Angeles(five sites), Duarte, Menlo Park, Elk Grove, Irvine, Pleasanton and San Carlos. The locations could change, so keep an eye on the agenda, which also includes the specific addresses.

'No Job Too Big, No Job Too Small'

What does a stem cell watchdog do for fun?

In the case of John M. Simpson(pictured), stem cell project director for Consumer Watchdog of Santa Monica, Ca., he takes two weeks vacation and goes to work in the Obama campaign in Missouri, one of the battleground states in this year's historic presidential election.

Simpson, who has been observing and participating in the affairs of the California stem cell agency for several years, is doing a bit of everything in Joplin, Mo., the fourth largest metro area in the "show me" state.

It is a far cry from expenses and lifestyle of California. The average home price is around $70,000-$80,000. Once the lead and zinc capital of the world, tourism now drives the Joplin economy, generating $220 million annually for the 400,000 persons who live in the metro area (49,024 for the city proper).

More than 70 years ago, Depression-era bank robbers Bonnie and Clyde pillaged several businesses in the community and were chased out of town in a gunfight, leaving their camera behind. The images in it were later developed and may be the most famous of those of the two thieves.

Simpson, however, is not interested in banks. He is looking for beds. Places where out-of-state volunteers can rest during the big push for Obama turnout next Tuesday.

We asked Simpson why he is taking his vacation time to work the long and arduous hours involved in the final stage of a presidential campaign.

He said the election is pivotal, a time to unite the country and move away from "Republican rule that is dominated by the interests of big business."

California seemed to be comfortably in the Obama camp. So Simpson volunteered for out-of-state work. He attended a two-day "Camp Obama" training session in October. They put him in touch with the folks in Missouri.

In addition to scrounging up bunks for volunteers, Simpson is setting up speaking engagements for Obama surrogates, lugging furniture and sweeping floors. "No job too big, no job too small" is Simpson's credo. He reported, however, that he can't keep up with the 20-something, paid staffers who put in 20 hour days. He said he can only do 12 hours.

Simpson is recording some of his experiences on his Facebook site. You can read them after registering as a friend of John.

UCI Defends Lab Press Notice

The University of California, Irvine takes umbrage at our item that pointed out that the school did not credit the California stem cell agency (the California Institute for Regenerative Medicine) specifically by name in its press notice on the Oct. 24 ground-breaking for a stem cell lab financed in part with $27 million in agency funds.

The omission occurred in a news release sent out widely to the media. We characterized the omission as a minor PR gaffe and noted that one page on the UCI site carried a photo caption describing the lab as a "CIRM institute.'

Jennifer Fitzenberger, assistant director of media relations, sent us an email that said,

"Our stem cell center website and event invitation make very clear the new building will be a CIRM institute: http://stemcell.uci.edu/. CIRM is very clearly listed on more than one UC Irvine webpage in connection with our groundbreaking event, not just one as your blog item states."

The ground-breaking received extremely limited media coverage(three items in advancing of the event), based on a Google news search to this morning.

Here is a link to the news release that was issued on the day of the event. That release did mention the California Institute for Regenerative Medicine by its full name. Here is a link to the Sue and Bill Gross Stem Cell Research Center at UCI, which is the name of the stem cell research operation at the campus.

As we noted in the item below, this is not a major issue, at least for us. But CIRM directors have retained the power to approve the names of labs that they help finance – one indication of the importance that they attach to naming and the credit it implies. The reality is that none of these labs are going to be commonly known as CIRM facilities. Rather they will be referred by the names of the donors or some piece of vernacular originating on campus.

UC Irvine Breaks Ground on Stem Cell Lab

In a bit of a minor PR gaffe, UC Irvine announced its groundbreaking ceremonies on Friday for a new stem cell lab that will be partially financed with $27 million in CIRM funds without specifically mentioning the California stem cell agency by name.

The news release named Robert Klein and the Independent Citizens Oversight Committee, but nowhere was the phrase "the California stem cell agency" or "CIRM" used. The Independent Citizens Oversight Committee is the ungainly official name for the CIRM board of directors, but few Californians would make that connection.

One page on the UC Irvine web site did, however, carry a small rendering (see photo) of the lab which identified it as the "Sue and Bill Gross Hall: A CIRM Institute." All of this PR hooha makes little difference to the stem cell effort. However, CIRM directors have expressed their firm desire for PR credit by retaining the right to approve the naming of labs that they finance with public money. The names are not official until approved by CIRM directors.

UK, CIRM Ink Collaboration Agreement

The California stem cell agency has expanded its international connections once again, this time linking to the United Kingdom with an agreement that potentially will finance scientists working in California with scientists working half-a-world away.

No money, however, has yet been committed. Reporter Bernadette Tansey of the San Francisco Chronicle also reported that the touchy issue of ownership of IP has not yet been worked out.

The agreement was announced earlier this week. It follows similar agreements in June with Australia and Canada.

According to Maggie Shiels of BBC radio, CIRM Chairman Robert Klein said,

"...(O)ne of the diseases the CIRM was likely to focus on in the future would be stem cell therapy for a type of macular degeneration that leads to a blindness that affects 7% of the US population over 75.

"Mr. Klein said the UK was well ahead in animal trials in this field and that the deal could pave the way for earlier than hoped for human trials."

"'We are very hopeful that this collaboration can bring us together in human trials to prove the first global embryonic stem cell therapy. It will hopefully break open this entire field,' he said."

According to Monya Baker, writing on The Niche (the Nature magazine stem cell blog), Lord Paul Drayson, the UK minister of science, said,

"UK’s National Health System made his country particularly able to carry out clinical trials and gather clinical data."

Don Gibbons, chief communications officer for CIRM, was quoted as saying,

"We could do a one-off with an investigator in Paris, but that bogs us down."

Baker said the agreement permits CIRM to accept applications "under the same rules and avoid bureaucracy."

If Klein's optimism is borne out, the "break-through" on the first embryonic stem cell therapy could mean that Great Britain will be the first to see the clinical fruits of research funded at least in part by California taxpayers.

The UK/CIRM announcement received light news coverage. For example, Bernadette Tansey's story was tucked away on page D2 of the Chronicle.

A meeting is scheduled for January 2009 among scientists and others to determine the "most fruitful options" for collaboration.

CIRM IP Hearing Set for Oct. 29

For those of you interested in profits from California-financed stem cell therapies, you should pay attention to the latest CIRM meeting on intellectual property.

The IP Task Force has scheduled a session Oct. 29 to discuss what appears to be a routine matter, but it could also involve discussions that go beyond routine.

Here is the language from the agenda. No additional information is available to the public at this point.

"Consideration of draft amendments to consolidate non-profit and for-profit intellectual property regulations and begin formal process of adoption."

The meeting has teleconference locations from which interested parties can participate. They include San Francisco, La Jolla, Irvine and San Carlos. More be be added later to the agenda.

Tracking the Little Hoover Commission and CIRM

The Little Hoover Commission, which is looking into the governance of the California stem cell agency, has posted some material concerning its inquiry, accessibility and schedule.

The first meeting will be held Nov. 20 in Sacramento with the second Jan. 22, also in Sacramento. The agenda says,

"As part of its study, the commission will explore the transparency and accountability of the existing governance structure."

The agenda also says that more information can be had by contacting project manager Eric Stern. To be notified of events concerning the CIRM inquiry, send a message to littlehoover@lhc.ca.gov. The phone number for the commission is 916-445-2125.

Fresh Comment

"Ron" has filed a comment on the "courtier" item below, including the text of a San Francisco Business Times article on the veto of SB1565.

CIRM and the Cause of Philanthropy

By now, you all have heard about Larry Lokey's whopping $75 million gift to Stanford to help build a new stem cell lab. But there is another bit of the story that has not received much attention.

And that is the role of the California stem cell agency in creating a friendly climate that encourages our wealthiest citizens to make huge contributions to human embryonic stem cell research and science in general.

Stanford and Lokey did not specifically cite CIRM and Prop. 71. But the agency has done much to portray favorably hESC research and draw the attention of scientists who need to believe there is a stable source of potential funding for their research. If not, they will choose another path of inquiry.

Four years ago, hESC was the poor stepchild of the NIH, all but banned by the Bush Administration. That is unchanged at the federal level. But California's Prop. 71 fired up the efforts in a number of other states and created a sense that the science could proceed even without the sanction of the NIH.

Lokey is not alone in making a major contribution to stem cell research. Eli Broad, Denny Sanford and others have also donated tens of millions of dollars in California.

Their generosity has set an example and a standard for others to emulate. The hESC philanthropy trend serves both science and charity well.