Mulling Industry Ties: CIRM, Charities and Cash

The Wall Street Journal this morning carried a piece about the multimillion dollar linkages between some charities and the biomedical industry. The article offers some food for thought concerning the California stem cell agency and its financial crisis along with changes in the strategic direction of the agency.

Reporter Keith Winstein wrote that charities are "increasingly frustrated with the slow emergence of new disease treatments" and are pumping tens of millions of dollars into industry.

He quoted Robert Beall, the head of the Cystic Fibrosis Foundation, as saying,

"Academics are really not good at taking good understandings of the basic defect and translating it to new therapies. We had to get the drug companies to start to get involved with cystic fibrosis."

Winstein said that "about a dozen disease-based charities recently have started funding early-stage drug research at start-up companies -- usually in exchange for royalties or stock options." They include the cystic fibrosis foundation, the CHDI Foundation and the Juvenile Diabetes Research Foundation, of which CIRM Chairman Robert Klein is a director.

The article said that the investments create "potential conflicts for charities, which are called upon for impartial advice to patients but could end up with financial stakes in high-price treatments."

Winstein reported that Aaron Kesselheim, a physician at Brigham and Women's Hospital in Boston, says the investments can create a "potential minefield." Winstein continued,

"Normally, a patient-advocacy group might be expected to argue for lower prices for pharmaceuticals -- but a group with a royalty stake or equity in a drug maker has the opposite interest as well.

"Disease-focused charities also often give recommendations to doctors, patients and the FDA. The fibrosis foundation runs a pharmacy network to dispense drugs, and accredits treatment centers. The impartiality of such activities might be questioned if a group had a stake in one of several competing drugs, says Dr. Kesselheim.

"'Equity relationships can create substantial unconscious biases in the way that these foundations conduct their business that might lead them away from the ideal public-health strategies,' he says.

"'For example, a generic drug might be really useful for patients with MS, or epilepsy, and because the foundation has these sort of close ties with for-profit companies, then they might have subconscious biases against advocating for those sorts of outcomes that might lower costs.'"

CIRM is currently working on a plan to sell California state bonds to private foundations and perhaps others to help fund the stem cell agency's grants. The proposal could dovetail with the foundations' desires to push therapies into the marketplace along with generating reasonable and safe returns in its investment portfolio.

At the same time, CIRM is emphasizing its connection to industry with a push towards bringing therapies into the marketplace. The agency expects to release a $210 million RFA in the next several days for a disease team project that will be one of its largest grant rounds. The agency expects more than 100 applicants for the grants, which are aimed at pushing stem cell research closer to producing a commercial product. Commercial enterprises are expected to be among those seeking CIRM cash. The disease team round is also likely to see the launch of a $500 million biotech lending program for both industry and nonprofits. Last month, CIRM Chairman Klein told directors that the disease team round is a "very, very important" element in pitching the bonds to foundations.

(Editor's note: The WSJ article may not be accessible without a subscription. If you would like to see the full article, email djensen@californiastemcellreport.com and I will send you a copy.)

San Diego Consortium Pushing Ahead on $115 Million Lab

San Diego's Sanford Stem Cell Consortium, an alliance of UC San Diego, Scripps, Burnham and Salk, says that it remains committed to its $115 million lab construction project and that site preparation is currently underway.

Louis Coffman, vice president of the consortium, made the comment Monday in response to a report in the UC San Diego campus newspaper that the project, funded in part with $43 million from CIRM, had been put on an indefinite hold because of financial reasons. CIRM last month disclosed that it is facing a severe cash flow problem because of its inability to sell state bonds.

Coffman said that site preparation has begun but that actual construction will not start until the consortium concludes "the definitive ground lease" with UC San Diego, a process expected to take three to four weeks. Coffman said,

"And it will take a similar amount of time to nail down definitive financing terms and then likely several weeks after that to consummate financing."

Coffman also told the California Stem Cell Report, "SCRM (the consortium) has not expressed doubt that it will receive the grant funds from CIRM. We are confident that CIRM will pay SCRM the grant funds due to SCRM when due.

"California¹s financial challenges have raised potential lender¹s concerns about CIRM¹s ability to pay the grant funds, but CIRM has the means and is working on a document meant to assuage those concerns.

"True, the tax exempt bond market turmoil has impeded our efforts to raise debt funds. But it is an impediment that we will overcome. The tax exempt bond market is showing signs of stabilizing and we continue to work with several groups who have expressed keen interest to help us raise the necessary funds.

"We are fully committed to this project to realize the promise of the Consortium, to harness the power of stem cells to develop the means to diagnose, treat and one day we hope to cure degenerative and other diseases and injuries."

The consortium has close links to the stem cell agency. Two members of the consortium's board of directors, John Reed of Burnham and Marsha Chandler of Salk, also sit on the CIRM board of directors. Scripps and UC San Diego also have representatives on the CIRM board, Floyd Bloom and David Brenner, respectively.

The CIRM grant to the consortium is conditioned on the organization's ability to raise matching funds and meet a completion deadline of December 2010.

CIRM Finances and Grantee Uneasiness

CIRM's financial difficulties have created a certain amount of unease in the California stem cell community. A good example of the anxiety surfaced during its board meeting that ran late into the evening on Jan. 28.

The session was the first public disclosure of the scope of the problems facing the stem cell agency.

Towards the end of the session, Louis Coffman, vice president of the Sanford stem cell consortium in San Diego, addressed the board about his organization's concerns. CIRM Chairman Robert Klein was quick to assure him that night and the next morning that the stem cell agency had legal, contractual commitments to all of its grantees. Here is what Coffman had to say and what Klein told the board the next morning, according to the transcript. First Coffman.

"I bring you a letter from my boss and one of your former members, Dr. Ed Holmes. He's been monitoring this via my e-mail all night long. He said,

"'Mr. Chairman, we appreciate what you, President (Alan) Trounson, and others are doing to realize the vision of CIRM for stem cell research in California and the nation. These are difficult economic times, and your creativity and innovation is appreciated and needed. However, we feel it is important for CIRM to meet its existing commitments in full and on schedule before taking on additional commitments.

"'To not meet the terms of prior NGA's will negatively impact the credibility of cirm as a funding agency. How will future grant awardees have confidence that funds will be there for their programs if existing commitments are not fulfilled?

"'We at SCRM (the consortium) and other entities like us have made warrants, commitments to institutions and individuals based on the NGA we received for our facilities project. We have made commitments to the (UC) regents, to our developers. We have made commitments to generous philanthropists. We've spent his money based upon this NGA, and our consortia members have committed to existing and newly recruited scientists and faculty based on this NGA.

"'We plead with the ICOC(the CIRM board) to honor these existing commitments and request that the adoption of new programs not come at the expense of those that have already been awarded.'"

The next morning Klein brought up consortium's concerns again, saying,

"I was on the phone with Ed Holmes at 10:30 last night going through the constitutional protections for existing commitments and discussing the work that (attorney) James (Harrison) has been doing at my request for the last five weeks on developing something for the banks so they could understand that they could rely upon constitutional protections and the funding authorization we have in place on existing contracts."

CIRM Eyes Three Firms for $200,000 Lobbying Job

The California stem cell agency has not yet made a decision on which of three firms to hire as a $200,000 lobbyist to promote a $10 billion aid package for the biomedical industry.

Don Gibbons, chief communications officer for CIRM, said proposals have been submitted by Van Scoyoc Associates, Hogan & Hartson and The Podesta Group.

The stem cell agency was on a fast track to hire a lobbyist, perhaps as early as last Friday, but Gibbons said that no decision had been made as of Monday.

Van Scoyoc is a Washington, D.C., firm whose web site says,

"We have been a central player in the multi-year effort to double funding for the National Institutes of Health, the National Science Foundation and the Centers for Disease Control and Prevention."

Wikipedia says the firm is 'the largest and most prestigious independent government affairs firm in Washington."

Hogan & Hartson is an international law firm with 1,100 lawyers and offices in both San Francisco and Washington. According to Wikipedia, it is "recognized for excellence in its life sciences and technology practice."

The Podesta Group's clients include Amgen and Genentech. Its principal, Tony Podesta, is "ranked as the the third most influential lobbyist in Washington," according to Wikipedia.

Torres Makes Pitch for Vice Chair's Job at CIRM

State Democratic Party Chairman Art Torres has made the case for his election as vice chairman of California's $3 billion stem cell research agency in a letter to Consumer Watchdog's John M.Simpson.

Simpson wrote late Friday about the statement and the race on his organization's blog.

Torres has a three-part agenda: Dealing with the CIRM funding crisis, enhancing community education/PR and consensus building, including creation of some sort of executive committee for the CIRM board of directors.

Torres said an executive committee could "increase the productivity of meetings." CIRM is currently overseen by a 29-member board of directors that has been hobbled by absenteeism. The absenteeism itself is not so bad, but it makes it difficult to maintain the required superquorum of two-thirds of the board's members necessary to do official business. And because of the size of the board, it is much more of a legislative and debating group than a sharply focused decision-making panel. For example, if each member of the board were to spend three minutes each addressing a single matter, it would take nearly 90 minutes to hear them all.

An executive committee for the board would seem to be desirable, if it can improve the board's efficiency and continue to conduct the people's business in public. But the task of creating one faces several obstacles. One is Prop. 71 itself, whose 10,000 words lock all sort of minutia into the state Constitution and state law and which may make it difficult, if not impossible to create such a panel. Another barrier could come from resistance from some board members who may feel that their voices would not be well heard by an executive panel. And still another is that formation of an executive committee could run into resistance from CIRM Chairman Robert Klein. It could dilute his hold over the board, whose size and diversity of opinion can muddle its focus on some matters. An executive committee could hobble Klein's independence and perhaps call a halt to some of his forays into areas that the panel does not consider high priority.

Running against Torres is Duane Roth, already a member of the CIRM board and a biomedical industry-connected executive. Simpson earlier received a statement from Roth and has written about it.

Simpson's piece drew comment from CIRM board member David Serrano Sewell, concerning objections that Torres, a former state legislator, would "politicize" the board. He noted that CIRM itself was created through a powerful political process, a $30 million ballot initiative in 2004.

He continued:

"Second, most (not all) of the people appointed to the ICOC got on by way of politics, that is to say their name was submitted to a Constitutional Officer, and a third party (usually someone with some heft) advocated for that person.  Some people call that 'lobbying' and there is nothing wrong with that at all."

Sewell continued,

"'Politics' is not a dirty word.  Exhibit A - President Obama, he secured the nomination and won the election by executing some sophisticated political moves and I am glad he did, our country is better off as a result!"

Election of a vice chairman by the board is not expected any sooner than the CIRM's board meeting in March.

CIRM Launches Public Forums With Cast of Stem Cell Headliners

The California stem cell agency will conduct six public meetings in the next three months aimed at promoting the cause of stem cell research and airing proposed changes in its strategic direction.

A gaggle of stem cell research stars will be featured at three Town Hall meetings March 18 in San Francisco, March 31 in San Diego and April 22 in Los Angeles. Their challenge will be to pass the "Taxicab Talk Test," a communications effectiveness measure that originated in La Jolla, Ca.

Two other meetings will focus on the CIRM strategic plan March 5 at the City of Hope in Duarte in the Los Angeles area and March 11 in San Francisco. The purpose is to gather public comment about the proposed changes in CIRM's strategic plan. Another session focused on the business community is scheduled for Feb. 20 at Invitrogen in Carlsbad, Ca.

Nearly all public meetings of the state's $3 billion stem cell agency generate meager audiences, 20 or less in most cases. Whether the latest sessions can generate bigger numbers will be one measure of their success.

We asked Don Gibbons, chief communications officer for CIRM, about the Town Hall forums and outreach efforts to build attendance. He replied,

"These town forums are about educating anyone in the public that we can convince to attend, and, yes, they are strictly science, an update on the progress with their tax dollars. The one in SF is on Market Street after work so that we can get members of the business community. We are printing posters for the Muni/Bart tunnels along Market Street and doing outreach through the email lists of our grantee institutions and patient groups."

Part of CIRM's mission is to educate the public and promote human embryonic stem cell science. While polls show support for the research, the public has only a vague understanding of what is involved and the likelihood of success. That makes public support vulnerable to sudden changes should bad news surface.

PR and communications efforts such as CIRM's have several objectives. One is shore up support from those already in favor hESC research. Another is to reach out and rope in new advocates. Still another is or should be to gather names and email addresses of attendees to build databases for further communications efforts.

One measure of CIRM's success is the Taxicab Talk Test, a concept that we heard first from researcher Jeanne Loring of Scripps in La Jolla, but that we have now reconfigured as a "communications effectiveness measure." She said all researchers should be able to lay out the case for hESC for a taxi driver during a five-minute ride. That means speaking with clarity, brevity and persuasiveness. By the end of the ride, the driver should be nodding in agreement. But, of course, he or she is also motivated by the possibility of a handsome tip.

As far as we know, CIRM is not offering "tips" to attendees at its meetings. But it should circulate feedback forms in the audience to test the effectiveness of the speakers and the general presentation. Something similar should be done at the meetings on the strategic plan to seek written comment from those who may not have a chance or desire to speak publicly.

In addition to Loring, here are the speakers scheduled to appear at the three Town Hall meetings: Renee Reijo Pera of Stanford, Tamara Alliston of UC San Francisco, Bruce Conklin of UC San Francisco, Mahendra Rao of Invitrogen, Stuart Lipton of the Burnham Institute, Hanna Mikkola of UCLA, Donald Kohn of Childrens Hospital Los Angeles and Leslie Thompson of UC Irvine.

CIRM and the Stem Cell Industry: A Lobbying Question

The state of the stem cell/biotech biz drew some attention late last week in Business Week along with a piece on Stockpickr.com dealing with Geron.

Business Week reporter Ben Levisohn painted a depressing picture for most "middling" companies. He wrote that Big Pharma is buying Big Biotech – not the smaller companies. He said,

"That's bad news for small biotech companies, who are already facing a spate of problems. A recent study estimated that 50% of the roughly 380 publicly traded biotechs have less than one year of cash remaining. In the past, they would have raised new capital by selling shares, merging, or partnering with a larger outfit. But for publicly traded companies, equity deals are out—none has been brought to market in the last year, and few are expected to see the light of day in 2009. And even if a deal could be brought to market, with the smallest 10% of stocks in the Nasdaq Biotechnology Index trading down 84% from their 52-week high, vs. 21% for the largest 10%, an equity deal wouldn't make financial sense for many companies."

Over on Stockpickr.com, they had this to say,

"Over the last three months, shares of biotechnology firms Geron (GERN) and StemCells (STEM) are up roughly 200%, compared with a decline in the S&P 500 of almost 5% and a decline in the Nasdaq Biotechnology Index of about 3%.

"So why have both names massively outperformed the boarder market?"

Stockpickr laid out Geron's upcoming clinical trial and surrounding hoopla, but concluded:

"There are still several unknown variables that could take the short-term momentum out of both names."

The Business Week and the Stockpickr pieces could be construed as arguments for the $10 billion biotech aid package promoted by CIRM Chairman Robert Klein. However, the question for the stem cell agency is whether it should be in the business of lobbying the federal government on behalf of the industry. Klein would probably put the question another way: Should CIRM support assistance to the biotech biz so that therapies will result and suffering eased?

Waiting for Obama -- The Stem Cell Delay

Wondering what Obama is wating for? When will he revoke George Bush's rules on human embryonic stem cell research?

It might be in a few weeks or perhaps even much longer, based on a story in the Philadelphia Inquirer.

Reporter Marie McCullough wrote earlier this week,

"Rep. Mike Castle (R., Del.), a congressional champion of the research, said that last week, he explicitly asked White House officials about it.

"'I believe there will be an executive order lifting the funding ban,' Castle said. 'My speculation is that it will happen in a few weeks. . . . They've had a lot of things to deal with. I see no bump in the road.'"

She continued,

"Not until four days before the inauguration, during a CNN interview, did Obama say he would 'prefer' that Congress pass legislation removing Bush's restrictions, 'because those are the people's representatives.'

"That comment prompted some patients' groups to gripe that Obama was backpedaling on his campaign promise.

"But leading scientists also believe that research policy is better set by a comprehensive law than by a revocable directive.

"'I would agree with that,' said John Gearhart, a stem-cell-research pioneer who was wooed last year from Johns Hopkins University to the University of Pennsylvania. 'As researchers, we need a stable base.'"

Legislation can require many months, if not longer, to work its way through Congress, depending on other competing priorities, of which there are many, in Washington.

Fresh Comment

"Anonymous" has left a comment on the $200,000 lobbyist item, asking the question, why can't the biomedical industry do its own lobbying?

Nature's Niche Discusses CIRM Finances

The Niche -- Nature magazine's blog on stem cell issues -- carried a summary this week of CIRM financial matters.

Monya Baker linked to a number of stories, including those on this blog, and commented on the national picture as well. She said,

"The irony about President Obama’s election is that even if the financial crisis is stemmed, scientists studying pluripotent stem cells (both reprogrammed and embryonic) may soon feel like they have less money rather than more. If the NIH budget does not increase, but interest in stem cells continues to, expect more scientists to be chasing the same amount of money and the already low, low funding rate to go down. Meanwhile, the ability and incentives for donors to put up funds for stem-cell research will decrease."

CIRM Board Member Pizzo Writes About Stem Cell Budget Woes

Stanford medical school dean Philip Pizzo, a member of the board of the California stem cell agency, this week offered his assessment of the current state of CIRM's financial affairs.

Writing Tuesday in a newsletter to the medical school staff, Pizzo described the the situation as "ironic" for CIRM, which was designed to be impervious to the vagaries of the state's budget wars.

He said that over the past few years, the NIH has struggled with funding while CIRM "filled a vital and important niche." Pizzo wrote,

"How ironic then to witness a very serious potential setback to CIRM's efforts."

He continued,

"Given the problems in the current bond sale efforts, CIRM and the ICOC (the CIRM board) will pursue an alternative through 'private placement.' This is an ambitious task with lots of challenges -- but it is worth a serious effort. The basic mantra of the ICOC is that we have faced adversity before (which I can affirm is absolutely true) and that we have found ways to overcome major external challenges. We are committed to doing that again."

Pizzo also summarized the discussion last week on CIRM's financial woes with particular emphasis on what CIRM has meant to Stanfod (more than $100 million).

The Stanford Medical School also produced a piece by Krista Conger that discussed CIRM's funding issues.

Pizzo's piece was timely with a positive spin that did not ignore the magnitude of the problem. Other CIRM board members would do well to emulate his effort and distribute their perspectives widely to their staffs and associates.

Audience Numbers for First CIRM Audio-cast

Here is the count from the California stem cell agency on the audience last week for its first-ever audio Webcast of its board meeting.

CIRM spokesman Don Gibbons reported that on Thursday there were 21 users on the phone line and 27 online. On Friday, 23 listened in via the phone line and 85 online. He said there was "no way to know" if those were separate users or "folks coming in and out."

While the numbers appear to be small, they are significantly larger than the typical on-site public audience at board meetings. We have attended a number of board meetings where there are less than 15 persons from the public in the audience, substantially less than the combined total for the 29-member board and CIRM staff in attendance.

Last week's meeting was handicapped by short advance notice of the audiocast. Plus the both board sessions were lengthy, particularly the Thursday afternoon session which stretched past 9 p.m.

Look for higher numbers in March and April as more people become familiar with the service.

Kudos for CIRM Audio Webcast

Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, Ca., is a big fan of the new audio Webcasts of the meetings of the board of the California stem cell agency.

Here is an unsolicited comment from her today:

"I love it! I attend the meetings when I can- but I do have another job, so I'm delighted that I can be there without getting on a plane. I think the broadcasts will go a long way toward helping the public understand why this work is so important, and allow the people who voted for Prop. 71 to know what great things are being done on their behalf."

We agree with her and applaud CIRM for mounting the effort last week. It is not without some problems, but it is a good step towards fulfilling the CIRM promise to adhere to the highest standards of openness and transparency.

We invite other readers to respond as well. You can comment either directly by clicking on the word "comment" below, which permits anonymous comments. Or you can comment by sending an email to djensen@californiastemcellreport.com or to CIRM at info@cirm.ca.gov.

CIRM's $200,000 Lobbyist Could Be at Work by Friday

The California stem cell agency is on a fast track to hire a $200,000 lobbyist to secure passage of a $10 billion biomedical industry aid package being promoted by CIRM Chairman Robert Klein.

If all goes according to plan, the lobbyist's firm will be on board by the end of this week. CIRM posted the RFP only last Wednesday with a deadline of today for proposals. The skimpy advance notice indicates that Kiein probably has a particular firm ready to come aboard.

The $10 billion proposal ballyhooed by Klein was on last week's CIRM board agenda. Klein told directors then that heavy duty lobbying is needed in Washington to help provide funds to the biomedical industry in California.

But he put off more detailed discussion of the matter until March. Klein's supporting material for the industry aid package presented to directors did not mention that he plans to hire the $20,000-a-month lobbyist for 10 months. Another RFP is also promised after that period.

The proposal to hire the lobbyist, which CIRM calls a "federal government relations consultant," seeks a high-powered firm with a track record of achievement, a "strong presence" in Washington as well as a San Francisco Bay Area representative to advise Klein and other CIRM leaders on short notice.

To provide some perspective on the CIRM lobbying proposal, the state of California currently has a lobbyist, Linda Ulrich, in Washington, who is financed through the governor's office. She is a state employee with a salary of $138,276. according to a Sacramento Bee database. The Washington lobbying office obviously has additional but unknown expenses beyond Ulrich's salary, such as benefits which could run close to 50 percent of her pay.

Any CIRM lobbying effort would be substantially bolstered by the election of the politically well-connected leader of the state Democratic Party, Art Torres, as vice chairman of the CIRM board. Indeed, a lobbyist might not be necessary with Torres working for CIRM. All he would require is some staff support. But with the lobbyist and Torres together, CIRM would have considerably more clout.

Also in the running for vice chair's job is Duane Roth, a current member of the CIRM board. Current scuttlebutt has it that the election will occur at the CIRM board in March in Sacramento. (Search on items labelled "vice chair" for more background on the contest.)

At last week's meeting, John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., questioned the advisability of hiring a $200,000 lobbyist given CIRM's financial difficulties.

In response, Klein indicated no figure had been set for the contract.

Here is the language from the RFP:

"Expected Range for this Award is approximately $20,000 per month for the 10 months of the Agreement."

Simpson commented again on Monday about the lobbyist plan, Writing on his blog, he said,

"CIRM needs to ratchet back all discretionary spending.  Right now there is a request seeking proposals for a contract for a Washington lobbyist for up to $20,000 a month for 10 months. That's $200K.  And then there is still the proposal  to fund the International Stem Cell Research Committee meeting in San Francisco to the tune of $400K.

"My point is this: $100K here and $100K there and soon you're talking real money. CIRM simply doesn't have it, doesn't know where it's coming from and needs to stop spending on anything other than existing commitments until there is a clear way out of this crisis. Anything else runs the grave risk of simply digging the hole deeper."

Simpson On The CIRM Private Placement Plan

Consumer Watchdog's John M. Simpson, who sat in on the board meetings last week of the California stem cell agency, today offered his take on CIRM's financial troubles.

Simpson, stem cell project director for the Santa Monica, Ca., organization, noted that the discussions touched on the sale of the bond anticipation notes two years ago, when CIRM also faced fiscal difficulties. Those sales raised $44 million.

Simpson wrote,

"However, former ICOC Vice Chairman Ed Penhoet , who played a key role in selling many of the BANS, notes that most of the purchasers acted for philanthropic reasons and were prepared to lose the money if the courts ruled against CIRM.

"Those BANs were sold when the economy was booming, riding high on the housing bubble.  Today those sorts of investors are feeling the pinch like all the rest of us -- perhaps in some cases even more so.  It is by no means clear that a significant amount can be raised for CIRM by selling bonds privately."

CIRM Vice Chair Story Surfaces in LA Times

The Los Angeles Times, which rarely writes about the state's $3 billion stem cell research effort, has produced an article on the race for the vice chairmanship of the CIRM board.

Written by Eric Bailey, the story casts the contest between Art Torres, chairman of the state Democratic Party, and Duane Roth, a biomedical industry-connected executive and current member of the CIRM board, almost entirely in partisan political terms.

Torres is being support by "Democratic heavyweights" and Roth is the nominee of the Republican governor of California.

One matter that the Times did not mention was the $10 billion federal aid proposal by CIRM Chairman Robert Klein on behalf of the biomedical industry. Torres' presence on the CIRM board would give it extra clout in Washington and perhaps make it unnecessary to hire a $200,000 lobbyist to carry CIRM water in the nation's capitol.

It is not known when the board will actually choose between the two men.

CIRM Strategic Plan Hearings Begin Tomorrow

The California stem cell agency begins hearings into revisions of its strategic plan with a session Tuesday (Feb. 3, 2009) in San Francisco and another in Carlsbad near San Diego on Feb. 20.

The meetings will be heavily focused on industry concerns. Here are some of the questions being addressed tomorrow:

"What are the biggest challenges faced by commercial participants in this sector?

"What should the basic/translational/clinical balance of CIRM’s portfolio be today in order to reach the goals set out in Prop. 71? 18 months from now? Three/five years from now?

"What form should CIRM funding to companies take? Should there be company specific RFAs? Should there be something like SBIRs? Is there a preference between loans (recourse and non-recourse) and grants?

"Do reimbursement uncertainties impact your evaluation of financial opportunities presented by this sector? Should CIRM take a significant role in the discussion around placing a reimbursement value on 'cures?'

"Given that many of CIRM’s policies and regulations are locked in by law, are there any of them that are causing significant blocks to our strategic goals and are there ways to make adjustments to those policies and stay within the framework of the Prop 71 statute."

If you are unable to attend the meetings, you can submit written testimony to info@cirm.ca.gov.

You can find specific locations here and the agenda here.

California State Treasurer Eyes Private Bond Sale -- First in State History

The California state treasurer's office confirmed today that it is considering selling state general obligation bonds privately for the first time in state history.

The state is exploring the private sale because its $40 billion budget crisis has forced the cancellation of the normal sale of state bonds. About $3.8 billion has already been frozen in funding for infrastructure projects, resulting in delays or halts to 5,300 infrastructure projects statewide. Today the state controller began delaying payments to "more than a million aged, blind and disabled Californians that go to pay their rent, utilities, or put food on their tables (and) to state agencies that use the payments to fund critical public services, ranging from public safety to health and welfare."

In response to an inquiry from the California Stem Cell Report, Tom Dresslar, a spokesman for the state Treasurer Bill Lockyer (see photo), said,

"We are exploring the possibility of privately placing GO (general obligation) bonds. The purpose would be to get some dollars flowing into infrastructure projects."

He continued,

"It's premature to talk about when any such private placements might occur. All I can say is we're moving with a combination of swiftness and due diligence. It would not be in the State's interest or CIRM's interests to speculate about price.(CIRM is the $3 billion state stem cell agency.)

"As far as we know, the State never has sold GO bonds through a private placement. Our office has informed CIRM we will have no problem with CIRM conducting a private placement, as long as it doesn't compete with any State efforts to issue taxable bonds for other purposes."

On Jan. 16, Lockyer said,

"The bond market is showing signs it may allow California access, despite the State’s worsening cash crisis and its $41 billion budget shortfall. My office is actively exploring options for issuing bonds soon. We’re also exploring other possible arrangements that could help pump more money into projects. But there are no guarantees these efforts will succeed."

CIRM officials began talking publicly about selling state bonds privately early in December because of a shortage of cash at the $3 billion research enterprise, which depends on bonds for its funding.

Last week, CIRM Chairman Robert Klein mentioned that the state was also considering selling the bonds privately.

A Look Inside the Financial Woes at the California Stem Cell Agency

California's $40 billion budget crisis landed hard last week on its five-year-old stem cell agency, which is now engaged in the initial stages of an unusual effort to sell state bonds privately.

If CIRM is successful, it is believed that it may be the first time that the state has placed bonds privately and perhaps the first time for any state in the nation.

The scope of CIRM's fiscal difficulties were laid out last week during a board of directors meeting that heard words like dire, daunting and pain. CIRM director Carmen Puliafito, dean of the USC School of Medicine, said,

"We have a financial crisis looming."

He was not alone among the directors with that perspective. But at the same time, CIRM Chairman Robert Klein and others (presumably including Puliafito ) worried about the message being delivered concerning what is now the world's largest source of funding for human embryonic stem cell research. Klein and others stressed that while "challenges" exist, the private bond sale plan provides hope.

Bonds are the key to CIRM's financial survival. They are virtually its only source of funding, although it does have some cash that has been donated. The agency does not tap the usual sources of state revenue, such taxes and fees.

Currently California is not selling bonds because of its budget crunch and turmoil in the bond markets. If and when the state does begin sales, other state needs will take priority, leaving CIRM with the necessity to find cash to continue operations perhaps for as long as the next two years, according to a briefing at the CIRM board meeting Thursday evening.

Klein repeatedly stated, however, that current grants will be funded and that the state has a legal, contractual obligation to do so.

John Robson, CIRM's vice president for operations, walked through through the numbers for board members. Here is a summary of what his Power Point presentation contained. The entire presentation can be found at the end of this item.

CIRM had $158 million on hand as of Jan. 1. It has awarded $637 million as of last Thursday. It projects expenses of $139 million by July 1, when it will have $39 million on hand.

If no additional bonds are sold, by the end of 2010, CIRM will be $134 million short of being able to fund on-going commitments. If it tries to fund both on-going commitments and projects whose concepts have been approved by the board, it will need $320 million by the end of 2010. The shortfall would be $377 million if new projected new programs are added.

Robson presented several recommendations "to achieve scientific mission critical goals during (the) cash-flow shortfall." They included switching from annual to quarterly payments for grants, which could save $21 million to $109 million depending on which of the three scenarios are chosen. Another recommendation was possibly delaying requests for grant applications. Robson, however, identified as "mission critical" both the Bridges to Stem Cell Research grant round and early translational and disease team grants.

The $18 million Bridges program was approved on Friday but actual funding was delayed until the agency has a better understanding of the outlook for the plan to sell bonds privately.

Other recommendations/administrative actions included no additional "upfront funding" for its much-touted lab construction effort, which would save $55 million to $60 million. Another option was to reduce budgets for all grants by a fixed percentage.

The board itself took no action on the recommendations other than declaring that it would decide later on the actual funding of the two training grant programs approved on Friday. It indicated generally that the staff should make a change to quarterly funding. CIRM is also going ahead with requests for applications this month for its $210 million disease team round, which Klein said was critical. The board expects to hear updates on CIRM's financial condition at its meetings in March and April.

On Friday, we asked CIRM if it had additional comments on its financial situation for this piece and said the remarks would be published verbatim. We will carry the agency's remarks if and when we receive them. In the past, we have personally told both Klein and CIRM President Alan Trounson we are more than glad to carry comments from them verbatim on any CIRM-related subject of their choosing.

Klein on Friday indicated that at some point, the agency would make a general statement on its website about its fiscal difficulties.

CIRM has not yet posted a link to the Power Point presentations that Robson made to directors Thursday on its financial situation. However, CIRM communications chief Don Gibbons kindly sent a copy of the presentations to the California Stem Cell Report. Since CIRM perhaps has other, more important business than posting presentations, we have published them below. Robson's presentation begins on slide 4.

AP's Story on CIRM's Grants and Cash

The Associated Press has written a brief story dealing with the CIRM grants approved on Friday and touching on the cash woes at the stem cell research agency.

Here is the lead:

"The governing board of the California stem cell agency is delaying $58 million in research grants at least until March because of the poor economy and credit market."

The four paragraph story appeared on both the The Sacramento Bee and San Jose Mercury News websites.

On the Bee site, The AP article triggered four reader comments. All were hostile to the stem cell agency. No readers commented on the San Jose site, at the time of this writing. Here is a link to the article at the Bee.

Modest Coverage of CIRM Cash Problems

News coverage of the money woes of the California stem cell agency was skimpy today with only one mainstream media outlet discussing them at any length.

Our Internet searches turned up only three stories. They were in the San Diego Union-Tribune, the San Francisco Chronicle and the San Francisco Business Times.

Reporter Terri Somers of the San Diego paper produced the only story looking more deeply at the financial issues. The other two focused on approval of $58 million in training grants.

Somers wrote:

"The problem: Should the state stem cell institute keep approving research grants, even though it will run out of money about the end of September because of the state budget impasse?

"The answer: a resounding yes."

She wrote that CIRM is hoping to raise $138 million through the private placement of state bonds just to fund the programs through the end of 2010. Somers also quoted researcher Jeanne Loring of the Scripps Institute about the significance of CIRM's financial uncertainty.

"'You don't want to be hiring people for a couple months and then laying them off, especially since these are highly trained people we've already invested millions of dollars in,' said Loring, who has been promised about $7 million in three state grants.

"'I think the trouble is short-term, but I have to worry about the short and long term,' she said."

A shorter story by David Perlman of the Chronicle began,

"The governing board of the California stem cell agency tentatively approved $58 million in new grants Friday, but with the nation in recession and the bond market stagnant, board members decided to hold up the money and reassess the situation in March."

Ron Luety of the Business Times wrote,

"CIRM is considering a plan to sell bonds on the private market. Those sales are targeted at philanthropists who helped the state agency when lawsuits by taxpayer advocates and opponents to embryonic stem cell research delayed its startup.

"No timeline was set as to when the grants will be funded, but the CIRM board will study funding against at its March 12 meeting."

Overall, the coverage should be satisfying to CIRM, some of whose directors were deeply concerned about the negative message that its financial troubles would deliver to the public and the stem cell community.

State Colleges Win CIRM Grants

The California stem cell agency this afternoon said that the 26 training grants "tentatively" approved today totaled $58 million and included 11 aimed at undergraduates and masters level students and 15 targeting young scientists.

It was the first time that California state colleges managed to snag some of CIRM's $3 billion. One two-year community college also won approval. However, all will have to wait for later action actually freeing funds for their programs. The delay in funding prompted CIRM to call the board action "tentative" in its press release. Decisions on funding could come either in this spring, depending on the nature of the financial news for CIRM.

It was the second time in CIRM's brief life that it has approved grants without actually setting the funding in motion. In its first round of grants in 2005, also training programs, the board did not have the cash to fund the grants because of litigation. However, it wanted to send a message that it was in business and intended to move forward. By and large, that message was successful.

It is likely that today's action will also be reasonably successful in communicating the same message. The news release did not dwell on the hours that the board spent discussing what some board members called a financial crisis. The main reference in the news release to CIRM's financial plight was this paragraph:

"In light of the current financial situation in California, the board meeting began with a discussion of funding scenarios through 2010. At this time CIRM can fund all existing commitments through September of 2009."

CIRM is likely to review its financial condition again at board meetings in March and April.

You can find a list of grant winners and the size of their grants here.

"Bridges" Grants Approved by CIRM Board

The board of the California stem cell agency today all but approved the top-ranked applications for the Bridges to Stem Cell Research grant round but deferred actually funding them to a later date.

Final approval was delayed today because of quorum problems. However, another member of the board is expected later this afternoon and that should provide final action.

The applications that received approval were in the "recommended for funding" category that can be found here. CIRM is expected to identify the applicants later today.

CIRM Training Grants Approved

The California stem cell agency today approved tens of million of dollars in training grants for young stem cell scientists but deferred a decision on actually funding the efforts.

Approved were all the grants that the Grants Working Group said should be funded in the Training Grants II round. You can find the list here. CIRM is expected to issue a release later today identifying the winners.

CIRM Board to Act Today on Training Grants

The board of the California stem cell agency this morning decided to move forward with approval of two rounds of training grants but with a decision on funding to come later.

The board took the action following lengthy discussion of its current bleak financial condition.

Director Sherry Lansing, head of a Los Angeles foundation bearing her name, reiterated her plea that the board proceed with action on the grants, declaring that to do otherwise would send the wrong message.

Director Claire Pomeroy, dean of the UC Davis School of Medicine, argued that the first priority of the board should be fiscal responsibility. She said it was "most important to get our financial house in order."

Following the vote on the procedure, the board took a break and will resume its meeting in Burlingame shortly and will take up the specific grant applications.

CIRM Says California Stem Cell Report is 'One-Sided'

The chief PR person for the California stem cell agency this morning volunteered the following comment on the items that appeared last night on the California Stem Cell Report.

Don Gibbons said in an email:

"Once again you have written a one sided piece using only half Dr Pizzo's quote. He said we have heard two avenues this evening, a route to darkness AND a path to hope. We presented creative solutions to make existing funds stretch to meet all commitmets through October and a solution for ongoing funding that a national expert gave us 80 to 90 percent odds of suceeding."

Philip Pizzo is dean of the Stanford Medical School and a director of the California stem cell agency.

During last night's meeting, he raised questions about the proposal to sell bonds privately for CIRM.

At one point, Pizzo said that while he loved or respected the notion that there is a "pathway out of a route to darkness," the situation has changed dramatically from 2006 when CIRM sold bond anticipation notes to finance its operations. He said potential investors in CIRM bonds are feeling "tremendous pain right now." He said that "a reality check" might be in order on the prospects for the private placement plan.

PBS News Hour Examines Stem Cell Research

The PBS News Hour Thursday night broadcast an overview of the state of stem cell research, including discussion of the Obama Administraion's plans and the latest developments at Geron.

Featured were folks from UC San Francisco, Geron and Alan Trounson, president of the California stem cell agency. You can even catch a glimpse of this writer in a very brief comment. You can see the entire 8-minute video on the News Hour website.

California Stem Cell Money Woes in San Diego, Santa Barbara and San Francisco Area

How bad is the CIRM financial crisis? It is endangering the highly touted San Diego stem cell research consortium, according to the San Diego Union-Tribune.

Reporter Terri Somers said that financial woes have prevented the consortium "from securing the loans it needs to build a much ballyhooed $115 million stem cell research center (see rendering) in Torrey Pines." The consortium includes UC San Diego, Scripps, Burnham and Salk.

Somers wrote:

"San Diego is not alone in its troubles. The Buck Institute for Aging in the San Francisco Bay Area and the University of California Santa Barbara are among other California research institutes having difficulty obtaining money for research facilities.

"All three were planning to create stem cell research centers with a combination of private funds, loans and multimillion-dollar grants from the taxpayer-funded California Institute for Regenerative Medicine.

"But banks considering the loans now say they do not have the liquidity needed to finance the construction. And some lenders question whether California's budget crisis, which is preventing the state from issuing bonds, could stall its promised financing."

Somers continued:

"In an interview yesterday, Malin Burnham, a member of the San Diego consortium's board, recalled a recent conversation he had with a local banker about a $70 million construction loan for the research facility.

"He said, 'Malin, I'd love to do that deal. I know and like all four of your institutions, but I don't have any money to lend. The situation may change in 30 to 45 days, but today I just don't have any liquidity,' Burnham said."

Somers' story includes information from last night's CIRM board meeting.

CIRM Directors Wrestle With Bad News and Funding for Training

Directors of the California stem cell agency have put off action until at least later today on requests for $66 million in training grants following briefings that sketched out what some directors characterized as a financial crisis for the research funding enterprise.

Most of the nearly six-hour board meeting Thursday afternoon and evening in Burlingame, Ca., was devoted to what CIRM Chairman Robert Klein called a "crisis environment." Ultimately some directors began to question whether the board should even take up the requests for the training program grants. Some argued that they should be deferred at least until March or perhaps April when the state government financial picture might be clearer.

Others argued that the CIRM board should move forward with approvals with a caveat that the grants would be funded only if money was available. CIRM did that on its first round of grants in 2005, when it also faced the inability to sell the state bonds that it relies on.

Director Sherry Lansing(see photo), a former Hollywood film studio executive, said the agency should act on the training grants. She said,

"If we don't, we are sending a clear message that we are out of business."

The financial pressure on CIRM was bad news for applicants in the second-ranked tier of applications. Normally some of those are funded along with those in the top tier, but the directors' new caution would appear to make that unlikely whenever the applications come up for approval.

The board will resume its meeting this morning. You can listen in via the instructions that can be found here. Our reporting on the meeting is based on what could be heard on what was the first-ever audio Webcast of a CIRM board meeting.

Dark Financial Outlook for CIRM Disclosed Tonight

The financial condition of California's $3 billion stem cell agency tonight appeared bleak and "daunting," based on briefings provided to its 29-member board of directors.

One director, Philip Pizzo, dean of the Stanford School of Medicine, at one point described the presentations as akin to "a route to darkness."

CIRM's financial plight is the result of California's inability to sell state bonds because of the state's $40 billion budget crisis. CIRM relies on bond sales for funding. It has approved $635 million in grants, many covering several years, but currently does not have the cash to fund all of them.

The CIRM staff went through a detailed financial presentation, based on what we heard on the first ever audio Webcast of a CIRM board meeting. However, many of the specifics were not clear because the PowerPoint presentations containing them could not be viewed.

Nonetheless, the overall financial situation seemed challenging, to say the least.

CIRM Chairman Robert Klein promoted his plan to sell state bonds privately, which would appear to be the first ever such effort in the nation. The discussions also disclosed that the state of California is moving to sell other state bonds privately as well, which could theoretically make the state and CIRM financial competitors. Klein said, however, potential buyers of the CIRM bonds are not likely to be targeted by the state treasurer's office.

The briefings disclosed that even if the state budget crisis were solved tomorrow, CIRM would face financial difficulties. That's because it takes time to bring bonds to market. Bonds supporting more critical needs would be sold well before the state would consider offering the CIRM bonds.

Sherry Lansing, a CIRM director and head of a nonprofit foundation bearing her name, said,

"I don't think there is any other choice...We would be irresponsible not to try to do this(sell bonds privately)."

Following the staff presentations, the board adjourned for dinner. At the time of this writing, they are gathering to resume their meeting and continue the financial discussions. The proceedings can be heard by using the directions in the items just below.

Let's Hear Some Comments on CIRM's First Ever Webcast of a Board Meeting

If you are tuned into the CIRM board Webcast this afternoon and evening, please let us know what you think of the effort, either its technical aspects or the deliberations or both. You can comment by clicking on the word "comment" below. Anonymous comments are permitted. Or you can send your comments directly to djensen@californiastemcellreport.com.

Update on CIRM Board Webcast

If you are having trouble accessing the CIRM board Webcast this afternoon, Don Gibbons, chief communications officer for CIRM, reports that the correct access code is 984696. We entered that number in both boxes on the ATT screen and appear to be connected. The actual meeting has not yet begun, not an unusual delay for CIRM board meetings.

CIRM Finance Documents Surface Online

With only a few hours left before this afternoon's meeting of the board of the California stem cell agency, it has posted some figures on its website dealing with its current financial condition.

Missing is any kind of explanatory information about the significance of the numbers, definitions and assumptions used. None of the posted documents address the question of when the agency runs out of operational funds during the next 18 months if the state budget crisis continues. Nor do any address the question of when CIRM might run out of cash to pay grants already approved.

However, the three documents appear to show that CIRM's operating expenditures for the 2008-2009 fiscal year will be 22 percent, or $3 million, under budget, $10.4 million instead of $13.4 million. Much of the difference comes from a 20 percent variation ($1.4 million) in salaries and benefits, which are projected to hit $5.6 million, instead of the budgeted $7 million.

Some CIRM board members have expressed concern that the agency is under-staffed and that employees could suffer from burn-out because of their long hours. Indeed, the most recent audit of the agency shows $247,351 in outstanding unpaid vacation and annual leave as of last July. The agency is capped by law at 50 employees, which is one of the reasons for its large, $2.7 million outside contracts budget. Currently the agency has 38 staffers, the highest figure in its history. It has had openings for six hires for many months but has not filled the positions.

Other major budget categories projected to be under budget for the fiscal year include: outside contracts, $2.2 million, down $514,000 or 19 percent from projections; "other travel," down $206,000 or 37 percent from projections, and "other," down $276,000 or 31 percent.

The CIRM grant funding summary shows $703 million approved by the CIRM board by the end of the fiscal year, with $139 million actually out the door. No projections are made beyond June 30.

Not posted to the CIRM website is the latest audit of the agency by Macias Gini &O'Connell of Sacramento, Ca,, which is the firm that CIRM pays for annual audits. The audit covers the 2007-08 fiscal year and can be found on the state controllers website.

Here are links to the other two CIRM documents: actual and projected expenditures, budget allocation and expenditures.

New Instructions for CIRM Board Webcast

The California stem cell agency has posted fresh instructions on how to view the Webcast of its meeting today and Friday as well as those for listening in by telephone.

The main changes appear to be separate phone numbers for today and Friday. You can find the details here.

Bravo! Live Webcast of This Week's CIRM Board Meeting

The California stem cell agency late today announced it will offer – for the first time ever -- live, Internet access to the proceedings of its board meeting with the first Webcast coming tomorrow (Jan. 29 California time).

The move is an excellent and far-reaching step in opening up the proceedings to all those interested in the $3 billion agency, which is the largest source in the world for funding of human embryonic stem cell research. The action also furthers the agency's goals to enhance stem cell research collaboration both nationally and internationally.

The announcement of the Internet and phone access is not yet up on the CIRM website, but here is what Melissa King, who is the go-to person on all CIRM board matters, told subscribers to one of CIRM's alert services:

"We are pleased to offer you the ability to listen in to the ICOC meetings taking place on Thursday, 1/29 and Friday, 1/30 either on the phone or online. The details are below.

"NOTE: you will need Windows Media Player or RealPlayer to stream the audio online.

"Dial in: (866) 254-5938              
"Access Code: 984698

"Web streaming URL:
"http://65.197.1.15/att/confcast

"Enter Conference ID# 984698  Then click Go.

"Please note these are listen only access methods which we have made an effort to offer given requests for the ability to listen in live to our meetings. If you would like to address the ICOC with questions or comments in the context of this meeting, you are welcome to either attend the meeting in person or get written questions or comments pertinent to specific agenda items in to CIRM 5 days in advance of the meeting. General public comments are welcome (in writing in advance) as well, but we cannot guarantee they will be addressed at any specific meeting. Thank you."

CIRM has been talking about and working on providing this sort of access for some time. The agency and all those embedded in the CIRM effort are to be commended for making the Webcast available at this point. That said, we should caution potential viewers that CIRM board meetings do not always have the drama potential of, for example, The Wire HBO series. First-time Webcast efforts like this sometimes also have glitches. But the CIRM staff, we are certain, will overcome any difficulties. Congratulations to all.

(Editor's note: In the first paragraph of this item, we specified Jan. 29 California time. That's because a goodly number of those interested in CIRM are beyond the International Dateline. We are aware of that because they are among the readers of this blog.)

Correction

The "More Info Up" item on Jan. 28, 2009, incorrectly said that the state controller will begin issuing IOUs on Sunday. He will in fact be delaying payments, rather than issuing IOUs.

More Info Up for Tomorrow's CIRM Board Meeting, But None on its Financial Condition

Over the last two days, the California stem cell agency has added additional background material to its board agenda for tomorrow and Friday, but the public remains in the dark about such matters as CIRM's detailed views on its financial condition.

The material includes the latest version of the loan administration policy for CIRM's proposed $500 million biotech loan program and changes in research standards for CIRM grantees.

Also up is material connected to the effort by CIRM Chairman Robert Klein to have the stem cell agency join the list of those in Washington trying to climb aboard the trillion-dollar bailout/stimulus gravy train.

Included is a copy of a draft letter presented last week to the CIRM Finance Subcommittee that seems to have been intended to be sent out prior to the board meeting tomorrow. Klein's agenda also includes links to a Jan. 15 version of the House's 258-page stimulus bill and an undated, 76-page "discussion draft" of a report on the proposal.

Missing from CIRM board agenda are any documents having to do with CIRM's budget and financial condition as the state faces a $40 billion budget crisis. On Sunday, State Controller John Chiang is going to start stiffing state creditors – delaying payments for at least 30 days.

This time Chiang said those being stiffed will include "more than a million aged, blind and disabled " who need state assistance "to pay their rent, utilities or put food on their tables."

The stem cell agency is swaddled in relatively comfortable financial security that means that over the short term grantees will continue to be paid along with vendors. Over a longer term, nine months from now, CIRM appears to $435 million short of what it needs to fulfill the terms of all the grants it has approved. CIRM depends on state bonds for cash, and the state is not selling any as its credit rating continues to plummet.

(An earlier version of this item said incorrectly that the state controller would begin issuing IOUs on Sunday.)

Fixing Bad Links

The "CIRM Staff Nixes Appeal" item on Tuesday (Jan. 26, 2009), had bad links to Alan Trounson's denial letters. Here are good links to the Trounson letters re Susan Fisher and Prue Talbot.

The California Stem Cell Agency and $435 Million in Budget 'Bafflegab'

The finances of the $3 billion California stem cell agency are something less than transparent, a situation that today led a longtime CIRM observer to write about its "funny money" and the lack of an accurate accounting of where the agency stands.

The comments came from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., who wrote against the backdrop of California's $40 billion budget crisis. Simpson ran through the budget arithmetic and noted that CIRM has awarded $635 million in grants, many of which are multiyear. According to information Simpson compiled from CIRM, the state treasurer and state controller's offices, he said CIRM has committed $435 million it doesn't yet have.

CIRM Chairman Robert Klein had a chance to explain the situation last week before the directors' Finance Subcommittee. Instead, Simpson wrote, "there was discussion of a proposed loan program and two recaps" of how CIRM dealt with bond anticipation notes in 2005 and 2006.

Simpson said,

"What's been missing in all of this is an accurate accounting of where CIRM stands financially."

Simpson continued,

"Here's my two-cents worth:  Somebody in this highly paid group needs to present a real budget that shows when CIRM will run out of money.  Then there needs to  be a serious, realistic discussion about what to do about it. Approving more grants when you're already $435 million in the hole might just not be the prudent course.

"One thing for certain, the ICOC (the CIRM board) and public are entitled to a clear explanation of where CIRM stands financially, not bafflegab about pie-in-the sky funding schemes and Obama stimulus packages."

The subject of CIRM finances is on the board of directors' agenda for Thursday and Friday as it was last week before the Finance panel. In the past, the subcommittee presentation is merely repeated at the full board meeting.

What is needed is a straight-forward budget and finance document (far more than a sketchy PowerPoint presentation). It should include all the numbers, written explanations of assumptions and caveats, possible future scenarios, strategies to deal with various contingencies and the pros and cons. Anything less is a disservice to the people of California, not to mention the CIRM board and the hundreds of scientists whose work hangs on CIRM's financial well-being.

(We have told CIRM that if it has any comments on Simpson's remarks or this posting, we will carry its response verbatim. If you have comments, you can post them directly on this blog by clicking on the word "comments" below. Anonymous comments are permitted.)

(Editor's note: An earlier version of this item incorrectly said CIRM had approved $653 million in grants. The correct figure is $635 million.)

CIRM Staff Nixes Appeal Efforts from Two Scientists

The staff of the California stem cell agency has rejected two attempts to overturn negative decisions on two grant applications for a total of $2.8 million, one from the Bay Area and one from Southern California.

Following a relatively new procedure, CIRM President Alan Trounson said that the applicants failed to present "compelling evidence" for a change. Trounson referred to petitions by Susan Fisher(see color photo), a professor at UC San Francisco, who sought $904,172 , and Prue Talbot(see black and white photo), a professor at UC Riverside, who sought $1.9 million.

Both women disputed the decisions of the CIRM Grants Working Group on their applications, which were considered and voted on earlier behind closed doors. Later this week, CIRM directors could overturn the actions by reviewers. However, in December, in the only other instance of the use of the new petition procedure, the board stood by the decisions of reviewers after the CIRM staff could find no compelling evidence for a reversal.

Here is what Trounson had to say on Fisher's petition:

"We agree that reviewers considered this a meritorious application. The proposal to create an 'antibody tool kit for human embryonic stem cells and their progeny' was highly regarded but not unique. To clarify, there is at least one other application in Tier 2 that proposes the development of an antibody tool kit.

"In regard to the reviewer criticisms, we believe that reviewers were justified in raising concern about the PI’s overall commitments as the application lists 15 currently active projects that consume 87% of the PI’s effort. In addition, the PI lists 3 pending projects that would consume 40% effort. Regardless of additional personnel that can help lead the project, the PI is ultimately responsible for managing and ensuring that the project is carried out as proposed. We disagree that the only way to increase the percent effort of a given individual is to remove another individual from the project. The CIRM Grants Administration Policy limits the annual salary requests for each key person to $207,000. It does not, however, limit the percent effort that an investigator can commit to a project. In fact, a key person may contribute any effort between 1 and 100 percent without requesting any salary support from the CIRM grant. Therefore, the budget cap alone should not prevent an investigator from contributing greater effort when appropriate. We recognize that effort contributed to a project should be appropriately compensated, but the CIRM grant should not necessarily be viewed as the sole source of support."

Here is what Trounson said concerning Talbot's petition:

"We appreciate the arguments presented by Dr. Talbot on strengths of this proposal. Reviewers agreed that the institution’s designation as a Hispanic Serving Institution provides an important opportunity for the recruitment and training of underrepresented minorities and this point was highlighted and accounted for in the score and final recommendation. However, this important strength was balanced by the reviewers’ assessment of the overall quality and design of the training program. When compared to other competing proposals, this application did not convince reviewers that the training opportunities would provide sufficient depth and breath to trainees. It is also important to note that the existing training of students in stem cell biology referenced in the letter was not articulated in the application despite the opportunity to do so.

"The applicant’s letter also indicates that their application for the Training Grant Program in 2005 received a higher score and recommendation than for this review. We believe that there are many factors that might contribute to this difference including among others a general strengthening of competing programs in the last 3 years, a different composition of reviewers, and a different (although similar) proposal from the applicant. Reviewers based their recommendation on the proposal that was presented to them for the current competition and not the previous."

The links to Trounson's comments also contain the petitions filed by the two scientists and the public summary of their grant reviews.

(A footnote: Fisher is featured in a video on the CIRM home page and CIRMTV dealing with Obama's inauguration.)

(An earlier version of this item did not contain the amount requested by Talbot and the total for both grants.)

Rutgers' Young on Geron Trials

Wise Young, the director of Rutgers Center for Collaborative Neuroscience and a grant reviewer for CIRM, has pulled together a fine overview of the science and media coverage of the Geron clinical trial.

In a piece complete with numbered footnotes, Young (see photo) wrote,

"The media response was massive [18]. The story was carried by almost every news source [18-20]. The community response was initially strongly positive. Coming on the 3rd day after President Barack Obama’s inauguration, some thought that the approval of the first HESC trial was due to Obama’s coming to power.

"The exuberance faded as people read the fine print. First, the trial is not for people with chronic spinal cord injury. It is intended to be used within 2 weeks after injury for people with complete thoracic spinal cord injury. Second, the goal of the trial is to show safety and feasibility, not necessarily efficacy. Third, the cells have been differentiated to the point that they are no longer acting as stem cells but only as oligodendroglia."

Young also wrote,

"Geron’s web site and news reports indicate that the trial will treat 8-10 patients who are within 2 weeks after “complete” thoracic spinal cord injury. It will probably start in July 2009. However, many details are unclear. Before the FDA placed a hold on the trial application in May 2008, Geron had said that the cells would be transplanted into the spinal cord of patients undergoing spinal cord decompressive surgery and all the patients will receive a 2-month period of pharmacological immunosuppression . It is not clear that the same regimen will be used.

"In the meantime, the reaction of the spinal cord injury community has ranged from exuberance over the approval of the first HESC trial [22] to deep pessimism over comments by Okarma, who said that people with “complete” spinal cord injury have no chance of recovering any function, or something to this effect. Many people in the spinal cord injury community [23] were disappointed at being excluded from the study which is only for the newly injured."

Geron: Stock Market Star?

The Wall Street Journal reported today that Geron has become a "sudden star" on the options market.

The piece by Rob Curran said,

"On the options market, about 24,500 call contracts giving the right to buy the stock traded against 3,600 put contracts giving the right to sell, according to TrackData.

"At 4 p.m. (Monday) in Nasdaq Stock Market trading, Geron was up 15% at $8.15. That follows Friday's roughly 36% jump.

"Shares of the developer of therapies based on stem-cell research had languished in recent years along with academic and corporate research in its niche of genetic medicine. The shares rallied Friday after the U.S. Food and Drug Administration cleared the way for the first-ever trial of a therapy derived from embryonic stem cells. That sudden swing and the promise of more like it is what drew options traders to the stock Monday, said Frederic Ruffy, options strategist at Whatstrading.com.

"'The volatility in the share price attracts a lot of option traders,' Mr. Ruffy said.

"'One of the themes you can make a lot of money with is if you can ... predict new policies,' said William Lefkowitz, derivatives strategist at vFinance Investments. 'You don't really need results to make lot of money at the beginning of the administration.'"

At the time of this writing Tuesday morning, Geron stock stood at $7.55, down 7 percent.

If you cannot access the WSJ story and would like to see it, send an email to djensen@californiastemcellreport.com and I will send it to you.

Trounson and the California Stem Cell Story

As part of his job, CIRM President Alan Trounson trots around California and elsewhere, telling the story of how and why the state is pumping $3 billion into human embryonic stem cell research.

If you would like to hear one of his talks and see the PowerPoint presentations that he uses, you can do so by going to the web site of the Milken Institute, an economic think-tank in Santa Monica, Ca.

The institute is offering a two-hour video of Trounson, including his responses to questions following his talk last Thursday (Jan. 22). Trounson has an accessible and easy speaking style, and his presentation slides are downloadable.

Some of the highlights:

Trounson almost let the Geron cat out of the bag although by the time of his talk, the information had already been fed to a number of media outlets, including the New York Times and the Wall Street Journal for publication on Friday.

Trounson had high praise for his tiny, 38-person staff. He noted that CIRM operates with a 6 percent administrative budget cap, compared to 10 percent to 12 percent for administrative costs in other similar organizations with some running as high as 25 percent.

He predicted as many as 100 applications in the upcoming $210 million disease team grant round, which is part of the $1 billion that CIRM has already specifically committed to funding. The disease team round is one of the largest given by CIRM.

He said the performance of grant recipients is closely tracked with under-performers being advised to get their "underdone bits" properly done.

In response to a question about the $40 billion California state budget crisis, Trounson said it is having an "impact." But he said, "We are well insulated from the effects of politics and the economy." Trounson said CIRM has enough money to "get through about October." He noted that CIRM Chairman Robert Klein is making contingency plans should California be unable to sell the bonds that provide the funds for CIRM.

The budget deadlock and CIRM's budget is also up for discussion at the CIRM board of directors meeting this Thursday and Friday.

ISSCR , $400,000 and CIRM

Remember the request that the California stem cell agency pony up $400,000 to support next year's annual meeting of the International Society for Stem Cell Research in San Francisco?

It ran into some rocky sledding at the CIRM directors' meeting last month. Some of us had expected it to come back at the board meeting later this week.

But no. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., today wrote about last month's robust discussion of the request and has put together an explanation for the delay on his organization's blog. He quoted CIRM spokesman Don Gibbons as saying,

"We are examining other possible alternatives for the ISSCR meeting and will bring the issue back at a later date."

We were also wondering about the matter and last week separately queried scientist Irv Weissman of Stanford, incoming president of the society. He replied,

"I have no idea what is or is not on the ICOC (CIRM directors) agenda. I sure hope CIRM will assist the ISSCR convention, but I am not really knowledgeable what they can or cannot fund. I trust them to do the right thing. Irv Weissman, speaking for himself."

More Info for This Week's CIRM Board Meeting

The California stem cell agency today posted additional information for its board of directors meeting this Thursday and Friday, including fresh links to the underwriting plan for its $500 million biotech lending program.

We previously linked to that information but it is now on the official agenda for the sessions in Burlingame. Yet to come is the revised loan administration policy.

Also posted are the names and bios of proposed new alternate grant reviewers: Charles Cox of the University of Texas in Houston, John Rasko of the University of Sydney stem cell program and Peter Zandstra of the stem cell bioengineering program at the University of Toronto.

Another offsite teleconference location for Friday has been added beside the one in Colorado. The latest one is at or near UCLA in Los Angeles. Addresses can be found on the agenda.

Geron Price Still Moving Smartly Upward

Geron rose sharply again today, closing at $8.15, up 15 percent for the day.

Barrons reported that Needham Research upgraded its recommendation on Geron from hold to buy with a $9 price target. Needham said "significant unmet needs" exist "in the management of spinal-cord injuries."

Needham also said that Geron previously reported it had $165 million available at the end of 2008 with a projected burn rate of $50 million -- "financial resources...sufficient for operations for several years."

Meanwhile Motley Fool reported that a large group of its readers gave Geron a "distressing two-star ranking," meaning that it might lag the market.