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.