Friday, February 27, 2009

Overseeing Top CIRM Execs: A Reading of the Tea Leaves

Next Thursday, a key panel of the directors of the world's largest source of funding for human embryonic stem cell research will consider a matter that could give some indication of its future direction,

Nominally, the issue seems less than controversial. The agenda says it involves “consideration of policy/procedure for performance evaluation” of the chairman, vice chairman and president of the $3 billion stem cell agency.

But lying behind that bland language are such matters as the political and lobbying efforts of CIRM, its connections to industry and the election of a vice chairman to assist in those endeavors. Will the agency continue pushing hard to become a global powerhouse for stem cell research, pleading for billions from Congress for industry? Will it embrace the biomedical industry ever more closely, funding its efforts to bring products to markets? Or both, for that matter?

The agency could get to those issues through more closely defining the position of the vice chairman, which is now vacant, and discussion of related matters. The two contenders for the post come from radically different backgrounds. One is Art Torres, now the head of the California State Democratic Party and a former state lawmaker with good connections in the nation's capital. The other is Duane Roth, an executive with biomedical industry ties and head of Connect business development organization in La Jolla, Ca.

Roth was nominated by Gov. Arnold Schwarzenegger, a Republican. Torres was nominated by Democratic state Treasurer Bill Lockyer, whose good offices are especially important to CIRM as it attempts to market state bonds privately. The treasurer is the ultimate arbiter on state bond deals. On the other hand, the governor loaned CIRM $150 million in state funds a couple of years ago when it had another period of financial difficulty. The loan has been paid back, but CIRM has had to seek his support on other matters, such as his veto of legislation that the agency opposed,

Also entering into the mix is the salary for the vice chairman. The job carries pay that could run as much as $332,000. Torres says he needs a salary, but has not indicated a figure. Roth says he will not accept a salary. In December, CIRM directors awarded CIRM Chairman Robert Klein a $150,000 salary and defined his job as halftime. Klein, a millionaire real estate investment banker, previously declined a salary.

Sadly, the public is pretty much out of the loop in advance of the meeting on the policy/evaluation agenda item, which first came up Dec. 22 last year. The proposal discussed at that meeting was only described orally and never publicly disclosed in written form in its entirety. The only access to what it contains is the transcript of the meeting. Given CIRM's past performance, do not expect to see any written material ahead of the upcoming meeting.

Also missing from next week's meeting are proposed changes in CIRM's internal governance policies, which are closely tied to the responsibilities of the chairman, vice chairman and president. The proposal came up at the Dec. 22 meeting, and directors said it would come up again at the next governance meeting (the one that is next week). However, it is not on the agenda, although it could be discussed.

Next week's meeting will be available to the public to hear and participate in via teleconference locations in La Jolla (Roth's office), Duarte, Sacramento, Irvine and San Francisco. But don't expect a “full and frank” discussion, The board generally deals obliquely with these sorts of issues, It could also sidestep them entirely.

The specific location for the teleconference sessions can be found on the agenda. Sphere: Related Content

Fresh Comment

We have filed a response to John M. Simpson's comment on the “Honesty, Science and Politics” item. Among other things, our response says the No. 1 objective of CIRM right now should be to make sure it has cash next fall to pay its grantees. Sphere: Related Content

Thursday, February 26, 2009

Fresh Comment

John M. Simpson of Consumer Watchdog has posted a comment on the “Honesty, Science and Politics” item. Among other things, he says that when California voters approved Prop. 71, they did not expect to see an agency that would become “a platform for worldwide stem cell advocacy by Chairman Bob Klein.” Sphere: Related Content

Wednesday, February 25, 2009

CIRM Legal Costs Climb Towards $1 Million

Legal costs at the California stem cell agency are heading towards the $1 million mark this year and could well go higher as it embarks on an ambitious and unusual plan to market state bonds to dig itself out of a financial hole.

Next Thursday, the Governance Subcommittee of the CIRM board of directors is expected to increase payments for its main outside counsel, Remcho, Johansen & Purcell, of San Leandro, Ca., and also for Nancy Koch, who deals with intellectual property issues.

According to the most recent document from CIRM, as of Nov. 30, 2008, Remcho had already been paid $237,545 out of its $450,000 contract for the 2008-09 fiscal year. Also as of Nov. 30, Koch had been paid $82,306 out of a $150,000 contract for this fiscal year.

Their contracts and possibly other legal assistance agreements are up for "amendment" at next Thursday's meeting. The use of that word generally means that CIRM needs authorization for more cash to pay the lawyers.

According to CIRM's Dec. 22, 2008, report on outside services, total contracted legal services for the fiscal year amount to $812,930, including $140,431 for the California State Department of Justice. Not all of the total has been spent, but the budget did not anticipate the need for CIRM to engage in attempting to place state bonds with private investors.

CIRM's annual operational budget, which does not include grant payments, totaled about $13 million when approved last July. The currently contracted legal expenses amount to roughly 6.2 percent of the budget. The agency has also not filled the position of general counsel, which became vacant Aug. 15. It is still looking for a person to fill that position, which is now described as general counsel to the president.

CIRM will run out of money in about seven months unless it generates additional cash. That's because the financially troubled state of California has stopped selling the bonds that CIRM relies on to finance its operations and pay for research. Sphere: Related Content

Tuesday, February 24, 2009

What Bob Klein and CIRM Owe George Bush

Here is what Hank Campbell, the major domo of scientificblogging.com, says,
 "Whether you agreed with Bush or not, his restrictions on stem cell research were good for science - California alone threw $3 billion at human embryonic stem cell (hESC) research for no other reason than that Bush was against it, something that could never have occurred through the NIH, and scientists also found creative alternatives, also something that would probably not have happened."

Sphere: Related Content

Honesty, Science and Politics

Part of the justification for the existence of the California stem cell agency lies in the argument that scientific research should be above politics and government and apart from it.

However, science has rarely been apart from politics – at least in the last 50 or 60 years in this country.

New York Times
columnist John Tierney dealt with the intersection of the two in a Monday piece – headlined "Politics in the Guise of Pure Science" -- in which he raised questions about whether some of President Obama's scientific advisers can be "honest brokers."

He quoted Roger Pielke(see photo) of the University of Colorado on the matter, whose book, not so coincidentally, is entitled "The Honest Broker." Tierney said Pielke argues that "most scientists are fundamentally mistaken about their role in political debates. As a result, he says, they’re jeopardizing their credibility while impeding solutions to problems like global warming."

Tierney wrote,
"...(T)oo often, Dr. Pielke says, they pose as impartial experts pointing politicians to the only option that makes scientific sense. To bolster their case, they’re prone to exaggerate their expertise (like enumerating the catastrophes that would occur if their policies aren’t adopted), while denigrating their political opponents as 'unqualified'or 'unscientific.'"
Tierney cited recent statements by John Holdren and Steven Chu as examples. Tierney did not discuss human embryonic stem cell research in his piece, but he could have.

The case for hESC research is often imbued with messianic zeal and rhetoric about "missions" that seems more appropriate to an ideology rather than cold, hard scientific research. Hyperbole does not necessarily serve the public or scientists well over the long term, perhaps not even in the short. Instead, it can become a justification for spending on ill-considered, dubious efforts advanced to attain some sort visionary goal. Pielke's and Tierney's cautions are something for the overseers of California's $3 billion stem cell research program to keep in mind as they evaluate the agency's efforts in the next few months.

(Editor's note -- Tierney's column drew 156 comments at the time of this writing. You can read them here). Sphere: Related Content

Monday, February 23, 2009

Operator Error on Loring Comment

A kindly reader pointed out that the Loring comment could not be found on "Obama Chapter Two." That was an error on the part of this operator. Her comment is now available. Sphere: Related Content

Burrill Says Biotech Industry Profitable for First Time in History

The big headline from the influential Burrill & Company merchant bank is "Biotech Scores Black Ink" for the first time ever.

According to Peter Winter(see photo), editor of the Burrill Report, the biotech industry turned profitable in 2008. Winter made this "startling discovery" after analyzing the numbers for 360 publicly traded biotech companies. Presumably the conclusion might change if private firms were included.

The Burrill finding is another piece to consider in the case for and against the $10 billion biotech federal assistance package championed by CIRM Chairman Robert Klein.

However, Winter also said that only 67 of the 360 companies were profitable with the largest sums coming from only three companies: Genentech, Amgen and Gilead.

He said the have-not companies are struggling, and he predicted that a year from now, perhaps only 200 of the 360 companies will survive.

Burrill did not offer a text version of Winter's findings -- only a podcast. We respect Burrill and the authoritative information it provides, but we regard podcasts and recorded videos as a cyberspace abomination when it comes to dispensing information. When recordings replace carefully crafted, written analysis, they are an inefficient, inadequate and miserable substitute.

Just consider the numbers: Normal speech runs about 150 words a minute. Question-and-answer interviews, including trivial remarks, take longer. Downloading and listening to the Q&A with Winter took about 9-10 minutes. In that time, we could have read about 6,000 or 7,000 words or more. We also assume that nearly all the readers of this blog and the Burrill website can handle written information much more rapidly than listening to oral presentations, which often miss important details and nuances. The discipline of writing almost forces the inclusion of those elements.

Recordings on the Internet have their place and can communicate certain kinds of emphasis and emotion better than text. But for the most part, they are used on the Internet like some new gadget, whose novelty is more alluring than its effectiveness.

Serious enterprises that deal with hard facts and numbers should avoid them. That's the conclusion from the California Stem Cell Report in our cyberspace rant of the day. Sphere: Related Content

Fierce Biotech Poll: No Bailout for Biotech

A week-long poll by an industry publication shows that most respondents do not favor a federal bailout of biotech firms, with one reader commenting that "it's all about the survival of the fittest and smartest."

The informal poll was conducted online by Fierce Biotech. It showed that 51 percent answered no to the question "Does the US biotech industry deserve a bailout?" Forty-four percent said yes. Five percent said no.

The results of the poll have some implications for the California stem cell agency and the lobbying effort by its chairman, Robert Klein, to snag $10 billion for the biotech industry. He has already hired a powerful Washington lobbyist, the Podesta Group, for $200,000 to secure the package.

Maureen Martino(see photo), editor of Fierce Biotech, wrote about the poll, quoting some persons who emailed her.

Elinor Gulve was one of those. She wrote,
"Things have to play out in nature's own course. In this industry, it's all about the survival of the fittest and smartest."
Martino said,
"Readers expressed concerns about how the money would be distributed, and whether those government dollars would come with serious strings attached. Several respondents felt that the industry deserves government support, but that it should come in the form of tax incentives and funding for agencies like the NIH--not from a handout."
The poll was not a scientific random sample, just an expression of sentiment from those who felt strongly enough about the matter to respond, Nonetheless it was a bit surprising since the respondents presumably came from the industry and had the most to gain from dollops of federal dough. Results on polls are also shaped by the wording on the questions. If the question were phrased as: Was a bailout "needed" or would it be "useful" to the industry, the results might have been different.

We wrote earlier about this poll after it had been up for only a few days. The early trend was about the same as the final results after seven days. Sphere: Related Content

Fresh Comment

Jeanne Loring, director of the Center for Regenerative Medicine at Scripps, has posted a comment on the "Obama: Chapter Two" item. Among other things, she says that legislative is needed to change federal law on stem cell research. Sphere: Related Content

Friday, February 20, 2009

California Bond Picture Not Too Bright, Say Bond Managers

A couple of bigtime bond investors are shrugging off the California budget deal, reflecting sentiments that do not appear to augur well for the state stem cell agency's plan to sell state bonds privately to solve a cash crunch.

Reporter Martin Braun, writing for Bloomberg News, quoted two bond fund managers as saying that the fundamental state budget problems still exist in California.

Ken Naehu, who oversees $2 billion in municipal bonds at Bel Air Investment Advisors in Los Angeles, was quoted as saying,
“There won’t be a tremendous change in perception purely because the budget has passed. The municipal market is dominated by retail investors now and those investors have been scared, have been spooked."
Paul Brennan, who oversees $12 billion in muni bonds at Nuveen Asset Management in Chicago, including $1 billion in California bonds, was quoted as saying,
"Some of the budget is being balanced from either additional debt or this potential stimulus aid from Washington, that’s a one-time shot and that doesn’t solve the structural deficit."
Currently California has the worst bond rating of any state in the nation. That means that it will have to pay higher interest rates to attract investors when it resumes selling bonds. The state has not sold any bonds since last June.

The Bloomberg article also reported that state Treasurer Bill Lockyer said that the state is considering offering bonds within six weeks.

Bonds are virtually the only source of cash for the state stem cell agency. Sphere: Related Content

A Caution about Excessive Industry Coziness at CIRM

A longtime observer of the California stem cell agency is warning that the $3 billion enterprise is on the verge of becoming much too intimate with industry.

John M. Simpson
, stem cell project director of Consumer Watchdog of Santa Monica, Ca., said that a plan to create an industry biotech advisory group for CIRM is "fraught with pitfalls."

Writing on his organization's blog on Feb. 19, he said,
"Who picks the members? What would be the criteria for selection? Will the meetings be public? Will these advisors also be applying for grants?"
He noted that four members of the CIRM board of directors hold their positions because of their ties to the life sciences industry. Conducting special, public meetings with industry is okay, Simpson said. Biotech lobbyists can also take part in regular meetings of the agency.

But Simpson wrote,
"Creating an industry special interest group to whisper in the ears of CIRM executives is just wrong-headed.  What do you say to biotech companies not on the panel? Will there be an advisory group from academia, another from patient advocates and another advisory group from the public?

"But that's exactly what the ICOC (the CIRM board) and its committees are supposed to do with their public meetings.  Selecting some industry representatives and giving them special treatment and access to CIRM's leadership is simply wrong."
Sphere: Related Content

Thursday, February 19, 2009

The 'House of Cards' and a $400 Million Fund-Raising Drive

Borrowing $400 million for stem cell research is no small task, but one that CIRM has chosen for itself.

John M. Simpson
, stem cell project director of Consumer Watchdog of Santa Monica, Ca., today raised questions about the nature of the effort, given the nation's shaky economy and the "house of cards" that is the budget deal approved today in Sacramento.

Here is what Simpson said in an email:
"It strikes me that despite the budget deal, it still may be a long time before the state can get into the bond market.

"Key parts of the deal have to go before the voters in a special election in May. I don't see how you can sell bonds until the outcome of the election is known.

"And, it seems to me, the chances are excellent that the voters just might turn the proposal down throwing everything back to square one.

"I don't know what it does to private placement, but it seems to me that the just-passed budget may be a house of cards that collapses.

"I like to see myself is an optimist -- maybe I'm influenced by how much my own assets have tanked -- but I think it will be an uphill struggle to place $200 million before September when CIRM's cash runs out."
Sphere: Related Content

Who is on the Hook for $400 Million in Stem Cell Science?

An anonymous reader has posted a question on the "California budget mess" item, asking about who will pay back the $400 million in bonds that CIRM is seeking to sell privately to support its operations. We suspect some other readers may have the same question, so we are responding here.

But first, let's rephrase the question in more straight forward language: Who is going to pay the $400 million that the state stem cell agency is seeking to borrow privately?

The answer is the state of California and its taxpayers. The bonds are, in fact, loans to the state and become the "general obligation" of the state. They are no different than general obligation bonds that are sold by the state to execute other projects. The bonds do not rely on CIRM to generate revenue to pay them off. The state cannot declare bankruptcy, according to a briefing for CIRM directors last month. Thus investors would seem assured of earning a return at some point. Income from the bonds is also exempt from California taxes but not federal taxes, making them favored investments for California-connected persons and enterprises.

The state has "placed" only $250 million of the $3 billion in bonds authorized to be sold on behalf of CIRM. That initial round of borrowing was the first time ever that general obligation bonds have been used to "finance the development of intellectual capital," according to the state treasurer's office. Generally bonds are used to build roads, hospitals, housing and other "hard" assets.

Here is a rundown from the state treasurer's office on California bonds that should answer nearly all questions about the nature of the devices. Sphere: Related Content

California Passes Budget, Issuance of Stem Cell Bonds Still Distant

In the predawn hours today in Sacramento, California lawmakers passed a budget aimed at dealing with a $42 billion state deficit, but the spigot that feeds CIRM remains firmly closed.

Nonetheless, the action does assist with CIRM's own plans to bootstrap itself out of its cash crunch.

The state legislature has sent the spending proposal to the governor, who is expected to sign it in the next few days. The action sets the stage for possible issuance of state bonds, the funding mechanism for the California stem cell agency, which is facing a major financial shortfall.

State Treasurer Bill Lockyer is evaluating the new state budget to determine whether it enables the state to return to the bond market and under what conditions. However, even if bonds are sold in the next month or so, bonds for CIRM are not at the top of the $53 billion list.

In response to a query from the California Stem Cell Report, Tom Dresslar, a spokesman for Lockyer, said,
"We need to analyze the product(the budget) and get a firm handle on cash flow before we can say anything about how the budget will affect our ability to return to the bond market."
However, passage of the budget should help with the CIRM plan to sell privately $400 million in state bonds to provide funding for CIRM. The legislative action removes significant uncertainty and should help counter possible objections from potential buyers.

The treasurer's office has also assisted indirectly by leading the way on the private placement of state bonds, which has never been done in state history. Lockyer's office has already cut a deal with the San Francisco Bay Area Toll Authority to buy $200 million in state bonds. That means CIRM will not be in the unenviable position of being the first out of the trenches with a private sale and can point instead to a precedent.

Here are links to some budget stories: Wall Street Journal, Sacramento Bee, Los Angeles Times, San Francisco Chronicle and New York Times. Sphere: Related Content

Wednesday, February 18, 2009

Chapter Two of 'Waiting for Obama' -- The Vagaries of Vagueness

President Obama's delay in announcing changes in federal restrictions on human embryonic stem cell research today triggered another article on the resulting nervousness in stem cell circles.

This one came in the Washington Post. Written by Rob Stein, the piece, intended for publication Thursday, said,
"...{T)he delay and the vague language (from the administration) are making proponents nervous. Has Obama simply been too preoccupied with the economic crisis to focus on the issue? Is he hesitant to wade into one of the flashpoints of the culture wars? Could he even be considering a moderate move as part of his broad strategy of seeking the middle ground on even the most contentious issues?

"'The word the president is 'considering' it is too vague a word for me," (Amy Comstock Rick (of the Coalition for the Advancement of Medical Research) said. 'I don't know entirely what that means. If it means he's just working out the details that's great. But if 'considering' means 'reconsidering' we would be very upset.'"
Stein said the White House has reassured the worriers that something will happen soon. He also quoted Story Landis(see photo), head of the NIH stem cell task force, as saying,
"We are assuming that what we will be asked to do is develop guidelines for stem cell lines derived from embryos produced for reproductive purposes in excess of need."
But Stein added,
"Proponents of the research hope the executive order and resulting NIH guidelines would be more open-ended than that, allowing research on stem cells derived in other ways."
Landis' advice to researchers? If you are smart, start writing your grant now.

(Editor's note: Chapter One of "Waiting for Obama" can be found here.) Sphere: Related Content

Fresh Comments

Ty Tyler has published a comment on the "waiting for Obama" item.

David Granovsky
has posted a comment on the "CIRM touts" item. Sphere: Related Content

Tuesday, February 17, 2009

CIRM Touts Its Financial Outlook

CIRM has officially but quietly announced that it hopes to raise $400 million through 2010 by selling California state bonds privately, a task never before achieved in state history.

The information on the private placement goal was posted Friday on the CIRM web site with virtually no notice or fanfare. The CIRM home page, which often carries far more trivial matters, makes no reference to the item about the state of CIRM's troubled finances. The three-paragraph posting was placed near the top of the CIRM web page page entitled "Funding Opportunities" and "Current Requests for Applications."

As far as we can tell, the item is the only significant reference on the CIRM web site to the hours and hours spent by worried directors last month discussing the agency's cash woes, other than the transcript of the meeting itself.

While the agency is now about seven months away from running out of cash, the Friday item has a positive headline, "CIRM's Financial Commitments Are Secure." The language is tailored to reassure grant applicants, especially those applying for the $210 million disease team RFA that was also posted on Friday.

The financial-status posting also refers to a "CIRM program with the state treasurer" for private placement of bonds. If the program is actually in place, it is a significant advance on the situation discussed by directors just three weeks ago. Many questions were raised at the time by directors about the plan. CIRM Chairman Robert Klein, who devised the private placement effort, promised to report back to the board at its meeting March 12.

CIRM seems determined not to call public attention to its financial problems, given its handling of the matter as long ago as its December board meeting. The January meeting included a lengthy briefing on the subject, but the public had no advance notice from CIRM of the sweeping scope of the problem. Even directors seemed taken aback.

A number of the directors were concerned about the public relations message that would be delivered as a result of the briefing and the ensuing discussion. There was a decided effort at the time to put a positive spin on the news. However, while directors approved $58 million in grants, they balked at funding until they knew more about the agency's finances. Efforts were also made to reassure current recipients of CIRM grants that money would still be forthcoming.

The public relations and positioning tactics could be construed as Pollyannish. But the agency must act in a way to retain the faith of the stem cell community that it will continue to operate unimpeded by what it hopes are transitory issues. CIRM needs a positive outlook to attract the best proposals for its disease round. It also must sell a story of past accomplishment and a rosy future to potential buyers of its bonds. No one is going to invest in a sinking ship.

At the same, CIRM directors and its executives should not be misled about the realities. Waiting too long to act on other measures to deal with the cash crunch will only compound the problem.

(A side note: In an operation independent of CIRM, the state of California is expected to announce later this week that it will make its first private placement of general obligation bonds, which could help smooth the way for CIRM sales with nervous investors. If the state does, in fact, make the private sale, CIRM, which has recorded a number of firsts in its brief life, will not have the opportunity to record another.)

Here is the full text of CIRM's "secure finances" posting:
"California voters approved the sale of  $3 billion in bonds to fund the work of the California Institute for Regenerative Medicine. The State finance committee created to oversee those bonds has authorized the issuance of the full amount.  A total of $2.5 billion in authority remains in funding availability. Proceeds from sale of the bonds are constitutionally protected and can only be used to fund CIRM programs and operations.

"CIRM currently has significant cash reserves of $160 million, which can fund all existing commitments through at least September. The agency’s plans have always called for raising new capital on a cash-flow, as-needed basis. We expect the traditional bond market will open soon with resolution of California’s budget situation.  To supplement this public bond market, CIRM is working with the State treasurer’s office on a CIRM private placement of $200 million in general obligation bonds this year and $200 million again next year.  The CIRM program with the State Treasurer is designed to produce sufficient funding in 2009 and again in 2010 to maintain the pace of funding under CIRM’s proposed grant schedule.

"The Agency intends to continue the planning and review needed to maintain its mission on schedule and expects that additional bond funds will become available by the time they are needed."
Sphere: Related Content

Long Wait for CIRM in the California Cash Queue

How long is the line for cash in California before the state's stem cell agency might get some?

Think about $53 billion in bonds waiting to be sold. That is the amount, including CIRM-connected bonds, that has been approved but not yet brought to market. Compare that to the total of $7.35 billion in general obligation bonds sold by the state during the entire fiscal year 2007-08.

California state bonds are what pays for the grants to researchers and the operations of the stem cell research effort, which is now facing a serious cash flow problem. That's because the state has not sold bonds since last June. And it currently has $52 billion in bond indebtedness.

Once the budget mess in California is resolved, the state treasurer's office has told CIRM it will have to wait for funding until other, more pressing bond needs are met. Sphere: Related Content

Monday, February 16, 2009

NY Times Examines the California Budget Mess that Ensnared CIRM

California's $42 billion fiscal fiasco, which is threatening its $3 billion stem cell research effort, today drew some major and dubious media attention.

In a piece by Jennifer Steinhauer, The New York Times reported on the shameful shenanigans in Sacramento. Ballooning deficits, intransigent lawmakers and a governor who is "free of allies or influence" were just part of her first paragraph. The budget issues are so great that CIRM's relatively picayune problems did not merit even a word, although they have raised a loud alarm in state stem cell circles.

California faces a $42 billion budget shortfall. A partial solution is now before lawmakers in Sacramento, but a handful of Republicans, who are more interested in ideology than solving problems, are blocking passage.

Steinhauer wrote that the state, in a nearly unheard of move, has lost access to much of the credit markets and that its bonds are now rated the lowest in the nation. That is the reason that the California stem cell agency is now facing a hefty financial shortfall. The agency relies on bond funding, and the state has not sold any since last June.

Steinhauer continued,
"'No other state is in the kind of crisis that California is in,' said Iris J. Lav, the deputy director of the Center on Budget and Policy Priorities, a liberal research group in Washington. The roots of California’s inability to address its budget woes are statutory and political. The state, unlike most others, requires a two-thirds majority vote in the legislature to pass budgets and tax increases. And its process for creating voter initiatives hamstrings the budget process by directing money for some programs while depriving others of cash."
It was a voter initiative that created the California stem cell agency and isolated it from control by the governor or the state legislature. Instead the ballot measure, Prop. 71, gave CIRM direct funding from state bonds. The measure initially protected CIRM but now the agency has become part of the financial collateral damage in California's budget battles.

Robert Klein, chairman of the stem cell agency, has proposed an effort to sell bonds privately to ease CIRM through its hard times. The state has never before sold bonds privately, but is reportedly ready to do that soon – but not for CIRM. The stem cell agency will have to wait in line while more pressing needs are addressed. Meantime, Klein is trying to cobble together a plan for CIRM to peddle the bonds directly to foundations in the hopes of meeting two of the foundations' needs – a solid return on their investment (probably 5 to 6 pecent) and funding worthwhile research. He is expected to report on that effort at CIRM board meeting on March 12.

Klein, who is an attorney and real estate investment banker, led the drafting effort on Prop. 71. The idea was to make the agency immune from "political" tinkering. In the process, however, he wrote into the measure the seeds of a number of problems that have surfaced since its passage in 2004. The reliance on bond funding is just one, and it now puts the agency, once fiscally well-endowed, near the end of the line for cash as California works its way out of its budget mess. And because the whole arrangement is locked into the state Constitution and state law and virtually impossible to change, CIRM's tenuous situation will continue for some time regardless of what makes good sense either scientifically or in terms of sound policy.

Concerning our earlier comment about the shenanigans in Sacramento, many folks working up there deserve some responsibility for the budget crisis. But fundamentally it is failure of leadership – particularly that of Gov. Arnold Schwarzenegger, who appears to have lost much of the clout he once had and is also unwilling to devote his remaining political and financial resources to "persuading" GOP lawmakers to vote for a budget. (He would do well to study the exercise of power by Lyndon Baines Johnson.) The state GOP legislative leadership seems to be locked into some fantasy unconnected to the realities of the California economy. Democrats also have not conducted themselves well along with the host of special pleaders lobbying in Sacramento, ranging from teachers and business interests to environmentalists and prison guards. Sphere: Related Content

Saturday, February 14, 2009

Science, Marco Polo and Kissing

Given that today is Saint Valentine's Day, we are indulging in an aspect of science that may not have much to do with stem cells – kissing.

Sheril Kirshenbaum of NewScientist magazine has graced the online world with a look at one of the latest theories about the origins of kissing. It comes from neuroscientist V.S. Ramachandran of UC San Diego and the Salk Institute, who has been labeled the "Marco Polo of Neuroscience."

Kirshenbaum writes that Ramachandran "points out that since our ancestors needed to find ripe fruit, they would have been attracted to the color red."

She quotes the scientist as saying,
"Red thus became an indicator of food reward. Then something called 'evolutionary co-option' happened, turning red into a general signal for attraction."
Ramachandran says that despite changes that have resulted in an upright posture for human beings, swollen lips remain attractive to males "because of an atavistic persistence of evolutionary memory for attraction to red."

Kirshenbaum notes,
"This hypothesis is supported by the fact that bonobos ( a type of great ape) share our pink lips, as well as our inclination toward kissing, face-to-face mating and oral sex - much more so than pale-lipped chimpanzees."
In a separate piece, NewScientist editorialized,
"...(T)he role of kissing remains mysterious. Perhaps it is one of those facets of human behavior that will remain forever beyond our ken - but no less delicious for that."
As far as we can determine, Ramachandran is not a recipient of a grant from the California stem cell agency. But some clever folks at CIRM might be able to conjure up a concept for an RFA that could attract his attention and advance science in this important area. Color the application red. Sphere: Related Content

Friday, February 13, 2009

Financially Troubled CIRM Hires $200,000 Federal Lobbyist

The California stem cell agency has hired one of Washington's more influential lobbyists, The Podesta Group, to promote a $10 billion biomedical industry aid package being pushed by CIRM Chairman Robert Klein.

In response to an inquiry, Don Gibbons, CIRM communications chief, today said a contract had been signed with the firm, which was founded by Tony Podesta (see photo) in 1988. Gibbons did not disclose the value of the contract, but Podesta proposed a $200,000, 10-month deal in keeping with the terms of CIRM's request for proposals. Travel and other expenses incurred by Podesta would add to the total cost. The lobbying proposal also does not include travel expenses to Washington, D.C., for Klein, other CIRM directors or staff.

The losing firms were Van Scoyoc Associates and Hogan & Hartson.

Earlier we requested a copy of the 15-page Podesta proposal, which is a public record. Gibbons supplied a heavily censored version. More than five key pages were missing, leaving only their titles: "situation analysis" and "strategic framework."
.
Asked for an explanation for removal of the material, Gibbons quoted CIRM legal staff as saying,
"The Public Records Act incorporates, as an exemption, the trade secret privilege found in the Evidence Code.  Each responder was given the opportunity to assert that privilege for any part of the proposal it claims as a trade secret."
Without seeing the five removed pages, it is impossible to evaluate the Podesta proposal or whether it is realistic to expect any sort of result from the expenditure of $200,000 in California taxpayer funds. It is also clear that much of the bowdlerized, analytical material would likely consist of little more than what can be read in newspapers, industry publications and online information sources.

Most of the remaining material amounts to boilerplate descriptions of the firm and its work. However, Podesta did strike a ambitious chord or two, indicating that it would lobby for federal cash directly for the agency and would attempt to make CIRM a major biomedical player in the nation's capital.

Podesta wrote,
"Faced with the prospect of being unable to fund previously approved research and facilities grants, CIRM needs federal support in the form of appropriations, loan guarantees, and /or other measures to finance its research program through the end of calendar year 2010...."
In addition to grabbing some cash right now, Podesta said,
"Our strategy also positions CIRM to play a major role in shaping longer-term federal policies on biomedical research in general and stem cells in particular."
The firm said it is "the longest-tenured Washington representative of the pioneer biotech companies – Genzyme, Genentech and Amgen." It also represents Novartis Vaccines and Diagnostics and Novo Nordisk. Business Week has labelled The Podesta Group as one of seven "Uber-influencers: The Lobbyists Likely to thrive in the New Washington."

The hiring of the lobbyist has drawn fire from at least one critic, John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., who has called it an unnecessary, costly diversion from CIRM's stem cell research mission in California.

Simpson raised questions about the federal lobbying plan as early as CIRM's board meeting late last month. He specifically mentioned its $200,000 expense.

By that time the request for lobbying proposals, including its cost, had been on the CIRM website for two days. In response to Simpson, however, Klein said,
"The dollar amount of that is completely unknown at this time. It's in order to attract proposals and see what we have and what resources we need. So we're in an investigation stage of that."
Klein made that statement the morning of Jan. 30, the transcript of the meeting shows. The deadline for the proposals was 5 p.m. later that day with selection of a lobbyist scheduled for as early as two business days later.

We have raised additional questions with CIRM's Gibbons. They include whether CIRM's legal staff agrees that only "trade secrets" were removed from the Podesta proposal, whether all the material was removed at Podesta's request and whether CIRM removed material without a request from Podesta. The questions also include terms of the contract, whether the firm has actually begun work and whether Klein is seeking financial support from grantee institutions to pay for Podesta.

We will carry Gibbons' responses when we receive them.

If you would like copies of all three lobbying proposals, send an email to djensen@californiastemcellreport.com. Sphere: Related Content

CIRM/ISSCR Convention Proposal Reduced to $250,000

CIRM directors balked last year at coughing up $400,000 for the 2010 convention of the International Society for Stem Cell Research, but now the figure has been trimmed to $250,000.

John M. Simpson
, stem cell project director for Consumer Watchdog of Santa Monica, Ca., reported the new figure on his organization's blog. He said that CIRM has agreed to help the group raise the additional $150,000 for the San Francisco meeting.

But Simpson wrote,
"That's a mistake.  CIRM should focus with laser-like precision  on where its getting the money to fund existing grant commitments. This sort fund raising effort -- just like hiring a proposed lobbyist in Washington for roughly $200K --  is an unfortunate and unnecessary distraction."
Sphere: Related Content

Thursday, February 12, 2009

Online Poll Says Nyet to Biotech Bailout; Results Subject to Instant Change

Does the biotech industry deserve a bailout? No, according to the current results of an online poll being conducted today by Fierce Biotech, which calls itself "The Biotech Industry's Daily Monitor."

At least that was the conclusion at the time of this writing. It was a "finding" that might give minor pause to those pushing the $10 billion assistance package championed by the chairman of the $3 billion California stem cell agency, Robert Klein.

Here is what the poll showed at 3:33 p.m. MST today. Forty-nine percent answered negatively to the bailout question. Forty-three percent said yes. Eight percent were not sure.

We were surprised by the numbers because the Fierce Biotech audience presumably consists of folks inclined to support the industry wholeheartedly. But some poll respondents may have been taken aback by the avaricious clamor to climb aboard the already stressed bailout wagon in Washington.

The poll is totally unscientific. No total numbers are offered. You just go to the site and vote. It is even possible to vote twice, if you are crafty. (We did, once yes and once no, to assure complete balance.) Earlier in the day, something like 53 percent supported a bailout, but that changed as the day wore on, Even that number was surprising, however, given the nature of Fierce's audience.

The poll was also linked to an opinion piece by Daniel Nevrivy of the Nevrivy Patent Law Group in Washington, which argued for a bailout. He wrote,
"At a recent healthcare conference, the notion that the biotech industry receive government help was ridiculed by a well-known financial executive. Doing 'something stupid' over there--a reference to the U.S. auto industry bailout - doesn't mean you should do something stupid over here, remarked the executive. The remark is reflective of the evolving attitudes of Congress and the U.S. taxpayer over industry bailouts. Support for U.S. automakers, who regularly get beat by the foreign competition--even on their home turf--may have poisoned the well for other, more worthy industries like biotech that are now struggling."
Nevrivy argued that it is wrong to equate the two. He said US biotech is stronger than its foreign competitors, although it is suffering from a current cash crunch.

He wrote,
"Economists generally disfavor government support and subsidies; however, we are living in a world where the government is an active player, as well as a referee, and is picking winners and losers. If we have to pick winners and losers, doesn't it make a certain amount of economic sense to favor industries in which we have an advantage? If that is the case, it is wrong to equate support for the U.S. auto and biotech industries as equally bad ideas."
Sphere: Related Content

Wednesday, February 11, 2009

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.) Sphere: Related Content

Tuesday, February 10, 2009

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. Sphere: Related Content

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."
Sphere: Related Content

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. Sphere: Related Content

Monday, February 09, 2009

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. Sphere: Related Content

Sunday, February 08, 2009

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. Sphere: Related Content

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? Sphere: Related Content

Thursday, February 05, 2009

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. Sphere: Related Content

Wednesday, February 04, 2009

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? Sphere: Related Content

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."
Sphere: Related Content

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. Sphere: Related Content

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. Sphere: Related Content

Tuesday, February 03, 2009

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. Sphere: Related Content

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."
Sphere: Related Content

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."
Sphere: Related Content

Monday, February 02, 2009

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. Sphere: Related Content

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. Sphere: Related Content

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. Sphere: Related Content