CIRM and the Stem Cell Industry: A Lobbying Question

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

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

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

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

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

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

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

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

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

Waiting for Obama -- The Stem Cell Delay

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

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

Reporter Marie McCullough wrote earlier this week,

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

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

She continued,

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

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

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

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

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

Fresh Comment

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

Nature's Niche Discusses CIRM Finances

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

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

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

CIRM Board Member Pizzo Writes About Stem Cell Budget Woes

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

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

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

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

He continued,

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

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

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

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

Audience Numbers for First CIRM Audio-cast

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

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

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

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

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

Kudos for CIRM Audio Webcast

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

Here is an unsolicited comment from her today:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Here is the language from the RFP:

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

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

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

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

Simpson On The CIRM Private Placement Plan

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

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

Simpson wrote,

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

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

CIRM Vice Chair Story Surfaces in LA Times

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

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

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

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

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

CIRM Strategic Plan Hearings Begin Tomorrow

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

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

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

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

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

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

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

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

You can find specific locations here and the agenda here.

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

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

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

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

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

He continued,

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

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

On Jan. 16, Lockyer said,

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

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

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

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

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

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

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

"We have a financial crisis looming."

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

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

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

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

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

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

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

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

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

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

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

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

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

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

AP's Story on CIRM's Grants and Cash

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

Here is the lead:

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

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

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

Modest Coverage of CIRM Cash Problems

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

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

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

Somers wrote:

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

"The answer: a resounding yes."

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

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

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

A shorter story by David Perlman of the Chronicle began,

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

Ron Luety of the Business Times wrote,

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

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

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

State Colleges Win CIRM Grants

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

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

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

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

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

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

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

"Bridges" Grants Approved by CIRM Board

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

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

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

CIRM Training Grants Approved

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

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

CIRM Board to Act Today on Training Grants

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

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

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

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

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

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

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

Don Gibbons said in an email:

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

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

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

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