Monday, January 19, 2009

A California Stem Cell Question: Millions for Science vs. Cuts in Medical Help for the Poor

As California's public universities are turning away students and state cash is being cut for projects ranging from research labs to affordable housing, the California stem cell agency is on track to give away $66 million later this month.

The awards will come following CIRM's handout of more than $19 million last month.

No one – except for those congenitally opposed to hESC work -- is contending that all these millions are going to unworthy scientists or to dubious research. But the CIRM giveaways stand in marked contrast to what is happening to the rest of the state in the light of its $40 billion budget crisis.

If CIRM were, say, part of the state Department of Health, chances are good that it would not be able to spend taxpayer money so freely.

The disparity raises major public policy issues about the use of ballot initiatives to promote and protect various causes. Should the elderly and poor see their much-needed assistance and medical care cut while cash flows unimpeded, in this case, to researchers, some of whom are already exceedingly well funded?

A ballot initiative, Prop. 71, is just what created the $3 billion stem cell effort in 2004 – not carefully crafted legislation hammered out over months with all parties having their say in public. The measure was drafted in secret by CIRM Chairman Robert Klein (with the help of a couple of others he rarely acknowledges) and placed on the ballot with a signature-gathering effort that probably cost $1 to $2 million. (That is the most common way of placing an initiative on the ballot in California – hiring firms that specialize in such efforts and paying them on a per signature basis.)

Voters did speak, approving Prop. 71 with a 59 percent vote. However, the measure faced only the most feeble opposition. The groups concerned about ethical issues involving hESC were largely focused instead on re-electing George Bush as president.

The upshot is that the Golden State can do little now to enact even the most minor needed changes in the Prop. 71. It locked into state law and the state Constitution true minutia, such as specifying that CIRM Chairman Klein is in charge of putting out the annual report. Prop. 71 enacted super-majority quorum requirements that hamper the agency in conducting its official business and capped its staff size at a ludicrously low 50 persons to run a $3 billion program. And it created a board of directors dominated by the very enterprises that benefit the most from CIRM largess.

Klein, in order to insure that he and the agency would not have to heed the wishes of the governor or other elected officials, wrote into Prop. 71 an unprecedented, constitutional requirement for a 70 percent vote of the legislature to change the law, plus the signature of the governor. That makes it virtually politically impossible to make alterations in the measure. By contrast, even passing a budget for the state of California or raising taxes requires only a two-thirds vote. While less than that for changes in CIRM, the two-thirds requirement is now barring a solution to the state's disastrous financial problems.

All of that is a backdrop to the upcoming CIRM directors meeting Jan. 29 in Burlingame, Ca. In addition to giving away the big bucks, an overdue review of its financial condition is on the agenda. So far, however, no financial documents are posted on the CIRM web site. The subject came up last month repeatedly at the directors meeting in Irvine. Klein, however, shied away from discussing specifics.

But here are the basics: CIRM depends on state bonds for cash. The money flows directly to the agency. The governor and the legislature cannot touch it. But the state has stopped issuing bonds because of its precarious condition. CIRM says that so far it has plenty of cash. But it has awarded more than $600 million in multi-year grants, which need regular payments. One contingency Klein promises to discuss is the private placement of bonds. One would think those would have limited appeal when not even the state of California can find a market for its bonds.

Private placements, moreover, are not likely to be necessary. If California cannot get its financial act together in the next month or two, it will face problems of a magnitude that will dwarf such concerns as stem cell research. That pressure seems certain to force the state's public servants to cobble together a solution before CIRM runs aground financially. Nonetheless contingency plans are always good.

The grants scheduled to be awarded include $18 million to support up to 10 awards for three years "to augment the ranks of laboratory personnel trained in the state-of-the-art techniques required by stem cell research labs." Certainly a worthy endeavor while the state's educational institutions are being whipsawed financially.

The second round involves $48 million in training grants for young scientists, including stipends of up to $77,000 for three years, including research and travel, tuition and health insurance in some cases. Another worthy endeavor, an investment in the future. It is a remake of the first-ever grants awarded by CIRM in September 2005. The agency didn't have the money then to fund the grants immediately, but the cash ultimately came through and helped make the state attractive to new, young talent.

If you have thoughts on any of these issues, you can comment below by clicking on the word "comment" or you can write CIRM directly via its web site and ask to have your comments made part of the public comment allowed at each CIRM board meeting.

Sunday, January 18, 2009

$500 Million CIRM Lending Program Up on Wednesday; Details Missing

With only two business days left before a key CIRM meeting, California's stem cell research agency is keeping under wraps important details of how it plans to lend $500 million to the state's riskiest biotech ventures and make $100 million doing so.

Directors of the agency have approved the concept for what amounts to a biotech bank that would cater to enterprises that cannot gain normal financing. Loan default rates of up to 50 percent have been predicted by the plan's backers. The specifics, however, remain to be resolved. On Wednesday, the directors' Finance Subcommittee will dive into that complex subject.

Just what is being proposed at that session is not available to the public on CIRM's web site – only this cryptic language from the agenda:
"Consideration of policies and implementation plan/processes for CIRM loan program, including but not limited to the Loan Administration Policy and the role of delegated underwriters/financial service providers."
The lending program is the brainchild of CIRM Chairman Robert Klein, who has been pushing it for more than a year. The idea behind it is to help to provide funding for companies through what is known as a financial "valley of death" and to generate additional funds (the $100 million profit) for CIRM to use as additional loans or grants.

The closest thing to a current, basic, one-stop overview of the lending program is the proposal approved by CIRM directors in September. No business plan for the enterprise has been produced.

The biotech bank program calls for delegated underwriting of the loans, a practice much criticized at Fannie Mae, which had to be taken over by the federal government. CIRM does not have the expertise to run a half-billion dollar lending program, so an outside contractor must be hired. An earlier draft of a "concept plan" for underwriting was discussed Nov. 19, 2008, at a Finance Subcommittee meeting. It is not clear whether an identical plan will be offered on Wednesday.

Also discussed in November was a 12-page loan administration policy for loans to businesses. Directors made a number of suggestions for changes in it. The version to be considered on Wednesday is not available to the public on the CIRM web site.

Only two companies offered comments on the plans at the November meeting, International Stem Cell of Oceanside, Ca., and DNAmicroarray of San Diego. Both expressed general support of what they heard although they had some criticism of details.

Earlier this month, CIRM posted a request for information concerning the criteria and compensation for an underwriter, including provisions for dealing with conflicts of interest. According to CIRM, only one business responded, Silicon Valley Bank of Santa Clara, Ca., which has been involved in CIRM discussions about the lending program for months. CIRM expects to have more than one underwriter in order to avoid possible conflicts of interest.

In response to a question, CIRM spokesman Don Gibbons said last Thursday,
"We are also in discussion with a few other institutions and hope to have comments from them prior to the Finance committee meeting."
Gibbons has not yet responded to a request for the names of those companies.

Silicon Valley Bank and its parent group, SVB Financial Group, have 27 offices worldwide and 11,000 clients, according to its web site. The bank says that "more than half of all venture-backed companies in the U.S. are SVB clients."

The bank says,
"With an unmatched network of relationships with life science VCs and a dedicated team of life science experts, we are the partner of choice for emerging and established medical device and biotech companies."
SVB presented a plan to the Finance Subcommittee in September that laid out a possible business relationship with CIRM. Directors discussed the possibility of having a similar presentation at a full board meeting but were concerned about leaving the appearance that a decision had been made to go with Silicon Valley Bank. They suggested that if the bank's slides were used that its name be removed from them. It is not clear whether such a presentation will be made at Wednesday's meeting or at the full board meeting later this month.

Teleconference locations (two in San Francisco, one each in La Jolla, Berkeley, San Carlos, Palo Alto and Irvine) where the public can participate in the Wednesday meeting can be found on the meeting agenda.

Friday, January 16, 2009

Another Reed Ethics Item

Writing on the The Niche stem cell blog for Nature magazine, Monya Baker also posted an item on the ethics case involving CIRM director John Reed. Baker's account can be found here.

Thursday, January 15, 2009

Klein Ducks Little Hoover Questions

Late last year a California government efficiency agency investigating the state's $3 billion stem cell research effort asked its chairman, Robert Klein, what changes he would make in it after four years of experience.

Klein's response came in the form of what one might call a "modified stonewall." He will not answer the question because it would be "inappropriate" for him to give his views.

The matter involves the Little Hoover Commission, a state department charged with analyzing the performance of other state entities, and which has held one public hearing concerning CIRM. The commission's staffers and some of its members have also attended some CIRM meetings and interviewed other persons with an interest in the agency.

On Nov. 26, the Hoover commission sent a letter requesting Klein's views, a request first made at its hearing earlier that month. The letter asked for an answer by Dec. 15. On Dec. 19, Klein tried to rope in members of the CIRM board in fashioning a response, declaring that it would be "inappropriate" for him to respond, although he frequently says he wrote Prop. 71, the measure that created CIRM in 2004.

However, at least two board members balked. According to the transcript of the directors Legislative Subcommittee on Dec. 19, board member Jeff Sheehy, a communications manager at UC San Francisco, said,
"I would rather you just wrote the letter based on the items that you think are important."
Claire Pomeroy, dean of the UC Davis School of Medicine, told Klein,
"It's asking your opinion about writing the initiative, which was the process that happened before the board even existed. so it seems to me that it is appropriate for you to clarify your personal testimony in response to this letter."
Francisco Prieto, a Sacramento physician and CIRM board member, supported Klein's attempts to develop some sort of board consensus on changes.

During the meeting Klein indicated he would poll board members and perhaps staff about recommendations on possible changes.

Sheehy strongly objected to a detailed, full board review on the questions that the Little Hoover Commission directed to Klein. Sheehy warned that it could generate internal controversy that could have "negative consequences."

He said the board should focus on more important, unfinished work. Sheehy said,
"We're still working on trying to get a strategic plan for this institute....I can go down the list. We're still trying to get grants out. We're still trying to figure out a prescreening process. So there's a lot of the nitty-gritty stuff about our work we need to do."
On Dec. 22, Klein wrote a five-page letter to the Hoover Commission that said the "board is working well." He said the size of the board is beneficial because it provides diversity of viewpoints. He defended its conflict of interest rules, but did not mention the case of a director being investigated by the state for actions taken on the advice of Klein personally. He defended CIRM's transparency but did not discuss its perennial failure to provide timely public, Internet access to important background material on many proposals(including their texts) to be acted on at directors' meetings.

He also reiterated his refusal to give his personal opinion about changes. However, in the past he has publicly stated that the 50 person cap on staff was a mistake. He also has acknowledged attendance problems at board meetings, which often make it impossible to do business officially. Those problems stem from the structure of the board and its super-majority quorum requirements that are locked into state law. He also has supported triaging or prescreening grant applications because of difficulties with the grant review process.

We have asked CIRM for copies of the responses to Klein's queries concerning recommendations for changes. We will carry those when we receive them.

Wednesday, January 14, 2009

Reprogramming and Unicorns

CIRM President Alan Trounson has weighed in on some of the issues that attend the reprogramming of adult stem cells.

In a piece in the December 2008 issue of Cell Stem Cell entitled "Rats, Cats, and Elephants, but Still No Unicorn: Induced Pluripotent Stem Cells from New Species," Trounson noted that reprogramming is likely to attract attention from animal conservationists trying to preserve endangered species.

On the human front, he wrote,
"No matter how similar mouse, rat, and human iPSCs might be, it remains to beseen whether the usefulness of human iPSCs can be established, given the presence of viral sequences and of multiple copies of the transcription factors in potentially unregulated sites in the human genome. Regulatory agencies are likely to consider these lines to be genetically engineered and will consequently hold them to a very high bar in order to establish safety for use in human therapy. On the other hand, the potential availability of riPSCs for modeling human diseases will be very attractive to researchers and companies involved in drug discovery, as the mouse has often proven inadequate as a model for candidate therapeutics."

Chron on Reed Conflict Case

Reporter David Perlman of the San Francisco Chronicle on Wednesday wrote a piece on the ethics case involving a director of the California stem cell agency. Perlman secured a brief comment from the director, John Reed, who is also head of the Burnham Institute of La Jolla, Ca., Perlman wrote that Reed said only that he will now resume his activities on the CIRM board.

Tuesday, January 13, 2009

Reed Ethics Case Receives Modest Coverage

The ethics warning by California regulators involving a director of the state's $3 billion stem cell agency drew light news coverage today.

The conflict-of-interest incident received the most fulsome attention in two San Diego area newspapers, the Union-Tribune (Terri Somers writing) and the North County Times(Bradley Fikes writing). That's because the case involves John Reed, head of the Burnham Institute in La Jolla, Ca.

Erika Check, writing on the blog of Nature magazine, carried the following statement from Robert Klein, chairman of CIRM.
"We are delighted that with the completion of the review by the Fair Political Practices Commission. Dr. John Reed will reengage in his role as an ICOC [board] member. As CIRM matures, we continue to review and enhance our policies and procedures to avoid potential problems in the future."
It was Klein, an attorney who drafted much of Prop. 71, who advised Reed to write a letter lobbying the CIRM staff to reverse an unfavorable decision involving a $638,000 grant to Burnham. The letter prompted the state ethics investigation.

The Associated Press also wrote a brief story that appeared on various websites, including those of the San Francisco Chronicle, The Sacramento Bee and the San Jose Mercury News.

None of the stories carried a response from Reed, who Somers reported is traveling.

(An earlier version of this item did not contain the information from the Nature blog.)

Monday, January 12, 2009

Burnham's Reed Warned by State Ethics Agency on Conflict of Interest


California's government ethics overseers have issued a "warning letter" to a director of the California stem cell agency for attempting to influence the agency's staff to reverse a denial of a $638,000 grant to his research organization.

The attempt by John Reed, CEO of the Burnham Institute of La Jolla, Ca., was first disclosed by the California Stem Cell Report in November 2007.

Subsequently, John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca, asked the Fair Political Practices Commission to investigate Reed's action. California's top fiscal officer, Controller John Chiang, also called for an FPPC inquiry. Simpson disclosed the FPPC's warning today in a news release circulated nationally.

The FPPC said that Reed "intended to influence a decision that had the potential to affect his economic interests." The ethics agency said that Reed's action "raises ethical concerns," declaring,
"We are closing this matter with a warning letter....Dr. Reed is advised that failure to comply with the provisions of (state conflict of interest laws) can result in an enforcement action against him, including monetary penalties of up to $5,000 for each violation."
Reed recused himself from serving on the board during the FPPC investigation and appointed an alternate to fill in.

Simpson said he hoped that the 29 members of the CIRM board of directors had learned from the Reed incident. He said Reed can now return to the board and make a "positive contribution."

In response to an inquiry, Chiang's office said,
"Any conflict of interest threatens CIRM’s credibility and jeopardizes voters’ tremendous investment in stem cell research, which is why CIRM itself adopted a conflict-of-interest policy shortly after its creation.

"CIRM and the ICOC have a tremendous amount of work ahead of them – the controller hopes they can move forward and use the guidance provided by the FPPC to avoid any further conflicts in the grant process."
Simpson noted that the CIRM board is riddled with built-in conflicts of interest as the result of the language of Prop. 71, which created the $3 billion research effort.

Simpson said,
"Most of the people handing out the money are the very same people from the institutions that get the money. That means the conflict rules in place must be strictly adhered to and there must be consequences when they are violated.”
Reed wrote his letter seeking to influence the staff on the advice of CIRM Chairman Robert Klein, an attorney who wrote much of Prop. 71. Klein's action triggered calls for his resignation from The Sacramento Bee and Consumer Watchdog.

Sunday, January 11, 2009

Ted Kennedy Backs Torres as CIRM Vice Chairman

Will the next vice chairman of the world's largest funding source for hESC research be Sen. Ted Kennedy's candidate or that of California Gov. Arnold Schwarzenegger?

John M. Simpson
, stem cell project director for Consumer Watchdog of Santa Monica, Ca., disclosed Kennedy's endorsement of Art Torres, the head of the California Democratic Party, on the Consumer Watchdog blog last week.

Contesting Torres for the vice chairmanship of the $3 billion California Institute for Regenerative Medicine is Duane Roth, a current member of the CIRM board of directors, who was nominated by the Republican Schwarzenegger. Roth is also head of Connect, a San Diego area group supporting life science and technology businesses.

In a letter last month to CIRM Chairman Robert Klein, Kennedy said Torres is a friend of 37 years and declared that the former state lawmaker has an outstanding record of public service.

Torres' "years of advocacy for medical research and better health care for Californians will be a major asset" for CIRM, Kennedy said.

"A great deal is at stake," the Massachusetts Democrat said, "and I'm confident that Art Torres will make a difference for our country."

Simpson said he was not sure which candidate was best. Simpson wrote,
"The first task  for the ICOC (CIRM directors) is to define exactly what the vice chairman should be doing.  Both men need to offer a clear public statement of what he would bring to the position as well as his vision for the post." 
It is up to the 29-member CIRM board of directors to choose between Torres and Roth. No vote is yet scheduled.

CIRM's Financial Status, $500 Million Lending Program on the Table

Directors of the California stem cell agency next week will discuss how to run its ambitious and novel $500 million plan to lend money to the state's riskiest biotech ventures as well as the agency's own finances in the light of the Golden State's budget crisis.

The meeting of the Finance Subcommittee is scheduled for Jan. 21 at eight teleconference locations throughout the state. Businesses and others interested in the biotech loan effort should not miss the session.

Also on tap are plans to ask the Obama administration for loan guarantees that would, according to CIRM Chairman Robert Klein, enable CIRM to double its lending program to $1 billion.

No details are yet available on the agenda posted by CIRM on its web site.

Here is the information currently provided on the matters to be discussed:
"Consideration of policies and implementation plan/processes for CIRM loan program, including but not limited to the Loan Administration Policy and the role of delegated underwriters/financial service providers.

"Consideration of Stimulus Program topics

"Update on challenges of state finances and the impact on agency bond issues"
(Stimulus program topics are expected to include the loan guarantees.)

The loan program would target enterprises that cannot get normal financing because of their risk. Default rates are projected as high as 50 percent, but a $100 million "profit" is also expected. The excess is expected to be used for additional grants or loans.

Action taken at next week's meeting is likely to go before the full board of directors at its meeting on Jan. 29 in San Francisco.

The teleconference locations are in San Francisco(2), Menlo Park, La Jolla, Berkeley, Hillsborough, Irvine and Palo Alto. Specific addresses can be found on the agenda.

Tuesday, January 06, 2009

CIRM's $500 Million Loan Program: Lucrative Contract Looms

The California stem cell agency is seeking advice on its plan to have an outside contractor run a $500 million biotech lending program, and Friday is the deadline.

The information will play a key role in creating a potentially lucrative contract to administer the seven- to 10-year program for the $3 billion agency.

Banks, delegated underwriters and other financial service providers with an interest would be well-advised to weigh in with suggestions. The "request for information," however, is not limited to potential bidders but also solicits comments from "others with relevant experience or information."

CIRM is seeking information concerning the scope of services, models for relationships between "financial services providers/delegated underwriters" and CIRM, compensation structure and conflicts of interests.

CIRM is considering three possible models for the contractor:
"...a delegated underwriter model (delegated underwriter advances its own funds with CIRM guarantee), a hybrid model (delegated underwriter advances its own funds, but CIRM provides cash as collateral), and a fee for services model (CIRM originates loan and advances funds and pays financial services provider a fee for services)."
The stem cell agency states that its staff
"...does not have the internal expertise or capacity to manage all of the financial components of a loan program. CIRM therefore plans to externalize these tasks while maintaining ultimate control over the loan program. To ensure that CIRM obtains this expertise at the best value to California taxpayers, CIRM plans to issue a request for proposals to select two to three financial services providers/delegated underwriters. Because this is a start-up program, it is important to have at least two delegated underwriters at the outset. This would permit CIRM to learn from their different approaches and to refine our best practices. Furthermore, it would permit CIRM to transfer future transactions to another delegated underwriter if the relationship with one of the contractors is unsuccessful."
In February, CIRM plans to seek bids from potential contractors. The loan program is scheduled to begin this spring.

Wednesday, December 24, 2008

CIRM Begins Application Triage Experiment

The California stem cell agency is moving forward on its plan to perform closed-door, staff-connected triage on grant proposals before they move into the peer review process.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., reported on the action by CIRM directors on Tuesday. But he suggests an alternative that could serve CIRM's desire to reduce the number of applications on some grant rounds. Just open up the grant application process so that the public would know who is applying and hear the pros and cons on the applications.

Writing on his organization's blog, he said,
"It's our $3 billion that's being handed out. If you want our money, you ought to be willing to ask for it in public. Nothing builds more trust in a review process than having it completely transparent."
Simpson reported that Tuesday's special, teleconference board meeting failed to muster a quorum despite an attempt to set up multiple out-of-state locations for the convenience of traveling board members. Only 15 checked in. Nineteen are needed for a quorum. The full board has 29 members.

Failure to attain a quorum meant no action on the request by the International Society of Stem Cell Research for $400,000 to help finance its $1.5 million convention in San Francisco in 2010. It was the second time the board has failed to act on the request.

Here is a link to CIRM's four-page explanation of the triage proposal. The process will be applied in the $60 million basic biology round. The RFA should be posted before the end of this year with the "pre-applications" due towards the end of January.

Correction

The Dec. 22, 2008, item on the ISSCR grant request from the California stem cell agency incorrectly gave the figure as $420,000 as the result of erroneous information from CIRM. The correct figure is $400,000. The additional $20,000 appeared in the CIRM grant application from the ISSCR which we have been told automatically adds 5 percent "indirect costs" to the amount requested. However, the 5 percent does not apply in this case.

Tuesday, December 23, 2008

Correction

The "financial status" item on Dec. 22, 2008, incorrectly said that CIRM stated that its grant money will run out at the end of this coming June. As noted later in the item, CIRM said it can "cover grant commitments at least through July 2009."

Monday, December 22, 2008

Attention Scientists: CIRM Proposes Triage on Research Plans

The California stem cell agency is proposing a form of scientific triage on research proposals, weeding them out even before they get into the peer review process.

Up for consideration at tomorrow afternoon's CIRM board meeting, the pilot project could have major implications for stem cell researchers in California, allowing them to bypass screening committees at their institutions. The proposal also would create another layer in the closed-door CIRM grant approval process, vest major, new authority with the CIRM staff and push the CIRM board even further away from the de facto decisions on grant applications.

The plan has yet to be published by CIRM on its web site. However, Don Gibbons, CIRM's chief communications officer, made an electronic copy of the Power Point presentation available to the California Stem Cell Report. If you would like a copy, please email the California Stem Cell Report (djensen@californiastemcellreport.com) or CIRM (info@cirm.ca.gov).

The proposal would involve a "pre-application review" of proposals that would involve CIRM staff and two members of the grants review group. It is patterned after "comparable procedures from from the Gates Foundation/MJFF/NIH/Genome Canada."

Some members of the CIRM board of directors balked at the proposal earlier this month. CIRM staff is bringing it up again tomorrow with changes aimed at addressing directors' concerns.

One key reason behind the proposal is to help ease the workload of the scientists who come from out-of-state to review applications. Sometimes the number of applications have run into the hundreds, creating time-consuming situations where scientists are reluctant to devote their time.

It is also designed to ferret out applications that are nixed by institutions prior to coming to CIRM. Marie Csete, CIRM's chief scientific officer, said the agency has received complaints that the best science is not always getting to CIRM.

She told directors earlier this month that CIRM may "not be seeing the full range of science from young scientists."

The public can participate in the meeting from locations in San Francisco (3), Berkeley, Elk Grove, Healdsburg, Los Angeles (3), Koloa, Hi., Beverly Hills, Irvine (2), La Jolla (2), Stanford, Cornelius, NC, Sacramento, Philadelphia and Chicago. The out-of-state locations are presumably where some CIRM directors will be tomorrow afternoon but they are still legally public as far as CIRM meetings go. The specific addresses can be found on the meeting agenda.

Stem Cell Science Group Seeks $400,000 From CIRM

Consumer Watchdog calls it "unbelievable" and "a flagrant squandering of public money." The group says it serves no purpose other "than to inflate the already healthy egos of CIRM's globe-trotting executives "

The language comes from John M. Simpson, stem cell project director for the Santa Monica, Ca., group. Writing on the group's blog, he refers to a pitch by the prestigious International Society for Stem Cell Research for $400,000 from CIRM to pay for 28 percent of the cost of the society's 2010 convention in San Francisco.

Tomorrow afternoon, the grant request will be considered by the CIRM board of directors at a special teleconference meeting. Multiple locations are available throughout the state and even outside of the state where the public can comment.

The request first came before the board earlier this month with no written explanation or detailed justification of benefits to the state of California. Directors told CIRM staff to provide more details if funding was to be seriously considered.

CIRM has close ties to ISSCR. CIRM President Alan Trounson is on the board of directors of the society. CIRM Chairman Robert Klein was a member of an advisory committee to ISCCR in 2007, according to The Niche, Nature magazine's stem cell blog. Don Gibbons, CIRM's chief communications officer, is a member of the group's public education committee.

The request for the grant is signed by Irv Weissman of Stanford, whose medical school dean is on the CIRM board of directors. Weissman will be president of the group in 2009. Stanford has received $95 million in grants from CIRM. Weissman has received $2.6 million.

It is not uncommon for professional organizations to seek some sort of financial assistance from enterprises whose executives serve on the professional group's board of directors.

However, the timing on this pitch is unfortunate, to say the least, given the $40 billion California budget shortfall. Moreover, funding of the convention seems a tad lavish. For example, it includes $235,000 for marketing expenses, a figure that seems more appropriate for MacWorld than a gathering of stem cell researchers.

Even in brighter times, a $400,000 donation from the state would be dubious. Today it cannot be justified unless CIRM wants to chalk up some serious minus points with the folks in the state Capitol and with the public at large.

The public can participate in the meeting from locations in San Francisco (3), Berkeley, Elk Grove, Healdsburg, Los Angeles (3), Koloa, Hi., Beverly Hills, Irvine (2), La Jolla (2), Stanford, Cornelius, NC, Sacramento, Philadelphia and Chicago. The out-of-state locations are presumably where some CIRM directors will be tomorrow afternoon but they are still legally public as far as CIRM meetings go. The specific addresses can be found on the meeting agenda.

(Editor's note: An earlier version of this item incorrectly stated that the ISSCR grant request totalled $420,000. The erroneous information came from CIRM. The additional $20,000 appeared in the CIRM grant application from the ISSCR which we have been told automatically adds 5 percent "indirect costs" to the amount requested. However, the 5 percent does not apply in this case. )

CIRM Clarifies Its Financial Status: Grant Money Could Run Out by June

How long can CIRM continue to operate at full strength given the current state of California's fiscal crisis?

According to CIRM, the agency can cover its "grant commitments" through the end of next July and perhaps longer. After that, the agency will have only enough money to monitor existing grants and perform other "office operations" for another 12 months.

The response came from Don Gibbons, chief communications officer for CIRM. We asked him to clarify apparent discrepancies in CIRM's financial status that were posed in the item below.

The matter is of some import since the state of California has suspended the issuance of state bonds because of the budget stalemate in Sacramento. Bonds constitute virtually the only source of funding for CIRM.

However, we think it is highly unlikely that bond sales will be suspended for the next six months. The state's budget problems should not be minimized, but a solution is almost certain to be found before June. If not, CIRM funding will be among the least of the worries in California.

More to the point is the fact that CIRM enjoys a favored financial position while the rest of state government is struggling. That situation poses PR and policy problems for CIRM that we have discussed previously.

For the record, here is Gibbons' response to questions about CIRM's financial status. They involved the $168.9 million CIRM budget figure in a San Francisco Business Times article and a $160 million figure given to us by Robert Klein, chairman of the stem cell agency. They also involved Gibbons' statement in the Times article that said CIRM had enough to fund office operations until July 2010. Gibbons replied:
"Both are correct. We have enough to cover grant commitments at least through July 2009, but will still have enough in reserve to fund 'office operations' for another year so that we can continue to monitor existing grants, manage the standards review processes, etc."
Gibbons did not respond to our question concerning CIRM's reaction to the governor's request for a 10 percent payroll reduction and mandatory furloughs that amount to a 9 percent salary cut.

(Editor's note: In an earlier version of this item, the second paragraph incorrectly reported that CIRM said its grant money would run out at the end of next June. The next to the last paragraph has also been rewritten to clarify that there were two elements in the question placed to Gibbons.)

Layoffs Loom at California State Agencies, Not Likely at CIRM

More details about the financial condition of the California stem cell agency are emerging as sweeping layoffs and pay cuts have been ordered at other state agencies.

On Friday, Gov. Arnold Schwarzenegger said 238,000 state employees must take what amounts to a 9 percent pay cut via mandatory, unpaid furloughs. He also ordered payroll cuts that amount to 10 percent, beginning Feb. 1.

The governor asked state agencies that he cannot directly control, such as the University of California and CIRM, to take similar action.

Also on Friday, Ron Leuty of the San Francisco Business Times reported:
"The California Institute for Regenerative Medicine next month will weigh a contingency financing plan that could include bond anticipation notes and a private placement with major philanthropic backers.

"The move, which would have to be approved by the state stem cell bond committee and Treasurer Bill Lockyer, comes against the backdrop of a financial markets meltdown that has clipped access to capital for companies and government agencies alike."
Leuty continued:
"CIRM has $168.9 million on hand, said spokesman Don Gibbons, and has enough to fund office operations until July 2010."
That statement is somewhat at variance with figures provided by California stem cell Chairman Robert Klein. He told the California Stem Cell Report earlier this month at the meeting of the CIRM board of directors at UC Irvine that $160 million was available between now and the end of June.

We are querying CIRM concerning the discrepancy and the governor's payroll cuts.

However, CIRM has been chronically understaffed since its inception and actually needs to hire more employees to bring it up to its legal cap of 50, which is tiny compared to the magnitude of running a program that has now awarded more than $600 million in building and research grants. The agency has already indicated it wants to add the much-needed employees, and, in our view, is not likely to roll back staffing levels

Leuty also had an interesting financial tidbit concerning Klein, who says that he has spent personally $6.5 million on behalf of Prop. 71 and CIRM.

Leuty wrote:
"Klein, who operates a financial advisory firm in Palo Alto, said he spent $5.5 million shepherding Proposition 71 through approval and has swallowed $1 million in CIRM-related costs since then while working 40-hour-plus workweeks as chairman."

Thursday, December 18, 2008

CIRM Responds to Financial Disparity Questions

The California stem cell agency has responded to questions involving the cutbacks and issues raised in the "Handouts vs. Cutbacks" item below.

Don Gibbons
, chief communications officer for CIRM, said Klein is not personally affected by the cuts in funding for affordable housing.

We also asked:
"Does CIRM have anything to say about whether it is appropriate for it to continue handing out tens of millions of dollars or more while facilities for the deaf go unfunded and cutbacks are made in levee reinforcement to protect Sacramento from becoming another Katrina-like disaster, among the thousands of other affected projects?"
Gibbons complete response, which are carrying word-for-word, was:
"The projects being frozen are funded through Pooled Money Investment accounts and CIRM has less than $2 million in that fund.  CIRM bonds have delayed repayment schedules, so have no impact at all on this year’s budget."

Handouts vs. Cutbacks: Strange Financial Tales from the Golden State

Citing the state's severe financial problems, California officials Wednesday shut down $3.8 billion in cash for public works projects, including some closely connected to directors of the state's stem cell agency. The action came coincidentally just one week after the agency gave away $20 million in state funds to stem cell researchers.

The cuts in bond-financed programs struck at projects to aid both the deaf and ailing veterans as well as to assist in genomics research. Also hit were construction projects at medical facilities at UC Davis and UC San Diego, both of which have representatives on the CIRM board.

Funding for hundreds, perhaps thousands, of housing projects was halted, raising the possibility that the moves could personally affect CIRM Chairman Bob Klein, whose real estate investment banking firm specializes in affordable housing.

CIRM spending, however, is a mere piffle compared to the state's $40 billion budget shortfall. But their financial disparity highlights the stem cell agency's unusual nature and the public policy issues that arise when ballot initiatives lock up state funds and create a favored place for some state programs.

The stem cell agency enjoys a relatively rosy position compared to nearly all other state departments. As the result of Prop. 71, which altered the state constitution and state law, CIRM is assured of state bond funding that goes directly to the agency and which cannot be touched by the governor or the legislature. In response to questions from CIRM directors last week, Klein said that the agency had enough money to operate normally at least until the end of June next year. Compare that to predictions that California will not be able to pay its bills by the end of February.

CIRM currently is drawing its cash primarily from the proceeds of a $250 million bond offering that was completed in the fall of 2007.

However, the state is not currently issuing any additional bonds because of the state's budget crisis, which includes $60 billion in debt and the worst credit rating of any state in the nation, according to the Wall Street Journal. Without additional funding, CIRM could run out of money at some point. However, Klein last week told the California Stem Cell Report that CIRM has $160 million to tide it over through the end of June. He also said he is working on a private placement plan for CIRM funding, just in case. Klein said he has already identified some potential participants although he did not spell out details.

Gov. Arnold Schwarzenegger and California lawmakers are wrestling with the budget crisis but have a long history of financial fumbling. At the heart of their failures is a daunting requirement that the legislature must pass a budget or increase taxes only with a two-thirds vote. That gives a minority extraordinary power. In California's case, Republican legislators stand in the way as they have for decades, chanting a mantra of no-new-taxes regardless of the state's needs.

Putting together solutions that will right the foundering Golden State will require compromise and policy changes that ultimately may affect such privileged endeavors as the state stem cell agency. Good arguments exist for steady funding of any sort of scientific research, much less stem cells. But good arguments also exist for steady funding of the state's now troubled institutions of higher learning, once an example for the nation, as well as many other laudable state programs.

CIRM must step carefully in the next few months to avoid becoming a symbol of what is wrong with much of California state government and its finances.

(Note: We have asked CIRM for comment on the issues raised by the disparity between its financial condition and that of the state. We have also asked whether Klein is affected by the housing cuts. We will carry CIRM's response when we receive it. Additionally, the San Francisco Chronicle carried a report this morning that the cutbacks would affect the "state's stem cell research center in San Francisco." No further details were provided, and we could not find anything to support that in the list of projects from the treasurer's office that we reviewed.)

'Armageddon' and Klein's Salary

The new salary for the chairman of the California stem cell agency, Robert Klein, has caught the attention of Nature magazine, which headlined its article on the subject: "Salary for CIRM head despite deficit, Outcry as stem cell agency puts chairman on payroll."

Erika Check Hayden
wrote that CIRM directors approved the $150,000, halftime salary "even as the state plunges deeper into financial crisis." The term "financial Armageddon" also was quoted as coming from Gov. Arnold Schwarzenegger, who had expressed "deep concern" about the possibility of a salary prior to its approval last Wednesday by directors.

Nature magazine says it has 377,443 readers worldwide, mostly senior scientists and executives.

UCSF Snags $25 Million Stem Cell Donation

Despite the nation's financial woes, some philanthropists continue to pump out money with the latest coming from the Eli and Edythe Broad Foundation for the benefit of UC San Francisco's stem cell laboratory.

Broad, who made his fortune in home building and insurance, popped for $25 million on Wednesday. That brought his total for California stem cell research buildings to $75 million. He previously gave $20 million to UCLA and $30 million to USC.

Erin Allday of the San Francisco Chronicle wrote:
"The Broad Foundation donation, combined with a $35 million grant from the California Institute for Regenerative Medicine and a $16 million donation from Ray and Dagmar Dolby, means UCSF must raise another $47 million to complete funding for the new facility(see photo)."
Broad's contribution now brings him up to the level reached earlier this year by Lorry Lokey, founder of the Business Wire, who has funneled $75 million to Stanford for its stem cell work.

Gov. Arnold Schwarzenegger appeared for the UCSF announcement event along with CIRM Chairman Robert Klein. The donation garnered coverage throughout the state, including reports on television, which almost never covers the California stem cell agency. Google reported about 200 stories at different locations, including Taiwan and Australia. Most of those were the version from The Associated Press.

Richard Paddock of the Los Angeles Times wrote:
"Broad said that his foundation's investments have not suffered as much as other charitable foundations and that it would continue to meet its commitments.

"'I never thought I would say something like this, but we are blessed to be down less than 20%,' he said. 'So, we are going to keep on doing what we're doing and we'll look for better times.'"

Wednesday, December 17, 2008

Fresh Comment

David Serrano Sewell, a member of the board of directors of the California stem cell agency, has posted a comment on the item below, "Directors to Define Vice Chair Job...." One of his points is that the vice-chair election is not just about salary. I agree. It involves much more, including an as-yet-to-be-determined, clear expression from the full board about the scope of the job. We will have more on the subject of the vice chair's election in coming weeks.

How Would California Stem Cell Backers Do It Differently?

California's Little Hoover Commission, which is looking into governance and conflict of interest issues involving the $3 billion California stem cell agency, has raised some interesting questions that it wants answered in writing.

The questions are the subject of a meeting this Friday afternoon of a meeting of the Legislative Subcommittee of the CIRM board of directors.

In a Nov. 26 letter to CIRM Chairman Robert Klein, Stuart Drown, executive director of the bipartisan state agency, said:
"We’d like to follow up on the discussion about governance that came up during your testimony, in which you agreed to submit additional written remarks in response to Commissioner Loren Kaye’s questions:

"Would you write anything differently in the initiative, particularly in the governance area regarding the structure of the board, the composition, the ratio of independent or outside directors to the interested directors, the appointment processes, removal, conflicts? Is there anything you would, based on your practice now, do differently?

"Are there further changes, since the 2005 adjustments, that you would make now?

"Given the Institute’s very large board of busy people, do you think the ratio of the authority between you and the board as a whole is appropriate?

"The Commission would appreciate your response by December 15."
CIRM said Klein scheduled the meeting of the legislative committee in order to receive input from directors before responding to the Little Hoover request.

If you are interested in hearing the discussion or making comments, teleconference location sites can be found in San Francisco(two sites), Sacramento, Menlo Park, Healdsburg, Elk Grove and Palo Alto. The specific addresses can be found on the agenda. Locations may be changed or added so check the agenda for the latest information.

CIRM Directors To Define Vice Chair Job and Executive Evaluation Process


Directors of the $3 billion California stem cell agency expect to add some finishing details next week to employment arrangements with its chairman, Robert Klein, along with those of the vice chairman and the president.

On Monday, the directors' Governance Subcommittee, chaired by former Hollywood studio executive Sherry Lansing, will consider how they intend to evaluate the performance of Klein, CIRM President Alan Trounson and whomever fills the now-vacant vice chairmanship of the board of directors.

Last week, the board decided the position of chairman is a halftime job and agreed to pay Klein $150,000 a year. Klein, a multimillionaire real estate investment banker, said current economic conditions had compelled him to seek a salary. Klein had worked for free during the last four years.

At its meeting at UC Irvine last week, the CIRM board deftly sidestepped potentially negative fallout from from the pay matter. The issue had become somewhat charged after Gov. Arnold Schwarzenegger expressed "deep concern" concerning the salary reports.

Under CIRM's salary ranges, if Klein were to serve fulltime, he would be entitled to as much as half-a-million dollars-a-year, which could raise PR and policy issues at a time when California is facing an economic crisis.

In an interview Tuesday, Lansing said Klein is entitled to fringe benefits provided to all state employees but that he will not receive performance awards or merit pay under the compensation plan for CIRM employees.

Actions next week on the vice chairman's position could also help to determine who is likely to fill that slot. Next year, CIRM directors will choose a vice chairman between two candidates: Art Torres(left photo), currently head of the state Democratic Party, and Duane Roth(right photo), who currently serves on the CIRM board and is head of Connect, a San Diego businesses development organization with close ties to the life science industry.

Lansing said that the subcommittee will discuss duties of the vice chairman and what his responsibilities are likely to involve. One question that may come up is whether the board should approve a salary for the job. CIRM salary ranges provide for $180,000 to $332,000 for the position.

Roth says he will not seek compensation as vice chairman. Torres says he will need a salary.

Teleconference locations for the meeting where the public can sit in and comment are available throughout the state: San Francisco, Los Angeles, Stanford, Sacramento, La Jolla and Irvine. The specific addresses can be found on the agenda. They may change or increase before the Monday meeting so it is good to check in advance.

Monday, December 15, 2008

CIRM Panel to Consider Hoover Questions

California stem cell Chairman Robert Klein is seeking some help this Friday from members of the agency's board of directors in connection with the Little Hoover Commission's inquiry into the $3 billion research effort.

Members of the public will also have a chance to comment at several teleconference locations throughout California. The forum is a meeting of the directors' Legislative Subcommittee. The agenda item reads: "Consideration of request from Little Hoover Commission for additional information regarding CIRM governance, board appointment structure, and other policies."

We have been told that the Little Hoover Commission, a bipartisan state agency devoted to improving the performance of government, posed questions on which Klein is seeking board input.

The current teleconference locations are in San Francisco, Sacramento, Healdsburg, Irvine, Elk Grove and Palo Alto. More may be added before the day of the meeting or even on the day of the meeting. The current listing and specific addresses can be found on the agenda.

Business Snags $5.3 Million from CIRM

IRVINE, Ca. -- Six California companies snapped up $5.3 million last week in grants from the California stem cell agency, marking the first major industry funding from the $3 billion state research enterprise.

Up until the latest round of grants, only one company, Novocell Inc. of San Diego, had won a grant and that was for only $50,000.

However, the CIRM board did not approve business applications at the same rate as those from the nonprofit sector. Only one out of seven business proposals (41 in all) won approval last week compared to one out five nonprofit pitches(77 in all).

(The board put off action until next month on some grants so the figures could change when final action is taken.)

The six companies snagged about 26 percent of the nearly $20 million in grants for developing research tools and technology. The six also represented about 26 percent of the 23 grants that were approved.

CIRM President Alan Trounson said,
"These awards represent the entry of the biotechnology industry into CIRM-funded initiatives to accelerate progress."
Nonetheless, other companies appeared at the CIRM board meeting here to complain about the fairness of the review process, which they said was tilted towards academia. One company, DNAmicroarray Inc. of San Diego, suggested changes in definitions for "principal investigator" on grant applications that would reflect differences between business and the nonprofit sector.

Here are the companies and their awards:

VistaGen Therapeutics of South San Francisco, $971,558, PI Kristina Bonham; Fluidigm Corp. also of South San Francisco, $749, 520, PI Marc Unger; Gamma Medica-Ideas of Northridge, Ca., $949,748, PI Douglas Jay Wagenaar; Novocell Inc.of San Diego, $827,072, PI Evert Johan Kroon; Invitrogen of Carlsbad, $869,262, PI Ying Liu, and Vala Sciences of San Diego, $906,629, PI Patrick McDonough.

As of this morning, only one of the companies had generated a press releases about its CIRM grant, while at least some of the academic grant recipients were online as early as Wednesday with their good news. The release by Vala said, among other things, that its grant will be executed in close collaboration with laboratories at the Burnham Institute for Medical Research led by Vincent Chen and Mark Mercola.

Last week's meeting also marked the first time that CIRM directors allowed "extraordinary petitions" to challenge negative decisions on applications by the Grants Working Group. Three were received in time to be considered. Three others were also received but not by the deadline for consideration by CIRM staff and the board. The deadline falls five working days before the board meeting..

In each of the three cases, CIRM President Trounson said he could not find "compelling evidence" to change the score of the application or the decision of the working group. The full board can bring up petitions for public discussion but did not choose to do so.

Two petitions were filed by private businesses, International Stem Cell Corp. of Oceanside and DNAmicroarray Inc. of San Diego and one by the Salk Institute of La Jolla. Here are links to the petitions: International Stem Cell (filed by Jeffrey Janus, president, and William Adams, CFO), DNAmicroarray (filed by Babak Esmaeli-Azad, president) and Salk (filed by Juan Carlos Izpisua Belmonte, professor, Gene Expression Laboratory).

Adams also appeared before the CIRM board, citing "fundamental problems" involving the way business applications were treated. Some members of the board have expressed sympathy with the view that there is a tilt towards academia in the review process. CIRM is attempting to find more grant reviewers with a business background.

Reporter Terri Somers of the San Diego Union-Tribune wrote a story on the business grants. Bruce Bigelow of Xconomy.com also had a brief item, declaring that CIRM had "opened its spigot for funding business ventures."

Thursday, December 11, 2008

Klein's Salary: News Coverage is Modest

IRVINE, Ca. -- Approval of a $150,000, half-time salary for CIRM Chairman Robert Klein generated light news coverage both Wednesday and today.

The San Diego Union-Tribune actually had a reporter, Terri Somers, on the scene here in Irvine, where CIRM directors met the last two days. It was the only mainstream media outlet to cover the session, which included more far-reaching decisions than salary matters, such as an aggressive plan to spend $210 million to push development of clinical therapies.

Somers' story quoted Klein, Duane Roth, who has been nominated for the vice chairman's job, and John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., on the salary issue.

Simpson, who has looked at askance at high salaries at CIRM, said the most important matter was not the money for Klein but the fact that board defined the chairman's job as half-time. Prop. 71 gives the chairman a host of responsibilities, some of which conflict with the president's. Klein also has very much acted as an executive chairman, including micro-managing details at CIRM, according to some observers.

Other stories were written by Shane Goldmacher of The Sacramento Bee and Ron Leuty of the San Francisco Business Times. Here are links to Leuty's story and Goldmacher's account.

The continuing light news coverage of CIRM is a sign of the hard economic times at the mainstream media, particularly newspapers. It also reflects the declining novelty factor at CIRM. The organization was created four years ago by voters and now is approaching the news value level of nearly all state agencies. And that is virtually nil.

Traditionally state agencies, with rare exceptions, are all but ignored by the mainstream media. Given the difficult decisions news organizations currently must make concerning deployment of ever declining resources (reporters), coverage of CIRM is certain to shrivel in the future. The exception would be a scandal or a major scientific breakthrough.

CIRM Identifies Winners of Tools and Tech Grants

Here is a link to the CIRM news release concerning action by its board on Tuesday and Wednesday, including a list of the names of grant applicants approved in the $20 million tools and technology round.

Also included is information on the $210 million disease team round as well as the $60 million basic research round, which were approved by the board.

Wednesday, December 10, 2008

CIRM Issues Statements of Praise for Klein

The California stem cell agency has released statements praising California stem cell Chairman Robert Klein in the wake of today's decision by CIRM directors to pay him $150,000 for half-time work.

The following came from George Daley, former president of the International Society for Stem Cell Research and associate professor at Harvard Medical School.
"I am happy to say that Bob Klein has not only been the major driving force behind expanded funding for stem cell research within California, but he has been a tireless booster for stem cell research internationally. By the sheer energy and dedication to his cause, Bob is remaking California into the international center for stem cell research. In my recent visit to major laboratories at UCSF and UCSD, I saw first hand how the Prop 71 funding is changing science for the better. I have no doubt that in the future, when we look back on the prime drivers of the revolution in stem cells, we'll have to all acknowledge Bob Klein's profound contributions."
The following came from Richard Murphy, who served as a consultant and interim president for CIRM as well as a member of its board of directors:
"As a member of the ICOC and as Interim President of CIRM, I witnessed first hand Bob Klein's incredible commitment to the stem cell initiative in California. He brings together business expertise, an entrepreneurial spirit, and a fierce commitment to use stem technology to improving the health of people with incurable diseases. He has spent countless hours during the day, nights,and weekends bringing all the complex parts of this initiative together, and without him Proposition 71, CIRM, and California's world leadership of stem cell research would not exist. I feel privileged to know him and to have worked with him. Given his commitment to this cause, there is no question he will continue this work in the future, as CIRM encounters the inevitable challenges that will arise. California and the world are fortunate that Bob Klein has done what he has, and I am confident he will continue to work in the future towards the benefit of all of us."

CIRM Board Approves $150,000 Salary for Chairman Klein

The board of the California stem cell agency today approved a $150,000, half-time salary for its chairman, Robert Klein, who has served in that position for four years, working without pay.

Board members said that it was impossible to compensate Klein sufficiently for his contributions to the agency. They said the salary was based on what they believed was dictated by the nature of the position – not the individual.

The salary was approved on a unanimous voice vote by the board, which gave Klein a standing ovation prior to approving the salary.

The CIRM pay range provides for a salary as high as half-million dollars annually for the chairman. Gov. Arnold Schwarzenegger last week expressed "deep concern" about reports concerning the salary.

Klein, who owns a real estate investment banking firm, has said he can no longer afford to donate his time.

The only critical voice on the salary came from a member of the public, patient advocate Don Reed, who said it was not nearly enough.

CIRM board member Claire Pomeroy, dean of the UC Davis School of Medicine, said the decision on Klein's salary was not related to a vacancy in the vice chairmanship position. That position is entitled to a salary as high as $332,000.

Two candidates for the job have been nominated -- Duane Roth, who will not accept a salary, and Art Torres, who needs one. That position will not come up until next month at the earliest.

$20 Million Handed Out by CIRM and First Ever Successful Conflict Appeal

IRVINE, Ca. -- Directors of the California stem cell agency today approved $20 million for research grants to develop tools and technology for stem cell research, but not before overturning the decisions of reviewers on two grants.

The applications were removed from the list that reviewers said should be funded. They were moved to a category that will be considered next month. The action came as CIRM directors worried about the financial condition of the agency and of the state of California, which is facing a $28 billion budget shortfall.

CIRM Chairman Robert Klein assured the board that the agency had sufficient funds to operate at least through June. The agency derives its funding from state bonds. The cash that comes from those bonds cannot be touched by the governor or the legislature. However, the state has stopped selling bonds because of the nation's ongoing financial crisis.

The agency did not provide the names of the scientists and institutions whose grants were removed from the funding list, but their numbers are 1050 and 1062.

The board also approved a $1.7 million new cell line grant. It was the first-ever successful appeal of a negative decision by the CIRM Grants Working Group on conflict-of-interest grounds. As we reported earlier, the application was removed in June from consideration of the new cell lines applications.

CIRM President Alan Trounson told directors today that the applicant appealed the negative decision on the basis of a personal conflict of interest on the part of a reviewer. He said "circumstantial evidence" existed that the application "may not have been fairly reviewed."

He said that such allegations are hard to prove and that such conflicts "may not be recognized by both scientists."

Ed Penhoet, a member of the CIRM board, said that scientists often have strong disagreements and that should not be taken as necessarily involving malice.

CIRM has not yet released the names of either the recipients of the tools and technology grants nor that of the new cell line grant applicant

Correction

The "$1.7 Million Grant" item on Dec. 8 incorrectly identified the chairman of the CIRM Working Group as Dana Orkin. His correct name is Stuart Orkin.

California Governor Nominates Roth as CIRM Vice Chair

IRVINE, Ca. -- Gov. Arnold Schwarzenegger has nominated a San Diego biotech veteran as vice chairman of the $3 billion California stem cell agency, setting the stage for a contested election between him and the chairman of the state Democratic Party.

Terri Somers of the San Diego Union-Tribune late Tuesday reported the nomination of Duane Roth(see photo), who now sits on the board of directors of the agency. He says he would not accept a salary, which could run as high as $332,000 annually. Art Torres is the other candidate and has said he needs a salary, but we have been told he thinks a figure of $332,000 would be excessive.

Roth is the head of Connect, a group that assists start-up tech companies. Torres is a veteran politico and former state lawmaker.

Somers quoted Schwarzenegger as saying in a letter to the CIRM board:
"'As I'm sure you already know, Duane is a hard-working board member who has long been an advocate for stem cell research and active member of the life sciences community. He is thoroughly familiar with (the California Institute for Regenerative Medicine) and his elevation to the vice-chair position would promise a seamless transition."
Somers wrote:
"The governor first nominated board member Claire Pomeroy, vice chancellor for human health sciences at UC Davis and dean of its medical school, for the vice chairman post. But Pomeroy asked that her nomination be withdrawn, citing time constraints and a desire to avoid potential conflicts of interest because UC Davis programs are eligible for institute funding."
The vice chairmanship is currently vacant after Ed Penhoet, a multimillionaire businessman, resigned to take a non-paying position on the CIRM board. Penhoet has never taken a salary for his CIRM work. Nor has CIRM Chairman Robert Klein, also a multimillionaire businessman.

However, CIRM directors are scheduled today to act on a salary request by Klein, who says he can no longer afford to work for free. It could place Klein in an awkward position to accept a salary while the vice chairman goes unpaid.

The CIRM board is not expected to make a decision on the vice chairmanship today.

Tuesday, December 09, 2008

Torres Says He Needs Salary From CIRM

IRVINE, Ca. -- Art Torres, chairman of the California state Democratic Party, says he will need a salary if he is to serve as vice chairman of the $3 billion California stem cell agency.

In an item by Shane Goldmacher for Capitol Alert, the online service of The Sacramento Bee, Torres was quoted as saying:
"'I do need a salary because I am not a wealthy person,' he said, adding that 'what that compensation should be is up to the board.'"
The vice chair is eligible for as much as $332,000 annually.

Goldmacher also reported:
"He (Torres) touted his connections - he was first elected to the Assembly in 1974 - as beneficial for promoting the mission of the stem-cell agency.

"'That's over 34 years of relationships and experience that is important to communicate the needs of this mission,' he said.

"Torres is also building upon those connections to win the vice-chairmanship. (Lt. Gov. John) Garamendi's nomination letter states that Assembly Speaker Karen Bass, Senate President Pro Tem Darrell Steinberg, and Speaker of the House Nancy Pelosi have all endorsed Torres for the post.

"Torres appears to have some support on the board, as well.

"'I'm keeping an open mind, but (Torres) is well-qualified for this position,' said David Serrano Sewell, who fills the patient advocate slot for multiple sclerosis on the stem-cell panel. 'He has the legislative, business and volunteer experience. Just as important he has the relationships with legislators in Sacramento and Washington D.C., built over 20 years, that will greatly benefit our mission.'"

$1.3 Million Price Tag on CIRM Chair and Vice Chair Compensation

IRVINE, Ca. -- An executive salary deal involving CIRM Chairman Robert Klein and a paid vice chairman, quite likely the man now heading the state Democratic Party, could cost the California stem cell agency something on the order of $1.3 million a year.

That includes $840,750 in salary and 50 percent of that figure to cover fringe benefits for both men. The $1.3 million total also assumes that both Klein and the vice chairman receive the top end of the salary range for those positions: $508,750 for Klein and $332,000 for the vice chairman.

Art Torres, head of the state Democratic Party, veteran politico and former state lawmaker from the Los Angeles area, has been nominated by state Treasurer Bill Lockyer to fill the vice chairman slot. Torres apparently has the support of two other state constitutional officers, who are the individuals who nominate vice chair candidates. Gov. Arnold Schwarzenegger, who has expressed "deep concern" about the executive salary proposals, has not yet announced his nominee.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said he has heard that Torres will expect a salary. Torres' term as chairman of the Democratic Party expires in April. According to what Simpson has been told, Torres would work for free until that date.

We have queried Torres concerning the matter and will carry his comments when we receive them.

The CIRM board votes on a vice chairman from among the nominees put forward by the state constitutional officers. A contested election, involving a candidate who would not accept a salary vs. one who would, could put Klein in an awkward position. His salary is likely to be approved by CIRM directors meeting here this afternoon and Wednesday, and it would be unseemly to have the multimillionaire chairman taking pay while the vice chairman does not.

The actual vote on the vice chairmanship is not expected any sooner than late January or possibly later.

Based on the last figures we saw for the CIRM budget, it does not appear to include funds for compensation for the chairman and vice chairman.

State Democratic Party Chief Nominated as CIRM Vice Chair

The head of California's Demoratic party, Art Torres, has been nominated as a candidate for the vice chairmanship of the state's $3 billion stem cell agency.

State Treasurer Bill Lockyer, also a Democrat and Torres colleague, offered the former state legislator to fill the post, which carries a salary range of $180,000 to $332,000. If elected by the board, Torres would take the position vacated by Ed Penhoet, who resigned to assume a non-paying membership on the board. Penhoet did not accept a salary.

It was not clear whether Torres(see photo) would accept a salary or continue in his position as chairman of the California Democratic Party should he be elected to the CIRM post.

Terri Somers of the San Diego Union-Tribune reported on the nomination this morning. She wrote:
"The institute's board will select a new vice chairman from a group of candidates nominated by the state's constitutional officers. Torres said yesterday that he also expect to be nominated by Lt. Gov. John Garamendi and Controller John Chiang."
In a letter Friday to CIRM Chairman Robert Klein, Lockyer said,
"Art has always been a champion for funding basic scientific research, including early funding for AIDS research. After leaving public office, he continued his patient advocacy serving on the boards of the AIDS Healthcare Foundation and OneLegacy organ transplant foundation. As chair of the California Democratic Party, he led it in endorsing Prop. 71 and ensured the measure was prominently highlighted in campaign material to over a million California voters."
Torres had a 20-year career as state senator and assemblyman, representing an area in Los Angeles. His leadership positions in the Legislature included chairmanship of the Assembly Health Committee.

Monday, December 08, 2008

Once rejected $1.7 million grant is resurrected

In "a highly unusual" situation, directors of the California stem cell agency this week are likely to approve a $1.7 million grant application that was pulled off a previous round after scientific reviewers turned it down.

In June, CIRM President Alan Trounson removed the application from the list of those being considered for new cell line grants. During a brief exchange at the June meeting of CIRM directors, Chairman Robert Klein said that "there was a problem with it, that it technically has to be re-reviewed." Trounson said he directed that the application be reexamined after he discussed it with the chairman of the review group, Stuart Orkin of the Dana Farber Institute.

There was no further comment in June by CIRM directors on the proposal, numbered 642-1 and labeled "derivation of new ICM-stage hESCs."

In the initial consideration of the application, reviewers raised several scientific questions and concerns about the proposal, according to the summary posted on the CIRM web site. No scientific score for the application was disclosed by CIRM, which considers scores for rejected proposals not suitable for public release.

One member of the Grants Working Group, Chad Cowan of Harvard, was barred from participating in review or discussion of the applicant because of a conflict of interest. CIRM did not specify the nature of the conflict.

The latest summary of the review of the application says that its "technologies and methodologies are not novel and not particularly innovative." But the review also said other aspects of the proposal are "laudable" and that it has "significant potential."

The application was given a scientific score of 80 out of a possible 100. No reviewers were excluded from participation in the most recent review of the application. Cowan is currently listed as an alternate member of the Grants Working Group. It is not known whether he participated in the latest review of 642-1.

The identity of the applicant and his affiliated institution is being withheld by CIRM. The agency makes a practice of withholding the names of successful applicants until the full board acts, although exceptions to the policy have come up. Names of rejected applicants are never released.

Last July, we asked Don Gibbons, CIRM's chief communications officer , for more information on the re-review, which may be the first such public case.

Our questions included:
"Is the grant being re-examined in connection with provisions in the grant administration policy that state that appeal grounds are 'strictly limited to circumstances in which a demonstrable financial or scientific conflict of interest' played a role?

"If not, what sort of additional information justified redoing the review?

"Did the information come to CIRM first? Who generally provided the information: the applicant or ??? Was it forwarded with or without a recommendation to the chairman of the Grants Working Group? What action did he take?"
Gibbons replied at the time that it was the "president's decision." Gibbons said,
"This grant was a highly unusual circumstance; something that has not happened before and something we don’t expect to happen much, if ever, in the future. We are not treating it as an appeal through the GAP. New information came to us, and the president, in consultation with the chair of the working group, decided that it merited sending the grant back to the working group for further review."
Following approval of the grant Tuesday or Wednesday, CIRM is expected to release the name of the researcher and the institution.

(Correction: An earlier version of this item identified the chairman of the Working Group as Dana Orkin. His correct first name is Stuart.)

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