CIRM Legislation Easily Clears the California Senate

The California State Senate today overwhelmingly passed legislation aimed at ensuring a return to the state on its $6 billion stem cell research investment as well as providing affordable access to therapies that may be developed.

The bill, SB771, cleared the Senate on a 38-0 vote. It now goes to the Assembly, where it also requires a three-fifth vote for approval, not to mention passage through at least two committees.

The measure is authored by Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee, and Sen. George Runner of Antelope Valley, chair of the Senate Republican Caucus.

The size of the vote in favor of the bill seems to indicate that the opposition to the bill by the California stem cell institute and the state's biotech industry has not been effective so far. But the vote also could reflect the strength of its authors in the Senate, where their colleagues might be reluctant to offend. The Assembly could be a different matter.

We have not yet seen any news stories on the Senate vote. Those may not be available until Thursday.

(Regarding the $6 billion figure in the first paragraph, that represents the total investment by the state: $3 billion for research and $3 billion in interests for state bonds.)

CIRM Lab Grants: News Coverage Around California and China

Here are links to additional news stories on the $50 million in lab grants approved Tuesday by the California stem cell agency.

Lisa Krieger, San Jose Mercury News, story also appeared in Woodland Daily Demorat, Contra Costa Times and San Mateo County Times, excerpt:

"'We're hoping our facility will be a dynamic place for people to learn and share ideas about embryonic stem-cell research,' said Renee Reijo Pera, professor of obstetrics and gynecology and director of human stem-cell research at Stanford. UCSF's Arnold Kriegstein, director of the university's stem-cell program, said: 'It's terrific. We'll be able to double the size of our research facilities.'"

Xinhua news service, People's Daily, China, excerpt:

"'Once again, our state is leading the nation in stem cell research,' (Gov. Arnold) Schwarzenegger said. 'With the grants announced today, California has issued more than 200 million dollars in grants to pursue potential therapies and cures for debilitating diseases."

Gary Robbins, Orange County Register, excerpt:

"UC Irvine has collected an additional $3.9 million for the study of human embryonic stem cells, raising its backing from the state to about $17.5 million and making the campus among the most heavily funded in the world in this nascent area of biomedical research."

David Raclin, Riverside Press Enterprise, excerpt:

"The grant is UCR's third of the year from the California Institute for Regenerative Medicine. Two UCR professors were awarded a combined $1.1 million in February."

Richard Halstead, Marin Independent Journal, excerpt:

"(Jim) Kovach (president of the Buck Institute) said it is too early to say if the Buck Institute is likely to aggressively pursue additional grants from the California Institute. Kovach said the Buck Institute might need to dedicate an entire building - 60,000 square feet or more - to succeed in that endeavor."

San Francisco Business Times, excerpt:

"The new shared research laboratory (at the Buck Insititute)will consist of 36 lab benches and spaces for equipment and procedures commonly used in stem cell research. The training facility will include a multi-purpose room and office space for weeklong training courses that will take place four times each year.

Shanna McCord, Santa Cruz Sentinel, excerpt:

"With the grant money, UCSC plans to build a central facility on campus dedicated to human embryonic stem cell research, train scientists and provide new opportunities for faculty, said Ann Pace, assistant director for UCSC's Center for Biomolecular Science and Engineering. Renovation of the Sinsheimer Building on Science Hill is part of the plan, including the development of laboratory suites and training rooms, Pace said."

Jeanmarie Todd, Bloomberg, excerpt:

"The grants are 'a prelude to the $222 million in major facility grants'' the institute will consider 'early next year,' according to an e-mailed statement today(6-5-07)."

The Los Angeles Times, The Sacramento Bee and Davis Enterprise do not seem to have carried stories today. Links to the San Francisco Chronicle and San Diego Union-Tribune were carried Tuesday(see below).

Correction

The "Gives Away $50 Million" item on June 5, 2007, incorrectly stated that of the institutions represented on the Oversight Committee, only one did not receive a lab grant. Actually, there were two, Cedars-Sinai in addition to the City of Hope. Our thanks to the person who called this to our attention.

Lab Grant News Coverage

Here are links to two stories today on the CIRM lab grants(see the item below): Terri Somers, San Diego Union-Tribune, and Carl Hall, San Francisco Chronicle. Hall was not present at the Los Angeles meeting.

Stanford Fires First

Stanford publicist Amy Adams was the first out this afternoon among recipient institutions with a press release on the $4.1 million grant to her Palo Alto institution. You can find her item here.

CIRM Gives Away $50 Million for Stem Cell Labs

"We have to be as generous as we can," said Duane Roth, a member of the Oversight Committee that controls the $3 billion California state stem cell research effort.

The comment from the CEO of Alliance Pharmaceutical Corp. came shortly before the board approved its first-ever laboratory grants – some $50 million to 17 institutions. Twenty-two applied.

Roth echoed comments from others on the 29-member committee. Claire Pomeroy, dean of the UC Davis Medical School, said, "We're building an array of services across the state."

A handful of the committee members raised questions about whether the panel should be more or less generous than reviewers who made recommendations to the full committee. David Baltimore, former president of Caltech, said, "When a vote has been taken, it sets a very high bar to change that recommendation."

He said the Oversight group should exercise lest it undercut the grant review process.

CIRM's press release said:

"These facilities are scheduled to be complete and available to researchers within six months to two years of the grant awards.

"The grants will fund dedicated laboratory space for the culture of human embryonic stem cells (hESCs), particularly those that fall outside federal guidelines. (Current federal policy prohibits research involving hESCs isolated after August 2001 from being conducted in laboratories constructed with any federal funding.) CIRM’s grants will support the development of core laboratories to be used by multiple investigators that may be shared by multiple institutions, and provide an environment for scientific research on hESCs under CIRM’s medical and ethical standards."

It continued:

"The grants will provide funds for the design and renovation of laboratory space, equipment for the new research facilities, and operating expenses for three years. Six of the recipient institutions will receive additional funds to provide training courses for scientists and technical staff in the growth and maintenance of hESCs."

The release quoted stem cell Chairman Robert Klein as saying,

"'Today we passed the $200 million mark in funding for embryonic stem cell research. The grants approved today are a prelude to the $222 million in major facility grants we’ll consider early next year. It’s critically important that California provide a ‘safe harbor’ where scientists can work on new stem cell lines without endangering their institutions’ federal funding. It’s equally important that we help finance new facilities to house the growth of this emerging life sciences field. These grants establish a great collaborative model that leverages the intellectual capital of California’s leading scientific institutions for the benefit of all Californians.'"

Here are the recipient institutions: Salk Institute, $2.3 million; Buck Insitute, $4.1 milion including a stem cell techniques funding course; Scripps, $1.7 million; UC Davis, $2.8 million; UCLA, $2.9 million; UC Santa Cruz, $2.7 million; Children's Hospital Los Angeles, $2.8 million; UC Riverside, $2.9 million; Burnham Insitute, $3.8 million including course funding; Gladstone Institutes, $1.7 million; Stanford, $4.1 million including course funding; UC Berkeley, $2.1 million; UC Santa Barbara, $2.3 million; UC San Diego, $2.8 million; UC San Francisco, $3.9 million including course funding and USC $3.6 million including course funding.
 
UC campuses in Davis, Riverside, Santa Barbara and Santa Cruz as well as Scripps moved into funding positions after receiving "mixed" recommendations from the two initial review groups.

Fourteen representatives from the institutions applying for the grants sit on the Oversight Committee. All but one of those institutions, the City of Hope, received funding. Oversight Committee members are barred by law from voting on or participating in discussions involving grants to their institutions.

Only one mainstream media reporter was present for the today's session, Terri Somers, of the San Diego Union-Tribune.

Correction

The "CIRM Tonight" item below omitted UCLA as one of the institutions that was recommended for funding by both groups. Thanks to the gent from UCLA who pointed this out.

Gaucho Scientists Likely to Win Stem Cell Grant

UC Santa Barbara appears to be on its way to winning a $1.8 million stem cell lab grant from the California stem cell institute.

That was the biggest development out of Monday night's meeting of CIRM's Oversight Committee, which met at the Luxe Hotel on Sunset Boulevard in Los Angeles.

The committee did not have a quorum, so it could not take official action. But the group approved a recommendation to move the UCSB grant to the top tier of grants expected to be approved.

The application had received low marks from the facilities working group but was ranked high for its research plans. The low marks were mainly related to construction costs in Santa Barbara, which is one of the more expensive areas in which to build in California.

No Gauchos, as UCSB denizens are known, appeared before the committee. Nor did representatives of any of the other lower ranking proposals make a last minute pitch to save their plans for stem cell labs.

Perhaps they will appear Tuesday morning, but we suspect they are not fully aware that they can appear before the Oversight Committee to explain why their proposals are worthy of funding.

CIRM Tonight: Juggling $48 Million in Lab Grants

The California stem cell institute meets this evening to hand out as much as $48.5 million for laboratories for embryonic stem cell research.

A news conference is scheduled for noon on Tuesday to announce CIRM's actions, but it is likely to be mostly settled by 9 p.m. PDT or so tonight. We will carry a report following the end of the meeting.

The ultimate decision on the grants is made by the Oversight Committee of the institute, which is the group meeting this evening. But it has been loathe to make significant changes in grant recommendations by its working groups.

The 22 applications were reviewed by two CIRM working groups –- one that focused on facilities and one that was more oriented towards the research.

Recommended for funding by both the facilities and grants working groups are grants to the Salk Institute, Buck Institute, Burnham Institute, Gladstone Institute, Stanford, UC Berkeley, UC Irvine, UC San Diego, UC San Francisco and USC.

No funding was recommended on applications from UC Riverside and the Palo Alto Institute of Medicine by both the facilities and grants groups.

The facilities group recommended no funding for UC Santa Barbara, but the grants group gave it a favorable recommendation.

Negative recommendations were made by the grants group on applications from Scripps, Cedars-Sinai, UC Davis, UC Santa Cruz, Beckman Research Institute (City of Hope), Blood Systems Research Institute (San Francisco) and California Pacific Medical Center Research Insitute (San Francisco). But facilities group gave these insitutions a favorable recommendation.

Copies of the applications, rankings and much, much more can be found here.

CIRM's Research Standards -- A Look at Their Principles and Reasoning

If you looking for a good overview of the rationale and background for the research standards enacted by the California stem cell agency, check out an article on PLoS Medicine by three men deeply involved in the subject.

The piece is called "Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine's Medical and Ethical Standards." It was written by Geoffrey P. Lomax, Zach W. Hall and Bernard Lo.

Hall is the former president of CIRM. Lomax deals with the institute's research standards development. Lo is with UC San Francisco, where he deals with medical ethics. He also serves as co-chair of CIRM's standards working group.

The ESC regulations developed by CIRM broke new ground in some areas and were the most refined in the nation at the time they were promulgated.

The article notes:

"Because other states and jurisdictions may also be developing standards for hESC research, consideration of the principles that guided the CIRM efforts and the innovative measures that it enacted may be useful to others."

One of the excellent attributes of the piece is that it is not hidden behind a private Web site that costs hundreds of dollars to access. It can be found gratis at the www.plosmedicine.org.

Fresh Comments

Lawrence Ebert has posted a comment on the $220 million item. Don Reed has posted a comment on Canadian-California item. Thanks, Don, it is nice to be back in the Old Country.

The $220 Million Lab Giveaway and Its Rules

Scientific laundromats, silos and collaboration benches.-- all were part of the discussion Thursday as the California stem cell institute began developing its criteria for giving away $220 million to build major research facilities.

The meeting was unusually well attended, with the audience easily exceeding the size of those usually at CIRM's Oversight Committee meetings. The actual numbers, however, were less impressive – something slightly over 30.

They were there because they represented universities and others hoping to win multimillion dollar grants to build new science complexes. USC(at least six representatives)UC San Francisco (at least two), Stanford(at least two), Children's Hospital of Oakland(one), UC Berkeley(two), UC Davis (one), UC Irvine (one) all were on hand.

The CIRM Facilities Working Group, which makes recommendations on lab grants, heard some interesting suggestions during the presentations and questions following.

Robert Klein, chairman of CIRM, several times said he expected some applicants to match the grant amount 100 percent, well exceeding a possible nominal match requirement of only about 20 percent. Also surfacing during the discussion was the suggestion that applicants who could line up major contributions – in kind or cash -- from industry might also be more favorably regarded. Other possible industry linkages could be important as well.

Some of the additional questions surfacing directly or indirectly: Is there going to be an effort to spread the grants around the state? How can smaller institutions compete successfully? Will there be more than one round of grant applications?

Irv Weissman, Stanford's eminent stem cell researcher, told the group, "You will be beset by all sorts of political and geographic forces."

"People will try to fool you," he said.

Weissman and others urged an emphasis on excellence. He said the track record of the institutions and their scientists is the best way to assure that.

Jeff Bluestone, director of the UC San Francisco Diabetes Center, also emphasized excellence. He and Weissman additionally spoke of the need to prevent scientists from becoming isolated in "silos" in the proposed labs.

"Successful buildings are ones that have people bumping into each other," Bluestone said.

At one point, CIRM Oversight Committee member Janet Wright used the expression "scientific laundromats" to describe space that can allow for informal research exchanges.

Weissman offered up collaboration benches as one way of bringing in researchers from locations that do not have facilities that match those of major institutions.

Jeff Sheehy, a CIRM Oversight Committee member, said he was interested in providing for opportunities for many institutions.

"Everybody should get a fair shot at attempting to do stem cell research in California," he said.

Thursday's hearing in San Francisco was the first of four. The next will be Monday in Los Angeles, the third June 11 in Sacramento and the fourth in San Diego June 19. You can find more information here and here.

Grant applications are expected to be solicited this August with grants awarded early next year.

Needless to say, it would behoove any institution that expects to seek building grants to attend and participate in these meetings. They offer an opportunity to shape the criteria but also can provide insight into the thinking of some of the players who will be making decisions on who receives the money.

CIRM Legislation Now on Senate Floor

Legislation to ensure a fair return to California from products developed as the result of state-funded stem cell research has moved to the floor of the state Senate, where it faces a major challenge for passage.

The bill, which is also aimed at ensuring affordable access to state-funded stem cell cures, must gain a super, super-majority vote to win approval in the Senate. The requirement for a 70 percent vote was written into the state Constitution in Prop. 71 by stem cell proponents who wanted to make it difficult for elected officials to fiddle with the $3 billion research effort.


The bill, SB771, cleared the Senate Appropriations Committee on Thursday after the Democratic Senate leadership approved its removal from a "suspense" file.

It is not known when the measure by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will come up for a vote in the Senate.

The Canadian-California Stem Cell Treaty

California Gov. Arnold Schwarzenegger did not exactly blow the dome off the Capitol -- newswise -- with his stem cell announcement in Canada yesterday.

Coverage was minimal. Perhaps the most details can be found on the governor's web site. California stem cell Chairman Robert Klein, who traveled to Canada as part of the governor's party, is also featured there with a video blog on stem cell matters.

Some excerpts from the governor's statement:

"(Ontario Premier)Premier McGuinty announced the formation of a new Cancer Stem Cell Consortium that will bring together the best minds and resources in California and Canada to fight cancer through stem cell research.

"This project was initiated by the stem cell and regenerative medicine working group of the Canada-California Strategic Innovation Partnership, a unique collaboration between California and Canada stakeholders from academia, the private sector and government."

"The Ontario Institute of Cancer Research will donate the first $30 million (Canadian) to fund the Consortium, benefiting both Canadian and Californian researchers."

"UC Berkeley's Stem Cell Center and Canada's International Regulome Consortium will coordinate research and take advantage of each institution's expertise."

The CIRM Budget and Burger King

The California stem cell agency plans to nearly double its staff during the next 12 months or so.

That means it will grow from tiny to not-so-tiny. In other words, from 24 workers to 41.

The additions are much needed. Beleaguered might be too strong a term to apply to the staff, but it probably was appropriate on some days during the last two years.

The additions are part of the budget approved earlier this week by CIRM's Governance Committee. The spending plan totals about $8 million for administrative functions, up from about $7.3 million for the current fiscal year, which ends June 30. The full Oversight Committee is expected to approve the proposal next week in Los Angeles.

CIRM is already seeking applications for the following positions: president, associate legal counsel, grants management officer, grants management specialist, grants technical assistant and scientific program and scientific review officers.

The agency will also see a substantial decrease in costs related to the now finally finished litigation, but CIRM will add $200,000 for legal work related to intellectual property issues.

Lest you fear that CIRM is on a path of rampant bureaucratic growth, Prop. 71 capped the number of employees at 50 to administer the $3 billion research effort. We would have to check, but it is probably fewer than it takes to run a Burger King.

CIRM Legislation: A Cash Cow or Bum Steer?

Legislation to ensure that California garners a decent return on its $6 billion investment in embryonic stem cell research has hit a roadblock and faces a critical hearing on Thursday.

The measure is SB771 by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley. Kuehl is chair of the Senate Health Committee and Runner is the No. 2 GOP leader in the Senate.

The bill has been shunted into a "suspense" file, along with many others, because the chair of the Senate Appropriations Committee, Tom Torlakson, D-Concord, is uncertain whether the measure would generate more revenue than would the regulations of the California stem cell agency itself.

If the measure is not removed from the suspense file, it will be placed on hold for this year and is not likely to be brought up again until January.

Discussions have been underway between Kuehl, Torlakson, Senate President Pro Tem Don Perata, D-Oakland , and Senate Majority Leader Gloria Romero, D- Los Angeles, about the fate of the bill. Kuehl and Runner are contending that it is impossible to make revenue comparisons between the bill and CIRM regulations because the regulations are not in final form. They also argue that arguments by the biotech industry concerning the adverse impact of the bill are highly speculative. Industry is also not fond of CIRM's rules.

Although the Kuehl bill is up for a nominal public vote, without a nod from the Senate leadership, the bill is not likely to be removed from the suspense file.

The staff of the Appropriations Committee has prepared an interesting analysis of SB771 that indicates that the measure would generate $56 million more for the state over a given period than would CIRM's regulations. Here are some excerpts:

"Based on a direct comparison of state revenues generated under SB 771 and under the CIRM regulations, SB 771 would produce more revenue than the CIRM regulations. In a ten year projection of a sample project modeled under three scenarios (a licensed invention, a low success royalty, and a high success royalty) with an $8 billion public investment, SB 771 would have produced $183.5 million compared to $127.7 million under the CIRM proposed regulations.

"The California Institute for Regenerative Medicine believes that the sample comparison above is misleading, that financial market forces, the interests of private research companies, and the unique nature of cellular therapies will produce disincentives which will substantially reduce the projected returns of 771."

The analysis said it reviewed economic studies of potential Prop. 71 returns although it did not cite them by name. It said the studies projected royalties to the state of between $160 million and $1.1 billion.

Earlier this month, an item appeared on the Internet that bears on the biotech industry position that anything that promises to inhibit returns on stem cell products (such as SB771) will discourage research. In an item called "What Price Innovation?," Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, wrote about industry arguments that Democratic national health care reform plans would choke medical research. Goozner said:

"Is there any evidence to suggest that the pace of significant medical breakthroughs can be associated with higher drug industry sales, profits, profit margins or, perhaps most significantly, R&D expenditures? Or, put another way, given the past decade's very high rates of sales growth, profit growth and R&D expenditure growth, how does one explain the steady downward decline (trend line; there is, of course, year-to-year variation) in the number of significant new drugs emerging from industry labs?"

Where's the Money?

Even today headlines talk about the stem cell "gold rush" in California. And it is years after the Prop. 71 campaign financed a study that seemed to promise as much as $1 billion to the state from state-backed stem cell research.

While the headlines may reflect a paucity of imagination on the part of headline writers, the dreams of buckets and buckets of stem cell cash still energize much of the dialogue concerning ESC research.

Jesse Reynolds, writing on the blog Biopolitical Times, recently revisited the subject of stem cell swag. The occasion for commentary was an article in Nature Biotechnology.

Reynolds, who works for the Center for Genetics and Society in Oakland, said what is remarkable about the piece is what's missing. He wrote:

"There’s no reference to the over-the-top -- yet widely-cited -- optimistic scenarios spun in an economic analysis that was widely touted, and funded, by the campaign to establish the (California) state program."

Reynolds noted that Stanford University professor of health research and policy Laurence Baker was a co-author of both the Prop. 71 campaign study and the Nature Biotechnology article, a fact that Reynolds said was not acknowledged in the magazine.

Reynolds said Baker furiously backpedaled from his campaign study. Reynolds quoted the Nature Biotechnology article as saying:

"[A]t this point predicting particular breakthroughs or economic benefits would amount to little more than speculation.... New stem cell therapies will not necessarily reduce [health care] spending; indeed they may drive spending up...Forecasting and even retrospectively assessing the success of Proposition 71's IP provisions will be extremely difficult."

The economic promises of stem cell research are as of much interest today as they were three years ago. Lawmakers are currently struggling to ensure that the state does, in fact, share in any profits. The biotech industry and CIRM are opposed to that legislation (SB771), authored by State Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee.

CIRM itself is in the midst of drawing up rules for revenue sharing involving future grants to California businesses. And elsewhere in the country, other states are launching stem cell research efforts, peddling the idea that it can funnel vast economic benefits into the state.

$30 Million California-Canadian Stem Cell Effort

California Gov. Arnold Schwarzenegger is off on a Canadian junket – privately funded – to promote stem cell research and wine, among other things.

According to some reports, he is scheduled to announce, along with Canadian counterparts, a $30 million stem cell research effort involving the Ontario Institute for Cancer Research and a cancer stem cell consortium in Ontario and California.

According to Robert Benzie of the Toronto Star:

"Schwarzenegger will disclose a new project between the University of California at Berkeley and the International Regulome Consortium, led by Michael Rudnicki, scientific director of Canada's Stem Cell Network and director of Ottawa's Sprott Centre for Stem Cell Research."

Beyond that, little was known about the project, although it appears to be an effort worked out between the researchers with the politicians weighing in at announcement time. Schwarzenegger's own Web site did not mention it on its home page this morning, which emphasized the wine aspects of the trip.

The governor's Canadian foray attracted some controversy because it was privately funded with none of the donors disclosed.

Kevin Yamamura wrote in The Sacramento Bee about the private nature of the trip, although he did include a list of some of the top corporate executives accompanying the governor.

Yamamura quoted Bob Stern, president of the Institute for Governmental Studies in Los Angeles, as saying,

"Why can't the state pay for it? It just looks wrong. Basically, you're having special interests pay for the trip. If taxpayers were paying, we'd know it's all California-taxpayer related."

We're Back!

The California Stem Cell Report will begin postings anew later today. We have spent much time in the Sea of Cortez and later on land in Mexico, preparing our salty home (a sailboat) for a bit of a rest during the next few months. It may not be much of a rest for us, however. Our major assignment will be to help care for some grandchildren for a bit. The sweet little things aside, you all can look forward to more exciting California stem cell tales beginning shortly.

Hoisting Anchor

The California Stem Cell Report will be on a hiatus beginning Saturday morning. As many of you know, this effort is produced primarily from a sailboat on the west coast of Mexico. We are putting out to sea and will not have access to the Internet – only clear water, hopefully reasonably calm seas and pleasant temperatures – for the next few weeks. Look for resumption of operations sometime after the middle of May. The break also means that comments submitted to the blog, which are moderated, will not be posted while we are wandering about the briny deep.