Leveraging the Media, Money and Change

One could call it the rhetoric of money and momentum. "Bidding wars," "stealing" and "fierce" competition. It's all are part of the coverage of California stem cell issues that is emerging in the wake of the announcement that a noted Japanese researcher is opening a lab in San Francisco.

Dale Carlson, chief communications officer at the California stem cell agency, fed the generally positive stories with the separate release of a list of nearly 50 other researchers who have moved to California since the passage of Prop. 71. The list turned an already meaty scientific story into an even meatier one – a trend with national and global implications.

Reporter Daniel Levine of the Journal of Life Sciences produced a good example. His Aug. 20 piece was headlined "Money Changes Everything." He wrote that the move by Shinya Yamanaka caps a trend that has "changed the landscape for stem cell research by drawing top scientists to the Golden State."

Levine also queried Stanford, UCLA and UC San Francisco to flesh out the scientific migration and recruitment story.

We are likely to see at least a few more stories along this line as the news filters out from scientific and regional publications.

In another story on the Yamanaka move, reporter Ron Leuty of the San Francisco Business Times said that Yamanaka expects to be reprogramming human cells to create embryonic stem cells in the "next year or two."

Leuty also reported that the scientist is expected eventually to move his entire lab operation to the Gladstone Institutes. Yamanaka has a 20 person lab at Kyoto University. The Gladstone operation is expected to have four to six persons shortly.

Leuty said the "first fellow" in Yamanaka's California operation is funded by a grant from the California stem cell agency.

More Adding Up on Private Funding for Stem Cell Research

Attorney Ken Taymor. executive director of the Berkeley Center for Law, Business and the Economy at UC Berkeley, sends the following re our earlier item about state and private funding for stem cell research.

Thanks for bringing James Fossett's excellent report to our attention. A very, very quick search online raises questions about the accuracy of the calculation of private support for stem cell research in California (really a nit, but worth clarifying; I don't think it goes to the heart of his insights). At least three other major gifts have been reported in the press - excerpted below with URLs. In addition, as the report does note, the Show Me state is showing the Stowers the door, so while the money is coming from Missouri, it appears that it will be spent everywhere but Missouri. The news reports on donations in California of which I am aware are as follows:

"Sound pioneer Ray Dolby and his wife gave $16 million to the University of California, San Francisco to start a stem cell center that will perform research without federal funds."

http://sfgate.com/cgi-bin/article.cgi?f=/n/a/2006/05/10/financial/f224444D16.DTL

"USC announced it has received $25 million from the Broad Foundation to create the Broad Institute for Integrative Biology and Stem Cell Research at the Keck School of Medicine of USC."

http://www.usc.edu/uscnews/stories/12093.html

"Without seeing a dime of this [Prop 71] money, numerous California universities and research institutes already have committed to expanding their stem cell research programs, often with help from private donors. They are doing it with the help of philanthropists, who have given more than $250 million to California universities and research programs since 2005, Klein said. Those donations include a $20 million gift to the Stanford University Medical School from the New York-based Virginia and D.K. Ludwig Fund. The money from the fund, which is known for its support of cancer research, allows the school to establish a stem cell research center."

http://www.signonsandiego.com/news/business/biotech/20061219-9999-lz1n19stem.html

NAS Opens Session of Public Officials on Stem Cell Cooperation

Following a flap over closed door meetings, the National Academy of Sciences is opening to the public the next meeting of its group looking at interstate cooperation on stem cell research.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said the next session will be held in Boston in October. He attributed the information to Warren Wollschlager of the Connecticut Department of Health, who will chair the session.

Simpson was thrown out of a California meeting of the group earlier this year by an official from the National Academy of Sciences, who said the session was private. The group consisted mainly of public officials who are associated with state programs funding stem cell research with public funds.

Simpson said in a news release:

"I’m glad to see the change of heart. Too often the scientific establishment has displayed a paternalistic 'trust-us-we-know-best' attitude that in fact undercuts public support for science. Scientists need to engage and educate, otherwise we end up with the know-nothing attitude too often exemplified by the current administration."

Our view: The academy is moving in the right direction. This is public business and should be conducted openly. Anything less only feeds the anti-science forces. Closed door meetings and secrecy breed suspicion.

For earlier stories on this subject, click below on the label "interstate cooperation."

Gaining Brains in California

Thomson, now Yamanaka, plus nearly 50 more. So goes the count of a stem cell scientists dipping their toes – if not their entire corpus – into the California stem cell pool.

A few days ago, Shinya Yamanaka of Kyoto University said he was opening a lab at the Gladstone Intitutes in San Francisco. Yamanaka excited the stem cell world recently with his work in reprogramming adult stem cells to return an embryonic state. Earlier this year, UC Santa Barbara said Jamie Thomson of the University of Wisconsin was establishing a lab at the seaside campus.

Dale Carlson, chief communications officer for the California stem cell agency, said the state is a becoming a mecca for stem cell researchers. He produced a list (see item below) of nearly 50 who have come to California since Prop. 71 created CIRM and funded it with $3 billion in state bonds.

The headline on the story by Mary Anne Ostrom in the San Jose Mercury News read, "Japanese scientist's move reflects state's rising clout." David Hamilton's piece on Venture Beat described Yamanaka's move as "certainly a coup," likening it to a "brain gain." But he also said Yamanaka will be spending only a week a month in San Francisco for the next year or two. Rob Waters of Bloomberg quoted CIRM interim chief scientific director Arlene Chiu as saying it was a "great coup" for Gladstone and California. Steven Edwards of Wired.com called Yamanaka "one of the hottest prizes in stem cell reasearch."

Here is a link to the Gladstone press release. See the item below regarding moves by other scientists to California.

Names of Stem Cell Researchers Moving to California Since Prop. 71

Here is the list of stem cell scientists who have come to California since January 2005 following the passage of Prop. 71. The list was prepared by the state's stem cell agency. Scientists that it is currently funding have figures next to their names.

Migration of Stem Cell Researchers to California
(Since January 2005)

Established stem cell investigators who moved to California:

Martin Pera, Ph.D., from Monash University (Australia) to USC

Michael Clarke, M.D., from the University of Michigan to Stanford

Stephan Heller, Ph.D., from Harvard to Stanford $2,469,373

Peter Donovan, Ph.D., from Johns Hopkins to UC Irvine $2,509,438

Jan Aileen Nolta, Ph.D., from Washington University to UC Davis

Gerhard Bauer, M.D., from Washington University to UC Davis

David Rowitch, M.D., from Harvard to UCSF

Benoit Bruneau, Ph.D., from the Hospital for Sick Children in Toronto to a joint appointment at the Gladstone Institutes and UCSF

Michael Kahn, Ph.D., from University of Washington to USC;

M. Ian Phillips, Ph.D., from University of South Florida to USC

Deepak Srivastava, M.D. from University of Texas to the Gladstone Institutes and UCSF
$3,164,000

Markus Muschen, M.D., Ph.D., from Heinrich-Heine-Universitat Dusseldorf to Childrens Hospital Los Angeles and USC

Ronald Li, Ph.D., from Johns Hopkins to UC Davis

Paul Knoepfler, Ph.D., from Fred Hutchinson Cancer Research Center to UC Davis


Young investigators who trained in top labs and moved to California:

Noburo Sato, Ph.D. from lab of Brivanlou at Rockefeller to UC, Riverside

Qi-Long Ying, Ph.D. from lab of Austin Smith, Institute for Stem Cell Research at University of Edinburgh to USC

Kara McCloskey, Ph.D. from Nerem's lab at Georgia Tech to UC Merced

Xianmin Zeng, Ph.D. from Rao's lab at NIH to Buck; Institute $4,140,162

Kathrin Plath, Ph.D., from Jaenisch's lab at MIT to UCLA

Robert Blelloch, M.D., Ph.D., from Jaenisch's lab at MIT to UCSF $631,831

Holger Willenbring, M.D., from Grompe's lab in Oregon to UCSF $342,962

Tiziano Barberi joined City of Hope from Lorenz Studer's lab at Sloan

April Pyle was recruited to UCLA from the Donovan lab at Johns Hopkins

Gage Crump, Ph.D., from Kimmel’s lab at University of Oregon to USC

Tod Kippin, Ph.D., from Van Der Kooy’s lab at University of Toronto to UC Santa Barbara

Leslie Lock, Ph.D., from the Donovan lab at Johns Hopkins to UC Irvine

Gautam Dravid, Ph.D., from Johns Hopkins to Childrens Hospital Los Angeles

Dennis Evseenko, M.D., Ph.D., from New Zealand to Childrens Hospital Los Angeles

Andrew Cuddihy, Ph.D., from Canada to Childrens Hospital Los Angeles

Hanna Mikkola, M.D., Ph.D., from Harvard to UCLA $577,037

William Lowry, Ph.D., from Rockefeller University to UCLA $571,575

Bennett Novitch, Ph.D., from University of Michigan to UCLA

Ping Zhou, Ph.D., from Nolta lab at Washington University to UC Davis

Suzanne Pontow, Ph.D., from Nolta lab at Washington University to UC Davis

Camie Chan, Ph.D., from Johns Hopkins to UC Davis

Wenbin Deng, Ph.D., from Harvard/Children's Hospital Boston to UC Davis

Chong-Xian-Pan, Ph.D., from the University of Indiana to UC Davis

James Byrne, Ph.D., from Oregon Health Sciences University to Stanford



Established stem cell scientists with part-time appointments in California:

James Thomson, Ph.D. – UC Santa Barbara (University of Wisconsin)

Shinya Yamanaka, M.D., Ph.D. – Gladstone Institutes and UCSF (Kyoto University)

Nissim Benvenisty, M.D. – Cedars-Sinai (Hebrew University)

Michal Schwartz, Ph.D. – Cedars-Sinai (Weizmann Institute of Science)

Dan Gazit, Ph.D., D.M.D. – Cedars-Sinai (Hebrew University)

Clive Svendsen, Ph.D. – Stanford (University of Wisconsin)


Private Sector:

Mahendra Rao, M.D., Ph.D., from NIH to Invitrogen and UC Irvine

Advanced Cell Technologies (Michael West, Ph.D.) has expanded with a new facility in Alameda

Stem Cell Sciences (Peter Mountford, President and CEO) is expanding into California from the UK

Melissa Carpenter, Ph.D., from Canada to CyThera, Inc. in San Diego


Transfers within California:

Emmanuelle Passegue, Ph.D., from Stanford to UCSF

Wange Lu, Ph.D., from Caltech to USC

Renee Reijo Pera, Ph.D., from UCSF to Stanford $2,469,104

David Telander, M.D., from Jules Stein Eye Institute/UCLA to UC Davis

Amander Clark, Ph.D., from UCSF to UCLA

08/15/07

The "Show-Me" State and $985 Million in Stem Cell Funding

Jim Fossett of the Rockefeller Institute has pulled together a reasonably complete account of private donor support for stem cell research in the United States – something in the neighborhood of more than $1.7 billion.

Interestingly California is rather low on the list with a piddling $100 million. Missouri is No. 1 with $985 million from the Stowers.

The rundown is part of a policy brief called "Federalism by Necessity," which describes state and private efforts at human embryonic stem cell research. It supports Fossett's belief and mine that we are not likely to see an upsurge in federal stem cell spending after the next presidential election.

Giving Bush The Treatment

Stanford's Chris Scott looks at how George Bush might encounter stem cell therapy some years down the road in a case involving the famed "Jenna" line of stem cells. You can read it here on Scott's blog, The Stem Cell Blog.

Bee Editorializes on CIRM Presidential Search

The Sacramento Bee editorialized this morning on the search for a permanent president of the California stem cell agency, wondering whether obstacles exist that make recruitment difficult.

The editorial pointed out problems with compensation. It noted the structural issues in the management structure along with the role of California stem cell Chairman Robert Klein. And it said interim president Richard Murphy has taken steps to ease concerns about possible conflicts of interest. The final paragraph of the editorial also said:

"In fact, it's quite possible that Murphy could help the institute fashion a management structure in line with that of other prestigious research institutions. Earlier this year, Murphy described the institute's executive structure as a 'dog's breakfast' -- in other words, 'a mess.' For six months, he'll be boss of the kitchen. Bon appetit."

CSUS' $31 Million Training Proposal Faces More Scrutiny

A "breathtaking," $31 million proposal to train 4,000 young persons in biotech skills has been sent off for more critical examination by two directors of the California stem cell agency.

Last week six representatives of the California State University and College system presented the five-year plan to CIRM's directors, who both praised and criticized it. One, Janet Wright, called it "breathtaking" and "visionary."

The proposal represents a joint effort by the 114 community colleges in California and the 23-campus state university and college system (which does not include the University of California).

The proposal keyed off the widespread belief that biotech firms in California have difficulty finding skilled workers. Such expressions by industry groups often can be translated to: "We cannot find enough workers at the wages we are willing to pay."

John Reed, head of the Burnham Institute and a member of the CIRM Oversight Committee, questioned whether CIRM is the best source for funding the training program. He noted that Prop. 71 was aimed at providing funding for research that is not available from the federal government. He said there is no prohibition against any agency providing biotech training. Reed asked for specific statistics on the need in California as opposed national statistics provided by CSUS. (Reporter Terri Somers of the San Diego Union-Tribune had more from Reed on his views.)

Ed Penhoet, vice chairman of CIRM, also expressed an interest in more information. He wanted to know how successful are CSUS' existing training programs.

Other questions could be asked as well. If there is a great need for training and if biotech is as important to the California economy as argued by CSUS, one could wonder why the system is not already doing the training on its own. It would seem to be a basic part of the system's mission. One could ask whether alternative approaches to the training exist – something less costly than $31 million. However, the figure translates to $7,500 a student, which might be a bargain.

One could wonder why this proposal was not presented to the staff earlier and vetted for answers to just such questions, including Reed's and Penhoet's, prior to coming to the board. The CIRM board is constantly pressed for time for matters that only it can decide, such as the rules for the $227 million lab program, which came up later in the day of the presentation. By mid-afternoon, Oversight Committee members were disappearing to catch planes and to take care of their other many responsibilities. A written, staff analysis of the plan would have already developed answers to questions posed by Oversight Committee members and saved valuable time.

CSUS promised to address all the concerns in writing before the October meeting of the Oversight Committee, when committee members David Serrano Sewell and Marcy Feit are scheduled to report back on the proposal. Hopefully, they will ask the staff to weigh in as well.

FTCR: Secrecy Supports Anti-Science Crowd

Does openness on research grant reviews mean bad science? Does cloaking the identities of massive public institutions serve a public purpose?

Earlier today we asked John M. Simpson , longtime CIRM watcher for the Foundation for Taxpayer and Consumers Rights, for his thoughts on the secrecy policies at CIRM(see item below). Here is what he had to say.

"CIRM's penchant for secrecy makes no sense. People who want public money should have to explain how they will use it in public.

"This is not complex. Other states, like Connecticut, have figured out how to do it.

"The argument is that scientists won't apply for grants out of fear that their applications might be rejected. Frankly, all the scientists I know have thicker skins than that. Their egos aren't fragile. In fact a number of junior scientists have said they'd like to see some sun shine into the secrecy-shrouded peer review process.

"But let's set the the question of the individuals' identity aside for a moment. There is absolutely no ground for a refusal to identify the institutions which have applications under consideration.

"The only thing I can figure is that the current scientific culture is elitist and subscribes to the view that the public can't be trusted to make good judgments. Ironically, in the end that's an approach which leads to the know-nothing, anti-science attitude of the current federal administration.

"I want to support science and scientists, but when you insist upon retreating behind closed doors you do not make it easy for me or for yourselves. Engage the public; explain what you do and why. Do it in public. You'll be surprised and pleased at the support you get."

CIRM Says No to Public Access on Faculty Grants

The California stem cell agency today refused to disclose the names of the institutions whose faculty members are seeking $85 million in public funds.

Dale Carlson, chief communications officer for CIRM, said that the institutions' names would not be disclosed until after the grants are awarded in December. He said the justification for the secrecy was the same as for the secrecy on applications for previous research grants.

Basically CIRM wants to ensure candor in the evaluation of individual research proposals and avoid embarrassing them or damaging their reputations. But CIRM did not make it clear how institutions such as UCLA or Stanford could be embarrassed or harmed by the disclosure that they nominated scientists for the prestigious awards or how the evaluation process could be damaged by such identification.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said that not only should the institutions be named but that the individual scientists also should be publicly identified.

In some ways, CIRM is more open than other more cloistered institutions, such as the NIH, we are told. But in other ways, it remains tightly under wraps.

Comparisons are difficult to make with other government agencies or universities. CIRM, although it is a state agency and operates with state funds, is not subject to the normal gubernatorial or legislative oversight. Operational minutia concerning the agency is codified in state law and cannot be changed without another vote of the people or a super, super-majority vote in the legislature. Such independence does not exist at the University of California or the NIH.

At the same time, the board is rife with conflicts – all entirely legal because they were approved by voters in Prop. 71, which created the agency. Fifteen members of its board of directors, for example, have ties to institutions that could stand to benefit by tens of millions dollars in its latest $227 million lab grant program.

What that means is that CIRM should be more, rather than less open in order to maintain public confidence in its worthy endeavors.

Not Upcoming

Our report on the $31 million CSUS training proposal to the California stem cell agency has been delayed until this weekend.

CIRM Presidential Search: Looking for the Right Phenotype

Is there too much "reflection" in the search for a permanent president of the $3 billion California stem cell agency, which has been operating on a lame-duck-CEO basis since December?

At least one member of the agency's 29-member Oversight Committee thinks so. Jeff Sheehy told The Scientist that the board is focusing excessively on persons with strong scientific backgrounds and not enough on good managers.

Writer Bob Grant quoted Sheehy as saying,

"I feel like we have a lot of deans of medical schools on our board, and they keep looking in the mirror. I'm not sure that's the phenotype that we need in this job."

Grant continued:

"Sheehy added that Murphy's appointment only delays the institute's need to seriously consider this identity issue. 'In a way he's a band-aid on a deeper problem we have,' said Sheehy, 'which is not coming to terms with what the job is. I think we keep punting on this issue.'"

The main focus of Grant's piece was the appointment of Richard Murphy, former head of the Salk Institute in the San Diego area, as interim president. Murphy was quoted as saying,

"My job as president is going to be, first and foremost, to make sure the operation of CIRM is efficient and effective."

Murphy added,

"I don't think that the role of the president is to evaluate science."

Grant noted Murphy will not take part in decisions affecting San Diego institutions. Grant also wrote:

"Evan Snyder, stem cell program director at San Diego's Burnham Institute for Medical Research, told The Scientist that though Murphy has recused himself from making direct funding decisions when San Diego institutions are involved, he will be valuable to the community because of his intimate knowledge of science in the area. 'He has an appreciation for what's going on in San Diego, and I know that will be a great benefit to us,' Snyder said. The Burnham Institute has already received almost $13.5 million in CIRM money."

In a separate addition to the story, Grant quoted California stem cell Chairman Robert Klein as making it clear that it was not seeking candidates for the permanent position who want to maintain active labs. That was a stumbling block in the previous presidential search.

Fifty-nine Scientists Reach for CIRM's Golden Ring

The odds do not appear to be too bad in the California stem cell agency's new and generous $85 million faculty award program. It could make 25 stem cell researchers quite happy this holiday season.

Fifty-nine persons filed letters of intent to apply for the awards that could run as high as $3 million annually. CIRM could give out as many as 25 grants, if it decides it has that many worthy candidates. That, of course, means one out of 2.36 applicants could be funded.

The scientists come from 29 California institutions, whose names were not immediately disclosed. We have asked for the names of the institutions and will carry CIRM's response when it is forthcoming.

CIRM's press release today said,

"New Faculty Awards will fund the research of promising M.D. and Ph.D. scientists in their early years as independent lead investigators and faculty members. They are intended to develop a new generation of clinical and scientific leaders in stem cell research.

"While previous CIRM research grants focused on human embryonic stem cell research, the New Faculty Awards will support research across the full range of stem cell types – human and animal, adult and embryonic."

The schedule calls for the awards to be approved at the board's December meeting. The deadline for applications is Aug. 30 but those who did not file letters of intent are out of luck. Between now and then, the applications will be reviewed behind closed doors by a group of out-of-state scientists and some members of the CIRM Oversight Committee, who have filed public economic disclosure statements. However, the scientists involved in the review do not have to file public statements. They file secret economic disclosure statements with CIRM. Their private statements are also aimed at identifying potential professional conflicts.

Kessler Looking for More Than CIRM, UCSF?

Is one of the directors of the California stem cell agency looking for new challenges?

The In Vivo blog has an interesting piece on David Kessler, a former FDA commissioner and dean of the UC San Francisco medical school.

The item was written by Ramsey Baghdadi, the managing editor of "The RPM Report," a publication devoted to prescription drug regulation, policy and market access.

Baghdadi reviews Kessler's background, declaring that he "is arguably the most controversial commissioner in recent times for the way he took on drug companies, Big Tobacco and even orange juice producers." Baghdadi said Kessler has surfaced recently in the news and that means that "he's angling for something."

Baghdadi's bet is on a position with a large academic research institution where Kessler could finish off his crusade against tobacco as opposed to director of NIH or secretary of Health and Human Services.

CIRM Overseers to Consider More Public Disclosure on Lab Grants

California stem cell Chairman Robert Klein has put off requests to open up the lab grant process until the October meeting of the Oversight Committee, but says he is "supportive" of increasing public access to information.

In response to our letter last week asking that the names of applicants, their letters of intent and applications be designated as public records, Klein replied by email Tuesday, saying:

"Your letter has been provided to all ICOC board members. I’m supportive of increasing access to information on the major facilities grants. I will ask the board to formally consider this policy as an agendized issue with a staff report at the October 2007 board meeting."

Public access to lab grant review proceedings came up during the Oversight Committee hearing on Wednesday. John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, asked that all meetings in which grant applications are reviewed be open to the public.

Klein pointed out that only the scientific review sessions are closed. The reviews by the Facilities Working Group are open and the names of applicants would be disclosed at that point.

Simpson said that argument seems to mean that you can't embarrass the institutions about "not doing good science but you can for doing bad facilities." The board has also emphasized that the scientific review is paramount in assessing the applications.

Arlene Chiu, interim chief scientific officer for CIRM, opposed opening the scientific review meetings to the public. She said full candor is needed to evaluate the programs at various institutions. That is not likely to occur if it is done in public, she said.

Our view is that the scientific review should be open, but we understand her argument. Sensitive or "proprietary" information, however, could be evaluated in private, if necessary, with the bulk of the review sessions in public. The same logic could also apply to information on applications, although full disclosure is preferred.

During Wednesday's meeting, Michael Friedman, an Oversight Committee member and president of the City of Hope, said the lab grant process is "the most politically charged" of CIRM's activities. That reflects the fact that 15 out of the 29 members of the Oversight Committee have ties to institutions that could stand to benefit from the grants.

Following Wednesday's meeting, Klein told the California Stem Cell Report that he wanted to "make steady progress towards more disclosure." But he said it may take some time for all to become "more comfortable" with complete openness.

What do you think? Should universities and research institutions seeking $227 million in public funds be required to publicly disclose their identities and other information? You can comment clicking by on the word "comment" below. Ironically, our blog host, Google, permits anonymous postings but, of course, most of you will want to identify yourselves, right? Fire away.

Upcoming

The $31 million training proposal by California's state university and college system has been sent off for further study by directors of the California stem cell agency. Members of the Oversight Committee spoke favorably about the concept but also raised questions. We will have more on the subject, probably tomorrow, but you can find a fresh story on the matter by Terri Somers of the San Diego Union-Tribune at this link.

Still More On Murphy

The online version of the Wall Street Journal today carried a brief item on the appointment of Richard Murphy as interim CIRM president. If you can't find it here because of paid registration, send an email to djensen@californiastemcellreport.com, and we will forward it to you.

John M. Simpson of the Foundation for Taxpayer and Consumers Rights released a formal statement on Murphy. Here is the text.

"I am concerned that the search has taken so long and don't believe that the board began serious search efforts rapidly enough when Zach Hall announced his retirement plans. Given the unfortunate need for an interim president, I think Richard Murphy will make a good leader.

"At the stem cell board meeting I raised questions about his membership on the board of the California Healthcare Institute, a lobbying group for the biomedical industry.

"I was relieved to learn that Murphy had left that board when he retired from the Salk Institute, although I don't think he should have been a member while on the stem cell board.

"He has been a sensible and steady influence on the stem cell agency's board, and I hope and expect he'll make a a significant contribution to the agency. In my role as constructive critic, it's my job to hold his feet to the fire when necessary and ensure that he does so."

Sharpen the Pencils, Line Up the Finest Grant Writers!

Lab builders around California can expect to see the detailed requirements for $227 million in grants from the California stem cell agency in a couple of weeks.

On Wednesday, the Oversight Committee for the institute gave the go-ahead on the proposal, but with not without some changes. One boosted the funding range on the size of some of the grants. In the CIRM Institute category, the top of the range moved from $40 million to $50 million. In the Center of Excellence category, the top rose from $20 million to $25 million.

Ed Penhoet, vice chairman of the agency, said $40 million might not be enough. He said the board wanted to encourage collaboration on the labs but that if grant size were not large enough, each institution instead might submit separate applications. Jeff Sheehy noted that only one "true" consortium seems to currently exist. That is in the San Diego area and involves UC San Diego, Salk, Burnham and Scripps.

John Reed, another Oversight Committee members and president of Burnham, unsuccessfully sought to change the proposed scoring to give 20 instead of 15 points out of 100 in the "shared resources" category. He argued that would reflect the board's strong encouragement of collaboration. John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumers Rights, noted the change would help tilt scoring towards consortiums.

The board approved virtually all of the other elements of concept plan for the lab grants, and CIRM staff said the RFA would be out within a couple of weeks. Final approval of the grants is scheduled for next April, with an initial screening of the scientific portions of the applications at a January meeting of the Oversight Committee.

Link to CIRM Info on Murphy

Here is the link to the CIRM press release on the appointment of Richard Murphy as interim president of the agency.

Murphy Talks About His New Role

The new interim president of the California stem cell agency says he has no intention of being a placeholder until a permanent president is found, according to the San Diego Union-Tribune.

Reporter Terri Somers interviewed Murphy following his appointment. He said,

"I want to be hands-on. That is part of the attraction for me and part of what (the institute) needs right now."

Murphy said,

"I think it's an exciting time for the (institute), with application requests ready to be issued for large facilities and applications for new investigators grants going out,” he said. “And now there's also discussion about a new (request for applications) for disease-oriented research groups, which I think is a great way of kick-starting disease-oriented research related to stem cells."

Here is more from Somers' story about the sometimes ticklish relationship between California stem cell Chairman Robert Klein and CIRM's former president, Zach Hall:

"'I think Bob and Zach are very talented people. . . . (The institute) did very well in a very short time period,' Murphy said. 'I think Klein is a genius. The guy created Proposition 71 out of nothing and worked very diligently to put (the institute) on the map in a short period of time despite having a lot of hurdles to get over. I look forward to learning a lot from Bob.'"

"Meanwhile, he said, he expects to continue the very open relationship that he had as a board member serving with Klein.

"Murphy does not think Klein's active role at the institute is causing the president search to drag on. In fact, he and others involved in academia said it is not uncommon for recruitment and hiring for such a position to take a year. Nor do they think money or the high cost of housing is an issue, with the salary range set around $500,000(note: the salary currently is capped at $412,500)."

Somers reported that Murphy said "he has no interest in the job long term, although he had been approached several months ago to apply for the permanent position."

In other coverage, Andrew Pollack of the New York Times wrote a brief story on the appointment that also mentioned the California Stem Cell Report reporting on the presidential search.

More On Richard Murphy and His Role at CIRM

As promised, here is more on the appointment of former Salk Institute President Richard Murphy as the interim president of the California stem cell agency.

Murphy was voted on following a 2.5-hour lunch/executive personnel session, which Oversight Committee Chairman Robert Klein originally predicted would last one hour. Only one no vote was heard during the voice vote following the executive session. That was from Jeff Sheehy. We did not have a chance to catch up with him following the meeting, but he told us earlier he was "not comfortable with the direction" the Oversight Committee was going. His comment came shortly after he was the sole negative vote on whether even to allow the subject of a possible interim hire to be considered at today's meeting.

Murphy starts work tomorrow, although he is not scheduled to relocate from the San Diego area to San Francisco until after Labor Day. His contract runs until March 4.

As we reported below, his salary will be $300,000 for roughly six months of service. That compares to the current $412,500 annual salary cap on the permanent president's salary. However, Murphy will not accept fringe benefits from CIRM. The cost of state fringe benefits range from 35 percent of salary to more. Murphy will forgo Salk-financed retirement benefits such as health insurance. That was part of a move to avoid the appearance of any conflicts of interest involving Salk.

Murphy will recuse himself from any decisions involving San Diego area institutions. John M. Simpson of the Foundation for Taxpayer and Consumers Rights raised another possible conflict involving Murphy's service on the board of the biomedical industry group, the California Healthcare Institute. That institute has lobbied CIRM for intellectual property rules that are favorable to industry. However, Philip Pizzo, a member of the Oversight Committee and dean of Stanford's medical school, said Murphy had resigned from the CHI board. Pizzo said he knew because he currently services on the CHI panel.

Murphy, 62, also agreed not to be a candidate during the search for a permanent president at CIRM.

Some of you may recall that Murphy earlier this year was involved in reconfiguring the dual executive structure at CIRM to make it more appealing for recruitment purposes. At one point, he called the agency's executive structure "a dog's breakfast."

As for a look at the conventional news coverage of the appointment of a new, albeit interim CEO for the world's single largest source of funding for human embryonic stem cell research, we filed a report for Wired.com. Reporter Terri Somers of the San Diego Union-Tribune was quick with a story on Murphy's appointment at 3:33 p.m. today although she was not present at the meeting.

San Diego is a global hotbed for stem cell research. Somers is currently the leading California reporter on California's stem cell business, which is No. 1 in the nation. No other writer has devoted the energy or time in the last year to the subject, but of course that could change.

We surmise that cost-cutting imperatives, currently rampant in the sagging newspaper business, prevented her from traveling. A poor decision for a paper that circulates in one of the hottest spots in the world for stem cell research, but a decision that is not much different than ill-considered moves by most of the ailing daily newspaper enterprises in this country. What newspapers sell is audience. The buyers are advertisers(75 percent or so revenues have traditionally come from advertisers). When the content is nil or irrelevant, audience shrinks, which it has been doing nationally for several decades as cost-cutting mavens ruled the day in the newspaper business. Business researchers at UC Davis have done a serious study that illuminates this trend.

But, as they say, I digress. Here are some other links to the only other two stories on Murphy we found at the time of this writing, although they are quite brief: Jim Downing, Sacramento Bee; San Francisco Business Times.

Former Salk CEO Named as Interim CIRM President

Neuroscientist Richard A. Murphy, the former president of the Salk Institute, was named today as the interim president of the California stem agency.

The Oversight Committee of the agency approved the appointment on a split voice vote(one no). Murphy begins work tomorrow on a six-month, $300,000 contract. He will recuse himself from "any decisions" involving San Diego institutions.

We have more on this later.

CSUS Cash Wranglers Make Largest Pitch to CIRM

The San Diego Union-Tribune today explored an attempt to "wrangle" $31 million out of the California stem cell agency by the state college and community college systems.

Reporter Terri Somers appears to be the only mainstream reporter in the state writing about the sweeping proposal, which comes up today before CIRM's Oversight Committee in San Francisco.

Here are some excerpts from her story:

"This is the first time an entire state system has asked for funding from the state stem cell institute, although several nonprofits have had funding suggestions.

"'This is definitely the largest request we have seen, and of course their constituency is the largest educational system in the world,' said Robert Klein, chairman of the stem cell institute's board.

"Of the $208 million in research and training grants approved by the institute, $109.9 million has been promised to scientists and laboratories in the University of California system. The UC system, which is separate from the CSU system, is more widely known for its doctorate and post-doctorate programs."

She continued:

"The strategic plan includes $38 million for training of undergraduate and master's degree-level technical staff. It also includes $147 million for training programs, some of which the Cal State and community college systems can compete for.

"But the the systems would like the $31 million to set up their own cohesive, statewide programs."

Somers wrote:

"Whether the stem cell institute could legally fund these proposals is something Klein said he expects its lawyers to discuss today.

"'There is a great deal of flexibility in Proposition 71 to address ideas of high merit,' Klein said of the voter initiative that created the institute."

Interim CIRM President in The Works?

The California stem cell agency is moving towards hiring an interim president to head the $3 billion institute while it completes its search for a new chief executive.

California stem cell Chairman Robert Klein last week told the California Stem Cell Report that he hoped to advance the search in a "material way" at Wednesday's Oversight Committee. It appears that comment is linked to a cryptic, recently posted addition to the agenda for consideration of a "personal services" contract.

Stem cell scuttlebutt has it that a six-month contract would be offered to the interim president. Some possibilities could include two Oversight Committee members who left the board recently because they no longer held the positions that qualified them for seats on the committee. They are the former president of Caltech and Nobel Prize winner, David Baltimore, and the former head of the Salk Institute, Richard Murphy. Other possibilities include Ed Penhoet, vice chair of the Oversight Committee, and Paul Berg, a Stanford Nobel Prize winner who has filled in as an alternate on the panel.

Former President Zach Hall announced his retirement last December and departed at the end of April. His responsibilities were picked up on an interim basis for the past three months by two current executives at the agency, who already had full plates.

As early as last January, some members of CIRM's Oversight Committee were worried about drift at the institute during the transition to a new president, especially if there were a significant hiatus while a new president was found.

FTCR: Open Up $227 Million Lab Grant Program

A watchdog of the California stem cell agency today called for making public the names of applicants for the institute's massive $227 million lab construction program.

Writing in an op-ed piece in The Sacramento Bee, John M. Simpson of the Foundation for Taxpayer and Consumer Rights said:

"Putting scientific review on a pedestal behind closed doors does nothing to help the public's understanding of, and therefore faith in, the process. Looming over it all is the legally mandated, conflicted structure of the board. Virtually all of the university and research institutes represented on the board will seek money for buildings. It behooves members in their own best interest to demonstrate pure motives by keeping the process completely transparent.

"The stem cell committee should direct that scientific review of building projects be handled like the facilities review -- in public. As it stands now, the two-step process is apparently premised on the notion that it's unwise to risk embarrassing an institution for its lack of scientific ability, but it's all right to say it doesn't know how to construct a decent building. That approach serves neither scientist nor architect, but especially not the public."

Simpson's position echoes ours. We sent a letter last week to the Oversight Committee, asking it to take action on the matter at its meeting Wednesday in San Francisco.

$5 Million Boost for Major Lab Building Proposal?

The California stem cell agency has posted a "concept plan" for a $227 million lab grant proposal that contains more details, definitions and timelines.

It also includes proposed breakdowns for the various funding categories (CIRM institutes, centers of excellence and special programs). Institutes would compete for grants each of $25 to $40 million, centers of excellence for $10 to $20 million and special programs for $5 to $10 million.

However, the concept plan, available on CIRM's website, said:

"There is no analytical basis at this time to determine the appropriate amount of funds to be allocated to each category, and this information will not be available to the ICOC until the GWG (grants working group) submits its recommendations."

The document went on to say that CIRM staff “has evaluated several scenarios for funding” and recommends that the Oversight Committee on Wednesday adopt the ranges above, presumably for the time being.

CIRM also said that the agency committed less than expected in its earlier shared lab proposal, making another $5 million available for the latest grant effort. It recommended that the Oversight Committee commit the additional funds to the major lab grant effort.

Much of the material in the plan duplicates earlier documents, but, as they say, the devil is in the details, plenty of which are contained in the concept plan.

Fresh Comment

Patient advocate Don Reed sent the following comment on an item below involving him. “The post about the "Wonder Women of the ICOC" was a joy to write--and as for the unsung heroines (and heroes) of the CIRM, please know I intend to sing about you folks as well! “

Kerfuffle Erupts Involving Geron, Biopolitical Times

Geron, stem cell scientist Hans Keirstead, New Yorker magazine and Wired.com – all play a part in a recent piece about failed promises on the Biopolitical Times blog.

Jesse Reynolds of the Center for Genetics and Society has posted a good wrapup of the kerfuffle, in which Kierstead takes on Reynolds and vice versa. It all began last week when Reynolds said that Geron has repeatedly promised the beginning of stem cell trials that have not materialized within the predicted time frame. Wired.com picked up the Reynolds piece. Kierstead then commented online that Wired.com had peformed a “tremendous disservice to the stem cell field.”

Reynolds replied in the latest posting:

"The truth is that (Brandon) Keim (of Wired) and I did little more than cite public statements made by Geron's chief executive. Isn't it (Tom) Okarma (president of Geron) who is disserving the stem cell field by misrepresenting the feasibility of Geron's stem cell clinical trials over and over again?"

Reynolds' term for the time periods that have elapsed between predictions of clinical trials? “Okarma units.”

California State Colleges Seek $31 Million From CIRM

California's huge state college system is proposing that the California stem cell agency finance a $31 million, five-year program to train thousands of persons to work in biotech and related fields.

Officials of 23-campus, California State University and College system are scheduled to appear before CIRM's Oversight Committee this Wednesday to tout the proposal. No hint of the size or scope of the proposal is available on the committee's agenda. After several days of questioning, state college officials finally confirmed that this document that we found on the Internet lays out details and justification for the training program.

The document says that state and community colleges are in the best position to educate the workforce required by the state's stem cell industry. The goals of the effort including a doubling of the number of CSUS students graduating with training in biotech and related fields over the next five years. It also calls for creation of new courses, graduate level programs and creation of regional training facilities.

California stem Chairman Robert Klein placed only a cryptic notation concerning the CSUS matter on Wednesday's Oversight Committee agenda. No further information was available except for the response from CSUS.

(For those of you unfamiliar with higher education in California, the CSUS is completely separate from the University of California.)

Peril and the CIRM Presidential Search

Attempting to understand the presidential search of the California stem cell agency certainly meets the definition of a task fraught with peril. It is a process that is being conducted behind closed doors and whose participants are sworn to secrecy on any significant details. All of which is entirely appropriate.

Nonetheless the search is fundamentally important to the current and future health of the $3 billion effort and is worthy of some public scrutiny.

We wrote earlier this week about the process, and today another piece of ours appeared on Wired.com.

To summarize: compensation, personal chemistry, structural management issues all are complicating the recruitment effort. But there are others, one of which is the desire for a blue ribbon scientist to run the agency. But the new president would also be expected to give up his lab and research work. The first search in 2005 apparently brought forth some scientists/presidential candidates who wanted to continue their lab work. This time around that seems to have been ruled out by the Oversight Committee. So that narrows the field.

Former president Zach Hall earlier this year suggested to CIRM directors that a new president could do very well without having a high-toned scientific pedigree. But when we talked to Oversight Committee member Jeff Sheehy last week, he said candidates with a good scientific vision were the ones that excited him. Of course, Sheehy is but one of 29 members of the committee.

Hall also said in an interview last month that the Oversight Committee “must be willing to enable a new president to take a strong leadership role.” It was a comment based on the ticklish relationship between him and California stem cell chairman Robert Klein, which was exacerbated by Prop. 71's unnecessary dabblings in management minutia. Those are now locked in state law and virtually immutable.

Finally come comments from John Simpson of the Foundation for Taxpayer and Consumers Rights. He is a longtime observer of CIRM and reasonably fair-minded. We asked him for his thoughts on the search. Here is the text of what he sent us:

"The selection of CIRM's president is undoubtedly the ICOC's single most important task. He or she will be the chief executive of an enterprise that is costing California taxpayers $6 billion.

"Zach Hall helped define the president's role and deserves credit for getting the fledgling agency off the ground. The new president faces the daunting task of moving forward from entrepreneurial, adrenaline-filled days of a start-up mode to maintaining an established agency where the routine is, indeed, routine.

"He or she must be seen to do the public's business in public and will need vision to move the agency forward.

"A thick skin and diplomatic skills will be a necessary in dealing with some of the oversized egos on the ICOC as well as the various members of the public who take an interest in the agency.

"Judging from hints dropped by ICOC Chairman Bob Klein, the new president will have to deal with a new board chairman within a year; Klein will likely step down in 2008. That could make the new president's job easier.

"The average California probably won't pay much attention to the agency even though $6 billion of taxpayer money is at stake unless something goes terribly wrong, or incredibly right -- meaning a significant scientific breakthrough results from California's efforts.

"The most likely scenario is the middle ground. Incremental advances, but no flashy breakthroughs.

"If the ICOC can pick the perfect person, however, Californians will ultimately take notice because the president will actually deliver on the wild promises made during the campaign to pass Proposition 71."

One caveat to Simpson's remarks. While Klein did speak last December about stepping down next year, it is not a done deal.

Time for More Openness in $220 Million Grant Program

The California Stem Cell Report today formally called on directors of the California stem cell agency to open up the $220 million lab grant process by making the names of applicants and other related information a matter of public record.

In a letter to California stem cell Chairman Robert Klein, David Jensen, publisher of the report, said such action would conform to the letter and spirit of the California Constitution, which guarantees the public a broadly construed right of access to information about “the conduct of the people's business.” He also said opening up the information would help to preserve public confidence in embryonic stem cell research.

Here is the text of the letter:

"This letter is to request that the Oversight Committee -- as part of the RFA to be considered for major labs at the Aug,. 8 meeting -- stipulate that the names of the applying institutions, their letters of intent and applications are a public record when they are received by the California Institute for Regenerative Medicine.

"Such action by the ICOC would serve the best interests of CIRM and its goal of adherence to the highest standards of openness and transparency. It would also comply with the letter and spirit of the California Constitution, which declares that the people of California have “the right of access to information concerning the conduct of the people’s business” -- a right that is to be “broadly construed.” As you know, 83 percent of voters approved that constitutional right of access in November 2004 when they passed Prop. 59.

"In many ways, the California Institute for Regenerative Medicine is very open, which is a tribute to the Oversight Committee's commitment to transparency.

"But now, as the agency embarks on its single largest round of grants, it is time to take another step to protect the public interest and the agency itself as well. Fifteen members of the Oversight Committee have ties of one sort or another to institutions that may well seek funds in this round of lab grants. The entire University of California system is represented on the board, along with Stanford University, the Burnham Institute and other well-regarded institutions. On Aug. 8, the board will set the rules under which employers of many of its members stand to benefit by tens of millions of dollars. Combine all that with the critically important but closed-door, scientific review of the applications, and you have an information void that can only lead to the worst sort of speculation. Making the applicant names and other information public goes a long way in helping to prevent such a situation.

"In the past, CIRM has made a case for privacy on research grant applications from individual scientists. But applications from government and nonprofit institutions are fundamentally different. They are not subject to the same concerns that individual researchers might have regarding their reputations or work.

"We urge you to act in the public's best interest and open up the $220 million lab grant process by making public the names, letters of intent and applications from all institutions seeking funds. Such a move will enhance CIRM's reputation and help to maintain public confidence in embryonic stem cell research."

A Wired Look at CIRM Presidential Search

Wired.com has a piece by yours truly on the effort to find a new president for the California Institute for Regenerative Medicine. We will carry more a few more details on the effort later on Friday. You can find the Wired article here.

Corn, Ham and the Women of CIRM

From Hollywood's Sherry Lansing to Davis' Claire Pomeroy, patient advocate Don Reed covered them all. Wonder Women, he called them.

Reed is the irrepressible patient advocate who doggedly attends almost every meeting involving the California stem cell agency and then goes on to fight the stem cell fight nationwide via the Internet.

On his blog – stemcellbattles.com – the July 31 posting involved the women on CIRM's Oversight Committee. Reed did not mention the women who staff the agency, including the two who are now in charge of the effort. But he probably will.

With Lansing, Reed reached into the past and rented a movie, Rio Lobo, in which she appeared with John Wayne. Lansing's heart-of-gold character did away with a bad guy who had done her wrong, but then helped Wayne to walk again.

Reed himself is a goodhearted fellow. Some people might think his writing style a little corny, but I once had a high school speech teacher who constantly reminded me, “Corn is better than ham any day of the week.”

A $100 Million Collaborative Effort

CIRM Oversight Committee members Ed Penhoet and Claire Pomeroy enjoyed a $100 million day earlier this week in Sacramento.

The occasion was the announcement that the Gordon and Betty Moore Foundation was giving the money to UC Davis to establish a nursing school. Penhoet is president of the foundation. Pomeroy is dean of the medical school at UC Davis.

The Moore donation is the largest ever made to UC Davis and one of the largest ever for the University of California system.

Gordon Moore is one of the founders of Intel. His son, Ken, was present for the announcement. A story written by Bill Lindelof and Dorsey Griffith reported the following:

"He (Ken) said a nurse came into his mother's room and told her it was time for a shot. Betty Moore balked, but the nurse insisted.

"'Turns out she got the insulin shot that should have gone to the patient in the neighboring bed,' said Ken Moore. 'They nearly had two deaths out of one medical error. That was the start of her really being interested in nursing care.'"

Sharon Stello of the Davis Enterprise reported:

"UCD spokeswoman Lisa Lapin said initial connections between the foundation and the Davis campus were made between Claire Pomeroy, UCD vice chancellor for human health sciences and dean of the medical school, and Penhoet, both of whom serve on the California Stem Cell Commission(sic). They started talking about mutual visions for nursing education, and the conversation evolved into the grant."

CIRM Director Nova Taking Her Firm Public

Tina Nova, a director of the California stem cell agency, is looking for a big payday when the company she heads, Genoptix, goes public, seeking to raise $86 million.

The Carlsbad, Ca., firm has filed documents with the federal government announcing its plans for an initial public offering. Genoptix, which reported its first quarterly profit this year, provides laboratory and diagnostic services to hematologists and oncologists. It is backed by venture capitalists including
Enterprise Partners, Chicago Growth Partners, William Blair Capital Partners, Alliance Technology Ventures, Tullis-Dickerson, Excelsior Venture Partners and others.

Nova is one of 29 members of the Oversight Committee for CIRM. The IPO filing, which has lots of interesting business details, can be found here.

CIRM, Entropy and the Presidential Search

The California stem cell agency entered its fourth month today without a permanent president, although its directors knew last December that the post would be vacant by summer.

On Monday, Robert Klein, chairman of the agency's Oversight Committee, told the California Stem Cell Report that he expected the search to move forward “in a material way” at next Wednesday's meeting of CIRM directors. However, he did not predict a decision on either a candidate or a new salary for the president.

Klein said he was “committed to getting absolutely the right person.” He said the search is not taking long when compared 12 to 18 month efforts to find top academic or university executives.

The Oversight Committee met three times in unusual, teleconference meetings between the end of June and the end of July to consider candidates and compensation. But those meetings, conducted mainly in private, ended with no public action.

The presidential search is not on the public portion of the Oversight Committee's agenda Wednesday, but the matter can be taken up during the group's scheduled personnel session, which also will be behind closed doors.

Following last week's meeting of the CIRM standards group, Jeff Sheehy, a member of the Oversight Committee, said in an interview that compensation is a significant factor in the search, which apparently involves candidates from academe. He noted that CIRM cannot provide special housing allowances that are often part of the compensation mix in academic recruitment efforts. Nor can the institute provide loans to its employees. Academic employment also can provide tenure and other financial opportunities that would not be available to a CIRM president.

Since the beginning of May, two capable CIRM staffers have picked former president Zach Hall's responsibilities on an interim basis. But earlier this year, we pointed out that organizations with lame duck CEOs and interim presidents can easily slip into drift. No one wants to make a decision that would tie the hands of a new president. Hiring new staffers can also be difficult. While it is hard to quantify the impact, it can be quite harmful. More than one director has voiced that concern.

As far back as last January, Oversight Committee member Michael Goldberg warned fellow directors against complacency. Goldberg has more than a nodding acquaintance with such issues as a venture capitalist who directs life science investments for Mohr Davidow Ventures of Menlo Park, Ca.

He said,

"There's a whole organization there that's been charged with an enormous responsibility of administering the research apparatus of the CIRM, and it's leaderless. I don't like working for an organization that's leaderless. I say leaderless, I don't mean that in the sense it doesn't have a chair engaged and vice chair engaged and (outgoing president Zach Hall's) engagement, but it's not the same as an organization that's moving forward.

"There's entropy in my experience at this stage of an organization's life with a leader who's announced his departure....That should give us actually an increased sense of urgency, if anything. so I'd like to do everything we can to fast track the process without sacrificing any of the transparency and engagement with stakeholders that I think we're all committed to."

CIRM Directors to Address Business IP and Lab Grants

Directors of the California stem cell agency meet next Wednesday with a $220 million matter foremost in their minds, but other issues, such as intellectual property rules for grants to businesses, also are up for action.

Criteria and procedures for the $220 million lab grant RFA – the largest single grant effort by CIRM – are likely to dominate the discussion. The meeting is expected to be the last stop before grant applications are sought. California stem cell Chairman Robert Klein is talking about approving the first stage of the grants in January(see item below).

Proposed payback requirements for businesses that receive grants from CIRM, which are part of the IP regulations, are up for possible action. The agenda is vague, but if I were a business interested in having a voice on what could be a multimillion dollar matter, I would want to be present for the Wednesday meeting in San Francisco.

The agenda also includes a proposal for pre-approval of certain Japanese stem cell lines in CIRM-funded research and changes aimed at making it easier to do research in California on reprogramming of somatic cells.

One cryptic agenda item lists consideration of an unspecified proposal from the California State University system. No details were available on the agenda at the time of this writing, but we are attempting to find out more.

Stem Cell Lab Building Plan Heads for Approval Next Week

The California stem cell agency Monday moved forward on its largest single grant effort – a $220 million proposal for new research labs – with hopes that some construction could begin as early as next January.

The Facilities Working Group of the California Institute for Regenerative Medicine (CIRM) sent criteria, evaluation standards and grant review procedures for the lab grants to the agency's Oversight Committee for approval when it meets Aug. 8 in San Francisco.

Major universities and research institutions in California, ranging from Stanford to UC San Diego, are lining up for the money. Some have been planning since November 2004 when Prop. 71 created CIRM and provided it with $3 billion in funding, the largest single financial source for human embryonic stem cell research in the world.

The group did not settle on a firm timetable, but Robert Klein, chairman of the Oversight Committee, said he expected to see initial approval of the grants in early January. He said that would mean that some institutions could begin construction shortly thereafter.

That would be possible under a new, two-step grant review process approved by the working group Monday. It calls for the scientific component of the proposals to be approved first via the scientific grants group with facilities group action later. Klein said high rankings at the first stage of approval (at a yet to be scheduled Oversight meeting early in January) would permit some ambitious institutions to begin work. Jeff Sheehy, a member of the Oversight Committee and the facilities group, said the new process could speed up final approval by at least a month compared to the smaller, shared lab grant review completed earlier this year.

The facilities group also indirectly addressed the ticklish question of dividing the grant money between smaller, less-established institutions and the heavyweights of stem cell research. The proposed grant rules call for applicants to choose as many as three scientific areas where they believe they have strength: basic and discovery research, preclinical research, preclinical development and clinical research. The areas were dubbed, respectively, Element X, Element Y and Element Z.

If a university identifies itself as having strength in all three elements (XYZ), it will compete against other similar XYZ institutions as a “CIRM Institute.” If it has strength in two elements, it will compete as “CIRM Center of Excellence.” If strength is in one area, the competition will be among other single-strength “CIRM Special Programs.”

The grant process places emphasis on value, leverage and urgency, which account for 70 out of 100 possible points. The urgency component (20 points) requires a two-year construction timetable with financial penalties for failing to meet deadlines. The value component( 25 points) calls for a “good return to the taxpayer,” among other things. The leverage component (also 25 points) is aimed at forcing the institutions to come up with major financial support for their proposals in addition to CIRM funding.

Several times the discussion focused on ambiguities in the criteria such as “facility assets,” “enhanced capability” and “reasonable and necessary.” Some of these are likely to be refined as a final RFA is developed. But Klein told the small audience at today's meeting at CIRM headquarters in San Francisco, “We're going to make a lot of subjective decisions.” It was a refrain he came back to several times.

Following the meeting, when we asked him about the difficulties posed for applicants by ambiguous terms, he said they do create challenges. But he said the criteria is designed to “accommodate the creativity” that California institutions have. He and others on the facilities group said they wanted to provide ample opportunity for imaginative approaches to lab construction, management and collaboration.

The facilities group also approved a rule aimed at preventing double-dipping in the grant process. It permits only one application per institution with funding for a single project on a single site. This means, for example, that if a legally constituted consortium applies for a grant, members of that consortium cannot apply for another grant separately.

John M. Simpson, stem cell project director of the Foundation for Consumer and Taxpayer Rights and a longtime attendee at CIRM sessions, praised the overall process for the lab grants. Often a critic of CIRM and the grant process at one point, he said the facilities group meetings benefited both the agency and applicants, generating a higher participation from the applicants/public compared to many other CIRM sessions. That “enhances the output,” he said.

Simpson is correct about the larger turnout, but even that is small, ranging from 30 to 40 persons at its peak during the recent round of meetings. What surprised us is the fact that some potential applicants did not regularly attend the sessions. That means they will miss important nuances that are not available via online transcripts and Power Point presentations. As for attendance by the general public, nobody bothered, but that is not much different than public proceedings at any other state agency.

To see more specifics of what the facilities group considered, see this location. The document is likely to be reposted in several days with changes from today's meeting as part of the Oversight Committee agenda.

Golden Eggs on The Stem Cell Blog

Time to move off this channel briefly and visit The Stem Cell Blog (published by Chris Scott of Stanford) to read a guest posting from this writer on the $220 million lab grant program at the California stem cell agency. It begins:

“You could call it a stem cell variation of the chicken and egg question.

“But in this case, it involves edifices – not eggs. And researchers – not roosters. Which is more important?”

A little later this afternoon we will have an update right here on this site concerning this morning's developments at CIRM. The Facilities Working Group modified the rules for making the lab grants and moved them along to the full Oversight Committee for consideration Aug. 8. The intention is to see at least some institutions begin construction on their approved facilities in January.

ACT, NIH and No Go Federal Funding

Despite all the hoopla on the Potomac about stem cell research, don't expect the federal situation to change any time soon and eliminate the justification for California's own $3 billion stem cell research effort.

The latest evidence for that came in a piece Sunday by Rick Weiss of the Washington Post. It demonstrated the hidebound nature of the NIH as well as the constraints it faces. The piece did not have to mention NIH's tight financial situation.

Here are the first few paragraphs of Weiss' story:

"With the active encouragement of the Bush administration, U.S. scientists in the past year have developed several methods for creating embryonic stem cells without having to destroy human embryos.

"But some who now wish to test their alternatively derived cells have found themselves stymied by an unexpected barrier: President Bush's stem cell policy.

"The 2001 policy says that federal funds may not be used to study embryonic stem cells created after Aug. 9 of that year. It is based on the assumption that the only way to make the cells is by destroying human embryos -- a truism in 2001 but not any longer.

"As a result, the National Institutes of Health recently refused to consider a grant application for what would have been the first federal study to compare several of the new, less politically contentious stem cell lines.

"'This is not the way to make good health policy,'" said Robert Lanza, the frustrated vice president for research and scientific development at Advanced Cell Technology (ACT) in Worcester(see editor's note below), Mass. Lanza submitted the study proposal with stem cell experts from several major research labs."

Even with a change of administration in 2009 and a Democratic Congress, it will take a considerable amount of bureaucratic shuffling to chart a new NIH and federal course on embryonic stem cell research. Then additional funds would have to become available or be taken from existing research – an effort that would be strongly resisted. Some would argue at that point that states are already handsomely financing ESC research, and more is not needed from the feds. Even if funds become become available, then the NIH has to go through another lengthy award process.

(Editor's note: ACT is headquartered in Alameda, California – not in Massachusetts. Why is it in the Golden State? Because that is where the money is. We should also note that a public relations agency for ACT is sending copies of the Weiss story to various interested parties, probably throughout the country. Nothing wrong with that. If you have a drum, you probably should beat it.)

Stanford's Chris Scott and His New Stem Cell Blog

A snappy new blog on stem cell issues has popped up at Stanford University, complete with a reading list and podcasts.

Called "The Stem Cell Blog," it is published by Chris Scott, director of Stanford's Program on Stem Cells in Society and author of the book, "Stem Cell Now." (You can find a picture of Scott here.)

The first post dates back to June 26 with a graphic account about research with live pigs. More recently, the blog has a post based on work by Susan Stayn, Stanford's state stem cell legal expert. Called “What Color is Your State?” it begins like this:

"Taking a cue from Homeland Security, we’ll periodically publish a color-coded ranking of American states and their legislative positions on embryonic stem cell research."

You can also download the state rankings in a PDF file.

We have added The Stem Cell Blog to our links on the left of this site.

Weekend Reading: Guide to a $220 Million Giveaway

For all of you stem cell lab hopefuls, the California stem cell agency has posted 29 pages of Power Point presentations that will be used during Monday's meeting on the $220 million program.

It includes the latest thinking from the “interested parties” meeting earlier this week as well as other fresh developments. We have not yet digested the material, which is a bit complex. But if you have a horse in this race, check it out. Monday's meeting is the last before the massive program comes up at the full Oversight Committee session Aug. 8.

Here is the link to the documents.

CIRM Group Gives Nod to Japanese Cell Lines

The California stem cell agency Friday moved to add some Japanese stem cell lines to two already approved foreign lines and to make it easier for California researchers to engage in experiments to reprogram somatic stem cells.

Meeting in San Francisco in a national teleconference session, the Standards Working Group made positive recommendations in both areas that will be taken up Aug. 8 by the agency's Oversight Committee.

The Japanese lines are ones that are derived under the “Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells.” Geoff Lomax, senior CIRM officer for the standards group, said researchers are seeking as many lines as possible. He also said a delegation of Japanese scientists had requested inclusion of the lines. UK and Canadian stem cell lines already enjoy pre-approval.

The group also discussed the question of varying deadlines for using embryos for derivation of stem cells. Prop. 71 sets a deadline of 12 days after cell division. The Japanese deadline is 14, as is the UK, according to testimony. Bernie Lo, chairman of the standards group, noted that it is not currently
actually possible to derive embryonic stem cells beyond 12 days.

After some discussion, Lo asked CIRM staff to research the issues involved so that CIRM can act quickly when derivations can occur after 12 days.

The group additionally recommended that CIRM permit reprogramming experiments on existing somatic stem cells that do not necessarily meet the informed consent requirements intended to be used for new cell lines. Ann James, senior university counsel for Stanford University, said researchers at her school wanted maximum flexibility.

Kevin Eggan of Harvard, a member of the CIRM group, said such cell lines have been in use for perhaps as long as a decade and represented a valuable starting point for research into how to reprogram adult cells into pluripotent ones – the characteristic that makes human embryonic stem cells so valuable. Others noted that it would be all but impossible to replicate today's informed consent requirements for those older lines.

Patricia Olson, scientific program officer at CIRM, said permitting use of the older lines would only allow CIRM-funded researchers to do what others already do outside of California.

Background material from CIRM on these issues can be found here.

Thomson Report Carried by Nature, Chronicle of Higher Education

Nature magazine and the Chronicle of Higher Education have picked up a report from this blog on Jamie Thomson's ties to UC Santa Barbara.

The report in Nature briefly discussed the flap involving the Wisconsin Alumni Research Foundation's ownership on patents originating from Thomson's work on human embryonic stem cells.

The Chronicle's story on its news blog cited the Nature item as its source. Both publications also mentioned this blogger's report, noting that the Thomson connection helped UCSB win a $2.3 million grant from CIRM.

CIRM Grants: Checks Not in the Mail, Squeaky Clean Review Underway

Directors of the California stem cell agency have approved $170 million in grants so far this year, but none of the money has yet reached researchers, universities or other recipients.

In early June, directors were told that the first wave of the funds -- $45 million approved five months ago -- was likely to receive the administrative go-ahead before the beginning of July. But that schedule has gone by the boards, and it is not clear exactly when the checks will ultimately be sent.

At the heart of the issue is the review of the details of the grants that occurs following their approval by the Oversight Committee.

Arlene Chiu, interim chief scientific officer for CIRM, told the committee last month, "We strive to be good stewards of the public's money."

Each one of the 117 proposals is examined by CIRM staff for compliance with its rules and state law. Slowing the process are the newness of the procedures, the small size of the CIRM staff(about 25)and even the speed at which the recipient institutions respond to requests for additional information. It is fair to say that universities do not necessarily act speedily even when millions of revenue are on the line.

CIRM has also been without a permanent president since the beginning of May, raising the possibility that the process might be moving faster with a permanent CEO in place. However, Dale Carlson, chief communications officer for CIRM, said, "I’ll tell you categorically that’s not a factor."

We asked Carlson about the funding process. Here is his reply verbatim:

"The length of time reflects several factors. First, we are looking at a large number of approved grant applications, particularly relative to the staff available to conduct the administrative review.

"Second, the requested costs on every application need to be carefully reviewed to ensure that they are accurate and in keeping with our policies. Facilities and indirect cost reimbursement rates also need to be checked, verified, and may need to be adjusted to fall in line with prevailing rates from other national grant-making institutions.

"This too is proving more time-consuming than we'd originally estimated.

"Third, some institutions are more prompt than others in responding to requests for documentation.

"This is still a new exercise for us. We're being very careful and thorough to ensure we get it right. It should go faster in the future.

"Fortunately, the recipient institutions understand that we are working with a new and small staff, and are by and large being very patient with our process. I think they share our interest in seeing this exercise properly completed, as it should generate efficiencies down the road.

"We are making every effort to send out all the notices of grant award (NGAs) in the coming weeks. The release of funds by the State Controller's Office follows the return of signed certification statements, and we obviously have no control over how quickly institutions turn those around."

Caution and care are to be commended in the case of this review. CIRM is still an infant organization. Laying a good groundwork for the future remains paramount. Plus financial foulups are viewed harshly in the media. Witness the stories earlier this spring about expensive lunches by some CIRM directors, a trivial expense that some reporters focused on in their stories about a state audit of CIRM. Bigger numbers would generate bigger and more unfavorable stories with a negative impact on CIRM's reputation.

CIRM Presidential Search: No Announcement Yet

Directors of the California stem cell agency failed to take public action today for the third time in the last month in their seven month search for a new president.

No announcement was made following the closed door session of the Oversight Committee. The last words – "progress is being made" – came from stem cell chairman Robert Klein on July 12. Klein had expected to fill the position by June.

Lab Grant Evaluation Standards

The evaluation standards for the $220 million lab grant program have now been posted on the CIRM website and are available here.

Upcoming This Week: Japanese Stem Cell Lines, Lab Grants and Presidential Search

From $220 million in lab grants and Japanese stem cell lines to the latest chapter in the search for a CEO, the California stem cell agency is set for a busy week.

We want to point out the background material prepared for the Standards Working Group meeting on Friday. Posted last week well before the meeting, the paper neatly summarized the history behind the matters being considered, touched on the issues involved and offered up draft language to deal with the problem in two cases. It was a good example of staff work that improves the decision-making process.

The standards group, which regulates CIRM-funded research, will consider whether to include some Japanese stem cell lines as "approved" for study. They would join some lines from Great Britain and Canada as ready to use. That means that research using them does not have to go through a more lengthy review process. Specifically, the Japanese lines being considered are ones derived under the "Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells."

The group is also scheduled to consider a problem in connection with informed consent requirements and research involving somatic cell lines. The agency's regulations created a situation in which "existing somatic cell lines obtained with informed consent may not be available for reprogramming experiments unless consent was obtained in accordance with the exact requirements of section 100100 (of CIRM regulations)."

The staff report said,

"The SWG might consider a more flexible standard for use of somatic cells. Interviews with leading researchers suggest the inability to utilize commonly available commercial somatic cells (non-covered stem cell lines) lines would limit CIRM-funded researchers from attempting to replicate studies."

On Wednesday, CIRM will conduct a session for "interested parties" on the $220 million lab grant effort. Proposed evaluation standards are scheduled to be posted Monday on the CIRM web site. Earlier, the agency posted the criteria and scoring. On July 30, the Facilities Working Group will wrestle with the subject once again, but the ball is rolling faster, so you applicants should pay close attention. Don't be shy about communicating with the agency if you can't be at the meetings.

On Tuesday, the Oversight Committee will convene for the third time in a month for a special, teleconference meeting to consider presidential compensation and candidates. They are legally equipped to come to a decision in their seven-month effort. But our bet is that no new president will be announced.

Nature Magazine Trumpets California 'Upstart'

The California stem cell agency's $85 million faculty awards program received some attention today on the website of Nature magazine.

A brief piece by Monya Baker noted that the program had been announced by "an upstart state-funded initiative to make California a stem-cell research hub."

She wrote:

"US biomedics moving from postdoc to independent research often struggle to find stable sources of funding. New investigators receive only 6% of US National Institutes of Health (NIH) R01 awards, the multi-year grants that US universities rely on. Similar to R01, the CIRM grants will fund direct project costs of $300,000 for academics and $400,000 for clinicians. Worries over money hamper long-term thinking, says Xianmin Zeng of the Buck Institute in Novato, California, who plans to apply. Many foundations give only small amounts of money over one or two years, she says. 'For young investigators to get a stable environment, they need a stable foundation,' Zeng says."

Klein Rebuffed in Lobbying Effort for New Stem Cell Nonprofit

California stem cell Chairman Robert Klein -- and associates -- Tuesday failed in their initial efforts to secure a land use change that would have swapped Northern California farmland for a new, nonprofit stem cell research institute that Klein would have chaired.

The proposal was put off by Yolo County supervisors during an angry meeting, reported Mary Lynne Vellinga of The Sacramento Bee. However, the proposal is not likely to vanish. Its chief backer, developer Angelo Tsakopoulos, is a persistent businessman. The stem cell proposal was one of three land use proposals that the supervisors were considering. Vellinga wrote:

"Tuesday's vote shelves -- at least for now -- a proposal by Sacramento developer Angelo K. Tsakopoulos to build an incubator for stem cell research just south of Interstate 80 outside Davis, and to fund it with profits from the construction of an unspecified number of homes.

"The county has been considering inclusion of some 1,500 acres, about 60 percent of the land owned by Tsakopoulos, for an 'innovation corridor' targeting life science and biotechnolgy.

"A bevy of stem cell experts, researchers and accident victims in wheelchairs -- including Ms. Wheelchair California -- turned out Tuesday to support the idea.

"'With your approval, the suffering people would have hope,' said Roman Reed, who was paralyzed when he broke his neck playing football. A state law named after Reed sets aside money for paralysis research.

Robert Klein, chairman of the state-funded California Institute for Regenerative Medicine, also made an appearance. He has been working with Tsakopoulos to promote the idea of a center, which he plans to head.

The supervisors took pains to stress that they would love to see a stem cell research center built in Yolo County but don't support the idea of building housing on the valuable farmland next to the Yolo Bypass. “'The money (for the center) comes from building the houses; that's not something I can support in that area, no matter how much I care,' Thomson said.”

For more on this issue, see the Yolo item below. Searching on the label Yolo will also turn up additional items.