Friday, August 10, 2007

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.

Thursday, August 09, 2007

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.

Wednesday, August 08, 2007

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."

Tuesday, August 07, 2007

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.

Monday, August 06, 2007

$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.”

Sunday, August 05, 2007

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.)

Friday, August 03, 2007

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."

Thursday, August 02, 2007

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.

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