Former Top Exec at Stem Cell Agency Appointed President of Huntington Medical

The former chief scientific officer of the California stem cell agency, Marie Csete, yesterday was named the president of the $53 million Huntington Medical Research Institutes in Pasadena, Ca.

Marie Csete, Huntington photo

Csete left the stem cell agency in 2009, after serving for a little more than a year. Her departure involved tension between her and former agency President Alan Trounson.  She told the journal Nature,

"When it became clear to me that my considered clinical advice was not respected, I concluded that it made no sense for me to stay at CIRM.”

Csete was the last person to hold the position of chief scientific officer at the agency. Trounson left the agency in July last year.

Huntington reported assets of $53 million in late 2013 and funds a wide variety of research. 

Trounson Resigns as President of $3 Billion California Stem Cell Agency

The California stem cell agency today announced the resignation of Alan Trounson, who has served for nearly six years as president of the $3 billion research enterprise.

Trounson, an internationally known pioneer in IVF research, said he was resigning so that he could rejoin his family in Australia, where he has spent most of his personal and professional life.

Trounson's wife and youngest son moved back to Australia from California about three years ago. In a news release from the stem cell agency, Trounson said,

“(T)he agency needs a full-time president, and I need to spend more time with my family. The two needs are incompatible, so it is necessary for me to step down as president."

In an email to the California Stem Cell Report, Trounson said,

“I have a 12-year old son who misses me terribly for the last 2.5 years we have been separated (as do the other 3 older children). I have sacrificed considerable personal family rewards to continue to commit to driving CIRM's vision.”

Trounson joined the California Institute of Regenerative Medicine (CIRM), as the agency is formally known, in late 2007. He was personally recruited by Robert Klein, the first chairman of the stem cell agency, during a trip to Australia. Trounson also said today that then Gov. Schwarzenegger asked him to serve.

During Trounson's tenure, the agency's portfolio has soared from $283 million and 156 awards to its current $1.9 billion and 570 awards. It has about $600 million remaining in uncommitted funds.

Trounson's departure comes at a critical moment for the agency, which is trying to find a way to continue with major operations beyond 2017, when the money for new grants will run out. It is also pressing hard to commercialize stem cell research, the primary goal of Prop. 71, the ballot initiative that created the agency in 2017.

CIRM said Trounson has agreed to stay on as the agency begins its search for a new president. The agency said it is discussing the possibility of some sort continued affiliation for Trounson with the stem cell effort.

Members of the agency's governing board had high praise for Trounson today. Jonathan Thomas, chairman of the board, said in the CIRM news release that Trounson helped established the agency as a “world leader.”

“He has led us through some challenging times, been the driving force behind some truly innovative ideas – such as the Bridges and Creativity Training Programs, the Alpha Clinic model for delivering new therapies to patients, a stem cell genomics program and an iPS cell bank for interrogating the cause and developing new treatments for really serious and complex diseases.”

Sherry Lansing, chair of the directors' Governance Subcommittee and a former Hollywood studio head and former chair of the University of California regents, described Trounson as an “irresistible force.” She said,

“We are much, much closer to cures, thanks to his efforts."

Trounson's years at CIRM were not without controversy. In 2009, Marie Csete left the agency as its chief scientific officer. She told the journal Nature her advice was “not respected” at the agency.

This year, news surfaced on the California Stem Cell Report concerning Trounson's conduct in connection with a $21,630 gift from Klein to the agency along with a conflict-of-interest case involving a scientific grant reviewer who Trounson recruited.

The stem cell agency has had difficulties recruiting candidates for president in the past -- for among other reasons -- the early legal challenges and because of its dual executive arrangement legally dictated by Prop. 71. The dual CEO situation means that the chairman and president have overlapping responsibilities. CIRM is also an unusual mix, at least for a state agency, of science, academia, business and politics. Previous presidential searches also have become enmeshed in an internal debate over whether the president should be a big name scientist or more of an administrator.

The agency currently has new challenges that include creation of a“strategic road map” for its future and tough decisions on which projects to back for commercialization – not to mention the agency's short life span if it cannot find new financing.

In response to a query, Kevin McCormack, a spokesman for the agency said no severance is being provided to Trounson. The spokesman said Trounson's current salary is $490,008, the same as when he joined the agency.

You can find the CIRM press release here. Here is the text of Trounson's email to the California Stem Cell Report.

Amgen Exec Named to New VP Post at California Stem Cell Agency

The California stem cell agency today named Ellen Feigal, an executive at Amgen, Inc., to the new position of vice president for research and development.

Feigal(left) with Claire Pomeroy, dean of
 the  UC Davis School of Medicine in 2007
 at an awards ceremony involving Feigal.
 Pomeroy is also a member of the
CIRM board of directors.

She will begin work at the $3 billion research enterprise Jan. 31, leaving her current post as executive medical director for global development at Amgen, which is based in Thousand Oaks, Ca., north of Los Angeles.

Feigal will fill a position that has been vacant since the summer of 2009, basically the No. 2 spot at CIRM. CIRM President Alan Trounson created the post in the wake of the departure of Marie Csete as chief scientific officer. The VP position replaces the chief scientific officer position.

The vice president's position has a salary range that runs from $286,000 to $529,100. It is the same range as for chairman or president of CIRM. In response to a query, Don Gibbons, the agency's chief of communications, said Feigal would be paid $332.000.

CIRM's press release said,

"Feigal will report to Trounson and will work closely with other CIRM executives to build and manage the pre-clinical and clinical programs, both within California and with CIRM’s international collaborators, as well as interactions with the NIH, FDA and other regulatory bodies. She will also manage the assembly and oversight of CIRM’s clinical advisory committee that will assess project progress, milestones and go/no-go decisions. A key aspect of her portfolio will be working with the biotechnology, pharmaceutical and investment sectors as well as academia to enable and enhance development of clinical applications from CIRM’s science portfolio."

Trounson said,

“As CIRM matured and moved more of its resources into translational and clinical science, we saw the need to formalize a role for a vice president for research and development, and Ellen’s career trajectory and experience fill our vision for that role perfectly."

The CIRM press release said,

"Feigal distinguished herself in many positions in academia, the federal government, non-profit research organizations, small pharma and large biotech companies. She has focused on assessing novel therapies, training young investigators in how to assess novel therapies, and in building partnerships and coalitions to enhance translational research. In her position at Amgen she also led the scientific/clinical interface with patient advocacy organizations and formalized the company’s policy on expanded access to therapies for those with limited or no treatment options."

The news release continued,

"In addition to her work at Amgen, Feigal currently serves as Adjunct Professor and Director of the American Course on Drug Development and Regulatory Sciences at the University of California, San Francisco. The course, developed under her leadership in collaboration with the FDA, UCSF’s Department of Bioengineering and Therapeutic Sciences, its Center for Drug Development Sciences and the European Center of Pharmaceutical Medicine at the University of Basel, was launched in 2007. It is taught over two years, with six sessions, each four days in length in Washington, D.C. and a separate parallel course in San Francisco. Feigal will step down as course director and adjunct professor as she takes on this new position at CIRM."

In 2007, Feigal received UC Davis Health System's first-ever "Transformational Leadership Award," which honors someone who has “enhanced the profession, improved the welfare of the general public, provided for personal distinction and brought honor to our university.”

UC Davis said,

"Her collaborative work with organizations such as the Food and Drug Administration, National Cancer Institute, Translational Genomics Institute and Critical Path Institute are helping to cut through red tape and bring life-saving drugs to patients as quickly and safely as possible."

Science Magazine Assesses CIRM: 'The Good, Bad and Ugly'

Science magazine examined California's $3 billion stem cell research effort in a piece published during the holidays, and the third paragraph of the story began with this quote,

“It's the usual CIRM circus.”

Whether one thinks the comment was well-deserved or not, it falls far short of the type of publicity that the agency needs, especially as it considers mounting a bid to secure an additional $5 billion from California voters.

Overall, the two-page article was pretty much a straight-forward overview of where CIRM stands at the beginning of 2011. The story began, however, with a look at the shenanigans of CIRM Chairman Robert Klein as he tried unsuccessfully last year to hand pick his successor. And that was what triggered the “CIRM circus” comment from Marie Csete, former chief scientific officer for CIRM.

The piece by Greg Miller was entitled, “CIRM: The Good, the Bad And the Ugly” – another less-than-felicitous phrase concerning the public agency. The article covered the basics: dollars handed out, labs built, concerns about high salaries and conflicts of interest and the recent external review report. It noted that many scientists view CIRM as a “tremendous success.” But it also reported that patient advocates “are tired of waiting for stem cell cures.” Miller's article continued,

“...(E)ven CIRM supporters say the institute has to improve its relationships with industry if it hopes to fulfill its mandate: generating stem cell therapies that help people suffering from conditions like diabetes and Parkinson’s disease. A recent report by a panel of external scientists convened by the CIRM board said translating basic science into therapies should be a major priority going forward.”

Miller wrote,

“Not surprisingly, CIRM grantees are not complaining. 'I just moved into a spectacular new building,' says Arnold Kriegstein, the director of the new Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California, San Francisco (UCSF). CIRM kicked in $35 million for the new facility, about a third of its cost.”

(Editor's note: UCSF has received $111 million in grants. The dean of its medical school sits on the CIRM board of directors, as do several other medical school deans whose institutions have received hundreds of million dollars.)

The article continued,

“Several California biotech leaders say they have been frustrated by their interactions with CIRM. 'In the past, there’s been a lack of recognition that it takes a company to actually take a treatment forward from the bench top into the clinic,' says Chris Airriess, chief operating officer of California Stem Cell Inc. in Irvine. Airriess says his company has twice applied, unsuccessfully, for CIRM money. He and others place much of the blame on the review process, which he says is structured too much like the NIH review process for academic research grants. CIRM reviewers criticized his company’s applications for the lack of new science, but Airriess says that misses the point. 'Companies are trying to stabilize a technology and commercialize it rather than push the bleeding edge,' he says.

“Even companies that have succeeded say it hasn’t been easy. Earlier this year, San Francisco–based iPierian won a $6 million early translation award and a $1.5 million basic biology award. 'We put a ton of effort into understanding what was being asked for,' says CEO Michael Venuti.”

Science magazine concluded,

“CIRM President Alan Trounson says he is sensitive to these (industry) concerns but doesn’t think the review process is problematic: 'Companies that have put in well-formed proposals have done very well.' But he acknowledges that CIRM has had difficulty attracting proposals, particularly from larger companies. He’d like to set up an industry advisory board to help improve industry relations.

“In the coming months, he and others will be waiting anxiously to see who succeeds Klein as chair. Patient advocates want an advocate at the helm. Scientists would prefer a scientist. Trounson, who may have to work most closely with the new boss, says he’s hoping for someone with expertise in the delivery stage of therapeutic development. 'The basic science, as long as we look after it, will take care of itself,' he says. The real challenge for CIRM, he says, is getting the science into the clinic. 'We need more help on how to make it all happen.'”

In terms of the negative information in the piece, one thing helpful to CIRM is that the article is tucked away behind a subscription barrier, so it is not likely to be available to mainstream journalists (whose employers are notoriously cheap) as they do research on the agency. Nonetheless, the article is likely to be checked by most scientists interested in CIRM affairs and quite possibly by any potential, major contributors to an election campaign for more billions for the agency.

But the real problem is not with the publicity or the slant of the article – it is with the actions of Klein and the agency. There would have been little dubious to write about concerning the choice of a new chair if Klein had not tried to engineer the selection of his successor in a closed-door process that raised charges of conflict of interest. And as far as issues with the biotech industry go, those have been apparent for several years, but little has been done to deal with them.

(If you are interested in receiving the entire article, please email a request to djensen@californiastemcellreport.com, and I will send it to you.)

$250,000, Six-Month Contract for CIRM's Lewis

The new interim vice president for research and development at the California stem cell agency holds a $250,000, six-month contract that calls for him to push hard to develop clinical applications that CIRM hopes will demonstrate the success of its $3 billion effort.

The hiring -- as a consultant -- of Alan Lewis (at right), onetime head of ViaCyte, Inc. of San Diego (formerly Novocell) and the Juvenile Diabetes Research Foundation,  brings at least a temporary halt to the search to fill the new VP post that was created after Marie Csete resigned suddenly as chief scientific officer. The CIRM Web site no longer lists the VP position as available.

CIRM President Alan Trounson sought unsuccessfully for a nearly a year to fill the job. This spring he appeared to have run afoul of resistance to his plans for compensation for the post, which would normally top out at $332,000 annually if the position were filled by a regular CIRM employee.

Under the terms of Lewis' contract, he is expected to work about 24 hours a week and meet with CIRM officials at least once a week at the agency's San Francisco headquarters. (CIRM provided an unsigned copy of the contract, which is a public document, at the request of the California Stem Cell Report.)

Lewis is the third top executive of CIRM to be working on a part-time, paid basis. The others are CIRM Chairman Robert Klein, who receives $150,000 for half-time work, and co-Vice Chairman Art Torres, who is paid $225,000 for four days a week. By way of contrast, CIRM President Alan Trounson receives $490,008 annually for fulltime work.

Lewis' agreement runs from June 21 through the end of this year at a rate of $2,500 a day, “with pro-ration (sic) for less than four hours.” The contract is capped at $250,000 not including travel expenses.

On June 23, Trounson told the CIRM governing board that Lewis would be serving as a consultant two or three days a week "to help us with the clinical, preclinical programs." Trounson did not mention that Lewis would carry the title of interim vice president for research and development nor did he mention the size of the contract. If it had been above $250,000, it would have required director approval.   

Lewis is expected to travel widely and possibly internationally. Trips from his home in Solana Beach near San Diego in Southern California to CIRM's headquarters will be paid for by CIRM.

Lewis has had a long business career, which raises questions about possible conflicts of interest. In addition to Novocell, he worked for Signal Pharmaceuticals and Celgene in the San Diego area. He left Novocell in 2008 to work for the diabetes group. The CIRM contract said Lewis affirmed that “there exists no actual or potential conflict between the consultant's family, business or financial interest and the services provided under this agreement.”

ViaCyte is the recipient of more than $26 million in awards from CIRM.

Lewis must file a statement of economic interests that is required of most state officials. We have asked CIRM for a copy of that document.

Here is how the contract describes Lewis' responsibilities:

“• Consult Senior Management on biotechnology, pharmaceutical and investment sectors to enable and enhance the development of clinical applications in CIRM’s scientific portfolio.
“• Consult on the preclinical and clinical development phases of CIRM’s programs and projects involving not-for-profit and for-profit teams, including assembling and working closely with CIRM advisory committees to provide oversight of these programs and make go/no go recommendations to the President for continuation of CIRM support.
“• Work in close collaboration with the Executive Director of Scientific Activities.
“• Integrate basic discoveries where possible into the translational and preclinical pipeline and identifies gaps in CIRM’s scientific program for delivery of cell therapies and related products.
“• Develop and implements strategies to aid clinical applications such as in the critical areas of manufacturing, drug and cell product safety and efficacy.
“• Consult Senior Management regarding interface approaches with national and international regulatory organizations”

The contract differs somewhat from the CIRM news release on Lewis. It said that he would “take direction” from the executive director of scientific affairs – not work in collaboration. This is of significance because their duties overlap and could be a source of friction if not carefully managed.

(Photo from San Diego Union-Tribune)

(Editor's note: An earlier version of this item incorrectly said that Lewis' contract was not mentioned by Trounson at the June CIRM board meeting.)

Former Novocell/JDRF Chief Hooking Up With CIRM

Alan Lewis, the fomer head of Novocell (now ViaCyte, Inc.) and the Juvenile Diabetes Research Foundation, will be joining the $3 billion California stem cell agency shortly, the California Stem Cell Report has learned.

It is not clear what his responsibilities will include or whether he will be serving as a consultant or on staff. The agency has been seeking a vice president for research and development for nearly a year.

CIRM President Alan Trounson created the vice president's position after Marie Csete resigned abruptly as CIRM's chief scientific officer about 12 months ago. Trounson said he would not fill the post of chief scientific officer. Instead, Trounson came up with the new VP position and said he would seek someone with industry experience. He seemed to have a candidate ready this spring. The CIRM board convened closed-door meetings to discuss compensation for the post, but the sessions ended with no announcement.

Lewis, however, could be filling another position either on staff or as an outside consultant. Lewis resigned as head of JDRF in May for personal reasons. He said he would be returning to Southern California to be with his family.

He joined JDRF in January 2010. He served as president of Novocell from 2006 until he left for the foundation. CIRM Chairman Robert Klein has also been involved in juvenile diabetes issues and was recognized in 2006 as “public service leader of the year” by JDRF. After Lewis left Novocell, it received a $20 million loan from the agency. ViaCyte/Novocell has received four awards from CIRM for a total of $26.3 million.

We queried CIRM concerning Lewis. The agency was noncommital. Lewis could not be reached for comment.

CIRM Moving to Hire VP at More Than $332,000

The California stem cell agency may well have a new vice president of research and development by the end of this month and at a salary exceeding the $332,000 allotted for the position.

CIRM directors will meet one week from today to consider raising the existing pay range for the position. CIRM President Alan Trounson obviously has a candidate that wants more than $332,000, and the board is not likely to reject Trounson's choice. To do so would indicate a lack of confidence in Trounson.

CIRM has not disclosed exactly what the new salary will be or explained why it is needed. Don't look for that information until the day of the meeting and probably only if you are in attendance at one of the telephonic meeting locations around the state. CIRM generally has not posted such sensitive salary information in advance of meetings.

Trounson was eager to find someone with industry experience. Last July, Trounson told directors that he wanted “someone with the skill base to have more of a focus in their role with biotech/pharma – translation – clinical applications, which is where we are moving with our translational, disease teams and clinical grants and where we are thin in capacity.”

Trounson hired Levin and Company at a cost of $100,000 to help with the search.

The new position was created by Trounson after Marie Csete resigned suddenly last June as CIRM's chief scientific officer. She said her advice was not respected. Her position will not be filled, but her responsibilities are being parcelled out to the new VP and Patricia Olson, executive director of scientific activities, who has been with the agency since its early days. Under a new structure announced last August, Olson reports directly to Trounson as will the new VP. Previously Olson reported to the chief scientific officer.

The compensation for the new post was scheduled to come up at the CIRM board meeting earlier this month in the State Capitol. CIRM chairman Robert Klein took the matter off the table the day of the meeting, saying negotiations were not at the right stage.

The move came on the same day as The Sacramento Bee carried a front page story that said California state workers received 4 percent less pay last year than in 2008 as a result of the state's financial crisis. Approval of a salary beyond $332,000 creates a public relations risk for CIRM, given the severe cutbacks elsewhere around the state. CIRM's salaries are already quite generous compared to other state agencies.

Salaries are easy for the public to criticize and to understand, especially compared to arcane scientific studies that may not seem immediately relevant to many people. Additionally, boosting a $332,000 salary without telling the public in advance why or specifying the size of the increase plays into the hands of those who are critical of CIRM's lack of transparency and openness.

The new VP will have a financial impact on CIRM beyond the salary. He or she is expected to have at least two or more staffers assigned to work for him or her. They will be new hires at CIRM, which is already chafing under the legal limit of 50 employees. In fact, Trounson has warned that the quality of work could slip unless a way is found to circumvent or repeal the cap.

Another matter is on the table as well next Monday. The item says,

"Consideration of guidance and CIRM’s Medical and Ethical Standards regarding use of previously NIH approved lines in CIRM-funded research and additional lines that are comparable to CIRM’s recommendations to the NIH and/or would be grandfathered or approved under those recommendations.”

No further explanation was offered by CIRM.

Interested parties can take part in the board proceedings at teleconference locations throughout the state including San Francisco(4), Los Angeles(2), La Jolla(2), San Diego, Duarte, Berkeley, Sacramento, Pleasanton and Healdsburg. More locations could be added in the next few days. Specific addresses can be found on the agenda.

Fomer Top Exec at CIRM Hired by San Diego Firm

The former chief scientific officer for the California stem cell agency, Marie Csete, has landed at a San Diego firm, where she has been named executive vice president for research and development.

Csete resigned from her state government post last June, creating a bit of a stir. She told Nature magazine that her advice was not respected at the $3 billion stem cell agency.

Csete has joined Organovo, Inc., a privately held regenerative medicine company that is focused on creating tissue on demand for research and surgical applications.

The company's news release yesterday quoted the company's president, Keith Murphy, as saying,

"She has extensive experience in clinical transplant and is a leader in the understanding of stem cell behavior. In her previous role, Marie was instrumental in fostering translation of early technologies to practical results. Marie is an excellent fit to lead the company's efforts to move our therapeutic pipeline rapidly to the clinic."

Instead of filling Csete's position as chief scientific officer, CIRM President Alan Trounson created the new post of vice president of research and development. That job is not yet filled.

The only media coverage of Csete's appointment that we could find was in the San Diego Business Journal, a brief story by Heather Chambers.

Rundown on Grant Termination Stories

Our grant termination story last week is continuing to draw readers. However, other stories were carried as far back as last April. Here is a complete list of articles on the subject.

April 24, 2009
CIRM: Some Scientists' Grants to be Pulled
Some researchers who have been funded by California's $3 billion stem cell agency are going to lose their grants because of a lack of progress, according to a top CIRM official.

June 14, 2009
CIRM Pulls a Grant, Aggressive Monitoring Reported
In what appears to be a first, the California stem cell agency has pulled at least one grant from one of its researchers, apparently because of a lack of progress.

June 17, 2009
CIRM Pulls Three Grants from Researchers
SAN DIEGO -- The California stem cell agency tonight said it has terminated three research grants for lack of progress, but declined to release immediately the names of the researchers or the institutions involved.

Nov. 2, 2009
CIRM Scrutinizes Grantee Performance: The Tale of Three Terminations
Playing the rich uncle to California stem cell researchers is unquestionably satisfying, but the folks at the state's $3 billion stem cell agency sometimes bear messages for scientists that may be less than warmly received.

Text of Csete's Description of CIRM Grant Monitoring

CSCR Withholds Names of Terminated Grantees to Avoid Unnecessary Harm
The California Stem Cell Report is not naming the three scientists whose grants were terminated by the state's stem cell agency because doing so would unnecessarily damage their reputations.

CIRM as Regulator, Compliance Enforcer
In addition to handing out $3 billion in grants to California stem cell researchers, CIRM is also a regulator, monitoring the conduct of its grantees' research to ensure they adhere to the agency's stringent ethical standards.

Nov. 5, 2009
More on the Tale of Three Terminations
Some confusion has arisen in connection with a story in the Scientist magazine concerning our account of the termination of three grants by the California stem cell agency. In an attempt to clarify the situation, we are providing more information on the decision by the California Stem Cell Report to withhold the names of the researchers and also on the actions of the California stem cell agency.

More on the Tale of Three Terminations

Some confusion has arisen in connection with a story in the Scientist magazine concerning our account of the termination of three grants by the California stem cell agency.

In an attempt to clarify the situation, we are providing more information on the decision by the California Stem Cell Report to withhold the names of the researchers and also on the actions of the California stem cell agency.

CIRM was slow to release the information, which by state law is public record, but the agency did not withhold it. Here is the string of events.

Last June, I was at the CIRM board meeting at which Marie Csete , then CIRM's chief scientific officer, gave her account of how the CIRM SEED grants were monitored. (CSCR carried the text of her remarks and those of directors in the four related items posted this week.)

At the meeting, I asked both the CIRM attorney, James Harrison, and the chief communications officer, Don Gibbons, for the names. They asked for a week or so delay in providing them in order to be sure the researchers had been told their names were public record and to discuss the matter with CIRM's executive committee. Given the potential impact on the researchers, that seemed appropriate.

Some weeks passed, and I still had not heard back. So I queried Gibbons by email concerning the names. He ultimately provided information that led to their identification.

Over the decades that I have spent as a reporter and editor, my practice then and now is to publish the names of individuals involved in public matters. In the case of CIRM, the agency leads an unprecedented, $6 billion (including interest) experiment with taxpayer dollars that could have a major impact on science, making it all the more important that the agency be critically examined.

That said, it is incumbent on journalists to consider the personal and professional impact of the publication of names on the individuals involved, many of whom are secondary to the matter at hand. In marginal cases, editors and reporters should weigh the pros and cons of such publication and whether the potential damage outweighs the possible public good. In this case, some of the questions for me were: Will better policy result if the individuals are identified? Was there wrongdoing? Is it unfair to single out these individuals while others who may be involved in more serious misdeeds (say for example, possibly some NIH grant recipients) remain anonymous?

Given current practices surrounding government research grants, public disclosure of the names in this case would carry a great potential for harm to the individuals and little public benefit. The problem is largely created by NIH grant monitoring practices, among others. As I understand it, the NIH rarely, if ever terminates a grant for lack of progress. When NIH grants are terminated, they appear to involve cases of malfeasance or some sort of wrongdoing. Such does not appear to be the case involving the three CIRM grants. However, the perception in the scientific community, right or wrong, is certain to be colored by the NIH approach. I also think it is fair to say that many CIRM researchers are not accustomed to CIRM's monitoring, particularly the three researchers, all of whom have long and respected careers.

Probably the most important question raised by this case is: Why does the NIH give away money and not monitor the grant progress much as CIRM does? CIRM Director Floyd Bloom, former editor-in-chief of Science magazine, said that under NIH practices a researcher is free to "change directions, convert personnel into equipment funds, and essentially re-program the proposed project." It may be stretching it a bit, but some folks from Enron and WorldCom are serving prison time for doing much the same thing.

As for CIRM's openness and transparency, given decades of experience with California state government, it is not much different than many state agencies, which is not a high hurdle. CIRM certainly could do better, especially considering the conflicts of interest that are built into its board.

The agency has pledged to adhere to the highest standards of openness but has fallen short of that measure, which goes beyond mere legal requirements. For example, CIRM's 29 directors and additional top management must file statements of economic interest under the state's conflict of interest laws. The governor of the state of California posts his statement online along with the top officials in his administration. CIRM does not meet that standard. Instead, interested parties must make a specific request for a public record that is not on the CIRM Web site. Responses on records requests sometimes take weeks and weeks. CIRM refuses to disclose in any form the economic interest reports from the reviewers who make the de facto decisions on grant applications. That makes it all but impossible for grant applicants or the public to determine if conflicts exist. CIRM also regularly fails to post important background material well in advance of its directors meeting, meaning that interested parties do not have enough time to comment intelligently or make plans to attend the meetings. More examples could be cited.

The Scientist story has generated little comment on its Web site, but one remark caught my eye today. Rafaela Canete-Soler said,

“The (monitoring and termination) policy at the CIRM seems to me timely and appropriate. By the tone of the article and the sentiments of the researchers, I can only express my admiration for them, as well as for CIRM and the way the evaluation seems to have taken place. We all know that projects and ideas do not always work the way that we had planned.

“I once heard that changes for the best almost always happen first in California, then in the United States and then in the rest of the world. The policy of NIH of liberty to take the research where it leads you does not appear to be sustainable any longer. For a very simple reason: resources are finite. Priorities and objectives, particularly those proposed by researcher, and for which they are funded, are to be followed up and nurtured within the framework of a sound and healthy competition system.”

CIRM Scrutinizes Grantee Performance: The Tale of Three Terminations

Playing the rich uncle to California stem cell researchers is unquestionably satisfying, but the folks at the state's $3 billion stem cell agency sometimes bear messages for scientists that may be less than warmly received.

That's when they become regulators and stewards of the public's money. Particularly when they exercise that responsibility in a more rigorous way than is the practice at the NIH.

CIRM is not making much of the fact that it has revoked three grants because of a lack of progress. It took us more than a month to secure the identities of the researchers who fell under CIRM's scrutiny. The agency, however, should take pride in its oversight. It enhances the credibility of the $3 billion agency and serves notice to all grantees that CIRM is more than a sugar daddy and takes its responsibilities seriously.

Only four months ago, CIRM directors heard a report on monitoring of grants that merits attention following approval of the largest research grant round in the agency's five-year history. The $230 million in disease team grants pose special challenges for the tiny agency. Its staff, currently without a chief scientific officer, will be called on to make go, no-go decisions on continued funding as researchers hit or miss bench marks in projects involving as much as $20 million.

One can only imagine the ruckus if CIRM staff recommends that funding be halted on a $20 million, four-year grant involving such high-profile and respected institutions as UC San Francisco, UCLA, Stanford, Salk and City of Hope, among others.

CIRM opened the window a bit on its oversight of grants at the board meeting in San Diego last June. Marie Csete, then chief scientific officer for CIRM, described in a positive fashion her office's monitoring of the $45 million SEED program, the first ever research grants by CIRM. She said CIRM's efforts saved some grants that would have perished. But it took a question from director Ricardo Azziz, chairman of the Department of Obstetrics and Gynecology at Cedars-Sinai Medicial Center, to bring out the information that three grants had been terminated.

As for the issues raised during the monitoring, Csete said,

“In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. Institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the (grants) out the door for various reasons.”

CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication, at Scripps, praised Csete and her staff's work. He said,

“This kind of nurturing, interactive relationship with the PIs's is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push.”

We spoke by telephone with two scientists whose grants were revoked and exchanged email with the third, who was out of the country. None are particularly pleased about losing their grants, but their comments offer insight into the process. We are not identifying them in this piece. To do so would place an unnecessary onus on them, given the current practices in the scientific grant community and the different monitoring procedures at the NIH. None of the issues with the grants appear to involve malfeasance.

One of the researchers said he was “bitter” about CIRM's action, declaring it caused a “huge uproar” at his institution. (Prior to our conversation, we had heard unconfirmed reports about significant unhappiness on the part of recipient institutions.) This researcher said CIRM's monitoring practices were a departure from those of the NIH, which allows “the liberty to take the research where it leads you.” Nonetheless, he continues to support CIRM.

Another scientist said he parted “amicably” with CIRM but confirmed that its practices are different than the those of the NIH. (The NIH has not responded to our queries concerning how many grants it has revoked for lack of progress.)

This researcher told us,

“I think that it is very important for CIRM to closely monitor its grantees. As a California taxpayer, I want to know that state revenues supporting the CIRM effort are well utilized. Furthermore, CIRM (and its grantees) need to make good on the promise of translating the science of stem cell biology into novel therapies.”

The third told us in an email that his grant had been “prematurely terminated.” He said the work has been completed without the CIRM support and the research accepted for publication in a prestigious journal next year. He also called CIRM a “great organization” and expressed the hope that it will lead to “great cures.”

The round of grants that Csete reported on involved only $45 million, substantially less than the $230 million in the disease team round. The stakes are now much larger. Powerful teams, some international, will be at work. Impending clinical trials will also create a vision of handsome profits, in addition to hoped-for prestige and accolades. CIRM directors have indicated they expect some of the disease team grants to fail. But revoking funds for one of those grants or loans will require a lot of steel on the part of the CIRM staff.

Csete abruptly resigned from CIRM after the June meeting. Her departure and the workload at CIRM likely meant that some of the monitoring efforts were pushed back. Most of the work is done by science officers, but at crucial points, it requires the intervention of CIRM's highest level scientist.

In the wake of Csete's departure, CIRM President Alan Trounson created a new position, vice president for research and development. A search firm has been hired for $100,000 to help recruit a candidate who will make go, no-go decisions on the disease team round along with other grants. Trounson is hoping to find someone with substantial experience in the biotech industry.

Whoever fills the job should not only be something of a scientific diplomat but also be able to face the big dogs of stem cell science and tell them no. CIRM's first responsibility is to generate results for the people of California and to serve as ardent stewards of the public's money.

(Below is a transcript of the entire discussion by the CIRM board in June concerning Csete's monitoring effort. Also below is a piece concerning our decision not to publish the names of the scientists whose grants were revoked as well as another item dealing with CIRM's efforts to ensure compliance with its ethical and research standards.)

Editor's note: The California Stem Cell Report first published an item on the termination of CIRM grants last April. Here is a rundown on all the stories published on this site as of Nov. 9, 2009, concerning grant termination.

CSCR Withholds Names of Terminated Grantees to Avoid Unnecessary Harm

The California Stem Cell Report is not naming the three scientists whose grants were terminated by the state's stem cell agency because doing so would unnecessarily damage their reputations.

It is our understanding that none of the issues involved malfeasance. Additionally, CIRM's progress monitoring appears to be more rigorous than the standards applied by the NIH, whose practices have set benchmarks in the scientific community.

Publication of the names could create erroneous, negative perceptions about the individuals involved.

We made the decision not to publish their identifies after discussions with a number of individuals, including two of the researchers. In our past occupation as an editor at a mainstream newspaper, publication of their identities would have been pretty much of a foregone conclusion. But given that we are no longer constrained by newspaper standards, some of which are very good and some not so good, we did not want to mindlessly do something that would unnecessarily harm the three.

We also asked CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication at Scripps, for his thoughts on publication of the names. Here is how he responded.

“For NIH grants, after the grant is awarded, one writes a 'progress report' annually in what is termed a 'non-competitive' renewal. For the duration of the award, the investigator is free to follow leads, change directions, convert personnel into equipment funds, and essentially re-program the proposed project. Only if the PI seeks to renew that grant must the changes be justified.

“In process described to us in June by Marie Csete, the scientific staff are in frequent contact with our CIRM-supported PIs, assessing their progress towards the goals they were approved to pursue, and for several of our competitions with stated milestones, assessing whether that progress will get them to their milestones. Lack of progress can be sufficient grounds to terminate the funding, and apparently those are the 3 cases you mention. Since we are kept blind to the PI names and institutions when we decide to award funding, I don't see that it is constructive to CIRM or those PIs to disclose names after termination.”

Text of Csete's Description of CIRM Grant Monitoring

On June 17, 2009, Marie Csete, then chief scientific officer for the $3 billion California stem cell agency, briefed its directors in San Diego on how CIRM monitors the progress of its grantees. Following her presentation, one director asked her how many grants had been terminated because of lack of progress. Three, she replied.

Here is the transcript of her remarks and the discussion by directors. Here is a link to the slides that she used. They begin on p. 22 of the file.

Csete: I guess the last thing I'm supposed to speak about is our mechanism for looking at progress reports. And the first opportunity we had to aggregate data on this was for the SEED grants, which are now more or less in their second year of funding for most of the investigators. And as a reminder, I think all the way back a few years, this was a grant program designed to develop human embryonic stem cell biology in the state. And since it was early, it was more idea based rather than preliminary data-based, and we really hoped to attract nonstem cell biologists to the field as well as cell and developmental biologists who were working perhaps on other stem cells, but had not done human embryonic stem cell work.

As such, the seed grants were acknowledged to be rather high risk, high gain. And I was involved in the SEED grants as a reviewer. So I have insight into the process from the beginning even before I came here to CIRM. I have to say that the overwhelming message I want to leave you with here is that despite a slow start, that was the bump in the road, that the SEEDs are really overwhelmingly successful. And we looked this week to find that there are already 64 papers coming out of the SEED program even though, again, these were new investigators in this field.

So it is important also, thanks to Bettina (Stephen, a CIRM science officer), to remind you that progress reports are not just progress reports -- and this has been an education for both the science office and for our scientists – that they really serve as a focus of a way that the science officers and our grantees can have a point of communication. It also allows us to get a heads up on where the data is, on what papers are being submitted, on potential patents that are coming out. Also when we discuss the progress reports in the science office meeting, it allows us to match scientists from our individual portfolios with other scientists whose progress we're hearing about in the meeting. In general, I have to say that I've gotten a lot of positive feedback from our PI's about the interactions with our science officers and our grantees.

So this is the process that we've sort of come to. And I've condensed a very complex diagram that has arrows going out every which way. On the right(on a slide she presented), you have a lot of gold stars. And the gold stars is what usually happens. On the left I put symbols showing how much communication happens at each one of these steps. So for the vast majority of the progress reports, things look good, and we generate an NGAs(notice of grant approval) with the next year's funding on the SEED grants.

But what I'm showing you in the middle is what happens when we receive a progress report that's not satisfactory. So we did receive some where we saw that the projects were not advancing. They were slow. The vast majority were those gold stars that, you know, went right back for the second year of funding.

In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the NGAs out the door for various reasons. So right away, by having a communication with the PI after the progress report was in, we could help them. We could intervene and make the right calls to try to get and kick start these programs.

When there was insufficient data for us to judge how much work had been done, the science officer would request supplemental data. That often required a couple of phone calls and a couple of exchanges of e-mail because, again, we were interested in hearing what people would normally not send in as a progress report: difficulty getting cell lines grown, difficulty doing certain kinds of experiments so that we could see common features across our SEED grantees and allow them to help each other.

When the supplemental data suggested that there was still insufficient progress, I would look at the report, and we also had discussions with the entire science office. At that point, if we couldn't come to a way to jump start a project, we would have a conference call with the PI, and at this point we'd bring in the institutional official as well, the science officer who has this PI in their portfolio, and I, and we would have another call to try to get this program back on track. And very often what that meant was that we made a plan with the investigator to give them some more time so that they could generate some data and try to pick up where the progress was slow. So the time differed depending on the problems that were there, hiring problems, for example. If after this time period another supplemental progress report comes in and there was inadequate progress, we decided that we would notify the investigator that the project just didn't seem to be going anywhere, that there was no real plan to get it back on track and that there was a potential for termination.

Again, the AOOs were all involved in this as well. and if there was no response within two weeks to that potential termination letter, then the grant was terminated and the second year's funding was not advanced.

So what did we learn from this process? We learned that it's critical for us to be working with the PIs to keep the grants on track and how appreciative the PIs are when we do work with them to keep them on track. By the way, we also found several grants that would not have gone on because the investigator was interested in not pursuing the original goal of the research and was going to drop the work. We felt that these areas were so critical for the ideas that were part of the seed program, that we found other investigators who were co-PIs or related to the grant to take over and worked with these new investigators and found mentorship to keep that work going. So it went in both directions. We saw adequate progress where the grants would not have gone on had we not intervened. And I think that this is a very interim report for you because the final success of the SEEDs will be seen over the next year when the final reports come back. We know that papers are going out. We know that research is proceeding apace now; I think much to the effort of each of the individual science officers who worked very closely with the grantees. But it will be important to evaluate how many new labs were brought into human embryonic stem cell and pluripotent stem cell research. And I should also say that a lot of the investigators left to their own devices would have stopped what they were doing with their SEED grants and simply gone on to derive ips cells, and we would have had no portfolio had we (not) been actively managing the grants. But most importantly, the success of this program will be determined on how these investigators go into others of our programs and other large-scale funded grants with the work that was developed from the SEED. And we already have success in that area. We're seeing that one SEED grantee continued on and got an early translation award from CIRM last month.

So overall we've had enormous success, I think, with the SEED program, and we're still in the middle of it. And we've learned a lot about process that will help us to be managing larger scale projects and to work with our investigators in a really positive way.

CIRM Chairman Robert Klein: So, Dr. Csete, will you remind us the number of SEED grants originally awarded?

Csete: Seventy-four.

Klein: So 74 grants, and we've seen 62 or 63 papers at this point.

Dr. Csete: Sixty-four papers.

Klein: So a very high level of productivity. Thank you very much.
Dr. Bloom?

Director Floyd Bloom: This kind of nurturing interactive relationship with the PIs is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push. So it's a wonderful thing you've done.

Director Ricardo Azziz: I just want to echo that, for starters. I think it takes a tremendous amount of work to help these investigators forward. Again, presumably, they are also very appreciative of your efforts. of the 74 applications, how many – you spoke about the process that you are going through -- how many have been terminated for nonproductivity?

Csete: Three.

Azziz: Three of the 74. Thank you.

Klein: Okay. any additional board comment? Thank you very much, Dr. Csete.

CIRM Hires Levin to Help Find New VP

The California stem cell agency has hired the self-styled “boutique” executive search firm of Levin & Company, Inc., to help find a vice president for research, a new position created in the wake of the sudden departure of Marie Csete as chief scientific officer earlier this year.

According to CIRM, Levin has signed a $100,000 contract with the agency. Levin beat out Korn/Ferry International, McCormack & Farrow, Caliber Associates, Russell Reynolds Associates, Spencer Stuart and The A-list.

Csete announced her resignation in June and subsequently told Nature magazine that her advice was not respected.

CIRM President Alan Trounson created the new research and development position with an eye to attracting candidates with more commercial research backgrounds. CIRM's salary range for the position tops out at $332,000.

In its proposal, the firm said,

“While we recognize that CIRM may have limitations on what it can offer (such as a bonus), we have had demonstrated experience in recruiting for clients with similar restrictions, such as early stage companies which are unable to offer bonuses, or international clients which cannot provide an equity package.”

Levin has a long history in the life sciences industry. In its proposal, it said it had completed search assignments for CEOs for the following stem cell-connected firms: Osiris Therapeutics, Cellerant Therapeutics, StemCells, Inc., and ViaCell.

The firm said its CEO, Christos Richards (see photo), would personally lead the search, personally interview each finalist and negotiate the final package.

Levin projected a timetable of four to six months from the beginning of the search (Aug. 24) to the start date of the vice president. It said the period could be shorter but said “a search taking longer than six months leaves the potential for a dissatsified client.”

Levin, which has its corporate office in Boston, also has offices in San Francisco, Los Angeles and Pennsylvania.

Whopping Pay Hike Proposed for CIRM Grant Reviewers

The California stem cell agency, which constantly stews about recruiting and keeping enough top notch scientists to review its grant applications, is now proposing to pay them $750 a day, which could total as much as $10,000 per reviewer for each grant round.

If the compensation reaches that level, it would be a 500 percent increase in the flat $2,000 that was previously provided.

The pay hike comes before the CIRM board later this week. In a memo, the CIRM staff said it was needed in order for the agency to be “competitive” in securing reviewers, who are usually well-known and respected scientists.

CIRM offered no figures for the overall estimated cost of the increase in what it calls "honorarium." But at $750-a-day, which amounts to $195,000 if it were applied on annual basis, the amount is pay – not honorarium.

We based our cost estimates on information provided in 2007 by Richard Murphy, then interim president of CIRM. Murphy also had served as head of the Salk Institute and as a member of CIRM board.

Murphy told the California Stem Cell Report that when he did grant reviews it took him one to two weeks to review the grants and write them up, including meeting time and travel. Based on that, the proposed pay for reviewers – which covers days of service, not just actual meetings -- could run from $3,750 to $10,000 per grant ground for each reviewer. Of course, the amount depends on how fast a reviewer works and could be less or more.

The number of grant reviewers actually used varies, depending on the need for specialists. However, 13 sit as regular members of the grant review group and many, many more as alternates or ad hoc members.

Murphy spoke to us at a CIRM board meeting during which the compensation was boosted from $500 a day to the flat $2,000. The $500 only applied to meeting days. The compensation does not include travel expenses, which are also reimbursed by CIRM.

As CIRM indicated, retaining skilled reviewers appears to be getting tougher. Lifting of the federal ban on hESC grants would certainly would seem to create more demand from the NIH for scientific reviewers who might also be recruited by CIRM. And the stem field generally is much more active than it was in 2005, when CIRM got started, generating more demand for reviewers. All of those reviewers also have their own personal research projects to attend.

The need for increased CIRM incentives is also likely linked to the absence of a chief scientific officer (CSO) at CIRM. One of the “the most important and least appreciated aspects of the CSO's role has been to personally beg, harangue and plead” with other scientists to serve as reviewers, as one person told us.

The post is now vacant after the resignation of Marie Csete earlier this year. Csete had served as CIRM reviewer and was well-respected and well-known in her field, giving her the heft to bring in reviewers.

It is likely to be some months before her post is filled.

CIRM also cited as justification for the pay increase an increasing future workload as grant rounds become more complex.

More Coverage on the New Research VP Position at CIRM

For more on creation of the new VP of research and development at CIRM, see a posting by Monya Baker on The Niche, Nature magazine's stem cell blog.

Among other things, Baker wrote,

“In the last organizational plan, (former chief scientific officer Marie) Csete had reported to (CIRM President Alan) Trounson, and Patricia Olson, director of scientific activities, had reported to Csete. Science officers, who decide what kinds of grant programs will be offered, reported to Olson. Under the new organizational chart, Olson will report directly to President Trounson, as will the vice president of R&D. (The general counsel and the vice president of operations already report to Trounson).”

In a related development, seven executive search firms have responded to CIRM's RFP to help in finding a Csete replacement.

In response to a question from the California Stem Cell Report, Don Gibbons, chief communications officer, said the firms are: Korn/Ferry International, McCormack & Farrow, Levin and Company, Caliber Associates, Russell Reynolds Associates, Spencer Stuart and The A-list.

CIRM paid Spencer Stuart about $500,000 previously for two presidential searches. In neither case did Spencer Stuart produce a candidate who would accept the job.

Also at yesterday's meeting, Trounson left open the possibility that CIRM might have to pay more than $332,000 to fill the position. That is the top of the current salary range at CIRM for the post. Csete earned $310,000. Trounson, however, said yesterday he hopes to fill the position without boosting the salary range.

Support for Public Health Care Option, but "Nyet" to Hoover

SACRAMENTO – The California stem cell agency appears to be on track to reject nearly all of the recommendations for improvements in its operations made by the state's good government agency, the Little Hoover Commission.

Meeting yesterday in a teleconference session, the directors' Legislative Subcommittee concluded its discussion of the Hoover report with a consensus “nyet” to the commission.

The panel earlier last month rejected the most sweeping recommendations, including reducing the size of the board of directors from 29 to 15 and trimming the powers of its chairman. The action was taken based on an opinion from the CIRM's outside counsel that the legislature could not make those changes.

Yesterday, the subcommittee went along (no vote was taken) with the CIRM staff response, which can be found here and here. The panel did agree to poll its scientific grant reviewers on whether they would resign if their statements of economic interests were made public. It also agreed to post vote tallies in the future by the board of directors on grant applications.

Art Torres, chairman of the subcommittee and a former state legislator, will prepare a report on the group's discussion and present it to the full board at its meeting Aug. 19-20 for ratification.

The Legislative Subcommittee, on a 6-3 vote, also expressed support for a public option in the national health care reform legislation. Director Jeff Sheehy, a UC San Francisco communications manager and AIDs activist, and Torres backed the effort.

Sheehy said access to health care and future stem cell therapies is critical to CIRM's mission. Duane Roth, co-vice chairman of the board of directors, opposed the endorsement, citing problems elsewhere in the world with government-run health care plans.

The endorsement will come before the full board at its meeting later this month.

Also meeting yesterday was the full CIRM board, again in a teleconference session, to discuss a proposal by President Alan Trounson connected to finding a replacement for Chief Scientific Officer Marie Csete, who has resigned.

Trounson plans to create a new vice president for research and development to enhance CIRM's engagement with industry. The title and additional responsibilities could also make it more appealing to possible job candidates.

Trounson's proposal does not require board approval but he is obviously taking care to ensure support from the CIRM board.

The plan hit a bump when Claire Pomeroy, dean of the UC Davis School of Medicine, raised questions about reporting ambiguities in Trounson's organizational chart, which seemed to conflict with the reporting lines in the job description dealing with basic science research.

Sherry Lansing, chairperson of the Governance Subcommittee and former head of a Hollywood film studio, indicated that the plan seemed to justify the creation of a third VP. In that case, the executive director of scientific activities would be designated as a vice president.

In other action, the board added Gerald Levey, dean of the UCLA School of Medicine, and Ted Love, a Bay Area biomedical businessman, to the newly created Evaluation Subcommittee. Levey was then elected chairman of the committee and Francisco Prieto, a Sacramento physician, vice chairman.

The full list of committee members can be found here, minus the Levey and Love additions.

For the record, we should note that some of the material for yesterday's two meetings was posted extremely late on the CIRM web site. One memo dealing with the Hoover report was not available at teleconference location in Sacramento, although it may have been posted on the Web at the time of the meeting. The staff's discussion draft of the Hoover report did not appear until the day before the meeting. Likewise for the organizational chart.

CIRM Seeks Help in Search for Csete Replacement

The California stem cell agency wants to hire an executive search firm – its third such arrangement in the last four years – to recruit a successor to Marie Csete to lead the organization's scientific research efforts.

CIRM contracted with a search firm, Spencer Stuart, on two different occasions in the past in an effort to find a president for the $3 billion enterprise. Despite spending about $500,000, the searches never turned up a candidate who would accept the job.

In both cases, the two men who ultimately accepted the presidency surfaced by other means.

CIRM's latest effort calls for a timetable of no more than six months to find a vice president for research and development, a new position at the agency. The post would cover the responsibilities of CIRM chief scientific officer, the title that Csete carried.

Alan Trounson, CIRM president, said the new position is aimed at attracting candidates with more commercial research backgrounds.

The RFP said the salary is likely to be $180,000 to $332,000, although it left the door open to going higher. CIRM asked search firms to provide advice on salary levels based on “industry trends and best practices.”

The CIRM board has yet to approve creation of the new vice presidency although the RFP was posted 11 days ago. Bids from search firms must be in by Monday. The board takes up consideration of the new post on Thursday.

Here are links to funding for Spencer Stuart: 2005, 2008.

CIRM Seeking More Industry Experience in Top Science Officer; New Post Proposed

The California stem cell agency wants to put more sizzle into its search for a replacement for Marie Csete, who resigned as its chief scientific officer recently and subsequently said her advice was not respected.

Alan Trounson, president of CIRM, is asking its directors to create a new post called vice president, research and development that will be attractive to scientists with commercial experience. The search comes just as the agency is about to award its critical disease team grants, which, at $210 million, are the largest research grant round in CIRM history.

Csete's resignation and her complaints about the organization have received international attention and raised questions about CIRM's management, which the agency has not responded to publicly.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said Csete's position was the second most important at CIRM. He said,

“Before this new position is created, I think there needs to be a full, public explanation of why the former chief scientific officer, Dr. Marie Csete, resigned after a little more than a year on the job.”

In a memo to CIRM directors, Trounson said the new position would provide an opportunity to “find someone with the skill base to have more of a focus in their role with biotech/pharma – translation – clinical applications, which is where we are moving with our translational, disease teams and clinical grants and where we are thin in capacity.”

The new vice president would report to Trounson and apparently rank at the same level as the vice president for operations, John Robson. The new person would be the third in four years to fill the post or its equivalent.

Trounson's proposal, which will come before CIRM directors Aug. 6 in a special teleconference meeting, did not specify a salary range. Don Gibbons, chief communications officer for CIRM, did not respond to questions about pay. Currently the salary range for Robson and the chief scientific officer tops out at $332,000. Csete was paid $310,000.

Trounson's memo said that the new position is designed to attract applicants with “academic-commercial R&D experience.” Trounson said,

“Pharma is now wishing to engage with us and we need some experience at this interface which we haven’t had to date. The biotech firms had been a bit put off due to a lack of success in granting but are now very keen to re-engage if we can solve some of the issues that have arisen.“

Trounson said the new VP would have primary responsibility for relations with the FDA and the NIH. He said the person would “oversee the basic science and translational to clinical program and partner with the executive director of scientific activities to support and empower the science team.”

The designation of an “executive” director of scientific activities also appears to be new. The current CIRM organizational chart refers only to a “director of scientific activities.”

The CIRM president's memo said a “number of very good people” have indicated an interest in the new VP post.

The Aug. 6 meeting is open to the public and is available at teleconference locations throughout the state, including San Francisco(3), Los Angeles(3), Sacramento, La Jolla(3), Pleasanton, Healdsburg, Duarte, Stanford, Berkeley, Irvine and Palo Alto. The specific addresses can be found on the agenda.

CIRM Director Love Wades into the Trenches at CIRM

It is not exactly an internship, but one of the directors of the California stem cell agency is working as a volunteer at CIRM during the next few months.

The director is Ted Love, a physician and businessman, who until recently was CEO of Nuvelo, Inc., of San Carlos, Ca. He has served on the CIRM board since its first meeting in December 2005.

Earlier this month, CIRM announced that Love will be assisting the agency's management one to two days a week until CIRM appoints a new chief scientific officer. The agency noted that Love has “extensive experience bringing medical therapies to the market.” CIRM said Love will be of “considerable value” in connection with the $210 million disease team grant round scheduled for approval later this year.

Love sits on the board of directors of Arca biopharma, Inc., of Broomfield, Colo., Affymax, Inc., of Palo Alto, Ca., and Santarus, Inc., of San Diego, Ca. Arca is the biopharmaceutical company that absorbed Nuvelo earlier this year. Affymax is another biopharmaceutical business, and Santarus acquires and develops products dealing with gastrointestinal problems.

Given ongoing issues about conflicts of interest at CIRM and more recent questions about micromanagement by CIRM directors, we posed several questions to the agency about Love's involvement.

Amy Adams, CIRM communications manager, responded. She said Love will not be acting chief scientific officer in the absence of Marie Csete, who has announced her resignation. Adams said,

“Ted Love is acting as a part time advisor to the president on the overall architecture of our grants programs.”

We asked,

“Does any of his work involve potential conflicts of interest considering his involvement in Arca and potential future employment in the biotech industry? “

Adams' response:

“No. To the extent that any potential conflicts arise, Ted will recuse himself from participating in the decision.”

She said none of his work will involve applications from any company that has applied for a grant or that is expected to apply for a grant. Adams said that it is “uncertain at this time” what role he will play in the review of the disease team applications by the grants working group.

We also asked,

“How can Love fulfill his oversight responsibilities as a CIRM board member when he is actually performing the tasks that could come under board scrutiny?”

Adams replied,

“He will be assisting the science office on an interim basis and does not expect that his brief tenure at CIRM will interfere with his oversight responsibilities. Indeed, he thinks it will give him a better understanding of CIRM's internal operations.”

She said that Love will receive no compensation for his work, including the per diem granted board members for meetings.

We also queried longtime CIRM observer John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., about his thoughts on Love's volunteer work. Simpson replied,

“Ted Love has been a substantial and important contributor to the ICOC. He is a talented executive who brings the perspective of the bio-medical industry to the table. That’s a necessary perspective, but by no means the only important perspective. If he can briefly help CIRM after the departure of Chief Science Officer Marie Csete, that’s probably a good thing. I worry, however, that if this arrangement lasts too long and he becomes too involved in day-to-day operations, it will be difficult for him to fulfill his oversight responsibilities on the board.

“I also wonder what advising 'the president on the overall architecture of our grants programs' means. That phrase prompts me to wonder about the status of the revised strategic plan, which was first presented in a draft last December. It was the subject of hearings in February and March, but still hasn’t come back to the ICOC. If I were a board member, I would have wanted to approve that revised plan before I even considered the budget for 2009-2010. “

A footnote on all this: Prop. 71 has specific criteria for board members. Love was appointed to the board when he was CEO of Nuvelo, but he no longer is an “executive officer of a commercial life science entity.” He can continue to sit on the board because of his position as board member of a life science firm.