Monday, July 05, 2010

CIRM's Self Interest Demands More Openness

Cobbling together a $3 billion research program from scratch is no simple task. No chairs, no phones, no computers, no payroll system but no employees either or, for that matter, an office – that was picture more than five years ago when the California stem cell agency launched its unprecedented enterprise.

Adding to CIRM's teething problems were the state's “sunshine” laws. They require the agency's meetings and its records to be open to the public. On top of that was a newly minted change in the state Constitution, also in 2004, that for the first time in state history guaranteed the public the right to access to the people's business.

Some adamant advocates of sunshine laws seem to believe that compliance with all that openness is an easy matter that has little organizational impact. But even the state Department of Justice, in its guide to open meeting laws, acknowledges that the sunshine requirements place an “unnatural” burden on state endeavors. “Frustrating” and “inefficient” were a couple of other terms applied to the “sunshine” law.

It is much easier to sit down in a quiet, private room – away from the great unwashed – and organize a complex enterprise that, in the case of the stem cell agency, is to this day still trying to work out the kinks.

Nonetheless, a “higher value” exists, according to the Department of Justice. A seat must be reserved at the table for the public.

Which brings us to the “Incident at the Marriott” last month. That's when CIRM barred two academics from a meeting that CIRM said was aimed at gathering information for “critical decisions regarding the direction our funding should take.” Certainly a topic of considerable public interest since CIRM's costs (all cash borrowed by the state) run to $6 billion, including interest.

Since that we wrote that item, the barred academics have sent us a copy of the agenda for the meeting that they were originally seeking to attend. Among the matters to be discussed was the sensitive subject of "reimbursement" of human egg donors.

However, a scientist in attendance at a related workshop that day said we were off base when we deplored CIRM's flouting of state law.

The researcher, who must remain anonymous, said in an email,
"This meeting was about sharing the scientific details of the work of the few researchers who have been able to get SCNT to work in animals. There was a scientific discussion about the feasibility of human SCNT, and about what the scientific community would learn if SCNT were to be successful in humans. The goal was to share information about the science. Since so little is published about this field, the scientists were given a safe environment to frankly discuss their unpublished work and their failures. This was a landmark meeting, and it was all about science. It would have never accomplished its goal of scientific communication if the public had been invited. There will be a public report. If the ethics of egg donation are to be the main topic, then there should be another meeting, because that is an entirely different subject."
We respect that point of view and acknowledge that some scientists could have been reluctant to be forthright. But warnings about the possibility of the withholding of information have been common in the decades that I have been connected with state government issues. The reality is that interested parties usually become quite candid when cash is at stake – especially the potential loss of funding.

The paramount consideration in all this is the public nature of the stem cell research effort. When the supporters of Prop. 71 went to the people asking for the money, they implicitly acknowledged that public concerns come first – not scientific sensibilities. And without the public involvement, there would be no California stem cell agency.

By operating under a cloak of quasi-secrecy, CIRM ill serves its own interests. It lays down a record that will fuel opponents, much to their glee, a few years from now when CIRM has its hand out for more state cash, a move that CIRM Chairman Robert Klein is already discussing.

The law, the state Constitution and agency's self-interest are clear. CIRM should maximize its openness and welcome involvement by the public – not to mention its special constituencies in industry and academia.


(Editor's note: Some readers are interested in directly raising their concerns about the lack of openness at CIRM. They can send an email to mking@cirm.ca.gov and ask that it be distributed to directors. If you wish, you can send a copy to us at djensen@californiastemcellreport.com and we will reprint it. Even if it is on the other side of this matter.)

The Agenda from the Incident at the Marriott

CIRM barred two academics from a meeting last month in what appears to be a violation of the state open meeting laws. Below is the agenda, as provided by the two, for the meeting that they were attempting to attend.

A scientist from New York and one from Australia were on the panel at the meeting, whose topics included the level of reimbursement for human egg donors, a subject that readily moves into cash-for-eggs questions. The agenda provides no clear indication of a need to protect proprietary information, as contended by CIRM.

Tina Stevens of San Francisco State University, one of the two persons barred by CIRM, said of the CIRM meeting agenda,
“Please note that the proposed discussion questions following the agenda items concern, in part, paying women for their eggs for research -- something that California has clearly prohibited. Why does CIRM think it is or should be empowered to consider, make, skirt, or change policies that impact women's health without broad public awareness, input, and debate?”
Here is our original item on the “Incident at the Marriott” and a follow-up item. Here is the agenda from the June meeting.
“Session 6. Procurement of human oocytes:
“What has been the experience to date?
“15 minute talks / 30 minute discussion
“Chair Renee Reijo-Pera, Stanford University
“11:10 am Jeffrey Janus, International Stem Cell Corporation
Procurement of human oocytes in California and Russia: five years experience of International Stem Cell Corporation.
“11:25 am Scott Noggle, NYSCF
“11:40 am Bernie Tuch, Sydney, Australia
“11:55 am Aaron Hsueh, Stanford University
“12:10 pm Discussion
“Questions to consider for presenters and for discussion
“What levels of donor reimbursement are necessary to support research? (Is it feasible for CIRM to support SCNT research without allowing reimbursement)
“Are there reasons for donors to prefer research donation over reproductive use of oocytes?
“What is the experience of research donors with regard to OHSS or other adverse outcomes?
“Are research donation programs being evaluated for donor satisfaction?”

Friday, July 02, 2010

Comment on Lewis' $250,000 Contract

An anonymous comment was filed this morning on the “$250,000 Lewis” item. We are publishing it here instead of the usual posting as a “comment.” The reason being that, as filed, the post contained a personal remark about Alan Trounson, one that could be considered potentially libelous. We encourage all those posting comments to avoid personal remarks about all individuals. Comments about how individuals perform their jobs are acceptable and may be extremely forceful.

Here is the comment as edited. We substituted “wildly” for the originally phrase in the comment.
“Interesting..first the budget fiasco and now the stealth hiring of Lewis with a contract number just below one requiring governing board scrutiny. Methinks Trounson believes he is a law unto himself and that he need not seek approval for any activity or spending. While state workers get minimum wage, Trounson spends (wildly).”

$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.)

Wednesday, June 30, 2010

Alan Lewis Joins CIRM as VP for Research and Development

The California stem cell agency today confirmed that that Alan Lewis, formerly of head of Novocell and the Juvenile Diabetes Research Foundation, will be joining its small band in in San Francisco.

Lewis was named interim vice president for research and development. He will be working two to three days a week and focus on  “identifying strategic opportunities and developing action plans to fulfill the mission of the Institute.”

In the CIRM news release, Patricia Olson, executive director of scientific activities for CIRM, said,
“His many years of experience in developing therapies for patient benefit in both for-profit and non-profit organizations will be valuable to CIRM as we expand our program to include clinical projects.”
The announcement from CIRM said Lewis will take direction from President Alan Trounson and Olson.

Trounson, who has been seeking to fill the VP slot for about a year, was not quoted in the release nor was CIRM Chairman Robert Klein.

CIRM did not immediately disclose Lewis' compensation. The VP position has a salary range that tops at $332,000. The news release did not say whether Lewis would be an employee or an outside contractor. However, a CIRM insider told us he would be a contractor. The agency is heavily reliant on outside contractors because it is limited by law to 50 staffers. Currently it has about 45 employees.

Lewis' old firm, now known as ViaCyte, has $26.3 million in awards from CIRM.

The California Stem Cell Report first reported Lewis' link-up with CIRM on Monday.

Escape Therapeutics: The Latest Business to Win a CIRM Grant

A firm founded by a part-time, but award-winning poet was the only company to receive a grant in last week's round from the $3 billion California stem cell agency.

The firm is Escape Therapeutics of Palo Alto, Ca. The principal investigator on the $1.5 million CIRM grant is Basil Hantash(see photo), founder of the firm and an Illinois native who held a biodesign fellowship in 2006-07 at Stanford.

Only one other company filed an application in the $25 million immunology round, originally budgeted for $30 million. That firm's name was withheld by CIRM, which is their general policy concerning unsuccessful applicants.

CIRM reviewers gave Hantash's application a 72 score. The review summary cited some weakneses in the application, but said it was “worthwhile and achievable.”  In the words of the reviewers, the research was “well designed, logical and an interesting approach to pursue.”

Founded in 2006, Escape does not have a Web site. But, according to a company document provided by Hantash, Escape is an early stage, privately held biotech firm “focused on accelerating the commercial availability of allogeneic stem cell therapies by solving the key translational hurdle preventing their clinical utility – immune mismatch and subsequent donor rejection.”

The information continued,
"Invented by Escape’s founder Dr. Hantash while at Stanford University, the company’s platform technology represents a significant potential breakthrough that can revolutionize the treatment of blood-borne disorders such as leukemia, type I diabetes, and autoimmune diseases. Escape’s innovative technology allows for the creation of the world’s first allogeneic, 'off-the-shelf' therapy capable of being used in any patient irrespective of their HLA profile."
In addition to the last week's grant, searches on the Web showed that Escape has other ties to CIRM. It is one of four internship sites for a CIRM training program run by San Jose State University. Asked for comment, Hantash said,
"Escape focuses the training process on translational stem cell research skills, rather than pure academic basic science research. Our interns were the first to publish out of all the interns in the program, so we feel they gain commercialization experience while retaining the rigor of academics. This is a marriage of a Stanford-like focus on entrepreneurship and an industry eye on developing life-saving products to alleviate patient suffering."
Hantash was a partner from 2007 to 2009 at Proteus Venture Partners, a San Francisco Bay Area investment and advisory firm focusing on regenerative medicine. Proteus was heavily involved in CIRM proceedings concerning the agency's $500 million biotech loan effort. Hantash said his responsibilities included fund-raising and deal sourcing and evaluation.

A number of references on the Internet refer to Hantash as an award-winning poet. We asked him to provide a sample of his work. It can be found here.

(Photo of Hantash from Proteus web site)

"Seduction" -- A Poem by a Stem Cell Scientist

At the request of the California Stem Cell Report, Basil Hantash, CEO of Escape Therapeutics, Inc., of Palo Alto, Ca., sent us this sample of the poetry he writes while not working on stem cell research.

(On Aug. 11, 2010, Hantash emailed us, asking us that the poem in this item be removed from the Web site. He said tended "to agree with the anonymous comment that it may not be an appropriate venue."
As a courtesy to him, we have removed the poem.

(We heartedly disagree with the anonymous comment. A narrow-minded focus hampers all of us -- not only scientist and policy wonks.)

Tuesday, June 29, 2010

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.

Monday, June 28, 2010

Top 10 Tips for Snagging Cash from CIRM

For businesses seeking clues about how to win cash from the $3 billion California stem cell agency, a UC Davis researcher is offering 10 free tips.

We took a look today at the advice offered up by Paul Knoepfler on his blog. It all makes good sense to us. But what do know? We have never received a grant from CIRM. Knoepfler has.

Here are a couple of his suggestions.

No. 3 –
“Read the RFA very carefully. Perhaps even read it 5 times. It may seem straightforward, but think about the key words being emphasized by the funding agency.”
No. 6 –
“Hire professional grant writers with experience in industry and academia. This is an investment well-spent.”
We also have a couple of our own.

Attend meetings of the CIRM board of directors, particularly those dealing with grant approval. Nothing else will inform you as well concerning the board's thinking on grants. You will also have to a chance to meet some of the very sharp people who control the purse strings.

Read all of the extraordinary petitions filed by rejected grant applicants. Read at least 50 or more of the summaries of reviewers' comments on applications, splitting the material between top-ranked grants and ones that did not make the grade.

Good luck!
 

Stem Cell Information Resource

A Silicon Valley firm has compiled a fine list of sources dealing with stem cell issues and regenerative medicine, ranging from investment info to links to reports on stem cell research in China and Singapore.

The list of resources was put up by Proteus Venture Partners. Many of the sources are familiar but the list is long and comprehensive. Sad to say, it does not include the California Stem Cell Report.

You can find the information roundup here.

Sunday, June 27, 2010

NIH and Exculpation

For those of you not fully informed of the tricky byways of stem cell science, the Boston Globe carried a nuanced editorial today that laid out the significance of an arcane “exculpatory” matter last week

Arcane, that is, to folks who do not fiddle with human embryonic stem cells.

The case involved possible use in federally funded research of embryos donated some years back. The feds said no because they were given under conditions that do not meet today's ethical tests, although the donations met the standards of the day, which actually was only a decade or two ago. The Globe called the NIH action a “major blow.”

You can read all about it here.

Saturday, June 26, 2010

Biopolitical Times Says More Openness Needed at CIRM

The Biopolitical Times says the public has a right to attend the meetings of advisory groups to the $3 billion California stem cell agency.

On June 23, the online publication of the Center for Genetics and Society of Berkeley, Ca., commented on our report about how CIRM barred two academics from one of its meetings. We said that the action certainly violated the spirit of a relatively new provision of state Constitution that gave the public a broadly construed right to access to government activities, and likely violated the letter of the law as well.

Jesse Reynolds, project director on biotechnology accountability at the center, agreed. He wrote that “CIRM is a public agency, and the public has a right to attend such influential deliberations.”

One of our readers, Justine Durrell, asked this week how CIRM could begin to address its problems with openness. One of the first things it could do is to be sure that such meetings are open to the public and be sure that interested parties are notified in a timely fashion in advance of the meetings.

Wednesday, June 23, 2010

Tracking CIRM Grants: "Thin Ice" Lurking?

Directors of the California stem cell agency today approved a $15.7 million operating budget for next fiscal year – 28 percent higher than this year's spending – and requested a report from its staff concerning its critical grants management system.

The report was sought after CIRM Director Michael Friedman, CEO of the City of Hope, said he wanted to “express in the strongest possible terms my discomfort” with the decision by CIRM staff to build a custom grants management system.

He said that “unless you are prepared to spend enormous amounts of money, you are stepping on some very thin ice.”
“Everybody has seen horrible examples of custom-designed system that go bad.”
Friedman asked if any subcommittee of directors had approved the decision to go forward with a custom system. The answer was no, but that the decision had been carefully considered by CIRM staff.

At that point in the meeting, we lost the Internet connection to the CIRM audiocast. By the time it was restored , the budget discussion had concluded with approval of the spending plan. Don Gibbons, chief communicastions officer for CIRM, told us by email that the report had been requested. (We will revisit the budget discussion after the agency posts a transcript of the meeting.)

On Monday, when we reported some of the details of the budget, we noted that spending on information technology is scheduled to jump 53 percent from $817,000 to $1.2 million, an increase of about $433,000. Most of that goes for the grant system.

CIRM is trying to oversee more than $1 billion in grants to more than 300 recipients and, at the same time, hand out many hundreds of millions more in the next year or so. It is building custom programs for entire process, from applications to oversight. Currently, CIRM has a $125,000 RFP out for “systems analysis and software development services” and hopes to have a company on board next month.

The board also discussed the strategic financing report(see here and here), which will be wrapped into an external review of CIRM's strategic plan next fall. There appeared to be no clear consensus at this point whether the agency should make grants as speedily as possible or husband its resources to deal with unexpected opportunities in the fast-moving stem cell field. Related to that was a discussion of the CIRM grant portfolio. No action was needed on either item.

Comments by John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., were discussed briefly after they were read into the record. Simpson said he was “troubled” by what appears to be a lack of a level playing field for grant applicants from business and the dominance of academic institutions, who constitute a plurality on  the board.

CIRM Chairman Robert Klein said he did not think that the biotech industry agreed with Simpson's concerns about whether business grant applications were being treated fairly. Klein noted that BIO, a national biotech industry group, recently recognized him with a national award, indicating that the group valued CIRM's contributions. But Klein said more progress was needed.

Vice Chairman Art Torres indicated that he took Simpson's concerns about the seriously but said the public does not understand just how stringent are the conflict of interest standards at the agency.

Directors also approved the a concept proposal for a $45 million round of grants for basic biology research.

You can find slides from the report by CIRM President Alan Trounson here. He discussed recent stem cell research, a proposal for a CIRM online journal and upcoming CIRM workshops. The slides also include those used for the budget presentation.

Fresh Joy from Cyberspace

We have a new connection to the CIRM audiocast. Directors are taking up the strategic financing report now. CIRM VP John Robson is speaking.

Joys of Cyberspace

We have lost the audiocast connection to the CIRM board meeting so reports may be limited. The broadcast disappeared entirely, resumed with one side of someone's phone conversation and then provided a steady electronic hiss.

'Troubling' Trend: Is CIRM Playing Field Level for Business?

A longtime observer of California stem cell matters today said he is troubled by a trend at CIRM that appears to give short shrift to research at biotech businesses in the Golden State.

John M. Simpson has been watching the California stem cell agency since late 2005, along with participating in its affairs, most notably development of its IP policies.

Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., prepared this statement to be read at today's CIRM board meeting in San Diego. Simpson is on the East Coast on other business and may not be able to reach the Washington, D.C., teleconference location to deliver his remarks personally. Here is the full text.
“I apologize that that I was unable to attend today's ICOC meeting. I
appreciate this statement being read into the record on my behalf.

“When Consumer Watchdog began its Stem Cell Project almost five years ago, I
naïvely expressed concerns that the program would be hijacked by the biotech
industry. That has -- at least so far -- not happened; rather, it has been
dominated by academic research institutions, whose representatives hold the
largest number of seats on the board.

“I believe the trend is troubling enough to ask whether the playing field is
level for all applicants. I believe there are grounds for concern.

“Here are some suggestions to improve the situation:

“-- A task force should be convened to consider why companies have fared so
poorly and what should be done. All sessions must be public.

“-- A workshop should be scheduled with interested companies to discuss ways
to improve their applications. It must be opened to the public.

“-- An effort should be made to recruit scientific reviewers with substantial
experience in research programs conducted by businesses.

“-- CIRM meetings that currently include only grantees should be expanded to
include all legitimately interested parties. Currently you have an annual
conference for all grantees. This must be opened to include all grant and
loan applicants, even if they were unsuccessful. If there is a concern
about expenses, unsuccessful applicants could be charged a modest fee. What
better venue to learn what makes a successful application than a conference
that includes CIRM's awardees? It would also create opportunities for
developing collaborations. Currently CIRM continues to suffer from the image
that it is a closed club. Opening conferences to all applicants -- and even
other interested parties -- would help correct that.

“Thank you for your consideration.

“John M. Simpson”

Mystery Item No. 16 Revealed

Here is a link to Mystery Item No. 16. It involves an overview of CIRM's current grant portfolio and is designed to "facilitate programmatic decision-making." Pat Olson, executive director of scientific activities, is presenting the assessment as we write. Her Power Point presentation appears to have been posted by CIRM yesterday afternoon. We reported incorrectly earlier today that the material was not available this morning.

CIRM Directors Discuss Strategic Financing Plans

Directors of the California stem cell this morning began their meeting with a discussion of strategic financing plans. The scenarios being examined would mean different end dates for funding more research. Under one possibility, no grants would be approved after 2014. Another would see funding end in 2017. Both scenarios do not envision funding beyond the remaining $2 billion that CIRM has.

More Live Coverage Today: CIRM Budget and Financial Projections

The California stem cell agency begins its board meeting at 10:30 a.m. PDT this morning, and we will be filing stories as warranted.

Today's matters include the proposed $15.7 million operational budget for the fiscal year that begins one week from tomorrow. The spending plan is a 28 percent increase over its current expenditures. Also on tap are strategic financial projections and a discussion of whether the agency should spend its remaining $2 billion more quickly or more slowly. CIRM expects to continue its work for at least another nine years, even if it does not receive additional funding after its money runs out.

CIRM President Alan Trounson will review the latest stem cell research and highlight his priorities. He also normally goes over upcoming CIRM workshops that may be of interest. He is likely to give a post-mortem on the international stem cell conference last week in San Francisco. CIRM paid $200,000 to be a co-sponsor. Through its arrangements with the city of San Francisco, it also wangled $100,000 in free space at Moscone Center. CIRM additionally paid for an unspecified number of non-CIRM employees to attend the conference.

(Editor's note: An earlier version of this said that information on agenda item 16 had not been posted by June 23. The presentation was apparently posted on the CIRM Web site the afternoon JUne 22.)

Tuesday, June 22, 2010

Immunology Grants: CIRM Gives $25 Million to 19 Researchers

Directors of the California stem cell agency today approved $25 million for immunology research, overturning four negative decisions by its grant reviewers.

Directors faced a record nine public petitions to reverse its reviewers. After some grumbling, the directors, who see only a summary of the application and reviewer comments, okayed the four.

Successful petitioners included Jeanne Loring of Scripps, Husein Hadeiba of the Palo Alto Institute for Research Education and Judith Shizuru of Stanford University. A fourth grant that failed to pass muster by reviewers was also approved by the board, but without a petition. That went to Yang Xu of UC San Diego.

Forty-four applications were reviewed by the CIRM Grants Working Group, which approved 15, all of which were ratified  by the full board in addition to the four reviewer-rejected proposals. 

The board almost never overturns a positive decision by reviewers and only occasionally approves an application that has been rejected.

The CIRM directors have not been happy with their appeal/petition process for several years. A review of the procedures is scheduled for later this summer. Some changes are certain to be enacted and will affect the outcome of future applications.

Today one CIRM director again expressed exasperation. He was not clearly identified during the Internet audiocast of the board meeting, but he described himself as a scientist. Noting that the directors had limited information about the applications, he said,
“I don't think we have the ability to add value to the process.”
He also said,
“What do we think we are doing... Are we going to fund bad science?”
He said CIRM is “getting more and more applications on the margin.”

CIRM Chairman Robert Klein said the stem cell agency would only fund good science.

Loring was the lone researcher to appear before the CIRM directors at their meeting in San Diego. She said she was only there to answer questions. Elaine Reed of UCLA addressed the board via a teleconference location at the City of Hope in Duarte. However, she was not successful. Any person is entitled to speak to the board under state law.

Director Jeff Sheehy, who serves on the grants review group, said the round may be the first time that stem cell scientists have teamed with transplant immunologists to focus on issues of rejection of stem cells.

CIRM staff told the board that initially only 10 out of 44 applications qualified for approval, based on reviewer scores. Five more were added for “programmatic” reasons, which appears to mean that they are worth pursuing because they fit CIRM's goals.

Summaries of all the reviews of the grants can be found here. Click on the number of the grant to go to the review. Here is a link to the CIRM press release that identifies all the winners by name along with the number of their grant. Names of the rejected applicants are withheld by CIRM with the exception of those who file public appeals. Names of reviewers on specific grants are also withheld along with their statements of their financial and professional interests.

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