CIRM Millions To Help Snag Duke star Wechsler-Reya for Burnham

The recipient of CIRM's first Research Leadership Award, with $5.9 million in funding, is Robert Wechsler-Reya (at left) of Duke University, a reliable source said today.

He told the California Stem Cell Report he is considering leaving Duke and joining the Sanford Burnham Institute in La Jolla, Ca., where the CIRM-funded research is expected to be performed. Sanford Burnham is providing “an extremely generous commitment of laboratory space, matching funds for equipment, additional support for relocation and research, and access to excellent core facilities,” CIRM grant reviewers said.

(An earlier version of this item said Wechsler-Reya had decided to leave Duke. After it was published, he said in an email that he had not yet made a decision. CIRM, however, does not fund work performed outside of California.)

The reviewers also said that Sanford Burnham “has committed to recruiting the candidate's spouse(Tannishtha Reya, also at Duke, photo at right), who is an independent stem cell scientist; this represents a particularly beneficial leveraging of award funds.”­

The leadership award program, budgeted for a total of $44 million over two years, is aimed at recruiting top talent to California by means of assisting institutions with financing. The effort's goal is to attract perhaps eight scientists, although the first round this year drew only one applicant.

The stem cell agency has not identified Wechsler-Reya in keeping with its secrecy policy concerning the names of applicants. Directors are expected to approve the grant either tomorrow or Thursday. Then the agency will confirm the name.

John Reed, chief executive of Sanford Burnham, is also a member of the CIRM board of directors. He or his alternate is expected to be recused from both the discussion and voting on the grant for Wechsler-Reya. Reviewers have already approved the grant. CIRM directors almost never overturn positive decisions by reviewers, who conduct their work behind closed doors.

We have queried both researchers concerning the grant and their plans. We will carry their responses verbatim when we receive them. (See the "Still Mulling" item.)

The Lucky 11 and $167 Million in Stem Cell Research Cash

The California stem cell agency has pinpointed 11 likely winners of grants and loans up to $20 million each in the agency's ambitious disease team round, which was once projected at $210 million.

The awards are scheduled to be formally approved next week by the CIRM board of directors at a two-day meeting in Los Angeles at the Luxe Hotel. CIRM's Grants Working Group decided earlier that 11 proposals merited funding. The CIRM board almost never rejects a recommendation for funding by its reviewers.

The cost of the 11 applications is $167 million, well below the $210 million budgeted for the disease team round. Twenty other proposals were rejected by reviewers who gave them scientific scores of less than 70 on a scale of one to 100. Some patient advocates for the rejected research, which includes projects involving Huntington's Disease and spinal cord injury, are likely to make a pitch at the CIRM board meeting for funding of some of the rejected applications.

The CIRM board has final authority to make the grants, although it is loath to overrule its scientific reviewers.

Names of the recipients are not scheduled to be released until after board action, which could come on Tuesday or Wednesday. However, the public summaries of the reviews generally contain enough information to determine the identity of the winners, if you are well-informed about stem cell research or willing to scratch around on the Internet.

For example, the review summary of the top-ranked application – with a score of 90 for $14.6 million for stem cell therapy for AIDS – said,

“Reviewers noted that the investigators have already successfully navigated many of the regulatory hurdles with the FDA and RAC through previous clinical trials in hematopoietic transplantation in HIV patients.”

Regarding another application that sought $20 million for cell therapy for diabetes, the review summary said,

“The principal investigator (PI) has experience in encapsulation and has led the efforts that resulted in recent publications in top tier journals. The world-renowned immunology collaborator is well published, has experience in translational immunology and clinical trial design, and will lead a group of established immunologists at the collaborating institution.”

The summaries also contain the names of reviewers who were excused from examining the application because of conflicts of interest, both professional and financial, additional information that can help identify winners.

The names of the applicants are not raised during the CIRM board discussion, which is public. The idea is the board members should be blind to the institutions seeking the funds. But some of the board members are well-versed enough in stem cell science to be able to identify applicants without an Internet search.

The earlier de facto decisions, however, are made behind closed doors by scientific reviewers and some CIRM board members. The statements of the economic interests and potential professional conflicts of scientific reviewers are filed with CIRM but are not made public, a practice that has triggered public complaints by a few researchers. Others grumble in private, wary of making their views publicly known because CIRM controls $3 billion in grant money that might not come their way if they are too cranky.

On tap for next week's meeting is discussion of a CIRM survey of its scientific reviewers regarding public disclosure of their financial interests. The results are expected to be negative, and the CIRM board is not likely to go against the wishes of its reviewers. Some CIRM directors fear the loss of reviewers if they are forced to make public their financial interests.

The Little Hoover Commission, the state's good government agency, recommended the survey because of the power of the reviewers over the public purse.

Some of the applications at next week's meeting are expected to involve loans to businesses, the opening foray into what is projected to be a $500 million program. CIRM directors are expected to go along with today's decisions on loan practices by their Finance Subcommittee.

In response to a query, Don Gibbons, CIRM's chief communications officer, said that the subcommittee approved both staff recommendations concerning evaluation of recourse loans and changes in the loan administration policy.

He said the panel also approved the “hybrid recommendation” in its financial review of loan applications. A CIRM document said,

“Under this proposal, CIRM staff would review and evaluate the information provided by CIRM’s delegated underwriter or financial consultant and the Grants Working Group, determine whether an applicant is eligible for a recourse loan or a non-recourse loan, and negotiate any conditions.”

Under certain conditions, however, the staff's determination could be reviewed by the Finance Subcommittee.

Financially Troubled CIRM Hires $200,000 Federal Lobbyist

The California stem cell agency has hired one of Washington's more influential lobbyists, The Podesta Group, to promote a $10 billion biomedical industry aid package being pushed by CIRM Chairman Robert Klein.

In response to an inquiry, Don Gibbons, CIRM communications chief, today said a contract had been signed with the firm, which was founded by Tony Podesta (see photo) in 1988. Gibbons did not disclose the value of the contract, but Podesta proposed a $200,000, 10-month deal in keeping with the terms of CIRM's request for proposals. Travel and other expenses incurred by Podesta would add to the total cost. The lobbying proposal also does not include travel expenses to Washington, D.C., for Klein, other CIRM directors or staff.

The losing firms were Van Scoyoc Associates and Hogan & Hartson.

Earlier we requested a copy of the 15-page Podesta proposal, which is a public record. Gibbons supplied a heavily censored version. More than five key pages were missing, leaving only their titles: "situation analysis" and "strategic framework."
.
Asked for an explanation for removal of the material, Gibbons quoted CIRM legal staff as saying,

"The Public Records Act incorporates, as an exemption, the trade secret privilege found in the Evidence Code.  Each responder was given the opportunity to assert that privilege for any part of the proposal it claims as a trade secret."

Without seeing the five removed pages, it is impossible to evaluate the Podesta proposal or whether it is realistic to expect any sort of result from the expenditure of $200,000 in California taxpayer funds. It is also clear that much of the bowdlerized, analytical material would likely consist of little more than what can be read in newspapers, industry publications and online information sources.

Most of the remaining material amounts to boilerplate descriptions of the firm and its work. However, Podesta did strike a ambitious chord or two, indicating that it would lobby for federal cash directly for the agency and would attempt to make CIRM a major biomedical player in the nation's capital.

Podesta wrote,

"Faced with the prospect of being unable to fund previously approved research and facilities grants, CIRM needs federal support in the form of appropriations, loan guarantees, and /or other measures to finance its research program through the end of calendar year 2010...."

In addition to grabbing some cash right now, Podesta said,

"Our strategy also positions CIRM to play a major role in shaping longer-term federal policies on biomedical research in general and stem cells in particular."

The firm said it is "the longest-tenured Washington representative of the pioneer biotech companies – Genzyme, Genentech and Amgen." It also represents Novartis Vaccines and Diagnostics and Novo Nordisk. Business Week has labelled The Podesta Group as one of seven "Uber-influencers: The Lobbyists Likely to thrive in the New Washington."

The hiring of the lobbyist has drawn fire from at least one critic, John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., who has called it an unnecessary, costly diversion from CIRM's stem cell research mission in California.

Simpson raised questions about the federal lobbying plan as early as CIRM's board meeting late last month. He specifically mentioned its $200,000 expense.

By that time the request for lobbying proposals, including its cost, had been on the CIRM website for two days. In response to Simpson, however, Klein said,

"The dollar amount of that is completely unknown at this time. It's in order to attract proposals and see what we have and what resources we need. So we're in an investigation stage of that."

Klein made that statement the morning of Jan. 30, the transcript of the meeting shows. The deadline for the proposals was 5 p.m. later that day with selection of a lobbyist scheduled for as early as two business days later.

We have raised additional questions with CIRM's Gibbons. They include whether CIRM's legal staff agrees that only "trade secrets" were removed from the Podesta proposal, whether all the material was removed at Podesta's request and whether CIRM removed material without a request from Podesta. The questions also include terms of the contract, whether the firm has actually begun work and whether Klein is seeking financial support from grantee institutions to pay for Podesta.

We will carry Gibbons' responses when we receive them.

If you would like copies of all three lobbying proposals, send an email to djensen@californiastemcellreport.com.

CIRM Grant Review: Questions About Fairness, Conflicts and Accuracy

Here is the text of article by yours truly concerning questions about fairness in the CIRM grant review process that ran Sept. 18, 2008, in BioWorld Perspectives.
Following this item, you can find related posts, including the text of responses we received from businesses that we queried and links to related CIRM and other documents.

CIRM Grant Controversy Continues with Publication of Biotech Company Names

By David Jensen

BioWorld Perspectives Contributing Writer

Editor's note: David Jensen publishes the California Stem Cell Report and has written nearly 2,000 items on the California stem cell agency since 2005. Jensen's Perspective last month, "Red Flags Remain in Plan to Help Biotechs," dealt with the controversy surrounding CIRM.

Questions are being raised about the fairness, conflicts of interest and even the accuracy involved in the grant review process of California's $3 billion state stem cell research program, the San Francisco-based California Institute for Regenerative Medicine (CIRM).
While nearly all of the rejected applicants remain silent, a handful of stem cell companies have publicly discussed their concerns.
Complaints About CIRM Add up in 2008
One California stem cell company, Advanced Cell Technology Inc., of Los Angeles, has complained about a financial conflict of interest on the part of one unnamed reviewer. Others have complained about inaccuracies in reviews, the failure to provide an opportunity to rebut reviewers and the lack of a grant resubmission process like the National Institutes of Health. Privately, more complaints are aired about reviewer conflicts and a tilt at CIRM toward funding "big guns," well-established senior scientists.
Last month, Alan Trounson, president of CIRM, told the agency's directors that "large numbers" of rejected applicants have contacted the agency concerning reconsideration of their rejected applications or related issues. But when asked more recently for specifics, a spokesman for the agency minimized the number, saying it amounts to no more than 10 on any round of grants.
CIRM acknowledges its review process is not perfect. It is working on a formal procedure for requests for reconsideration, which will come before directors on Sept. 24 or 25. But basically, CIRM sees no fatal flaws in the making of its grants, which now total $614 million over three years. When CIRM's review process came under fire last month, Trounson told directors, "Scientists, like other people, kind of believe [if] they live in California [they] should get a grant, [that] CIRM was set up to give them grants."
The agency first had to deal with public complaints from a rejected applicant last January. Questions of fairness surfaced more visibly later in the year, the first time that businesses have been permitted to apply for CIRM cash.
Out of the 18 applications from the private sector only one business, Novocell Inc., of San Diego, has received a grant. In the case of Novocell, it amounted to $50,000 to help plan for a much larger disease team grant.
Watchdog Publishes Names of Biotechs That Likely Applied for Grants
Until recently, the names of the rejected business applicants were unknown. CIRM's policy is to withhold the identities of all rejected applicants. But last month, Consumer Watchdog, of Santa Monica, Calif., a nonprofit group that has followed CIRM for nearly three years, disclosed on its website the names of the 18 businesses that filed letters of intent (LOI) to apply for grants.
The list reads like a Who's Who of California biotech companies. According to John M. Simpson, Consumer Watchdog's stem cell project director, firms that filed an LOI to apply for the Disease Team Planning Grant were: Advanced Cell Technology; BioCardia Inc., of South San Francisco; DNAmicroarray Inc., of San Diego; Genomics Institute of the Novartis Research Foundation, of San Diego; International Stem Cell Corp., of Oceanside; Novocell; Panorama Research Inc., of Mountain View; RegeneMed Inc., of San Diego; StemCyte Inc., of Covina; and Stemedica Cell Technologies Inc., of San Diego.
The companies that filed an LOI to apply for New Cell Lines Grant were: Advanced Cell Technology; BioTime Inc., of Alameda; California Institute of Molecular Medicine, of Ventura; Cascade Life Sciences Inc., of San Diego; DNAmicroarray; Gene Security Network Inc., of Redwood City; International Stem Cell.; Raven Biotechnologies Inc., of South San Francisco; RegeneMed; the Supercentenarian Research Foundation, of Inglewood; VistaGen Therapeutics Inc., of South San Francisco; and WaferGen Biosystems Inc., of Fremont.
Simpson noted that some companies earlier had "groused" about their treatment. And he asked, "Did the companies get a fair shake or not?"
We queried all 18 concerning the grant reviews. Fifteen did not respond to the questions. One said it was satisfied, one said anonymously it was quite dissatisfied, and one was withholding judgment until the next round of grants. At least three additional companies, however, have publicly told CIRM directors that they have issues with the agency's review process.
Alan Lewis, CEO of Novocell, responded to our query, saying he was pleased with the process. Lewis said his company has "developed a relationship with CIRM" and tried to help it in formulating the grant process. He noted that "very few" industry representatives often attend CIRM meetings.
At the August meeting of CIRM directors, Steven Kessler, a scientific director at Advanced Cell Technology, said that his company had filed information that one of the reviewers had a financial conflict of interest as the result of ties to another company. Kessler did not identify the individual or spell out the exact nature of the conflict. He told directors that he was told by the agency "the way CIRM interprets its own conflict of interest policy, the example I gave you was not a conflict of interest."
Kessler also cited the low success rate of business applications as "clear evidence of bias."
At the same meeting, William Adams, chief financial officer of International Stem Cell, indicated that CIRM directors were excessively worried about "ticking off" scientific grant reviewers with public criticism of the quality of their reviews.
At the June directors meeting, Kenneth J. Woolcott, chief business officer of Cascade LifeSciences, commented on the process but did not seek an appeal, having been told none was available. Shortly after Woolcott left the meeting, a reconsideration letter from an applicant from a nonprofit was read by a director, resulting in the approval of that grant.
Woolcott was not pleased when he learned about the situation. He then sought reconsideration of the Cascade application, alleging that its review included factual errors involving a "fundamental oversight." He also said reviewers did not adhere to the published review criteria. CIRM rejected Cascade's request. (See links below for more information.)
In response to our query, another California company researcher, who asked for anonymity, said reviewers' comments on his application were "ridiculously incomplete" and "misinformed." "You can tell when people really didn't read it," this scientist said.
Leading to Positives for Future Stem Cell Grants?
Consumer Watchdog's Simpson said that the publication of the names of rejected businesses has had a healthy impact. (In fact, BioWorld Today reported last month that the biotech industry is poised to receive more CIRM funding in the future.)
"I'm not advocating that anybody be required to divulge proprietary information, but the application process needs to be more transparent," he said.
"My publishing the names of the applicants has enabled them to communicate with one another, compare notes and figure out how to voice what appear to be very legitimate concerns about the grant-making process.
"I'm by no means a big fan of the biotech industry, but I think this is a case where awards have been tilted toward academia. There ought to be a level playing field."
Interested in reading more? Here are some links to documents relating to the California stem cell agency and complaints about fairness in its grant review process:

• Consumer Watchdog Identifies Businesses Rejected for CIRM Grants
  
• CIRM's August Proposal for a Reconsideration Procedure (this draft is likely to be modified before CIRM's meeting later this month)
  
• Transcript of August 13, 2008, CIRM Meeting
  
• Cascade LifeSciences Seeks Reconsideration
  
• Text of Cascade's Reconsideration Letter
  
• CIRM Response to Cascade Complaints
  
• Transcript of June 26, 2008, CIRM Meeting Involving Cascade

Fallout From Disclosure of the CIRM 18

Alan Trounson, president of the California stem cell agency, has sent a letter concerning disclosure of the names of 18 companies who expressed an interest in applying for grants from the $3 billion research program.

Trounson wrote the letter to the companies after Consumer Watchdog revealed the names that CIRM had attempted to keep confidential as part of its pseudo policy of secrecy. Pseudo because CIRM chooses to keep some names secret and reveal others. And many of its public grant review summaries contain enough information that any reasonably well-informed person can determine the identity of the applicant should he or she want to make the effort.

In his letter, Trounson expressed regret about the disclosure and said that CIRM has issued a "reminder" concerning its confidentiality policies.

John M. Simpson, stem cell project director for Consumer Watchdog, published a copy of Trounson's letter on Tuesday. Simpson commented:

"From what I've heard, representatives of companies on the list are talking with each other about why it was only one of the 18 companies, Novocell, received an award. They're comparing notes about the grant review process and how they feel it was biased against for-profit entities.

"There's a good chance they will work together as a group and take their concerns to the stem cell oversight committee, possibly as early as its September meeting.

"See what happens when a little light shines in?"

CIRM's Secret 18 Disclosed

The Consumer Watchdog group today pulled away a bit of the veil of pseudo-secrecy that surrounds much of the grant process at California's $3 billion stem cell agency.

CIRM – most of the time – refuses to disclose the names of enterprises or individuals seeking its taxpayer-financed largess, unless they have actually won some CIRM cash. However, the agency chooses to identify applicants when it is convenient for CIRM purposes, as was the case in the mammoth lab grant program earlier this year.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., has long contended that good government practices demand the release of the names of those who seek funding from the state of California.

Today on his blog, he disclosed the names of 18 companies that were looking for grants from CIRM. Only one, Novocell, eventually received a grant, despite oft-expressed desires by some CIRM directors that California companies should receive the benefit of state financing.

Simpson noted that some rejected business applicants have complained about CIRM's review process, contending that it "is skewed towards academic science." Some CIRM directors have also questioned the approach of its scientific reviewers, saying that they may overlook worthwhile efforts that are heavily focused on bringing cures into the hospital. Simpson suggested that the companies he identified might want to get together and talk.

Simpson said the names were drawn from a document "used for internal CIRM vetting processes" involving letters of intent, which are required in order to apply for a grant. Simpson wrote:

"Here's the list of firms which filed an LOI (letters of intent) to apply for the Disease Team Planning Grant:  Advanced Cell Technology, Alameda; BioCardia Inc., South San Francisco; DNAmicroarray Inc., San Diego; Genomics Institue of Novartis Research Foundation, San Diego; International Stem Cell Corp., Oceanside, Novocell, San Diego; Panorama Research Inc., Mountain View; RegeneMed Inc., San Diego; StemCyte Inc., Covina; and Stemedica Cell Technologies, San Diego.

"Here are the companies that filed an LOI to apply for New Cell Lines Grant:  Advanced Cell Technology, Alameda; BioTime, Inc., Emeryville; California Institute of Molecular Medicine, Ventura; Cascade Life Sciences Inc, San Diego; DNAmicroarray Inc., San Diego; Gene Security Network, Portola Valley; International Stem Cell Corp., Oceanside, Raven Biotechnologies Inc., South San Francisco; RegeneMed Inc., San Diego; Supercentenarian Research Foundation, Inglewood; VistaGen Therapeutics Inc., South San Francisco and WaferGen Biosystems, Fremont."

Strong Interest in $41 Million CIRM Faculty Award Program

The California stem cell agency's effort to boost "young" researchers with grants of up to $2 million has attracted 55 letters of intent, nearly as many as the first round of program last year.

The faculty awards are designed to develop relatively young and promising researchers and particularly physician-scientists at a critical stage in their careers – providing them with salary and research funding for three to five years.

The $41 million grant program comes on top of a similar program last year that drew 59 letters of intent. Ultimately, the agency gave away only $54 million to 22 researchers out of the $85 million allotted in 2007. The grants were curtailed because five CIRM directors violated the agency's conflict-of-interest policies by writing letters on behalf of applicants from their institutions.

CIRM said the letters resulted from an "innocent misunderstanding." CIRM disqualified the 10 applications involved. The directors involved suffered no CIRM penalty, although some reportedly took steps to ease the economic or professional pain of applicants who were affected.

In December, CIRM directors ordered up a second round of faculty awards in order to give another chance to applicants disqualified last year because of their deans' conflict violations.

The names of the institutions and researchers submitting letters of intent this month were not disclosed by CIRM, which keeps them secret. Only the winning applicants names are released and then only after they are approved for funding.

In response to a query, Don Gibbons, chief communications officer for CIRM, released the number of intent letters and said 31 institutions were represented. He did not provide a breakdown for numbers from academic institutions and nonprofit research organizations.

CIRM has directed applicants in the second round not to disclose whether they competed in the first. Disclosing such information in this round could mean disqualification of the applicant.

Grant reviewers, however, are not likely to have too much trouble identifying applicants who are making their second run – unless their latest applications are totally different than the first or the reviewers' memories are faulty.

Fourteen grants are expected to be approved this summer following a closed-door review of the applications by the same CIRM panel that reviewed the first round of the grants. Scientists on that panel do not have to publicly disclose their financial or professional interests. Instead their disclosures are made privately to CIRM.

The application deadline is April 3, although no one can apply unless a letter of intent has already been sent.

LA Times Piece on CHA RMI Has Response from Researcher

The Los Angeles Times Monday ran its story concerning CHA RMI and its $2.6 million California stem cell grant, including a statement from the main researcher on the project.

The Times story was picked up the KNBC television station in Los Angeles, which did not add any new information to the account.

The Times piece by reporter Mary Engel began by noting that the grant went to a research center whose founding president is "embroiled in an international dispute over authorship of a medical journal article." Then it listed the ethical allegations concerning an associated fertility clinic.

Engel's story also had this from the researcher involved:

"In an e-mail to The Times, the lead scientist for the grant, Jang-Won Lee, said he was not involved in any of the allegations. The research, he said, will undergo thorough scientific and ethical review, and is aimed at developing therapies for a devastating neurodegenerative disease."

She also had this quote from John M. Simpson, stem cell project director for the Foundation for Consumer and Taxpayer Rights, concerning the secrecy involved in the grant review process.

"'Had everyone known that a grant was being discussed to that organization, things would have gone slower and questions would have been raised then.'"

We have a query into CHA for a response on the issues that have been raised and have promised that we will run it verbatim when we receive it.

For previous items on this see: "Grant Recipient," "Little Notice" and "CHA Example."

Advisory

The press release by the Center for Genetics and Society concerning the CHA grant has now been posted on its web site. Here is the location.

The CHA Example: How CIRM Decides Who Gets the Big Bucks

The $2.6 million California stem cell grant involving the CHA Regenerative Medicine Institute received a score of 77 from a panel of grant reviewers, although they commented that it "can be easily qualified as overly ambitious."

Approval of the application last week by the Oversight Committee of the California Institute for Regenerative Medicine has resulted in calls for an investigation into CHA RMI's nonprofit status and its links to a Korean scientist involved in an international plagiarism case, among other things.

The CHA application first came up for a review last January by a CIRM working group, chaired by Stuart Orkin of the Dana Farber Cancer Institute. Fourteen other scientists held seats on the group. Seven members of the Oversight Committee sat on the panel. Only one is from Los Angeles, where CHA RMI has its office. It is not known whether she was in attendance when the CHA application was discussed. All of the scientists are from out-of-state.

Meeting privately, the reviewers recommended the CHA application and others for funding. The CHA application was placed in the first tier of grants that were sent on to the Oversight Committee. The scores of the first tier grants ranged from 95 to 66. The reviewers received detailed information on the proposal, including the names of the principal researcher as well as its methodology. Only one reviewer was recused from considering the grant. He was Jeffrey Rothstein of John Hopkins, who works in ALS research, a field that was also targeted by the grant.

Prior to action by the Oversight Committee, the names of all CIRM grant applicants and their institutions are secret except during the private meetings of reviewers, according to CIRM policies. The Oversight Committee is also not told their names during the votes on the reviewers' recommendations. The names of the winning applicants are only disclosed after the vote. The names of the losers will never be disclosed by CIRM.

CIRM says its secrecy is justified for a number of reasons. The agency says it is the traditional way grant applications are handled in the scientific community. It is professionally damaging, CIRM also says, for scientists to be publicly identified as not being able to win grants. It is also damaging to be criticized in public. Maintaining secrecy means that scientists are more likely to propose more ambitious and riskier research than would otherwise be the case. The results of science will be better in the aggregate, thus benefitting the public more than would identifying the applicants and their institutions, CIRM says.

During last week's Oversight Committee meetings when the grants were approved, the 29 members of that panel were not told the names of the applicants or the institutions. They were given a summary that is also available to the public. Individual members were given a list of the grants by number on which they could not vote or participate in the debate. Those lists were withheld from the public at the meeting. Just prior to voting on or discussing an individual grant, a list was read of the committee members who could not participate in the debate. At that point, well-informed members of the audience and probably many members of the committee could identify the actual institutions involved and often the individual researchers. The persons who could not are ones who are not as well informed on stem cell research.

The Oversight Committee voted on the first tier of grants as a block. At that point, no list of recused members was read to the public. Rather each member announced that they were voting in favor of the block with exception of grants where they had a conflict. CIRM's outside counsel recommended the procedure.

Following the vote, CIRM posted a list on the Internet of Oversight Committee members recused from voting on the CHA grant. They are Ricardo Azziz, chair of Department of Obstetrics and Gynecology at Cedars-Sinai in Los Angeles, Jeanne Fontana, a surrogate for John Reed, head of the Burnham Institute in La Jolla, and Richard Murphy, president of the Salk Institute, also in the La Jolla area. Reasons for their recusal were not posted.

(The California Stem Cell Report has argued often against much of the secrecy in the grant-making process for a variety of reasons. We will write more about the issue later.)

In response to a query, Dale Carlson, chief communications officer for CIRM, supplied the following:

"The CIRM grant review and administration process does not end with the ICOC's vote on deciding which applications to approve or not approve for funding. To that point, the review process by the Grants Working Group is focused on scientific merit. After that, there is an internal administrative review by Institute staff to ensure that each approved application is from an institution and principal investigator that meet the eligibility requirements of the specific Request for Applications (RFA); of the requested budget and proposed facilities for the proposed project; and of the institution's mechanisms for complying with our grants administration policy and medical and ethical standards.

"The administrative review process can take several weeks (we are still working on the SEED grants approved in mid-February, for example) and only after it's completed to our satisfaction do Notice of Grant Awards (NGAs) go out to recipient institutions and researchers. Checks follow NGAs.

"The NIH grants review process is similar."

The principal investigator on the CHI RMI grant is Jang-Won Lee. Little information is available about him on the CIRM web site. Carlson said the score of 77 on his grant is an average of each score by each reviewer. Here are the rankings of the grants.

Below is the text of the strengths and weaknesses of his application based on the CIRM reviewers assessment. More information on the grant can be found at this location.

"STRENGTHS: The proposal is well-written and includes preliminary data in pigs and novel methods. The research plan is nicely developed and the PI has the appropriate expertise, at least in animal cloning (less with hESCs), to be successful in this endeavor. Success of the PI in the porcine model adds strength to the plan. A large collection of letters of support provides evidence of enthusiastic collaboration with the PI that will add critically needed expertise to the project. The plan to differentiate and transplant hESC-derived neural cells in a well-established mouse model with experts in the field strengthens the lack of experience with hESC culture (but not derivation) by the rest of the group.

"WEAKNESSES: This is a proposal that can be easily qualified as overly ambitious. The author provides a shopping list of all the experiments that will happen after the ALS SCNT embryos have successfully been established and characterized. This seems premature. The proposal would be successful if the derivation is first done accurately and convincingly to generate a handful of lines that will be available for the community. Preliminary data on enucleation, SCNT and hESC derivation in an animal model should be done before proposing these studies. Specifically, SCNT on frozen oocytes in an animal model should be done before using completely viable, clinically useful human oocytes. The use of frozen oocytes for SCNT has not been established, and is likely to be a significant technical problem for enucleation and whole cell injection. There is no indication of a plan to enucleate the oocytes in the proposal and a clear rationale for using one or both of the methods used previously by the collaborator who developed the method is required. A plan for the derivation of hESCs is also needed along with a rationale for the use of ALS cells for tranplantation studies, rather than normal cells. It also appears that no one on this project has experience with this hESC derivation, or the derivation of any ESC lines.

"The section on clinical grade ESCs is not necessary for the proposal and should be removed. These ESCs are not stable lines that have been shown to be maintained in vitro. In fact, they appear by the literature and preliminary data to be a mixture of hESCs and hESC-derived differentiated populations. The plans to differentiate hESCs for transplantation do not require this intermediate step. It is unfortunate, because the application of novel SCNT techniques is a reasonable way to move the field of SCNT and hESC biology forward. If the rest of the proposal was as well-designed as the pig studies, the score would be very high."

SEED Grant Recommendations Available

The scored recommendations for funding of SEED stem cell research grants by the California stem cell agency are now available on CIRM's web site.

The posting lists the titles of all the applications, their score, recommendation for funding along with a "public benefit" and "public review report" and a summary of the CIRM working group's review. The public benefit report was prepared by the applicant.

Names of the applicants remain secret.

The Oversight Committee will make the awards next week.

Twenty-five Secret Applicants for $48.5 Million in Public Funds

On the surface, the odds look pretty good in CIRM's $48.5 million grant program for "shared" stem cell labs.

The institute plans to hand out as many as 15 grants, and only 25 institutions have filed letters of intent. Of course, their names are secret by order of CIRM, even though every major University of California campus is certain to have filed. Include Stanford, USC, the Burnham and Salk Institutes, etc., and it is not hard to come up with something close to 25 non-profit and academic institutions. That number may shrink by the deadline for formal applications.

The reason for the secrecy is concern that losing institutions would be embarrassed. Nonsense, we say. Moreover, this is public money that is being given away, and it should not be done behind closed doors any more than absolutely necessary.

According to CIRM's press release, the institutions must provide a 20 percent match of the total cost for renovation and equipment.

CIRM also said,

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

The grants are expected to be awarded this June.

Do you think the names of the applicants should be secret? You can respond by using the "comments" function below. Anonymous comments are permitted.

CIRM Guide to the $100 Million Grant Process

The California stem cell agency has posted on its Web site a useful guide to its plans for handing out more than $100 million in research grants, including timelines and other procedures.

Much of the information has been available before but it was scattered and hard to find. Now it has been compiled in a tidy package. Some of the information is fresh. For example, the memo said:

"In the first week of February, we will release a list of all the SEED Grant applications. That list will include the title of the research proposal, the numeric score (1 to 100) it received from the Grants Working Group, and the Working Group’s recommendation (Recommended for funding, Recommended if funds available, or Not recommended for funding at this time). From our Web site, viewers can click on the application number to open a public abstract of the proposal, a statement of its benefits to California, the applicant’s proposed budget, and a summary of the Working Group’s review."

The memo also reiterated the agency's intention to maintain its secrecy concerning the names of those seeking millions of dollars in government funds – a dubious practice adopted because that it is the way it always been done (at least on the federal level) to protect rejected applicants from embarrassment. We should note that some of the applicants have already disclosed that they have applied, making the attempt at secrecy a bit ineffectual and raising questions about why the applicants disclosed when the granting agency prefers secrecy.

The memo was prepared originally for use by the ink-stained wretches of the media, but it has value for anyone interested in the grants. You can clip it and post it on the outside of your petri dish.