California's Stem Cell Research Performance; Agency Schedules More Awards

Overview of applications and funding outcomes in CIRM 2.0 as of July 23 -- CIRM chart

Highlights

One contract signed

17 applications received

Demand leveling off

Mills says 'metrics' good

The governing board of the $3 billion California stem cell agency is scheduled to meet on Aug. 20 to give away more millions for late stage preclinical research as part of its ambitious and "radical" overhaul of its funding effort.

The one-hour teleconference meeting will have its­­­ main location in San Francisco. Seven other offsite locations are also available for the public, ranging from Napa to San Diego.

The only item on the agenda is consideration of an unspecified number applications for funding work leading up to a clinical trial. (See here for the request for proposals -- PA15-01.)

The number of applications to be considered and their review summaries are not yet available on the Web site of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. However, they are part of what CIRM President Randy Mills calls CIRM 2.0, what he terms a “radical” change in the way the agency handles applications.

Deadlines for applications in this late-stage research round, funded at $100 million for this fiscal year, come up at the end of every month. The goal is to generate better applications and speed the cash to researchers.

The program began Jan. 1. So far, only one contract has been signed for a research project, Mills reported to the CIRM governing board on July 23. ­­­ However, four have been approved by the CIRM governing board out of 17 that applied between January and June. 

Mills told the board last month,

“The demand is leveling down more closely to what we thought it would be. So in May we received three applications, in June we received two applications.

“The review team was very worried in April when we had five applications because that's more than we actually anticipated we would have, but it seems to be normalizing down around the two or three a month area which is closer to what we had predicted.

 “One other thing I want to point out here -- which was neat in April -- is we sent three programs for what we call budget review. And that's before we send these things to the grants working group for actual scientific adjudication, we send them for external budget review to make sure that the budgets are appropriate for the scope of work being offered.

“We actually had one fail. And I like that because that says that system is working. And if something is going to go through the process and have a budget that's not justifiable, we're able to catch it, and we're able to kick it out. In this case we made them go back and think through their budget a little more closely.

“With all that said, it seems to be working well from a metrics standpoint. We're very pleased. Only in January did we have the one delay, and we haven't had an off mark since.”

In addition to San Francisco, Napa and San Diego, locations where the public can participate in the meeting and lobby for or against a specific research application can be found in Irvine, Redwood City, Sacramento and Los Gatos. Specific addresses can be found on the agenda.

California Hits Its Mark on Faster Delivery of Cash for Stem Cell Research

• Caladrius to get first installment on nearly $18 million 
• Agency President Randy Mills Pleased with CIRM 2.0 Overhaul

 SAN FRANCISCO -- The California stem cell agency may not be faster than a speeding bullet, but it is running way more quickly than it was a year ago.

For researchers and patients, that means the agency’s millions are moving more rapidly into development of therapies and cures with the goal of beginning to save lives sooner rather than later.

The signal event came last week when the agency, formally known as the California Institute for Regenerative Medicine(CIRM), signed off on a contract with Caladrius Biosciences, Inc., of New York.

As soon as Caladrius signs the agreement, it will receive a check for $3 million, the first installment on a nearly $18 million award that was approved by directors less than a month ago. 

Randy Mills

CIRM President Randy Mills was delighted last Friday when he told the California Stem Cell Report about the action on the Caladrius award. (Caladrius was formerly known as NeoStem.)

Mills, who has been head of the agency for only a little over a year, mentioned the news during a 45-minute conversation in his office at CIRM headquarters.

It was the first award paid out under Mills’ new, CIRM 2.0 program, an effort designed to speed cash to researchers and improve the quality of applications. It is also the first CIRM award in a stage three trial, the last step in the process of winning government approval for widespread public use of a therapy.

The agency approved the actual Caladrius contract last Thursday, 21 days after the directors’ approval. Mills’ goal was to act on the contract within 45 days.

CIRM’s 2.0 clock shows Caladrius’ application for the melanoma therapy coming in at the end of February, 113 days ago. Mills’ goal is to have action completed on an application within 120 days from the time it officially enters the 2.0 system -- instead of up to two years as in the past. 

The firm offered its initial application at the end of January, but it was sent back for improvement. 

Next up in the first round of CIRM 2.0 awards is final action on a $5 million award to Shaomei Wang of Cedars-Sinai that was also approved on May 21 by CIRM directors.

Mills said last Friday that CIRM 2.0 has not been perfect and that in some cases implementation required "brute force." But he is pleased overall. Later this year, Mills and his team plan to apply CIRM 2.0 to basic and translational awards, all of which will mean significant changes for hundreds of California scientists. 

California's Stem Cell Grant Reviewers Set for More Oversight on Research Awards

The California stem cell agency today moved forward on creation of new rules for its research awards, ranging from more fiscal scrutiny to elimination of paperwork.

The aim of the move is to improve the quality of the research and speed development of stem cell therapies by the $3 billion agency.

The Science Subcommittee of the agency’s governing board, as expected, unanimously approved the rules, which are nearly certain to be ratified Thursday by the full board at its meeting in Berkeley.

The proposals are part of CIRM 2.0, a major change at the agency initiated by Randy Mills, who became president of the agency last May. 

In addition to the grant regulations, the subcommittee unanimously approved changes in procedures involving the conduct of the closed-door grant review meetings. 

The grant reviewers, formally known as the Grants Working Group, make the de facto decisions on all applications. The agency’s board has legal authority to accept or reject applications, but has almost never rejected a positive recommendation from its blue-ribbon scientific reviewers.

One change involving the scientific reviewers, all of whom come from out-of-state, calls for them to exercise oversight on the progress of the research and on “continued funding.” The reviewers would report their findings to the full CIRM board or the agency’s president. That would be in addition to CIRM staff monitoring and quarterly reviews by new panels of advisors.

Another change in the review process calls for a patient advocate member of the review group to be more actively involved in the review of applications. One advocate would be asked for his or her views on an application but would not score the application. All of the patient advocate members of the review panel are also members of the agency board.

In addition to the seven members from the agency board, including its chairman, each group of reviewers for a particular award round includes 15 scientists from outside California. They are drawn from a list of more than 100.  Their financial and professional interests are not disclosed to the public. Applicants are not notified which researchers review their applications.

California Stem Cell Agency Cancels $19 Million Award to StemCells, Inc.

StemCells, Inc. has lost its controversial, $19 million award from the California stem cell agency, it was disclosed today.

Cancellation of the forgivable loan was revealed in slides posted on the agency's Web site as part of the presentation today by its new president, Randy Mills, to the agency's board of governors.

The slide said the Alzheimer's award was "discontinued due to lack of functional improvement observed in preclinical studies" after the agency had provided the publicly traded firm with $9.6 million. It was not immediately clear whether any of the money will be repaid.

The company has not yet announced the loss of the award but has been asked for comment.

The most recent cash infusion came last spring in a move that coincided with the appointment of former CIRM President Alan Trounson to the StemCells, Inc., governing board. Trounson joined the board only seven days after leaving the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.  The move surprised and shocked the agency, but it said its limited investigation detected no illegal action in the disbursement to the company. (Also see here.)

The StemCells, Inc., application was approved by the 29-member CIRM board in 2012, on a 7-5 vote,  after being rejected twice by the agency's blue-ribbon reviewers. The approval followed heavy lobbying by the former chairman of the agency, Robert Klein. It was the first time that the board had approved an award that reviewers had turned down twice. It was also the first case of such public lobbying by Klein.

Later in 2012, Pulitzer Prize-winning columnist Michael Hiltzik of the Los Angeles Times wrote that the award was "redolent of cronyism."  Hiltzik asked rhetorically what was the company's secret in winning approval of the award. He then wrote,

“StemCells says it's addressing 'a serious unmet medical need' in Alzheimer's research. But it doesn't hurt that the company also had powerful friends going to bat for it, including two guys who were instrumental in getting CIRM off the ground in the first place.”

Hiltzik referred to Klein and eminent Stanford research Irv Weissman, a co-founder of StemCells, Inc., who still sits on its board and holds considerable shares in the Newark, Ca., company.

Weissman was a key backer of the ballot measure that created CIRM in 2004 and helped raise money for the ballot campaign.  Trounson has recused himself on some matters dealing with applications connected to Weissman. Trouson has been a guest at Weissman's ranch.

A Brief Look at the $12 Million California Stem Cell Bridging Program

The directors of the California stem cell agency later today are expected to approve $1.2 million for two University of California stem cell researchers as part of what the agency calls a “bridging” program.

The effort has received little attention but could be a key for some research as scientists try to turn more basic efforts into something that could reach the marketplace.

Patricia Olson, executive director of scientific activities , has prepared some slides for today’s meeting in Millbrae, Ca., that lay out a bit of the scope of the effort.

She reported that the goal of the program is to accelerate development of stem cell therapies. She said the bridging program is aimed at providing an “efficient and seamless advancement of promising CIRM-funded translation and development projects towards and through clinical development.”

No RFA is used for the effort. Instead scientists must submit a brief proposal that could lead to further consideration. Up to $12 million has been allotted to the effort. Olson did not present information on how many proposals have been submitted.   

Randy Mills and His $640 Million California Stem Cell Experience

The new president of the California stem cell agency -- even before his appointment last week -- participated in handing out more than $640 million in awards from the agency to businesses and academic researchers.

Perhaps more importantly, all of those awards involved advanced stages of research leading to clinical trials, the current focus of the Golden State's research enterprise.

The participation of Randy Mills, the former CEO of Osiris Therapeutics, in the approval of the grants and loans came during the closed-door review of their applications. He was a member of the panel of out-of-state reviewers used in eight CIRM award rounds. The panel of scientist is large, but each award round uses only a small subset of the total group. 

Mills' five years as a reviewer gives him a special insight that is not even shared by most of the members of the CIRM governing board. Only seven members of the 29-member CIRM board sit on the review panel.

CIRM Chairman Jonathan Thomas, who is a non-voting member of the grant review panel, last week said that Mills demonstrated "a sharp intellect and a keen analytical mind" during grant reviews.

The grant reviewers make the de facto decisions on the vast majority of grant applications. The governing board has almost never overturned a positive decision by the reviewers. The full board receives only the review summaries that are available to the public, with the exception of proprietary information. Indeed, board members have complained over the years about not having enough information to make decisions when faced with appeals from rejected applicants.

The reviewer sessions are where the scientific merit of the proposed research is scrutinized and criticized in detail and scored. Until recently, other issues were considered as well, what the agency calls “programmatic” review, which covers nearly everything.

The role of the president of the agency during the closed-door review is not clear, although he does not have a vote. Alan Trounson, the current president of the agency, was believed by some California researchers to be active during the closed-door process, injecting comments and likely affecting decisions by reviewers at least on some occasions. However, the agency does not release transcripts or minutes from the review sessions.

Late last year, the CIRM president was authorized to make public recommendations to the full board concerning applications. That process is new, but stirred controversy in January in the $40 million stem cell genomics round.

Here are the award rounds involving Mills and the dollar amount that was budgeted for each: Strategic partnership I, $30 million; strategic partnership II, $40 million; strategic partnership III, $80 million; disease team II, $240 million; disease team III, $100 million, early translational II, $80 million, and early translational IV, $70 million. A specific amount for the 8th round, disease team II planning, was not available at this writing on the CIRM Web site, but that round was relatively small, $1 million or so or less.

$40 Million Stem Cell Genomics Award: Details Still Being Worked Out

BURLINGAME, Ca. – The California stem cell agency and a Stanford-Salk consortium have yet to come to terms on a final agreement on a $40 million stem cell genomics award.

The governing board of the agency approved the proposal in late January during a process that was marked by controversy, including complaints about irregularities,unfairness, score manipulation and the role of its president, AlanTrounson.

All awards are subject to review by the agency's staff, which works out final details and assures that all terms are met.

Asked about the status of the award, Kevin McCormack, senior director of public communications for CIRM, said this morning that the agency was still talking with the consortium. He did not go into details about what issues are involved.

Board Counsel at California Stem Cell Agency Engaged in Examination of $40 Million Genomics Award

The California stem cell agency yesterday confirmed that the counsel to its governing board, James Harrison, is involved in the examination of its $40 million genomics round, which has been criticized for irregularities, unfairness,score manipulation and the role of its president, Alan Trounson.

Harrison has been with the board since its inception and wrote parts of Proposition 71, the ballot initiative that created the $3 billion research effort in 2004. Harrison, who is a partner in the Remcho Johansen & Purcell law firm of San Leandro, Ca., also has expertise in conflicts of interest and ethics. He is on contract with the agency and is not an employee.

In response to a question Feb. 8, asking whether Harrison was looking into the grant review process in the genomics round, Kevin McCormack, senior director for communications, confirmed that the agency was examining how the applications were handled. However, he did not reply directly to the question of whether Harrison was involved in the inquiry.

After being asked again yesterday, McCormack said,

“As you know after every review we go back to see what we could have done better and that usually involves several staff members at the agency, including James, who look at what happened and try to identify ways to improve next time.”  

California's $70 Million Alpha Stem Cell Clinic Competition Ratchets Up

A $70 million race was kicked off last month as the California stem cell agency invited eight institutions to compete to create what it calls Alpha Clinics, enterprises that would attract patients from throughout the world for stem cell therapies.

The agency hopes the plan will lay a foundation for the stem cell industry in California and capitalize on the growing allure of stem cell treatments. CIRM President Alan Trounson, who plans to leave the agency this year, has been pushing the Alpha Clinic plan since 2011.

Beyond the agency's millions, CIRM has told applicants rather delicately that they have an obligation as well. “Show us the money” is the message obliquely contained in the agency's request for applications (RFA) for the Alpha awards.

The issue of matching funds is a tender spot for the agency this week given the flap that arose in the recent $40 million stem cell genomics round. A requirement for contributions was not mentioned in that RFA, leading some unsuccessful applicants to not include any. Stanford won with what it says is $7 million in matching funds.

CIRM's Alpha Clinic RFA does not mention cash, matching or money. But it does say the selection criteria involves in-kind or “other forms of support” and “sustainability,” which usually means a plan for raising cash or showing that cash is in hand. A coupled RFA is a tad more explicit. It mentions criteria involving “financial strength,” leveraging “assets” and “effectiveness in attracting a funding steam” after the award runs out. One or more applicants may think that the best way to show effectiveness in funding is to demonstrate it from the very beginning with a handsome sum.

Eight existing academic centers with hospitals were invited to apply last month to become Alpha Clinics, which will be one of CIRM's signature efforts, given the size of the round and its scope. Up to five awards will be made in that $55 million plan.

In a related RFA, five applicants have been invited to apply for one $15 million award to create a stem cell information and data management center. Not all of the five have been invited to apply in the clinic round. Awards in both categories will be for five years.

Kevin McCormack, senior director for communications at CIRM, said the invitations to compete were culled from 14 letters of intent to apply. The stem cell agency generally declines to disclose the identities of applicants for awards, although it has done so on at least one occasion in the past.

CIRM says its Alpha Clinic plan is aimed at providing “critical operational support for the conduct of clinical trials for investigational stem cell therapies” and to create “centers of excellence” for approved stem cell therapies. Applicants should show that at least two “lead clinical trials” will be conducted at their institutions along with a “committed source of funding” for each trial. CIRM said it would not pay for the trials or construction or renovation of facilities.

In addition to gathering medical data, the $15 million information center will be involved in marketing to potential patients and public communication. The RFA calls for the center to campaign against the “dangers of stem cell tourism,” which is increasingly growing overseas. The information center will also be involved in developing data to convince insurance companies and governments to cover the cost of stem cell therapies, which are predicted to be very expensive.

Because no more than five clinics may be funded, the chances for the eight are good. However, the CIRM governing board is increasingly feeling financially pinched as the agency's funds dwindle. Cash for new grants is expected to run out in the latter part of 2017. The board could back away from the idea of five clinics depending on what grant reviewers say.

Applications are due March 14. Board action is expected this summer with funds going out next fall or shortly thereafter.

A Question of Orthodoxy: Would California Have Funded Vacanti?

As UC Davis stem cell scientist Paul Knoepfler points out, it was a blockbuster story that grabbed attention around the world.

Not only within the professional stem cell community, but outside it as well because of the promise that the use of human embryonic stem cells could be avoided.

Charles Vacanti

So Knoepfler wangled an interview for his blog with Charles Vacanti, the man of the hour. He is head of the anethesiology department at Brigham and Women's Hospital in Boston. He is also a “virtual outsider to the highly competitive and fast-moving stem cell field,” says Carolyn Y. Johnson in a piece in the Boston Globe.

But it was Vacanti and his people who made the discovery that a simple acid bath could be used to generate pluripotent stem cells.

Sometimes people who catapult into the news as Vacanti did, especially in a controversial area, shy away from close questioning. Asked about how the interview came about, Knoepfler replied,

“I simply asked and amazingly he said 'yes' and was nice enough to answer 10 fairly tough questions.”

You can read the Q&A with Vacanti on Knoepfler's blog as they explore the science and the techniques. Knoepfler also has conducted a poll on whether people believe in Vacanti's stem cells. As of the latest voting, 25 percent are “not sure but leaning slightly towards they are real.”

One thing is fairly certain based on the Johnson's Globe piece on Vacanti, which was headlined,  “Ignorance led to invention of stem cell technique.”  Vacanti's research would not likely have been funded by California's $3 billion stem cell agency.

Its grant review process is dominated by persons who also dominate the current thinking in the stem cell arena. And Vacanti represents a departure from orthodoxy. He also would have been found lacking on a host of grounds, ranging from his professional background to his earlier research.

As Johnson reported in her story,

“'In science, the prevailing opinion is called dogma. And dogma is often right, and often wrong,' said Arnold Caplan, a biology professor at Case Western Reserve University and friend who has acted as a sounding board for some of Vacanti’s ideas.”

California Stem Cell Agency Withholds Key Information in $40 Million Genomics Proposals

The California stem cell agency has declined to disclose publicly a critical criteria – the amount of matching funds offered by each applicant -- in its ambitious $40 million genomics round scheduled to be acted on later today.

A spokesman for the $3 billion state agency yesterday said the figures were not a public record. However, the agency has public revealed such figures in the past.

The matching funds played a major role in the top ranking of a $33 million genomics proposal by a Stanford-led consortium. Lack of matching funds also was deemed a serious problem by the agency's grant reviewers, who operate behind closed doors, in an application led by the Scripps Research Institute.

When asked for the figures, Kevin McCormack, senior director for public communications, said,

 “That is proprietary information, and so it's not available.”

He has not yet responded a follow-up question about the rationale for cloaking such figures in secrecy that goes beyond the simple assertion that they are proprietary. Generally, proprietary information is considered to be trade secrets or involve intellectual property or unique business methods.

Financing is commonly disclosed by businesses and is even required by federal law when a company is publicly traded.  

$21 Million Likely for California's Basic Stem Cell Research

Directors of the California stem cell agency tomorrow are expected to approve at least $21 million for basic research into “significant, unresolved issues in human stem cell biology.”

The round was originally slated for $40 million but grant reviewers decided to fund only 20 applications out of 62. The round began with 341 scientists filing pre-applications.

(Here is a link to reviewers' summaries and rankings as well as a link to the CIRM staff's Power Pointpresentation.)

CIRM President Alan Trounson and his staff recommended approval of five additional applications totaling$4.8 million. The rationale in their recommendations could be considered fulsome compared to what Trounson offered on the $40 million genomics round also to be considered tomorrow.

Five additional researchers filed letters with the CIRM governing board seeking its approval. Those letters can be found on the agenda for tomorrow's meeting. Seven researchers filed formal appeals with the CIRM, which are now dealt with behind closed doors by the agency's staff.

The 20 applicants given the nod by reviewers were placed in a tier one category that is virtually certain to be approved by the board with no debate. Others were ranked in a wobbler category called tier two, meaning it could go either way for the scientists. The remainder fell into tier three – not recommended for funding by reviewers.

The board is increasingly turning to proposals that will turn more advanced research into clinical treatments. If directors do not go for spending the entire $40 million budgeted, they would save money that could be used for clinical trials. However, aside from the general arguments for doing basic research, those grants provide large sums to recipient institutions to pay for their overhead. And many of the agency's board members come from institutions that could benefit from payments for those overhead costs. Those board members will not be allowed to vote on applications involving their institutions.

(Editor's note: The number of researchers filing formal appeals was not contained in an earlier version of this article.)

California's $40 Million Genomics Awards: Stem Cell Agency Defends its Review Practices

The California stem cell agency today defended itself against charges that scoring on grant applications was manipulated in its $40 million genomics grant round to the benefit of a consortium headed by Stanford University researchers.

In response to a query from the California Stem Cell Report, the agency said its practices were “consistent with many previous reviews.” The agency also said that its RFA specifically allowed the adjustments that were made by the agency.

In a letter to the agency's board, Pui-Yan Kwok, leader of a proposal offered by UC San Francisco and UC Berkeley, had challenged the scoring on a $33 million proposal from the Stanford consortium. If the board goes along with reviewers and CIRM President Alan Trounson, Stanford's application will be the only one approved on Wednesday at the board meeting in Berkeley.

Trounson has recommended to the board that it not fund three other applications that were approved for funding by reviewers. He offered no rationale for his recommendation. The board, however, has almost never rejected positive recommendations from its reviewers on hundreds of applications during the last nine years. 

Here is the full text of the agency's response as delivered by Kevin McCormack, senior director of public communications.

“I think the UCSF researcher was mistaken when he said: 'We were surprised to see that the genomic center scores of the top two applications were based on the reviewers removing from consideration the poorest performing center-initiated projects.  The fact that the reviewers could propose removal of individual center-initiated projects was never mentioned in the RFA.'  

“Because the RFA specifically states: 'The GWG will make funding recommendations to the ICOC concerning which Centers and which Center-initiated projects (within a particular award) to fund. The GWG may also make specific recommendations concerning the budget for each proposed award. The ICOC will make final funding decisions.' 

“This practice is consistent with many previous reviews in which the GWG recommended removal of distinct Specific Aims or proposed activities. 

“Also in the letter, the UCSF researcher says: 'Even more appalling is that this was applied only to the two applications (that) ended up with the highest scores.  The end result is that two centers' scores were artificially inflated to 88 and 82, respectively.  Despite this uneven application of the review process, two other applications received Tier 1 (recommended for funding) scores.  This appearance of preferential treatment makes the process suspect.' 

“However, reviewers were instructed that they could recommend removal of specific Center Initiated Projects (provided that at least 2 remain) if they felt this action would strengthen the overall proposal. This option was available for every application considered.

“For proposals where there was no recommendation to remove Center Initiated Projects, reviewers did not believe that the overall score would be significantly increased by such removal.”

California's $40 Million Genomics Round and Conflicts of Interest

Concerns about conflicts of interest have dogged the California stem cell agency since its earliest days, and they continue into this week's $40 million genomics round.

They were first raised in the ballot campaign of 2004 when California voters were asked to create the $3 billion research program. And they were of sufficient concern eight years later that the highly regarded Institute of Medicine said in a $700,000 study of the agency that it should act to minimize potential damage.

The institute said in its 2012 report, commissioned by the agency itself,

“Far too many board mem­bers represent organizations that receive CIRM funding or benefit from that funding. These com­peting personal and professional interests com­promise the perceived independence of the ICOC(the governing board), introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board.

The latest concerns arise, however, not in connection with the governing board. They have surfaced in connection with the closed-door grant review process and subsequent recommendations by CIRM President Alan Trounson in a plan to create one or two stem cell genomic centers. Trounson advised the board to approve $33 million for a single proposal led by researchers at Stanford University.

Two applicants in the genomics round, UC San Francisco and the Scripps Research Institute, have complained in letters to the agency's board about unfairness, apparent preferential treatment and manipulation of scores on the Stanford application, among other things. The applicants do not specifically allege that conflicts of interest exist in the genomics round. Nor do they identify a motive behind what one applicant said were “appalling” actions.

But the round has a checkered history that does, in fact, involve actual conflicts of interest.  connected to Trounson, CIRM grant reviewer Lee Hood of Seattle and Stanford stem cell researcher Irv Weissman. Some concerns were also voiced privately by researchers as far back as 2012 when renown genomics researcher Craig Venter, now part of the Stanford application in this week's round, pitched the CIRM board on stem cell genomics. Only an hour or two following his presentation, the board, with virtually no discussion, approved the concept behind the genomics round along with a $40 million budget. Approval came on a voice vote with no dissent.

Applications came in about eight months later for what CIRM said would be one or two awards that would propel California into a world class leadership position in the new field. Trounson recruited Hood, who is another internationally recognized genomics expert, to serve as a grant reviewer. As reported by the California Stem Cell Report in May 2013, one reviewer in the first of two genomics grant review sessions raised a question about Hood's participation. Hood subsequently acknowledged that he failed to disclose his relationship with Weissman, who was involved in what was then a $24 million application from Stanford. The men are friends and partners on a ranch in Montana. CIRM staff had failed to detect the conflict.

Prior to the genomics round Trounson had acknowledged he had a conflict-of-interest in connection with another Weissman-related proposal. In 2012 in a round not related to genomics, Trounson, who has visited the Hood-Weissman ranch as Weissman's guest, recused himself from the board's public discussions of applications from StemCells, Inc., a company founded by Weissman.

Under CIRM's procedures, Trounson does not vote on applications during the review process. But beginning last year the board gave him and his staff new authority to make recommendations on applications after they were acted on by reviewers.

Following the Hood violation, the proposals were sent back to scientists for resubmission. By the time Stanford's proposal was approved by reviewers and came to Trounson for his consideration, Stanford had removed Weissman's name. According to a letter from Stanford, the associate director of Weissman's stem cell institute at Stanford, Michael Clarke, is now a “collaborator” on the project.

In documents on the CIRM Web site, Trounson also told the board, with no explanation, that it should not approve any cash for the applications for two competing proposals from UC San Francisco and Scripps and a third believed to be from UCLA. All three were recommended for funding by CIRM's blue-ribbon reviewers, all of whom are from out of state. Normally the board has rubber-stamped hundreds of such recommendations by reviewers. It would be a radical change for the board to turn its back on reviewers' opinions on three major proposals.

The California Stem Cell Report asked the agency last week whether all staff members, including Trounson, who were involved in the recommendations were screened for “personal, professional and financial conflicts.”

Kevin McCormack, senior director of communications for the agency, replied,

“Dr. Trounson’s participation in the staff recommendations regarding the stem cell genomics award was consistent with state law and CIRM policies.”

McCormack also said that the CIRM legal staff “ensured, as they always do, that employees with conflicts did not participate in the review of applications in which they had a conflict.”

Our take:

It is not unreasonable to consider that Clarke, the associate director of Weissman's institute, is a surrogate for Weissman in the Stanford proposal and presents at the very least the appearance of a conflict of interest for Trounson

The situation does not well serve the agency, which is in the process of trying to develop funding for its operations after 2017, when money for new grants will run out. Prospective investors, be they private or public, would expect the agency to act in such a manner that would avoid the sort of flap that has arisen in the genomics round. That is not to mention the need to maintain the confidence of the public and the stem cell community. 

California's Stem Cell Genomics Round Receives National News Attention

The Associated Press, a worldwide news service, has picked up and distributed a rewritten version of Sunday's story in The Sacramento Bee about the California stem cell agency's $40 million genomics round.

The AP article has appeared on a wide array of online news sites served by the AP including the San Francisco Chronicle, Newsdaily, Modern Healthcare, California Healthline, the Washington Times, a host of television station news sites and many more.

The California stem cell agency is not often the subject of national media attention but stem cells and genomics can combine to generate media interest. 

The AP story does not go beyond the story that appeared in The Bee (written by yours truly) and does not include charges of unfairness and score manipulation reported Saturday on the California Stem Cell Report. The story in The Bee had an early deadline and the information on the allegations surfaced too late to include in The Bee article.

The stem cell agency says it is preparing a response to the charges.  

The AP is a member-based business. Under the usual arrangements with its members, such as The Bee, it is entitled to pick up and redistribute stories that are published by its members. 

Alan Trounson's Opaque Messages, Genomics and $40 Million

Cryptic is probably a good word for the messages delivered last week by the president of the California stem cell agency, Alan Trounson, in his recommendations in the agency's $40 million genomics round. Odd might be another.

Some might say Trounson is ill-serving both the board that hired him and California taxpayers.

Alan Trounson
UCSD photo

In a document on the CIRM Web site, Trounson, who is a noted researcher from Australia, says the 29-member governing board of the agency should give $33 million to a Stanford-led consortium to create a stem cell genomics center. That coincides with the opinions of the agency's blue-ribbon scientific reviewers.

Trounson's rationale, however, is no more than a 23-word phrase among four paragraphs that are little more than a generic description of a stem cell genomic center. The Stanford proposal, he said, “will fulfill all of the aims of the RFA and provide an excellent, responsive and comprehensive genomics resource for California stem cell researchers.”

Trounson's recommendations on three competing proposals(here, here and here), all of which were also approved for funding by reviewers, are even more opaque. He simply says,

“CIRM Staff Recommendation: Do not fund”

Trounson's name is missing from the CIRM documents nixing the three proposals. But Trounson calls the shots at the agency and signs off on any advice to his board.

His recommendations would be a dramatic and major change in how the board treats the positive decisions of its reviewers. Over its nine-year history, the board has almost never overridden positive findings by reviewers. Invariably they are rubber-stamped with no discussion at public board meetings.

CIRM's directors are loathe to substitute their judgment for reviewers for a variety of reasons. One is that the board members do not see the actual applications – only the same review summaries provided to the public. The identities of the applicants are also withheld from directors prior to their vote on applications. Board members have repeatedly said they do not have sufficient information to reverse reviewer decisions. They also do not want to offend reviewers. The board fears that they might abandon the task of reviewing applications for the agency if their decisions are not supported by the board.

Trounson, who announced last fall he is leaving the stem cell agency, offered no explanation for his move to turn the longstanding board practice on its head. Nor did he discuss why the genomics round should be limited to one award when the RFA stipulated one or two.

He did not discuss the policy implications of the state of California giving a $33 million leg-up to a single consortium in a hot, fast-growing scientific and business arena. He did not comment on the possibility that this consortium would be less than welcoming to rival researchers. 

He did not discuss whether creation of this consortium was akin to creating an organization like WARF that sets the rules and controls the playing field on the use of important human embryonic stem cell lines, much to the displeasure of many scientists, including Trounson himself. Nor did he even publicly disclose the amount of money that was requested by researchers whose applications he would deny.

There may be good reasons for Trounson's position. But he owes the board and the public more than a cryptic decree sent forth from his post at 210 King Street in San Francisco.  Especially in light of the charges of unfairness, score manipulation and more leveled last week by rival researchers in the round.

Sacramento Bee: California Stem Cell Agency Betting Big on Genomics

The Sacramento Bee today published an article by yours truly on this week's $40 million genomics round and its significance.

It was a freelance piece that was aimed at a general audience. The article also had an early deadline – last Wednesday. After it was submitted, additional developments popped up, some of which made it into the article. However, the piece was actually in print by the time of the most recent developments related to researchers' serious complaints about the genomics review process. So those elements did not make it into the story .

Here is the article. See here for how it looked on The Bee's Web site.

California’s stem cell agency poised to bet big on genomics research

By David Jensen
Special to The Bee

The state of California is preparing to make a bet of up to $40 million on a fast-moving field that promises to revolutionize medicine and ultimately lead to personalized stem cell treatments that can be tailored for a patient’s genetic makeup.

Directors of the California stem cell agency are meeting in Berkeley on Wednesday to create one or two stem cell genomic centers that they predict will make the state a world leader in the new field. Scientists and businesses from biotech centers in the Bay Area, San Diego and elsewhere are competing for the money.

The move into genomics comes as the $3 billion agency struggles to fulfill the promises of the ballot initiative campaign of 2004, when voters approved its creation with a total of $6 billion in state spending, including the interest on bonds sold to finance the endeavor. So far, no therapies or cures have emerged from the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. It will run out of cash for new awards in less than three years and needs some high-profile results to raise more money.

Scientists and biotech businesses say they hope that genomics, the study of genes and their relationships, can lead to a catalog of disease genes and pave the way for new therapies that are tailored to individual needs. Linking stem cell treatments, which also promise extraordinary results, could provide even more effective treatments. UC Davis stem cell researcher and blogger Paul Knoepfler describes the stem cell genome effort as part of a “revolution.”

“Genomics is going to become a key part of all of our lives whether you like it to be or not,” he says on his blog.

“Right now, in a lot of ways, doctors are making educated guesses as to how to treat us patients more generally,” Knoepfler says. “By knowing our genomic information, our genotype – the information tucked away in our genomes –they could be making far more educated choices about treatments, and we could be making far more informed decisions about our health.”

The National Institutes of Health says that genes play a role in nine out of the 10 leading causes of death in this country. “Genomics is helping researchers discover why some people get sick from certain infections, environmental factors and behaviors, while others do not,” the institute says.

The nascent field is not without controversy. The U.S. Food and Drug Administration recently cracked down on the Google-backed genetics firm 23andMe of Mountain View, saying that it had failed to show that its testing produced accurate results. The company last month said it would stop providing health information with its tests. The danger to the public, say some medical experts, is that people might act on inaccurate or poorly understood genetic information and unnecessarily undergo drastic or harmful procedures intended to ward off future disease.

Such concerns haven’t slowed growth in the genomics industry, however. Various studies say that the current annual sales of genomic products exceed $3 billion and peg the annual growth rate at anywhere from 10 percent to 17 percent.

The stem cell agency two years ago this month sized up the situation and decided it was time to jump in. The agency’s governing board gave the go-ahead – on a voice vote with virtually no discussion – to the concept behind this week’s awards. CIRM directors had already been primed at the time by a presentation by Craig Venter, head of the La Jolla Institute bearing his name and internationally famed for his genomics work. Venter told the CIRM board that “there will not be any clinical stem cell applications without understanding genomics.”

Venter said genomics is needed to tell whether a particular stem cell therapy will cause more harm than good. Venter also told the board that he already had embarked on a stem cell genome effort. He is believed to be competing for the CIRM funding, and his talk raised eyebrows among some researchers because it was so closely tied to the board action.

The agency opened the door to applications from researchers and institutions in October 2012, eight months after the talk by Venter, who appeared at the agency’s invitation. The review of those applications and the identities of the applicants are cloaked in secrecy, which is the traditional way scientific grants are awarded in this country even when they involve public funds.

A combination of out-of-state scientists and six CIRM board members scores the grants and makes its decisions. The full, 29-member CIRM board will have the final say in a public meeting in Berkeley on Wednesday, but it almost never departs from the recommendations for approval by its reviewers. CIRM announces only the names of the winners and does not release the names of rejected applicants because it might embarrass them.

Last week, CIRM President Alan Trounson and his staff recommended funding only one of the applications – for $33 million – although reviewers had approved four, according to documents at the CIRM website. No public explanation was immediately provided, except that CIRM spokesman Kevin McCormack said the reviewers actually “did not recommend funding all of the applications,” although that was clearly stated on the website, as has been the practice on the review of thousands of previous applications.

The funding round is budgeted for $40 million, but could be more or less depending on the wishes of the board.

A number of the major educational institutions in the state are likely to be involved in this week’s awards. Stanford University’s name surfaced last year when a conflict-of-interest violation in the initial grant review was reported by the California Stem Cell Report. CIRM grant reviewer Lee Hood of Seattle, renowned internationally for his genomics work, acknowledged that he had failed to disclose his conflict in connection with a $24 million application involving Irv Weissman, director of Stanford’s Institute for Stem Cell Biology and Regenerative Medicine.  Weissman and Hood are longtime friends and own property together in Montana.

The closed-door review also marked the first time in CIRM’s history that reviewers, all from out of state, failed to finish with a decision supporting any of the proposals, according to CIRM. Reviewers’ comments were sent back to applicants, who resubmitted their proposals for review in November in another closed-door session. This time, Hood did not participate.

In addition to Stanford, California enterprises that have a strong interest in genomics and that are possibly involved in the competition include: Illumina and Sequenom of San Diego, Life Technologies of Carlsbad, CombiMatrix of Irvine, Pacific Biosciences of Menlo Park and Complete Genomics of Mountain View, which is owned by BGI, a Chinese business that is the largest genomics sequencing firm in the world. Others include Scripps, the San Diego Supercomputer Center at UC San Diego, the Novartis Genomics Institute and Fate Therapeutics, both of San Diego, and UC Santa Cruz.

UC Davis has just begun an $18 million genome operation in partnership with BGI, but Richard Michelmore, director of the Davis Genome Center, said it was not involved in any of the CIRM applications. (Ken Burtis, who is a member of the faculty of the Davis Genome Center, is a member of the CIRM governing board.)

The expected winner of the $33 million award is a group headed by Stanford University’s Michael Snyder, director of its Center for Genomics and Personalized Medicine, based on documents posted Friday on the stem cell agency’s website.

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David Jensen publishes the California Stem Cell Report – californiastemcellreport.blogspot.com --and has followed the stem cell agency since 2005.

California's $40 Million Genomics Round: Charges of Unfairness, Factual Error and More

Scientists at two major California research institutions have leveled charges that the state stem cell agency's $40 million genomics round is tainted with unfair and non-scientific considerations along with factual errors, manipulation of scores and apparent preferential treatment.

The statements were contained in letters (see here and below) to the governing board of the state agency from researchers at UC San Francisco and the Scripps Research Institute in La Jolla, who were competing in the round. The allegations involve the agency's closed-door grant review process in which a seven-member consortium led by Stanford University appears the likely winner.

CIRM President Alan Trounson has recommended approval of Stanford's $33 million bid. It was the only application that he supported out of four recommended for funding by CIRM's prestigious grant reviewers. Trounson also specifically recommended not funding the three other applications, including those from UCSF and Scripps. The board's longstanding practice has been to fund all awards recommended by reviewers.

Pui-Yan Kwok
UCSF photo

Pui-Yan Kwok, leader of the UCSF bid, and Jeanne Loring, who heads Scripps effort, have taken their complaints about the process to the agency's 29-member board which meets Wednesday in Berkeley to act on the applications to create one or two stem cell genomics centers in California.

In an e-mail to the California Stem Cell Report today, Kwok said his team has examined the summaries of the grant reviews posted on the CIRM Web site. He said,

“We were surprised to see that the genomic center scores of the top two applications were based on the reviewers removing from consideration the poorest performing center-initiated projects.  The fact that the reviewers could propose removal of individual center-initiated projects was never mentioned in the RFA. 

“Even more appalling is that this was applied only to the two applications (that) ended up with the highest scores.  The end result is that two centers' scores were artificially inflated to 88 and 82, respectively.  Despite this uneven application of the review process, two other applications received Tier 1 (recommended for funding) scores.  This appearance of preferential treatment makes the process suspect."

In his letter late yesterday to the board, Kwok said such actions are “inconsistent” with practices of the National Institutes of Health, whose standards are the norm for virtually all scientific grant reviews. The stem cell agency's review practices are patterned after those of the NIH.

Jeanne Loring
Scripps photo

In her letters to the board and the CIRM staff, Loring addressed four major factual errors that she said were made by reviewers. They ranged from a belief by reviewers that the RFA sought a matching financial commitment from applicants to a belief that Loring's partner in the project, Illumina, Inc., of San Diego, would not make its scientific tools easily available to researchers.

Loring said, however, the only “serious concern” expressed by reviewers in the CIRM review summary was the “lack of material commitment” from the applicants.

Loring said,

“This comment...suggests that other applications did offer to provide extra money for their (genomic) centers. Since there was no written request for additional funds, and we were not informed that contributions would be expected or considered as a measure of scientific merit, we were put at a significant disadvantage.”

(Reviewers praised the Stanford application for its “very substantial matching funds from multiple participating institutions.”)

Loring also stressed the benefits of the partnership with Illumina, a world leader in genomics. The firm recently announced a device that can sequence a human genome for $1,000, which sent its stock jumping this month. She said that Illumina's sequencer is the only one approved by the FDA for clinical diagnostics. She said that partnering with Illumina will give researchers access to tools that can have an “immediate impact” on their clinical studies on cancer, heart disease and inherited diseases.

(On Jan. 27, the agency released a statement defending its procedures. An item dealing with that can be found here.)

The stem cell agency has long come under fire from the biotech community because of the tiny percentage of its funding that goes to industry. Loring noted that last week that the only body charged with overseeing the finances of the agency, the Citizens Financial and Oversight Committee, stressed that it was necessary to form partnerships with industry.

In addition to Illumina, Loring is working with researcher Nicholas Schork, who this month joined Craig Venter's institute in the San Diego area. Venter is internationally famed for his genomics work. She said that the linkage with the institute will provide her project with “even broader access to genomic expertise.” The Venter Institute is involved with the Stanford application as is UC Santa Cruz.

Illumina also sent a letter to the CIRM written by Mostafa Ronaghi, the company's senior vice president and co-project director on the Loring application. Ronaghi said that Illumina makes affordable research tools and will help with planning experiments and analysis. Also involved in the Scripps-Illumina bid is co-investigator Jian-Bing Fan of Illumina.

Kowk said Ophir Klein of UCSF and Steven Brenner of UC Berkeley are co-directors of their effort. Other researchers involved are Michael McManus, Joe Costello, Susan Fisher, Neil Risch and Arnold Kriegstein, all of UCSF; Lin He and Dan Rokhsar, both of UC Berkeley, and Amander Clark of UCLA.

The California Stem Cell Report has queried Stanford concerning a list of its participants.

The names of the other applicants in genomics round are not known. The stem cell agency will not release the names of winning applicants until after the board acts and never releases the names of rejected applicants. The agency also withholds the names of applicants from the board prior to its action on them unless the applicants “self-identify,” usually in the form of letters to the board, which are a public record. Board members also do not have access to the actual application nor does the public. Some board members have complained in the past about not having enough information to act when applicants appear directly before the board.

Directors have final legal say on all applications. They do not, however, have to act on any of them. They can increase funding beyond the $40 million originally budgeted for this round or lower it. They can also send the applications back to reviewers for reconsideration or approve them with conditions.

Here is a copy of Kwok's letter, which the stem cell agency has not yet posted.

  UCSF letter re $40 Million California Genomics Round by DavidJensen

Stanford Genomics Consortium Likely Winner in $33 Million Stem Cell Agency Project

A seven-member consortium led by Stanford University's Center for Genomics and Personalized Medicine is expected next week to win a $33 million award from the California stem cell agency to create a stem cell genomics center.

Michael Snyder
Stanford photo

Information confirming the identity of the likely winner was posted on the CIRM Web site today. It came in the form of a letter from Michael Snyder, director of the Stanford genomics center.  In the document, Snyder told stem cell agency directors that his group is “very pleased with the overall enthusiasm” for its
application.

CIRM's reviewers gave the proposal an overall scientific score of 88 and recommended it for funding. It was the only application in the genomics round that was also supported by CIRM President Alan Trounson and his staff.

Trounson recommended no funding for the three other applications that the agency's prestigious reviewers had approved for cash.

The board is certain to hear presentations at its meeting next Wednesday from one or more of the applicants that were rejected by Trounson and his staff. The board has final say on all applications and can add or subtract money for the genomics round, which is budgeted for $40 million.

The nine-year-old practice of the board has been to fund virtually all of the applications backed by its scientific reviewers, all of whom come from out of state. Trounson's recommendations would represent a sharp departure from that practice.

Earlier this week the agency offered no public rationale on its Web site for its recommendations to reject the reviewer-backed applications. However, either late yesterday or early today, a CIRM document dated Jan. 15 was posted by the agency that provided more information. The terse statement said that the Stanford proposal – with the changes recommended by the CIRM staff –  “will fulfill all of the aims of the RFA and provide an excellent, responsive and comprehensive genomics resource for California stem cell researchers.”

Snyder's letter to the CIRM board asked it to approve Stanford's entire application and rebuff staff recommendations for changes. He said that some of the grant reviewer objections were “based on material errors of fact or scientific details that were not explicitly addressed in the proposal due to space limits.”

Stephen Quake
Stanford photo

Michael Clarke
Stanford photo

Snyder's letter also identified two other Stanford researchers involved in the project:  Stephen Quake, a professor of bioengineering, and Michael Clarke, associate director of the Stanford stem cell institute headed by noted stem cell scientist Irv Weissman. Clarke was identified as a “collaborator” and Quake as a principal investigator on one of the consortium's projects.

None of the other competing institutions was identified by CIRM. The stem cell agency does not release the names of winners until after the board acts on their applications. The agency never releases the names of rejected applicants for fear of embarrassing them.

CIRM's summary of the grant review said the Stanford proposal involves seven major academic and nonprofit institutions that are providing “very substantial matching funds.”

The summary continued,

“Although some reviewers expressed minor concerns that the multiple, geographically separated components of this large and interdependent program could pose an administrative challenge, overall, reviewers expressed much confidence in the demonstrated abilities and collaborative experience of the program leaders for achieving a shared vision.”

Reviewers cited as a “major strength” the ability of applicants to handle the processing of massive amounts of data needed for genomics research. The summary said,

“The leader of this center component is a pioneer in the field and has an outstanding track record in the proposed activities.”

California's Stem Cell Genomics Awards: An Untidy Affair

The California stem cell agency's $40 million genomics round seems to be turning into a bit of a muddle.

The agency's Web site said this week that four applications were approved for funding by CIRM's prestigious grant reviewers, whose recommendations go to the agency's governing board next week. However, CIRM President Alan Trounson and his staff are recommending that only one of those applications, a $33 million proposal, be approved by the board. Those other recommendations from reviewers, the agency said today, are not really recommendations.

Alan Trounson
CIRM photo

The move by Trounson, who announced last fall that he is leaving the agency, reflects the most aggressive action taken by the staff on grant applications since they began making recommendations on them last year. 

As of this writing, the CIRM Web site has yet to offer a rationale for the staff's recommendations. The review summaries of the applications said simply, 

"CIRM Staff Recommendation: Do not fund"  

So the California Stem Cell Report queried the agency this morning about the matter.

Kevin McCormack, CIRM's senior director for communications, replied that the reviewers actually “did not recommend funding” the three out of the four applications despite what the agency officially says on its Web site. The language and graphic on the Web site, however, conform to the agency's practice involving thousands of applications over the last nine years. Its governing board has been exquisitely careful to heed the positive recommendations of its reviewers. 

The unusual situation – not to mention the dollars at stake -- seems certain to trigger public presentations by rejected applicants at the governing board's meeting next Wednesday in Berkeley. The board can override both staff and reviewer recommendations as well as increase or decrease the money available for the genomics round.

To fully understand the muddle, it is necessary to understand some details of the CIRM grant review process. The CIRM Grants Working Group -- composed of six voting CIRM board members, and a long list of out-of-state scientists plus other experts from time to time, or some subset of the group -- examines the applications behind closed doors. The scientific members score the grants and then they are voted on by the full panel. The results of the reviewer decisions are presented to the public in tiers. Tier one is invariably funded by the board with no discussion at the later public board meetings. In the history of CIRM, only one or two applications have been downgraded from tier one. The definition of tier two has varied, but these basically are wobblers – applications with some merit but not quite enough to win approval from reviewers. Occasionally the board reaches into tier two to approve an application. Tier three applications are not recommended for funding by reviewers.

Four applications for funding to create stem cell genomics centers were placed in tier one, according to documents on the CIRM Web site this week. Their scientific scores range from 88 to 75. A fifth application was scored at 70 and placed in tier two. The names of the applicants were withheld in keeping with CIRM's practice. The agency only announces the names of winners. CIRM says it withholds the names of rejected applicants to avoid embarrassing them.

Here is McCormack's full explanation for the variation between the longstanding practice of the agency and what has happened in the genomics round.

“Tier 1 in this case really means 'fundable' as in adequate for funding.  Assignment to this tier was based solely on scores from scientific review.  Reviewers understood that only one or possibly two centers would be funded (that was clearly stated in the RFA) and did not recommend funding all of the applications.”

McCormack is correct that the RFA said one or two. Most CIRM RFAs have similar language. The RFA for the basic biology round, also to be considered on Wednesday, for example, says that as many as 30 grants may be awarded. It could be less, and it could be more depending on the board's druthers.

In the past, CIRM staff has offered the board a brief written statement supporting their recommendations on applications. Presumably that will be posted on the CIRM Web site soon.

Craig Venter
Venter Institute photo

The latest situation is not the first unusual event in the genomics round, which began publicly two years ago this month at a CIRM board meeting in San Diego. It was then that the board approved the concept for the $40 million round on a voice vote with almost no debate. The CIRM directors had already been primed by 30-minute presentation by Craig Venter, the famed genomics expert who heads the San Diego area institute bearing his name. Venter, who was invited to appear by the agency, built a case for the importance of genomics and said he had already begun a stem cell genomics effort. He is believed to be one of the competitors for next week's funding for CIRM. His presentation raised eyebrows among some scientists because of its close tie to the board vote on the plan.

The genomics round was also marked by a conflict-of-interest violation last year involving eminent Stanford stem cell researcher Irv Weissman and Lee Hood of Seattle, renowned internationally for his genomics work. Hood had been recruited by Trounson to be a reviewer in the round. However, at the review session, Hood failed to disclose his relationship to Weissman, who was involved in a $24 million application from Stanford. They are longtime friends and own property together in Montana.

Reviewers at that session were unable to come up with recommendations for funding. It was the first time in CIRM history that has occurred. The reviewer comments were subsequently sent back to applicants who resubmitted their proposals for review last November.

As for the $33 million proposal recommended by Trounson and his staff, the review summary says it involves seven major academic and nonprofit institutions. The review said the applicants are offering “very substantial matching funds.”

The institutions are also widely scattered. The review summary said,

“Although some reviewers expressed minor concerns that the multiple, geographically separated components of this large and interdependent program could pose an administrative challenge, overall, reviewers expressed much confidence in the demonstrated abilities and collaborative experience of the program leaders for achieving a shared vision.”

The study of genomics also requires manipulation of massive amounts of data, a matter of importance to reviewers. The review summary said that aspect of the proposal was a “major strength.” The summary said,

“The leader of this center component is a pioneer in the field and has an outstanding track record in the proposed activities.”

During its public discussion of grant proposals, the CIRM board is not told the name of the applicants. It only works from the public summary of the proposal and does not see the actual application. Board members with conflicts of interest are prohibited from engaging in the discussion or voting.