Genomics Center Discussion Begins

Deliberations in the $40 million genomics round at the California stem cell agency have begun.

California's Stem Cell Directors Back at Work

Directors of the California stem cell agency have resumed their meeting and expect to take up the $40 million genomics round after dealing with three brief items.

California Stem Cell Directors Working Through Lunch

Directors of the California stem cell agency are fetching their meals for a working lunch as they continue with their agenda at their meeting in Berkeley. Still to be heard are applications in the $40 million genomics round.

Just prior to lunch, the directors paid tribute to Michael Goldberg, who is leaving the board after serving since its inception in 2004. In his remarks after hearing his colleagues and noting the arduous history of the agency, he said,

"They tried to kill us. They failed. Let's eat."

$27 Million Approved for Basic Stem Cell Research in California

Directors of the California stem cell today approved, 11-0, about $27 million for basic research into workings of stem cells.

The round was originally budgeted for $40 million, but grant reviewers did not approve grants that would have required that level of funding.

Reviewers recommended 21 grants for approval for a total of $21 million. CIRM staff recommended another five costing $4.8 million. The 29-member board added another two grants totaling $1.1 million.

The board rejected other pitches by reviewer-rejected applicants for reconsideration. The stem cell agency later today is expected to release the names of all the winners. It never releases the names of rejected applicants.
 (Here is a link to the CIRM press release with the names of the winners.)

Stem Cell Ethics to be Examined in March

In its $700,000 study of the California stem cell agency, the Institute of Medicine recommended that it finance more work dealing with ethical issues in stem cell research. 

Today, CIRM President Alan Trounson announced that the agency was participating in a workshop in Berkeley in March. The above chart was presented at the meeting of governing board of the agency this morning. 

For more information, email the agency at info@cirm.ca.gov

$21 Million of Basic Research Being Discussed by Stem Cell Agency

Directors of the California stem cell agency have begun discussion of applications in its grant round involving basic biology research. The board is expected to award at least $21 million in this round. 

Conflicts Listed in Upcoming Voting in California's $40 Million Genomics Round

Here is a list of members of the governing board of the California stem cell and the conflicts of interest that exist on each application in the $40 million genomics round.

The list was provided by the stem cell agency at the request of the California Stem Cell Report.

The members listed in each row are are barred from voting on the grant listed in the far left column. (Following the first posting of this list, the agency said, "Steve Juelsgaard is erroneously listed as being in conflict with genomics application 6683 under the Data and Coordination Management category." Later in the day, the agency also reported another error.  "Jacob Levin is included for application 6708, but does not have a conflict.")

List of California Stem Cell Agency Directors with Conflicts of Interest on Voting in the Genomics Round by DavidJensen

A Reading List for California's $40 Million Stem Cell Genomics Round

Here are links to recent stories dealing with the California stem cell agency's $40 million stem cell genomics round -- a plan to make the state the world leader in the new field.

Thursday Jan. 23, 2014
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.

Friday Jan. 24, 2014
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.

Saturday Jan. 25, 2014
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.

Sunday Jan. 26, 2014

Sacramento Bee: California Stem Cell Agency Betting Big on Genomics
The Sacramento Bee today published an article by the publisher of the California Stem Cell Report on this week's $40 million genomics round and its significance. The Associated Press picked up the story and distributed it nationally.

Sunday Jan. 26, 2014
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.

Monday Jan. 27, 2014
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.

Monday Jan. 27, 2014
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.

Wednesday Jan. 29, 2014
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.

Wednesday, Jan. 29, 2014
The California Report -- Stem Cell Agency Puts $40 Million Up For Grabs in Genomic Research Grant This is a public radio show produced by KQED in San Francisco.

Wednesday Jan. 29, 2014

Stanford Consortium Wins $40 Million to Create Stem Cell Genomics CenterDirectors of the California stem cell agency today approved a $40 million proposal ultimately targeted at creating medical treatments tailored to a patient's genetic makeup and making the state a world leader in stem cell genomics.

New CEO for California Stem Cell Agency in May

The California stem cell agency expects to make a decision on a candidate for a new president by May, the chairman of its governing board said this morning.

J.T. Thomas opened this morning's meeting by addressing the search for a new president to replace Alan Trounson, who has resigned but is serving temporarily.

Warren Roth, a representative of the Korn Ferry search firm, said that it expects to present candidates in late March. He said the board would be able to interview candidates in April.

The board has a regular meeting scheduled for May 29.

California Stem Cell Agency Opens Meeting to Discuss $40 Million Genomics Proposals

Directors of the California stem cell agency began their meeting today in Berkeley at 9:11 a.m. It is not yet clear at what time they will take up the proposals in the $40 million stem cell genomics round.

Stem Cell Agency Yet to Begin

Today's meeting of the governing board of the California stem cell agency appears to be a bit late in starting. We are checking on the situation.

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.  

Tracking the Evolution of the Stem Cell Genomics Applicants

The plan to create one or two stem cell genomics centers in California at a cost of $40 million began in 2012. Since then there have been some changes, some of which resulted from the failure of reviewers to recommend any proposals in 2013.

Last week, the California Stem Cell Report (CSCR) asked the California stem cell agency(CIRM), which is scheduled to make a decision today on an at least one application, about several of the changes. Here are the texts of the questions and answers from the agency.

CSCR: Has the cast of applicants changed since the initial review in early 2013? Have some dropped out or been added? Have the applications been recast significantly for the most recent review?

CIRM: Applicants to the first round of review were eligible to participate in the second round.  Although review criteria remained the same as those stated in the RFA, applicants were allowed to change proposal components, establish new collaborations and/or combine efforts.  

CSCR: How many letters of intent (LOI) were received with a breakdown on the number from academic and business enterprises?  How many applications were received, also with a breakdown on academic and business?

CIRM: For the first round, there were 9 LOI's; 7 of these submitted applications.  No LOI was required for the second round.  All first round applicants participated in the second round of competition, but several have combined efforts, so there were 5 applications in the second round.  Three of these applications were collaborative proposals combining both for-profit and not-for-profit organizations, while the other two were from not-for-profit institutions.

Upcoming: Live and Complete Coverage of Tomorrow's $80 Million Stem Cell Meeting

Check in tomorrow on the California Stem Cell Report for gavel-to-gavel coverage of the meeting of the governing board of the $3 billion California stem cell agency. As much as $80 million is at stake, including a $33 million plan by a Stanford consortium to create a world-leading stem cell genomics center.

The meeting is scheduled to begin at 9 a.m. PST. Coverage will begin at that time with stories filed as developments warrant.

For those who want to attend the event, it will be in Berkeley. Teleconference locations are in La Jolla and Los Angeles. The meeting will be audiocast on the Internet with a WebEx transmission of documents that are displayed for the board. Full instructions are on the meeting agenda along with the addresses of the teleconference locations and the actual meeting.

Goldberg Departs from California Stem Cell Board; Panetta and Miller Join

The California stem cell agency is losing another of the original members of its governing board but two new ones with markedly different backgrounds will be joining the 29-member panel tomorrow.

Departing is Michael Goldberg, a venture capitalist from the San Francisco Bay area. He has served as head of the board's finance subcommittee. Along with Marcy Feit, another longtime board member, he has cleaned up the accounting

Michael Goldberg
Mobihealth News photo

mess that once made the $3 billion agency's operational budget nearly incomprehensible.

In response to a question from the California Stem Cell Report, Goldberg said,

"John Thomas's leadership (as agency board chairman) has long been firmly established and it is now time for me to step aside to allow for a new appointee to contribute to taking CIRM to the next level.

"I will be forever indebted to have had the privilege to serve my fellow Californians as a member of the ICOC(the agency governing board). As a patient advocate and member of industry I am extraordinarily proud of what CIRM has accomplished to date and enormously enthusiastic about our future prospects for improving patient care and bettering the health care economics of our state."

Joe Panetta
Biocom photo

Joining the board in Berkeley tomorrow are expected to be Joe Panetta, head of Biocom, and Hollywood actress and writer Lauren Miller. Both were appointed by California Gov. Jerry Brown, who sometimes is noted for his unusual choices in personnel.

Panetta, however, does not fit that category. He is a longtime figure in the biotech community in California. He has been head of Biocom, the life sciences industry association in the San Diego area, since 1999. He fills the vacancy left by the death of Duane Roth, who was also came from the San Diego business community.

Lauren Miller
Ivan Nikolov/WENN photo

Brown's other appointment, Lauren Miller, comes from a far different perspective. She wrote the script for the movie "For a Good Time, Call..." Last spring, she and her husband, actor and director Seth Rogen, staged a fundraiser last year called “Hilarity for Charity” on behalf of Alzheimer's, generating more than $500,000 in donations.

CIRM quoted Miller in a press release as saying,

“To have the opportunity to learn about, and support the research for so many important diseases is such a great honor and responsibility and I look forward to starting.”

The agency also said,

“Miller’s commitment to raising awareness about Alzheimer’s comes from her family’s battle against the disease. Her grandfather died of Alzheimer’s and her mother was diagnosed with it when she was just 55 years old.”

Miller replaces Leeza Gibbons, another celebrity who is a patient advocate for Alzheimer's.

$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 Stem Cell CEO Search: Dangling a 16-page Lure

The California stem cell agency yesterday posted what could be called a recruiting brochure for the effort to hire a new president to replace Alan Trounson.

The document, which was prepared by the search firm Korn Ferry, is couched in language designed to stimulate interest in those seeking a challenge and opportunity.

• “Few technologies have captured the imagination of the public quite like human stem cells,” the brochure begins.
• “Transformative public funding,” it says at one point.
• “One of the most influential agencies in the universe of stem cell research,” it says at another.

The 16-page brochure deals directly with less pleasant aspects of the job such as the likelihood that the agency could wind up in hospice care in three years when the money for new grants runs out.

It is also surprisingly forthright about the longstanding and controversial problem of the dual executive arrangement decreed by law. It may be the first time that the agency has so directly admitted publicly and formally that the overlapping responsibilities of the president and chairman have caused serious difficulties. 

The document says,

“This unique partnership has amply demonstrated its value when the president and chair have worked well together, but the organization has suffered when this has not been the case. An ability to adapt to this model of governance and management will be a critical attribute for the next president.”

The CIRM/Korn Ferry brochure is explicit about the direction of the agency towards pushing therapies into the marketplace and clinic. That is significant because of continuing pressures to well fund basic research, which means less money for efforts that are closer to clinical use. The document says,

"With the remaining resources of the state’s commitment, it is CIRM’s intention to focus its funding decisions increasingly on a host of projects with particular clinical promise, bringing the science it has strategically cultivated to the fruition of human therapy.  Both the governing board and the staff of CIRM are committed to this pivot in organizational priorities, driven to fulfill the dream of the people of the State...."

It is unclear when a new president will be on the scene. There is talk about a hire being made by April or May, but having the new person actually in the office five or more days a week could be a different matter. Trounson said last November he would stay on for awhile. But his family remains in Australia, where he is seeking to return.

The directors' Presidential Search Subcommittee meets tonight in Berkeley to discuss the brochure, which the agency labels a "candidate position statement." Korn Ferry has a $160,000 contract with the agency. The agency has previously used search firms in its presidential recruitment. None of them have come up with the person that was ultimately hired.  

Teleconference locations where the public can comment are available in Costa Mesa, La Jolla and San Francisco. Specific addresses can be found on the agenda.

(Editor's note: The three sentences on the size of the Korn Ferry contract and the success of previous search firms were not contained in an earlier version of this story.)

Inside Stem Cell HQ: A Look at the Tiny Staff

The staff of the $3 billion California stem cell agency is small – very small.

Cynthia Schaffer
CIRM photo

At one point point midway in its history, they probably probably amounted no more than the number of workers at your average Burger King. Today the staff even outnumbers the 29 persons who sit on its governing board. At one point in years past, it did not.

The staff has had its share of turnovers, but there is something certainly different about its esprit compared to most state agencies.

Yesterday, one of its longtime staffers, Cynthia Schaffer, wrote a little about the nuts-and-bolts operations and the nearly 60 persons who work at stem cell HQ at 210 King Street, across the street from the the San Francisco Giants baseball park. Her item appeared on the agency's blog. Check it out.

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.