California Stem Cell Appeal: $1.8 Million Needed for Removing Bone Replacement Bottleneck

A UC Davis researcher is making a strong pitch to the California stem cell agency to finance a $1.8 million effort to “resolve bottlenecks in engineering replacement bone and cartilage.”

J. Kent Leach, UC Davis photo

J. Kent Leach, an associate professor in the departments of biomedical engineering and orthopedic surgery, said his proposal addresses “a major hurdle in regenerative medicine of the musculoskeletal system (that) impairs the inherent personalized medicine component of stem cell-based methods.”

In a letter to the agency’s board for its meeting tomorrow, Leach said the research team involved is “arguably the most qualified team in the nation to conduct these studies.” 

Other scientists participating are Laura Marcu and Kyriacos Athanasiou.

Kyriacos Athanasiou
UC Davis photo

Reviewers for the $3 billion agency, who make the de facto decisions on awards, scored the application at 72 and did not approve it for funding. The agency’s staff also nixed the proposal, declaring,

“There is another application recommended for funding in Tier 1 that proposes to optimize and apply the same imaging technology platform to a different test system. In addition, the scientific leadership of the two applications is the same.”

Leach said,

“The co-PI (Dr. Marcu) of this proposal is also PI (principal investigator) on RT3-07879, which is focused on assessing stem cell repopulation and remodeling of engineered vascular tissue constructs. 

Laura Marcu, UC Davis photo

"However, the use of this technology for monitoring the maturation of engineered bone and cartilage, tissues composed of dense matrix reflective of the differentiation of contributing stem cell populations, is substantially different from cardiovascular applications. Of course, both applications involve instrumentation based on optical spectroscopy and ultrasound principles, but the implementation and subsequent commercial hurdles for this technology is very different.”

 (For the summary of reviewer and staff comments, see application RT3-07981 in this document.)

Leach noted that another competing application in the round received an identical 72 score and was approved by the agency’s staff.

The grant round was budgeted for as much as $35 million. Reviewers and CIRM staff recommended approval of awards totaling $29.2 million.

Scientists making appeals directly to the board have not been successful in the last 12 months or so. The board has been more reticent about overturning reviewer and staff recommendations since it changed review and appeal procedures in 2013.

A Show-and-Tell Tomorrow on Handing Out California's Next $1 Billion for Stem Cell Research

Want to know more – from the horse’s mouth, so to speak -- about how California’s stem cell agency plans to give away its next $1 billion?

The public and researchers have a chance to hear directly tomorrow, via the Internet, from the agency concerning its plans for CIRM 2.0, the name of its new fast-track plan for handing out cash.

Registration is required, however, for the Webinar, which is scheduled for 12 p.m. PST.  CIRM says,

“Questions may be submitted in advance of the Webinar via email to cschaffer@cirm.ca.gov or via Webex registration.  During the webinar questions may be submitted via the Webex Q&A functionality.”

CIRM 2.0 was initiated by CIRM President Randy Mills as part of his efforts after he was appointed last spring. Mills will be personally presenting the proposal for the Webinar.

The agency says the plan is intended to put money in the hands of researchers with greater alacrity and improve the quality of grant applications. The agency describes the changes in the award process as radical.  Read more about it here, here and here. 

California Stem Cell Agency Overhauls Grant Review Conflict Rules; Secrecy Remains

The California stem cell agency this week is expected to begin sweeping out its current conflict-of-interest rules for multi-million dollar research applications and giving applicants wider range to disqualify some grant reviewers in advance.

Little about the operation of the rules, however, will be disclosed to the public or applicants, although the regulations are critical to the integrity of the $3 billion operation.

The new grant review procedures received a preliminary go-ahead Nov. 24 from the Governance Subcommittee of the governing board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. The proposals will come before the full board this Thursday at a meeting in Berkeley.

James Harrison, the outside counsel to the CIRM board, described the changes concerning scientific grant reviewers as “substantial” in a memo to the board. One key provision would involve “a screening mechanism that would permit applicants to identify up to a total of three individuals (including labs and companies) whom the applicants believe could be biased (whether for personal, professional, competitive, or any other reasons).”

The exact mechanism was not otherwise described in Harrison’s memo. 

CIRM’s grant review process is currently shrouded in secrecy in keeping with tradition in the scientific research community and will remain that way under the new rules. Virtually all of the grant review is performed behind closed doors. Identities of specific reviewers on an application are withheld. Names of applicants are withheld. Financial and professional interests of the reviewers are withheld, revealed only to some CIRM staffers.

When an applicant files a complaint about a financial conflict of interest on the part of reviewers, all of the information is withheld.

That is the environment in which the agency’s scientific reviewers operate while they make the de facto decisions on virtually all of the $1.8 billion that has been handed out over the last 10 years. The governing board rarely overturns a positive decision by its reviewers, all of whom come from out of state.  

In response to a question today, Kevin McCormack, a spokesman for the agency, said that the secrecy would continue under the new rules. He said applicants could examine the list of more than 100 potential reviewers if they had concerns about conflicts. A much, much smaller number is actually involved in a specific application review. Those names are withheld. 

No restrictions exist, however, on applicants publicly disclosing their conflict-of-interest concerns either directly to the board or to any other private or public entity.

The proposed conflict changes would also disqualify reviewers from evaluating an application from a person who has “been on opposing sides of a formal legal dispute.”  A reviewer would be required “to recuse himself or herself if the member believes his or her objectivity could be compromised for any reason.”

Other changes would expand the scope of financial conflicts by including relationships with partnering organizations and subcontractors.

The Harrison memo said,

“The intent of this change is to capture other financial interests that could create a conflict of interest with respect to a particular application because they are significant participants in the proposed project or stand to benefit financially if the project is successful.”

The proposed rules originated more than a year ago as an outgrowth of a discussion at a stem cell agency board meeting involving earlier possible changes. The board was told that only two cases have surfaced involving violations by reviewers. No names were mentioned during the board meeting.

One case involved reviewer Lee Hood, a renown scientist from Washington state, in a conflict connected to another internationally known scientist, Stanford researcher Irv Weissman, in a $40 million round. The other involved John Sladek of the University of Colorado, who was head of the grant review group, in a $45 million round.  The violations were first disclosed publicly by the California Stem Cell Report. The agency did not post the violations on its Web site, reporting them only to the California legislative leadership as required by law.

At the October 2013 agency meeting of the agency governing board meeting, Jeff Sheehy, a board member and communications manager at UC San Francisco, asked if the Hood and Sladek violations would also be considered violations under the rules being proposed at that 2013 meeting.  Sheehy was told that they would not, according to the transcript of the meeting. Sheehy replied,

“Well then, I think it's not possible for me to even support the initiation of this process because in the last case(Hood-Weissman), at least what I've been told, the identification of the conflict, which was the reviewer and the grantee held property together, and the identification of that conflict was made by a fellow reviewer. So if we have a conflict that is deemed material by members of the scientific community, it's hard for me to understand why the net that we're casting should make the holes bigger in order to let the fish out.”

After some discussion of Sheehy’s remarks and other concerns voiced by board member Stephen Juelsgaard, former executive vice president of Genentech, the proposed changes were sent to the Governance Subcommittee for revision.  

Harrison’s memo for this week’s meeting did not specify whether the two past violations would now also be considered violations under the latest rules.

The new rules would apply initially to the agency’s new, $50 million fast-track clinical program and then be extended to all applications.  The action this week will impose the regulations on an interim basis while they work their way through the state’s official rule-making process during which the public may comment.

In addition to the Berkeley meeting location, interested parties can participate at a teleconference location in Sacramento and two in Los Angeles.  Specific addresses can be found on the agenda. Room numbers can be learned by emailing mbonneville@cirm.ca.gov.  Comments or suggestions can be sent to that email address as well.

California Stem Cell Speed-Up: $50 Million for New, Rapid-Action Program

The mystery at the $3 billion California stem cell agency has cleared up.

The agency yesterday posted a document that provided some details on just what is to be considered next week by the agency’s board of directors, and it is very big stuff -- $50 million worth.

It involves what the agency’s new president, Randy Mills, calls CIRM 2.0 and is intended to speed considerably the agency’s work on research that is closer to reaching the public. (The agency is commonly referred to as CIRM after its official name. the California Institute for Regenerative Medicine.)

The information on the new effort came only one business day prior to scheduled action on the plan by the directors’ Scientific Subcommittee, which meets Monday. The proposal is expected to win approval at the board’s full meeting next Thursday in Berkeley.

Mills’ plan calls for spending $50 million between now and next July on grant applications that will be received every month, instead of sporadically as in the past.  The objective of the program is to create "a more streamlined process for awarding and administering grants that will include frequent and predictable submission opportunities followed by rapid review, quick funding decisions, streamlined contracting and the prompt initiation of research."

Applicants can ask for as much money as they want. No caps are being set in advance, but the research budgets will be thoroughly analyzed prior to review. Indirect costs will be limited, however, to only 10 percent of the award. That is a major reduction.  Kevin McCormack, a spokesman for CIRM, said last year that a 20 percent cap exists on indirect costs on awards. Grants also provide for “facilities” costs at an additional percentage that can be much higher than the 20 percent.  The rate varies from institution to institution.  

Matching funds will be required by both business and nonprofit applicants in some cases in the three-stage program. Business applicants will have to show that they have six months of “cash on hand” from the date of the application submission. 

Applications will be due on the last business day of each month, presumably beginning Wednesday Dec. 31. The CIRM board would act on the award about 90 days following submission. Work must begin within 45 days of approval of awards by the full board, about 130 days after submission of the application, according to Mills' memo to the CIRM board. 

Mills’ plan also calls for a major change in appeals of negative reviews, saying they would be limited to “demonstrable conflicts of interest” as defined by CIRM’s existing policies. Mills’ memo said the change was being made because of “the open opportunity to apply and amend  rejected applications.”

Mills has said successful applicants will be strongly guided by CIRM. Unsuccessful applicants will be coached by CIRM on how to alter their proposals if the agency feels their plans have strong potential.

Parties interested in commenting on the plan or suggesting changes can send their remarks to the directors by emailing them to mbonneville@cirm.ca.gov. They can also participate in Monday’s 90-minute meeting at teleconference locations in San Francisco, Duarte, Los Angeles, Irvine, La Jolla and Oakland. Addresses can be found on the meeting agenda, but specific room numbers are not given. Those can be obtained by calling CIRM at 415-396-9100 or email to mbonneville@cirm.ca.gov.

The California Stem Cell Report will have more on this and other CIRM 2.0 changes prior to next Thursday’s meeting.

Former California Stem Cell Board Member Shestack Comments on the Agency's Record

Jonathan Shestack, a former member of the board of the California stem cell agency, was interviewed by telephone during the reporting for the 10th anniversary article today on the California stem cell agency.

Jonathan Shestack (left) and CIRM Chairman J.T. Thomas
at 2012 board meeting. CSCR photo

Shestack served on the board from 2004 until 2013. A Hollywood producer, he has been a longtime patient advocate for autism. He and his wife co-founded Cure Autism Now in 1995. Here is a link to Shestack's resignation letter from the board.

The 10th anniversary article was written by David Jensen, the publisher of this blog, and appeared in The Sacramento Bee.

Here is a summary of Shestack’s comments, which were trimmed from print article for space reasons.

He said, “CIRM has funded an amazing amount of great projects. It does an amazing amount of good.” He said, however, it should be “more bold going forward.”

Shestack was critical of the senior staff at the agency. He said they did “not like to do what the board wants.” He said, “The staff made a monkey out of the (10) patient advocates (on the board) for eight years.” There was no mechanism by which the board could pressure the staff on “programmatic” issues, he said.

Shestack said he was disappointed in the funding for research funding for autism. He said the agency wants to take credit for more funding on autism than is justified. He suggested that alternative grant-making proposals would been useful, such as creating a round for research on specific diseases.

Shestack was critical of the way in which grant rounds were handled. He said it led to “bloated proposals that people felt they had to approve.” He said the agency could have “more ruthless” on the “big disease” rounds and more willing to spend on basic research. “Ossified” is the way he described the grant-making process. During the review of grant applications, he said the staff “exerted a lot of pressure but in a passive-aggressive way.”

On conflict of interest issues, he said, “Trying to legislate away all conflict is a way to install permanent idiocy.”  Knowledgeable people in a small field such as stem cell research are nearly always going to have conflicts. He said the key is to manage them properly.

Shestack remarked on the impact of the state laws concerning open meetings. Compared to the private sector, they were “incredibly onerous” and made it difficult to do things, although he recognized they were necessary.

Shestack said the board is one of the best he has ever served on.  He said all the members were “pulling incredibly hard for the success of the agency. None of them had a hidden agenda.”

$40 Million California Stem Cell Genomics Agreement Signed; A Checkered Past

The California stem cell agency and a Stanford-led consortium have reached agreement on a $40 million stem cell genomics project that triggered complaints about irregularities, unfairness, score manipulation and the role of its then president, Alan Trounson.

The agreement was concluded last month with Stanford, UC Santa Cruz and the Salk Institute in La Jolla, five months after the award was approved by the governing board of the $3 billion agency, which is known as CIRM. The final signature came July 2 when Santa Cruz signed. Salk signed on June 26 and Stanford June 18, according to Kevin McCormack, a spokesman for the agency.

The effort is aimed at paving the way for therapies tailored to a patient’s genetic make-up and positioning California as a world leader in stem cell genomics.

Trounson’s role came under fire when he recommended approval of the Stanford application. The agency’s blue-ribbon grant reviewers, whose advice is rarely rejected by the CIRM board, also recommended funding three competitors. 

The round had a checkered history as a result of a conflict of interest involving scientist Irv Weissman of Stanford and scientist Lee Hood of Seattle, who own a ranch together in Montana. Trounson, who has visited the ranch as Weissman’s guest, recruited Hood to review the applications, including Stanford’s proposal which then specifically included Weissman.

The Stanford application that was ultimately approved did not include Weissman.  Michael Clarke, the No. 2 person in Weissman’s stem cell program at Stanford, was included, however, and was praised by name by Trounson during board consideration of the Stanford application. (See here for discussion of conflicts preceding the board action.)

Seven days after leaving CIRM at the end of June, Trounson was named to the board of directors of StemCells, Inc., of Newark, Ca., which holds $19.4 million in awards from the agency. The firm was co-founded by Weissman, who now sits on its board.  The Trounson appointment surprised the agency and triggered a rash of bad publicity for CIRM. (See here and here.)

The agency’s new president, Randy Mills, banned CIRM employees from communicating with Trounson about StemCells, Inc., matters and announced that he would not accept employment from CIRM grantees until one year after he leaves the agency.

The New, Official Life Expectancy of the California Stem Cell Agency

Randy Mills' calculations on cash for future CIRM funding

Randy Mills, the new president of the $3 billion California stem cell agency, rewrote some of the agency’s history last week and extended the life span of the now nearly 10-year-old enterprise.

All that talk about the agency running out of money for new awards in 2017? Bushwa, he basically said. “It’s simply not true,” he told the directors of the agency at their meeting in Millbrae.

Mills' comments appeared to be directed at media stories, including those on this Web site, that mention the 2017 timetable. However, the date was not concocted by the writers of those stories. It came directly from the agency itself, which has never challenged it until Mills did last week. The timetable was even referenced as recently as December 2013 by the agency’s directors.

Randy Mills

That said, Mills’ view of the spending possibilities for the California Institute for Regenerative Medicine(CIRM), as the agency is formally known, is not inaccurate. It comes from his fresh, business-oriented analysis of the agency’s finances. It is based on different assumptions than those used previously by the agency.  His perspective does not appear to assume, for example, that all the grant rounds approved in concept by the board will go forward at their existing levels.

A case in point came last week when Mills recommended and the board approved slicing $5 million out of a $15 million component of the agency’s Alpha clinic RFAs. It was the first time that the board has so heavily cut a previously approved "concept" figure.

The agency's last major review of the cash available for awards occurred at last December’s board meeting. CIRM Chairman J.T. Thomas said at the time, 

“We now find ourselves with the reality that, having started with $3 billion, we are down now to how to deploy our last $600 million….”

Pat Olson, executive director of scientific activities, said,

“There’s essentially $950 million yet to be awarded, 321 (million) of the concept approved and the 629 (million) of the future.”

Steve Juelsgaard

Steven Juelsgaard, a CIRM board member and former executive vice president of Genentech, however, looked at the numbers with basically the same view as Mills. Juelsgaard, who has been chipping away at some of the financial assumptions of the agency, said,

“So we’ve been talking for the longest time as if we have three to four years worth of money to spend, right? I asked myself, well, why is that true? Who made that decision that it’s three to four years? That length of time is driven by how quickly we spend our money, not by anything else. So if we spend our money more slowly, we could go for six years or eight years or whatever the number is that you want to pick. It’s all a matter of burn rate.”

Enter Mills five months later as president. By last week, he was telling board members that, yes, they have enough money to give out awards until 2020 at a rate of $190 million a year.  He said that about $1 billion is available.  

“We will be able to fund most anything that meets our criteria.”

Of course, if the agency spends more than $190 million a year, the money will run out faster. And the  agency is engaged in clinical trials and commercialization efforts, which are far more expensive than basic research.

But Mills’ 2020 timetable has some significant advantages even if it slows the pace of awards. It gives the agency substantially more time to arrange some sort of financing for the future. Currently its only real source of funding is state bonds. Its ability to authorize those bonds ends in 2017, according to the agency. Currently Thomas is examining the possibility of some sort of private-public financing arrangement. Asking voters to approve another bond measure has not been ruled out, but it could be problematic politically.  The additional time would improve the possibility that clinical trial results would emerge that would resonate with the public as well as with private funding sources.

While Mills paints a rosier financial picture than the agency previously offered, he also has demonstrated a clear fondness for focused austerity. It fits with the mood of the board. Juelsgaard, who is chairman of the agency’s Finance Subcommittee, is also attempting to bring a sharper financial perspective to the agency at a time when directors are clearly feeling a pinch.  

Gone are the days when $120 million was added with modest discussion to one round of grants. No longer is the governing board throwing another $23 million at already hefty efforts to lure stem cell stars to California labs.

Instead last December, after directors were told that only $629 million out of $3 billion was left uncommitted, CIRM Director Jeff Sheehy, in a comment echoed in tone by other board members, said,

“I just think all of us are starting to get concerned about the burn rate. We’re just flying through the money.”

 One of Mills’ first public actions involved the agency’s $17 million annual operational budget, which is limited by state law. On top of those limitations, in May he whittled the spending plan down to the point where it could be described as less than the previous fiscal year, given inflation.

Also in May, when directors were considering elimination of what was left of the $57 million researcher recruitment program, Mills basically disengaged himself from support of the effort. He told directors,

“It’s not that I don’t like the concept of recruiting great people….It’s just we have to make sure we recruit the people we need.”

Mills' actuarial exercise was not the first involving CIRM's mortality. Back in 2004, it was widely believed that the agency had only a 10-year life, a belief held by some of its staffers, which would have meant this year would have been the agency's last. That misconception grew out of the agency's 10-year authorization to issue bonds. That authorization is now commonly believed to have begun in 2007 because that was the year litigation about the agency was ultimately resolved. It may well be that the date of CIRM's final reckoning will change once again before its last check goes out the door.

A USC Researcher's Perspective on the Grant Round Involving StemCells, Inc.

A USC scientist late today sent an email that dealt with the 2012 decisions that resulted in the award of $19.3 million to StemCells, Inc., by the California stem cell agency. The award was made on a close vote (7-5) despite being rejected twice by the agency’s reviewers.

It was the first time that the agency’s 29-member board had approved an application that was turned down twice by its respected reviewers. 

The circumstances surrounding the award were unusual in other respects, and we are providing links to stories carried by the California Stem Cell Report at the time to provide additional context. The links are at end of the scientist’s email.

The author of the note is Lon S. Schneider, a professor of psychiatry, neurology and gerontology at the Keck School of Medicine at USC.  He was co-PI on an application in the same round as the StemCells, Inc., proposal. His application was rejected by the CIRM board despite having a higher score than the StemCells, Inc., application. 

Then-CIRM President Alan Trounson recused himself from the public discussion of the proposal by StemCells, Inc., because of his relationship with Stanford researcher Irv Weissman, who sits on the company’s board.  This month, Trounson was named to the StemCells, Inc., board seven days after leaving the stem cell agency, triggering a flap over conflicts of interest.

Here is Schneider’s note:

“In view of the CIRM’s comment today that they commissioned their own lawyers to investigate and find no conflicts, I thought that I’d share some thoughts with your readers based on my experiences with CIRM.  An investigation of CIRM’s actions during the last month or so would – almost by definition – not reveal a serious conflict because the alleged conflicting behavior would have occurred at the time that the StemCells, Inc. contracts were awarded, if it happened at all.  Bending milestones after a contract is awarded and when one’s foot is out the door is of little concern and can be corrected.

“My interest in Mr. Trounson’s alleged actions is that my colleague and I submitted an Alzheimer's disease grant that was scored higher than StemCells’ Alzheimer’s grant in the same funding cycle. Yet, StemCells’ appeal was funded, while our appeal was not even accepted as an appeal application.  Our recourse was to protest during the public comments part of the CIRM board meeting at which StemCells’ was awarded their contract.  In my opinion, Mr. Trounson and the CIRM staff were clearly antagonistic to us and strongly supportive of StemCells.  Board members were not aware of our appeal.  Indeed, the Alzheimer’s disease advocate on the CIRM board, Leeza Gibbons, who was well-rehearsed in her advocacy for StemCells, Inc, had to be informed during a break on what our grant was about so that she could support it as well.

“StemCell’s sinecure for Mr. Trounson reinforces my opinion that the StemCell/CIRM arrangement was – let’s say -- interesting.  No doubt, others will disagree and point out why our proposal – although rated higher than StemCells – was deficient and should not have been funded while StemCells’ should have been and was.  They, of course, may have a point, and I will continue to believe that the StemCell contract was awarded in no other way than with probity. I thought I would nevertheless share these observations.”

Here are links and excerpts from the 2012 articles.

StemCells, Inc., Wins Another $20 Million From California Stem Cell Agency

Following a second impassioned pitch by its former chairman, Robert Klein, the governing board of the California stem cell agency approved a $20 million award to a financially strapped biotech firm, StemCells, Inc., of Newark, Ca.

An Unseemly Performance: Former Chair of Stem Cell Agency Promotes $20 Million Research Proposal

Bob Klein is nearly an icon in the history of the $3 billion California stem cell agency. And when he appeared before its governing board last month and aggressively touted a $20 million grant proposal already rejected by agency reviewers, his actions raised eyebrows.

Arm-twisting and Emotion: Stem Cell Directors Move to Reform Appeals on Multimillon Dollar Grants

Frustrated with politicking, “arm-twisting,” lobbying and “emotionally charged presentations,” the governing board of the $3 billion California stem cell agency today approved short-term changes in its grant appeal process and ordered up a study to prepare long-term reforms.

California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards

During the last few months, the $3 billion California stem cell agency, which is approaching its eight-year anniversary, has chalked up a number of important firsts.

$5 Million Sliced from California's Ambitious Alpha Stem Cell Clinic Program

Directors of the California stem cell agency today cut $5 million from their $70 million plan to create a series of Alpha stem cell clinics aimed at making the Golden State the leading location in the world for stem cell therapies.

On a 6-1-1 vote, the directors trimmed the effort, much touted by former agency President Alan Trounson. Eliminated was a data/information center whose tasks would have included marketing and patient education. The center also would have worked on strategies to persuade the federal government and insurance companies to pay for what are expected to be enormously expensive treatments.

The board has 29 members. However, only eight were allowed to vote because of conflicts of interest among the others. 

The cut by the board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, came after its new president, Randy Mills, recommended scaling back the effort. He told the board the plan was not “clearly justified.”

He said in a memo,

“The proposal as written is too broad and overly complex to be successful. In a word, it lacks focus.”

Mills proposed that a refined RFA be reissued with $10 million in funding, which the board approved. It was the first time that the board had retroactively revised a concept plan and directed that an RFA be reissued.  

The Alpha clinic concept first surfaced publicly in 2011. Trounson and two other CIRM executives promoted the plan in a scientific journal financed by the stem cell agency. (See here and here for more.)

Trounson wrote that the scientific community owes it to persons suffering from diseases “to rapidly implement the best and safest practices for cell therapy clinical trials and move toward fast-tracking in therapies where safety and efficacy has been proven.” Nature Medicine said it would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

Eight institutions have applied for the main portion of the award, which is designed to make California a one-stop shopping center for stem cell therapies. The hope is that patients will be attracted from throughout the world. Up to five awards are scheduled to be made for those clinics.

A separate RFA deals with the data center. Five institutions have applied in that RFA, including some also involved in the main portion.  The agency has already received all of the applications in both categories. Based on testimony today, it appears that UC San Diego, the City of Hope and Stanford have all submitted applications in the data center round. 

Although the applicants have not been identified by the agency, virtually all are likely to be represented by persons sitting on the CIRM governing board because of the nature of the concept plan and the RFA.

Review of the applications is scheduled for this September but was originally scheduled for June. In one of his first public actions, Mills delayed the review. The agency said it needed more time to secure knowledgeable reviewers, who must come from out-of-state.

Reduction of the size of the proposal will free cash for other research efforts. Directors are feeling increasingly pressed by financial issues. The agency is scheduled to run out of cash for new awards in less than three years. It is looking into some sort of public/private combination of financing that will allow it to continue in the same fashion beyond 2017.

The CIRM board approved the original Alpha concept in July 2013. At the time, the plan was hailed by the directors, who spent little time discussing the data center that was revised today.

Earlier items on the California Stem Cell Report incorrectly indicated that the effective reduction proposed totaled $15 million instead $5 million.

Fallout From the Trounson Affair: A Taint on the California Stem Cell Agency

Directors of the $3 billion California stem cell agency meet tomorrow in the San Francisco Bay Area, but the hottest topic is not on the agenda, and that is the Trounson Affair.

Alan Trounson
SF Business Times photo

The term is shorthand for the host of questions raised by the appointment July 7 of Alan Trounson, former president of the agency, to the board of StemCells, Inc. The company is the recipient of $19.4 million from the agency, cash that was awarded under unusual circumstances on a narrow 7-5 vote.(See here and here.)

Two days after Trounson’s appointment, the agency’s new president, Randy Mills, announced a “full review” of the activities involving StemCells, Inc., a publicly traded firm based in Newark, Ca.

News and commentary about the matter has slowly emerged since the appointment. None of it reflects well on the agency, which is trying to devise some way to secure public or private funding beyond 2017 when the cash for new awards runs out.

The most visible article appeared in the Sunday Los Angeles Times, which has a readership of 4 million in print and online. Michael Hiltzik wrote that cronyism is rife at the California Institute for Regenerative Medicine(CIRM), as the agency is formally known.  He said,

“How bad are the conflicts? When the (29-member) board considered a proposal earlier this year to spend $16 million to attract three star scientists to California, so many members had to recuse themselves that only nine were left to vote. (Six ended up voting in favor.)

“When conflicts of interest are so rife that only one-third of your board can weigh in on a major policy issue, that's tantamount to not having any board at all.”

The tone was echoed in other pieces, including one in the San Francisco Business Times, where the headline said,

 “'Trounson affair' another strike against California stem cell agency.”

Other articles appeared in the San Diego U-T and the San Francisco Chronicle. The Orange County Register published an editorial that said the agency has “operated as a cash cow for a tiny circle of well-connected individuals and institutions.”

The Trounson appointment “reignites charges of cronyism,” said a headline on allgov.com. Pete Shanks of the Biopolitical Times wrote, 

"Let's be blunt: This looks like a pay-off. Technically, what Trounson and (Irv) Weissman (of Stanford) and StemCells, Inc., just did may not be illegal. But it's shameless.”

The Scientist magazine wrapped the Trounson appointment into a piece that included news about a lawsuit against StemCells, Inc., that charged the company was endangering patients in clinical trials. 

The talk ricocheted around California’s stem cell community. One longtime reader of the California Stem Cell Report, who is a patient advocate, said in an email that Trounson’s conflicts of interest are “now even more transparent and make the previous grant decisions even more suspect.” “Self-dealing” is how this supporter of stem cell research described the situation.

Another reader and knowledgeable observer, who also must remain anonymous, described the Trounson appointment as “brazen.” And yet another who is quite familiar with the agency said,

“No one seems to understand what conflict of interest means.  I don't understand how they can even think that it is OK to do this.”

We should note that these remarks come from persons who back stem cell research and the agency.

In some ways, however, public attention to the matter could be described as minimal. The stem cell agency is little known to most people, and the Trounson Affair did not garner front page headlines. But like some sort of immortal cell, the stories will live on. Twenty years ago, the individual stories would have faded, buried in the morgues of the mainstream media. However, today, given Google searches, they will become embedded in all future reporting about the agency – not to mention knife-edged opposition research should another bond measure be placed before voters to fund the agency.

The Trounson Affair also highlights the need for the agency to stiffen its revolving door restrictions – the regulations that would have prevented his immediate appointment to a post at an enterprise that has benefited from the agency’s largess. It is a problem that will grow as the agency nears its financial demise. CIRM staffers will naturally be looking for places where they can find future employment.

The state has some minimal laws restricting future employment by agency personnel. But the agency needs to do more, a difficult task given that such action basically will change the terms of employment for staffers. But failure to confront the issue will only lead to more debacles.

CIRM’s “full review” of the situation is well-taken. However, the agency has not publicly defined even generally what a full review entails nor has it responded to questions from the California Stem Cell Report about the nature of the inquiry. The agency also has not indicated whether it is seeking an outside, independent entity to conduct the review. One possibility would be State Controller John Chiang, who is the chairman of the only state body (the Citizens Finanancial Accountability and Oversight Committee) charged with oversight of the agency. Another would be the state’s Fair Political Practices Commission, the state department charged with enforcing conflict of interest laws.

One California researcher and CIRM grant recipient has noted that the flap obscures the work that the stem cell agency has done. In a comment filed on an item on the California Stem Cell Report, Jeanne Loring, director of the Center for Regenerative Medicine at The Scripps Research Institute, said that despite “the errors in judgment” at the agency, 

“CIRM is at the heart a remarkably effective driver of cutting edge research. By focusing on a narrow area of research and encouraging international collaboration, CIRM has singlehandedly pushed the whole world's stem cell research forward. If CIRM were a drug company, it would be considered miraculous that so many promising treatments are in the pipeline just eight years after it started."

Loring makes a good point. And it would be a shame if the good work of CIRM is discredited because of a failure to deal forthrightly, quickly and publicly with conflict of interest issues at the agency. 

Verastem Bid for Nearly $10 Million from California Nixed

A Massachusetts firm called Verastem, Inc., heard some bad news recently about its pitch for $9.9 million from the $3 billion California stem cell agency.

The Cambridge firm sought the cash from the agency to help out with a clinical trial dealing with breast cancer.

However, the agency’s directors were told in a memo on the CIRM Web site, 

“Weaknesses in the scientific merit of the proposal combined with portfolio considerations led to a staff recommendation NOT to fund.“

By portfolio considerations, the staff seemed to mean that the agency had already awarded funds in the same scientific area.

The agency’s reviewers, who come from outside California, gave the application of score of 74. Formal action will be taken on the application at Thursday’sboard meeting in the San Francisco Bay Area.

California Stem Cell Conflict Case Covered by Los Angeles Times

The Los Angeles Times today published a brief story on the Trounson-StemCells, Inc., affair, declaring that the California stem cell agency was taking steps deal with a “risk of conflict of interest.”

Amina Khan wrote the piece, which included quotes from John M. Simpson of Consumer Watchdog of Santa Monica, Ca., who said,

“The thing smacks as if this is StemCells, Inc., giving a payback to (Alan) Trounson(former president of the agency) after the agency awarded $19 million to StemCells Inc. That’s just the way it looks. And I think they have to explain quite clearly why that is not the case.”

Trounson was appointed to the board of StemCells, Inc., of Newark, Ca., last Monday.  StemCells, Inc.’s directors received as much as $99,000 in 2013.

Khan carried little new on the situation, although the issue was undoubtedly new to virtually all of 1.4 million readers of the Times, the state’s largest circulation newspaper.

Stanford's $40 Million Stem Cell Genomics Award Still Hanging Fire

More than four months after a Stanford-led consortium won a $40 million stem cell genomics award, the California stem cell agency has not yet concluded a formal contract with the researchers.

The award was approved Jan. 29 by the agency's board following a process that Stanford's competitors said was marred by unfairness, apparent preferential treatment and manipulation of scientific scores.

The award is aimed at creating medical treatments tailored to a patient's genetic makeup and making the state a world leader in stem cell genomics.

In response to a query from the California Stem Cell Report, Kevin McCormack, senior director for communications, said that the contract with the consortium remains unsigned. He said, however, that the agency is hopeful that final details will be worked out soon.

California's $70 Million Alpha Stem Cell Clinic Project Runs Into Roadblock

The California stem cell agency's $70 million Alpha Clinic plan has hit a stumbling block in the drive to make the Golden State the“go-to” location worldwide for stem cell treatments.

The agency reported today that it has encountered difficulties in lining up the necessary expertise to make the decisions on the complex applications, which are now awaiting judgment. The closed-door review session was originally scheduled for this month.

The delay surfaced when the California Stem Cell Report asked the agency about the reviews of the applications. In a brief response, Kevin McCormack, senior director for communications for the California Institute for Regenerative Medicine (CIRM), said,

“It's being rescheduled because it is just taking a little longer than anticipated to get the caliber of experts needed to review something as complex as this.”

McCormack said the new review session would probably be held in the fall. The agency expects to have 15 experts from outside of the state to examine the applications in addition to eight members of the agency board. 

The Alpha clinic proposal attracted applications from eight, unidentified, major California institutions earlier this year. The intention is to create one-stop locations for stem cell treatments that would lure patients and scientists from around the world.

The plan is a much-touted initiative by former CIRM President Alan Trounson, who resigned to rejoin his family in Australia. Randy Mills, the former CEO of Osiris Therapeutics, replaced Trounson six days ago. Trounson has been pushing Alpha Clinics since 2011. Just last month, he extolled the proposal before hundreds of regenerative medicine specialists at a Berkeley conference sponsored by the Regenerative Medicine Foundation.

Trounson said that the clinics would serve as a “proving ground” to develop business models, to build and share data and to create a strategy that would help convince insurance companies and Medicare to pay for the treatments.

He said that existing clinical research centers are not able to provide all the resources necessary for development and application of stem cell treatments. He said developing clinical expertise in a “random, spontaneous way doesn't work in the best interests of the patient.”

Trounson, who is renown for his IVF work, said the existing structure of the IVF industry in the United States is evidence of the weakness of an unstructured approach.

Agency spokesman McCormack did not answer a question about whether applicants would be given a chance to modify their proposals in the wake of the delay. One of the aspects of the RFA involves applicants providing some sort of matching funds or equivalent support to leverage the funds provided by the state of California. More time could mean that applicants could round up more matching cash.

The delay also could possibly endanger existing commitments of support and affect employment arrangements as well as building schedules.  

California Stem Cell Directors Reject Conflict Charge on $13 Million Heart Research Proposal

Directors of the California stem cell agency today rejected a $13 million application for heart research despite allegations that the agency's review involved a conflict of interest.

The vote was 3-8 on the proposal by Eduardo Marban, director of the Cedars-Sinai Heart Institute, who complained that a conflict existed during the review of the application.

The agency said it conducted an "extensive" examination of Marban's charges and determined that no legal violation of the agency's conflict of interest rules had taken place.

Appearing before the board, Marban said that the review was a "white-wash." He also said the CIRM staff's re-examination of the scientific issues was inadequate.

Marban did not disclose specifics of his complaints about the nature of the conflict. Nor did the agency. But he referred to unspecified actions by a "venture capitalist." CIRM said no venture capitalists were involved in the review.

CIRM Director Jeff Sheehy asked CIRM staff whether any California residents were among the reviewers during the grant round involving Marban. Gil Sambrano, CIRM's associate director, review, said there were and indicated they served as "specialists." Sambrano also said one of  the reviewers in the round had a conflict because he was involved in one of the grant applications being reviewed.

CIRM has long contended that to avoid conflicts of interest no persons from California served as grant reviewers. However, Sambrano said that provision applied legally only to members of the grant review group, formally known as the Grant Working Group, and did not apply to the use of specialists. Sambrano said the specialists do not participate in the actual act of scoring during the closed-door reviews of grant applications.

Marban's application received a score of 48 out of 100 with a range of  20 to 74, CIRM disclosed today.

Several members of the board, including Chairman Jonathan Thomas, said it was necessary for the board to respect the opinions of grant reviewers and the conclusions of its staff.

Marban has been highly regarded by the agency, which cited his research during a review earlier today of CIRM's accomplishment. He has received $7 million in grants and a company he founded, Capricor, has received $20 million.

CIRM has long cloaked its grant review process in secrecy, in keeping with the traditions of scientific peer review, even though the awards involve public money. The reviews are conducted in private. The names of the applicants are not disclosed. The names of reviewers are not disclosed. The reviewers' economic, personal and professional interests are not disclosed. Scores on rejected grants are not disclosed, unless the applicant appears publicly before the board. Names of applicants appealing reviewer decisions are not disclosed unless they also communicate publicly with the board. That provision was put in place last year by the board.

The total number of directors voting on the application was only 11 compared to 29 on the board. The number is small because of conflict of interest rules at the agency.

For more on the Marban story, see here and here.

$72 Million for Commercial Stem Cell Therapies?

The $3 billion California stem cell agency next week is likely to move to pump about 12 percent of its remaining, dwindling cash into business-friendly efforts to develop commercial therapies.

Coming before the agency's governing board on March 13 are two “concept” proposals for grant and loan programs totaling $72 million that are in line with CIRM's drive towards the marketplace and fulfillment of the promises of the 2004 ballot campaign that created the agency.

The proposals are coming from the agency's staff and fit with the strategic direction of the board. Such proposals have almost never been rejected in the past. But the board has demonstrated some fiscal concern in recent months as its uncommitted funds have shrunk to roughly $600 million, according an estimate presented by agency Chairman Jonathan Thomas in late January. The agency is scheduled to run out of cash for new awards in 2017.

The largest new proposal before the board would provide up to $40 million for four or five preclinical development awards. They would be aimed at development activities prior to a phase one clinical trial and at helping to attract future funding. Businesses and non-profits would eligible with businesses possibly taking a forgivable loan.

The second proposal would provide up to $32 million for possibly three awards in the agency's strategic partnership program ranging from $10 million to $12 million. The objective would be completion of a phase one or phase two clinical trial within three years. Matching funding would be required. Both businesses and non-profits would be eligible with forgivable loans a possibility for businesses.

If potential competitors for the awards are interested in shaping the direction of the proposals, next week's meeting in Burlingame is the time to appear before the board. The next step is posting a request for applications, scheduled for April and May. Board action on applications would come early next year.

$40 Million California Genomics Award: Missing Names of Conflicted Reviewers Disclosed

When the governing board of the California stem cell agency last month considered proposals for a $40 million genomics stem cell center, it failed to disclose the names of the grant reviewers who were barred from reviewing the applications because of conflicts of interest.

Normally, the names are reported to the public when the $3 billion agency posts summaries of the reviews of applications – prior to consideration of the proposals by the agency's board.

The departure from the agency's normal grant-making procedures is not the first in the genomics round, which is the subject of an internal examination by the agency that includes the board's outside counsel, James Harrison of Remcho Johansen and Purcell of San Leandro, Ca. Allegations of conflicts of interest and complaints about the role of CIRM President Alan Trounson, score manipulation, irregularities and unfairness have been raised.

It is unlikely that the normal disclosure of conflicted reviewers' names would have affected the outcome of the genomic awards at the governing board meeting Jan. 29. However, if questions had been raised at the public board meeting about the absence of the names, concerns about the closed-door review process may well have been elevated, given the earlier conflict-of-interest violation involving reviewer Lee Hood.  

The names of the reviewers with conflicts were added to the review summaries this week following an inquiry Monday by the California Stem Cell Report, which sought to double-check the apparent fact that no reviewers were in conflict since none were listed as recused.

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

“There were some conflicts of interest with the genomics review but apparently there is a bug in our data system, which is why they aren't showing up. We're going to fix that so thanks for bringing it to our attention.”

Here are the names of the reviewers now listed on the CIRM review summaries as being recused and the four applications involved. The four were recommended for funding by reviewers.

Stanford-Salk's winning application, Richard Gibbs, Maynard Olson; UCLA, Bradley Bernstein, Richard Gibbs, Aarno Palotie, Barry Rosen; Scripps-Illumina, Maynard Olson, Martin Pera, Jared Roach; UC San Francisco–UC Berkeley, none.

Amid Allegations of Unfairness, California's Stem Cell Agency Begins Examination of $40 Million Genomics Award Round

The California stem cell agency today said it has begun an examination of the grant review process in its $40 million genomics round, which has been criticized for irregularities, unfairness, score manipulation and the role of its president, Alan Trounson.

The agency confirmed the inquiry after the California Stem Cell Report asked last Thursday asked whether the board's counsel, James Harrison, was looking into the matter.

Kevin McCormack, senior director for CIRM communications, replied today in an email,

“There are always ways in which we can improve our performance, and we regularly review our processes to try and ensure we do a better job with each round of funding. We have been looking into the genomics award to identify areas where we can improve the process for future awards.” 

McCormack did not specifically respond to the question of Harrison's involvement. We have queried McCormack again about whether Harrison is involved. (McCormack subsequently confirmed Harrison's participation.)

Harrison, who is with Remcho Johansen and Purcell of San Leandro, Ca., has been outside counsel to the board since its inception. He drafted portions of Proposition 71, which created the $3 billion research effort in 2004. Harrison has expertise in conflict of interest and ethics issues as well as other related public policy matters.

Harrison's role at the agency exceeds that of a simple attorney. His length of service, knowledge and skills give him much wider influence.

CIRM's examination of the genomics round review followed complaints from rejected applicants and others about the process, which has been covered extensively by the California Stem Cell Report.

Trounson has come in for criticism in connection with the review and his subsequent recommendation in favor of the successful Stanford-led bid. One of the critics is Jeanne Loring, head of the stem cell program at the Scripps Research Institute and whose genomic application was rejected by Trounson and the CIRM staff. Her application and two others were recommended for funding by reviewers. Loring has contradicted Trounson's assertion that all applicants were given information that matching funds were part of the review criteria. Her application contained none. Stanford said it had $7 million.

Loring said that Trounson has interfered in CIRM's review processes in favor of Stanford. Trounson has been a guest at a Montana ranch owned by Irv Weissman, head of the Stanford stem cell program. Trounson did recuse himself in an earlier round involving an application linked to Weissman, but did not recuse himself in the genomics round.

Weissman was not listed in the latest Stanford application, but was in its original version. The associate director of Weissman's Stanford stem cell institute, Michael Clarke, was included in the final CIRM-approved version. Trounson lauded Clarke at the governing board's meeting last month in support of the Stanford project.

California's $40 Million Stem Cell Genomics Award: Irregularities, Complaints and Integrity

A number of firsts were recorded last month as the California stem cell agency gave $40 million to a Stanford-led consortium to put California in the global forefront of stem cell genomics.

Not all of those firsts necessarily enhanced the reputation of the California Institute of Regenerative Medicine (CIRM), as the $3 billion agency is formally known.

The unusual events and irregularities surrounding the award, CIRM's largest research grant, merit additional attention, given their implications about the integrity of the agency's grant review process and how the agency does its business.

The California Stem Cell Report recently asked a number of persons connected with the round and other knowledgeable individuals about the process. Their comments included a judgment that the agency staff “took a lot of liberties behind closed doors.” One of the rejected applicants "unequivocally" disputed assertions by CIRM President Alan Trounson that all applicants were informed by him about the need for matching funds, a key criteria for grant reviewers. The request for applications did not contain such a requirement.

The comments came in addition to earlier complaints by rejected applicants that scores had been manipulated in an “appalling” fashion and that scientific merit was not the first order of business in assessing the top four applications.

Also surfacing was a problem generated by Proposition 71, the ballot initiative that created the stem cell agency in 2004. The measure set up a 29-member governing board, including deans of medical schools and others with ties to research organizations. The board was supposed to exercise its expertise on funding decisions. However, only seven members of the board actually voted in the genomics round. Most of the rest had legal conflicts of interest and were not allowed to even participate in the discussion. It is not unusual for that sort of situation to arise during funding decisions by the board.

The CIRM stem cell genomics story began publicly in a scientifically big way with an article in the journal Nature Biotechnology in January 2012  by Trounson and two members of his staff. In it, Trounson said his proposal was needed so that the agency could take a "firm and lasting grip" on stem cell leadership.

Later that month, the governing board of the agency approved the concept for one or two genomics award. In February 2013, grant reviewers for CIRM, whose identities are withheld by the agency, took a crack at the applications. However, they declined to send any applications forward to the board for final action. It was the first time in the agency's nine-year history that has occurred. The reviewers offered no public explanation for the move.

The closed-door review session was marked by a conflict-of-interest violation by Lee Hood of Seattle, Wash., an internationally known genomics specialist, who was recruited by Trounson to be a reviewer in the round. Hood is a close friend of Irv Weissman, who heads Stanford University's stem cell institute. Weissman was named in Stanford's then $24 million application. Hood and Weissman also own a ranch together in Montana.

Trounson has been a guest at the ranch. In 2012, he recused himself during CIRM board discussions of two applications involving Weissman. The applications were from StemCells, Inc., of Newark, Ca., for $20 million each. StemCells, Inc., was founded by Weissman, who still holds a large amount of stock in the firm and serves on its board of directors.

Following the unsuccessful genomics review in February 2013, the applications were sent back to researchers with reviewer comments. The proposals could be retooled for a re-review in the fall, they were told.

After the fall review, the reviewers – minus Hood -- sent the applications to the board with recommendations to fund all four despite the fact that they would cost $146 million, well above the $40 million budgeted for the round. It was the first time that reviewers had made such a decision. Normally they stay within the budget, but they offered no public explanation for their actions in the genomics round.

At that point the CIRM staff, headed by Trounson, became more involved. Under new procedures, the staff may make recommendations concerning applications. In this case, they recommended that only the Stanford application be funded, but only after restoring a provision eliminated by reviewers. Trounson also recommended no funding for the three other top applications in the round. It was the first such major intervention by Trounson and the most aggressive staff move on grant applications.

Trounson offered only a 23-word phrase for recommending the Stanford application and no explanation for rejecting the other three. Stripped from the public review summaries for the three competing applications were the dollar amounts that they had requested. It has been the longstanding practice of the agency to include those figures. The amounts ultimately were made available to the board at its Jan. 29 meeting.

At that meeting, Trounson strongly backed retention of funding in the Stanford application for a project led by Michael Clarke, associate director of Weissman's stem cell institute at Stanford. Following the 2013 conflict violation involving Hood and Weissman, Weissman was removed from Stanford's application. Clarke was included, however. No questions were raised at last month's board meeting about whether Clarke could be regarded as a surrogate for Weissman's interests and whether that would involve a conflict of interest for Trounson.

Late in the meeting, Trounson also said that he had personally told all the applicants, with the exception of Stanford, that matching funds were expected as part of the applications, an assertion disputed following the meeting by Jeanne Loring of the Scripps Research Institute, whose rejected proposal contained no matching funds.

She said in an email,

"During the ICOC (governing board) meeting, Alan Trounson said that he had told us during his visit to all of the first round grantees that it would be important provide money for 'matching' funds. I state unequivocally that he did not tell me or anyone in my lab about this."   (Loring's boldface)

Stanford said its application contained $7 million in matching funds. The agency withheld the figures when they were requested by the California Stem Cell Report prior to the Jan. 29 board meeting, although it has released the figures in at least one other grant round.

Complaints about manipulation of the scores were raised prior to the board meeting by Pui-Yan Kwok,  leader for an application from UC San Francisco and UC Berkeley. He said that the scores of the top to applications were “based on the reviewers removing from consideration the poorest performing center-initiated projects.” He described the situation as appalling.

The agency defended its practices at the board meeting and in response to questions. It said the scoring procedures were permitted under the RFA. It said that while the procedures may be different than those of the NIH so is the stem cell agency. It said that all persons involved had been screened for conflicts of interest under CIRM rules and state law. 

In response to a query by the California Stem Cell Report concerning the process and the questions that needed to be addressed, Loring replied,

“I am concerned about the interference of the CIRM president in influencing the ICOC decisions. He has de facto power to promote or defeat specific applications, and he often wins by promoting one applicant over another. Stanford and Stanford faculty-founded companies such as Stem Cells. Inc., should not be so blatantly promoted over others. The relationship between the president and the head of the stem cell program at Stanford involves personal favors which make him conflicted and he should at the very least recuse himself from any discussion or recommendation of Stanford faculty's applications.”

Loring continued,

“The 29-member board is difficult enough to deal with, but now that most of the members are considered to be conflicted and are not allowed to even discuss the applications, we are left with a small number of non-scientists making decisions about scientific merit.

“I know that at least 5 members of the ICOC were very upset that they were unable to voice their opinions about what should be their mission- to guide CIRM's policies and choices for funding so that they are in the best interest of the voters.”

(For the full text of Loring's remarks see here.)

Other critical comments came from a longtime observer of the agency, who asked not to be identified, and who said,

“It appears that CIRM staff took a lot of liberties behind closed doors in driving this initiative to its final outcome. For example, what happened to require a resubmission and re-review etc. Did they change anything about this initiative in the process?  Were certain criteria shared with some but not all applicants?

“It also appears that the board was taken by surprise and not prepared to deal with the complexities in this initiative.  Clearly staff has not kept them in the loop and they had little access to the details of the process and how reviewers were managed.  They have always funded the vast majority of what the reviewers scored highly, and still did not break the bank.  This is a brand new situation where the reviewers recommended more grants than they could afford to fund.  This happens a lot in the NIH (especially today with severe budget cuts), so NIH has developed many processes to deal with this.  CIRM has not seen anything like this before.”

During the board meeting, some board members questioned parts of the grant review process. The anonymous observer said, 

“The questions (all legitimate) raised by the certain members of the board were by and large not understood or picked up by the other voting members, so they went nowhere. 

“Too many thoughtful board members were conflicted out, leaving the decision-making to a handful who are not prepared to deal with this complex situation.  I blame the IOM (Institute of Medicine) report in giving too much power, without the appropriate process, to staff.  Staff can recommend, but if the board has no information other than what staff provides, then they are acting in the dark.”

(For the full text of those remarks see here.)

In response to the same query, Michael Snyder of Stanford and Joe Ecker of the Salk Institute in La Jolla, co-leaders of the Stanford-led effort, did not raise any questions about the CIRM review process. They said,

“The net result (of their proposal) is that this center will help bring cutting edge technologies to all stem cell researchers in California and along with the funded projects will help keep California at the leading edge of two important fields: stem cell research and genomics, and thereby help accelerate both the science and therapeutics treatments possible in this field, and spur industry and economic development. questions.”

(For the full text of their remarks see here.)

(Editor's note: An earlier version of this item incorrectly said the first name of Michael Clark was William.)