Tracking CIRM Grants: "Thin Ice" Lurking?

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

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

He said that “unless you are prepared to spend enormous amounts of money, you are stepping on some very thin ice.”

“Everybody has seen horrible examples of custom-designed system that go bad.”

Friedman asked if any subcommittee of directors had approved the decision to go forward with a custom system. The answer was no, but that the decision had been carefully considered by CIRM staff.

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

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

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

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

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

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

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

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

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

Fresh Joy from Cyberspace

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

Joys of Cyberspace

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

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

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

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

Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., prepared this statement to be read at today's CIRM board meeting in San Diego. Simpson is on the East Coast on other business and may not be able to reach the Washington, D.C., teleconference location to deliver his remarks personally. Here is the full text.

“I apologize that that I was unable to attend today's ICOC meeting. I
appreciate this statement being read into the record on my behalf.

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

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

“Here are some suggestions to improve the situation:

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

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

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

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

“Thank you for your consideration.

“John M. Simpson”

Mystery Item No. 16 Revealed

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

CIRM Directors Discuss Strategic Financing Plans

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

More Live Coverage Today: CIRM Budget and Financial Projections

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

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

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

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

Immunology Grants: CIRM Gives $25 Million to 19 Researchers

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

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

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

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

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

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

Today one CIRM director again expressed exasperation. He was not clearly identified during the Internet audiocast of the board meeting, but he described himself as a scientist. Noting that the directors had limited information about the applications, he said,

“I don't think we have the ability to add value to the process.”

He also said,

“What do we think we are doing... Are we going to fund bad science?”

He said CIRM is “getting more and more applications on the margin.”

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

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

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

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

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

CIRM Board Moves to Closed Door Session

Directors of the California stem cell agency have moved into an executive session to consider confidential items in applications for $30 million in funding for immunology research. It is unclear when the public session will resume, but our guess in an hour or so.

Correction

We incorrectly reported in three earlier items that 45 applications for immunology items were received by CIRM and 16 approved. Actually, 44 were received and 15 approved.

CIRM Board Begins Consideration of Immunology Grants

The board of the Californiai stem cell agency has begun its open session with consideration of $30 million in grants for immunology research. Nine rejected candidates are seeking reconsideration of their applications.

Following consideration of the grants, Chairman Robert Klein said the board would the report by President Alan Trounson.

CIRM Board in Executive Session

The board of the California stem cell agency this morning promptly went into executive session but may begins its open meeting by about 1:30 p.m. or 2 p.m. PDT.

We plan to resume monitoring the meeting again at that point. If you are attempting to listen to the Internet audiocast, you should be hearing music but no voices. The executive sessions are usually in a different room, and the audiocast will resume when the board members return.

Don Gibbons, chief communications officer for CIRM, provided the time estimate. However, the board could take longer or return earlier.

Scripps' Loring on CIRM Grant Petitions

Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, filed a comment today that shed some additional light on the nine petitions that are seeking to overturn negative decisions on their grant applications.

Loring, who has served on grant review committees with the NIH, said,

“I don't think the intention of any of the petitioners was to subvert the review system. Grant applicants who are used to the NIH system expect to have a chance to revise and resubmit their applications in response to the reviewers' critiques.”

Loring, one of the nine petitioners, was reacting to an anonymous comment that the appeals were “undermining the review process and challenging the authority of the reviewers.”

You can read her full comment at the end of the “CIRM Challenged” item.

Live Coverage of CIRM Board Meeting

Stick with the California Stem Cell Report if you want to track the events in San Diego tomorrow and Wednesday at the meeting of the board of California stem cell agency. Whether it is the nine efforts to overturn negative actions on grant applications or the future path of the agency, we will try to bring it all to you in a timely and straightforward manner. We will be monitoring the session via the Internet from a mooring on an estuary in El Salvador and will be filing stories as warranted.

At some point we even hope to be able to tell you what a “Development Candidate Portfolio Review" is. That's item 16 on the agenda. No further explanation of the subject has been offered to the public with only about 12 hours remaining before the meeting begins.

CIRM Challenged by Nine Scientists on Negative Grant Decisions

A ninth researcher has filed a petition to overturn a negative decision on a grant application scheduled to be considered at a meeting tomorrow of the board of the $3 billion California stem cell agency.

The scientist is Judith Shizuru, the third applicant from Stanford to seek reconsideration of an application in the $30 million immunology round. Forty-four applications were filed. Fifteen were approved by the CIRM Grants Working Group. Nearly one-third of those rejected have now appealed the actions.

Regardless of the decisions by the grant review group, the CIRM board can do as it pleases with applications. However, it has been loath to overturn reviewer decisions. A number of board members are uncomfortable with the entire appeal process, including public appeals by scientists at its meetings. Nonetheless, some researchers have been successful.

In addition to Shizuru, here are the the names of the others who have submitted what CIRM calls “extraordinary petitions:” Olivia Martinez and Joseph Wu, both of Stanford; Defu Zeng and Chih-Pin Liu, both of the City of Hope; Genhong Chen and Elaine Reed, both of UCLA;  Jeanne Loring of Scripps, and Husein Hadeiba of the Palo Alto Institute for Research and Education, Inc.

With the exception of Hadeiba, all the institutions of the scientists have members on the 29-person CIRM board. However, they are barred from taking part in discussion of or voting on the grants in question.

An anonymous comment filed on one of our earlier items on the petitions said the "situation is out of control." The comment also declared that the researchers "are undermining the review process and challenging the authority of the reviewers."

Links to all the petitions letters can be found on the agenda for the CIRM board meeting. The summaries of the reviewers' comments can be found here. Click on the number of the grant to read the summary.

Here are two earlier items we wrote on the petitions: "Yamanaka Invoked" and "Six Scientists."

(Editor's note: An earlier version of this item incorrectly said the applications totalled 45 and that 16 were approved.)

Kleiner Piece Listed in 'Best of Web'

Our article last week on the Kleiner-CIRM connection rated a “Best of the Web” listing on the widely read Gooznews Web site.

The article shared the distinction with stories from the Wall St. Journal and New York Times, among others.

Gooznews is published by Merrill Goozner, a longtime journalist and author of “The $800 Million Pill.”

For those of you who may have missed the Kleiner piece, here is the first paragraph:

"A biotech company heavily backed by venture capitalists who contributed nearly $6 million to the election campaign that created the California stem cell agency was awarded a $1.5 million grant this spring from the very same agency."

The piece was also mentioned on healthycal.org, a solid government policy Web site published  by Dan Weintraub, the former Sacramento political columnist. 

Stem Cell Agency Budget Soars 28 Percent

The California stem cell agency plans to spend $15.7 million next year for its day-to-day operations, up 28 percent from this year's estimated spending of $12.3 million.

The $3.4 million increase is for the fiscal year that begins in 10 days. The hefty hike in spending comes at a time when the rest of state government is mired in a financial crisis that shows no signs of ending. CIRM's funds are provided, however, from state bonds – money borrowed by the state – and cannot be touched by the governor or the legislature under the terms of Prop. 71, which created the agency.

Because CIRM's budget consists of borrowed cash, the ultimate cost of its operations will be substantially higher than the nominal figures provided by the agency. CIRM has access to $3 billion in bonds. With interest, that translates to roughly a $6 billion bill for the state of California. In other words, the agency's operations will really cost nearly $32 million – not $15.7 million. And the $490,008 salary of CIRM President Alan Trounson will actually cost the people of California something a hair shy of $1 million.

But even at $32 million, CIRM's budget can easily be eclipsed by one or two of the beefy rounds of grants that the agency awards for stem cell research.

As we noted last week, the stem cell agency provided a much more detailed look this year at its spending plans, a vast improvement over the information that was offered a year ago. However, CIRM did not calculate percentage increases from this year's actual spending compared to what is proposed for next year. Both the percentage increases reported in this piece, along with the actual dollar increases, are the work of the California Stem Cell Report. They are drawn primarily from numbers on CIRM's “projected expenses” document.

The biggest increase in the budget is for salaries and benefits – a 22 percent ($1.5 million) increase from about $7 million to $8.5 million. The agency, which now has 45 employees, plans to hire five more persons in the coming year. The budget documents do not discuss hiring scenarios if legislation passes that would remove the 50 person cap at CIRM. Increases in state-mandated benefits amount to $400,000. Assuming an average of 47.5 employees for the year, salaries and benefits will consume $178,589 for each staffer.

The second largest item in CIRM's operational budget is for outside contracts. The agency relies heavily on non-state help because of the personnel cap. The figure for the coming year is $2.8 million, up 21 percent from $2.3 million this year.

The cost of meetings for the grant working group, which judges grant applications, will soar 151 percent from $452,000 this year to $1.1 million, a jump of $683,000. The budget documents available online do not explain the increase. But they do report that the figure would cover 12 meetings. The grant group archives show that it held only four meetings during the current fiscal year.

Another big jump will be seen in spending for information technology, particularly for the grant management system, which CIRM has been doggedly wrestling with for several years. Spending in that area will rise 53 percent, from $817,000 to $1.2 million, an increase of about $433,000.

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

CIRM's spending plans (see here for all the budget documents) will be considered today by the directors' Finance Subcommittee in a scheduled one-hour teleconference meeting that has public locations in Cornelius, N.C, San Francisco(2), Los Angeles, San Diego, Stanford, Irvine and La Jolla.

At a San Diego meeting beginning on Tuesday, the full board is expected to approve the budget with no major changes. Teleconference locations for the public are available in Washington, D.C., and the City of Hope in Duarte, Ca.

Out-of-state locations are provided for directors who cannot attend the meetings in person, but the sites are public by law.

The full board meeting can also be heard on the Internet. Instructions for dialing in can be found on the agenda. Addresses of teleconference locations are also on the agenda, but some are so vague that you should call CIRM in advance for additional directions.

More Grant Appeals Filed: Yamanaka Invoked

The California stem cell agency has set another benchmark, although this is one that it may not want to trot out at international stem cell gatherings.

Eight scientists whose applications were rejected for funding by the CIRM grants working group and scientific reviewers are seeking to overturn those decisions at the agency's board meeting in San Diego on Tuesday.

It is the largest number of “extraordinary petitions” ever filed and amounts to more than one out of every four applications that were turned down. The total number of applications received was 44. Fifteen were approved. Some of the researchers are likely to appear at the board meeting and make a personal pitch.

The CIRM board has budgeted $30 million for this round of grants. Regardless of the actions by the grant review group, the board can do whatever it wants with the applications, including rejecting all 44.

The board, however, almost never rejects a positive decision by reviewers and rarely overturns the judgment of the scientific reviewers who evaluate the applications during closed-door sessions.

Yesterday we carried an item on the six scientists who had filed petitions at that point. Today CIRM posted two more petitions. They are from Husein Hadeiba of the Palo Alto Institute for Research and Education, Inc.(see petition here) and Joseph Wu of Stanford(see petition here). Both focused on scientific criticism offered in the review summaries. (All the summaries can be found here. Individual reviews can be found by clicking on the number of the grant.)

In support of his appeal, Wu cited remarks this week in San Francisco by Shinya Yamanaka, winner of the prestigious Kyoto Award, also this week. Referring to criticism of his application as having an “unclear rationale,” Wu wrote,

“We believe the 'unclear rationale' is actually a 'clear rationale' and is being adopted by iPS cell pioneers such as Shinya Yamanaka and his whole team in Japan.”

We also should note that the agency seems to be moving more quickly to post these petitions, a definite improvement over past efforts.

(Editor's note: An earlier version of this item incorrectly said the applications totalled 45 and that 16 were approved.) 

Tracking the Wild CIRM

Looking for more on the history of the California stem cell agency?

Here are two Internet sites – other than our particular collection here on the California Stem Cell Report -- that collect stories on California stem cell events that have occurred since Prop. 71 was passed in 2004

The first is on Sfgate.com and includes a variety of stories and video.

The second is healthvote.org. It carries a great deal of material, including TV ads from the campaign. Its news watch feature is useful but not up to date and not complete. Here is the "check up" segment that includes an article that addresses the question of “what has happened since the election?”

Incident at the Marriott: Stem Cell Agency Bars Public From Meeting

The California stem cell agency barred two academics from entering one of its conferences earlier this week in San Francisco.

The action appears to violate the spirit and probably the letter of the California State Constitution and state open meeting laws. Under section three of the constitution, approved by 83 percent of voters in 2004, members of the public have a broadly construed right of access to what their government is doing. That includes meetings at San Francisco hotels.

The incident involves Tina Stevens of San Francisco State University and and Diane Beeson of California State University, Hayward. Stevens is executive director of the Alliance for Humane Biotech. Beeson is on the board of directors – none of which has to do with whether they should have access. The law entitles the lowliest worker an equal right to government access.

Here is the account that Stevens and Beeson sent to the California Stem Cell Report.

“On Monday, June 14 we went to San Francisco's Sutter Street Marriot Hotel to attend the CIRM - Medical Research Council Human SCNT Workshop. Both academics with long-standing interests in women's health and research policy, we were heading for the session on, 'Procurement of Human Oocytes: What has been the Experience to Date?' Despite the fact that there was no public notice of an upcoming workshop on a topic of sustained interest to women's health advocacy groups, we heard about it via the grapevine and decided to attend. But upon arrival, we were barred at the door. The session on egg procurement had been switched to an earlier morning time slot and already had taken place, we were told. Our printed agenda was outdated. Further, we would not be granted entrance to the meeting underway. Why? It was closed to the public because conferees maintain concerns over protecting their intellectual property. Questions remain. What intellectual property concerns could there be over oocyte procurement policy? Why was the agenda switched up? Why wasn't a workshop concerning egg donation posted on the CIRM website in the first place when the topic is known to be of serious concern to the public, especially to women's health advocates?

“Outside the conference room, hotel staff bustled over luncheon preparations: plump rolls, dome-covered serving dishes and stacks of shiny crockery near folded cloth napkins, multiple gleaming beverage urns. California can't muster tax dollars to fund classes for students at public universities but has managed to finance posh buffets for scientists who've prioritized safeguarding their intellectual property over the public's right to know.”

We sent a copy of their account to Don Gibbons, chief communications officer for CIRM. Here is his response:

“All of CIRM's scientific workshops are by invitation only. These workshops are designed to gather information for critical decisions regarding the direction our funding should take. In order to get the latest, most up-to-date information, we have to assure scientists that their proprietary and unpublished information will not be made public. The workshop this week was not on egg donation, it was on nuclear transfer research and whether or not CIRM should continue to consider funding projects in that field or whether other technologies had made the pursuit of this difficult science no longer necessary. As always, we will be publishing a report from the workshop on our web site.

“The women who wrote to you were not told to leave, they were asked to wait until the staff member managing the event could get one of the senior staff to talk to them. They were asked for their names or IDs so she could inform us of who was making the request and they refused to provide any names or identification.

“Our lunch was simple chicken, tofu with carrots and plain steamed rice. We were offered coffee, tea and water. Hardly posh. When you are asking folks to work for you for free and take a very short lunch break it seems reasonable.”

Our take: We have written more than once concerning problems with CIRM's lack of openness. We have commented on the rampant conflict of interest issues at the agency and its lack of accountability, along with its move towards increasing closeness to the biotech industry. All of which go to CIRM's credibility and the public's trust in the agency. This lastest incident appears to be another case that does not reflect well on CIRM.

CIRM says the meeting was aimed at securing “information for critical decisions” about how it is going to spend taxpayers' money. That subject would certainly seem to be a matter of considerable public interest and justify a public need to know. As for asking for identification, that appears to be a clear violation of state law. The state attorney general's guide to California's open meeting law says agencies covered by the act are barred from imposing “ANY CONDITIONS” on attendance at a meeting.

As for the need to protect intellectual property, proprietary or unpublished information, that claim is simply poppycock. CIRM has not disclosed how many persons were in the closed-door meeting, but it is impossible to keep information secret when even more than a handful of persons is present, and most likely not even then.

Prop. 71, approved by 59 percent of voters in 2004, exempted CIRM from some aspects of the state's sunshine laws. It is not clear whether those exemptions apply in this case. But the state Constitution (section three) was also changed by voters in 2004 to guarantee the right of the public to access. That change was approved by a much larger vote (89 percent) than Prop. 71. It is our understanding that if conflicts exist in such cases, the measure with the larger vote takes precedence.

Legalities aside, it is not in CIRM's best interest to bar persons from any of its sessions – not to mention that it is not in the best interests of the people of California. CIRM needs to do more than meet the minimum standards of the state's sunshine laws. To fail to do so will create a record that will surely harm CIRM's public support and hamper its efforts to secure more funding after it runs out of the $2 billion it has left to spend.