NY Times: CIRM Moves Away From hESC

The New York Times today reported that the California stem cell agency has made a “tacit acknowledgment that the promise of human embryonic stem cells is still far in the future.”

Reporter Andrew Pollack wrote that only 4 of the 14 disease team projects approved by CIRM today involve embryonic stem cells. He said,

"The others will use so-called adult stem cells or conventional drugs intended to kill cancer stem cells, which are thought to give rise to tumors."

Pollack continued,

“The grants thus represent a departure from the program’s original mission. California voters approved the 10-year, $3 billion effort in 2004 largely to get around restrictions on embryonic stem cell research imposed by the administration of President George W. Bush.”

Pollack asked CIRM Chairman Robert Klein about the emphasis on non-hESC projects in the disease team round at news conference today. Klein said that the commitment to voters was to “pursue the very best cell type for each disease.”

Nature magazine also pointed out today that the disease team round involved few grants using hESC.

A Peek at News Coverage of CIRM's $230 Million Disease Team Round

California's stem cell research effort today climbed over the $1 billion mark with its whopping disease team round. The awards began generating news coverage internationally this afternoon, and more stories will surface later today and tomorrow.

Erika Check Hayden filed a report on Nature magazine's breaking news blog. She said CIRM regards the round as the “crown jewel of its portfolio.” She said that some of the grants will go “for therapies that, in some cases, are unlike any ever before approved by the FDA.”

Hayden wrote,

“Only a handful will employ human embryonic stem cells, despite the fact that most of the fanfare surrounding the passage of Proposition 71, the ballot measure that created CIRM, concerned the fact that CIRM would fill the gap left by a lack of federal funding for work on these cells. But Bob Klein, architect of Proposition 71 and chair of CIRM's governing board, said, 'Our commitment to the voters was that we would pursue the very best cell type for each disease based on the scientific and clinical evidence.'"

Rob Waters of Bloomberg emphasized the business aspects and had a separate piece on Sangamo Biosciences of Richmond, Ca., a publicly traded company that shared in a $14.6 million award with City of Hope in Duarte, Ca.

Oddly, the largest newspaper in California, the Los Angeles Times, had not carried a word as of this writing on the roughly $80 million in grants to institutions in the Los Angeles area.

The New York Times may well have story late today or tomorrow. Its Los Angeles-based reporter, Andy Pollack, could be seen on the Webcast of the news conference, asking a question about the slim use of human embryonic stem cells in the disease team grants.

Here are links to other stories:
Thomas Kupper of San Diego Union-Tribune
San Diego News Network
Steven Brown of the San Francisco Business Times
DelMar Times

CIRM News Release: More than $250 Million in Disease Team Round, Including International Partners

The California stem cell agency has posted its press release on the largest research round in its history.

The release notes that, with funding from international partners, the total comes to more than $250 million. The release also contains the identities of all the winning researchers and their institutions.

CIRM News Conference Link

Here is a link to the live news conference on CIRM's $230 million disease team program.

California Stem Cell Agency Approves $230 Million Aimed at Clinical Trials

The California stem cell agency today formally awarded $230 million to 14 teams of scientists in the largest and most ambitious round of research grants in CIRM history.

Already the world's largest source of funding for human embryonic stem cell research, the $3 billion agency said the grants and loans would lead to the beginning stage of clinical trials in four years.

The disease team round also marks the first foray into what is expected to be a risky, $500 million loan program for the biotech industry. The round is additionally a critical step in building support for continued funding of the agency, which will lose the ability to finance itself sometime in the next decade.

The goal of the disease team effort is to generate filings to begin a clinical trial within four years or less. That would presumably lead to creation of therapies that could alleviate the suffering of thousands. CIRM could also use the results to ask the legislature or the people of California, by ballot measure, for additional funding.

The disease team round is the first major effort involving international partners, Canada and the United Kingdom. Organizations in those countries are collaborating with California partners and adding many more millions to the research largess.

All of the grants in tier one were approved, although application 1471 had conditions attached because of a change in the employment of a co-PI in the United Kingdom.

Concerns About Size of Disease Team Round

Some CIRM directors seem to be concerned about the overall size of the disease team package and the original budget of $210 million.

There may well be an effort to trim the overall size, which would mean that some grants in tier one are removed. Normally all grants in tier win ultimate approval from directors, but they have the ability to do whatever they want.

City of Hope Wins Initial Appeal

Directors of the California stem cell agency this morning gave a positive nod to an attempt to win approval of an application from the City of Hope in the agency's disease team round.

The board approved, on a unanimous vote, a motion to move the application into the first tier of grants expected to be approved later today.

The grant was proposed by Karen Aboody of City of Hope in Duarte, Ca., to study development of treatments for brain tumors.

Aboody filed an extraordinary petition to overturn a negative decision by CIRM reviewers, who gave the application a score of 43 on a scale of 100.

CIRM Vice Chairman Duane Roth said he would support the grant because information in the review was incorrect. Another director concurred with Roth's comments.

The size of the grant was not immediately available.

(Editor's note: The vote tally is based on votes that were audible on the board Web audiocast. The ultimate figure may vary slightly.)

City of Hope Grant Being Discussed

The CIRM board is now discussing an appeal on a grant proposal by Karen Aboody of the City of Hope.

CIRM Directors Nix Buck Appeal

Directors of the California stem cell agency turned back an attempt to win approval of a $17 million application from the Buck Institute on a stem cell research proposal involving Parkinsons disease.

The board rejected, on a 6-11 vote with one abstention, a motion to move the application into the first tier of grants expected to be approved later today.

The grant was proposed by Xianmin Zeng of Buck and co-PI Mahendra Rao, vice president of Invitrogen and former head of the stem cell group at National Institute of Aging.

Scientific reviewers gave the application a score of 53 and did not recommend it for funding.

Zeng filed an “extraordinary petition” and personally appeared before the board this morning. She said the criticisms by reviewers were minor or technical and have already been addressed or are being addressed.

The motion to move ahead on the grant was offered by CIRM Director Joan Samuelson, who has Parkinsons.

(Editor's note: The vote tally is based on votes that were audible on the board Web audiocast. The ultimate figure may vary slightly.)

Buck Institute Application Being Discussed

The board of the California stem cell agency has resumed its discussion of disease team grants and loans. Currently it is considering an effort by Xianmin Zeng of the Buck Institute for Age Research to overturn a negative decision on her application by science reviewers.

Looking at CIRM Grant Appeals Issues

Here are links to documents relating to the California stem cell agency and complaints about fairness in its grant review process.

Text of CIRM policy on appeals via "extraordinary petition."

An October 2008 examination of transparency and conflict of interest issues

Consumer Watchdog Identifies Businesses Rejected for CIRM Grants

First ever successful conflict appeal, December 2008

CIRM's August 2008 proposal for a reconsideration procedure

Transcript of August 2008 CIRM Meeting

Proposal by CIRM Director Jeff Sheehy on grant appeals, July 2008.

First mainstream media article ( July 2008) about complaints about fairness in CIRM grant-making

Cascade LifeSciences Seeks Reconsideration

Text of Cascade's Reconsideration Letter

CIRM Response to Cascade

Transcript of June 2008 CIRM Meeting Involving Cascade

Transcript of the January 2008 CIRM directors meeting, which heard the first public appeal of a scientific review. Search on the term "luben," which is the misspelling of the name of Bertram Lubin, president of Childrens Hospital Oakland Research Institute, who appeared before the directors seeking reconsideration.

Nature magazine article April 30, 2008, in which Lubin comments on CIRM

California Stem Cell Report account of part of the January meeting involving the Lubin appeal.

Weissman's $20 Million Proposal Dodges Rejection

A $20 million grant application from reknown scientist Irv Weissman of Stanford tonight avoided disaster as CIRM directors overturned a decision by scientific reviewers to reject the proposal.

The application was moved, 14-2 vote with two directors abstaining, into the top tier of disease team grants that are headed for approval by the directors tomorrow morning.

Another $20 million application from Stanford's Gary Steinberg was also moved into the first tier on a separate vote, which was either 13-3 or 12-4. One director's vote was inaudible on the Web audiocast.

The Steinberg and Weissman applications bring to 13 the number of grants in the first tier for a total of $207 million. That is just under the $210 million budgeted for the disease team effort, the largest research grant round in CIRM history.

Both applications were the subject of an “extraordinary petition,” along with four other applications. One of those efforts was not successful tonight. No director made a motion to move a $12 million proposal by Aileen Anderson of UC Irvine to the first tier.

(Weissman's petition can be found here, Steinberg's here, Anderson's here. The other petitions are from Judith Shizuru of Stanford(here), Karen S. Aboody of the City of Hope(here) in Duarte, Ca., and Xianmin Zeng of the Buck Institute(here) in Novato, a town north of of San Francisco.)

The directors have recessed until tomorrow morning. They did not take up the other petitions tonight as they worked their way through the grants that CIRM's grant reviewers said were not worthy of funding. Weissman's application received a scientific score of 65, below the cutoff line of 70. Steinberg's and Anderson's scores were not available.

Regarding the Weissman application, CIRM Chairman Robert Klein said some of the reviewers may have been less than objective because they do not believe that cancer stem cells exist. The subject is a matter of some scientific dispute. CIRM President Alan Trounson disagreed with Klein on the possibility of prejudice but said that the grant could be worthy of funding.

Director Ted Love, who served as CIRM's chief scientific officer during the review, said the board could feel comfortable funding the grant or not. He said he did not think it would be “unwise” to fund the application.

Weissman's name was not mentioned during the discussion, but some commented about respect for the principal investigator. The United Kingdom is also involved in the grant, providing an additional $4.3 million, according to Trounson.

The board is scheduled to resume deliberations at 8:30 a.m. PDT tomorrow in Los Angeles. CIRM has scheduled an 11 a.m. news conference to formally announce the grant winners. The meeting will be audiocast on the Web. Directions for listening are on the agenda.

Correction

The “public appeal” item on Oct. 27, 2009, incorrectly said that extraordinary petitions filed by six grant applicants were not available on the CIRM Web site. The petitions were not noted on the CIRM board agenda but could be found three layers down on six of the 20 summaries of the grants rejected by reviewers.

Weissman's Grant and Appeal Now Being Discussed

Currently being discussed by the CIRM board is a rejected grant (1485) by noted Stanford scientist Irv Weissman.

Advisory

The meeting of the California stem cell agency board has resumed with much improved clarity. Up for discussion are the $167 million in disease team grants and loans.

Six Rejected Grant Applicants Make Public Appeal to CIRM Board

Six research teams that lost out in CIRM's closed door reviews of their applications for up to $20 million dollars are now seeking to overturn the decisions.

The rejected applicants include three from Stanford(Irv Weissman, Judith Shizuru and Gary Steinberg), one from the City of Hope (Karen S. Aboody) in Duarte, Ca., one from UC Irvine(Aileen Anderson) and one from the Buck Institute(Xianmin Zeng) in Novato, a town north of of San Francisco.

Their “extraordinary petitions” are not yet available on the board's agenda, but their existence was confirmed by John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca. Simpson was attending the meeting in Los Angeles and supplied the applicants' identities from CIRM documents available at the session.

We queried him about the petitions after hearing a partial comment on the Web audiocast of the meeting, which has been largely muddled at our location in Mazatlan.

Simpson also said that one key board member told him that the six petitions raise “substantive scientific issues.” The efforts to overturn the negative results raise some other interesting issues because CIRM budgeted $210 million for the disease team grant round while reviewers only approved $167 million.

The extraordinary petition process is relatively new at CIRM. It was created in September 2008 in response to public appearances by rejected applicants at CIRM board meetings. None have been successful using that method and none have been successful in using the extraordinary petition process.

A number of board members have been clearly uncomfortable with the public presentations by unhappy applicants. They have also been loath to overturn the decisions of the Grants Working Group and the scientists who are members of it.

The issue bubbled up in June 2008, leading to an extended public board discussion of the appeal or reconsideration process. CIRM allows "appeals" only in the case of conflicts of interest on the part of reviewers. However, reviewers do not have to publicly disclose their economic or professional interests.

The extraordinary petition process requires the applicant to file a request for reconsideration five days prior to a directors meeting. CIRM's president will then evaluate it and make a finding on whether it has merit.

Here is an account of how the petition process worked last January.

(Editor's note: An earlier version of this item incorrectly said the petitions were not available on the CIRM Web site.)

CIRM Board Recesses for Confidential Grant Review

Directors of the California stem cell agency have gone into executive session to discuss confidential information related to applications for $167 million grants and loans in the agency's disease team round.

The CIRM board moved into closed door discussions tonight shortly after the CIRM staff presented a brief overview of the round. It is not clear when the board will return to open session.

The agency has called a news conference for 11 a.m. PDT tomorrow to formally announce the awards and publicly identify the winners.

Advisory

If you are having difficulty hearing the audiocast of the meeting of the CIRM board, so are we. We are told that they are working on improving the quality.

Trounson's Report to Directors Posted by CIRM

The California stem cell agency has posted the slides that its president, Alan Trounson, will use to brief directors this afternoon on the state of CIRM.

They include his assessment and summary of recent stem cell research worldwide, his priorities and upcoming rounds for new grants.

Also on tap is a briefing by Geoff Lomax, senior officer for medical and ethical standards, on CIRM's Compliance Program. It is a presentation that CIRM grant recipients and their allied institutions should pay close attention to.

CIRM is expected to have about $1 billion in grants in place by the end of this week. Close monitoring of that cash and the performance of the recipient institutions and scientists is critical to CIRM's credibility.

Brighter Financial Outlook for CIRM

The California stem cell agency began 2009 with an alarming and surprising report about its financial condition. Today the picture is much brighter.

John Robson, vice president for CIRM operations, is scheduled to brief the agency's directors this afternoon about the current state of CIRM finances.

His best news will be about the $118 million CIRM received from the recent California bond sale. The cash will provide funding up to about June of 2011. Unless something truly catastrophic happens, California is likely to sell billions in more bonds between now and then, some of which will keep CIRM research funds flowing.

In response to a query, Don Gibbons, CIRM's chief communications officer, also told us a few days ago that $14.8 million of previous CIRM(state) debt has been reclassified as tax-exempt bonds. That means lower interest costs for the state.

You can find Robson's Power Point presentation (slide 36) here.