CIRM Schedules Action on New Directions for May

Directors of the California stem cell agency last week curtailed discussion of recommendations for changes in the agency's direction, including stronger ties with the biotech industry, putting off the matters until their May meeting.

At last Thursday's meeting, CIRM President Alan Trounson quickly ran through his agency's response to the proposals last fall from a blue-ribbon panel commissioned by the agency. But other matters, including selection of a new chair, occupied the board's time.

CIRM's staff response to the commission did not contain specific implementation plans and was vague on some of the matters.

Art Torres, co-vice chair of the CIRM board, told directors that he would like to see directors vote specifically on the staff proposals regarding CIRM's international leadership role, improvement of communications and PR and movement away from traditional funding models (responses 3, 5 and 7 in the CIRM memo).

Director Jeff Sheehy, a communications manager at UC San Francisco, asked the CIRM staff to provide in May a "clear implementation path" for its proposals, including specific actions that the staff would like the board to take.

The recommendations will affect how CIRM allocates its remaining cash, including support for basic research versus grants and loans for efforts more focused on producing clinical therapies. The proposals could mean putting more cash behind research before the results have been "written up," in Trounson's words. The staff recommendations also could mean more cash for biotech firms, including grant rounds that would be limited to business applicants.

Commenting on involvement of biotech companies with CIRM, Trounson said,

"Companies sometimes don't know we are in this space. They all don't read our web site avidly."

He added,

"Clearly we're not meeting their needs."

CIRM Directors Move to Alter Role of Chair of $3 Billion Stem Cell Program

Directors of the California stem cell agency, in sharply divided moves, today said that its next chairman should serve in a part-time capacity in largely an oversight role.

The board's actions are aimed at giving guidance to four elected state officials who have the authority to nominate persons for the job, which carries a salary that can reach as high as $500,000 for fulltime work. The moves are the latest effort by the board to deal with top-level management issues that have troubled the agency since its inception.

In a 17-5 vote, the 29-member board approved a motion designating the position as parttime with the "best assessment" that it needed only a 50 percent to 80 percent time commitment, depending on the candidates.

On an 11-8 vote with three abstentions, the board approved a motion indicating that the new chair would fill more of an oversight role with the board delineating the responsibilities of the chair and president. The state's top fiscal officer, Controller John Chiang, warned yesterday that the current co-executive situation "severely compromises" accountability at CIRM.

The board hopes to elect a new chair perhaps as early as May but possibly in June to replace Robert Klein, whose term has expired.

Finding a replacement roiled the board last fall. Discussion was also vigorous today during the debate over the role of the chair – an issue that has troubled CIRM since its earliest days. Prop. 71, which created CIRM in 2004, established a dual executive situation that has created friction and still troubles the agency today, CIRM President Alan Trounson acknowledged during today's meeting.

Duane Roth, co-vice chair of the board and a San Diego businessman, noted the longstanding problem
He said,

"This has been flagged...as something we need to get fixed."

Director Claire Pomeroy, dean of the UC Davis School of Medicine, said that CIRM has evolved to the point that the board must ensure that the staff is respected and allowed to run the organization. She said,

"We should empower them to go and do their job without the micromanagement of our board."

She said the public understands that CIRM has not been optimally functional because of the "lack of clarity" between the roles of the chair and the president.

Art Torres, co-vice chair of the board and a fomer state legislator, also warned that the nominating state officials – governor, treasurer, controller and lieutenant governor – may well find themselves hard pressed to nominate someone for a $500,000 state job as the state faces a financial crisis.

Some board members offered suggestions that the time commitment range be altered to 20 to 80 percent or from 20 to 100 percent but those proposals did not win sufficient support.

The board also recommended additional criteria for the position that included "experience with advocacy, proven vision and leadership abilities, and prior scientific understanding and experience with governance."

The board 's timetable calls for nominations from the officials by April 11 with public presentations by candidates at the May board meeting.

Here is the text of the successful motion by Director Jeff Sheehy, a communications manager at UC San Francisco on the role of the chair.

"The Governance Subcommittee recommends that the board clearly delineate the discrete responsibilities of the chair, vice chairs and president, and that the chair and vice chairs lead a robust oversight effort, including taking advantage of the skills of the board members in conducting their oversight role, and if the chair and vice chairs possess expertise in the areas of responsibility assigned to the chair in Proposition 71, then the board may elect to take advantage of their expertise operationally in those areas as well."

Here is a link to the CIRM press release that deals with the succession issue and other matters at today's meeting.

Stem Cell Directors Adjourn Meeting

CIRM directors have concluded their meeting. We will have a story coming up shortly on action dealing with the selection of a new chair.

CIRM Directors Taking Up Chair Selection

The governing board of the California stem cell agency has resumed its session with a discussion of the selection of a new chair.

California to Partner with AlphaMed on Stem Cell Research Journal

A $600,000 venture into scientific publishing with a North Carolina firm today received the go-ahead from the governing board of the California stem cell agency.

Anthony Atala

The endeavor with AlphaMed Press of Durham, N.C., is expected to focus on translational aspects of stem cell research. The research journal would operate independently of CIRM and have a $1 million annual budget. CIRM would contribute $200,000 of that for each of three years.

Some members of the CIRM board expressed a desire for assurances that the journal would publish "negative" findings, which they said some journals are loath to do. Director Philip Pizzo, dean of the Stanford School of Medicine, said commercial interests have actively moved to suppress the publication of negative findings. Pizzo had high praise, however, for the new journal's editor, Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine.

A CIRM staff memo said that the AlphaMed had agreed to publish negative results, but the matter is expected to be brought up at the May CIRM board meeting. That raises the possibility that a final contract with AlphaMed may be delayed, although that issue was not discussed at the board meeting.

CIRM President Alan Trounson said AlphaMed currently has an office in Palo Alto and plans to expand it.

Lunch Break for CIRM Board

The governing board of the California stem cell agency is on a lunch break/executive session. Still to come today is action on the selection process for a person to replace Robert Klein as chairman of the enterprise.

CIRM Board Reverses Initial Rejection on $1.8 Million Grant

A UCLA stem cell researcher today won approval of an $1.8 million grant when directors of the California stem cell agency overturned an initial, negative decision by grant reviewers.

The proposal by Martin G. Martin deals with inherited diarrheal disorders. In January, Martin appealed the rejection by reviewers, and the board sent the proposal back to the grant panel. CIRM staff reported that reviewers changed their position in light of additional information.

The board recently altered its appeals procedures to facilitate sending applications back to reviewers when directors need more information when acting on appeals.

World Stem Cell Summit Garners Support from State Stem Cell Agency

The California stem cell agency board today approved $125,000 to send as many 125 persons to the World Stem Cell Summit in Pasadena in October.

Up to 75 would be patient advocates, a group that will be key in drumming up support for a new $3 billion to $5 billion bond ballot measure that has been proposed by by CIRM Chairman Robert Klein. The other 50 would be researchers and others involved in CIRM grant programs. The subsidies would be paid with funds donated to the agency by private parties.

The stem cell meeting is sponsored by a stem cell advocacy organization, the Genetics Policy Institute.

Board members raised questions about the cost of the registration -- $495 -- at the convention. They also asked whether any speakers or parts of the program would be controlled by industry sponsors. A representative of the convention said sponsors cannot "pay to play."

During the board discussion, CIRM staff disclosed that the agency also expected to receive a request for a $50,000 conference grant to support the meeting from Caltech, one of the convention sponsors.

San Leandro Law Firm Awarded $700,000 by California Stem Cell Agency

The California stem cell agency today approved on a voice vote a 32 percent increase($160,000) in fees this year for Remcho, Johansen & Purcell of San Leandro, Ca., for its work as outside counsel for the agency. Also approved was a $545,000 contract for 2011-12.

The firm, principally through James Harrison, has represented CIRM since 2004. Harrison is one of the five attorneys who drafted the ballot initiative that created the agency. A CIRM memo said the $350 per hour rates for partners and $265 per hour rates for associates at the firm are "significantly lower than the market rates for firms with similar expertise."

The memo presented to the board today did not explain why additional funds were needed this year. Nor did it give provide an overall figure for the current contract. A CIRM document from last June reported that Remcho was slated originally to be paid $475,000 this year.

CIRM staff reported the $475,000 figure during the meeting after being asked for it by Director Ted Love, a biotech industry executive. The board was also told that an increased workload generated the need for the 32 percent increase in the Remcho contract this year.

Another $22 Million to Go to 17 California Stem Cell Research Institutions

Directors of the California stem cell agency today approved a $22 million extension of the $50 million shared lab program that was scheduled to expire in 2012.

CIRM said the programs at 17 research institutions are a "valuable resource." A CIRM memo declared,

"These labs provide dedicated (safe harbor) research space, specialized instrumentation, a supply of cell lines and culture materials, and stem cell expertise. Additionally, they supply instruction and training in cutting-edge methods both as formally offered courses and one-on-one, customized instruction. This training function extends to the CIRM Bridges programs that rely on the Shared Labs to provide basic stem cell techniques courses for Bridges trainees. Furthermore, the Shared Labs serve as foci for collaboration, networking, and information exchange for stem cell research communities at the various institutions."

CIRM staff said CIRM funds cover about 20 to 25 percent of the cost of running the labs.

Duane Roth, a San Diego businessman and co-vice chairman of the CIRM board, raised a question about whether the productivity of each shared lab was evaluated as part of the proposal. The answer was no. Subsequently, the board directed the staff to provide such evaluations in the future.

Roth noted that CIRM's external review panel has recommended that the agency should focus on funding only the best programs.

The CIRM board has 29 members but only eight in attendance today could vote on the extension. The others had connections to the grant recipients that created a legal conflict of interest.

CIRM Directors Begin Business Meeting

Directors of the California stem cell agency have settled into their business session with action scheduled today on approval of a once-rejected $1.8 million grant by a UCLA researcher and a closed-door meeting on CIRM's first-ever involvement in clinical trials, a $50 million loan round for stem cell companies. Geron and Advanced Cell Technology are likely to be among the applicants. 

CIRM Directors Begin Business Meeting

Directors of the California stem cell agency have settled into their business session with action scheduled today on approval a once-rejected $1.8 million grant by a UCLA researcher and a closed-door meeting on CIRM's first-ever involvement in clinical trials, a $50 million loan round for stem cell companies. Geron and Advanced Cell Technology are likely to be among the applicants. 

CIRM Chair Should Back Away from Management Role, Says Top State Official

The board of the $3 billion California stem cell agency should direct its chairman to step aside from management of the organization and concentrate on oversight, it was told this morning.

In remarks prepared for delivery at the directors' meeting in Burlingame, Ruth Holton-Hodson, a representative of California's top fiscal officer, said,

"Frankly, it is difficult to uphold the appearance of accountability and objectivity when the board chair is involved in both management and oversight of CIRM's operations. Under the current model, the chair is essentially responsible for evaluating and approving much of his own work."

Holton-Hodson, deputy state controller, spoke on behalf of state Controller John Chiang. He is one of four statewide elected officials who can nominate candidates for chair of CIRM. He is also chair of the only state body charged specifically with financial oversight of the stem cell agency.

Holton-Hodson reiterated a number of points made by Chiang in his letter to the board yesterday. She said,

"It is also important to keep in mind that the chair is but one member of the ICOC Governing Board(the CIRM board of directors). Good governance must rely on the actions of the whole board, not a single member. As CIRM moves into the next phase, it is important that it be driven by a fully engaged oversight board, rather than a single individual, regardless of how talented that individual may be.

"As the Controller stated in his letter, CalPERS and CalSTRS (the state's mammoth retirement systems) both have a policy of voting in support of shareholder resolutions that separate the chair and the CEO of corporate boards because board independence is at the heart of effective governance and accountability. The public deserves no less from publicly-funded agencies and undoubtedly thought that independent oversight is what they would be getting from a body named the Independent Citizens' Oversight Committee(the formal name of the CIRM governing board)."

Later today the board is expected to discuss the selection of a person to replace Robert Klein, whose term has expired as chair.

Stem Cell Directors Conclude Cardiovascular Session

The briefing on cardiovascular disease for directors of the California stem cell agency has concluded. The governing board  is expected to convene shortly to deal with other matters, ranging from selection of a new chair to a $125,000 program to send patient advocates to the World Stem Cell Stem Summit in Pasadena.

CIRM Directors Begin Meeting Today

Directors of the California stem cell agency have begun their session today with a briefing on cardiovascular disease. The actual business meeting will probably begin in roughly 45 minutes although the agenda had called for a start time of 9 a.m. PST.

The meeting can be heard via an Internet audiocast. Instructions for the audiocast can be found on the agenda. The California Stem Cell Report will provide ongoing reports today on the meeting as warranted.

Upcoming Coverage this Morning of CIRM Board Meeting

We plan to bring our readers live coverage of the meeting today of the board of the California stem cell agency, assuming our Internet connection from Nicaragua holds up. The board is expected to discuss the selection of a new chair and the agency's response to recommendations for closer ties to industry and aggressive outreach for promising research outside of California. Readers can listen to an Internet audiocast of the session, which is scheduled to begin at 9 a.m. PST. Directions for the audiocast can be found on the agenda.

Dual Execs at CIRM Severely Weaken Oversight, CIRM Directors Told

California's top fiscal officer today called on directors of the state's $3 billion stem cell agency to overhaul the role of its chairman, declaring that oversight of the enterprise is "severely compromised" when the chair is part of management.

In a letter to the 29 members of the CIRM board of directors, State Controller John Chiang said,

"It is difficult to uphold the appearance of accountability and objectivity when the board chair is involved in both management and oversight of CIRM's operations. In essence, under the current co-executive model, the chair is responsible for evaluating much of the work of the chair."

CIRM directors meet tomorrow in Burlingame to discuss the selection of a new chair to replace Robert Klein, who is its first and only chairman. Proposition 71, written by Klein and a handful of associates, legally gives the chair overlapping responsibilities with the president, a situation that has created friction in the past. Klein has additionally reached deep into the organization to deal with relatively minor matters.

Chiang said,

"The (directors') most important role – to provide independent oversight of the California Institute for Regenerative Medicine management – is severely compromised when that management includes the (board) chair."

Chiang, a Democrat, is one of four state elected officials who can nominate candidates for chair of CIRM. Chiang is also the head of the only governmental entity specifically charged with financial oversight of the agency. Last fall Chiang nominated Art Torres, co-vice chair of CIRM, to replace Klein, whose term has expired. Torres declined to run following a flap that arose when Klein tried to engineer the selection of his successor.

Chiang noted that principles of good corporate governance call for boards to "be objective and distinct from management."

Chiang continued,

"I understand that part of the concern in moving to an oversight function from the co-executive model is the need for the chair to have expertise in certain areas as bond finance or the process of moving research to commercialization. Corporations and public agencies throughout the nation hire that expertise rather than rely on the chair."

A representative from the controller's office is expected to appear before the CIRM board at its meeting in Burlingame tomorrow. Remote locations in Irvine and two in Los Angeles are available where the public can participate in the meeting. Specific addresses can be found on the agenda. Instructions for listening to the Internet audiocast also can be found on the agenda.

(Ron Leuty of the San Francisco Business Times has also written about Chiang's letter. Leuty's article can be found here.)

California Stem Cell Agency Ventures into Publishing

The California stem cell agency appears ready to partner with the AlphaMed Press of North Carolina to start a new scientific journal dealing with stem cell research and efforts to translate the findings into clinical treatments.

CIRM's venture into publishing comes amid a proliferation of new journals devoted to stem cell research.

CIRM plans to commit $600,000 over a three-year period to kick off the new publication, which would be edited by Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine.

In a memo to the CIRM board, agency president Alan Trounson said competing proposals from Elsevier, one of the larger scientific publishers in the world, and the International Society for Stem Cell Research, were not as good as that offered by AlphaMed, which has published the "Stem Cells" journal for 29 years.

Trounson is currently listed on the AlphaMed web site as a member of its editorial board. Don Gibbons, chief communications officer for CIRM, said in January, however, that Trounson had resigned from the panel.

In an email, Gibbons said,

"Alan has been an editorial board member at 'Cell Stem Cell' and 'Stem Cell.' His role was to peer review articles submitted for publication. He did not receive compensation, expense reimbursement, travel, or any other form of payment from either publisher. There is no conflict of interest under CIRM or state rules. When these two publishers submitted proposals, however, Alan decided to (and did) resign from the editorial boards."

AlphaMed's editorial board also includes a number of CIRM grant recipients.

In an acknowledgement of the difficult scientific publishing environment, Trounson plans to change the original terms of the RFP to stipulate that the journal be self-sustaining in five years instead of three.

Stem cell journals have proliferated in recent years, according to an article Aug. 7, 2010, in "Stem Cell Reviews and Reports." In the piece, Paul Sanberg and Cesar Borlongan, both with the medical school at the University of South Florida, reported on what they called a "rapidly evolving field." They said 18 journals now exist directly focusing on stem cell research and another 16 have "relevant overlaps to stem cell research." They noted that their count is not "exhaustive."

Sanberg and Borlongan wrote,

"With new journal proliferation comes competition. It has recently come to light that publishing stem cell studies has been fierce and sometimes hostile, with allegations of biased reviewers blocking competitors’ novel findings, leading to significant delay in publication or outright rejection (http://news.bbc.co.uk/2/hi/8490291.stm). New stem cell journals and traditional journals must amend their policies to allow more transparent review and editorial decision handling of stem cell and similar cutting edge research. Stem cell research is one of the most entrepreneurial areas of medical science. It is therefore not surprising that entrepreneurial publishers have developed numerous publication outlets for this rapidly expanding field. Ultimately, whether this stem cell journal proliferation continues, and aids the field of stem cells to 'differentiate' into a more mature research arena, will depend on the quality of peer review and science of stem cells."

Trounson's memo to the board did not address the issues raised in the Sanberg-Borlongan article.

He said the new, open-access journal would have full editorial independence, would publish "negative data" and periodic commentaries from CIRM that have been "appropriately" peer reviewed. Funds for the project are included in this year's CIRM budget. Trounson earlier said that new journal would help to accelerate the “the entire field as knowledge is aggregated and shared more readily” and encourage collaboration between stem cell biologists, clinicians and engineers.

The main office for AlphaMed is in Durham, N.C., although it has an office in California, according to Trounson.

Although CIRM is barred from funding research outside of California, CIRM's Gibbons said,

"Nothing in our statute prevents us from contracting for other services outside of California."

Trounson's memo said the first articles will go online this December with the print publication in January.

His memo appears to be principally an information item for the CIRM board on Thursday. It did not specify what action, if any, was needed by the board to execute the agreement with AlphaMed.

Here are links to the proposals by the three competing organizations.

CIRM Directors Moving on New Chairman and New Directions for Stem Cell Agency

Directors of the California stem cell agency are likely to settle this May on a new chairman of the $3 billion enterprise, replacing the man who has been the spirit behind the effort even before it was a gleam in voters' eyes.

The proposed timetable for election of a successor to Robert Klein, the first and only chair of CIRM, will come before directors at their meeting in Burlingame on Thursday.

Also on the agenda are far-reaching recommendations from CIRM management for new directions for the six-year-old, unprecedented state research program.

However, most attention is likely to be focused on the selection of Klein's replacement in a process that is proceeding more openly and orderly than last year's closed-door attempt by Klein to engineer the selection of his successor.

This week Klein offered his own view of the role of the chair in a new memo to board members, arguing for a person who would work on an 80 percent to 100 percent basis, presumably at a salary that could run to $500,000 a year. Klein, a real estate investment banker and lawyer, has worked without salary for most of his six-year term. In December 2008, the board designated his position as 50 percent with a $150,000 salary.

The directors' Governance Subcommittee last month recommended that the new chair work on an 50 to 80 percent basis, which could mean a salary in the range of $137,500 to $400,000. The subcommittee also recommended additional criteria for the new chair, which will come before the board on Thursday. Director Joan Samuelson added her additional thoughts for a global role for CIRM in a memo to the board.

The subcommittee backed away from making an immediate decision on delineation of responsibilities of the chair and president. Under Prop. 71, which created the stem cell research effort, the chair and president have overlapping responsibilities that have created friction in the past and generated criticism from the state's good government agency, the Little Hoover Commission.

Under the proposed timetable for selection of Klein's replacement, the board would provide the nominating state officials (governor, lieutenant governor, treasurer and controller) with recommended criteria, anticipated time commitment and salary range. The officials would be asked to make nominations by April 11. An evaluation subcommittee of directors would then conduct closed-door sessions with candidates. At the May 3-4 board meeting, candidates would make public presentations to directors with a possible final vote following. Klein has said he will serve only until the end of June.

Selection of the new chair will also be influenced by board decisions on implementation of the recommendations of last fall's external review report. Prepared by a blue-ribbon panel, the report recommended improved ties with the biotech industry, expansion of CIRM's international links and a more active role in seeking out promising research areas.

Some industry executives have been been critical of CIRM. Biotech businesses have received a tiny fraction of the $1.1 billion handed out so far by the agency.

CIRM management's response to the external report called for closer ties with industry, including formation of a special advisory panel and possibly twice-a-year RFAs specifically targeting industry. Management also proposed that some translational RFAs could require partnerships between academia and industry.

The management response additionally recommended reaching out to involve research elsewhere in the country. The 12-page memo said,

"When entities with promising new developments outside California are identified, CIRM will encourage them to partner with California institutions and apply to general or specific RFAs. The challenge is to find ways to pull projects under CIRM’s umbrella while staying within the spirit and regulations that govern the Institute."

Some of the management language in its memo is tentative, rather than flatly declaring that this or that task should be done, and does not require up or down votes by the board, if any votes are required at all. How the board responds to those suggestions will be critical in shaping future CIRM action.

The external review report also recommended clearer delineation of the responsibilities of the chair and president. The management memo appeared to agree but made no specific suggestions.

The blue-ribbon report recommended improvement in public awareness of the agency and its work. In response, the management memo, among other things, recommended hiring a public communications officer in the office of the chair, who would presumably operate independently from the current communications staff, which is under the president. CIRM already has a large public relations/communications effort, including outside consultants.

The management memo mentioned an "office of science education and communication" within CIRM that would enhance its public relations efforts. The memo said,

"The amount of effort required to produce continually renewed content cannot be under estimated."

In addition to the Burlingame location, the public can participate in the directors meeting at locations in Irvine and Los Angeles. Specific addresses can be found on the agenda. The meeting is also expected to be audiocast on the Internet.

Passage to Panama

We were remiss in not alerting our faithful and not-so-faithful readers earlier that we have begun a passage to Panama from El Salvador. As many of you know, we live on a sailboat south of the border, with the exception of trips to the Old Country (the U.S.) from time to time. For the last nine months, the boat has been in El Salvador. But the lure of other ports has compelled us to hoist the hook and move on, which meant that we lost regular Internet connections. However, you can expect a spate of fresh items in the upcoming week since we are now in San Juan del Sur in Nicaragua, where cyber cafes seem to be on every corner.