Friday, April 30, 2010

Stem Cell Agency Seeking Legislative Removal of 50-person Staff Cap

Directors of the California stem cell agency yesterday decided to work with a state legislator on a proposal that would give CIRM much needed relief from an ill-considered limit that caps the agency's staff at 50.

Previously CIRM was moving towards an effort to kill the legislation, at least for the next year or so, because of other provisions it found less than agreeable.

The cap on CIRM staff was written into law by Prop. 71, which created the $3 billion stem cell research effort in 2004. The limit was an obvious attempt to defuse opposition arguments that the ballot initiative would create another large state bureaucracy. However, in a bit of redundancy, the measure also contained a spending limit on administrative expenses.

The personnel limit left CIRM with a staff about the size of that of a 24/7 Burger King to monitor currently more than 300 researchers and more than $1 billion in grants. Another $2 billion will be going out the door over the next four years or so.

Several months ago, CIRM President Alan Trounson warned directors that the quality of the agency's work could suffer as a result. State Sen. Elaine Kontaminas Alquist, D-San Jose, subsequently introduced legislation aimed at reforming CIRM and ensuring affordable access to taxpayer-financed therapies. The bill, SB1064, also would eliminate the 50 person cap.

Yesterday's action by directors marks the first time that CIRM has moved from adamant and successful opposition to any legislation that would change Prop. 71. The agency has had a sometimes stormy relationship with some lawmakers (see here, here and here) but has gradually moved away from abrasive tactics.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., praised CIRM's new position. In an email, he said,
"Instead of the usual stiff arm extended toward the Legislature from within circled wagons, Art Torres is drawing on his political skills to negotiate a deal that satisfies everyone. It's about time.”
CIRM Vice Chairman Torres, former head of the state Democratic Party and a longtime legislator, told directors that he and others were negotiating with Alquist to come up with legislation that would be acceptable to CIRM and remove the personnel cap. Torres said that he was working to add a provision for compensation for CIRM board members who are patient advocates and who serve on various CIRM working groups. The provision would provide pay for days attending the meetings as well as days preparing for them.

The patient advocate directors, seven in all not counting Torres and Klein, are critical to CIRM's operations because many of the other directors have conflicts of interest that prevent them voting on some matters. Some of the patient advocates, such as UC Regent Sherry Lansing, also have significant conflicts, leaving only about four of five relatively free to vote on almost any matter. The patient advocates, however, can lose salary from their jobs when they take time off for CIRM affairs. Such is not the case with other directors, such as medical school deans and executives, who also have staff that they can use to assist on CIRM matters.

Enactment of a bill is not a foregone conclusion. The CIRM legislation requires a 70 percent vote of both houses of the legislature, an unusual and exceedingly difficult hurdle to clear. It effectively ensures minority control over any changes and was written into Prop. 71 by CIRM Chairman Robert Klein, who plans to step down from his post in December.

It is unclear at this point what other provisions will remain in the bill. Torres said he hopes to conclude negotiations in about three weeks.

Simpson noted Torres' legislative effectiveness and deep contacts in Sacramento. “Kudos to the politically savvy vice chairman,” Simpson said. At the directors meeting yesterday, Torres was careful to note that other directors were involved in lobbying legislators including co-Vice Chair Duane Roth, who has Republican contacts; Lansing, a well-connected former head of a Hollywood studio; Michael Goldberg, a venture capitalist, and Leeza Gibbons, an Alzheimers patient advocate and Hollywood celebrity.

Simpson indirectly noted that salaries at CIRM, among the highest in state government, could provide a public relations problem in the State Capitol, where lawmakers have already made draconian budget cuts. In a reference to Torres' salary, Simpson said, “At $225K a year given the state's financial crisis, they're still paying him too much.”

Our take? We disagree with Simpson about Torres' salary but do think that CIRM salaries, whose range tops out at $508,750 for the CIRM president, pose a perception problem that needs to be carefully handled by CIRM.

Scanty Coverage of CIRM's $28 Million in Grants

The announcement yesterday that the California stem cell agency had given away $28 million for research attracted extremely modest attention in the mainstream media.

Our automated searches turned up only two brief items today: one in the San Francisco Business Times and one on the Orange County Register Internet site. Both focused primarily on the grants in their local areas.

The light coverage was to be expected. CIRM is receiving little media attention, a situation that is likely to continue short of a scandal or major research breakthrough.

Thursday, April 29, 2010

$22 Million for Biology: CIRM Directors OK Two Reviewer-rejected Grants

California stem cell directors today approved more than $22 million in basic biology grants, overturning negative decisions by reviewers on two applications.

The directors ratified all 14 grants supported by reviewers, plus applications from researchers at UC Davis and the Sanford-Burnham Institute in La Jolla. The total was well under the $30 million that CIRM budgeted for the biology grant round.

The Davis grant was the subject of an “extraordinary petition” by its top researchers, Eric Kurzrock and Jan Nolta. They said in their petition that reviewers “simply overlooked important details” and committed “factual errors.” The petition was initially rejected by CIRM staff but the board decided to approve the grant for “programmatic” reasons.

Nolta appeared before the board along with patient advocates, including a tearful mother with an ailing child. Nolta is one of the few researchers who regularly attend CIRM board meetings. Patient advocates also sometimes attend board meetings and speak on behalf of specific grants.

The Nolta grant was approved on an 11-9 vote, but the board cut the amount of the grant by one-third. CIRM listed the grant at nearly $1 million in its news release.

Another extraordinary petition was rejected by the board. It was filed by Edward De Robertis of UCLA, who is also a Howard Hughes Medical Investigator. He appeared personally before the board last night. De Robertis has not been a regular at board meetings. Nor did patient advocates speak on behalf of his research.

CIRM directors also approved a $1.6 million application by Huei-sheng Chen of Sanford-Burnham that reviwers had nixed.

Fourteen of the 16 grants went to institutions that have representatives on the CIRM board. That is in keeping with the pattern over the last five years. More than $900 million out of the $1 billion in grants so far have gone to institutions with links to board members. CIRM directors with conflicts of interest are not allowed to vote on or take part in the discussion about the applications affecting their enterprises.

Of the non-board-connected recipients, one $1.5 million grant went to a business, iPierian, Inc. a South San Francisco biopharmaceutical company, and researcher Barta Strulovici. Another $1.5 million grant went to Tony Wyss-Soray at the Palo Institute for Research and Education, a nonprofit involved with the Veterans Administration system.

CIRM received 154 pre-applications  in this round that were screened by staff and a few outside reviwers. Fifty-seven pre-applicants were invited to make full applications. Fifty-two applications were received and reviewed. Reviewers made positive decisions on 14, which they sent to the board. CIRM did not announce the number of applications received from businesses.

Duke Researcher Wins $6 million Grant From California -- With a Condition

California will give a Duke University cancer stem cell research nearly $6 million if he comes to work in the Golden State at the Sanford-Burnham Institute in La Jolla.

Directors of California's $3 billion stem cell agency, as expected, today approved the research grant for Robert Wechsler-Reya. The grant is the first installment in a $44 million program aimed at luring eight stellar researchers from their posts elsewhere in the country.

Wechsler-Reya's name was not mentioned during the brief discussion of the grant by CIRM directors at their meeting in Los Angeles. But the California Stem Cell Report identified him on Tuesday. CIRM issued a news release today that confirmed our report.

CIRM Chairman Robert Klein indicated that negotiations between Burnham and Wechsler-Reya need to be concluded by the end of June, a stipulation that Burnham has apparently agreed to. Klein said approval of the grant “would be helpful in concluding the relationship.” Burnham is additionally courting Wechsler-Reya's spouse, Tannishtha Reya, another Duke researcher.

CIRM expects to review another round of applications in its recruitment program in July. The agency needs to know whether it has eight or seven grants left to make.

CIRM President Alan Trounson said it was also important to have some diversity in expertise among the scientists who are recruited. In other words, CIRM does not necessarily want to lure only cancer stem cell scientists to the state.

At one point on Tuesday, CIRM's outside counsel, James Harrison, said the grant was being taken off the directors' agenda. His statement followed our item that said Wechsler-Reya had not made a decision about leaving Duke. Later in the day, Harrison said that he made a mistake about the matter.

Burnham will not be eligible for another recruitment grant if the Wechsler-Reya goes through. Each institution is limited to one.

CIRM Directors Meeting Underway

Directors of the California stem cell agency have begun their meeting today. They are currently discussing applications for basic biology grants. Reviewers recommended funding 14 for a total of $19.6 million. Last night directors discussed scores on grants that were not recommended for funding, raising the possibility that some might be funded.

CIRM Receives Another $112 Million

Alan Trounson, president of the California stem cell agency, last night outlined his priorities, provided more details on a key strategic review of its program and sketched out upcoming CIRM events.
Directors were also told that the agency received an additional $112 million as the result of recent California state bond sales. That should ensure CIRM has enough cash to operate until the end of 2011. Bonds are virtually the only source of cash for the agency, but they flow directly to CIRM untouched by the governor or legislature.

CIRM has posted Trounson's slide presentations on its Web site. Also included are biographies of scientists who will participate in the strategic review. You can find Trounson's presentation here, budget information here and the biographies here.

Wednesday, April 28, 2010

California Stem Cell Directors End Public Session Tonight

Directors of the California stem cell agency just concluded their public session tonight without approving any grant applications or taking other significant action. Their session will resume tomorrow morning at the City of Hope in the Los Angeles area. We will have coverage again then.

$5.9 Million Grant to Duke Scientist Moving Forward Again

Directors of the California stem cell agency began a discussion tonight of a $5.9 million grant to help lure a Duke University scientist to California despite a statement earlier today that the matter would not be brought up.

James Harrison, outside counsel to CIRM, this afternoon said in an email that the matter would not be considered. Asked about the change this evening, Harrison replied in an email, “I was wrong! Chalk it up to miscommunication while everyone was in transit.”

CIRM Chairman Robert Klein initiated a staff presentation on the application. Directors discussed it briefly and will discuss it again tomorrow in public after it comes up in an executive session tonight.

The grant is expected to go to Robert Wechsler-Reya to help recruit him to the Sanford-Burnham Institute.

John Reed, CEO of the institute, is a member of the CIRM board of directors. His alternate, who is filling in for him tonight, will not be allowed to participate in the discussion or vote on the grant.

CIRM Directors with Conflicts of Interests on Biology Grants

Here is the list of the CIRM board members scheduled to be recused from voting on or discussing grant applications this evening on which they have conflicts of interest. You can find the review summaries of the grants here. The list was prepared by CIRM legal staff.
CIRM Basic Biology Award II
Application # Members in Conflict
RB2-01494 Feit,Hawgood,Lansing,Sheehy
RB2-01496 Lansing,Levin,Steward
RB2-01497 Brody,Goldberg,Pizzo
RB2-01498 Brody,Goldberg,Pizzo
RB2-01499 Azziz
RB2-01500 Lansing,Penhoet,Price
RB2-01502 Azziz,Lansing,Levey
RB2-01504 Gill,Lansing
RB2-01507 Brody,Goldberg,Pizzo,Pomeroy
RB2-01512 Fontana
RB2-01514 Gill,Lansing
RB2-01523 Azziz,Lansing,Levey
RB2-01526 Feit,Hawgood,Lansing,Sheehy
RB2-01527 Pomeroy
RB2-01530 Brody
RB2-01534 Lansing,Levin,Steward
RB2-01540 Feit,Hawgood,Lansing,Sheehy
RB2-01542 Bloom,Fontana
RB2-01547 Bloom,Gill,Lansing
RB2-01549 Feit,Hawgood,Lansing,Sheehy
RB2-01550 Lansing,Levin,Steward
RB2-01553 Brody,Goldberg,Pizzo
RB2-01562 Azziz,Lansing,Levey
RB2-01566 Brody,Goldberg,Pizzo
RB2-01567 Feit,Lansing,Pomeroy,Prieto
RB2-01571 Azziz,Lansing,Levey
RB2-01577 Lansing,Levin,Steward
RB2-01580 Brody,Feit,Goldberg,Hawgood,Lansing,Pizzo,Sheehy
RB2-01581 Brody,Goldberg,Pizzo
RB2-01585 Gill,Lansing
RB2-01588 Azziz,Lansing,Levey
RB2-01592 Brody,Goldberg,Pizzo
RB2-01597 Feit,Hawgood,Lansing,Sheehy
RB2-01598 Fontana
RB2-01600 Brody,Goldberg,Lansing,Pizzo
RB2-01602 Feit,Hawgood,Lansing,Sheehy
RB2-01603 Lansing
RB2-01608 Feit,Gill,Hawgood,Lansing,Sheehy
RB2-01609 Azziz,Lansing,Levey
RB2-01616 Brody,Goldberg,Pizzo
RB2-01622 Brody
RB2-01627 Lansing,Levin,Steward
RB2-01628 Pomeroy
RB2-01629 Lansing,Levin,Steward
RB2-01630 Brody,Goldberg,Pizzo,Pomeroy
RB2-01637 Brody,Goldberg,Pizzo
RB2-01640 Brody,Goldberg,Pizzo
RB2-01645 Brody,Gill,Lansing
RB2-01646 Bloom,Gill,Lansing

Live Coverage of Today's CIRM Directors Meeting

We will have live coverage and stories as warranted from today and tomorrow's meeting of the CIRM board of directors. We will be listening via the Internet from our post here on the water in El Salvador. The agenda includes $30 million in grants, perhaps reasons for the delay on the Wechsler-Reya grant, changes in outside contracting policies and a vote to stifle legislation that would reform CIRM and ensure the affordability of any taxpayer-financed therapies. The meeting begins at 4 p.m. PDT.

Action Stalled on $5.9 Million CIRM Grant to Recruit Duke Scientist

The California stem cell agency today called an abrupt halt to scheduled approval of a $5.9 million grant to lure a Duke University cancer stem cell researcher to the Sanford-Burnham Institute in La Jolla, Ca.

No reason was immediately offered for the removal of the grant application from the agenda today of the CIRM directors. James Harrison, outside counsel for CIRM, said in an email,
“This item will not be considered at this meeting.”
The CIRM governing board was expected to approve the funding for Robert Wechsler-Reya at their two-day meeting in the Los Angeles area. It would have been the first grant in a $44 million, two-year program to assist California institutions in recruiting top scientists.
Wechsler-Reya and his spouse, Tannishtha Reya, also a Duke stem cell scientist, are both being courted by the Sanford-Burnham.

We are seeking more explanation from CIRM and comment from Wechsler-Reya.

Wechsler-Reya Still Mulling Move to California's Burnham

Cancer stem cell researcher Robert Wechsler-Reya says he has not yet made a decision to leave Duke University and come to California, where he would be the recipient of CIRM's first Research Leadership Award.

Directors of the California stem cell agency today or tomorrow are scheduled to approve a $5.9 million grant for Wechsler-Reya to help lure him and his wife, stem cell scientist Tannishtha Reya, to the Sanford-Burnham Institute in La Jolla, Ca.

The California Stem Cell Report yesterday queried Wechsler-Reya concerning the award. Here is the verbatim text of his response:
“Thanks for your interest in the Leadership award.  I just recently received the news, and am very honored to have been chosen by the CIRM committee as the first recipient of this Award.  The prospect of interacting with the vibrant stem cell community at Sanford-Burnham, and in the broader San Diego area, would be truly unique, and we are really excited about this opportunity. However, as you can imagine, this would be a major move for me and my family, and therefore we plan to take some time to think about it before making a decision.
“In that vein, a couple of suggested corrections to your blog:
“- Since I have not yet decided to leave, I wouldn't say that I'm leaving Duke. ('He is considering leaving Duke' would be more accurate)
“- I'm not sure the first round drew only one applicant; there may have been more applicants, but the committee made only one award
“If you have any other questions, please feel free to contact me.  (I'm giving a talk tomorrow, and out of town until Thursday, so it may take me some time to get back to you).”

Tuesday, April 27, 2010

CIRM Millions To Help Snag Duke star Wechsler-Reya for Burnham

The recipient of CIRM's first Research Leadership Award, with $5.9 million in funding, is Robert Wechsler-Reya (at left) of Duke University, a reliable source said today.

He told the California Stem Cell Report he is considering leaving Duke and joining the Sanford Burnham Institute in La Jolla, Ca., where the CIRM-funded research is expected to be performed. Sanford Burnham is providing “an extremely generous commitment of laboratory space, matching funds for equipment, additional support for relocation and research, and access to excellent core facilities,” CIRM grant reviewers said.

(An earlier version of this item said Wechsler-Reya had decided to leave Duke. After it was published, he said in an email that he had not yet made a decision. CIRM, however, does not fund work performed outside of California.)

The reviewers also said that Sanford Burnham “has committed to recruiting the candidate's spouse(Tannishtha Reya, also at Duke, photo at right), who is an independent stem cell scientist; this represents a particularly beneficial leveraging of award funds.”­

The leadership award program, budgeted for a total of $44 million over two years, is aimed at recruiting top talent to California by means of assisting institutions with financing. The effort's goal is to attract perhaps eight scientists, although the first round this year drew only one applicant.

The stem cell agency has not identified Wechsler-Reya in keeping with its secrecy policy concerning the names of applicants. Directors are expected to approve the grant either tomorrow or Thursday. Then the agency will confirm the name.

John Reed, chief executive of Sanford Burnham, is also a member of the CIRM board of directors. He or his alternate is expected to be recused from both the discussion and voting on the grant for Wechsler-Reya. Reviewers have already approved the grant. CIRM directors almost never overturn positive decisions by reviewers, who conduct their work behind closed doors.

We have queried both researchers concerning the grant and their plans. We will carry their responses verbatim when we receive them. (See the "Still Mulling" item.)

Monday, April 26, 2010

CIRM's Nearly $6 Million Carrot

The California stem cell agency this week is expected to pony up $5.9 million to help lure an unidentified but “emerging leader” in cancer stem cell research to the Golden State.

The multi-year grant is the first in CIRM's fledgling program to assist California institutions with recruiting top talent from elsewhere in the country.

In keeping with its policy of secrecy concerning the names of applicants, the agency did not disclose either the name of the individual or the institution involved. But you can read a summary of reviewer comments here in which they gave the application a score of 83 out of 100.

No other applications were listed in the first round of what CIRM calls its Research Leadership Awards Program. The $44 million, two-year effort is aimed at recruiting top talent – “the most productive and promising early-to-mid career scientists in stem cell biology and regenerative medicine.”

The program stands to benefit some of 14 or so institutions that have representatives (some have more than one) on the 29-member CIRM governing board, which will vote on the application from the researcher Wednesday or Thursday at its meeting in the Los Angeles area. CIRM staff does not reveal the names of the applicant or institution to directors.  If a director has a conflict on an agenda item, he or she is not permitted to vote on the matter or even take part in the discussion. Following the vote, CIRM will disclose the winner in a press release.

The initial response to the recruitment assistance program seems modest, but CIRM is aiming to attract perhaps only eight researchers. And that depends on whether institutions such as the University of California, Salk, Scripps and others can offer up suitable candidates. At one point Kevin Eggan and Amy Wagers, both of Harvard, were identified in stem cell scuttlebutt as possible targets of the recruitment effort. But it is unclear whether they are still in play.

The awards are likely to draw more attention as institutions and potential candidates begin to focus on the largess to be approved later this week.

Sunday, April 25, 2010

Remcho Up for 30 Percent Hike at CIRM; Contracting Changes Also on Table

Directors of the California stem cell agency are being asked this week to approve a 30 percent, $150,000 annual increase in payments to its longtime outside legal counsel, who gives advice on everything from the performance evaluation of the CIRM chairman to pregnancy leave.

The contract with Remcho, Johansen & Purcell of San Leandro, Ca., comes before CIRM directors Wednesday and Thursday at their meeting in the Los Angeles area.

Also on the agenda are revisions in the agency's policies for the outside contractors that are absolutely essential to CIRM's operation. Contracts with outside enterprises total roughly $3 million. Their expenses are the second largest item in CIRM's operational budget.

Documents detailing the Remcho and contract policy moves were posted on the CIRM Web site on Friday, only two business days before the CIRM board meeting.

In the case of Remcho, its man at CIRM is James Harrison, who worked with CIRM Chairman Robert Klein during the Prop. 71 campaign that created CIRM in 2004. Klein, Harrison and a few others wrote the ballot initiative.

Remcho was hired in a no-bid contract after the election. Klein has said that arrangement was approved by the state attorney general because of the specialized nature of Prop. 71.

Remcho currently has a two-year, $1 million contract with CIRM that ends this June. Directors are being asked to add $150,000 this year to the contract and approve a new one for 2010-2011 for $475,000.

CIRM staff prepared a three-page memo detailing the scope of Remcho's work, which includes virtually every piece of the CIRM pie: its finances, $500 million loan biotech industry loan program, contract negotiations, performance evaluation of the chairman and president, preparation of RFAs, contracting policies, legislation and even creation of a pregnancy leave policy.

The memo, however, did not state a reason for the $150,000 increase this year for Remcho nor did it say whether the hike was for work already performed.

Remcho bills CIRM at a rate of $350 an hour for work by its partners and $265 for associates, which CIRM says is significantly discounted. The contract would amount to about 3,100 hours for one partner, roughly a year-and-a-half of fulltime work, assuming a 40-hour week and two weeks vacation.

Directors are additionally being asked to alter their existing contracting policies in a manner that would remove some contracts from their normal oversight. Under the proposed changes, Remcho's contract and others below $600,000 for any single year would not have to be approved by the CIRM board.

New policy language would state:

“When a contract has a duration greater than 12 months, the approval threshold shall be based on the contract amount authorized for the initial year and separately for each subsequent year.”

No justification for the addition of the language was presented by CIRM staff, but it would clarify some ambiguities. It would also give the staff far greater leeway in executing contracts and avoid coming to the board with matters that could be controversial.

Board approval would be required only when the amount of the contract “is expected” to be more than $600,000, instead of the current $500,000. Approval of the directors' Governance Subcommittee would be required when the contract is likely to be more than $300,000 instead of $250,000.

Our take? Harrison performs admirably for CIRM. He is more than competent and nearly unflappable. But the arrangements that led to Remcho's close ties to CIRM, totally acceptable in the world of business, raise persistent concerns involving fairness to other law firms that might bridle at suggestions that they could not perform the lucrative work as well as Remcho. It may be impossible, for all practical purposes, to open the work to others, but directors should recognize the perception problems the contract presents.

As for the changes that would remove some contracts from the directors' approval, they should be rejected. CIRM's unusual dependency on outside help in a business and academic world of competitive secrets plus its need to monitor more than $1 billion in research requires careful and regular oversight by directors.

Thursday, April 22, 2010

CIRM Directors to Hand Out $30 Million and Wrestle with Contracting Policies

Directors of the California stem cell agency meet next Wednesday and Thursday in the Los Angeles area to give away more than $30 million and to make undisclosed changes in its policies for outside contracting, which now run roughly $3 million annually.

CIRM, which is limited by law to only 50 employees, is heavily dependent on outside contractors for everything from public relations to legal advice to federal lobbying. Outside contracts are the second largest item in CIRM's operational budget, behind only its salaries and benefits.

The outside work includes such sensitive matters as computer systems and programs involving proprietary information from grant applicants and recipients and oversight of their performance.

The agenda for next week's meeting contains no information on exactly what contracting changes are being proposed. That is in keeping with CIRM's de facto policy of withholding such details from the public until it is too late for interested parties to comment in a timely fashion. With only three business days remaining before the meeting, CIRM Chairman Robert Klein has released only six words on the proposed changes: “consideration of amendments to contract policy.”

In a related matter, the board will consider the agency's contract with Remcho, Johansen and Purcell of San Leandro, which has served as its primary legal adviser since 2005. Currently it has a two-year, $1 million contract that is scheduled to expire at the end of June. CIRM also withheld information on the Remcho agenda item.

As far as grants go, the board is scheduled to hand out a budgeted $30 million for “basic biology” research and another undisclosed amount for CIRM “research leadership awards.” The latter program is new and is budgeted for $44 million over two years with grants as high as $4.5 million each. The purpose of the program is to assist institutions in luring “paradigm-shifting” scientists to California.

The basic biology round is aimed at both business and nonprofit applicants, including proposals with Japanese collaborators.

Here is a link to scores on all the biology grants to be considered next week along with summaries of reviewer comments, although the directors' agenda does not provide a link to the information. (Review summaries could not be found on the CIRM Web site for the researcher recruitment grants.)

Reviewers approved 14 biology grants, including a $1.4 million application with a score of 66. That grant was slotted for approval despite having a lower score than two other grants that scored ahead of it with 71 and 69.

The directors have final legal authority on approval but almost never overturn a favorable decision by scientific reviewers, who operate behind closed doors and do not have to disclose publicly their economic and professional interests.

Concerning the grant with the 66 score, the CIRM review summary said,
“The reviewers acknowledged that the PI is a strong leader in his/her field with an outstanding publication record in high impact journals. They did note, however, a limited experience with hESC or iPSC. While they appreciated the complementary expertise of the collaborators, the reviewers were puzzled by what they perceived to be a lack of engagement with the local community of stem cell scientists at the applicant's institution. The research environment and facilities were considered excellent.”
Under the “programmatic review” section of the summary, CIRM indicated the rationale for approval. CIRM said,
“A reviewer reasoned that this proposal fills a programmatic need in the area of hematopoiesis for CIRM. Though the application was judged risky, the proposal was felt to represent a scientific direction with great potential. The review panel discerned that the benefits of studying RUNX1 in humans warranted the risks and outweighed the concerns over feasibility.”
One scientific reviewer did not participate in the decision because of a publicly undisclosed conflict of interest. He is Ali Brivanlou of the Rockefeller University. The grant review group includes members of the CIRM board who also may vote during the group's review process.

Significantly not on the agenda is an item dealing with compensation for a new vice president of research and development, whom the agency has been seeking since last summer. The matter has been on the table for several past meetings. The absence this time could mean that no further discussion of the matter is required since a person has been hired. If so, look for an announcement next week.

CIRM directors are also expected to seek to stifle the latest legislative attempts to reform CIRM operations, improve its transparency and ensure affordable access to taxpayer-financed therapies. Their strategy is to have the measure, SB1064, sent to interim study, which would shunt the effort aside for a year or so.

The board meeting will be available via the Internet(audio only). The Wednesday meeting will take place in Monrovia at the Doubletree Hotel and Thursday at the City of Hope in Duarte. Instructions for logging into the audiocast can be found on the agenda. If you want to follow the discussion, you may want to have a copy of the agenda and any background material handy for reference.

CIRM Reform Legislation Advances in Senate

Despite industry opposition, legislation aimed at improving transparency and accountability at the $3 billion California stem cell agency easily cleared its first legislative hurdle this month.

The bill, also aimed at ensuring affordability of taxpayer-financed stem cell therapies, was sent to the state Senate Appropriations Committee on a 6-0 vote in the Senate Health Committee, which is chaired by the bill's author, Sen. Elaine Kontominas Alquist, D-San Jose.

The California Healthcare Institute opposed the bill, SB1064. The biomedical industry group said the measure's requirements for affordability would create a “disincentive” to commercialization of therapies and give CIRM less flexibility.

The board of the stem cell agency is expected next week to formally ask that the bill be sent to interim study, which would effectively kill the measure for the next year or so. However, the legislation contains a rather large carrot for the stem cell agency, which is struggling with a legal cap that limits it to only 50 employees to monitor the $1 billion in grants CIRM now has out – not to mention another $2 billion that it intends to give away. The legislation would remove the staff limit, which CIRM President Alan Trounson has said is endangering the quality of CIRM work. A spending limit on administrative expenses would remain in place.

CIRM Chairman Robert Klein and a handful of his associates in 2004 wrote the staff cap into the 10,000-word ballot measure, Prop. 71, that created the agency. It was an obvious ploy to defuse potential opposition arguments that CIRM would become another large government bureaucracy. Klein led the political campaign on behalf of Prop. 71.

Earlier this year, Alquist said that she was introducing the legislation because CIRM is essentially accountable to no one. Her action followed a call by a sister organization to CIRM that urged greater accountability and transparency on the part of the agency, whose 29-member board is packed with representatives of institutions that have received the bulk of the $1 billion given by CIRM.

The sister organization is the Citizens Financial Accountability Oversight Committee and is chaired by state Controller John Chiang, the state's top fiscal officer. Chiang endorsed Alquist's legislation as did the Little Hoover Commission, a state good government agency that studied the stem cell agency. Much of the Alquist legislation is based on the findings of the Hoover Commission.

Among other things, Alquist's bill would eliminate overlapping responsibilities between the CIRM chairman and president, which have been the source of turmoil in the past. It would change the selection process for the chairman and require performance audits of CIRM and its directors. Currently, CIRM operates with unprecedented autonomy in state government. Its finances and budget cannot be touched by the governor or the legislature. Cash flows from state bonds directly to CIRM in an unfettered stream, regardless of the state's financial crisis and severe cut backs elsewhere.

According to the Health Committee staff analysis by Lisa Chan-Sawin, Alquist states that
“while stem cell research is an important and laudable goal, concerns about transparency, accountability and oversight raised by the public, the independent Citizen's Financial Accountability Oversight Committee, the Little Hoover Commission, and the State Controller detract from CIRM's ability to provide grants and loans in the most efficient way. These concerns divert resources and attention from CIRM's ability to maximize voter's investment in stem cell sciences.”

Wednesday, April 21, 2010

Exciting(?) California Stem Cell News Upcoming

Look for fresh items beginning tomorrow on the California Stem Cell Report. We have finished our obeisance to King Neptune with a four-night, nonstop, sleep-deprived passage from Mexico to El Salvador. We are now ensconced in a rustic marina at the mouth of the Estero de Jaltepeque after surfing over the bar this morning in our 39-foot home, the sailing vessel Hopalong.

Friday, April 16, 2010

Off to El Salvador

The California Stem Cell Report, which has been quiet for the past week or so, will also be quiet until late next week. We leave tomorrow morning on a passage to El Salvador from Hualtuco in southern Mexico, roughly a four or five night sailing voyage. We will bring you all the California stem cell news that is fit to print after we drop anchor in Bahia del Sol and catch up on our sleep(sailing 24 hours a day also means standing watch night and day with only two persons aboard).

Friday, April 09, 2010

Knoepfler Blog Added to Links

We are in the midst of cleaning up the aging links that we have posted on the California Stem Cell Report. But first we want to call your attention to a new addition – the Knoepfler Lab Stem Cell Blog.

It is a researcher-oriented blog written by UC Davis Assistant Professor Paul Knoepfler and the folks at his lab. Knoepfler is interested in developing an exchange of information and discussion of issues among researchers, focusing on the science of stem cells. Some of the blog's recent headlines include: "Stem Cell Myths -Part 2- Teratoma are Good," "Stem Cell Banking--how far should we go?" and "What will be the next big news/paper on iPS cells?"

If you have a suggestion for a link to an Internet site dealing with stem cell issues, particularly those related to California, please send your suggestions to

Thursday, April 08, 2010

Latest on New CIRM VP and Compensation

The California stem cell agency could be eyeing the possibility of beefing up non-salary compensation for a new vice president, who it has been seeking to hire since last summer.

The move appears to be in lieu of boosting the existing VP pay range beyond $332,000 and comes as CIRM President Alan Trounson seems to closing in on a candidate. On two recent occasions, the question of compensation for the new VP for research and development has been on the agenda of CIRM directors. In both cases, however, it was removed with no action. CIRM Chairman Robert Klein explained on one occasion that negotiations were not quite at the appropriate stage.

We have reported that directors were expected to be asked to increase the salary to meet the demands of the new VP. Otherwise there would be no reason to place VP compensation before directors. However, Don Gibbons, chief communications officer for CIRM, said in an email:
“You should know that despite your repeated assertions otherwise, there has never been any discussion of exceeding $332,000.”
We then asked Gibbons whether other types of compensation were being considered or the compensation package restructured in some way. Gibbons replied that “parts of compensation packages other than annual salary can require board review,” but did not elaborate.

The salary is touchy politically because California remains in the throes of a financial crisis that has resulted in major cutbacks around the state. CIRM, on the other hand, has not felt the impact because its budget cannot be touched by the governor or the legislature.

John M. Simpson
, stem cell project director for Consumer Watchdog of Santa Monica, Ca., attended the last directors meeting that was scheduled to address the compensation issue. He asked CIRM Chairman Klein about the matter.

According to the meeting transcript, Klein replied:
“We continue to calendar it and will for flexibility in each of our calls until we have gotten to a point that we can make a decision. It provides us the flexibility to consider it. But until we get to the point where we have done all of our due diligence and come to final terms, we're not in a position to take any action if, in fact, action is required. The president has the authority to hire this person. And to the extent that they need any additional approvals from us, we carry that on our agenda. So until we've hired him, we'll continue each time to have it on the agenda because it gives us flexibility.”

Wednesday, April 07, 2010

Geron and ACT Could Apply in $50 Million Clinical Trial Loan Program

Two more potential applicants for the California stem cell agency's $50 million clinical trial program were identified today by Nature Medicine magazine.
In a piece by Christian Torres in its April edition, the magazine indicated that Geron of Menlo Park, Ca., and Advanced Cell Technology of Santa Monica, Ca., may well apply.

Torres wrote:
“Trials must take place in the state to qualify, and only companies or researchers with an investigational new drug (IND) application on file with the US Food and Drug Administration (FDA) are eligible for funding. Currently, that leaves only two known projects in the running: a treatment for spinal cord injury by Menlo Park–based Geron and a therapy for Stargardt’s macular dystrophy, a retinal disease, by Santa Monica–based Advanced Cell Technology.”
Earlier, iPierian, Inc., of South San Francisco was identified as another potential applicant.

The Nature magazine article indirectly raises questions about whether iPierian would be eligible for the loan program. The clinical trial proposal approved by directors last month said that applicants would be required to have an “IND filed by application deadline on the novel cell therapy derived from human pluripotent stem cells proposed for CIRM funding.”

However, during the board discussion, CIRM staff said the filing would be required three weeks prior to the grant review, probably in October. An “active” IND would be required at the time of the notice of award, which typically would be within six months of board approval of the application. CIRM President Alan Trounson would also have the ability to extend that another six months.

(The board discussion can be found beginning on page 41 of the meeting transcript.)

We are querying iPierian about its intentions.

Last month, Trounson said he knew of only three companies that would be in a position to apply for the clinical trials loans.

Torres also interviewed the co-chair of iPierian's scientific advisory board concerning the CIRM program. Torres wrote,
Deepak Srivastava(at right), director of the Gladstone Institute of Cardiovascular Disease in San Francisco(and iPierian's scientific co-chair), says the CIRM announcement is important for academic researchers who 'have faced a major road block with venture capitalists and companies, who find these therapies too risky for their appetite.'

“'With CIRM, we can finally fund this high risk, but necessary, step,' he says.”
The RFA for the clinical trial program is expected to be posted next month, with board approval of one or two applications in December.

Monday, April 05, 2010

Ipierian to Seek Multimillion Clinical Trial Loan from CIRM

One of the handful of companies likely to be eligible for CIRM's ambitious clinical trial loan program has identified itself – iPierian, Inc., of South San Francisco.

According to Ron Leuty of the San Francisco Business Times, the firm will seek funding for possible therapies for Lou Gehrig's disease and spinal muscular atrophy.

Last month, CIRM directors approved the $50 million program, its first venture into clinical trials. The one or two winning applicants could see cash by the end of this year. Directors were told that perhaps only three firms might be eligible to apply. They were not identified at the meeting because that would raise conflict of interest questions. CIRM also does not identify applicants for grants or loans for fear of embarrassing them if they lose their bids for cash.

Leuty wrote about the CIRM clinical trial program on Friday. He quoted John Walker(at left), president of iPierian, as saying that CIRM's assistance fits “very nicely” with the company's plans to generate a therapy candidate within three years.

Ipieran is backed by Kleiner Perkins Caufield and Byers, Highland Capital Partners, FinTech Capital Partners and MPM Capital, which have provided $31.5 million to the firm.

Ipierian came into being last July when iZumiBio and Pierian merged. The company's Web site said it was collaborating with Gladstone Institutes and Kyoto University's Center for iPS Cell Research and Application with Shinya Yamanaka, whose lab first succeeded in creating iPS cells in mice.

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