CIRM Grants: Checks Not in the Mail, Squeaky Clean Review Underway

Directors of the California stem cell agency have approved $170 million in grants so far this year, but none of the money has yet reached researchers, universities or other recipients.

In early June, directors were told that the first wave of the funds -- $45 million approved five months ago -- was likely to receive the administrative go-ahead before the beginning of July. But that schedule has gone by the boards, and it is not clear exactly when the checks will ultimately be sent.

At the heart of the issue is the review of the details of the grants that occurs following their approval by the Oversight Committee.

Arlene Chiu, interim chief scientific officer for CIRM, told the committee last month, "We strive to be good stewards of the public's money."

Each one of the 117 proposals is examined by CIRM staff for compliance with its rules and state law. Slowing the process are the newness of the procedures, the small size of the CIRM staff(about 25)and even the speed at which the recipient institutions respond to requests for additional information. It is fair to say that universities do not necessarily act speedily even when millions of revenue are on the line.

CIRM has also been without a permanent president since the beginning of May, raising the possibility that the process might be moving faster with a permanent CEO in place. However, Dale Carlson, chief communications officer for CIRM, said, "I’ll tell you categorically that’s not a factor."

We asked Carlson about the funding process. Here is his reply verbatim:

"The length of time reflects several factors. First, we are looking at a large number of approved grant applications, particularly relative to the staff available to conduct the administrative review.

"Second, the requested costs on every application need to be carefully reviewed to ensure that they are accurate and in keeping with our policies. Facilities and indirect cost reimbursement rates also need to be checked, verified, and may need to be adjusted to fall in line with prevailing rates from other national grant-making institutions.

"This too is proving more time-consuming than we'd originally estimated.

"Third, some institutions are more prompt than others in responding to requests for documentation.

"This is still a new exercise for us. We're being very careful and thorough to ensure we get it right. It should go faster in the future.

"Fortunately, the recipient institutions understand that we are working with a new and small staff, and are by and large being very patient with our process. I think they share our interest in seeing this exercise properly completed, as it should generate efficiencies down the road.

"We are making every effort to send out all the notices of grant award (NGAs) in the coming weeks. The release of funds by the State Controller's Office follows the return of signed certification statements, and we obviously have no control over how quickly institutions turn those around."

Caution and care are to be commended in the case of this review. CIRM is still an infant organization. Laying a good groundwork for the future remains paramount. Plus financial foulups are viewed harshly in the media. Witness the stories earlier this spring about expensive lunches by some CIRM directors, a trivial expense that some reporters focused on in their stories about a state audit of CIRM. Bigger numbers would generate bigger and more unfavorable stories with a negative impact on CIRM's reputation.

CIRM Presidential Search: No Announcement Yet

Directors of the California stem cell agency failed to take public action today for the third time in the last month in their seven month search for a new president.

No announcement was made following the closed door session of the Oversight Committee. The last words – "progress is being made" – came from stem cell chairman Robert Klein on July 12. Klein had expected to fill the position by June.

Lab Grant Evaluation Standards

The evaluation standards for the $220 million lab grant program have now been posted on the CIRM website and are available here.

Upcoming This Week: Japanese Stem Cell Lines, Lab Grants and Presidential Search

From $220 million in lab grants and Japanese stem cell lines to the latest chapter in the search for a CEO, the California stem cell agency is set for a busy week.

We want to point out the background material prepared for the Standards Working Group meeting on Friday. Posted last week well before the meeting, the paper neatly summarized the history behind the matters being considered, touched on the issues involved and offered up draft language to deal with the problem in two cases. It was a good example of staff work that improves the decision-making process.

The standards group, which regulates CIRM-funded research, will consider whether to include some Japanese stem cell lines as "approved" for study. They would join some lines from Great Britain and Canada as ready to use. That means that research using them does not have to go through a more lengthy review process. Specifically, the Japanese lines being considered are ones derived under the "Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells."

The group is also scheduled to consider a problem in connection with informed consent requirements and research involving somatic cell lines. The agency's regulations created a situation in which "existing somatic cell lines obtained with informed consent may not be available for reprogramming experiments unless consent was obtained in accordance with the exact requirements of section 100100 (of CIRM regulations)."

The staff report said,

"The SWG might consider a more flexible standard for use of somatic cells. Interviews with leading researchers suggest the inability to utilize commonly available commercial somatic cells (non-covered stem cell lines) lines would limit CIRM-funded researchers from attempting to replicate studies."

On Wednesday, CIRM will conduct a session for "interested parties" on the $220 million lab grant effort. Proposed evaluation standards are scheduled to be posted Monday on the CIRM web site. Earlier, the agency posted the criteria and scoring. On July 30, the Facilities Working Group will wrestle with the subject once again, but the ball is rolling faster, so you applicants should pay close attention. Don't be shy about communicating with the agency if you can't be at the meetings.

On Tuesday, the Oversight Committee will convene for the third time in a month for a special, teleconference meeting to consider presidential compensation and candidates. They are legally equipped to come to a decision in their seven-month effort. But our bet is that no new president will be announced.

Nature Magazine Trumpets California 'Upstart'

The California stem cell agency's $85 million faculty awards program received some attention today on the website of Nature magazine.

A brief piece by Monya Baker noted that the program had been announced by "an upstart state-funded initiative to make California a stem-cell research hub."

She wrote:

"US biomedics moving from postdoc to independent research often struggle to find stable sources of funding. New investigators receive only 6% of US National Institutes of Health (NIH) R01 awards, the multi-year grants that US universities rely on. Similar to R01, the CIRM grants will fund direct project costs of $300,000 for academics and $400,000 for clinicians. Worries over money hamper long-term thinking, says Xianmin Zeng of the Buck Institute in Novato, California, who plans to apply. Many foundations give only small amounts of money over one or two years, she says. 'For young investigators to get a stable environment, they need a stable foundation,' Zeng says."

Klein Rebuffed in Lobbying Effort for New Stem Cell Nonprofit

California stem cell Chairman Robert Klein -- and associates -- Tuesday failed in their initial efforts to secure a land use change that would have swapped Northern California farmland for a new, nonprofit stem cell research institute that Klein would have chaired.

The proposal was put off by Yolo County supervisors during an angry meeting, reported Mary Lynne Vellinga of The Sacramento Bee. However, the proposal is not likely to vanish. Its chief backer, developer Angelo Tsakopoulos, is a persistent businessman. The stem cell proposal was one of three land use proposals that the supervisors were considering. Vellinga wrote:

"Tuesday's vote shelves -- at least for now -- a proposal by Sacramento developer Angelo K. Tsakopoulos to build an incubator for stem cell research just south of Interstate 80 outside Davis, and to fund it with profits from the construction of an unspecified number of homes.

"The county has been considering inclusion of some 1,500 acres, about 60 percent of the land owned by Tsakopoulos, for an 'innovation corridor' targeting life science and biotechnolgy.

"A bevy of stem cell experts, researchers and accident victims in wheelchairs -- including Ms. Wheelchair California -- turned out Tuesday to support the idea.

"'With your approval, the suffering people would have hope,' said Roman Reed, who was paralyzed when he broke his neck playing football. A state law named after Reed sets aside money for paralysis research.

Robert Klein, chairman of the state-funded California Institute for Regenerative Medicine, also made an appearance. He has been working with Tsakopoulos to promote the idea of a center, which he plans to head.

The supervisors took pains to stress that they would love to see a stem cell research center built in Yolo County but don't support the idea of building housing on the valuable farmland next to the Yolo Bypass. “'The money (for the center) comes from building the houses; that's not something I can support in that area, no matter how much I care,' Thomson said.”

For more on this issue, see the Yolo item below. Searching on the label Yolo will also turn up additional items.

Correction

The item below incorrectly said CIRM is scheduled to approve grants at a rate of $54,000 an hour this year. The correct figure is $29,000 an hour. The $54,000 rate included the major lab grants, which do not appear likely to be approved this year.

Klein, Chimeras and the Yolo Land Deal

In the eyes of some, the unusual lobbying by the chairman of the $3 billion California stem cell agency on behalf of an effort to swap farmland for a new, nonprofit stem cell research institute is not necessarily unethical or inappropriate.

No public hue or cry has erupted over the issue. Yes, two stem cell agency watchdogs have expressed dismay or outrage. One newspaper said Robert Klein should give up his state post if he continues to pursue the lobbying effort. But another good government advocate privately said he did not detect illegal or even unethical conduct.

So what's at stake here? One question centers on whether Klein has something to gain that conflicts or appears to conflict with his role as a state employee. Another question involves whether he is using inappropriately his position as chairman of the CIRM. Would he have been asked to lobby for the land deal if he were not overseeing the agency?

The answer to that question is: Probably not. Klein would be little more than another Darrell Issa if he were not the chair of CIRM's Oversight Committee. “Darrell who?” you might ask. Issa, like Klein, played a major role into a ballot measure that has had an enormous impact on California. In Issa's case, he financed, with $1.7 million of his own money, the effort that placed the gubernatorial recall on the 2003 ballot and sent Arnold Schwarzenegger to the state house. Issa was widely believed to be considering a run for governor. But today he remains an obscure California congressman.

Klein would have lapsed into similar obscurity without his high visibility post at CIRM. He now travels to Australia and Korea to hobnob with international stem cell scientists. He is profiled by Fortune magazine. He is an articulate, aggressive global salesman for human embryonic stem cell research.

But that is almost totally due to his state post. He heads his own private, national stem cell lobbying group in California, but that does not provide the prestige and power that accrues as the result of heading a concern that is giving away money this year at the rate of $29,000 an hour.

Tomorrow(7/12), Klein plans to bring his state-endowed prestige and power to bear on five Yolo County supervisors, some of whom have greater political ambitions and need to raise funds. Failure to act favorably on the 2,800-acre land use change could dry up some potential sources of funding, some of whom may well have ties to Klein, who is a prodigious fundraiser. Those considerations will certainly be going through the minds of supervisors as they hear him speak.

A spokeswoman says that Klein will not benefit financially from the deal that would make farmland along Interstate 80 between Sacramento and UC Davis available for development. In return, Yolo County, one of the top tomato producers in the nation, would be home to a stem cell research center with a $300 million or so endowment. Klein would chair the new institute. The Sacramento Bee reported that Klein is “cagey” about whether he would hold his state position at the same time. However, the proposed nonprofit would certainly look to CIRM for funding of at least some of its activities. Even if Klein has left CIRM by the time those grants are sought, he will still enjoy considerable, residual clout as the result of his CIRM connections. The situation is akin to those Pentagon officials who leave the government and go to work for enterprises seeking lucrative Defense Department contracts.

Klein is a multimillionaire real estate investment banker, who continues to operate his own business. He and Angelo Tsakopolous, the Sacramento developer and major political contributor seeking the land use change, go back a few years, but Klein's aides say they have never done business together. Klein's association with Tsakopolous has already proved beneficial. The developer's firm, AKT, gave $125,000 to Klein's lobbying group, Americans for Stem Cell Therapies and Cures, last April. If the Yolo deal is successful, it could lead to joint real estate work in the future. Tsakopoulos is a firm believer in building good relationships.

From Klein's point of view, he believes more research is better. To fail to bend his best efforts to promote the field and develop more resources would be to short change a campaign he has already devoted years to. Should he remain aloof from an ambitious project because of the tender sensitivities of some? No, he would answer. That's not the way to bring cures to millions of suffering people.

In stem cell circles, scientists talk of the “yuck factor” and chimeras, the mythological beasts composed of more than one animal. Some say that if a stem cell experiment creates such a creature and generates a “yuck” response, the experiment should be dropped.

Klein, who is a man of many parts, generates a “yuck” for his Yolo lobbying, his harshest critics say. We do not entirely disagree. His multiple roles raise questions about his primary priority. Serving as chairman of CIRM was perceived under Prop. 71 as a fulltime position complete with a $412,500 salary (which Klein to his credit does not take). Klein wrote substantial portions of that law. It is now time for him to respect its intent.

(Correction: An earlier version of this said CIRM was scheduled to approve grants at a rate of $54,000 an hour this year.)

Fresh Comment

Christopher Scott, executive director of Stanford's Stem Cells in Society program, has posted a comment on the Thomson item below, raising some interesting questions regarding Thomson's affiliation with UCSB.

Proposed Criteria for Major CIRM Lab Grants

Here is the text of the proposed criteria for the $220 million in lab grants scheduled to be given out later this year. The text was provided by CIRM.

Criteria, Definitions & Scoring
Recommended by the Facilities Working Group for RFA 07-03

Value (Special Features, Innovation/Sustainability
Costs)
Definition:
The investment represents a good return to the
taxpayer while considering costs, quality, geographic
location, and benefits of the project. The facility has
innovative elements that encourage conservation and
renewable resources. The project costs are reasonable
and necessary.
Scoring: 25


Leverage

Definition:
The CIRM investment prompts additional investments
that are consistent with the CIRM objectives; these
investments are additional capital funding for the
project. These costs include project cash expenditures
prior to the Notice of Grant Award and may include
(1) the purchase of land and/or a building at the
documented cost to the institution and (2) other
capitalized project cost. The project leverage
attributable to internal project overhead and
architectural and engineering costs will be no more
than 10% of the total project costs.
Scoring: 25

Urgency

Definition:
Places a high priority on completion of the project
within two years; and the delivery of projects on an
expedited scheduled. The institution, the team and
approach has a historic and proven track record of
delivering capital projects on an expedited schedule.
Start Date: Notice of Grant Award
End Date: The base building is available for
occupancy and/or installation of equipment.
Scoring: 20

Shared Resources

Definition:
The project benefits from facility assets at the
applicant site or collaborating institutions that reduce
the cost and increase the value for the mission.
Scoring: 15

Functionality
Definition:
The planned space design for the base building and
tenant improvements is consistent with the CIRM
objectives of meeting current programmatic needs and
expanding regenerative medicine research capacity
and capabilities. The facility provides for long term
flexibility while meeting scientific objectives.
Scoring: 15

Adopted on July 12, 2007

Thomson's New Lab Under Construction In Santa Barbara

Ever so quietly, eminent stem cell researcher Jamie Thomson is coming to California – at least part-time.

The move has attracted little public notice. The news has oozed out, much as tar seeps onto the sandy beaches of Santa Barbara, where Thomson's new lab is under construction on a bluff overlooking the Pacific Ocean.

His appointment as an unpaid adjunct professor at the University of California campus there has definitely produced something less than big headlines.

But Thomson's impending presence did play an indirect role in helping to secure a $2.3 million grant for the campus from the California stem cell agency.

The CIRM review of the UCSB grant repeatedly referred to Thomson, who works fulltime at the University of Wisconsin, without naming him. It noted that UCSB, which has five Nobel Laureates, came up with $1 million to establish Thomson's lab. The review said “that the close proximity of the recently-recruited PI will keep the effort (meaning management of CIRM-funded research) state-of-the-art.”

The review continued:

“There was continued discussion on the nature of the interactions with the newly-recruited PI (Thomson). The letter from this PI describes the establishment of a satellite lab at the home institution and four collaborations, three of which have been initiated (including one with the PD), and one of which is to be initiated. This new PI offers experience in growing cells in serum-free, feeder-free conditions. How this PI will work out the situation with a satellite lab is unclear, but s/he suggests that 5-8 people will be working on-site at the applicant institution. It was noted that this PI will provide advice and consultation but there was no percent effort commitment nor any indication of how much time s/he would spend at the institution.”

We should note that the grant was not for Thomson's work.

The only California story we have seen on Thomson's appointment is a five-paragraph article by Nick Welsh in the Independent, a free weekly newspaper in Santa Barbara. Welsh quoted Dale Carlson, chief communications officer for CIRM, as saying:

"This is a great coup for Santa Barbara. He is one of the finest, if not the very finest, researcher in the field."

Correction

The “Lab Criteria” item below did not include the name of Janet Wright as one of the CIRM Oversight Committee members attending the Facilities Group meeting.

Scientists and Their PR Responsibilities

Good advice on the role of scientists in the ongoing debate about embryonic stem cell research can be found on Nature's new blog on stem cell issues.

Monya Baker, San Francisco news editor for the magazine, commented on the recent testimony that the Bush administration squashed dissenting view among its appointees, which we should note happens with almost any powerful presidential administration, or for that matter, gubernatorial(see stories about how Arnold appears to be micromanaging the state's smog board).

Baker said it was important for scientists to be publicly engaged lest Luddites carry the day. She wrote:

"To be part of the solution, scientists must spend time away from the lab bench. The scientific community should get its views (and the evidence for them) into the public sphere, writing letters to editors and politicians, speaking to schools and gatherings.

"When scientists do so, they balance enthusiasm with caution, caveats with imagination. They should be able to tell personal anecdotes without fear of being mocked by their peers. To maintain credibility, not to mention civility, scientists should understand opposition to stem-cell research and describe which opinions are backed by data, which are not, and which exist independent of data.

"Consistent efforts can help turn a raucous debate into a reasoned one."

We add that it takes repetition, repetition and more repetition to have an impact.

CIRM Panel Sets Lab Criteria, Nitty Gritty Still Pending

Much work remains to be done on the details for the criteria for $220 million in stem cell research lab grants to California universities and research institutions, but “great progress” was achieved earlier this week, according to one long longtime observer.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said the lengthy session “accomplished a lot.” He wrote in an email that the

"CIRM staff needs to fill in major details with draft language now that broad policy objectives have been set. It was a long meeting, but a necessary one if the public is to have faith in the mechanism of doling out $220 million in building grants."

Simpson, who was a newspaper editor for many years prior to his current position, offered this account of this week's events.

The Facilities Working Group during a marathon seven-hour meeting Thursday unanimously decided to require that the 20 percent matching requirement necessary under Prop. 71 to receive a facilities grant be made in cash.

The eight FWG members present also agreed to refer to amounts contributed to a project beyond the 20 percent threshold as "leverage."

The panel selected five criteria to use in making the awards and the points
that would be awarded to each of the criteria. Assuming that an applicant
could receive 100 points, the criteria and and possible value are:

--Urgency (20 points)
--Value (25 points)
-- Leverage (25 points)
--Functionality (15 points)
-- Shared resources (15 points)

The members considered the possibility of using a scale with more total
points as long as the ratio among the criteria remained the same and
suggested CIRM staff give that further thought.

All agreed that if CIRM is to maximize its impact on stem cell research
facilities across California, it will be necessary to encourage institutions
to bring as much "leverage", that is cash, to building projects as possible.

"We'll have to get substantial cash leverage," said Bob Klein, ICOC
chairman.

All of the procedures and criteria developed by the FWG for the proposed
$220 million in facilities grants must be approved by the ICOC.

The FWG also voted to recommend that grant recipients be required to use
buildings financed with CIRM money for regenerative medicine for a definite
period of time, perhaps 10 or 20 years. They decided to leave the exact time
requirement to be determined by the ICOC.

The panel also developed definitions for each of the criteria. The next step
is for the CIRM staff to propose draft language for standards to evaluate
each of the criteria. The proposals will be discussed at a meeting of
"interested parties" (representatives of institutions likely to seek money)
on July 25.

The FWG will is expected to meet July 30 to complete its recommendations so
they can be forwarded to the ICOC for its August meeting.

Arlene Chiu, acting chief scientific officer, outlined a proposal to consider a two-step process to review the facilities grants. They would be reviewed first by the Scientific Working Group for scientific merit and then be forwarded to the ICOC. After ICOC review, the proposals would go to the
Facilities Working Group for review and recommendation to the ICOC.

The FWG did not act on that proposal because by that point in the meeting it
was short of a quorum, Joan Samuelson and Stuart Laff, having departed around 6 pm. The consensus appeared to be that the staff recommendation made sense.

Other committee members attending were: David Lichtenger, chairman; Klein; Edward Kashian; David Serano Sewell; Janet Wright and Jeff Sheehy. Around 20 people, mostly representatives of institution seeking money, attended.

(Editor's note: An earlier version of this item did not include Janet Wright as one of the committee members attending the Facilities Group meeing.)

The Bee Calls for Klein Resignation If He Continues to Lobby on Land Deal

The Sacramento Bee said today that California stem cell Chairman Robert Klein should resign from his post at the $3 billion state institute if he continues to lobby on behalf of a controversial Northern California deal that would swap favorable land use decisions for a private stem cell research facility.

The editorial noted that Klein's stem lobbying group, Americans for Stem Cell Therapies and Cures, earlier this spring received $125,000 from the Angelo Tsakopolous' land development company, which is seeking to convert farmland to commercial development. In return, a $200 millon stem cell nonprofit institute would be created at the location. The more than 2,000 acres is located on Interstate 80 between Sacramento and UC Davis.

The Bee wrote in an editorial:

"Klein says there's no connection between his efforts to retire campaign debt (owed by his lobbying group) and his support for the Yolo project, but it nonetheless creates an appearance of paycheck politics. If Klein wants to continue to promote the Yolo project or any project that could overlap with his duties as a state official, he needs to resign from CIRM. The sooner the better."

The newspaper said that Klein makes a "compelling case" for the type of research facility that would be built at the site by a nonprofit institute that would be headed by Klein. The Bee wrote,

"But if the case is strong, the multiple hats that Klein is wearing with this project are troublesome....He is cagey when asked if he would also continue to chair CIRM. There's the potential that the industries and researchers who would be part of this Yolo research center would also seek funding from the California institute, which would put Klein in a serious conflict of interest."

Fresh Comment

Jesse Reynolds of the Center for Genetics and Society makes an interesting point in a comment on the Lansing item below. He notes that Jeff Sheehy, who serves as a patient advocate and is on the Facilities Group, is employed by UC San Francisco.

Sherry Lansing Resigns from Lab Grant Group; Conflicts of Interest Cited

University of California Regent Sherry Lansing today resigned from the group that is setting criteria for the California stem cell agency's $220 million lab grant program. 

California stem cell Chairman Robert Klein announced Lansing's resignation at the beginning of the meeting of the Facilities Working Group. 

He said Lansing, who is in Portugal, was leaving the group because she "wants things to go forward and because she sees possible conflicts with her role as a UC regent and the working group's work," according to John M. Simpson, of the Foundation for Taxpayer and Consumers Rights. 

Simpson is attending the meeting in the San Francisco area this afternoon. A number of UC campuses are expected to seek building funds under the program. The facilities group makes funding criteria recommendations to the full Oversight Committee, on which Lansing also has a seat. 

That committee will make the final decision on the rules for receiving the grants. Many of its members are employed by or have links to institutions that are likely to apply for funds. 

With the resignation of Lansing, none of those institutions have seats on the 10-member facilities group. The only members of the Oversight Committee now on the panel are five patient advocates. The other members come from the private sector or, in one case, the state Department of Corrections.

More On the Presidential Search, Plus Lab Grants and ICOC Vacancies

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, offered the following observations on today's CIRM events, including this afternoon's meeting on the criteria for $220 million in lab construction grants and vacancies on the Oversight Committee.

Simpson, who has followed the agency closely for about two years, was present for this morning's meeting of the Oversight Committee concerning its attempts to find a new president. Simpson said in an email:

"'Steady progress' is being made toward selecting a president and chief executive of CIRM, Robert Klein, ICOC chairman, said this morning after an early morning executive session of the board. He declined, however,...to be specific about a time table to complete the selection. He said selecting the right candidate was the most important issue, not the schedule."

Simpson said board went into executive session about 7:15 a.m. Klein predicted a 15 to 30 minute meeting.

Simpson continued:

"The board resumed public session at approximately 8:15 am with Klein commenting that he should have offered a more realistic prediction of the length of the meeting given the board's proclivity for full discussion of
issues.

"'There were a lot of thoughtful comments,' Klein said."

Simpson said that he complained to the Oversight Committee about the failure of the Facilities Working Group to post background documents on the lab grant criteria well in advance of this afternoon's critical meeting. Simpson said the documents were vital to understanding the largest grant package CIRM has offered so far. He said he wanted to the full board to be aware of the situation.

Concerning the vacancies on the board, Simpson said,

"After the meeting in conversation with Tamar Pachter, General Counsel, and James Harrison, outside counsel, it emerged that both David Baltimore, former president of Caltech and Richard Murphy, former president of the Salk Institute, have resigned from the board. They had their ICOC positions by virtue of their jobs before recently retiring.

"With the vacancy created by the death ofLeon Thal, the ICOC has 26 members instead of the full compliment of 29. This means that a quorum -- something the board frequently has had difficulty mustering -- is now 17 members rather than 18."

The CIRM quorum requirement is large and is written into state law by Prop. 71. It cannot be changed by the Oversight Committee, only by an unlikely revision in the law. In contrast, other government entities often need only a simple majority of their members to take legal action. Large quorum requirements mean that a minority on a board can block action simply by not being present at a meeting.

CIRM Directors Still Looking for New President

Directors of the California stem cell agency this morning met again behind closed doors to discuss candidates to head the $3 billion research effort but adjourned without announcing a decision.

The search is now into its seven month. CIRM's first president, Zach Hall, announced his plans to leave early last December. The agency has been without a permanent president since the beginning of May, when Hall departed.

The Oversight Committee could have acted this morning. The matter of presidential compensation and candidates was properly noticed on its agenda. But virtually the entire teleconference meeting, which included a link to one director in Portugal, was in executive session, and no announcements were made during the public segment.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, asked during the public portion whether a new president would be named prior to the directors meeting in August.

Chair Robert Klein replied that artificial timelines could not be imposed and and that the search must focus on finding a president with the right scientific vision for the agency, according to CIRM officials. Previously the Oversight Committee had expected to fill the position in June.

Klein may call another presidential meeting within the next 10 or 15 days.

Stem Cell Snippets: Pachter, Kessler and Google

CIRM General Counsel – Jessica Jones has a brief Q&A on law.com with CIRM's new general counsel, Tamar Pachter. Among other things, Pachter was asked what is like working for a controversial agency. Her reply, "Is there a state agency that isn't controversial (laughs). It really doesn't affect my work all that much."

Egg Concerns – Anna Salleh for ABC Online reports concern in Australia about international trafficking in human eggs for stem cell research. Catherine Waldby of the University of Sydney is quoted as saying there are already problems in eastern Europe. Waldby's research is to be published in the New Genetics and Society Journal.


Kessler and Google Health Committee – CIRM Oversight Committee member David Kessler has been named to Google's Health Advisory Council. Kessler is also dean of the UC San Francisco medical school. The Google council is aimed at understanding health issues and providing "feedback on product ideas and development." Sergey Brin, co-founder of Google, contributed at least $100,000 to the Prop.71 campaign.

Poultry and CIRM's Oversight Committee

The California stem cell agency has two lame ducks on its board and another vacancy that has remained unfilled as the result of gubernatorial inaction since last February.

The vacancy on the Oversight Committee is the seat formerly held by Leon Thal, who died in a plane crash on Feb. 3.

Thal was appointed to the board by Gov. Arnold Schwarzenegger. State law requires him to fill the vacancy within 30 days. We asked the governor's office today when the post would be filled. Sabrina Lockhart, a spokeswoman, replied:

"Gov. Schwarzenegger is proud of California's leadership in stem cell research - which has placed our state on the cutting-edge of this potentially life-saving science. Because stem cell research is such an important priority for the Governor, he will fill the vacancy as soon as he finds an ideal candidate to fill the position."

It is not uncommon for governors to flout deadlines such as the one created by Prop. 71 for filling vacancies.

The lame ducks on the board are David Baltimore, former president of Caltech, and Richard Murphy, who retired earlier this month from his position as head of the Salk Institute.

Both hold their seats on the 29-member Oversight Committee as the result of their former professional positions. Both are expected to continue to serve at least for some time, which appears to be permissible under Prop. 71.

More Fresh Comments

Anonymous weighs in with more on the "cronyism" business related to the "90 Percent" item below. We have posted an answer to the question of why only 27 biographical sketches are found on the CIRM website for the 29-member Oversight Committee.

Fresh Comments

An anonymous comment has been posted on the "90 percent" item below, which raises a question about the significance of the item. We have posted a reply. "Faye" also had a comment about the terms of Oversight Committee members and whether they can be rotated out. We have posted additional information in response to her query. You can find all of this by going to the "90 percent" item and looking at comments at the end of the item.

New Lab Proposal Info Now Available

The California stem cell agency this afternoon posted 58 Power Point slides for the meeting of the Facilities Working Group Thursday afternoon. The slides summarize comments made at four earlier hearings, identify some questions that should be answered at this week's session and outline steps to be taken before the proposal is presented to the Oversight Committee Aug. 8 in San Francisco for approval.

While obviously sketchy, they are useful -- in fact mandatory reading -- for anyone interested in the subject of giving away $220 million for construction of new stem cell research labs in California.

Five-hour Research Lab Meeting: A Mockery?

The California stem cell agency Thursday afternoon is going to attempt to set criteria in five hours for handing out $220 million in research lab grants in a process that one watchdog likens to a "public relations sham."

No proposed criteria will be available prior to the public meeting. They may not be available at the beginning of the meeting either. Instead, the only advance, online offerings are likely to be marginally useful, Power Point presentations that will summarize issues and suggestions presented during previous four public sessions of the Facilities Working Group.

John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumer Rights, Monday said in an email to California stem cell Chairman Robert Klein,

"This facilities RFA is one of the most important and potentially contentious RFAs that CIRM will issue. It's supposed to be based on the input of four public hearings held around the state.

"The ICOC is to be commended for authorizing those hearings to gather public input about the policies.

"However, not making a draft of the policies to be discussed available with ample time for review by the public so they can make intelligent comments at the meeting makes a mockery of the entire process. It forces one to conclude that there was no real interest in meaningful public input and that your process was nothing more than a public relations sham."

Simpson added that not having the information in advance also makes it difficult for members of the working group to take intelligent action.

The only documents available online until late Monday afternoon were two facilities group transcripts from May 31 and June 4. Transcripts from hearings June 11 and June 19 were not available until Simpson called -- in his email to Klein -- for them to be posted forthwith.

The failure to post important material well in advance harkens back to earlier days of CIRM, when even members of its Oversight Committee complained publicly about not getting background material in advance. Some of that can be chalked up to growing pains.

But problem is obviously continuing. It has been compounded by not allowing enough time at meetings -- called by Klein or other committee chairs -- to cover all the necessary ground. In this case, for example, 11 persons sit on the Facilities Working Group. If each took only 10 minutes asking questions or making comments, that would consume nearly two hours. Then there is a staff presentation, questions and comments from representatives of California universities and institutions as well as from the general public. All with no draft criteria to actually read and study ahead of time.

Encumbering the process of handing out research lab grants fits with what one might call a modified stonewall strategy. CIRM does not have to make grants for lab construction. If it did not, CIRM would would have more money for research, which seems to be a priority of patient advocates on the Oversight Committee. On the other hand, executives from institutions represented on the committee could understandably take a different view although grants for their researchers are certainly important to them.

Whatever the case, the facilities group's hearings on the research lab criteria have been one of CIRM's more heavily attended series of events – mainly by folks from universities and nonprofit institutions.

It is a disservice to them, the public and CIRM itself not to provide a better opportunity for comment as well as thoughtful consideration by the working group.

Conflicts at CIRM: The 90 Percent Test

About ninety percent of the $209 million handed out so far by the California stem cell agency has gone to institutions that have "representatives" on the board that approves the funding.

The grants have gone for training new stem cell scientists, funding research and remodeling laboratories.

The group that approves the money is the 29-member Oversight Committee. Fourteen members of that committee have close links to the institutions that have received about $190 million in grants.

None of this is illegal but it illuminates the nature of the built-in conflicts of interest on the board. Prop. 71 created the situation. Nearly all the institutions in California that could be suitable recipients of stem cell research have some sort of representation on the decision-making board. The measure spelled out, for example, that five executive officers from University of California medical schools have seats on the board. It also stipulated that four executive officers from California research institutions sit on the Oversight Committee. The group would be hard pressed to come up with a long list of other institutions that would make suitable candidates for hefty stem cell funding.

Members of the Oversight Committee are barred from voting on grants to their institutions, and CIRM goes to considerable lengths to make sure that does not happen. However, all members of the committee can vote on the rules and standards for making the grants. And this week, a working group of CIRM is scheduled to devise rules for $220 million in grants for major labs at California institutions. Those standards will help establish, among other things, whether the money will be accessible to smaller institutions and spread geographically around the state or even whether that is a good idea.

While some have deplored the conflicts on the board, the situation is not likely to change soon. Prop. 71 can only be modified by another vote of the people or by a super, supermajority vote in the legislature and approval of the governor.

In the absence of a change, the Oversight Committee's structure and actions make it even clearer that CIRM should operate with a maximum of disclosure and openness, something the committee sometimes feels uncomfortable with.

Here are the names of the members of the Oversight Committee with links to institutions that have received grants and the size of the grants. Some members directly represent their institutions, such as the deans. Others, such as Sherry Lansing, have close links to an institution but serve as the result of some other designation. Lansing is a University of California regent, but serves on the board as a patient advocate.

David Baltimore, president emeritus Caltech, $2 million; Robert Birgeneau, chancellor UC Berkeley, $5.5 million; David Brenner, dean UC San Diego medical school, $17.7 million; Susan V. Bryant, dean School of Biological Science UC Irvine, $17.5 million; Michael A. Friedman, president City of Hope, $357,978; Brian E. Henderson, dean USC medical school, $9 million; David A. Kessler, dean UC San Francisco medical school, $30 million; Sherry Lansing, UC regent, 10 UC campuses have received grants; Gerald S. Levey, dean UCLA medical school, $15.8 million; Richard A. Murphy, president Salk Institute, $8.9 million; Philip Pizzo, dean Stanford medical school, $31 million; Claire Pomeroy, dean UC Davis medical school, $11 million; John C. Reed, president Burnham Institute, $17 million, and Oswald Steward, chair of the Reeve, Irvine Research Center, UC Irvine, as noted under Bryant, the campus has received $17. 5 million.

The amounts could be larger, for example, if we included the $8 million in grants to Children's Hospital of Los Angeles, which has close ties with USC. Or the $10 million to the Gladstone Institute, which has ties to UC San Francisco.

Short biographies of members of the Oversight Committee can be found here. More specifics on the size and nature of the grants can be found here(see the list at the end of the press release.

UC Davis Tightens Rules on Industry Influence

Efforts to control the influence of the medical industry in academia received more support recently at the UC Davis medical school, whose dean sits on the Oversight Committee for the $3 billion California stem cell agency.

Reporter Dorsey Griffith of The Sacramento Bee wrote earlier this week:

"UC Davis' ban against drug industry gifts, lunches and samples has expanded to include a prohibition of freebies from any company that markets its wares to the large health system.

"University of California, Davis, officials Monday announced the expanded new policy, which took effect Sunday.

"'There was consensus that we really needed to make sure that all our policies ensure that our behavior is totally transparent and ethical,' said Dr. Claire Pomeroy, vice chancellor and dean of the UC Davis School of Medicine. 'I think it's consistent with our values here of really being focused on the patient.'"

Pomeroy is one of 29 members of the Oversight Committee, which has its own set of issues dealing with conflicts of interests.

Stanford and UCLA, whose medical school deans also sit on the Oversight Committee, have similar rules, along with Kaiser Permanente Northern California, Yale and the University of Pennsylvania.

Yolo Stem Cell Proposal Attracts More Attention

A "farmland war," "unethical" – two of the descriptions emerging today in a fresh story about the Northern California land development/stem cell research project involving the head of the state's $3 billion stem cell agency.

CIRM Chair Robert Klein and Angelo Tsakopolous, a Sacramento area land developer, are lobbying for a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million. Earlier this spring, Klein's private lobbying organization received a $125,000 contribution from Tsakopolous' company. Klein would chair the proposed nonprofit.

In a story written by reporter Ralph Brave, the Sacramento News & Review today painted a bucolic picture of the development's location, which is hard on a very busy freeway just west of Sacramento. Brave wrote:

"This acreage has become the latest battleground in the ongoing war over the fate of Yolo County’s distinctive dedication to preserving farmland and open space. Although it’s just commenced, this particular battle’s mix of the area’s most powerful real-estate magnate, the head of the state’s stem-cell oversight committee, the re-evaluation of Yolo County’s General Plan governing development, and next year’s elections promises a prolonged, intense struggle that could determine much about the county’s and the region’s future."

The election issue involves at least the chair of the Yolo supervisors, a locally elected official who is seeking a seat in the California legislature. The dispute was characterized as a "farmland war" in a caption on a photo of a portion of the site.

Brave continued:

"Environmental attorney James Pachl told SN&R that Tsakopoulos’ 'proposal is an attempt to bribe the supervisors by offering to contribute to a fashionable charity in exchange for approval of AKT’s development project(AKT is Tsakopolous' company). Perhaps legal, but too unethical for most public officials to consider. The AKT property is valuable farmland, wildlife habitat and open space that should continue to be farmed.' A supporter of stem-cell research, Pachl expressed concern that 'the proposal will create a local political firestorm that will likely stop the project and damage the credibility of stem-cell researchers.'"

The newspaper also brought into its coverage another CIRM official, Claire Pomeroy, a member of the Oversight Committee and dean of the UC Davis School of Medicine.

Brave wrote that attendees at one dinner promoting the project included two Yolo supervisors, Klein and Pomeroy.

Brave said Pomeroy later told him that "it would not be 'appropriate to involve myself in land-use decisions.'"

Last Saturday, reporter Luke Gianni of the Woodland Daily Democrat quoted Pomeroy as saying,

"The concept of a research center for stem cells is a good one and something I support. A new research park in this region, in addition to the stem cell facilities we're currently building in Sacramento, could help complement the promising work our scientists are now doing in regenerative medicine."

Brave's story contained more details on financing the stem cell research facility, provided by Amy Daly, executive director of the Klein lobbying group, Americans for Stem Cell Therapies and Cures.

"Upon approval for residential and commercial development for some portion of the Tsakopoulos 2,800-acre property, 200 acres would be donated to a new nonprofit called Bridge to Cures. One hundred of those acres would be taken to a bank and used as collateral for a loan to finance the building of the research center and its labs. Part of the profits from the residential and commercial development would go into an endowment, to be used as loans, grants and other financing for biotech companies to advance stem cell and other biomedical discoveries into clinical applications."

Daly said the center's labs would be leased to for-profit companies. Earlier, she told the California Stem Cell Report that Klein would chair Bridge To Cures.

Size of the endowment has ranged from $50 to $400 million, depending on the size of the development that might be approved.

To see all the items on this subject, click on the label "yolo" below.

Recent Comments

Yvonne Perry, author of "Right to Recover, Winning the Political and Religious Wars over Stem Cell Research in America," has posted comments on the "Internet radio program" and the "TV coverage" items below.

News Coverage of Monday's WARF Stem Cell Matters

The latest developments in the WARF stem cell patent case received light coverage today among mainstream newspapers.

Stories appeared in three newspapers – the San Diego Union-Tribune, Milwaukee Journal Sentinel and the Wisconsin State Journal.

Coverage was straight forward. Wisconsin State Journal reporter David Walhlberg had this item concerning scientist James Thomson and his stem cell discoveries in 1998.

"...(T)he challengers added a new twist. They said Thomson had 'unique access' to an Israeli scientist who provided him with human embryos and enviable funding from the biotech firm Geron.

"'Had other scientists in the field been given the same access to those limited resources, they, too, would have been able to make the same accomplishment Dr. Thomson did,' the challengers wrote.

"Thomson did not respond to a request for comment Monday. In an e-mail interview last year, he said, "Some very good, simple ideas only seem obvious afterwards.'

"Andy Cohn, WARF spokesman, called the new filing 'a minor step in a long process.'"

Terri Somers of the San Diego Union-Tribune noted this case is a long way from being resolved and could wind up in court following the patent challenge.

No Aussie Location for July 12 Presidential Meeting

The folks down under are not going to have a chance to comment on the selection process for the next president of the $3 billion California stem cell agency.

Australia will be dropped from the list of remote locations for the teleconference meeting of the Oversight Committee on July 12. The site in Australia was listed on the agenda because California stem cell chairman Robert Klein was visiting the country. However, he will return on July 8. We are told that listing the Australian location was an error.

CIRM Takes Another Whack at Hiring President

In another attempt at hiring a new president for the California stem cell agency, directors of the $3 billion effort have scheduled their second unusual teleconference meeting in the last few weeks to consider compensation for the post and candidates for the position.

This one is for July 12. The last such meeting was held on June 26 and ended with no public action. The directors have sealed off any public comment after an embarrassing information leak earlier this year.

In order to act on candidates and compensation, state law requires that advance notice be given. Posting such a notice could just be a hopeful contingency measure in case a deal can be concluded by the meeting date. Nonetheless, a decision must be quite close.

One of the sticking points in the recruitment process has been the $400,000 salary for the position, which apparently has been too low for some. For more details on that see the "ticklish" item posted earlier.

Members of the Oversight Committee are calling in from 14 locations in California, according to the agenda, and one in Australia, where California stem cell Chairman Robert Klein is visiting. Members of the public can listen in at those locations during the public portions of the meeting and speak out as well. The June 26 meeting was almost entirely in executive session.

Twenty-nine persons sit on the Oversight Committee. Presumably more locations will be added as the meeting approaches. Otherwise, there may not be enough members on the teleconference to take legal action.

Melton, Cowan and Trounson Beef Up WARF Challenge

Three prominent stem cell scientists – two from Harvard and one from Australia – have bolstered a challenge to the embryonic stem cell patents held by the Wisconsin Alumni Research Foundation.

They are Douglas Melton and Chad Cowan, both of Harvard, and Alan Trounson of Monash University in Australia. Previously Jeanne Loring of the Burnham Institute had filed statements in support of the challenge to the patents of the discoveries by James Thomson of the University of Wisconsin.

Melton said,

"I very much believe Dr. Thomson deserves the scientific and public recognition he has received. However, he deserves that recognition because he undertook the arduous and timely task of getting fresh and high quality embryos to use as starting material for his work, and sufficient funding for such research, not because he did anything that was inventive... His perseverance and commitment deserve recognition and accolades. But I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious."

Melton's statement was released today by the Foundation for Taxpayer and Consumers Rights and the Public Patent Foundation. They filed the challenge last year in the wake of complaints in the scientific and commercial stem cell community about the restrictions and costs involving the WARF patents. The challenge won favorable preliminary ruling from the federal government, which WARF has responded to.

Carl Gulbrandsen, managing director of WARF, said earlier in a news release that:

"...the patents and publications the (Patent and Trademark Office) relied upon were not relevant to the isolation and proliferation of human embryonic stem cells. Gulbrandsen's comments were echoed by Dr. Colin Stewart, a leading stem cell researcher at the Institute of Medical Biology in Singapore, who submitted a declaration in support of the Thomson patents that emphasized the differences between mouse stem cells, which were prominent in the PTO's rejections, and the human embryonic stem cells that were isolated and characterized by Thomson."

More on the WARF response can be found at this site.

FTCR also has additional material, including the declarations from Trounson, Cowan and Loring, on its site.

The PTO now takes the arguments under submission. It is not expected to render a judgment for many months, perhaps as a long as a year.

Stem Cell Snippets: Burnham's Reed, Politics, Roth and the Non-meeting Meeting

Burnham Receives $2.5 Million – Donald Bren, an Orange County developer, is giving $2.5 million to the Burnham Institute to support research by its president, John Reed, who sits on the Oversight Committee for the California stem cell agency. On the Burnham board are Bren's wife, Brigitte, and Gayle Wilson, a former member of the Oversight Committee and wife of former Gov. Pete Wilson. Both were added to the Burnham board earlier this month.

Lansing Covering Bets? -- Los Angeles TV station KNBC reported that Sherry Lansing, a CIRM Oversight Committee member, could be covering her presidential bets. The station says she has made the maximum individual contribution -- $2,300 – to both Hillary Clinton and Barack Obama. The station reported that multiple contributions are common among major contributors. Variety also reported she hosted a fundraising dinner at her home for Democratic Sen. James Webb of Virginia.

Penhoet and Bloomberg – CIRM Vice Chairman Ed Penhoet dined with New York Mayor Michael Bloomberg shortly before the mayor renounced his membership in the Grand Old Party. Penhoet was at an affair at the home of technology financier Sandy Robertson, a partner in Francisco Partners, according to Kevin Maney on the Tech Observer blog. Testing the Silicon waters was how Maney described Bloomberg's foray.

Baltimore and Science – David Baltimore, former president of Caltech and a member of the CIRM Oversight Committee, is chairing the search committee to find a new editor for Science magazine to replaced retiring editor Donald Kennedy.

CIRM Director Has New Responsibilities – Duane Roth, a member of the CIRM Oversight Committee, has been named interim chairman of CleanTECH, a nonprofit group supporting environmental technology businesses in the San Diego area. Roth is also chief executive officer of Connect, a UC San Diego entrepreneurial program.

Meeting with No Business – The CIRM Standards Group has scheduled a meeting for July 27. Nothing is on the agenda.

Klein Rep Says No Financial Ties in Land-Stem Cell Proposal

California stem cell Chairman Robert Klein, who owns a real estate development firm based in Palo Alto, is not financially involved in a land development proposal in Northern California that promises to create a stem cell research center, according to a Klein representative.

In response to questions from the California Stem Cell Report, Amy Daly, executive director of Americans for Stem Cell Therapies and Cures, Klein's private lobbying group, said:

"Bob Klein's company's is not at all involved in this project other than to allow Bob to donate his time to the endeavor. There is no monetary benefit for Bob in this project. He is not getting paid and there will be no financial (or other) benefit to his company as a result of this project."

She also said that CIRM is not connected with the proposal near Sacramento and is "completely separate." CIRM itself has had no comment on the plan. The agency said it knows nothing about it.

Daly's response came as the Center for Genetics and Society Friday published sharp criticism of the plan on its blog "Biopolitical Times."

Jesse Reynolds, project director on biotechnology accountability, wrote that the proposal raises a question of whether another stem cell research center is justified. He continued:

"The second issue is the egregious nature of Robert Klein's conflicting roles. His lobbying group gets a hefty donation, and his imprimatur hints that the new center would be a likely magnet for public financial support. And who knows if he's got his own finger in the pot, given that his business dealings are obfuscated via dozens of corporations and holding companies.

"Meanwhile, he sits as not only a public servant, but as one with significant influence over how billions of public dollars are spent. Although he's promised not to profit from biotech while he's chair of the state stem cell agency, does he consider an investment in the land development part of this vow? And how would the public ever know?

"Regardless, as we've said before, Klein needs to decide whether he is a lobbyist or a public official. He can't be both."

Daly said that Klein and Sacramento developer Angelo Tsakopolous met only recently. She said that they "have not worked on any project in the past."

She wrote,

"As I understand it, they met in January 2007 when they both were in Washington for inaugural activities. Both are strong supporters of Nancy Pelosi.

"Around that same time, Yolo County had put into their general plan a desire to have an economic development proposal. The Tsakopoulos family owns land there and they were hoping to leave some lasting legacy for the county beyond just immediate economic development.

"Bob and Angelo had dinner here in California upon their return and discussed the possibility of a Regenerative Medicine Institute in Yolo County. Angelo and his children were thrilled to have an opportunity to change the world much in the way we believe Proposition 71 will change it. As I mentioned in my email to you yesterday, we are hoping that this Regenerative Medicine Institute, funded by the soon to be formed non-profit, Bridge to Cures, will bridge the funding gap for translational medicine that currently exists and that CIRM has not yet addressed."

She said opponents are trying to stop the project, which will be discussed by Yolo County supervisors July 17, before it moves beyond the discussion stage.

See below for an information sheet on the Yolo stem cell proposal being circulated on behalf of the effort.

Text on Development Plan Involving Klein

Here is the verbatim text of information supplied on behalf of a Northern California land development/stem cell research proposal involving California stem cell Chairman Robert Klein. It was supplied by the Sacramento political consulting and PR firm of Townsend Raimundo Besler & Usher.


Innovation Corridor

California and the nation face a serious shortage of comprehensive sites devoted to cutting-edge biomedical research, life science incubators and allied private enterprise support for university-related research and therapy development. A group of researchers, civic leaders and private entrepreneurs are working on a plan to provide the physical and economic infrastructure to support an international research center for regenerative medicine and biotechnology on Interstate 80 between Mace Boulevard and E. Chiles Road interchanges.

Life and Health Sciences – Leading California Into the Future

California is the world leader in life and health sciences and technological research. Biotechnology was born in California and today is one of the state's most important economic engines. A quarter of a million Californians work for more than 2,700 companies, making biotech a larger employer than the computer, aerospace, telecommunications or motion picture industries.

Demand for Research and Development Centers is Growing

Advanced R & D in the biosciences will be the most significant contributor to the well-being of Americans and to the nation's economic well-being for decades. That promise can only be realized, however, if researchers, civic leaders, universities, government officials and private entrepreneurs work together to overcome serious financial barriers and a shortage of sites where new therapies can be discovered.

Californians recently voted to make $3 billion available for stem-cell research but only $300 million for construction of sophisticated facilities to carry out that research. A leading California life sciences consortium recently found that high costs and a scarcity of approved R & D sites is a growing problem. It urged leaders "…to cooperate to identify areas where facilities (e.g., bio-research parks) can be located, to secure those areas, to provide incentives for development and for companies to locate there, and, most importantly, to maintain a level of ongoing support to keep these areas vital."

Innovation Campuses can Provide Infrastructure to Sustain R&D

Operational mixed-discipline research centers, life science incubators and therapy development centers cannot support themselves. Many potential tenants are start-up companies or non-profits. Most require venture capital, government subsidies, non-profit foundation grants and other support to provide working capital needed to carry a new medical therapy from validated discovery to clinical trial.

Regional Leaders Working with Yolo County to Identify Potential Innovation Corridor

The Yolo County Board of Supervisors has identified the Interstate 80 corridor between East Chiles Road and Mace Boulevard as a planning study area for a university-related research and development corridor. Regional leaders are working with the county to explore a practical plan to support the county's goal of a local environmentally sensitive, university-related R&D site.

Innovation Place Foundation to Provide the Incubator

Governed by a panel of leading local and international researchers, entrepreneurs and university representatives, an Innovation Place Foundation would develop a not-for-profit regenerative medicine and biomedical research incubator; support allied research in clean energy, agriculture and environmental sciences; and administer a for-profit mixed-discipline research park.

The foundation would operate with more than $200 million to provide working capital for research and therapy development advancing validated discoveries to clinical trials. Financial support would come from a share of the proceeds of ancillary and adjacent commercial and residential development that would follow SACOG Blueprint guidelines, provide a jobs-housing balance and protect agriculture and open space in step with Yolo County's heritage.

CIRM Faculty Awards Deadline in August

The big day – at least a day some scientists will not want to miss -- for the handsome faculty awards from the California stem cell agency is Aug. 9.

That is when the letters of intent are due from applicants for the $85 million program, which will provide salary and research support for up to five years for 25 California stem cell scientists. Arlene Chiu, CIRM’s interim chief scientific officer, said,

"These grants are designed to encourage newly independent investigators to pursue bold and innovative studies across the full range of stem cell types – human and animal, embryonic and adult. We will consider providing successful applicants salary and research funding for up to five years, ensuring that they have stable, secure financial support as they begin their independent scientific careers."

The awards are scheduled to be approved in December with cash actually coming next spring.

CIRM's press release can be found here. The RFA here. And an earlier item on the program here.

Klein and His Role on Proposed Stem Cell Research Center

The Northern California land deal/stem cell research center involving California stem cell chairman Robert Klein calls for him to head a new nonprofit group that would be endowed by the family of developer Angelo Tsakopolous.

In response to a query from the California Stem Cell Report, Amy Daly, executive director of Klein's lobbying group, Americans for Stem Cell Therapies and Cures, said,

"As you may be aware, there is a gap in funding in the life of therapy development where many good ideas for therapies and cures die for lack of funding. It is this funding gap that we hope to address with this project. California Institute for Regenerative Medicine has focused (and we believe will continue to focus) much of ithat come from early research and safely see them to the point in time where they are picked up by biotech and VCs (venture capitalists).

"We hope to inspire international collaboration by having board members from world-class institutions from around the world. These institutions, as well as UC Davis and other California institutions, will also have the opportunity to have satellite lab space near the incubator space that we are building for the therapy development."

She continued:

"This project will create a non-profit to bridge that funding gap and we believe it will be called Bridge to Cures. The family donating the land and endowment funds, the Tsakopoulos family, have asked Bob to chair the board of Bridge to Cures. The structure of the board will be similar to the Independent Citizens Oversight Committee with the addition of Angelo and Kyriakos Tsakopoulos and Eleni Tsakopoulos-Kounalakis. We expect that the board will choose to have working groups make recommendations to them similar to the working groups of California Institute for Regenerative Medicine. We hope to inspire international collaboration by having board members from world-class institutions from around the world. These institutions, as well as UC Davis and other California institutions, will also have the opportunity to have satellite lab space near the incubator space that we are building for the therapy development."

Daly's full statement is below.

Amy Daly Statement on Bridge to Cures

We queried Amy Daly, executive director of the Americans for Stem Cell Therapies and Cures, concerning the proposal for a land development project and stem cell research center near Sacramento. Here is her response verbatim.

Bob and Angelo had been spending time talking about this project to fund therapy development around the same time that Americans for Stem Cell Therapies & Cures was holding a fundraising dinner at the home of Robin and Marsha Williams to retire the outstanding campaign debt. The suggested donation for a couple to attend this dinner was $125,000. Angelo is very supportive of stem cell research (as you can see by his incredible generosity with this project) and so he and his wife attended this dinner.

As far as the project referred to in the Sacramento Bee today, there are
many details that were discussed but not included in the article.

"No one tried to strangle Herceptin, but it came near to starving in the
cradle."

As you may be aware, there is a gap in funding in the life of therapy
development where many good ideas for therapies and cures die for lack of
funding. It is this funding gap that we hope to address with this project.
California Institute for Regenerative Medicine has focused (and we believe
will continue to focus) much of its funding to fill the funding gap in early
research. We hope to take the ideas that come from early research and safely
see them to the point in time where they are picked up by biotech and VCs.
An example of this funding gap is found in the history of the development of
Herceptin, as noted here:
http://www.nytimes.com/books/98/09/20/reviews/980920.20henigt.html?_r=1&oref
=slogin.

Without philanthropic financial support for Herceptin during that funding
gap, it would not have been developed to the point where Genentech picked it
up. It is now the number one choice for the treatment of certain types of
breast cancer and saves countless lives.

This project will create a non-profit to bridge that funding gap and we
believe it will be called Bridge to Cures. The family donating the land and
endowment funds, the Tsakopoulos family, have asked Bob to chair the board
of Bridge to Cures. The structure of the board will be similar to the
Independent Citizens Oversight Committee with the addition of Angelo and
Kyriakos Tsakopoulos and Eleni Tsakopoulos-Kounalakis. We expect that the
board will choose to have working groups make recommendations to them
similar to the working groups of California Institute for Regenerative
Medicine. We hope to inspire international collaboration by having board
members from world-class institutions from around the world. These
institutions, as well as UC Davis and other California institutions, will
also have the opportunity to have satellite lab space near the incubator
space that we are building for the therapy development.

This is an incredible opportunity to help further stem cell research and
mitigate human suffering and I am proud that our non-profit has chosen to
support this effort.

Klein Involved in Major Land Deal-Stem Cell Research Center Proposal

California stem cell chairman Robert Klein and a prominent Sacramento area land developer are involved in a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million.

Reporter Mary Lynne Vellinga broke the news in The Sacramento Bee this morning. The developer is Angelo Tsakopolous, who has been active in Democratic fundraising and a major Sacramento developer for decades.

Tsakopolous' company, AKT Development, also contributed $125,000 on April 17 to Klein's private stem cell lobbying group, Americans for Stem Cell Therapies and Cures, which grew out of the Prop. 71 campaign committee. The contribution was not reported in The Bee story.

The Bee story "raises serious and troubling questions, some of which originate from Bob Klein's dual role as chairman of the ICOC and a stem cell political advocacy," said John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights. He told the California Stem Cell Report:

"I've said repeatedly that the dual role is inappropriate and word of this deal and the suggestion that Klein is involved in it while taking contributions is even more troubling."

Klein's activities with the lobbying group have stirred other concerns in the past about conflicts in the case of a man to heads a state agency giving away $3 billion in public funds. (See below for links to previous items on this subject.) Klein still presides over his own development firm, which is based in Palo Alto at the same address as the lobbying group.

The stem cell agency said it had no comment on the development proposal. "We don't know anything about this," said Dale Carlson, chief communications officer for CIRM.

Vellinga wrote that the proposal appears to be in the concept stage, but Tsakopolous and his supporters have hired a well-known political consulting and PR firm, Townsend Raimundo Besler & Usher, and promoted the plan with Yolo County officials.

Vellinga reported:

"The plan is similar in approach to efforts Tsakopoulos has made in Sacramento and Placer counties, where he offered to fund an NBA arena and a university, respectively, with the proceeds from new development on agricultural land that is now off limits to building.

"As outlined Wednesday by Tsakopoulos' spokesman, Jeff Raimundo, the Yolo proposal is short on specifics, such as how much housing, office or retail space he would seek permission to build on about 2,800 acres of land he controls between the city of Davis and the Vic Fazio Yolo Wildlife Area.

"In meetings with Yolo officials, including a dinner held at the Sutter Club in downtown Sacramento, Tsakopoulos and his supporters have stressed the benefits of the stem cell facility but have offered little detail about what it would take to finance it."

Vellinga continued:

"'Bob and Angelo thought this up,' Amy Daly, executive director of the Alliance for Stem Cell Research, said of the new idea for a research center. 'My understanding is that Angelo is looking for a legacy he can leave. He wants to do something big. And Bob lives, eats and breathes stem cell research.'

"Daly, who worked with Klein on the stem cell initiative, also is helping promote the Tsakopoulos plan. She said there is a significant funding gap for research that's beyond the basic stage but not ready to hit the market. The new center could fill that gap, she said."

Daly also worked for the California stem cell agency as director of patient and medical organization relations from Jan. 14, 2005, to Nov. 25, 2005.

Raimundo told the California Stem Cell Report that Yolo County supervisors "first started the dialogue about a biomedical research corridor." Raimundo said the project had a goal of generating a $200 million endowment for the center, although there were no details how the funds would be raised. He said any development would likely include residential and commercial building.

He told CSCR:

"This is a real convergence of a county that wants to boost its economic development and is willing to look at biomedical research complexes along I-80, a biotech community looking for research incubators in a comprehensive university-oriented R&D complex with allied ventures, and a willing and enthusiastic landowner.

"No specific plan has been created yet, but what ultimately is built here will be determined by the county as part of their general plan update."

Simpson, of FTCR, said,

"I'm extremely doubtful of a commercial real estate project that tries to ride on the coattails of 'stem cell research.'

"Many questions need to be answered about this deal by both Angelo Tsakopoulos and Bob Klein.

"A good start for Klein would be to decide if he wants to be chairman of the ICOC or of his political advocacy group. He should not serve as both."

Here are links to some previous items on Americans for Stem Cell Therapies and Cures. "Ongoing Threat," "Background Statement," "Two Hats" and "Unseemly Position."

(Personal disclosure from the California Stem Cell Report: Raimundo is a friend and former colleague at The Bee. Vellinga is also a former colleague. I have met Tsakopolous on several occasions and have directed news coverage of some of his enterprises. I have exchanged email with Markos Kounalakis, Tsakopolous' son-in-law and president of the Washington Monthly, and once submitted an article to that magazine that I ultimately withdrew from consideration because of the length of the editing process.)

Kuehl on CIRM Bill: Breathing Room, Yes -- Abandonment, No

In what may be the only mainstream media story on the subject today, the San Jose Mercury News quoted a powerful state legislator as saying she is not giving up on her legislation to guarantee the state a better return on its $3 billion stem cell research investment.

Reporter Steve Johnson quoted Sen. Sheila Kuehl, D-Santa Monica, chair of the Health Committee, as saying,

"I'm not abandoning the issue in any way."

Johnson wrote:

"Delaying the measure until the institute completes its (intellectual property) policy 'would remove one more thing they could say in opposition to my bill,' she said."

Johnson also quoted Dale Carlson, chief communications officer for CIRM, as saying the agency appreciates "being able to finish their policy without having to worry about legislators passing a competing one."

"We begged and pleaded for time to complete our regulatory process and it appears that's what they're giving us."

For more on SB771, see the items below.

CIRM Legislation: A Political Muscle Story or Casualty of a Full Plate or Both?

The legislative effort to step into the affairs of the California stem cell agency attracted virtually no public notice during its short life this year.

Only a handful of stories – or less – recognized the existence of SB771 (see item below).

But John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, has been active in the area involving the legislation and is a regular presence at CIRM meetings. He was acutely aware of the measure.

Today he issued a news release that said the legislature "missed an opportunity to ensure affordable access to any stem cell discoveries financed by California taxpayers."

Simpson continued:

"Sadly, both the proposed bill and regulations being developed by the stem cell institute fail to protect consumers from the possibility of unreasonable pricing of discoveries resulting from research they paid for. The bill was really about political muscle and how much influence the legislature should have over the stem cell institute, not the people's interests."

Another analysis could also note that the bill's author, Sen. Sheila Kuehl, has a very full legislative plate and that winning passage of the measure would be akin to winning the California lottery. In a word, remote.

Whatever the case, Simpson's statement and the shelving of the legislation are likely to attract little – or less – attention in the media.

CIRM Legislation Finished for 2007

Legislation to ensure a fair return to the state on its $6 billion stem cell research investment and to provide affordable access to any resultant therapies has been shelved for at least the remainder of the year.

A spokesman for Sen. Sheila Kuehl, D-Santa Monica, lead author on SB771, said the measure was put off to allow the stem cell agency to finish its regulations for intellectual property, the vehicle for determining how to split up potential largess from stem call products.

The spokesman, Peter Hansel, said that if the regulations "come up short," the authors of the bill intend to push it in 2008. Sen. George Runner of Antelope Valley, one of the legislature's Republican leaders, is also an author of the bill.

Hansel said,

"In the near term, the bill is going to be used to used for another unrelated purpose, but the authors intend to amend its provisions into another Senate bill in the Assembly once we identify a vehicle that is not moving. This should be viewed as a temporary move and not as any diminishment of the authors' underlying commitment to the issue."

The bill was opposed by CIRM and the California biotech industry. It easily passed the Senate. But to become law it needs a super, supermajority vote (70 percent) as well in the Assembly and the signature of the governor, who is a strong supporter of CIRM.

No Action Today on New CIRM President

Directors of the California stem cell agency met Tuesday in executive session to discuss candidates to fill the vacant post of president of the $3 billion enterprise, but came to no public decision.

Dale Carlson, chief communications officer for CIRM, said the special, teleconference meeting of the Oversight Committee adjourned without acting on a public agenda item calling for consideration of presidential compensation and candidates.

At this point, one can only speculate on why those matters were placed on the public agenda if no action was planned. One explanation is that hopes existed that a deal with an applicant could be concluded in time for the meeting, but for some reason an agreement could not be reached. State law does not permit the Oversight Committee to act on matters without adequate public notice.

Former president Zach Hall announced last December that he would leave the agency this month. In April, he said he was leaving earlier following a contentious meeting of the CIRM Facilities group.

The first presidential search was prolonged as well, missing the Oversight Committee's self-imposed deadline in 2005 by three months.

Presidential Search Committee Anticipates No Public Action Tonight

The presidential search subcommittee of the California stem cell agency has begun its meeting but is not expected to announce any action tonight.

Dale Carlson, chief communications officer for CIRM, said the group convened its teleconference meeting and promptly went into executive session to consider presidential selection issues. He said the group was not scheduled to make an announcement this evening.

The full Oversight Committee meets tomorrow morning at 7 a.m. to consider presidential salaries and candidates.

Coming Up

The presidential search subcommittee of the California stem cell agency meets at 5 p.m. California time today (midnight Greenwich Mean Time 6/26) with an unusual international teleconference meeting of the full Oversight Committee scheduled for 7 a.m. California time (2 p.m. Greenwich) tomorrow.

Presidential compensation and candidates are on the agenda for the Oversight meeting. But first they will pass through the subcommittee.

We expect to bring you coverage of any action by the subcommittee tonight, which will be largely behind closed doors, if anything is announced. The meeting is estimated to run for perhaps two hours.