The California stem cell agency Monday moved forward on its largest single grant effort – a $220 million proposal for new research labs – with hopes that some construction could begin as early as next January.
The Facilities Working Group of the California Institute for Regenerative Medicine (CIRM) sent criteria, evaluation standards and grant review procedures for the lab grants to the agency's Oversight Committee for approval when it meets Aug. 8 in San Francisco.
Major universities and research institutions in California, ranging from Stanford to UC San Diego, are lining up for the money. Some have been planning since November 2004 when Prop. 71 created CIRM and provided it with $3 billion in funding, the largest single financial source for human embryonic stem cell research in the world.
The group did not settle on a firm timetable, but Robert Klein, chairman of the Oversight Committee, said he expected to see initial approval of the grants in early January. He said that would mean that some institutions could begin construction shortly thereafter.
That would be possible under a new, two-step grant review process approved by the working group Monday. It calls for the scientific component of the proposals to be approved first via the scientific grants group with facilities group action later. Klein said high rankings at the first stage of approval (at a yet to be scheduled Oversight meeting early in January) would permit some ambitious institutions to begin work. Jeff Sheehy, a member of the Oversight Committee and the facilities group, said the new process could speed up final approval by at least a month compared to the smaller, shared lab grant review completed earlier this year.
The facilities group also indirectly addressed the ticklish question of dividing the grant money between smaller, less-established institutions and the heavyweights of stem cell research. The proposed grant rules call for applicants to choose as many as three scientific areas where they believe they have strength: basic and discovery research, preclinical research, preclinical development and clinical research. The areas were dubbed, respectively, Element X, Element Y and Element Z.
If a university identifies itself as having strength in all three elements (XYZ), it will compete against other similar XYZ institutions as a “CIRM Institute.” If it has strength in two elements, it will compete as “CIRM Center of Excellence.” If strength is in one area, the competition will be among other single-strength “CIRM Special Programs.”
The grant process places emphasis on value, leverage and urgency, which account for 70 out of 100 possible points. The urgency component (20 points) requires a two-year construction timetable with financial penalties for failing to meet deadlines. The value component( 25 points) calls for a “good return to the taxpayer,” among other things. The leverage component (also 25 points) is aimed at forcing the institutions to come up with major financial support for their proposals in addition to CIRM funding.
Several times the discussion focused on ambiguities in the criteria such as “facility assets,” “enhanced capability” and “reasonable and necessary.” Some of these are likely to be refined as a final RFA is developed. But Klein told the small audience at today's meeting at CIRM headquarters in San Francisco, “We're going to make a lot of subjective decisions.” It was a refrain he came back to several times.
Following the meeting, when we asked him about the difficulties posed for applicants by ambiguous terms, he said they do create challenges. But he said the criteria is designed to “accommodate the creativity” that California institutions have. He and others on the facilities group said they wanted to provide ample opportunity for imaginative approaches to lab construction, management and collaboration.
The facilities group also approved a rule aimed at preventing double-dipping in the grant process. It permits only one application per institution with funding for a single project on a single site. This means, for example, that if a legally constituted consortium applies for a grant, members of that consortium cannot apply for another grant separately.
John M. Simpson, stem cell project director of the Foundation for Consumer and Taxpayer Rights and a longtime attendee at CIRM sessions, praised the overall process for the lab grants. Often a critic of CIRM and the grant process at one point, he said the facilities group meetings benefited both the agency and applicants, generating a higher participation from the applicants/public compared to many other CIRM sessions. That “enhances the output,” he said.
Simpson is correct about the larger turnout, but even that is small, ranging from 30 to 40 persons at its peak during the recent round of meetings. What surprised us is the fact that some potential applicants did not regularly attend the sessions. That means they will miss important nuances that are not available via online transcripts and Power Point presentations. As for attendance by the general public, nobody bothered, but that is not much different than public proceedings at any other state agency.
To see more specifics of what the facilities group considered, see this location. The document is likely to be reposted in several days with changes from today's meeting as part of the Oversight Committee agenda.
With more than 3.0 million page views and more than 5,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency. David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.
Monday, July 30, 2007
Golden Eggs on The Stem Cell Blog
Time to move off this channel briefly and visit The Stem Cell Blog (published by Chris Scott of Stanford) to read a guest posting from this writer on the $220 million lab grant program at the California stem cell agency. It begins:
“You could call it a stem cell variation of the chicken and egg question.A little later this afternoon we will have an update right here on this site concerning this morning's developments at CIRM. The Facilities Working Group modified the rules for making the lab grants and moved them along to the full Oversight Committee for consideration Aug. 8. The intention is to see at least some institutions begin construction on their approved facilities in January.
“But in this case, it involves edifices – not eggs. And researchers – not roosters. Which is more important?”
Sunday, July 29, 2007
ACT, NIH and No Go Federal Funding
Despite all the hoopla on the Potomac about stem cell research, don't expect the federal situation to change any time soon and eliminate the justification for California's own $3 billion stem cell research effort.
The latest evidence for that came in a piece Sunday by Rick Weiss of the Washington Post. It demonstrated the hidebound nature of the NIH as well as the constraints it faces. The piece did not have to mention NIH's tight financial situation.
Here are the first few paragraphs of Weiss' story:
(Editor's note: ACT is headquartered in Alameda, California – not in Massachusetts. Why is it in the Golden State? Because that is where the money is. We should also note that a public relations agency for ACT is sending copies of the Weiss story to various interested parties, probably throughout the country. Nothing wrong with that. If you have a drum, you probably should beat it.)
The latest evidence for that came in a piece Sunday by Rick Weiss of the Washington Post. It demonstrated the hidebound nature of the NIH as well as the constraints it faces. The piece did not have to mention NIH's tight financial situation.
Here are the first few paragraphs of Weiss' story:
"With the active encouragement of the Bush administration, U.S. scientists in the past year have developed several methods for creating embryonic stem cells without having to destroy human embryos.Even with a change of administration in 2009 and a Democratic Congress, it will take a considerable amount of bureaucratic shuffling to chart a new NIH and federal course on embryonic stem cell research. Then additional funds would have to become available or be taken from existing research – an effort that would be strongly resisted. Some would argue at that point that states are already handsomely financing ESC research, and more is not needed from the feds. Even if funds become become available, then the NIH has to go through another lengthy award process.
"But some who now wish to test their alternatively derived cells have found themselves stymied by an unexpected barrier: President Bush's stem cell policy.
"The 2001 policy says that federal funds may not be used to study embryonic stem cells created after Aug. 9 of that year. It is based on the assumption that the only way to make the cells is by destroying human embryos -- a truism in 2001 but not any longer.
"As a result, the National Institutes of Health recently refused to consider a grant application for what would have been the first federal study to compare several of the new, less politically contentious stem cell lines.
"'This is not the way to make good health policy,'" said Robert Lanza, the frustrated vice president for research and scientific development at Advanced Cell Technology (ACT) in Worcester(see editor's note below), Mass. Lanza submitted the study proposal with stem cell experts from several major research labs."
(Editor's note: ACT is headquartered in Alameda, California – not in Massachusetts. Why is it in the Golden State? Because that is where the money is. We should also note that a public relations agency for ACT is sending copies of the Weiss story to various interested parties, probably throughout the country. Nothing wrong with that. If you have a drum, you probably should beat it.)
Labels:
federal funding,
federal policy,
media coverage
Friday, July 27, 2007
Stanford's Chris Scott and His New Stem Cell Blog
A snappy new blog on stem cell issues has popped up at Stanford University, complete with a reading list and podcasts.
Called "The Stem Cell Blog," it is published by Chris Scott, director of Stanford's Program on Stem Cells in Society and author of the book, "Stem Cell Now." (You can find a picture of Scott here.)
The first post dates back to June 26 with a graphic account about research with live pigs. More recently, the blog has a post based on work by Susan Stayn, Stanford's state stem cell legal expert. Called “What Color is Your State?” it begins like this:
We have added The Stem Cell Blog to our links on the left of this site.
Called "The Stem Cell Blog," it is published by Chris Scott, director of Stanford's Program on Stem Cells in Society and author of the book, "Stem Cell Now." (You can find a picture of Scott here.)
The first post dates back to June 26 with a graphic account about research with live pigs. More recently, the blog has a post based on work by Susan Stayn, Stanford's state stem cell legal expert. Called “What Color is Your State?” it begins like this:
"Taking a cue from Homeland Security, we’ll periodically publish a color-coded ranking of American states and their legislative positions on embryonic stem cell research."You can also download the state rankings in a PDF file.
We have added The Stem Cell Blog to our links on the left of this site.
Weekend Reading: Guide to a $220 Million Giveaway
For all of you stem cell lab hopefuls, the California stem cell agency has posted 29 pages of Power Point presentations that will be used during Monday's meeting on the $220 million program.
It includes the latest thinking from the “interested parties” meeting earlier this week as well as other fresh developments. We have not yet digested the material, which is a bit complex. But if you have a horse in this race, check it out. Monday's meeting is the last before the massive program comes up at the full Oversight Committee session Aug. 8.
Here is the link to the documents.
It includes the latest thinking from the “interested parties” meeting earlier this week as well as other fresh developments. We have not yet digested the material, which is a bit complex. But if you have a horse in this race, check it out. Monday's meeting is the last before the massive program comes up at the full Oversight Committee session Aug. 8.
Here is the link to the documents.
CIRM Group Gives Nod to Japanese Cell Lines
The California stem cell agency Friday moved to add some Japanese stem cell lines to two already approved foreign lines and to make it easier for California researchers to engage in experiments to reprogram somatic stem cells.
Meeting in San Francisco in a national teleconference session, the Standards Working Group made positive recommendations in both areas that will be taken up Aug. 8 by the agency's Oversight Committee.
The Japanese lines are ones that are derived under the “Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells.” Geoff Lomax, senior CIRM officer for the standards group, said researchers are seeking as many lines as possible. He also said a delegation of Japanese scientists had requested inclusion of the lines. UK and Canadian stem cell lines already enjoy pre-approval.
The group also discussed the question of varying deadlines for using embryos for derivation of stem cells. Prop. 71 sets a deadline of 12 days after cell division. The Japanese deadline is 14, as is the UK, according to testimony. Bernie Lo, chairman of the standards group, noted that it is not currently
actually possible to derive embryonic stem cells beyond 12 days.
After some discussion, Lo asked CIRM staff to research the issues involved so that CIRM can act quickly when derivations can occur after 12 days.
The group additionally recommended that CIRM permit reprogramming experiments on existing somatic stem cells that do not necessarily meet the informed consent requirements intended to be used for new cell lines. Ann James, senior university counsel for Stanford University, said researchers at her school wanted maximum flexibility.
Kevin Eggan of Harvard, a member of the CIRM group, said such cell lines have been in use for perhaps as long as a decade and represented a valuable starting point for research into how to reprogram adult cells into pluripotent ones – the characteristic that makes human embryonic stem cells so valuable. Others noted that it would be all but impossible to replicate today's informed consent requirements for those older lines.
Patricia Olson, scientific program officer at CIRM, said permitting use of the older lines would only allow CIRM-funded researchers to do what others already do outside of California.
Background material from CIRM on these issues can be found here.
Meeting in San Francisco in a national teleconference session, the Standards Working Group made positive recommendations in both areas that will be taken up Aug. 8 by the agency's Oversight Committee.
The Japanese lines are ones that are derived under the “Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells.” Geoff Lomax, senior CIRM officer for the standards group, said researchers are seeking as many lines as possible. He also said a delegation of Japanese scientists had requested inclusion of the lines. UK and Canadian stem cell lines already enjoy pre-approval.
The group also discussed the question of varying deadlines for using embryos for derivation of stem cells. Prop. 71 sets a deadline of 12 days after cell division. The Japanese deadline is 14, as is the UK, according to testimony. Bernie Lo, chairman of the standards group, noted that it is not currently
actually possible to derive embryonic stem cells beyond 12 days.
After some discussion, Lo asked CIRM staff to research the issues involved so that CIRM can act quickly when derivations can occur after 12 days.
The group additionally recommended that CIRM permit reprogramming experiments on existing somatic stem cells that do not necessarily meet the informed consent requirements intended to be used for new cell lines. Ann James, senior university counsel for Stanford University, said researchers at her school wanted maximum flexibility.
Kevin Eggan of Harvard, a member of the CIRM group, said such cell lines have been in use for perhaps as long as a decade and represented a valuable starting point for research into how to reprogram adult cells into pluripotent ones – the characteristic that makes human embryonic stem cells so valuable. Others noted that it would be all but impossible to replicate today's informed consent requirements for those older lines.
Patricia Olson, scientific program officer at CIRM, said permitting use of the older lines would only allow CIRM-funded researchers to do what others already do outside of California.
Background material from CIRM on these issues can be found here.
Thursday, July 26, 2007
Thomson Report Carried by Nature, Chronicle of Higher Education
Nature magazine and the Chronicle of Higher Education have picked up a report from this blog on Jamie Thomson's ties to UC Santa Barbara.
The report in Nature briefly discussed the flap involving the Wisconsin Alumni Research Foundation's ownership on patents originating from Thomson's work on human embryonic stem cells.
The Chronicle's story on its news blog cited the Nature item as its source. Both publications also mentioned this blogger's report, noting that the Thomson connection helped UCSB win a $2.3 million grant from CIRM.
The report in Nature briefly discussed the flap involving the Wisconsin Alumni Research Foundation's ownership on patents originating from Thomson's work on human embryonic stem cells.
The Chronicle's story on its news blog cited the Nature item as its source. Both publications also mentioned this blogger's report, noting that the Thomson connection helped UCSB win a $2.3 million grant from CIRM.
Wednesday, July 25, 2007
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.
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.
Tuesday, July 24, 2007
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.
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.
Sunday, July 22, 2007
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,
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.
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.
Wednesday, July 18, 2007
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:
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:
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.For more on this issue, see the Yolo item below. Searching on the label Yolo will also turn up additional items.
"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.”
Tuesday, July 17, 2007
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.
Monday, July 16, 2007
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.)
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
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
Sunday, July 15, 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:
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:
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."
Saturday, July 14, 2007
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:
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.We add that it takes repetition, repetition and more repetition to have an impact.
"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."
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