California's huge state college system is proposing that the California stem cell agency finance a $31 million, five-year program to train thousands of persons to work in biotech and related fields.
Officials of 23-campus, California State University and College system are scheduled to appear before CIRM's Oversight Committee this Wednesday to tout the proposal. No hint of the size or scope of the proposal is available on the committee's agenda. After several days of questioning, state college officials finally confirmed that this document that we found on the Internet lays out details and justification for the training program.
The document says that state and community colleges are in the best position to educate the workforce required by the state's stem cell industry. The goals of the effort including a doubling of the number of CSUS students graduating with training in biotech and related fields over the next five years. It also calls for creation of new courses, graduate level programs and creation of regional training facilities.
California stem Chairman Robert Klein placed only a cryptic notation concerning the CSUS matter on Wednesday's Oversight Committee agenda. No further information was available except for the response from CSUS.
(For those of you unfamiliar with higher education in California, the CSUS is completely separate from the University of California.)
Sunday, August 05, 2007
Friday, August 03, 2007
Peril and the CIRM Presidential Search
Attempting to understand the presidential search of the California stem cell agency certainly meets the definition of a task fraught with peril. It is a process that is being conducted behind closed doors and whose participants are sworn to secrecy on any significant details. All of which is entirely appropriate.
Nonetheless the search is fundamentally important to the current and future health of the $3 billion effort and is worthy of some public scrutiny.
We wrote earlier this week about the process, and today another piece of ours appeared on Wired.com.
To summarize: compensation, personal chemistry, structural management issues all are complicating the recruitment effort. But there are others, one of which is the desire for a blue ribbon scientist to run the agency. But the new president would also be expected to give up his lab and research work. The first search in 2005 apparently brought forth some scientists/presidential candidates who wanted to continue their lab work. This time around that seems to have been ruled out by the Oversight Committee. So that narrows the field.
Former president Zach Hall earlier this year suggested to CIRM directors that a new president could do very well without having a high-toned scientific pedigree. But when we talked to Oversight Committee member Jeff Sheehy last week, he said candidates with a good scientific vision were the ones that excited him. Of course, Sheehy is but one of 29 members of the committee.
Hall also said in an interview last month that the Oversight Committee “must be willing to enable a new president to take a strong leadership role.” It was a comment based on the ticklish relationship between him and California stem cell chairman Robert Klein, which was exacerbated by Prop. 71's unnecessary dabblings in management minutia. Those are now locked in state law and virtually immutable.
Finally come comments from John Simpson of the Foundation for Taxpayer and Consumers Rights. He is a longtime observer of CIRM and reasonably fair-minded. We asked him for his thoughts on the search. Here is the text of what he sent us:
Nonetheless the search is fundamentally important to the current and future health of the $3 billion effort and is worthy of some public scrutiny.
We wrote earlier this week about the process, and today another piece of ours appeared on Wired.com.
To summarize: compensation, personal chemistry, structural management issues all are complicating the recruitment effort. But there are others, one of which is the desire for a blue ribbon scientist to run the agency. But the new president would also be expected to give up his lab and research work. The first search in 2005 apparently brought forth some scientists/presidential candidates who wanted to continue their lab work. This time around that seems to have been ruled out by the Oversight Committee. So that narrows the field.
Former president Zach Hall earlier this year suggested to CIRM directors that a new president could do very well without having a high-toned scientific pedigree. But when we talked to Oversight Committee member Jeff Sheehy last week, he said candidates with a good scientific vision were the ones that excited him. Of course, Sheehy is but one of 29 members of the committee.
Hall also said in an interview last month that the Oversight Committee “must be willing to enable a new president to take a strong leadership role.” It was a comment based on the ticklish relationship between him and California stem cell chairman Robert Klein, which was exacerbated by Prop. 71's unnecessary dabblings in management minutia. Those are now locked in state law and virtually immutable.
Finally come comments from John Simpson of the Foundation for Taxpayer and Consumers Rights. He is a longtime observer of CIRM and reasonably fair-minded. We asked him for his thoughts on the search. Here is the text of what he sent us:
"The selection of CIRM's president is undoubtedly the ICOC's single most important task. He or she will be the chief executive of an enterprise that is costing California taxpayers $6 billion.One caveat to Simpson's remarks. While Klein did speak last December about stepping down next year, it is not a done deal.
"Zach Hall helped define the president's role and deserves credit for getting the fledgling agency off the ground. The new president faces the daunting task of moving forward from entrepreneurial, adrenaline-filled days of a start-up mode to maintaining an established agency where the routine is, indeed, routine.
"He or she must be seen to do the public's business in public and will need vision to move the agency forward.
"A thick skin and diplomatic skills will be a necessary in dealing with some of the oversized egos on the ICOC as well as the various members of the public who take an interest in the agency.
"Judging from hints dropped by ICOC Chairman Bob Klein, the new president will have to deal with a new board chairman within a year; Klein will likely step down in 2008. That could make the new president's job easier.
"The average California probably won't pay much attention to the agency even though $6 billion of taxpayer money is at stake unless something goes terribly wrong, or incredibly right -- meaning a significant scientific breakthrough results from California's efforts.
"The most likely scenario is the middle ground. Incremental advances, but no flashy breakthroughs.
"If the ICOC can pick the perfect person, however, Californians will ultimately take notice because the president will actually deliver on the wild promises made during the campaign to pass Proposition 71."
Time for More Openness in $220 Million Grant Program
The California Stem Cell Report today formally called on directors of the California stem cell agency to open up the $220 million lab grant process by making the names of applicants and other related information a matter of public record.
In a letter to California stem cell Chairman Robert Klein, David Jensen, publisher of the report, said such action would conform to the letter and spirit of the California Constitution, which guarantees the public a broadly construed right of access to information about “the conduct of the people's business.” He also said opening up the information would help to preserve public confidence in embryonic stem cell research.
Here is the text of the letter:
In a letter to California stem cell Chairman Robert Klein, David Jensen, publisher of the report, said such action would conform to the letter and spirit of the California Constitution, which guarantees the public a broadly construed right of access to information about “the conduct of the people's business.” He also said opening up the information would help to preserve public confidence in embryonic stem cell research.
Here is the text of the letter:
"This letter is to request that the Oversight Committee -- as part of the RFA to be considered for major labs at the Aug,. 8 meeting -- stipulate that the names of the applying institutions, their letters of intent and applications are a public record when they are received by the California Institute for Regenerative Medicine.
"Such action by the ICOC would serve the best interests of CIRM and its goal of adherence to the highest standards of openness and transparency. It would also comply with the letter and spirit of the California Constitution, which declares that the people of California have “the right of access to information concerning the conduct of the people’s business” -- a right that is to be “broadly construed.” As you know, 83 percent of voters approved that constitutional right of access in November 2004 when they passed Prop. 59.
"In many ways, the California Institute for Regenerative Medicine is very open, which is a tribute to the Oversight Committee's commitment to transparency.
"But now, as the agency embarks on its single largest round of grants, it is time to take another step to protect the public interest and the agency itself as well. Fifteen members of the Oversight Committee have ties of one sort or another to institutions that may well seek funds in this round of lab grants. The entire University of California system is represented on the board, along with Stanford University, the Burnham Institute and other well-regarded institutions. On Aug. 8, the board will set the rules under which employers of many of its members stand to benefit by tens of millions of dollars. Combine all that with the critically important but closed-door, scientific review of the applications, and you have an information void that can only lead to the worst sort of speculation. Making the applicant names and other information public goes a long way in helping to prevent such a situation.
"In the past, CIRM has made a case for privacy on research grant applications from individual scientists. But applications from government and nonprofit institutions are fundamentally different. They are not subject to the same concerns that individual researchers might have regarding their reputations or work.
"We urge you to act in the public's best interest and open up the $220 million lab grant process by making public the names, letters of intent and applications from all institutions seeking funds. Such a move will enhance CIRM's reputation and help to maintain public confidence in embryonic stem cell research."
Thursday, August 02, 2007
A Wired Look at CIRM Presidential Search
Wired.com has a piece by yours truly on the effort to find a new president for the California Institute for Regenerative Medicine. We will carry more a few more details on the effort later on Friday. You can find the Wired article here.
Corn, Ham and the Women of CIRM
From Hollywood's Sherry Lansing to Davis' Claire Pomeroy, patient advocate Don Reed covered them all. Wonder Women, he called them.
Reed is the irrepressible patient advocate who doggedly attends almost every meeting involving the California stem cell agency and then goes on to fight the stem cell fight nationwide via the Internet.
On his blog – stemcellbattles.com – the July 31 posting involved the women on CIRM's Oversight Committee. Reed did not mention the women who staff the agency, including the two who are now in charge of the effort. But he probably will.
With Lansing, Reed reached into the past and rented a movie, Rio Lobo, in which she appeared with John Wayne. Lansing's heart-of-gold character did away with a bad guy who had done her wrong, but then helped Wayne to walk again.
Reed himself is a goodhearted fellow. Some people might think his writing style a little corny, but I once had a high school speech teacher who constantly reminded me, “Corn is better than ham any day of the week.”
Reed is the irrepressible patient advocate who doggedly attends almost every meeting involving the California stem cell agency and then goes on to fight the stem cell fight nationwide via the Internet.
On his blog – stemcellbattles.com – the July 31 posting involved the women on CIRM's Oversight Committee. Reed did not mention the women who staff the agency, including the two who are now in charge of the effort. But he probably will.
With Lansing, Reed reached into the past and rented a movie, Rio Lobo, in which she appeared with John Wayne. Lansing's heart-of-gold character did away with a bad guy who had done her wrong, but then helped Wayne to walk again.
Reed himself is a goodhearted fellow. Some people might think his writing style a little corny, but I once had a high school speech teacher who constantly reminded me, “Corn is better than ham any day of the week.”
A $100 Million Collaborative Effort
CIRM Oversight Committee members Ed Penhoet and Claire Pomeroy enjoyed a $100 million day earlier this week in Sacramento.
The occasion was the announcement that the Gordon and Betty Moore Foundation was giving the money to UC Davis to establish a nursing school. Penhoet is president of the foundation. Pomeroy is dean of the medical school at UC Davis.
The Moore donation is the largest ever made to UC Davis and one of the largest ever for the University of California system.
Gordon Moore is one of the founders of Intel. His son, Ken, was present for the announcement. A story written by Bill Lindelof and Dorsey Griffith reported the following:
The occasion was the announcement that the Gordon and Betty Moore Foundation was giving the money to UC Davis to establish a nursing school. Penhoet is president of the foundation. Pomeroy is dean of the medical school at UC Davis.
The Moore donation is the largest ever made to UC Davis and one of the largest ever for the University of California system.
Gordon Moore is one of the founders of Intel. His son, Ken, was present for the announcement. A story written by Bill Lindelof and Dorsey Griffith reported the following:
"He (Ken) said a nurse came into his mother's room and told her it was time for a shot. Betty Moore balked, but the nurse insisted.Sharon Stello of the Davis Enterprise reported:
"'Turns out she got the insulin shot that should have gone to the patient in the neighboring bed,' said Ken Moore. 'They nearly had two deaths out of one medical error. That was the start of her really being interested in nursing care.'"
"UCD spokeswoman Lisa Lapin said initial connections between the foundation and the Davis campus were made between Claire Pomeroy, UCD vice chancellor for human health sciences and dean of the medical school, and Penhoet, both of whom serve on the California Stem Cell Commission(sic). They started talking about mutual visions for nursing education, and the conversation evolved into the grant."
CIRM Director Nova Taking Her Firm Public
Tina Nova, a director of the California stem cell agency, is looking for a big payday when the company she heads, Genoptix, goes public, seeking to raise $86 million.
The Carlsbad, Ca., firm has filed documents with the federal government announcing its plans for an initial public offering. Genoptix, which reported its first quarterly profit this year, provides laboratory and diagnostic services to hematologists and oncologists. It is backed by venture capitalists including
Enterprise Partners, Chicago Growth Partners, William Blair Capital Partners, Alliance Technology Ventures, Tullis-Dickerson, Excelsior Venture Partners and others.
Nova is one of 29 members of the Oversight Committee for CIRM. The IPO filing, which has lots of interesting business details, can be found here.
The Carlsbad, Ca., firm has filed documents with the federal government announcing its plans for an initial public offering. Genoptix, which reported its first quarterly profit this year, provides laboratory and diagnostic services to hematologists and oncologists. It is backed by venture capitalists including
Enterprise Partners, Chicago Growth Partners, William Blair Capital Partners, Alliance Technology Ventures, Tullis-Dickerson, Excelsior Venture Partners and others.
Nova is one of 29 members of the Oversight Committee for CIRM. The IPO filing, which has lots of interesting business details, can be found here.
Wednesday, August 01, 2007
CIRM, Entropy and the Presidential Search
The California stem cell agency entered its fourth month today without a permanent president, although its directors knew last December that the post would be vacant by summer.
On Monday, Robert Klein, chairman of the agency's Oversight Committee, told the California Stem Cell Report that he expected the search to move forward “in a material way” at next Wednesday's meeting of CIRM directors. However, he did not predict a decision on either a candidate or a new salary for the president.
Klein said he was “committed to getting absolutely the right person.” He said the search is not taking long when compared 12 to 18 month efforts to find top academic or university executives.
The Oversight Committee met three times in unusual, teleconference meetings between the end of June and the end of July to consider candidates and compensation. But those meetings, conducted mainly in private, ended with no public action.
The presidential search is not on the public portion of the Oversight Committee's agenda Wednesday, but the matter can be taken up during the group's scheduled personnel session, which also will be behind closed doors.
Following last week's meeting of the CIRM standards group, Jeff Sheehy, a member of the Oversight Committee, said in an interview that compensation is a significant factor in the search, which apparently involves candidates from academe. He noted that CIRM cannot provide special housing allowances that are often part of the compensation mix in academic recruitment efforts. Nor can the institute provide loans to its employees. Academic employment also can provide tenure and other financial opportunities that would not be available to a CIRM president.
Since the beginning of May, two capable CIRM staffers have picked former president Zach Hall's responsibilities on an interim basis. But earlier this year, we pointed out that organizations with lame duck CEOs and interim presidents can easily slip into drift. No one wants to make a decision that would tie the hands of a new president. Hiring new staffers can also be difficult. While it is hard to quantify the impact, it can be quite harmful. More than one director has voiced that concern.
As far back as last January, Oversight Committee member Michael Goldberg warned fellow directors against complacency. Goldberg has more than a nodding acquaintance with such issues as a venture capitalist who directs life science investments for Mohr Davidow Ventures of Menlo Park, Ca.
He said,
On Monday, Robert Klein, chairman of the agency's Oversight Committee, told the California Stem Cell Report that he expected the search to move forward “in a material way” at next Wednesday's meeting of CIRM directors. However, he did not predict a decision on either a candidate or a new salary for the president.
Klein said he was “committed to getting absolutely the right person.” He said the search is not taking long when compared 12 to 18 month efforts to find top academic or university executives.
The Oversight Committee met three times in unusual, teleconference meetings between the end of June and the end of July to consider candidates and compensation. But those meetings, conducted mainly in private, ended with no public action.
The presidential search is not on the public portion of the Oversight Committee's agenda Wednesday, but the matter can be taken up during the group's scheduled personnel session, which also will be behind closed doors.
Following last week's meeting of the CIRM standards group, Jeff Sheehy, a member of the Oversight Committee, said in an interview that compensation is a significant factor in the search, which apparently involves candidates from academe. He noted that CIRM cannot provide special housing allowances that are often part of the compensation mix in academic recruitment efforts. Nor can the institute provide loans to its employees. Academic employment also can provide tenure and other financial opportunities that would not be available to a CIRM president.
Since the beginning of May, two capable CIRM staffers have picked former president Zach Hall's responsibilities on an interim basis. But earlier this year, we pointed out that organizations with lame duck CEOs and interim presidents can easily slip into drift. No one wants to make a decision that would tie the hands of a new president. Hiring new staffers can also be difficult. While it is hard to quantify the impact, it can be quite harmful. More than one director has voiced that concern.
As far back as last January, Oversight Committee member Michael Goldberg warned fellow directors against complacency. Goldberg has more than a nodding acquaintance with such issues as a venture capitalist who directs life science investments for Mohr Davidow Ventures of Menlo Park, Ca.
He said,
"There's a whole organization there that's been charged with an enormous responsibility of administering the research apparatus of the CIRM, and it's leaderless. I don't like working for an organization that's leaderless. I say leaderless, I don't mean that in the sense it doesn't have a chair engaged and vice chair engaged and (outgoing president Zach Hall's) engagement, but it's not the same as an organization that's moving forward.
"There's entropy in my experience at this stage of an organization's life with a leader who's announced his departure....That should give us actually an increased sense of urgency, if anything. so I'd like to do everything we can to fast track the process without sacrificing any of the transparency and engagement with stakeholders that I think we're all committed to."
CIRM Directors to Address Business IP and Lab Grants
Directors of the California stem cell agency meet next Wednesday with a $220 million matter foremost in their minds, but other issues, such as intellectual property rules for grants to businesses, also are up for action.
Criteria and procedures for the $220 million lab grant RFA – the largest single grant effort by CIRM – are likely to dominate the discussion. The meeting is expected to be the last stop before grant applications are sought. California stem cell Chairman Robert Klein is talking about approving the first stage of the grants in January(see item below).
Proposed payback requirements for businesses that receive grants from CIRM, which are part of the IP regulations, are up for possible action. The agenda is vague, but if I were a business interested in having a voice on what could be a multimillion dollar matter, I would want to be present for the Wednesday meeting in San Francisco.
The agenda also includes a proposal for pre-approval of certain Japanese stem cell lines in CIRM-funded research and changes aimed at making it easier to do research in California on reprogramming of somatic cells.
One cryptic agenda item lists consideration of an unspecified proposal from the California State University system. No details were available on the agenda at the time of this writing, but we are attempting to find out more.
Criteria and procedures for the $220 million lab grant RFA – the largest single grant effort by CIRM – are likely to dominate the discussion. The meeting is expected to be the last stop before grant applications are sought. California stem cell Chairman Robert Klein is talking about approving the first stage of the grants in January(see item below).
Proposed payback requirements for businesses that receive grants from CIRM, which are part of the IP regulations, are up for possible action. The agenda is vague, but if I were a business interested in having a voice on what could be a multimillion dollar matter, I would want to be present for the Wednesday meeting in San Francisco.
The agenda also includes a proposal for pre-approval of certain Japanese stem cell lines in CIRM-funded research and changes aimed at making it easier to do research in California on reprogramming of somatic cells.
One cryptic agenda item lists consideration of an unspecified proposal from the California State University system. No details were available on the agenda at the time of this writing, but we are attempting to find out more.
Monday, July 30, 2007
Stem Cell Lab Building Plan Heads for Approval Next Week
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.
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.
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.)
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.
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