Thursday, January 27, 2011
CIRM Directors in Executive Session
CIRM directors have been in an executive session since about 11:18 p.m PST. They are discussing personnel issues and proprietary information concerning the $40 million tools and technology grant round. It is not clear when they will resume their public session.
CIRM Directors to Post Their Statements of Economic Interest Online
Directors of the California stem cell agency today decided to post their statements of economic interest on the CIRM web site along with those of the executives of the $3 billion enterprise. Also to be posted will be the expense claims filed by the same officials.
The action was approved on a unanimous voice vote. It came at the request of Citizens Financial Accountability Oversight Committee (CFAOC) one year ago when it urged more openness and transparency at the agency. The committee is chaired by the state's top fiscal officer, Controller John Chiang. It is a sister to CIRM, created also by Prop. 71 in 2004, and is the only state body specifically charged with overseeing CIRM's finances.
Chiang's office said the controller called the action "good news and a long-overdue step toward
transparency and accountability."
The postings will begin in April, the deadline for the 2010 statements of economic interest. Other state agencies, including the governor's and controller's office, already have been posting their own statements and expense claims. CIRM plans to confer with the CFAOC to be sure to comply properly with its request.
Director Sherry Lansing, chair of the Governance Subcommittee and a former Hollywood studio chief, said that CIRM "has nothing to hide, and it (the information) is already out there."
CIRM Director David Serrano Sewell, a deputy city attorney in San Francisco, was delegated to work with staff and the CFAOC to implement the postings.
The California Stem Cell Report posted the statements for the directors and staff last August after CIRM balked at complying with the unanimous request from the CFAOC. The postings by the stem cell report were noted more than once by directors today. Last month we began the process of gathering CIRM expense claims for posting but will suspend that effort.
Our take on today's board action? We applaud the CIRM directors. Today's vote represents a significant step forward in improving the agency's openness and transparency.
The action was approved on a unanimous voice vote. It came at the request of Citizens Financial Accountability Oversight Committee (CFAOC) one year ago when it urged more openness and transparency at the agency. The committee is chaired by the state's top fiscal officer, Controller John Chiang. It is a sister to CIRM, created also by Prop. 71 in 2004, and is the only state body specifically charged with overseeing CIRM's finances.
Chiang's office said the controller called the action "good news and a long-overdue step toward
transparency and accountability."
The postings will begin in April, the deadline for the 2010 statements of economic interest. Other state agencies, including the governor's and controller's office, already have been posting their own statements and expense claims. CIRM plans to confer with the CFAOC to be sure to comply properly with its request.
Director Sherry Lansing, chair of the Governance Subcommittee and a former Hollywood studio chief, said that CIRM "has nothing to hide, and it (the information) is already out there."
CIRM Director David Serrano Sewell, a deputy city attorney in San Francisco, was delegated to work with staff and the CFAOC to implement the postings.
The California Stem Cell Report posted the statements for the directors and staff last August after CIRM balked at complying with the unanimous request from the CFAOC. The postings by the stem cell report were noted more than once by directors today. Last month we began the process of gathering CIRM expense claims for posting but will suspend that effort.
Our take on today's board action? We applaud the CIRM directors. Today's vote represents a significant step forward in improving the agency's openness and transparency.
Minority Report Filed on Business Application Rejected by Reviewers
Some CIRM grant reviewers have filed a minority report on a tools-and-technology grant rejected by the agency's grant reviewers. The application was submitted by a business. The biotech industry has complained about the paucity of CIRM grants to business. The review summary said,
"Three elements were cited by the minority group in support of moving the application up to Tier 1: 1) the proposal was submitted by a "for profit" applicant; 2) the project uses bioinformatics approaches; 3) the proposed research expands a global capacity to assess safety of cell therapy products derived from embryonic stem cells that have been expanded in culture. Also, the proposal supports efforts to characterize 10 cell lines that are being derived as part of a previously funded CIRM award."The identity of the applicant was not disclosed.
Fifth Appeal by Rejected Applicant
A fifth scientist has filed an appeal of a negative decision by CIRM's scientific reviewers on his application for $1.2 million in the $40 million tools and technology round.
The researcher is Alexander Urban of Stanford University, the third scientist from that institution whose application was rejected. Here is the summary of the reviewers findings.
The researcher is Alexander Urban of Stanford University, the third scientist from that institution whose application was rejected. Here is the summary of the reviewers findings.
Stem Cell Directors Begin Meeting
Directors of the California stem cell opened their meeting this morning in Burlingame at 11:17 a.m. PST with introduction of two new members of the 29-member board and a new alternate for a regular member. The first order of business is the $40 million tools and technology round of grants. The board has a quorum but Chairman Klein warned that some directors will have to leave early -- not an uncommon situation for the board. The meeting is scheduled to end at 5 p.m.
Coverage of Today's Stem Cell Board Meeting
The California Stem Cell Report will be providing live coverage of today's meeting of the board of the California stem cell agency from our location in El Salvador. The meeting has not yet begun but it is likely to get underway soon. We will file reports as warranted throughout the day based on the Internet broadcast of the proceedings.
CIRM Study Says Stem Cell Spending Will Generate 25,000 jobs by 2014
The California stem cell agency today released a glowing report on its economic impact that was produced by a firm that was charged by CIRM with executing "a vibrant and aggressive strategy to support the goals and initiatives of CIRM.”
The agency's press release on the $300,000, 25-page study said that CIRM's spending will generate 25,000 "job years" and $200 million in new tax revenue by the end of 2014. CIRM has awarded $1.1 billion in grants, although not all of that has yet been distributed. The study projected the future impact of those funds in addition to cash already distributed.
The study was prepared by the LECG group and the Berkeley Research Group under an RFP that said the contract holder must "execute a vibrant and aggressive strategy to support the goals and initiatives of CIRM.”
CIRM Chairman Robert Klein said in a news release,
We have asked CIRM whether it intends to make the economic data underpinning the report available to the public and outside researchers, who can verify the study's conclusions. The agency's response will be carried when we receive it.
The agency's press release on the $300,000, 25-page study said that CIRM's spending will generate 25,000 "job years" and $200 million in new tax revenue by the end of 2014. CIRM has awarded $1.1 billion in grants, although not all of that has yet been distributed. The study projected the future impact of those funds in addition to cash already distributed.
The study was prepared by the LECG group and the Berkeley Research Group under an RFP that said the contract holder must "execute a vibrant and aggressive strategy to support the goals and initiatives of CIRM.”
CIRM Chairman Robert Klein said in a news release,
“This report demonstrates that we’ve delivered on the economic promise today, even as we continue to see strong positive milestones on the research side progressing rapidly toward therapies.”The agency's news release said more economic studies will be performed. But it said today's report
"...alone makes it clear that CIRM has provided a net gain to the state’s general fund during its early years. For its first five years, through the end of 2009, the agency paid its own debt service costs directly from its bond proceeds so there was no cost to the general fund during those years. From 2010 through 2012, the current estimate for the cost of debt service on CIRM bonds is $160 million. The state’s share of CIRM generated revenue—just from that first $1.1 billion awarded before July—will be an estimated $148 million.No doubt exists that the stem cell spending has had a beneficial economic impact. But whether it has had a "significant" impact on the California economy is in the eye of the beholder. The state's economy runs to something like $1.7 trillion a year. If California were a nation, it would rank among one of the larger economies in the world. The workforce totals around 18 million, making 25,000 jobs statistically less than a hiccup. Keep in mind as well that CIRM, until 2009, paid the interest on its borrowing with more borrowed funds, all of which adds to the total cost of the borrowing, which is about $3 billion on top of the $3 billion CIRM is handing out.
"The report does not, however, take into account grant awards made later in 2010 and those scheduled for 2011 and 2012, which will generate added tax revenue at a similar rate. With those additions, CIRM’s directly generated tax revenue should exceed its debt payments through some point in 2013 even without considering tax revenue from industry growth in the biotech clusters."
We have asked CIRM whether it intends to make the economic data underpinning the report available to the public and outside researchers, who can verify the study's conclusions. The agency's response will be carried when we receive it.
Details Finally Emerge on $200,000 Stem Cell Convention Subsidy Plan
The California stem cell agency last night belatedly gave the public its first glimpse at a $200,000 plan to subsidize attendance at an international stem cell conference in Toronto in June.
A one-sentence version of the proposal has been on the agenda of the directors of the California stem cell agenda for 10 days. However, the cost, number of persons involved and other details were not disclosed until only hours before the directors are scheduled to take it up this morning.
In a memo on the CIRM web site, Chairman Robert Klein estimated the cost at $2,000 per person for travel, hotel and registration expenses at the meeting of the International Society of Stem Cell Research, the world's largest such organization. He proposed sending "80 young California researchers who are actively involved in a CIRM-fund grant (including Bridges to Stem Cell Research, research training grants and other research award programs) and up to 40 California representatives of patient advocacy organizations."
The $24 million Bridges program covers training largely at California state and community colleges.
The memo did not present a justification for the convention travel subsidy. Instead, it said that CIRM paid for the attendance of 98 persons in a similar program for the ISSCR convention last year in San Francisco. It said the program was a "success" but provided no basis for that assertion.
CIRM, through Klein's office, has been trying to improve relations with patient advocate organizations, which will be a key to winning support of a proposed, new $3 billion to $5 billion ballot measure for the stem cell agency.
The program would use part of the $3.5 million that has been donated to CIRM by private individuals and be operated under the auspices of the ISSCR. The organization would be given the $200,000 to set up a "scholarship" program. Klein would run the program through his office, he said, to avoid placing any additional burden on CIRM's scientific staff. It was not clear whether the ISSCR would require reimbursement for its administrative costs in connection with the program.
A one-sentence version of the proposal has been on the agenda of the directors of the California stem cell agenda for 10 days. However, the cost, number of persons involved and other details were not disclosed until only hours before the directors are scheduled to take it up this morning.
In a memo on the CIRM web site, Chairman Robert Klein estimated the cost at $2,000 per person for travel, hotel and registration expenses at the meeting of the International Society of Stem Cell Research, the world's largest such organization. He proposed sending "80 young California researchers who are actively involved in a CIRM-fund grant (including Bridges to Stem Cell Research, research training grants and other research award programs) and up to 40 California representatives of patient advocacy organizations."
The $24 million Bridges program covers training largely at California state and community colleges.
The memo did not present a justification for the convention travel subsidy. Instead, it said that CIRM paid for the attendance of 98 persons in a similar program for the ISSCR convention last year in San Francisco. It said the program was a "success" but provided no basis for that assertion.
CIRM, through Klein's office, has been trying to improve relations with patient advocate organizations, which will be a key to winning support of a proposed, new $3 billion to $5 billion ballot measure for the stem cell agency.
The program would use part of the $3.5 million that has been donated to CIRM by private individuals and be operated under the auspices of the ISSCR. The organization would be given the $200,000 to set up a "scholarship" program. Klein would run the program through his office, he said, to avoid placing any additional burden on CIRM's scientific staff. It was not clear whether the ISSCR would require reimbursement for its administrative costs in connection with the program.
Wednesday, January 26, 2011
CIRM Directors Move Forward on Selection of New Chairman
A key committee of the directors of the California stem cell agency tonight moved to take a fresh look at the selection of a new chairman of the $3 billion organization and to conduct a self-evaluation of the board itself.
The proposal now goes to the full board of directors at their meeting in Burlingame tomorrow.
The Governance committee also agreed with a request made one year ago by the state Citizens Financial Accountability Oversight Committee that CIRM post the economic interest statements of its directors and top executives on the CIRM web site, said Don Gibbons, the agency's chief communications officer. The CIRM directors panel also agreed to post expense claims from directors and executives. The oversight committee is charged with examining CIRM's finances.
Gibbons said in an email that the new look at the selection of a new chairman was approved unanimously after a brief discussion. Gibbons said that directors also accepted a suggestion by CIRM Chairman Robert Klein, who says he is leaving in June, that directors be surveyed on whether they "should or should not get involved in financial details."
The proposal to develop a criteria for a chairman plus the self-assessment survey was offered by Claire Pomeroy, dean of the UC Davis School of Medicine and a member of the CIRM board. In an email to directors, she said her recommendations would help to "to ensure an open process free of conflict of interest and personal agendas." She said,
He said that the committee also approved a suggestion by Lansing concerning an additional aspect of the selection process. Gibbons said that it would create "a process in which if (a board member) finds someone that looks like an interesting candidate they can call one other member of the (Governance committee) and meet with that individual and report back to the committee in a public meeting on the potential candidate’s qualifications."
The proposal now goes to the full board of directors at their meeting in Burlingame tomorrow.
The Governance committee also agreed with a request made one year ago by the state Citizens Financial Accountability Oversight Committee that CIRM post the economic interest statements of its directors and top executives on the CIRM web site, said Don Gibbons, the agency's chief communications officer. The CIRM directors panel also agreed to post expense claims from directors and executives. The oversight committee is charged with examining CIRM's finances.
Gibbons said in an email that the new look at the selection of a new chairman was approved unanimously after a brief discussion. Gibbons said that directors also accepted a suggestion by CIRM Chairman Robert Klein, who says he is leaving in June, that directors be surveyed on whether they "should or should not get involved in financial details."
The proposal to develop a criteria for a chairman plus the self-assessment survey was offered by Claire Pomeroy, dean of the UC Davis School of Medicine and a member of the CIRM board. In an email to directors, she said her recommendations would help to "to ensure an open process free of conflict of interest and personal agendas." She said,
"This is our chance to emphasize the mission over in-fighting and can define what kind of organization CIRM and the board will be."Sherry Lansing, chair of the Governance committee and former Hollywood film studio chief, asked that the survey be completed in two weeks, according to Gibbons.
He said that the committee also approved a suggestion by Lansing concerning an additional aspect of the selection process. Gibbons said that it would create "a process in which if (a board member) finds someone that looks like an interesting candidate they can call one other member of the (Governance committee) and meet with that individual and report back to the committee in a public meeting on the potential candidate’s qualifications."
State Controller Chiang: Lubin Fills Children's Health Need on CIRM Board
Earlier today, the California Stem Cell Report asked the office of state Controller John Chiang to comment concerning the appointment of Bert Lubin to the CIRM governing board. Here is what Hallye Jordan, Chiang's spokesperson, sent.
"Controller Chiang was thrilled to appoint Dr. Bert Lubin for the position reserved for a California nonprofit academic and research institute because he is supremely qualified.
"Currently, there is no children's health representative on the ICOC(the stem cell agency's governing board), and Dr. Lubin fills this important gap. He has focused his career on health issues in minority communities, and is known for his research into sickle cell anemia.
"From the CHORI (which he founded) website: 'Under Dr. Lubin's leadership, basic, clinical and translational research activities expanded, and he transformed a small research program into a $50 million-a-year enterprise called Children's Hospital Oakland Research Institute. In 2008, CHORI ranked sixth in the nation for National Institutes of Health awards to children's hospitals.
"'CHORI investigators have organized programs in global health, cellular therapy, and personalized medicine. Grant support has increased 100-fold under Dr. Lubin's leadership due to the outstanding investigators he has recruited and supported.'
"Dr. Lubin was the unanimous choice of the Children's Hospital Association, and both Art Torres and Bob Klein were enthusiastic about his potential nomination.
"I've attached a letter of support that cites his 'long-standing interest in stem cells, basic research, clinical applications and technology transfer,' his interest 'in training young investigators interested in stem cell research,' and his worldwide recognition 'for the work he has done establishing the value of sibling stem cell cord blood banking.'"
Jordan additionally said, "Also, at the time we started our search, Salk was represented on the board so we were looking for new institutions."
You can find the letter of support here. It was written last October by Diana Dooley, now a member of California governor Jerry Brown's cabinet as secretary of the $83 billion state Health and Human Services Agency. At the time she wrote the letter, Dooley was president of the Children's Hospital Association.
"Controller Chiang was thrilled to appoint Dr. Bert Lubin for the position reserved for a California nonprofit academic and research institute because he is supremely qualified.
"Currently, there is no children's health representative on the ICOC(the stem cell agency's governing board), and Dr. Lubin fills this important gap. He has focused his career on health issues in minority communities, and is known for his research into sickle cell anemia.
"From the CHORI (which he founded) website: 'Under Dr. Lubin's leadership, basic, clinical and translational research activities expanded, and he transformed a small research program into a $50 million-a-year enterprise called Children's Hospital Oakland Research Institute. In 2008, CHORI ranked sixth in the nation for National Institutes of Health awards to children's hospitals.
"'CHORI investigators have organized programs in global health, cellular therapy, and personalized medicine. Grant support has increased 100-fold under Dr. Lubin's leadership due to the outstanding investigators he has recruited and supported.'
"Dr. Lubin was the unanimous choice of the Children's Hospital Association, and both Art Torres and Bob Klein were enthusiastic about his potential nomination.
"I've attached a letter of support that cites his 'long-standing interest in stem cells, basic research, clinical applications and technology transfer,' his interest 'in training young investigators interested in stem cell research,' and his worldwide recognition 'for the work he has done establishing the value of sibling stem cell cord blood banking.'"
Jordan additionally said, "Also, at the time we started our search, Salk was represented on the board so we were looking for new institutions."
You can find the letter of support here. It was written last October by Diana Dooley, now a member of California governor Jerry Brown's cabinet as secretary of the $83 billion state Health and Human Services Agency. At the time she wrote the letter, Dooley was president of the Children's Hospital Association.
Correction
The Salk item on Jan. 26, 2011, incorrectly stated that William Brody was being replaced on the CIRM board by Bert Lubin. Lubin actually replaced John Reed.
Salk Loses Seat at California's $3 Billion Stem Cell Table
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| Bert Lubin, new CIRM board member |
The La Jolla, Ca., research enterprise had held a position on the board since its inception in 2004. Most recently, William Brody, president of Salk, which has received $37 million in CIRM grants, filled the slot. Brody was appointed in August of 2009.
Brody was was replaced by Kristiina Vuori, president of the Sanford-Burnham Research Institute, also of La Jolla. At the same time, her boss, John Reed, CEO of Sanford was replaced on the CIRM board when state Controller John Chiang appointed Bert Lubin, president and CEO of Children’s Hospital and Research Center Oakland. Lubin made news three years ago when he became the first grant applicant to publicly appeal a negative decision on his application by CIRM's scientific reviewers. Lubin lost his bid during a heated debate among directors. At the time, directors expressed considerable discomfort with having to deal with a public appeal. Since then, the problem of appeals has continued to dog the board, although its Scientific Subcommittee is attempting to deal with the issue.
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| Kristiina Vuori, new CIRM board member |
Childrens Hospital Oakland currently holds a single $55,000 grant from CIRM.
Chiang's office had no immediate comment on the reasons behind Lubin's nomination. We are also querying Lubin and Brody for comment.(The controller's office later said Lubin would serve as an advocate for children's health.)
Vuori was appointed by former Lt. Gov. Abel Maldonado before he left office earlier this month. Sanford-Burnham has received $31 million from CIRM.
It is common for CIRM grants to go to institutions linked to its board. Many members of the board are employed by institutions that have received tens of millions of dollars from CIRM. The following institutions have seats on the board: Stanford, $176 million in grants; UCLA, $135 million; UCSF, $111 million; UCSD, $77 million; USC, $72 million; UC Irvine, $72 million; UC Davis, $61 million; City of Hope, $42 million; UC Berkeley, $37 million; Scripps, $37 million; UC Santa Cruz, $19 million; UC Santa Barbara, $13 million; UC Merced, $8 million; UC Riverside, $6 million, Cedars-Sinai, $9 million. One CIRM director, Sherry Lansing, a UC regent, accounts for many of the connections to the smaller UC campuses.
Directors with financial ties to applicants are barred from voting on their applications. Directors, however, approve concepts for grant programs and the rules for administering them. Reed and others ran afoul of conflict rules in 2007. The issue with Sanford's Reed was disclosed by the California Stem Cell Report. Reed was later warned by the state Fair Political Practices Commission. Reed acted after he was advised to do so by CIRM Chairman Robert Klein, an attorney who later said his advice was an "inadvertent error."
The structure of the board was dictated by Prop. 71, whose authors, including Klein, were interested in giving a seat at the financial table to the institutions who ultimately benefited from the largess.
The new appointees have six-year terms. They receive $114 a day while working on CIRM matters.
The appointments were disclosed this afternoon in a news release from CIRM. The statement said there were no changes in the other members of the board. Nine were reappointed. Others have eight-year terms.
(An earlier version of this item incorrectly said that Brody was replaced by Lubin.)
Two State Agencies Looking Into CIRM Tomorrow and Friday
This is a busy week for the California stem cell agency, but not all the action is in Burlingame where CIRM board convenes tonight for a preliminary round, followed by the main event tomorrow.
Two other state bodies will be looking at CIRM at meetings in Los Angeles and Sacramento. One of the panels is the only entity specifically charged with oversight of the $3 billion agency's finances. That is the Citizens Financial Accountability Oversight Committee(CFAOC), which convenes in Los Angeles on Friday. The second group is the state's good government agency, the Little Hoover Commission, which recommended in 2009 a number of changes at CIRM to improve its operations and transparency.
On tap for the CFAOC is a look at implementation of the first-ever law passed dealing with the Golden State's unprecedented $3 billion research effort. The measure, SB1064, removes a 50-person cap on the agency's staff, allows for compensation of up to $15,000 a year for some patient advocates serving on the CIRM board and requires the agency to commission the first-ever performance audit of its program.
The CFAOC is chaired by the state's top fiscal officer, Controller John Chiang. An early version of SB1064 contained a provision, supported by Chiang, that would have had the CFAOC commission the performance audit. But CIRM successfully lobbied to take the audit out of the hands of the CFAOC. You can expect questions to be raised during the Friday meeting about the progress of CIRM on setting up its audit.
Also likely to come up is the subject of staffing, particularly in connection with sweeping recommendations by CIRM's external review that would seem to require substantial additional staff.
A new member of the CFAOC, Jim Kovach, former head of the Buck Institute, is expected to be sworn in. Kovach was appointed by CIRM Chairman Robert Klein, whose last appointee to the panel attended one meeting last January and then quit. Kovach is a physician, a lawyer and former professional football player with the San Francisco 49ers and the New Orleans Saints.
You can find a host of budget and other financial documents related to the meeting on the CFAOC website.
The agenda for the Little Hoover Commission says only that a "scoping memo" involving CIRM will be presented to the full commission tomorrow afternoon in Sacramento. The commission staff has not elaborated on just exactly what that means although it comes under the subject of "schedule/project selection."
As for tonight's meeting of the CIRM directors' Governance Subcommittee, you can read about that here. The full board meeting that begins tomorrow morning was subject as well of a number of earlier piecesl on the California Stem Cell Report. (See here, here, here, here and here.) For those of you following those items, the agency still has not posted any information about the cost or scope of its proposal to pay for the attendance of perhaps hundreds of persons at an international stem cell conference in Toronto in June.
Two other state bodies will be looking at CIRM at meetings in Los Angeles and Sacramento. One of the panels is the only entity specifically charged with oversight of the $3 billion agency's finances. That is the Citizens Financial Accountability Oversight Committee(CFAOC), which convenes in Los Angeles on Friday. The second group is the state's good government agency, the Little Hoover Commission, which recommended in 2009 a number of changes at CIRM to improve its operations and transparency.
On tap for the CFAOC is a look at implementation of the first-ever law passed dealing with the Golden State's unprecedented $3 billion research effort. The measure, SB1064, removes a 50-person cap on the agency's staff, allows for compensation of up to $15,000 a year for some patient advocates serving on the CIRM board and requires the agency to commission the first-ever performance audit of its program.
The CFAOC is chaired by the state's top fiscal officer, Controller John Chiang. An early version of SB1064 contained a provision, supported by Chiang, that would have had the CFAOC commission the performance audit. But CIRM successfully lobbied to take the audit out of the hands of the CFAOC. You can expect questions to be raised during the Friday meeting about the progress of CIRM on setting up its audit.
Also likely to come up is the subject of staffing, particularly in connection with sweeping recommendations by CIRM's external review that would seem to require substantial additional staff.
A new member of the CFAOC, Jim Kovach, former head of the Buck Institute, is expected to be sworn in. Kovach was appointed by CIRM Chairman Robert Klein, whose last appointee to the panel attended one meeting last January and then quit. Kovach is a physician, a lawyer and former professional football player with the San Francisco 49ers and the New Orleans Saints.
You can find a host of budget and other financial documents related to the meeting on the CFAOC website.
The agenda for the Little Hoover Commission says only that a "scoping memo" involving CIRM will be presented to the full commission tomorrow afternoon in Sacramento. The commission staff has not elaborated on just exactly what that means although it comes under the subject of "schedule/project selection."
As for tonight's meeting of the CIRM directors' Governance Subcommittee, you can read about that here. The full board meeting that begins tomorrow morning was subject as well of a number of earlier piecesl on the California Stem Cell Report. (See here, here, here, here and here.) For those of you following those items, the agency still has not posted any information about the cost or scope of its proposal to pay for the attendance of perhaps hundreds of persons at an international stem cell conference in Toronto in June.
Live Coverage of CIRM Directors Meeting
The California Stem Cell Report will provide live coverage tomorrow of the meeting of the governing board of the $3 billion California stem cell agency. For those who want to listen in as well, you can find instructions for the Internet broadcast of the directors' session on the meeting agenda. The session is scheduled to begin at 9 a.m. PST, but usually starts late.
Tuesday, January 25, 2011
Late Info Posted for Stem Cell Agency Directors Meeting
The California stem cell agency today posted additional material for its directors meeting Thursday dealing with loan payback changes in its biotech loan program along with an update on its operational budget.
You can find a memo summarizing the loan changes here and the proposed regulations here. Obviously these come much too late – less than two days before the meeting – to expect thoughtful comment from most industry executives. The summary also did not provide an explanation of the reasons for the changes.
The budget figures can be found here.
You can find a memo summarizing the loan changes here and the proposed regulations here. Obviously these come much too late – less than two days before the meeting – to expect thoughtful comment from most industry executives. The summary also did not provide an explanation of the reasons for the changes.
The budget figures can be found here.
IOM Study of California Stem Cell Agency Still Pending
Back in August, directors of the California stem cell agency authorized a $615,000 study of their $3 billion enterprise by the prestigious Institute of Medicine at the National Academies of Science.
As of last week, a contract for the work had not been signed, although the two-year study was originally scheduled to be completed by September 2012 -- in time for a ballot measure campaign for an additional $3 billion-$5 billion in bond funding for CIRM.
According to the agency's press release on the study, the IOM study would be aimed at demonstrating "public accountability" and would provide "an independent evaluation of the performance and standards" at CIRM. Some CIRM directors have also expressed hope that the findings would help generate support for the ballot measure for more cash.
In response to a question about the status of the effort, Don Gibbons, chief communications officer for CIRM, said the contract is still being negotiated but provided no further details.
Last summer, CIRM directors approved the project on a voice vote with only one dissent. The study would cover virtually all of CIRM's activities, including areas that were examined closely last fall by CIRM's external review committee. When directors approved the IOM study, they also specified that IOM examine the "output of awarded grants, including their economic impact."
The IOM effort would be the third in a series of recent reports on CIRM. This year, the agency is also required, under a new state law, to commission the first-ever performance audit of its activities.
Duane Roth, co- vice chairman of CIRM and a San Diego businessman, cast the lone no vote. He raised questions about the staff time needed for the report (the external review took at least 2,000 hours). Roth also told directors,
The IOM has proposed that a panel of 14 persons prepare the report. It would meet four times. Two public workshops would be held in California. The report would be subject to a peer review process and "appropriate institutional review procedures." The final report would be delivered to CIRM after 12 to 13 months and at least 10 days prior to its public release.
You can read what was proposed in August below.
Proposed IOM study of California stem cell agency Aug. 2010
As of last week, a contract for the work had not been signed, although the two-year study was originally scheduled to be completed by September 2012 -- in time for a ballot measure campaign for an additional $3 billion-$5 billion in bond funding for CIRM.
According to the agency's press release on the study, the IOM study would be aimed at demonstrating "public accountability" and would provide "an independent evaluation of the performance and standards" at CIRM. Some CIRM directors have also expressed hope that the findings would help generate support for the ballot measure for more cash.
In response to a question about the status of the effort, Don Gibbons, chief communications officer for CIRM, said the contract is still being negotiated but provided no further details.
Last summer, CIRM directors approved the project on a voice vote with only one dissent. The study would cover virtually all of CIRM's activities, including areas that were examined closely last fall by CIRM's external review committee. When directors approved the IOM study, they also specified that IOM examine the "output of awarded grants, including their economic impact."
The IOM effort would be the third in a series of recent reports on CIRM. This year, the agency is also required, under a new state law, to commission the first-ever performance audit of its activities.
Duane Roth, co- vice chairman of CIRM and a San Diego businessman, cast the lone no vote. He raised questions about the staff time needed for the report (the external review took at least 2,000 hours). Roth also told directors,
"I would just caution that the outcome on something like this can cut both ways. And to go in just sort of blind trust that they're going reach the conclusion you want them to reach, I don't think is a foregone conclusion. So you at least ought to think about the downside of a rather critical one."Directors specified that "donor funds" be used to pay for the study as opposed to "taxpayer funds," meaning cash from state bond sales, which is the only major funding available to CIRM. Some private donors have contributed money (now roughly $3.5 million) to CIRM. Once the money is in the hands of CIRM, however, it all belongs to the taxpayers, although the donor funds may be used for purposes that are barred for bond funds. Spending the donor cash on a study also means that the funds will not be available for research or some other purpose.
The IOM has proposed that a panel of 14 persons prepare the report. It would meet four times. Two public workshops would be held in California. The report would be subject to a peer review process and "appropriate institutional review procedures." The final report would be delivered to CIRM after 12 to 13 months and at least 10 days prior to its public release.
You can read what was proposed in August below.
Proposed IOM study of California stem cell agency Aug. 2010
Monday, January 24, 2011
CIRM Stingy with Info on Matters Before Directors This Week
With less than three business days left before Thursday's meeting of the directors of the $3 billion stem cell agency, CIRM has not yet produced details for the public on three significant matters that are to be considered.
The agency's failure to provide the information for the biotech industry, researchers, patient advocates, policy makers and the public via the directors' agenda is not a onetime event. It is part of a pattern -- a de facto policy -- that reflects poorly on CIRM. Withholding information about board matters effectively stifles participation by the public and discourages coverage by the media. It also fails to meet the pledge of CIRM Chairman Robert Klein to adhere to the highest standards of openness and transparency.
However, more information on two items is now available. One involves a $6.6 million, visiting faculty program. Another deals with selection of grant reviewers, something of a sorepoint within the biotech industry.
The CIRM faculty plan states:
Also before directors are eight proposed new alternate scientific members of the grants review group. None appear to have significant biotech industry experience. The agency has drawn fire from industry for its lack of grant reviewers who have a business background. CIRM's own external review panel said last fall,
As for the previously mentioned three agenda items lacking information, one is a proposal to subsidize trips to Toronto in June for perhaps hundreds of persons to attend an international stem cell conference. The proposal contains no cost estimate nor does it indicate how many persons would be involved. We calculated a very rough estimate of $3,000 a person, depending on a number of variables. This may be worthwhile effort. We are inclined to think there is considerable value for scientists at such meetings. But so far CIRM has failed to do even a poor job of making the case for the subsidy program.
Another item needs much more explanation about why it is being considered this week. Only 22 words are devoted to it on the agenda although it is an unusual exception to the normal grant approval process. The item concerns an application for $4 million by Fred Gage of the Salk Institute in the early translational round. Decisions on that round were made last October by CIRM directors. Scientific reviewers did not approve the Gage application for funding, but it was set aside by the directors for additional consideration.
This week's agenda provides no hint concerning that background and no clue about why the application is still around. Its history can be unearthed from CIRM documents, although virtually all ordinary users of the CIRM web site would find the task daunting if not impossible. Here is a brief synopsis of the story:
At the Oct. 21, 2010, CIRM board meeting, CIRM Director Joan Samuelson, a patient advocate for Parkinson's and who also is living with the disease, moved to have directors override the negative decision by reviewers. During the discussion at the October meeting, CIRM Director Jeff Sheehy, also a patient advocate and member of the grants review committee, said in support,
Ultimately the board asked CIRM President Trounson to look into the grant and report back on his views.
Researchers, patient advocates and others interested in CIRM funding would be well-advised to read the discussion, which covers about 17 pages of the transcript beginning on p. 144. Also of interest at the Thursday meeting concerning funding is an appeal by a Stanford researcher, Stefan Heller, in the tools and technology round that is before directors.
The third matter that is shy of information involves changes in the agency's biotech loan program and its payback provisions. We wrote earlier about what those might involve. Our take can be found here.
The agency's failure to provide the information for the biotech industry, researchers, patient advocates, policy makers and the public via the directors' agenda is not a onetime event. It is part of a pattern -- a de facto policy -- that reflects poorly on CIRM. Withholding information about board matters effectively stifles participation by the public and discourages coverage by the media. It also fails to meet the pledge of CIRM Chairman Robert Klein to adhere to the highest standards of openness and transparency.
However, more information on two items is now available. One involves a $6.6 million, visiting faculty program. Another deals with selection of grant reviewers, something of a sorepoint within the biotech industry.
The CIRM faculty plan states:
"The CIRM Visiting Faculty Award will operate through supplemental awards to existing CIRM-funded research grants, all of which have been peer reviewed and approved by the ICOC. The funds will enable a sabbatical researcher (Visiting Scientist) to work on an existing CIRM-funded research project for 6-12 months. The supplemental CIRM funds will cover up to 50% of the Visiting Scientist's salary and fringe benefits costs, with the remainder being paid by the Visiting Scientist’s home institution."Applications would be submitted by the recipient of an existing research grant – who would be known as the "host scientist." The proposal envisions up to 30 awards with decisions on awards being made by CIRM staff.
Also before directors are eight proposed new alternate scientific members of the grants review group. None appear to have significant biotech industry experience. The agency has drawn fire from industry for its lack of grant reviewers who have a business background. CIRM's own external review panel said last fall,
"The majority of granting processes are designed on academic models. These processes do not necessarily fit the needs or timelines of industry and/or the realities of managing industry projects. Granting processes and funding criteria could be clarified and streamlined from an industry perspective and timelines for decision-making could be aligned with industry norms."Regarding the review's sweeping recommendations themselves, CIRM President Alan Trounson said in early December that he would report on how they should be implemented. His report is not on the board's agenda for this month. The next CIRM board meeting is scheduled for March 9-10.
As for the previously mentioned three agenda items lacking information, one is a proposal to subsidize trips to Toronto in June for perhaps hundreds of persons to attend an international stem cell conference. The proposal contains no cost estimate nor does it indicate how many persons would be involved. We calculated a very rough estimate of $3,000 a person, depending on a number of variables. This may be worthwhile effort. We are inclined to think there is considerable value for scientists at such meetings. But so far CIRM has failed to do even a poor job of making the case for the subsidy program.
Another item needs much more explanation about why it is being considered this week. Only 22 words are devoted to it on the agenda although it is an unusual exception to the normal grant approval process. The item concerns an application for $4 million by Fred Gage of the Salk Institute in the early translational round. Decisions on that round were made last October by CIRM directors. Scientific reviewers did not approve the Gage application for funding, but it was set aside by the directors for additional consideration.
This week's agenda provides no hint concerning that background and no clue about why the application is still around. Its history can be unearthed from CIRM documents, although virtually all ordinary users of the CIRM web site would find the task daunting if not impossible. Here is a brief synopsis of the story:
At the Oct. 21, 2010, CIRM board meeting, CIRM Director Joan Samuelson, a patient advocate for Parkinson's and who also is living with the disease, moved to have directors override the negative decision by reviewers. During the discussion at the October meeting, CIRM Director Jeff Sheehy, also a patient advocate and member of the grants review committee, said in support,
"One of the key factors that was very motivating was the stature of the scientist and paucity of people working in Parkinson's in California. Eminent neurologists within the room said we campaigned (in 2004 for Prop. 71) -- we had Michael J. Fox on TV -- we talked about Parkinson's as a target. But one of the problems in our ability to fund this in California is that there's a lack of a sufficient number of outstanding Parkinson's (researchers) -- other diseases are more or better represented, at least this is what is stated, and the opportunity to get this particular eminent scientist into this arena was a value in and of itself."The discussion at the October board meeting went beyond the specific grant and into procedures of the board and the grant review process, including discussion how of exceptions are made.
Ultimately the board asked CIRM President Trounson to look into the grant and report back on his views.
Researchers, patient advocates and others interested in CIRM funding would be well-advised to read the discussion, which covers about 17 pages of the transcript beginning on p. 144. Also of interest at the Thursday meeting concerning funding is an appeal by a Stanford researcher, Stefan Heller, in the tools and technology round that is before directors.
The third matter that is shy of information involves changes in the agency's biotech loan program and its payback provisions. We wrote earlier about what those might involve. Our take can be found here.
Sunday, January 23, 2011
CIRM Beefs Up Technology: More Info and Better Service for Applicants, Grantees Promised
The California stem cell agency is reporting technology improvements that they will hope will aid researchers and the public as well.
Amy Adams, CIRM communications manager and who deals with the agency's web site, wrote last Friday on the CIRM research blog:
Amy Adams, CIRM communications manager and who deals with the agency's web site, wrote last Friday on the CIRM research blog:
"As of our most recently posted RFA (Disease Team Therapy Development Awards) we’re all electronic. Grantees fill out an application online. If their application gets funded, the grantee can manage that grant online. Progress reports? Well, they still have to pull together the data, but it can be submitted online. Publications? Report them online. New applications? They go into your user account and you can manage all those grants from the same place. Time to submit a new form? No problem, CIRM makes sure there’s a notice in your account. Less time battling forms means more time doing research, which is good news for all people eager for new stem cell therapies.
"I’m not a grantee, so these miracles are all a bit abstract. However, I do know people inside CIRM are looking forward to not taking angry calls from grantees who are frustrated with our forms. And they are looking forward to having that data automatically in our database rather than needing to import it from PDF.
"The public will start seeing the benefit of these electronic developments over the next few months. Information that’s in our database can also be displayed on our website. I’m excited to start posting progress information and publications as part of our grant summaries. Stay tuned."
Saturday, January 22, 2011
On the Science of Being Wrong
A tidbit that caught my eye from an article by David Brooks in the Jan. 17, 2011, issue of the New Yorker.
"Human beings are overconfidence machines. Paul J. H. Schoemaker and J. Edward Russo gave questionnaires to more than two thousand executives in order to measure how much they knew about their industries. Managers in the advertising industry gave answers that they were ninety-per-cent confident were correct. In fact, their answers were wrong sixty-one per cent of the time. People in the computer industry gave answers they thought had a ninety-five per cent chance of being right; in fact, eighty per cent of them were wrong. Ninety-nine per cent of the respondents overestimated their success."
Four Researchers Appeal Grant Reviewer Decisions; Stanford Scientist Cites Broader Concerns
Four scientists from UCLA and Stanford are seeking next week to overturn negative decisions by CIRM's scientific grant reviewers on their bids for close to $2 million each. One Stanford researcher is raising important policy questions that go well beyond the scientific merit of the proposed research.
The appeals to the full board of the California stem cell agency come in the $40 millon tools and technology round, which is aimed at addressing "technical bottlenecks and (enabling) novel translational approaches." The awards are scheduled to be given out by the agency's directors Thursday in Burlingame.
The researchers who appealing directly to the CIRM board are Guoping Fan and Martin G. Martin, both of UCLA, who are seeking $1.8 million each, and Craig Levin and Stefan Heller, both of Stanford, who are seeking $1.9 million each.
Most of the appeals to the CIRM board focused heavily on science issues, but the letter by Heller addressed additional, broader issues.
Heller, who has financial ties to a San Diego firm dealing with hearing disorders, already holds a $2.5 million grant from CIRM that was awarded in 2007. Heller used the funds for research dealing with potential cures for deafness through human embryonic stem cells. Both he and CIRM reviewers say he is one of the few scientists working in that area, although some 3.5 million Californians suffer from debilitating hearing problems.
Heller's pitch to the CIRM board defended his science but also implicitly raised questions about the quality of CIRM's grant oversight. And he said that without additional funding, CIRM's initial $2.5 million investment could well be damaged. Heller wrote,
According to the CIRM review summary, Heller's application was denied "due to strong concerns regarding feasibility of developing an adequate hESC-derived otic cell model, especially because little progress was reported despite an ongoing CIRM-funded effort in this laboratory, reviewers were doubtful that technical hurdles would be overcome." Heller rejected the contention that he had made "little progress." CIRM monitors the progress of its grantees and has pulled grants from three recipients.
Heller said,
Here are links to the other appeal petitions and review summaries.
Fan appeal, review summary; Levin appeal, review summary; Martin appeal, review summary.
The appeals to the full board of the California stem cell agency come in the $40 millon tools and technology round, which is aimed at addressing "technical bottlenecks and (enabling) novel translational approaches." The awards are scheduled to be given out by the agency's directors Thursday in Burlingame.
The researchers who appealing directly to the CIRM board are Guoping Fan and Martin G. Martin, both of UCLA, who are seeking $1.8 million each, and Craig Levin and Stefan Heller, both of Stanford, who are seeking $1.9 million each.
Most of the appeals to the CIRM board focused heavily on science issues, but the letter by Heller addressed additional, broader issues.
 |
| Stefan Heller Stanford Photo |
Heller's pitch to the CIRM board defended his science but also implicitly raised questions about the quality of CIRM's grant oversight. And he said that without additional funding, CIRM's initial $2.5 million investment could well be damaged. Heller wrote,
"Now is the time to build on this asset and not to stop the funding and to disperse the researchers."He argued that hearing losses are a widespread affliction and deserve more attention. He said his research could create jobs in California, an economic argument that CIRM has been touting widely as justification for its efforts.
According to the CIRM review summary, Heller's application was denied "due to strong concerns regarding feasibility of developing an adequate hESC-derived otic cell model, especially because little progress was reported despite an ongoing CIRM-funded effort in this laboratory, reviewers were doubtful that technical hurdles would be overcome." Heller rejected the contention that he had made "little progress." CIRM monitors the progress of its grantees and has pulled grants from three recipients.
Heller said,
"We believe that the reviewers were not appropriately calibrated with respect to the state of the science in our field, which consists of only a few laboratories – compared to larger fields with many well-funded laboratories. On the other hand, successful development of novel therapies for hearing loss and balance disorders would affect the lives of millions of patients. Therefore, research activity in our field clearly remains disproportionate to the major medical need."He continued,
"The Heller lab is CIRM funded for 3 1/2 years and we have had several publications arising from CIRM funding including a major recent one in the journal Cell on mouse ESC guidance. The main results of our human ESC study are unpublished, we agree with this critique, but this does not mean that we have not made progress....Our ongoing CIRM comprehensive research grant has been funded based on a specific time plan and our current progress is very much in line with the original time plan."Heller wrote,
"We are one of less than five laboratories working on stem cell related approaches to find treatments for hearing loss. We strongly believe that our science has to be exemplary as one of the few representative laboratories of the field."Heller said,
"Our research group is an asset for CIRM in a small and specialized field with a high medical need. We have established a working and productive CIRM-funded group of people that joined us from outside the inner ear field that now, after 3 years, has reached a level of competence and productivity that comes close to groups working in much larger fields with more depth in basic science, as well as a much larger pool of personnel that readily joins these laboratories. Without the investment from CIRM, this group would not exist! Now is the time to build on this asset and not to stop the funding and to disperse the researchers. There are few laboratories in our field and progress is carried by a much smaller group of people than some of the larger fields that are well-supported by CIRM. Yet, a larger field much easier absorbs a major individual funding gap, whereas lack of sufficient funds will most certainly substantially hamper any progress in the hearing loss treatment field because we will lose the best and brightest coworkers of our laboratory. Our inner ear hESC group at Stanford would be in danger of dissolving, and research on the topic would have to start all over again, possibly severely slowing down the translation of hESC technology into the hearing loss field, thereby affecting millions of patients."In his job creation argument, Heller said his application
"...directly deals with removing the only existing bottleneck preventing the development of the first high-throughput drug discovery screens in the hearing space. We have been extensively talking with potential investors as well as with multiple big pharmaceutical corporations about feasibility of our approach particularly with respect of using the assay as asset for a new biotech firm. We have been meeting with high-throughput screening experts from two out of the top ten big pharmaceutical companies and have discussed our planned hESC-based screening assays with them. Removal of the existing bottleneck, the main topic of our grant application, will directly expedite the founding of a new drug-discovery company in the hearing field locally in the SF Bay area."Stanford's web site shows that Heller has financial links with Otonomy, Inc., a San Diego company "developing novel drug therapies for disorders of the inner and middle ear." According to Otonomy's web site,
"This field represents a large opportunity as there are no approved drug treatments for the nearly 30 million Americans facing debilitating hearing and balance disorders such as Ménière's disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment, and tinnitus."Heller reported that he receives more than $5,000 in consulting fees from the company and has more than $5,000 in equity in the firm. He also serves on the company's advisory board.
Here are links to the other appeal petitions and review summaries.
Fan appeal, review summary; Levin appeal, review summary; Martin appeal, review summary.
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