"I can’t help but think that the American economy has performed sluggishly ever since George W. Bush gave a speech to Congress successfully calling for a ban on human-animal hybrids. Clearly we need to deregulate this vital sector and win the future with chimera stimulus."A tip of the hat to Pete Shanks at the Center for Genetics and Society in Berkeley for flagging the item, which is, we think, tongue in cheek.
Tuesday, September 13, 2011
Little Noticed Stem Cell News
In the wake of the president's job speech last week, up popped this comment from writer Matthew Yglesias , author of "Heads in the Sands."
Thursday, September 08, 2011
Calimmune, the Berlin Patient and $20 Million from California Stem Cell Agency
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| UCLA Photo |
The firm, Calimmune, Inc., disclosed that its chairman is David Baltimore, former president of Caltech, Nobel Laureate and former member of the stem cell agency's governing board. One of Calimmune's advisors is the German physician, Gero Hutter, who successfully treated the Berlin Patient, Timothy Ray Brown, the only person in the world who has been cured of HIV and AIDs and who now lives in San Francisco.
In 2009, CIRM's governing board awarded a $20 million disease team grant to UCLA researcher Irvin Chen and Geoff Symonds, an Australian who is chief scientific officer of Calimmune of Tucson, Ariz. Earlier information on the Internet reported that Chen and Baltimore were co-founders of Calimmune.
Baltimore was not on the CIRM governing board at the time the grant was awarded. He resigned June 6, 2007.
Calimmune said on its website that its "singular purpose" is to bring "a one-time, cost effective therapy to the HIV community." According to the website, the firm was established "to develop innovative cell-based therapies for HIV" based on work from Chen's and Baltimore's labs.
Delaware state records show that Calimmune was incorporated in that state in 2006 although the company's website reports that it was founded in 2007. We have queried the company concerning the discrepancy.
Calimmune said it is seeking "to provide HIV-positive patients with a similar type of genetic resistance to HIV that occurs naturally in 1% of the European population. By treating a patient's own stem cells and T cells (cells specifically targeted by HIV), we aim to protect patients from the ravages of AIDS and eliminate the need for daily medication." Essentially, that would replicate the case of the Berlin Patient.
The company appears to have strong ties to Johnson&Johnson, or at least its executives have had in the past. Symonds worked in Australia for the firm from 1992 to 2009. Calimmune's chief financial officer, Bhavin Raval, was finance director for J&J Research in Australia from 2002 to 2009. Louis Breton, CEO of Calimmune, told the California Stem Cell Report in 2009 that none of the firm's funding originated with Johnson&Johnson.
Breton has not responded to queries from the California Stem Cell Report since 2009 including queries during the past week. The unanswered questions involve the number of its employees, whether the firm has any business beyond the CIRM grant activities and the address of the location where the CIRM work is actually performed. CIRM cannot fund work that is performed out-of-state.
Melissa King, executive director of the CIRM governing board, told the California Stem Cell Report that the firm "conducts its laboratory research at leased lab space on UCLA's campus." It also has laboratories in Australia, according to documents on the Internet. King said Calimmune's "corporate address" is on Wilshire Boulevard near UCLA. The Wilshire address appears to be only an address for service of process, according to California state records. Calimmune's Tucson address is the location of an investment firm, based on a visit by the California Stem Cell Report to the location last fall. We were told at the time that Calimmune rents space in the office.
In 2009, CIRM's grant reviewers scored the Chen-Symonds application at 79. They had high praise for the research team, but one reviewer expressed reservations. The summary of reviewer comments said,
"….the resources and investigators are outstanding and the team is superb, both scientifically and in therapy development. The Disease Team comprises a collaboration between two complementary groups, one academic and one corporate. Each brings unique expertise to the project, with the academic group providing scientific know-how and proof of concept and the corporate group providing expertise in biologics development and commercialization. The team leaders are accomplished, highly productive investigators with a demonstrated track record in the field of HIV research, gene therapy, and/or clinical drug development. Key members of this team made the initial scientific observations leading to their hypothesis and demonstrated proof of concept in tissue culture and relevant models....The principal investigator has built up a rich and well-considered network of collaborations and resources and there is no doubt that the environment will be sufficient for this task."CIRM also said,
"Another reviewer expressed the view that although the treatment will likely find a significant niche, the complexity, cost and potential toxicity of the approach will likely limit its use, even if successful."
CIRM Pay: Learning From the Internet's Viral Force
The viral nature of cyberspace and its impact on the California stem cell agency was demonstrated again this week in an item on the Business Law Daily Internet site in Sacramento.
The subject was CIRM salaries. Writer Chriz Rizo of the Business Law Daily picked up our item earlier this week on the salary issue along with information from the Sunday article by Ramon Solis at the Orange County Register.
Rizo's piece brought the salary matter to a new set of readers. The article was a clear demonstration of how media has been altered in the last 20 years. In that long past era, Solis' piece would have started and stopped in Orange County. Now it is accessible to widely separated audiences and additional Internet editors and writers globally, who are always hungry for something fresh. And in the future, Solis' piece and related articles will invariably turn up as reporters – not to mention the general public – google CIRM's activities.
That can be a plus and a minus for CIRM. The pieces on salaries are not a positive for CIRM. But if the agency learns to exploit the viral energy of the Internet with favorable stories, the power of cyberspace could turn to CIRM's favor.
The subject was CIRM salaries. Writer Chriz Rizo of the Business Law Daily picked up our item earlier this week on the salary issue along with information from the Sunday article by Ramon Solis at the Orange County Register.
Rizo's piece brought the salary matter to a new set of readers. The article was a clear demonstration of how media has been altered in the last 20 years. In that long past era, Solis' piece would have started and stopped in Orange County. Now it is accessible to widely separated audiences and additional Internet editors and writers globally, who are always hungry for something fresh. And in the future, Solis' piece and related articles will invariably turn up as reporters – not to mention the general public – google CIRM's activities.
That can be a plus and a minus for CIRM. The pieces on salaries are not a positive for CIRM. But if the agency learns to exploit the viral energy of the Internet with favorable stories, the power of cyberspace could turn to CIRM's favor.
Tuesday, September 06, 2011
High Salary Stories Hound State Stem Cell Agency
In most states, it is probably illegal nowadays to tie a can to a dog's tail. But that doesn't much help the $3 billion California stem cell agency.
It has a can on its tail, and nobody seems likely to come to its rescue.
The nagging irritation trailing CIRM comes in the form of repeated news stories about salaries at its executive levels. Just a few weeks ago, a round of pieces surfaced concerning pay at CIRM. The touchy subject popped up again this past weekend.
The Orange County Register carried a page-one story on Sunday with the headline "'Special fund' salaries fall off the radar." The fourth paragraph of the piece by Ramon Solis said,
Nonetheless, the issue of high salaries will dog the agency as long as they exist. CIRM pay is also likely to surface in a much more visible way in the event that the agency goes to the voters for another multibillion bond issue in a few years.
The agency's new chairman, Jonathan Thomas, has said that the agency is in a communications war. As part of its arsenal, it needs to devise strong counter measures to deflect what will be a continuing assault tied to its high salaries.
It has a can on its tail, and nobody seems likely to come to its rescue.
The nagging irritation trailing CIRM comes in the form of repeated news stories about salaries at its executive levels. Just a few weeks ago, a round of pieces surfaced concerning pay at CIRM. The touchy subject popped up again this past weekend.
The Orange County Register carried a page-one story on Sunday with the headline "'Special fund' salaries fall off the radar." The fourth paragraph of the piece by Ramon Solis said,
"Alan Trounson, president of the California Institute for Regenerative Medicine, the state stem-cell research agency, is the highest-paid nonacademic employee in the state, making an annualized salary of $490,008 as of June 2011. His salary is paid by bond funds."Solis continued,
"The regenerative medicine institute is a prime example of a well-funded state agency operating outside of the constraints of the General Fund.
"On average, institute employees made $103,435.08 in 2010, according to 2010 salary data from the State Controller’s Office – the most of any department in state government.
"In addition to employing the state’s highest-salaried nonacademic employee, Trounson, the institute also employees the state’s highest-paid part-time employee, Art Torres, the former chairman of the state Democratic Party, who made $230,000 last year as the institute’s co-vice chairman. Institute staff members, however, say Torres handles the responsibilities of two people. Staff maintain that the institute would have to spend more money on two separate employees if not for Torres.
"'Given the fact CIRM is a research funding institution, it is critical that CIRM have the ability to competitively recruit and retain employees who have the skills and backgrounds necessary for these positions,' said Melissa King, the institute’s executive director of the governing board, when asked about Torres’ and Trounson’s salaries.
"The institute has one of the smallest payrolls in state government, with just 46 employees who account for around 1 percent of the agency’s $3 billion budget, King said. Unlike other agencies in state government, the institute’s payroll and administrative overhead is capped at 6 percent of its budget, to ensure that most of its money goes to stem-cell research. The institute also has an added protection in that an independent committee composed of leaders in the biotech and medical industry as well as patient advocates set the salaries of its employees."It could be said that CIRM fared better in the Orange County Register story than many of the others in the past about its salaries. The piece noted that CIRM has a tight operational budget. The article also cited as "an added protection" an "independent committee" that sets CIRM salaries. The committee is the CIRM board of directors. The story also did not report that, with interest on the borrowed funds for Trounson's salary, its actual cost is around $1 million.
Nonetheless, the issue of high salaries will dog the agency as long as they exist. CIRM pay is also likely to surface in a much more visible way in the event that the agency goes to the voters for another multibillion bond issue in a few years.
The agency's new chairman, Jonathan Thomas, has said that the agency is in a communications war. As part of its arsenal, it needs to devise strong counter measures to deflect what will be a continuing assault tied to its high salaries.
Friday, September 02, 2011
Mentoring and the High Priest Syndrome
UC Davis stem cell researcher Paul Knoepfler recently took up on his blog the topic of mentoring younger scientists. He wrote,
Weissman's remarks recalled a piece in 2008 in the now sadly defunct "Nature Reports Stem Cells." In it, he obliquely referred to what I like to call the High Priest Syndrome, which is found in science and many other areas of work. One aspect of the syndrome is to create jargon that makes it difficult for outsiders to understand a speciality and thus enhance the reputation of its practitioners. Weissman told Nature:
"No one becomes a successful scientist on their own. I’m not going to channel Hillary Clinton and say it takes a village to make a scientist, but how does one avoid having the village idiot or worse as one’s mentor?"Knoepfler reflected on his mentoring experiences and also queried Irv Weissman of Stanford about his experiences. Weissman responded with a fulsome email that mentioned Ernst Eichwald, who Weissman said was "a pathologist who was tired of academia and moved to run a path lab practice at Montana Deaconess Hospital in Great Falls Montana." Weissman, a descendant of fur traders and junk dealers, said he was "amazingly lucky" to find people like Eichwald.
Weissman's remarks recalled a piece in 2008 in the now sadly defunct "Nature Reports Stem Cells." In it, he obliquely referred to what I like to call the High Priest Syndrome, which is found in science and many other areas of work. One aspect of the syndrome is to create jargon that makes it difficult for outsiders to understand a speciality and thus enhance the reputation of its practitioners. Weissman told Nature:
“I realized that the language of science substitutes Greek and Latin terms for plain English, that it was a way to keep people out of the field. He didn't need to say histocompatibility. He could say "tissue-transplantation compatibility", but I also realized I could understand it. Thanks to the freedom Dr. Eichwald gave me, I began designing my own experiments at 16.”Here are links to Knoepfler's Weissman item and the earlier mentoring piece. Here is a link to an item about Weissman's comments in 2008.
Thursday, September 01, 2011
Stem Cells Inc. Joining with LaFerla on Alzheimer's Effort
Stem Cells Inc. of Newark, Ca., this morning touted its research award from the California stem cell agency as an "encouraging vote of confidence" for its plans to develop a stem cell-based therapy for Alzheimer's disease.
In a widely distributed news release, Ann Tsukamoto, executive vice president of the publicly traded company said,
She also disclosed that Stem Cells Inc. is collaborating on the project with Frank LaFerla,director of the Institute for Memory Impairments and Neurological Disorders at UC Irvine.
Tsukamoto said that La Ferla
Stem Cells Inc.was trading at $2.43 this morning, down five cents from its close yesterday. Its low during the last 12 months was $2.02 and its high $12.70.
(Editor's note: An earlier version of this item had an incorrect figure for the amount of the Stem Cells Inc. planning grant.)
In a widely distributed news release, Ann Tsukamoto, executive vice president of the publicly traded company said,
"Our research, and that of our collaborators, provides a strong rationale for developing our HuCNS-SC neural stem cells as a potential treatment for Alzheimer's disease."
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| Frank LaFerla of UC Irvine UCI photo |
"...has shown that mouse neural stem cells enhance memory in a mouse model of Alzheimer's disease, and we have previously shown that our human neural stem cells can survive in the hostile environment reflective of an Alzheimer's brain. This award is an encouraging vote of confidence, and with CIRM's help, we will be better able to pursue our aim of developing a stem cell-based therapy for Alzheimer's disease."Last week, the company was one of four firms to receive a planning award -- $98,050 in the case of the Stem Cells Inc. -- for the upcoming $240 million disease team round in 2012. Stem Cells Inc. could be eligible for a CIRM grant of up to $20 million in the summer of next year.
Stem Cells Inc.was trading at $2.43 this morning, down five cents from its close yesterday. Its low during the last 12 months was $2.02 and its high $12.70.
(Editor's note: An earlier version of this item had an incorrect figure for the amount of the Stem Cells Inc. planning grant.)
Tuesday, August 30, 2011
Biotech Industry Scores in Stem Cell Agency Grant Round: Beginning of a Trend?
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| Proposal by Tim Hoey of OncoMed outscored leading research institutions. |
The industry has long been unhappy with its picayune share of the $1.3 billion that CIRM has given away so far. The agency has talked about moving towards a more business-friendly position, but last week's awards were the first hard-cash demonstration – albeit a tiny one – of CIRM's commitment.
The round totalled only $1.8 million. Four biotech businesses were awarded $368,519. However, the awards are for planning for applications for a whopping $240 million disease team round next year. It is all part of a CIRM's aggressive push for clinical therapies.
The success rate for the business applicants was also high – 50 percent. Eight firms applied, CIRM told the California Stem Cell Report. In all, 36 applications were received and 19 approved.
Since CIRM began approving awards in late 2005, only 7 percent of all grants have gone to businesses -- that in a state that is one of the hotbeds globally of the biotech industry.
Scoring the highest in last week's round with an 87 was the application , for $65,120 from Tim Hoey, a senior vice president at OncoMed Pharmaceuticals, Inc., of Redwood City, Ca. The score topped applicants from Stanford, UCLA and other vaunted stem cell research institutions. OncoMed is looking at developing a new anti-cancer drug.
The winning businesses included two publicly traded firms, Geron Corp. of Menlo Park, Ca., and Stem Cells Inc., of Newark, Ca. It was the second CIRM award for Geron, which won a $25 million loan last May for help with its spinal injury clinical trial.
Geron's $106,239 planning grant (scored at 79) involves an hESC treatment for heart failure. Jane Lebkowski, senior vice president and chief scientific officer, is the principal investigator on the project. Stem Cells Inc. received $98,050 for a look at an Alzheimer's treatment. Its proposal also scored 79. Alexandra Capela is taking the lead on the project.
The fourth winning business was Wintherix, LLC, San Diego, Ca., which scored 69 on its $99,110 application. John Hood, chief scientific officer and a co-founder of the firm will lead the research into a therapy for osteoporosis-related fractures.
Only one of the applications – the one from Geron – appears to involve research using human embryonic stem cells, the raison d'etre for voter approval of the California stem cell agency in 2004. The ballot measure that created CIRM was justified by backers because former President Bush had restricted federal funding of hESC research, a ban that has since been lifted by President Obama.
Thursday, August 25, 2011
Britain's Peter Coffey to Join UC Santa Barbara Stem Cell Team
STANFORD, Ca. – The seaside campus of UC Santa Barbara has scored a major coup in the world of stem cell science, successfully recruiting internationally reknown scientist Peter Coffey of the UK into its research program.
Coffey's decision to leave England emerged during a meeting here today of the governing board of the California stem cell agency, which awarded a $4.9 million recruitment grant to Coffey last fall. Coffey's name came up today during a discussion about extending the agency's $44 million recruitment effort.
CIRM President Alan Trounson said that Coffey had made a final decision about coming to California. CIRM directors were told that Coffey would be at work in November in Santa Barbara. Coffey is known for his work in eye disease and is readying a clinical trial on a therapy.
The growth of stem cell research at UCSB is one of the more dramatic stories to come out of passage of Prop. 71 in 2004, which created California's $3 billion research effort. The campus had virtually no stem cell program at the time. Its grants currently from CIRM run only to $13.5 million, but it has made the most of its research talent and added more.
Coffey is not the first world reknown stem cell scientist to be lured to the beachfront campus nestled below the Santa Ynez mountains. Jamie Thomson of the University of Wisconsin is co-director of the stem cell center at UCSB and an adjunct professor at the school. Thomson was the first researcher to isolate human embryonic stem cells.
In 2007, UC Santa Barbara's growing work in stem cells attracted a $3 million gift from one of the founders of Amgen, William Bowes. The addition of Coffey to its staff is certain to draw the attention of potential future donors along with such firms as Pfizer, which is a partner in Coffey's work in the UK and which has committed $100 million for stem cell research in that country.
Coffey has been collaborating with researchers at UC Santa Barbara, including Dennis Clegg, co-director of the UCSB Center for Stem Cell Biology and Engineering, for several years. Clegg was also instrumental in recruiting Thomson. The campus is involved in a $20 million, multi-institution grant from CIRM targeting macular degeneration, the major cause of blindness among the elderly. The California school has also established a center for the study of macular degeneration.
Coffey, UCSB, USC, Caltech, the City of Hope and University College, London, Coffey's former employer, are tied together in The California Project to Cure Blindness, which is seeking to "prevent the loss of vision and improve the quality of life for those suffering from age-related macular degeneration by 2015."
UCSB has not yet made an official announcement of Coffey's decision, but the California Stem Cell Report is querying the school.
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| Peter Coffey University College, London, photo |
Coffey's decision to leave England emerged during a meeting here today of the governing board of the California stem cell agency, which awarded a $4.9 million recruitment grant to Coffey last fall. Coffey's name came up today during a discussion about extending the agency's $44 million recruitment effort.
CIRM President Alan Trounson said that Coffey had made a final decision about coming to California. CIRM directors were told that Coffey would be at work in November in Santa Barbara. Coffey is known for his work in eye disease and is readying a clinical trial on a therapy.
The growth of stem cell research at UCSB is one of the more dramatic stories to come out of passage of Prop. 71 in 2004, which created California's $3 billion research effort. The campus had virtually no stem cell program at the time. Its grants currently from CIRM run only to $13.5 million, but it has made the most of its research talent and added more.
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| UCSB campus -- UCSB photo |
In 2007, UC Santa Barbara's growing work in stem cells attracted a $3 million gift from one of the founders of Amgen, William Bowes. The addition of Coffey to its staff is certain to draw the attention of potential future donors along with such firms as Pfizer, which is a partner in Coffey's work in the UK and which has committed $100 million for stem cell research in that country.
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| Dennis Clegg, co-director UCSB stem cell program -- UCSB photo |
Coffey, UCSB, USC, Caltech, the City of Hope and University College, London, Coffey's former employer, are tied together in The California Project to Cure Blindness, which is seeking to "prevent the loss of vision and improve the quality of life for those suffering from age-related macular degeneration by 2015."
UCSB has not yet made an official announcement of Coffey's decision, but the California Stem Cell Report is querying the school.
Researcher Alert – Stem Cell Agency Alters Review Procedures on Big Ticket Grants
The California stem cell agency today made major changes in grant review procedures for its key clinical trial and disease team rounds in an effort to improve decision-making and ultimately enhance the results of the research.
On a voice vote, the CIRM board voted unanimously to engage potential applicants earlier in the review process and to give them an opportunity to respond to key issues ahead of the formal review by the CIRM grant review group.
CIRM Director Os Steward of UC Irvine described the changes as an "extraordinary way to get it right." Director Claire Pomeroy, dean of the UC Davis School of Medicine, said the new procedures were an innovation that may be of great interest to other grant-making institutions. .
Under the changes, CIRM will hold a Q&A session with applicants in advance of submission of applications. After an initial evaluation, applicants will be provided key questions posed by reviewers that applicants can respond to prior to the final peer review.
During the final meeting of the grant review group, applicants would be asked to be available to respond by phone to any "pivotal questions" that arise. The process also would allow reviewers to defer an application for receipt of additional information.
The staff memo on the changes said the new procedures will provide "an additional level of certainty and a stronger foundation for making fully informed recommendations regarding the funding of these clinically applicable studies."
On a voice vote, the CIRM board voted unanimously to engage potential applicants earlier in the review process and to give them an opportunity to respond to key issues ahead of the formal review by the CIRM grant review group.
CIRM Director Os Steward of UC Irvine described the changes as an "extraordinary way to get it right." Director Claire Pomeroy, dean of the UC Davis School of Medicine, said the new procedures were an innovation that may be of great interest to other grant-making institutions. .
Under the changes, CIRM will hold a Q&A session with applicants in advance of submission of applications. After an initial evaluation, applicants will be provided key questions posed by reviewers that applicants can respond to prior to the final peer review.
During the final meeting of the grant review group, applicants would be asked to be available to respond by phone to any "pivotal questions" that arise. The process also would allow reviewers to defer an application for receipt of additional information.
The staff memo on the changes said the new procedures will provide "an additional level of certainty and a stronger foundation for making fully informed recommendations regarding the funding of these clinically applicable studies."
CIRM Approves Planning Grants for $240 Million Round
Directors of the California stem cell agency this afternoon made the first installment on a $242 million effort to drive stem cell research into the clinic.
The CIRM board approved $1.8 million for 19 planning grants for a $240 million disease team round to be awarded next year. Seventeen applications were rejected. Five of the awards had conditions that must be met before they could continue in the disease team competition.
Both academic and business researchers could compete for the grants.
UCLA researchers John Adams and Chia Soo were unsuccessful in asking the board to reverse a negative decision on their planning grant application.
Here is a list of the researchers and a link to the CIRM news release.
The CIRM board approved $1.8 million for 19 planning grants for a $240 million disease team round to be awarded next year. Seventeen applications were rejected. Five of the awards had conditions that must be met before they could continue in the disease team competition.
Both academic and business researchers could compete for the grants.
UCLA researchers John Adams and Chia Soo were unsuccessful in asking the board to reverse a negative decision on their planning grant application.
Here is a list of the researchers and a link to the CIRM news release.
Stem Cell Agency Chair Pleased With Likelihood of Fresh Funding
STANFORD -- The chairman of the California stem cell agency this morning expressed optimism about staving off a cash flow crisis at CIRM with additional funding from the sale of state bonds this fall.
Jonathan Thomas, a Los Angeles bond financier, told the CIRM governing board meeting here that he has been dealing with the governor's and state treasurer's offices during the past two months and is "very happy with the way things are going."
Without additional funding from state bonds, the $3 billion research enterprise will face a severe cash crunch next spring. Earlier this year, the state suspended the sale of general obligation bonds, the only source of funding for CIRM.
Thomas, elected in June as chairman of CIRM, did not go in details about the bond sale this fall. But he noted that it is a "tricky time" because of the state's financial crisis.
The size and timing of the bond sale is yet to be determined. The state treasurer's office has said many details are still being worked out.
Jonathan Thomas, a Los Angeles bond financier, told the CIRM governing board meeting here that he has been dealing with the governor's and state treasurer's offices during the past two months and is "very happy with the way things are going."
Without additional funding from state bonds, the $3 billion research enterprise will face a severe cash crunch next spring. Earlier this year, the state suspended the sale of general obligation bonds, the only source of funding for CIRM.
Thomas, elected in June as chairman of CIRM, did not go in details about the bond sale this fall. But he noted that it is a "tricky time" because of the state's financial crisis.
The size and timing of the bond sale is yet to be determined. The state treasurer's office has said many details are still being worked out.
Wednesday, August 24, 2011
Biotech Industry Alert: California Stem Cell Agency Moves Ahead with Industry-Friendly Efforts
The newly elected chairman of the $3 billion California stem cell agency is pushing forward with efforts to engage industry more deeply in state efforts to develop commercial stem cell therapies.
Industry has long been unhappy with its meager share of CIRM grants – 7 percent of $1.25 billion. A blue-ribbon panel commissioned by CIRM last year recommended major improvements.
The latest action by Jonathan Thomas, the Los Angeles bond financier who was elected in June to head the agency, comes in the form of a thrust to be led by CIRM co-Vice Chair Duane Roth, a San Diego businessman.
Thomas' plan for engagement of industry will be discussed this evening at Stanford at the first meeting of the board's new eight-member Intellectual Property Subcommittee.
Thomas' proposal, posted only early today on the CIRM web site, would expand the panel's current jurisdiction. The document said,
Thomas said Roth would be named co-chair of the IP Subcommittee with responsibility for industry relations. Juelsgaard will deal more generally with IP issues, including "developing a program to assist CIRM grantees in protecting intellectual property generated from CIRM-funded research and to ensure that the state has an opportunity to share in the revenues arising out of CIRM-funded research." That topic is on the agenda of this evening's meeting.
Also to be discussed is another industry-friendly effort: A $30 million "Opportunity Fund" to "enhance the likelihood that CIRM funded projects will obtain funding for Phase III clinical trials (e.g. follow-on financing), (ii) provide a potential source of co-funding in the earlier stages of clinical development, and (iii) provide CIRM funded projects with access to pharma and large biotech partners that can provide valuable expertise in the areas of regulatory, clinical trial design and manufacturing process development."
Industry has long been unhappy with its meager share of CIRM grants – 7 percent of $1.25 billion. A blue-ribbon panel commissioned by CIRM last year recommended major improvements.
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| Duane Roth |
Thomas' plan for engagement of industry will be discussed this evening at Stanford at the first meeting of the board's new eight-member Intellectual Property Subcommittee.
Thomas' proposal, posted only early today on the CIRM web site, would expand the panel's current jurisdiction. The document said,
Juelsgaard, former executive vice president of Genentech and currently a lecturer at Stanford Law School, was appointed to the board last May by Lt. Gov. Gavin Newsom. Juelsgaard once was reported as being considered as a possible candidate for chair of the agency."In light of CIRM’s desire to engage industry in its mission to deliver therapies and cures to patients who suffer from chronic disease and injury and the overlap between industry-related issues and the current jurisdiction of the subcommittee, Chairman Thomas, with the concurrence of Subcommittee Chair (Stephen) Juelsgaard, proposes to expand the jurisdiction of the subcommittee to include industry-related issues, such as: (1) participation by representatives of industry as members of the Grants Working Group; (2) the development and refinement of programs to incorporate industry into CIRM’s research programs; (3) financing issues relating to industry involvement with CIRM; (4) evaluation of barriers to industry engagement in CIRM-related or funded activities; (5) addressing means of encouraging industry interaction and involvement, especially in the areas of development, regulatory compliance, manufacturing and commercialization, with CIRM-funded research organizations that have identified potential promising therapies and (6) consideration and refinement of CIRM’s loan program."
Stephen Juelsgaard
Thomas said Roth would be named co-chair of the IP Subcommittee with responsibility for industry relations. Juelsgaard will deal more generally with IP issues, including "developing a program to assist CIRM grantees in protecting intellectual property generated from CIRM-funded research and to ensure that the state has an opportunity to share in the revenues arising out of CIRM-funded research." That topic is on the agenda of this evening's meeting.
Also to be discussed is another industry-friendly effort: A $30 million "Opportunity Fund" to "enhance the likelihood that CIRM funded projects will obtain funding for Phase III clinical trials (e.g. follow-on financing), (ii) provide a potential source of co-funding in the earlier stages of clinical development, and (iii) provide CIRM funded projects with access to pharma and large biotech partners that can provide valuable expertise in the areas of regulatory, clinical trial design and manufacturing process development."
Friday, August 19, 2011
Stem Cell Agency Cuts Travel Under Pressure from Governor
No more lollygagging in London – that's the message from Gov. Jerry Brown to the California stem cell agency.
Brown is trying to crack down on out-of-state travel, including two dozen "mission critical" international CIRM trips to such locations as Paris, Amsterdam, Japan and Australia.
The Sacramento Bee this afternoon reported the governor's efforts to limit CIRM travel at a time when the state is under extreme financial duress. Reporter David Sider of The Bee quoted Evan Westrup, a Brown spokesman, as saying,
The Bee said that following an inquiry earlier this week by the newspaper, new CIRM Chairman Jonathan Thomas wrote to CIRM board members that he is reducing his office's travel by more than 50 percent and "has asked officials to consider similar reductions elsewhere in the agency."
According to The Bee, Thomas noted that like former CIRM Chairman Robert Klein he considered the proposed travel "mission critical," but said,
For the 54-person agency, the total budgeted travel (in state and out of state) for this fiscal year is $494,000,down from the $500,000 budgeted in 2010-11. The out-of-state travel budget for the office of the chair is $100,000. For the president's office, it is $107,356.
One reader commenting on The Bee story said,
Here is the text of the memo by Thomas to board members:
Brown is trying to crack down on out-of-state travel, including two dozen "mission critical" international CIRM trips to such locations as Paris, Amsterdam, Japan and Australia.
The Sacramento Bee this afternoon reported the governor's efforts to limit CIRM travel at a time when the state is under extreme financial duress. Reporter David Sider of The Bee quoted Evan Westrup, a Brown spokesman, as saying,
"Now is not the time to be lollygagging in London on the taxpayer's dime. We have quite a bit to focus on here in California."The travel issue comes as the stem cell agency will be seeking support from the governor for a significant allocation from the sale of state bonds this fall. The agency will face a severe cash crunch late next spring unless it receives additional bond funding.
The Bee said that following an inquiry earlier this week by the newspaper, new CIRM Chairman Jonathan Thomas wrote to CIRM board members that he is reducing his office's travel by more than 50 percent and "has asked officials to consider similar reductions elsewhere in the agency."
According to The Bee, Thomas noted that like former CIRM Chairman Robert Klein he considered the proposed travel "mission critical," but said,
"I believe we can accomplish these goals while doing our part to reduce expenditures in these times of fiscal challenge."However, the amount of travel expense involved is tiny in comparison to the agency's research grants, which now total more than $1 billion. CIRM's operational budget is only $18.5 million.
For the 54-person agency, the total budgeted travel (in state and out of state) for this fiscal year is $494,000,down from the $500,000 budgeted in 2010-11. The out-of-state travel budget for the office of the chair is $100,000. For the president's office, it is $107,356.
One reader commenting on The Bee story said,
"In the world of research, there are meetings all over the world, and if you don't attend you become irrelevant. ...I know none of you(other readers) will agree, but research is very different than going to Las Vegas for the WIz BAG Conference, then out on the town. Research meetings are working meetings where people doing primary research work on the problems disjointed but collaboratively in the same breath."Our comment: CIRM's travel expenses are a symbol in the context of the governor's public austerity efforts. While symbols are important, the travel expenses do not affect or come out of the state budget. They come from bond funds. CIRM's operational budget – also funded by bonds – is very tight, some say too tight to do the job right. If Brown is concerned about spending by the stem cell agency, he should focus on significant expenditures – grants and loans -- and whether the state is getting the most for its money. One way would to do that would be a true performance audit conducted under the auspices of the state controller instead of under the control of the agency itself.
Here is the text of the memo by Thomas to board members:
"The Governor’s Office recently confirmed that CIRM’s Governing Board has the authority to approve the agency’s out-of-state travel, but requested that CIRM consider reducing its travel expenditures by 50 percent. I have reviewed the proposed budget for out-of-state travel for the Office of the Chair. Although I believe the proposed travel is mission critical, as it is intended to advance CIRM’s mission by leveraging CIRM’s investment in stem cell research with investments by other countries and states with which CIRM has collaborative funding rrangements, I believe we can accomplish these goals while doing our part to reduce expenditures in these times of fiscal challenge. I have therefore decided to reduce the out-of-state travel budget for the Office of the Chair by more than 50 percent. Furthermore, I have requested that the Finance Subcommittee review the out-of-state travel budget for the other offices within CIRM to determine whether similar reductions can be made consistent with CIRM’s mission."
Thursday, August 18, 2011
California To Proceed with Fall Bond Sale; Stem Cell Agency Could Benefit
The California state treasurer's office today reaffirmed that it intends to move ahead with a state bond sale this fall, which could be good news for the $3 billion California stem cell agency.
CIRM will face a severe cash crunch in less than 12 months, roughly May or June of next year, without additional dollars. Its only real source of funding is through the sale of California general obligation bonds.
Tom Dresslar, spokesman for state Treasurer Bill Lockyer, told the California Stem Cell Report today that details for the fall sale are still being worked out. He said in an email,
Reporter Kathleen Pender quoted Dresslar in this morning's San Francisco Chronicle as saying,
Earlier state plans called for a $2.4 billion bond offering in the spring of 2012, which the stem cell agency might also share in. However, that might cut very close in terms of CIRM's cash flow. Additionally, the state could be in the midst of another major budget crunch because of cutbacks that could be triggered in January.
CIRM will face a severe cash crunch in less than 12 months, roughly May or June of next year, without additional dollars. Its only real source of funding is through the sale of California general obligation bonds.
Tom Dresslar, spokesman for state Treasurer Bill Lockyer, told the California Stem Cell Report today that details for the fall sale are still being worked out. He said in an email,
"At this point, the only thing we can say with a good degree of certainty is that we'll sell (government obligation) bonds this fall. The number, size and structure of those transactions remains undetermined. Much will depend on priorities set by the Administration (of Gov. Jerry Brown), and how much new bonds they want to issue to keep current projects going or start new ones."Last May, the state said that it would sell only $1.5 billion in bonds this fall to keep borrowing costs down in light of the ongoing state budget crisis. Roughly $37 billion in long term bonds are awaiting sale, according to the state treasurer's office, including $1.9 billion in bonds for CIRM. That is likely to mean that CIRM will face competition in receiving an allocation from this fall's sale.
Reporter Kathleen Pender quoted Dresslar in this morning's San Francisco Chronicle as saying,
"We need to get a firm handle on the financial situation of ongoing infrastructure projects, how much money they need, how far can they go with their current cash."In June, the stem cell agency's new chairman, Jonathan Thomas, spoke frankly about CIRM finances just before he was elected chair. He told CIRM directors,
"The agency faces the real possibility that it will not have timely access to the amount of bond proceeds it expected and may be forced to look elsewhere in very short order to the full funding required to meet its projected short term needs or to evaluate how to push grants out or otherwise modify expenses if that becomes necessary. And let's not kid ourselves – this problem could last for a long time."Thomas was nominated for his post at CIRM by both Lockyer and Gov. Brown, which should be of benefit to CIRM in securing bond proceeds.
Earlier state plans called for a $2.4 billion bond offering in the spring of 2012, which the stem cell agency might also share in. However, that might cut very close in terms of CIRM's cash flow. Additionally, the state could be in the midst of another major budget crunch because of cutbacks that could be triggered in January.
Wednesday, August 17, 2011
More Information and Earlier for Public on California Stem Cell Issues
The California stem cell agency yesterday finished posting background information for its board meeting Aug. 25, which may be the first time it has provided the information so far in advance.
The postings allow the public and interested parties enough time to examine the material and make comments, if so desired. Matters before the board next week range from a major change in review procedures in big-ticket grant rounds to action on the first stage of a $243 million effort to push therapies into the clinic.
The improved posting performance appears to be linked to the election of a new chairman, Jonathan Thomas, who controls the board agenda. It is a welcome change from past practices in which information about important matters to be considered by the board was not made available in a timely fashion or sometimes was not available at all prior to a meeting. Even some board member have complained about late information.
Melissa King, executive director of the board, notified the California Stem Cell Report about the postings in an email. She said,
The full agenda can be found here with links to the background material.
The postings allow the public and interested parties enough time to examine the material and make comments, if so desired. Matters before the board next week range from a major change in review procedures in big-ticket grant rounds to action on the first stage of a $243 million effort to push therapies into the clinic.
The improved posting performance appears to be linked to the election of a new chairman, Jonathan Thomas, who controls the board agenda. It is a welcome change from past practices in which information about important matters to be considered by the board was not made available in a timely fashion or sometimes was not available at all prior to a meeting. Even some board member have complained about late information.
Melissa King, executive director of the board, notified the California Stem Cell Report about the postings in an email. She said,
"I just wanted to let you know that all the documents for the board meeting next week are now posted. The items without docs linked to them are ones for which there will be no documents These are the chairman's report and item # 14, consideration of report from Intellectual Property Subcommittee, both of which will be reports and will not require action by the board."Some of the information, however, is less than completely developed. One matter before the board involves discussion of its translational grant portfolio. The posted background material is a simple listing of the grants with no analysis or explanation of why the subject is being discussed and no indication of what decision points are necessary, if any. Another document involves ongoing work on CIRM's critical grants management program. The document is more an outline than a comprehensible narrative and is larded with technology jargon.
The full agenda can be found here with links to the background material.
Tuesday, August 16, 2011
California Stem Cell Agency Reviewers Scored Geron Loan Application at 66
Scientists evaluating the Geron Corp. application for a $25 million loan from the California stem cell agency gave it a score of 66 on a scale of 100.
The score was disclosed publicly this afternoon for the first time at the request of the California Stem Cell Report. Directors of the agency approved the loan last May, on a 16-1 vote, during a process that was a major departure from other funding rounds. Normally, the scores of applicants approved for funding are publicly disclosed prior to action by the full CIRM board.
James Harrison, outside counsel to the 29-member CIRM board, said in an email,
Harrison has defended the handling of the Geron application, declaring that it was needed to protect confidential information.
The score was disclosed publicly this afternoon for the first time at the request of the California Stem Cell Report. Directors of the agency approved the loan last May, on a 16-1 vote, during a process that was a major departure from other funding rounds. Normally, the scores of applicants approved for funding are publicly disclosed prior to action by the full CIRM board.
James Harrison, outside counsel to the 29-member CIRM board, said in an email,
"Geron's application received a scientific score of 66. For context, it is important to understand that CIRM utilized new criteria for the Targeted Clinical Development RFA on a pilot basis. As a result, the scores in this round should not be compared to scores for applications submitted in response to other RFAs, in which the piloted criteria were not used; the Geron score is only relevant when compared to other scores for applications in the same round. Here, there were no other scored applications presented to the Board as the other applicants withdrew. As a result, CIRM concluded that the most important information was whether or not the application had been recommended for funding and that presenting the score for the Geron application would not provide meaningful information."In addition to not disclosing the score prior to board approval, CIRM failed to provide the usual summary of grant reviewer comments. The three other applicants in the $50 million round all withdrew prior to presentation to the CIRM board – another first in CIRM's grant program. And no public explanation was provided at the time for the departures from long-established procedures used for more than 400 grants and loans.
Harrison has defended the handling of the Geron application, declaring that it was needed to protect confidential information.
California's $25 Million Loan to Geron: Approval Came Only After Major Departure from Longstanding Procedures
The state of California chalked up a historic first last May when its stem cell research agency approved a $25 million loan to a corporation engaged in another first – a clinical trial for a treatment created from human embryonic stem cells.
It was the first time that the state has funded a clinical trial -- one watched by untold numbers of persons globally who hope that stem cells will ease their pain and cure their suffering. The funding is also critical to Geron Corp. of Menlo Park, Ca., which initiated the safety trial for its spinal injury stem cell therapy.
CIRM President Alan Trounson told agency directors in May,
In response to questions from the California Stem Cell Report, CIRM defended its actions. James Harrison, the board's outside counsel, said the unusual handling of the Geron application was necessary to protect confidential information. Harrison said,
Regarding withholding the scientific score of the Geron application by reviewers, Harrison said publishing it would have been "confusing" because all the other applicants had dropped out.
Asked whether the applicants were encouraged by CIRM in any manner to drop their applications. Harrison replied,
Geron's application was approved in May by directors on a 16-1 vote. The dissent came from Joan Samuelson, a patient advocate member of the board and a member of the grant review group.
According to the transcript of the directors meeting, she said the trial was not ready and CIRM was not ready.
It was the first time that the state has funded a clinical trial -- one watched by untold numbers of persons globally who hope that stem cells will ease their pain and cure their suffering. The funding is also critical to Geron Corp. of Menlo Park, Ca., which initiated the safety trial for its spinal injury stem cell therapy.
CIRM President Alan Trounson told agency directors in May,
"It's just possible that this trial might have faltered without our backing."Approval of the loan, however, came after the $3 billion stem cell agency publicly deviated significantly from its normal funding procedures. The Geron application was not given a public scientific score, standard practice for all the other 433 applications that the agency has approved over the last six years. The usual summary of grant reviewer comments was not provided to the public or the board. The three other applicants in the $50 million round all withdrew prior to presentation to the CIRM board – another first in CIRM's grant program. And no public explanation was provided at the time for the departures from long-established procedures.
In response to questions from the California Stem Cell Report, CIRM defended its actions. James Harrison, the board's outside counsel, said the unusual handling of the Geron application was necessary to protect confidential information. Harrison said,
"CIRM has a significant challenge and responsibility to protect the confidentiality of the companies’ submissions as any violation could have adverse consequences for the companies, including a material disclosure, particularly for those companies that are publicly traded."Regarding the failure to provide a summary of grant reviewer comments, Harrison said a summary was indeed available, pointing to a document that contained only a 67-word listing of the criteria used by evaluators. By contrast, the top-scoring applicant for a $14.6 million disease team grant in 2009 had a 1,219 word summary review.
Regarding withholding the scientific score of the Geron application by reviewers, Harrison said publishing it would have been "confusing" because all the other applicants had dropped out.
Asked whether the applicants were encouraged by CIRM in any manner to drop their applications. Harrison replied,
"In this case, three applicants, on their own volition, withdrew their applications before the board meeting and therefore the applications were not presented to the board."Asked whether the other applicants had any sort of assurances that they would have a better chance later, Harrison said,
"CIRM has made no assurances, either directly or indirectly, to any applicants, including the applicants for the Targeted Clinical Development Awards, regarding future funding. CIRM does try to assist applicants by providing feedback, where appropriate."As to the lack of an explanation to the public and interested parties for the departure from longstanding procedures, Harrison did not respond directly. He said,
"This was CIRM's first clinical trial review and we expect to strengthen and refine the procedures for the next round, including explaining to the public how and why clinical review summaries differ from other CIRM grant review summaries."(The full text of Harrison's statement can be found here.)
Geron's application was approved in May by directors on a 16-1 vote. The dissent came from Joan Samuelson, a patient advocate member of the board and a member of the grant review group.
According to the transcript of the directors meeting, she said the trial was not ready and CIRM was not ready.
"There were lots of -- this is based on the peer review and the comments by the scientist members of the grants working group. There were many concerns that many of the scientist members felt should be satisfied before embarking on a clinical trial and they weren't."Ellen Feigal, CIRM's vice president for research and development, responded following Samuelson's remarks. Feigal said,
"I want to make it clear, making the decision to move towards and into a clinical trial is a very complicated decision. It's not black and white. It's based on judgment, on experience, on science, and the data, and there's not really a right or wrong answer. And I just think that the tenor of the discussions that we've had, the tenor of the discussions of the grant review group had were appropriately deliberative and considered all the different issues."(Editor's note: Discussion of the Geron application begins on page 142 of the May transcript. It picks up again on page 153. The 16-1 roll call vote on the application by the 29-member board can be found here. Five board members did not vote because of conflicts of interest. The others either were not present or did not answer the roll call. Votes by the grant review group are not disclosed. The names of scientists specifically evaluating applications are not disclosed except for the membership of the grant review group.)
Text of CIRM Response on Geron Funding Procedures
Here is the text of what the California stem cell agency said concerning the unusual procedures in the approval of the $25 million loan to Geron in May 2011. The statement came in response to emailed questions from the California Stem Cell Report. James Harrison of Remcho, Johansen & Purcell of San Leandro, Ca., outside counsel to the board, prepared the statement after consulting with the chairman, vice chairmen and senior management of the agency.
Here are the questions posed by the California Stem Cell Report..
Here are the questions posed by the California Stem Cell Report..
"Why wasn't the grant scored?Harrison's response:
"Were the other applicants encouraged by CIRM in any manner to drop their applications? Were the other applicants given any sort of assurances -- including a wink or a nod -- indicating that they would be approved or have a better chance later?
"Why wasn't the grant reviewers' summary posted on the CIRM web site? Was a grant review summary ever prepared?
"Does CIRM expect that its conduct in this case will inspire confidence on the part of other applicants that they will receive fair treatment in the future? How does the unusual handling of this round square with CIRM's vows to adhere to the highest standards of openness and transparency?"
"Before I answer your questions, I wanted to provide you with some context. As you know, the Targeted Clinical Development Award program represented CIRM’s first effort to fund clinical research, a highly specialized area of medical research. As a result, CIRM had to develop new criteria and processes for the review of applications. In addition, the agency hired Dr. Ellen Feigal, who has tremendous clinical experience, as Vice President for Research and Development to oversee CIRM’s clinical program. Indeed, Ellen participated in the Grant Working Group’s Targeted Clinical Development review within days of being hired. We recognized when we issued the Targeted Clinical Development RFA that this was an iterative process and we intended to learn from this first effort in order to refine our procedures for future rounds of clinical awards. We have already begun to work on these refinements, including a procedure to obtain supplemental information which will be presented to the Board in August.After receiving Harrison's comments, we asked the following questions.
"It is also important to bear in mind that one of CIRM’s major goals is to collaborate with the biotechnology and pharmaceutical sectors to bring therapies from the bench to the bedside, and CIRM’s clinical trial program represents one of our most important opportunities to engage with companies. In order to work with companies, we need to be able to assure them of CIRM’s capacity to protect their proprietary information and their ability to obtain financing. This is particularly true for companies involved in clinical research:. At this stage of commercial product development, many things are proprietary (e.g., FDA communications, data, clinical plans, etc.); therefore, CIRM has a significant challenge and responsibility to protect the confidentiality of the companies’ submissions as any violation could have adverse consequences for the companies, including a material disclosure, particularly for those companies that are publicly traded. Thus, we were mindful of the importance of protecting the confidentiality of the applicants for Targeted Clinical Development Awards.
"With that context, here are our answers to your specific questions:
"Why wasn't the grant scored? The Grants Working Group did score the application, but given the fact that the application was reviewed pursuant to new criteria and was the only application presented to the Board, we concluded that presenting the score without context would have been confusing. We therefore presented the GWG’s recommendation without the score.
"Were the other applicants encouraged by CIRM in any manner to drop their applications? Every applicant for CIRM funding has the right to withdraw its application for funding before the Board considers the application. In this case, three applicants, on their own volition, withdrew their applications before the Board meeting and therefore the applications were not presented to the Board.
"Were the other applicants given any sort of assurances -- including a wink or a nod -- indicating that they would be approved or have a better chance later? CIRM has made no assurances, either directly or indirectly, to any applicants, including the applicants for the Targeted Clinical Development Awards, regarding future funding. CIRM does try to assist applicants by providing feedback, where appropriate.
"Why wasn't the grant reviewers' summary posted on the CIRM web site? A public summary was prepared and posted on CIRM’s website; given the fact that much of the information relating to the review was proprietary, the summary was, by necessity, brief.
"Was a grant review summary ever prepared? Yes, see above.
"Does CIRM expect that its conduct in this case will inspire confidence on the part of other applicants that they will receive fair treatment in the future? Yes, we believe that the care CIRM took in protecting the confidential information of applicants serves applicants, grantees and the public. The protection of applicants’ confidential information is critical to CIRM’s success."
"How does the unusual handling of this round square with CIRM's vows to adhere to the highest standards of openness and transparency? CIRM’s mission is to fund research to find therapies and cures for chronic disease and injury – we believe that CIRM’s handling of the clinical trial awards serves this goal and is consistent with our commitment to transparency and to protecting applicants’ confidential information."
"I cannot find a summary of the reviewers comments. The only thing that I turned up was this, which is not a summary of what the reviewers had to say as provided in other grants:Harrison replied,
http://www.cirm.ca.gov/summary-application-ct1-05168
"Perhaps you can point me to something else.
"Given the great departure from normal grant review procedures, why was
there no attempt to explain that in public at the May meeting? But
perhaps I missed it in the transcript. Thanks."
"You identified the correct summary. As I mentioned in my earlier email, because of the proprietary nature of the information, the review summary was, by necessity brief. This was CIRM's first clinical trial review and we expect to strengthen and refine the procedures for the next round, including explaining to the public how and why clinical review summaries differ from other CIRM grant review summaries."
Monday, August 15, 2011
Stem Cell Directors Moving on $243 Million Program and Industry-Friendly Efforts
Directors of the California stem cell agency will meet next week to begin the first stage of giving away $243 million in their pursuit to push a stem cell therapy into the clinic.
The immediate effort involves $3.3 million in planning grants for the second round of the CIRM disease team program. Applications are targeting cancer, HIV, Alzheimer's, ALS, Huntington's Disease, Parkinson's and muscular dystrophy, among others. The next step in the disease team effort will be much larger – $240 million, to be awarded next summer with roughly $20 million for each grant.
For the smaller planning grants to be awarded next week, 36 researchers applied for cash of up to $100,000. Nineteen were approved for funding by the grants review group, which is tantamount to full CIRM board approval. Their scores ranged from 87 to 62. One application was approved for funding but no score was listed. However, that application was ranked below the application with a score of 62. CIRM provided no explanation for failing to publish the score. Names of applicants were not disclosed in keeping with the agency's longstanding practice.
The disease team round was open to both business and academic researchers. We have queried CIRM about whether any businesses applied. The stem cell industry has been less than happy with its meager share of CIRM grants. The $3 billion agency's new chair, Jonathan Thomas, has indicated he wants to make CIRM more industry friendly.
The board meeting next week will be Thomas' first full session as chairman. The meeting was originally scheduled for two days, which was not uncommon under the tenure of former Chairman Robert Klein. But next week's session has been reduced to one day under Thomas. The agenda also seems not as fully packed as under Klein, although it has two executive sessions that could consume a fair amount of time. One deals with the evaluation of CIRM President Alan Trounson. The other deals with proprietary matters on grant applications.
Heavy agendas during the Klein era often generated quorum problems because of the supermajority requirements for voting by the board. It took so long to work through the material that competing priorities among board members meant that some – sometimes quite a few – had to leave.
Today – with eight business days before the Aug. 25 meeting – the agenda has a fair amount of background material posted, giving interested parties a chance to examine the information in a timely fashion.
Included on the agenda is a document about CIRM's ongoing issues, including security, with its self-developed, computerized grants management program, a listing of its translational grant portfolio and a plan to extend its $44 million researcher recruitment effort.
The CIRM board also has plans to take up a report from its new Intellectual Property Subcommittee. The full board agenda contained no indication of what the report would deal with, but presumably it will involve a new, $30 million program aimed at the stem cell industry. That program will be acted on by the IP subcommittee next Monday, preceding the full board meeting. The panel's recommendation would normally go to the full board meeting on Aug. 25.
Also missing from the agenda is any explanation of the purpose of the discussion of the translational grant portfolio or analysis of the portfolio. Additionally, still to come is the latest version of changes in the grant review process for CIRM's big-ticket grant efforts as well as a job description for CIRM's first-ever chief financial officer.
The job description effort has been underway for some months and is linked closely to issues involving CIRM's controversial dual executive arrangement between the chairman and president. The new CFO will be reporting to both the president and the chairman.
The disease team planning grant item also reflected a change in the way CIRM presents the public summary of reviewer comments on the applications. The new format is more concise. Gone is the narrative format that often contained a more fulsome discussion of the applications. Here is a link to one summary on a planning grant application and another link to an application in January.
The immediate effort involves $3.3 million in planning grants for the second round of the CIRM disease team program. Applications are targeting cancer, HIV, Alzheimer's, ALS, Huntington's Disease, Parkinson's and muscular dystrophy, among others. The next step in the disease team effort will be much larger – $240 million, to be awarded next summer with roughly $20 million for each grant.
For the smaller planning grants to be awarded next week, 36 researchers applied for cash of up to $100,000. Nineteen were approved for funding by the grants review group, which is tantamount to full CIRM board approval. Their scores ranged from 87 to 62. One application was approved for funding but no score was listed. However, that application was ranked below the application with a score of 62. CIRM provided no explanation for failing to publish the score. Names of applicants were not disclosed in keeping with the agency's longstanding practice.
The disease team round was open to both business and academic researchers. We have queried CIRM about whether any businesses applied. The stem cell industry has been less than happy with its meager share of CIRM grants. The $3 billion agency's new chair, Jonathan Thomas, has indicated he wants to make CIRM more industry friendly.
The board meeting next week will be Thomas' first full session as chairman. The meeting was originally scheduled for two days, which was not uncommon under the tenure of former Chairman Robert Klein. But next week's session has been reduced to one day under Thomas. The agenda also seems not as fully packed as under Klein, although it has two executive sessions that could consume a fair amount of time. One deals with the evaluation of CIRM President Alan Trounson. The other deals with proprietary matters on grant applications.
Heavy agendas during the Klein era often generated quorum problems because of the supermajority requirements for voting by the board. It took so long to work through the material that competing priorities among board members meant that some – sometimes quite a few – had to leave.
Today – with eight business days before the Aug. 25 meeting – the agenda has a fair amount of background material posted, giving interested parties a chance to examine the information in a timely fashion.
Included on the agenda is a document about CIRM's ongoing issues, including security, with its self-developed, computerized grants management program, a listing of its translational grant portfolio and a plan to extend its $44 million researcher recruitment effort.
The CIRM board also has plans to take up a report from its new Intellectual Property Subcommittee. The full board agenda contained no indication of what the report would deal with, but presumably it will involve a new, $30 million program aimed at the stem cell industry. That program will be acted on by the IP subcommittee next Monday, preceding the full board meeting. The panel's recommendation would normally go to the full board meeting on Aug. 25.
Also missing from the agenda is any explanation of the purpose of the discussion of the translational grant portfolio or analysis of the portfolio. Additionally, still to come is the latest version of changes in the grant review process for CIRM's big-ticket grant efforts as well as a job description for CIRM's first-ever chief financial officer.
The job description effort has been underway for some months and is linked closely to issues involving CIRM's controversial dual executive arrangement between the chairman and president. The new CFO will be reporting to both the president and the chairman.
The disease team planning grant item also reflected a change in the way CIRM presents the public summary of reviewer comments on the applications. The new format is more concise. Gone is the narrative format that often contained a more fulsome discussion of the applications. Here is a link to one summary on a planning grant application and another link to an application in January.
Friday, August 12, 2011
California Stem Cell Achievements: The Perspective from Robert Klein
The former chairman of the $3 billion California stem cell agency -- Robert Klein -- last week fired off an email touting the accomplishments of his tenure in a statement that had many of the earmarks of an election campaign document.
The 3,770-word missive was emailed under the auspices of Americans for Cures, Klein's stem cell lobbying group which has the same address as his Palo Alto real estate investment banking firm. Presumably the email went to a national audience.
Americans for Cures said in an introduction to the statement that Klein is now preparing "for the next installment of this magnificent effort," which could well be another statewide bond election seeking additional billions for stem cell research. Klein directed the 2004 ballot campaign that created CIRM.
CIRM will run out of cash in about 2017. It relies on borrowed money – state bonds – for its operations and grants. Interest costs double the real expenses of the program, making what appears to be a $20 million grant actually cost around $40 million.
Another stem cell bond measure is not likely to be attempted until 2014 or later. California's current financial crisis makes it unlikely that a bond measure would win voter approval any time soon.
In his statement, Klein soft-peddled the state's current economic downturn, declaring that California was under "maximum financial stress" also in 2004. (Editors note: Unemployment in California was 6 percent just before the Proposition 71 election that created CIRM. In contrast, joblessness stood at 12.1 percent in June of this year.)
Titled "Bob Klein's last words as chair of the stem cell board," the document clearly reflects Klein's view of the California stem cell world. Almost needless to say is that there are other, more measured perspectives.
Here is the email from Americans for Cures and Klein.Statement by Robert Klein, Aug. 4, 2011, on his term as chairman of the California stem cell agency
The 3,770-word missive was emailed under the auspices of Americans for Cures, Klein's stem cell lobbying group which has the same address as his Palo Alto real estate investment banking firm. Presumably the email went to a national audience.
Americans for Cures said in an introduction to the statement that Klein is now preparing "for the next installment of this magnificent effort," which could well be another statewide bond election seeking additional billions for stem cell research. Klein directed the 2004 ballot campaign that created CIRM.
CIRM will run out of cash in about 2017. It relies on borrowed money – state bonds – for its operations and grants. Interest costs double the real expenses of the program, making what appears to be a $20 million grant actually cost around $40 million.
Another stem cell bond measure is not likely to be attempted until 2014 or later. California's current financial crisis makes it unlikely that a bond measure would win voter approval any time soon.
In his statement, Klein soft-peddled the state's current economic downturn, declaring that California was under "maximum financial stress" also in 2004. (Editors note: Unemployment in California was 6 percent just before the Proposition 71 election that created CIRM. In contrast, joblessness stood at 12.1 percent in June of this year.)
Titled "Bob Klein's last words as chair of the stem cell board," the document clearly reflects Klein's view of the California stem cell world. Almost needless to say is that there are other, more measured perspectives.
Here is the email from Americans for Cures and Klein.Statement by Robert Klein, Aug. 4, 2011, on his term as chairman of the California stem cell agency
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