Tuesday, November 03, 2009
Correction
The “stem cell web” item Nov. 1, 2009, incorrectly reported that only one reporter was present at the CIRM disease team news conference, based on information provided by a person who was also present. CIRM says two other reporters from local outlets were also on the scene.
Monday, November 02, 2009
CIRM Scrutinizes Grantee Performance: The Tale of Three Terminations
Playing the rich uncle to California stem cell researchers is unquestionably satisfying, but the folks at the state's $3 billion stem cell agency sometimes bear messages for scientists that may be less than warmly received.
That's when they become regulators and stewards of the public's money. Particularly when they exercise that responsibility in a more rigorous way than is the practice at the NIH.
CIRM is not making much of the fact that it has revoked three grants because of a lack of progress. It took us more than a month to secure the identities of the researchers who fell under CIRM's scrutiny. The agency, however, should take pride in its oversight. It enhances the credibility of the $3 billion agency and serves notice to all grantees that CIRM is more than a sugar daddy and takes its responsibilities seriously.
Only four months ago, CIRM directors heard a report on monitoring of grants that merits attention following approval of the largest research grant round in the agency's five-year history. The $230 million in disease team grants pose special challenges for the tiny agency. Its staff, currently without a chief scientific officer, will be called on to make go, no-go decisions on continued funding as researchers hit or miss bench marks in projects involving as much as $20 million.
One can only imagine the ruckus if CIRM staff recommends that funding be halted on a $20 million, four-year grant involving such high-profile and respected institutions as UC San Francisco, UCLA, Stanford, Salk and City of Hope, among others.
CIRM opened the window a bit on its oversight of grants at the board meeting in San Diego last June. Marie Csete, then chief scientific officer for CIRM, described in a positive fashion her office's monitoring of the $45 million SEED program, the first ever research grants by CIRM. She said CIRM's efforts saved some grants that would have perished. But it took a question from director Ricardo Azziz, chairman of the Department of Obstetrics and Gynecology at Cedars-Sinai Medicial Center, to bring out the information that three grants had been terminated.
As for the issues raised during the monitoring, Csete said,
One of the researchers said he was “bitter” about CIRM's action, declaring it caused a “huge uproar” at his institution. (Prior to our conversation, we had heard unconfirmed reports about significant unhappiness on the part of recipient institutions.) This researcher said CIRM's monitoring practices were a departure from those of the NIH, which allows “the liberty to take the research where it leads you.” Nonetheless, he continues to support CIRM.
Another scientist said he parted “amicably” with CIRM but confirmed that its practices are different than the those of the NIH. (The NIH has not responded to our queries concerning how many grants it has revoked for lack of progress.)
This researcher told us,
The round of grants that Csete reported on involved only $45 million, substantially less than the $230 million in the disease team round. The stakes are now much larger. Powerful teams, some international, will be at work. Impending clinical trials will also create a vision of handsome profits, in addition to hoped-for prestige and accolades. CIRM directors have indicated they expect some of the disease team grants to fail. But revoking funds for one of those grants or loans will require a lot of steel on the part of the CIRM staff.
Csete abruptly resigned from CIRM after the June meeting. Her departure and the workload at CIRM likely meant that some of the monitoring efforts were pushed back. Most of the work is done by science officers, but at crucial points, it requires the intervention of CIRM's highest level scientist.
In the wake of Csete's departure, CIRM President Alan Trounson created a new position, vice president for research and development. A search firm has been hired for $100,000 to help recruit a candidate who will make go, no-go decisions on the disease team round along with other grants. Trounson is hoping to find someone with substantial experience in the biotech industry.
Whoever fills the job should not only be something of a scientific diplomat but also be able to face the big dogs of stem cell science and tell them no. CIRM's first responsibility is to generate results for the people of California and to serve as ardent stewards of the public's money.
(Below is a transcript of the entire discussion by the CIRM board in June concerning Csete's monitoring effort. Also below is a piece concerning our decision not to publish the names of the scientists whose grants were revoked as well as another item dealing with CIRM's efforts to ensure compliance with its ethical and research standards.)
Editor's note: The California Stem Cell Report first published an item on the termination of CIRM grants last April. Here is a rundown on all the stories published on this site as of Nov. 9, 2009, concerning grant termination.
That's when they become regulators and stewards of the public's money. Particularly when they exercise that responsibility in a more rigorous way than is the practice at the NIH.
CIRM is not making much of the fact that it has revoked three grants because of a lack of progress. It took us more than a month to secure the identities of the researchers who fell under CIRM's scrutiny. The agency, however, should take pride in its oversight. It enhances the credibility of the $3 billion agency and serves notice to all grantees that CIRM is more than a sugar daddy and takes its responsibilities seriously.
Only four months ago, CIRM directors heard a report on monitoring of grants that merits attention following approval of the largest research grant round in the agency's five-year history. The $230 million in disease team grants pose special challenges for the tiny agency. Its staff, currently without a chief scientific officer, will be called on to make go, no-go decisions on continued funding as researchers hit or miss bench marks in projects involving as much as $20 million.
One can only imagine the ruckus if CIRM staff recommends that funding be halted on a $20 million, four-year grant involving such high-profile and respected institutions as UC San Francisco, UCLA, Stanford, Salk and City of Hope, among others.
CIRM opened the window a bit on its oversight of grants at the board meeting in San Diego last June. Marie Csete, then chief scientific officer for CIRM, described in a positive fashion her office's monitoring of the $45 million SEED program, the first ever research grants by CIRM. She said CIRM's efforts saved some grants that would have perished. But it took a question from director Ricardo Azziz, chairman of the Department of Obstetrics and Gynecology at Cedars-Sinai Medicial Center, to bring out the information that three grants had been terminated.
As for the issues raised during the monitoring, Csete said,
“In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. Institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the (grants) out the door for various reasons.”CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication, at Scripps, praised Csete and her staff's work. He said,
“This kind of nurturing, interactive relationship with the PIs's is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push.”We spoke by telephone with two scientists whose grants were revoked and exchanged email with the third, who was out of the country. None are particularly pleased about losing their grants, but their comments offer insight into the process. We are not identifying them in this piece. To do so would place an unnecessary onus on them, given the current practices in the scientific grant community and the different monitoring procedures at the NIH. None of the issues with the grants appear to involve malfeasance.
One of the researchers said he was “bitter” about CIRM's action, declaring it caused a “huge uproar” at his institution. (Prior to our conversation, we had heard unconfirmed reports about significant unhappiness on the part of recipient institutions.) This researcher said CIRM's monitoring practices were a departure from those of the NIH, which allows “the liberty to take the research where it leads you.” Nonetheless, he continues to support CIRM.
Another scientist said he parted “amicably” with CIRM but confirmed that its practices are different than the those of the NIH. (The NIH has not responded to our queries concerning how many grants it has revoked for lack of progress.)
This researcher told us,
“I think that it is very important for CIRM to closely monitor its grantees. As a California taxpayer, I want to know that state revenues supporting the CIRM effort are well utilized. Furthermore, CIRM (and its grantees) need to make good on the promise of translating the science of stem cell biology into novel therapies.”The third told us in an email that his grant had been “prematurely terminated.” He said the work has been completed without the CIRM support and the research accepted for publication in a prestigious journal next year. He also called CIRM a “great organization” and expressed the hope that it will lead to “great cures.”
The round of grants that Csete reported on involved only $45 million, substantially less than the $230 million in the disease team round. The stakes are now much larger. Powerful teams, some international, will be at work. Impending clinical trials will also create a vision of handsome profits, in addition to hoped-for prestige and accolades. CIRM directors have indicated they expect some of the disease team grants to fail. But revoking funds for one of those grants or loans will require a lot of steel on the part of the CIRM staff.
Csete abruptly resigned from CIRM after the June meeting. Her departure and the workload at CIRM likely meant that some of the monitoring efforts were pushed back. Most of the work is done by science officers, but at crucial points, it requires the intervention of CIRM's highest level scientist.
In the wake of Csete's departure, CIRM President Alan Trounson created a new position, vice president for research and development. A search firm has been hired for $100,000 to help recruit a candidate who will make go, no-go decisions on the disease team round along with other grants. Trounson is hoping to find someone with substantial experience in the biotech industry.
Whoever fills the job should not only be something of a scientific diplomat but also be able to face the big dogs of stem cell science and tell them no. CIRM's first responsibility is to generate results for the people of California and to serve as ardent stewards of the public's money.
(Below is a transcript of the entire discussion by the CIRM board in June concerning Csete's monitoring effort. Also below is a piece concerning our decision not to publish the names of the scientists whose grants were revoked as well as another item dealing with CIRM's efforts to ensure compliance with its ethical and research standards.)
Editor's note: The California Stem Cell Report first published an item on the termination of CIRM grants last April. Here is a rundown on all the stories published on this site as of Nov. 9, 2009, concerning grant termination.
CSCR Withholds Names of Terminated Grantees to Avoid Unnecessary Harm
The California Stem Cell Report is not naming the three scientists whose grants were terminated by the state's stem cell agency because doing so would unnecessarily damage their reputations.
It is our understanding that none of the issues involved malfeasance. Additionally, CIRM's progress monitoring appears to be more rigorous than the standards applied by the NIH, whose practices have set benchmarks in the scientific community.
Publication of the names could create erroneous, negative perceptions about the individuals involved.
We made the decision not to publish their identifies after discussions with a number of individuals, including two of the researchers. In our past occupation as an editor at a mainstream newspaper, publication of their identities would have been pretty much of a foregone conclusion. But given that we are no longer constrained by newspaper standards, some of which are very good and some not so good, we did not want to mindlessly do something that would unnecessarily harm the three.
We also asked CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication at Scripps, for his thoughts on publication of the names. Here is how he responded.
It is our understanding that none of the issues involved malfeasance. Additionally, CIRM's progress monitoring appears to be more rigorous than the standards applied by the NIH, whose practices have set benchmarks in the scientific community.
Publication of the names could create erroneous, negative perceptions about the individuals involved.
We made the decision not to publish their identifies after discussions with a number of individuals, including two of the researchers. In our past occupation as an editor at a mainstream newspaper, publication of their identities would have been pretty much of a foregone conclusion. But given that we are no longer constrained by newspaper standards, some of which are very good and some not so good, we did not want to mindlessly do something that would unnecessarily harm the three.
We also asked CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication at Scripps, for his thoughts on publication of the names. Here is how he responded.
“For NIH grants, after the grant is awarded, one writes a 'progress report' annually in what is termed a 'non-competitive' renewal. For the duration of the award, the investigator is free to follow leads, change directions, convert personnel into equipment funds, and essentially re-program the proposed project. Only if the PI seeks to renew that grant must the changes be justified.
“In process described to us in June by Marie Csete, the scientific staff are in frequent contact with our CIRM-supported PIs, assessing their progress towards the goals they were approved to pursue, and for several of our competitions with stated milestones, assessing whether that progress will get them to their milestones. Lack of progress can be sufficient grounds to terminate the funding, and apparently those are the 3 cases you mention. Since we are kept blind to the PI names and institutions when we decide to award funding, I don't see that it is constructive to CIRM or those PIs to disclose names after termination.”
Text of Csete's Description of CIRM Grant Monitoring
On June 17, 2009, Marie Csete, then chief scientific officer for the $3 billion California stem cell agency, briefed its directors in San Diego on how CIRM monitors the progress of its grantees. Following her presentation, one director asked her how many grants had been terminated because of lack of progress. Three, she replied.
Here is the transcript of her remarks and the discussion by directors. Here is a link to the slides that she used. They begin on p. 22 of the file.
Csete: I guess the last thing I'm supposed to speak about is our mechanism for looking at progress reports. And the first opportunity we had to aggregate data on this was for the SEED grants, which are now more or less in their second year of funding for most of the investigators. And as a reminder, I think all the way back a few years, this was a grant program designed to develop human embryonic stem cell biology in the state. And since it was early, it was more idea based rather than preliminary data-based, and we really hoped to attract nonstem cell biologists to the field as well as cell and developmental biologists who were working perhaps on other stem cells, but had not done human embryonic stem cell work.
As such, the seed grants were acknowledged to be rather high risk, high gain. And I was involved in the SEED grants as a reviewer. So I have insight into the process from the beginning even before I came here to CIRM. I have to say that the overwhelming message I want to leave you with here is that despite a slow start, that was the bump in the road, that the SEEDs are really overwhelmingly successful. And we looked this week to find that there are already 64 papers coming out of the SEED program even though, again, these were new investigators in this field.
So it is important also, thanks to Bettina (Stephen, a CIRM science officer), to remind you that progress reports are not just progress reports -- and this has been an education for both the science office and for our scientists – that they really serve as a focus of a way that the science officers and our grantees can have a point of communication. It also allows us to get a heads up on where the data is, on what papers are being submitted, on potential patents that are coming out. Also when we discuss the progress reports in the science office meeting, it allows us to match scientists from our individual portfolios with other scientists whose progress we're hearing about in the meeting. In general, I have to say that I've gotten a lot of positive feedback from our PI's about the interactions with our science officers and our grantees.
So this is the process that we've sort of come to. And I've condensed a very complex diagram that has arrows going out every which way. On the right(on a slide she presented), you have a lot of gold stars. And the gold stars is what usually happens. On the left I put symbols showing how much communication happens at each one of these steps. So for the vast majority of the progress reports, things look good, and we generate an NGAs(notice of grant approval) with the next year's funding on the SEED grants.
But what I'm showing you in the middle is what happens when we receive a progress report that's not satisfactory. So we did receive some where we saw that the projects were not advancing. They were slow. The vast majority were those gold stars that, you know, went right back for the second year of funding.
In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the NGAs out the door for various reasons. So right away, by having a communication with the PI after the progress report was in, we could help them. We could intervene and make the right calls to try to get and kick start these programs.
When there was insufficient data for us to judge how much work had been done, the science officer would request supplemental data. That often required a couple of phone calls and a couple of exchanges of e-mail because, again, we were interested in hearing what people would normally not send in as a progress report: difficulty getting cell lines grown, difficulty doing certain kinds of experiments so that we could see common features across our SEED grantees and allow them to help each other.
When the supplemental data suggested that there was still insufficient progress, I would look at the report, and we also had discussions with the entire science office. At that point, if we couldn't come to a way to jump start a project, we would have a conference call with the PI, and at this point we'd bring in the institutional official as well, the science officer who has this PI in their portfolio, and I, and we would have another call to try to get this program back on track. And very often what that meant was that we made a plan with the investigator to give them some more time so that they could generate some data and try to pick up where the progress was slow. So the time differed depending on the problems that were there, hiring problems, for example. If after this time period another supplemental progress report comes in and there was inadequate progress, we decided that we would notify the investigator that the project just didn't seem to be going anywhere, that there was no real plan to get it back on track and that there was a potential for termination.
Again, the AOOs were all involved in this as well. and if there was no response within two weeks to that potential termination letter, then the grant was terminated and the second year's funding was not advanced.
So what did we learn from this process? We learned that it's critical for us to be working with the PIs to keep the grants on track and how appreciative the PIs are when we do work with them to keep them on track. By the way, we also found several grants that would not have gone on because the investigator was interested in not pursuing the original goal of the research and was going to drop the work. We felt that these areas were so critical for the ideas that were part of the seed program, that we found other investigators who were co-PIs or related to the grant to take over and worked with these new investigators and found mentorship to keep that work going. So it went in both directions. We saw adequate progress where the grants would not have gone on had we not intervened. And I think that this is a very interim report for you because the final success of the SEEDs will be seen over the next year when the final reports come back. We know that papers are going out. We know that research is proceeding apace now; I think much to the effort of each of the individual science officers who worked very closely with the grantees. But it will be important to evaluate how many new labs were brought into human embryonic stem cell and pluripotent stem cell research. And I should also say that a lot of the investigators left to their own devices would have stopped what they were doing with their SEED grants and simply gone on to derive ips cells, and we would have had no portfolio had we (not) been actively managing the grants. But most importantly, the success of this program will be determined on how these investigators go into others of our programs and other large-scale funded grants with the work that was developed from the SEED. And we already have success in that area. We're seeing that one SEED grantee continued on and got an early translation award from CIRM last month.
So overall we've had enormous success, I think, with the SEED program, and we're still in the middle of it. And we've learned a lot about process that will help us to be managing larger scale projects and to work with our investigators in a really positive way.
CIRM Chairman Robert Klein: So, Dr. Csete, will you remind us the number of SEED grants originally awarded?
Csete: Seventy-four.
Klein: So 74 grants, and we've seen 62 or 63 papers at this point.
Dr. Csete: Sixty-four papers.
Klein: So a very high level of productivity. Thank you very much.
Dr. Bloom?
Director Floyd Bloom: This kind of nurturing interactive relationship with the PIs is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push. So it's a wonderful thing you've done.
Director Ricardo Azziz: I just want to echo that, for starters. I think it takes a tremendous amount of work to help these investigators forward. Again, presumably, they are also very appreciative of your efforts. of the 74 applications, how many – you spoke about the process that you are going through -- how many have been terminated for nonproductivity?
Csete: Three.
Azziz: Three of the 74. Thank you.
Klein: Okay. any additional board comment? Thank you very much, Dr. Csete.
Here is the transcript of her remarks and the discussion by directors. Here is a link to the slides that she used. They begin on p. 22 of the file.
Csete: I guess the last thing I'm supposed to speak about is our mechanism for looking at progress reports. And the first opportunity we had to aggregate data on this was for the SEED grants, which are now more or less in their second year of funding for most of the investigators. And as a reminder, I think all the way back a few years, this was a grant program designed to develop human embryonic stem cell biology in the state. And since it was early, it was more idea based rather than preliminary data-based, and we really hoped to attract nonstem cell biologists to the field as well as cell and developmental biologists who were working perhaps on other stem cells, but had not done human embryonic stem cell work.
As such, the seed grants were acknowledged to be rather high risk, high gain. And I was involved in the SEED grants as a reviewer. So I have insight into the process from the beginning even before I came here to CIRM. I have to say that the overwhelming message I want to leave you with here is that despite a slow start, that was the bump in the road, that the SEEDs are really overwhelmingly successful. And we looked this week to find that there are already 64 papers coming out of the SEED program even though, again, these were new investigators in this field.
So it is important also, thanks to Bettina (Stephen, a CIRM science officer), to remind you that progress reports are not just progress reports -- and this has been an education for both the science office and for our scientists – that they really serve as a focus of a way that the science officers and our grantees can have a point of communication. It also allows us to get a heads up on where the data is, on what papers are being submitted, on potential patents that are coming out. Also when we discuss the progress reports in the science office meeting, it allows us to match scientists from our individual portfolios with other scientists whose progress we're hearing about in the meeting. In general, I have to say that I've gotten a lot of positive feedback from our PI's about the interactions with our science officers and our grantees.
So this is the process that we've sort of come to. And I've condensed a very complex diagram that has arrows going out every which way. On the right(on a slide she presented), you have a lot of gold stars. And the gold stars is what usually happens. On the left I put symbols showing how much communication happens at each one of these steps. So for the vast majority of the progress reports, things look good, and we generate an NGAs(notice of grant approval) with the next year's funding on the SEED grants.
But what I'm showing you in the middle is what happens when we receive a progress report that's not satisfactory. So we did receive some where we saw that the projects were not advancing. They were slow. The vast majority were those gold stars that, you know, went right back for the second year of funding.
In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the NGAs out the door for various reasons. So right away, by having a communication with the PI after the progress report was in, we could help them. We could intervene and make the right calls to try to get and kick start these programs.
When there was insufficient data for us to judge how much work had been done, the science officer would request supplemental data. That often required a couple of phone calls and a couple of exchanges of e-mail because, again, we were interested in hearing what people would normally not send in as a progress report: difficulty getting cell lines grown, difficulty doing certain kinds of experiments so that we could see common features across our SEED grantees and allow them to help each other.
When the supplemental data suggested that there was still insufficient progress, I would look at the report, and we also had discussions with the entire science office. At that point, if we couldn't come to a way to jump start a project, we would have a conference call with the PI, and at this point we'd bring in the institutional official as well, the science officer who has this PI in their portfolio, and I, and we would have another call to try to get this program back on track. And very often what that meant was that we made a plan with the investigator to give them some more time so that they could generate some data and try to pick up where the progress was slow. So the time differed depending on the problems that were there, hiring problems, for example. If after this time period another supplemental progress report comes in and there was inadequate progress, we decided that we would notify the investigator that the project just didn't seem to be going anywhere, that there was no real plan to get it back on track and that there was a potential for termination.
Again, the AOOs were all involved in this as well. and if there was no response within two weeks to that potential termination letter, then the grant was terminated and the second year's funding was not advanced.
So what did we learn from this process? We learned that it's critical for us to be working with the PIs to keep the grants on track and how appreciative the PIs are when we do work with them to keep them on track. By the way, we also found several grants that would not have gone on because the investigator was interested in not pursuing the original goal of the research and was going to drop the work. We felt that these areas were so critical for the ideas that were part of the seed program, that we found other investigators who were co-PIs or related to the grant to take over and worked with these new investigators and found mentorship to keep that work going. So it went in both directions. We saw adequate progress where the grants would not have gone on had we not intervened. And I think that this is a very interim report for you because the final success of the SEEDs will be seen over the next year when the final reports come back. We know that papers are going out. We know that research is proceeding apace now; I think much to the effort of each of the individual science officers who worked very closely with the grantees. But it will be important to evaluate how many new labs were brought into human embryonic stem cell and pluripotent stem cell research. And I should also say that a lot of the investigators left to their own devices would have stopped what they were doing with their SEED grants and simply gone on to derive ips cells, and we would have had no portfolio had we (not) been actively managing the grants. But most importantly, the success of this program will be determined on how these investigators go into others of our programs and other large-scale funded grants with the work that was developed from the SEED. And we already have success in that area. We're seeing that one SEED grantee continued on and got an early translation award from CIRM last month.
So overall we've had enormous success, I think, with the SEED program, and we're still in the middle of it. And we've learned a lot about process that will help us to be managing larger scale projects and to work with our investigators in a really positive way.
CIRM Chairman Robert Klein: So, Dr. Csete, will you remind us the number of SEED grants originally awarded?
Csete: Seventy-four.
Klein: So 74 grants, and we've seen 62 or 63 papers at this point.
Dr. Csete: Sixty-four papers.
Klein: So a very high level of productivity. Thank you very much.
Dr. Bloom?
Director Floyd Bloom: This kind of nurturing interactive relationship with the PIs is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push. So it's a wonderful thing you've done.
Director Ricardo Azziz: I just want to echo that, for starters. I think it takes a tremendous amount of work to help these investigators forward. Again, presumably, they are also very appreciative of your efforts. of the 74 applications, how many – you spoke about the process that you are going through -- how many have been terminated for nonproductivity?
Csete: Three.
Azziz: Three of the 74. Thank you.
Klein: Okay. any additional board comment? Thank you very much, Dr. Csete.
CIRM as Regulator, Compliance Enforcer
In addition to handing out $3 billion in grants to California stem cell researchers, CIRM is also a regulator, monitoring the conduct of its grantees' research to ensure they adhere to the agency's stringent ethical standards.
The subject came up briefly at last week's board meeting in Los Angeles and is expected to come up again at the board meeting in December.
Geoff Lomax, senior officer for medical and ethical standards, had prepared a presentation to discuss, among other things, the agency's research standards monitoring program. But it was caught in the hurly-burly surrounding the disease team applications and was delayed until the next board meeting.
However, his slides are available and provide an introduction to the scope of what CIRM calls its compliance program.
The effort includes financial tracking, reporting on publications and IP and examination of institutions' own oversight programs along with site visits.
Lomax's slides also said,
The subject came up briefly at last week's board meeting in Los Angeles and is expected to come up again at the board meeting in December.
Geoff Lomax, senior officer for medical and ethical standards, had prepared a presentation to discuss, among other things, the agency's research standards monitoring program. But it was caught in the hurly-burly surrounding the disease team applications and was delayed until the next board meeting.
However, his slides are available and provide an introduction to the scope of what CIRM calls its compliance program.
The effort includes financial tracking, reporting on publications and IP and examination of institutions' own oversight programs along with site visits.
Lomax's slides also said,
“CIRM provided recommendations to two institutions regarding the need for more explicit procedures and policies to govern their oversight programs.Lomax's slides start with number 25 in this file.
“CIRM identified one patent that had not been reported; grantee has now addressed.
“CIRM has worked with two grantee institutions to ensure compliance with AALAC (animal care accreditation) requirements.”
Sunday, November 01, 2009
A $230 Million California Stem Cell Web
The publicity last week from recipients of $230 million from the California stem cell agency portrays an impressive web of scientists in the Golden State and beyond.
The list below began as a simple update of an earlier item with links to news releases from the beneficiaries of CIRM largess, in this case the agency's largest ever research round. But, as we gathered the information, what became abundantly clear are the significant financial and scientific ties between institutions that might seem to be rivals under other circumstances.
No doubt they continue to compete in other areas and will be competitors in the future for grants, talent and more. But in this case researchers put together powerful teams that won tens of millions of dollars for themselves and their institutions.
The releases from the institutions contain more information about the researchers and their projects than is contained in CIRM's press release on the disease team grants. But CIRM also provides separately summaries of the scientific reviews of the applications, which carry analysis, criticism and praise of the proposals.
Here is the latest list of news releases issued by the institutions and businesses.
Beckman Institute, shares $15 million with City of Hope and USC
The list below began as a simple update of an earlier item with links to news releases from the beneficiaries of CIRM largess, in this case the agency's largest ever research round. But, as we gathered the information, what became abundantly clear are the significant financial and scientific ties between institutions that might seem to be rivals under other circumstances.
No doubt they continue to compete in other areas and will be competitors in the future for grants, talent and more. But in this case researchers put together powerful teams that won tens of millions of dollars for themselves and their institutions.
The releases from the institutions contain more information about the researchers and their projects than is contained in CIRM's press release on the disease team grants. But CIRM also provides separately summaries of the scientific reviews of the applications, which carry analysis, criticism and praise of the proposals.
Here is the latest list of news releases issued by the institutions and businesses.
Beckman Institute, shares $15 million with City of Hope and USC
Burnham Institute, no news release available, shares $19 million with UC San Francisco and Ludwig Institute
Calimmune, Inc., of Tucson, Az, no news release available, shares $20 million with UCLA
Cedars of Sinai Medical Center, $6 million
Children's Hospital, Los Angeles, no news release available, shares $9 million with UCLA
City of Hope, $18 million and shares $15 million with USC and Beckman Institute
Ludwig Institute for Cancer Research, no news release available, shares $19 million with UC San Francisco and Burnham, $16 million with Salk and UC San Diego
Novocell, shares $20 million with UC San Francisco
Salk Institute. shares $16 million with UC San Diego and Ludwig Institute
Sangamo Biosciences, Inc., of Richmond, Ca., shares $15 million with City of Hope
Stanford, $32 million, and shares $20 million with UCLA and USC, $20 million with UCLA
Salk Institute. shares $16 million with UC San Diego and Ludwig Institute
Sangamo Biosciences, Inc., of Richmond, Ca., shares $15 million with City of Hope
Stanford, $32 million, and shares $20 million with UCLA and USC, $20 million with UCLA
UCLA, shares $20 million with Calimmune, Inc., of Tucson, Az.; $9 million with Children's Hospital, Los Angeles; $20 million with Stanford and USC; $20 million with Stanford
UC San Diego, $20 million , shares $16 million with Salk and Ludwig
UC San Francisco, shares $39 million with Ludwig Institute, Novocell and Burnham
UC Santa Barbara, shares $16 million with USC
The international partners listed in the CIRM news release are the Medical Research Council of the United Kingdom($8 million via the Weatherall Institute of Molecular Medicine, Oxford University, no news release available from Weatherall); the University Health Network ($35 million)of Toronto, Canada.
Here is a link to CIRM's disesease team press package, including a video of the lengthy news conference. Only one reporter from a major publication was present at the news conference, Andy Pollack of the New York Times. No television stations sent crews.
(Editor's note: The earlier item that we posted concerning the institutional press releases has vanished from this Web site for reasons probably only fully understood by Google, which provides the blogging service that we use. Also, an earlier version of this item incorrectly said Pollack was the only reporter present at the news conference. CIRM reports that two other reporters from local outlets were on the scene.)
The international partners listed in the CIRM news release are the Medical Research Council of the United Kingdom($8 million via the Weatherall Institute of Molecular Medicine, Oxford University, no news release available from Weatherall); the University Health Network ($35 million)of Toronto, Canada.
Here is a link to CIRM's disesease team press package, including a video of the lengthy news conference. Only one reporter from a major publication was present at the news conference, Andy Pollack of the New York Times. No television stations sent crews.
(Editor's note: The earlier item that we posted concerning the institutional press releases has vanished from this Web site for reasons probably only fully understood by Google, which provides the blogging service that we use. Also, an earlier version of this item incorrectly said Pollack was the only reporter present at the news conference. CIRM reports that two other reporters from local outlets were on the scene.)
Friday, October 30, 2009
Thursday, October 29, 2009
Off-Topic: Shades of Moby Dick
Stories are told from time to time and then retold and retold about whales attacking sailboats. Some of them sound fanciful and are third and fourth hand.
Here is a current account of what appears to be a genuine attack by whales or whales on a sailboat yesterday off the Baja California coast. The boat sank in a matter of minutes but no one was seriously injured.
This is the first verifiable whale attack that we have heard about off the Mexican coast in 11 years of sailing here.
Here is a current account of what appears to be a genuine attack by whales or whales on a sailboat yesterday off the Baja California coast. The boat sank in a matter of minutes but no one was seriously injured.
This is the first verifiable whale attack that we have heard about off the Mexican coast in 11 years of sailing here.
Blogger Talks to Novocell About First CIRM Loan
Little information was dispensed yesterday by the California stem cell agency about the first step in what is proposed to be a $500 million loan program for the biotech industry.
But a biopharmaceutical industry blogger provided some information about the $20 million loan to Novocell, Inc., a San Diego stem cell engineering company with an emphasis on diabetes therapies. It is the first beneficiary of the loan program.
CIRM directors approved the loan to help develop a novel cellular therapy for diabetes. The disease team effort includes a $2.8 million Novocell contract with Jeff Bluestone of UC San Francisco.
Alex Lash of the In Vivo blog talked to Novocell CEO John West. Kash wrote,
(Editor's note: An earlier version of this item misspelled Alex Lash's last name as Kash.)
But a biopharmaceutical industry blogger provided some information about the $20 million loan to Novocell, Inc., a San Diego stem cell engineering company with an emphasis on diabetes therapies. It is the first beneficiary of the loan program.
CIRM directors approved the loan to help develop a novel cellular therapy for diabetes. The disease team effort includes a $2.8 million Novocell contract with Jeff Bluestone of UC San Francisco.
Alex Lash of the In Vivo blog talked to Novocell CEO John West. Kash wrote,
“West...says the cash infusion from 'the stem-cell experts' was a validation of the firm's work and puts it in a 'good position' to look for its next round of venture funding.
“There are some minor details to work out first, though. West says Novocell hasn't yet received a loan document from CIRM and isn't exactly sure about the terms. Based on the loan program's guidelines, West is aiming for 10% warrant coverage and a payback period closer to 10 years, the far end of the range. 'We have a good feeling we'll work it out,' said West.
“CIRM loans will certainly have more generous terms than typical bank loans, and the agency has said it doesn't expect many of them to be paid back. West said he was surprised that Novocell was the only for-profit to lead a disease team application. But he noted that not many of the state's stem-cell related firms were far enough along to push a program into the clinic within four years, one of the top criteria of the agency's reviewers.”
(Editor's note: An earlier version of this item misspelled Alex Lash's last name as Kash.)
Disease Team News Coverage, Irony and a 'Sinking' State
The California stem cell agency's $230 million disease team research effort, which boosted CIRM's spending beyond $1 billion, attracted moderate news coverage this morning and late yesterday.
Some publications, however, appeared to ignore the story entirely, including the Los Angeles Times and The Sacramento Bee, based on our Internet searches. The performance of the Times was particularly strange since more than $80 million is going to institutions in that area.
The San Francisco Chronicle published a page one story by Erin Allday, who listed all the approved programs and interviewed some scientists. She quoted CIRM director Jeff Sheehy as saying,
One sharp-tongued blogger, Wesley J. Smith of “Second Hand Smoke,” wrote,
The Toronto Sun carried a small story. It appears that coverage was light in Canada and the United Kingdom, probably because the size of the grants involved there was relatively modest.
Here are our reports yesterday on the NY Times and Nature coverage.
Some publications, however, appeared to ignore the story entirely, including the Los Angeles Times and The Sacramento Bee, based on our Internet searches. The performance of the Times was particularly strange since more than $80 million is going to institutions in that area.
The San Francisco Chronicle published a page one story by Erin Allday, who listed all the approved programs and interviewed some scientists. She quoted CIRM director Jeff Sheehy as saying,
"These are not well-placed bets. These are carefully considered projects. We are not casually throwing away money hoping we'll get a cure at the end of the day. We're moving forward aggressively but with a rigorous review of science."The Chronicle, New York Times, Nature and the San Diego Union-Tribune all noted that most of the disease team grants do not involve human embryonic stem cell research, which was the rallying cry for Prop. 71, the political device that created CIRM. Thomas Kupper of the San Diego paper called that fact ironic.
One sharp-tongued blogger, Wesley J. Smith of “Second Hand Smoke,” wrote,
“So, do I now think that the CIRM is peachy keen because it is beginning to support ethical stem cell research? No! I don’t care if the CIRM swore off ESCR for good. The state is sinking beneath the red ink waves. School funds are being cut, the UC system is a mess, health care is shriveling, and our state parks are only going to be open on weekends. The Bay Bridge is falling–literally–apart and other infrastructure is in trouble. We have debt past the horizon with no relief ship in sight. If the CIRM really wanted to help California, it would close up shop.”On an industry blog, In Vivo, Alex Lash focused on Novocell, which will receive CIRM's first-ever loan for its research.
The Toronto Sun carried a small story. It appears that coverage was light in Canada and the United Kingdom, probably because the size of the grants involved there was relatively modest.
Here are our reports yesterday on the NY Times and Nature coverage.
Wednesday, October 28, 2009
NY Times: CIRM Moves Away From hESC
The New York Times today reported that the California stem cell agency has made a “tacit acknowledgment that the promise of human embryonic stem cells is still far in the future.”
Reporter Andrew Pollack wrote that only 4 of the 14 disease team projects approved by CIRM today involve embryonic stem cells. He said,
Nature magazine also pointed out today that the disease team round involved few grants using hESC.
Reporter Andrew Pollack wrote that only 4 of the 14 disease team projects approved by CIRM today involve embryonic stem cells. He said,
"The others will use so-called adult stem cells or conventional drugs intended to kill cancer stem cells, which are thought to give rise to tumors."Pollack continued,
“The grants thus represent a departure from the program’s original mission. California voters approved the 10-year, $3 billion effort in 2004 largely to get around restrictions on embryonic stem cell research imposed by the administration of President George W. Bush.”Pollack asked CIRM Chairman Robert Klein about the emphasis on non-hESC projects in the disease team round at news conference today. Klein said that the commitment to voters was to “pursue the very best cell type for each disease.”
Nature magazine also pointed out today that the disease team round involved few grants using hESC.
A Peek at News Coverage of CIRM's $230 Million Disease Team Round
California's stem cell research effort today climbed over the $1 billion mark with its whopping disease team round. The awards began generating news coverage internationally this afternoon, and more stories will surface later today and tomorrow.
Erika Check Hayden filed a report on Nature magazine's breaking news blog. She said CIRM regards the round as the “crown jewel of its portfolio.” She said that some of the grants will go “for therapies that, in some cases, are unlike any ever before approved by the FDA.”
Hayden wrote,
Oddly, the largest newspaper in California, the Los Angeles Times, had not carried a word as of this writing on the roughly $80 million in grants to institutions in the Los Angeles area.
The New York Times may well have story late today or tomorrow. Its Los Angeles-based reporter, Andy Pollack, could be seen on the Webcast of the news conference, asking a question about the slim use of human embryonic stem cells in the disease team grants.
Here are links to other stories:
Thomas Kupper of San Diego Union-Tribune
San Diego News Network
Steven Brown of the San Francisco Business Times
DelMar Times
Erika Check Hayden filed a report on Nature magazine's breaking news blog. She said CIRM regards the round as the “crown jewel of its portfolio.” She said that some of the grants will go “for therapies that, in some cases, are unlike any ever before approved by the FDA.”
Hayden wrote,
“Only a handful will employ human embryonic stem cells, despite the fact that most of the fanfare surrounding the passage of Proposition 71, the ballot measure that created CIRM, concerned the fact that CIRM would fill the gap left by a lack of federal funding for work on these cells. But Bob Klein, architect of Proposition 71 and chair of CIRM's governing board, said, 'Our commitment to the voters was that we would pursue the very best cell type for each disease based on the scientific and clinical evidence.'"Rob Waters of Bloomberg emphasized the business aspects and had a separate piece on Sangamo Biosciences of Richmond, Ca., a publicly traded company that shared in a $14.6 million award with City of Hope in Duarte, Ca.
Oddly, the largest newspaper in California, the Los Angeles Times, had not carried a word as of this writing on the roughly $80 million in grants to institutions in the Los Angeles area.
The New York Times may well have story late today or tomorrow. Its Los Angeles-based reporter, Andy Pollack, could be seen on the Webcast of the news conference, asking a question about the slim use of human embryonic stem cells in the disease team grants.
Here are links to other stories:
Thomas Kupper of San Diego Union-Tribune
San Diego News Network
Steven Brown of the San Francisco Business Times
DelMar Times
CIRM News Release: More than $250 Million in Disease Team Round, Including International Partners
The California stem cell agency has posted its press release on the largest research round in its history.
The release notes that, with funding from international partners, the total comes to more than $250 million. The release also contains the identities of all the winning researchers and their institutions.
The release notes that, with funding from international partners, the total comes to more than $250 million. The release also contains the identities of all the winning researchers and their institutions.
CIRM News Conference Link
Here is a link to the live news conference on CIRM's $230 million disease team program.
California Stem Cell Agency Approves $230 Million Aimed at Clinical Trials
The California stem cell agency today formally awarded $230 million to 14 teams of scientists in the largest and most ambitious round of research grants in CIRM history.
Already the world's largest source of funding for human embryonic stem cell research, the $3 billion agency said the grants and loans would lead to the beginning stage of clinical trials in four years.
The disease team round also marks the first foray into what is expected to be a risky, $500 million loan program for the biotech industry. The round is additionally a critical step in building support for continued funding of the agency, which will lose the ability to finance itself sometime in the next decade.
The goal of the disease team effort is to generate filings to begin a clinical trial within four years or less. That would presumably lead to creation of therapies that could alleviate the suffering of thousands. CIRM could also use the results to ask the legislature or the people of California, by ballot measure, for additional funding.
The disease team round is the first major effort involving international partners, Canada and the United Kingdom. Organizations in those countries are collaborating with California partners and adding many more millions to the research largess.
All of the grants in tier one were approved, although application 1471 had conditions attached because of a change in the employment of a co-PI in the United Kingdom.
Already the world's largest source of funding for human embryonic stem cell research, the $3 billion agency said the grants and loans would lead to the beginning stage of clinical trials in four years.
The disease team round also marks the first foray into what is expected to be a risky, $500 million loan program for the biotech industry. The round is additionally a critical step in building support for continued funding of the agency, which will lose the ability to finance itself sometime in the next decade.
The goal of the disease team effort is to generate filings to begin a clinical trial within four years or less. That would presumably lead to creation of therapies that could alleviate the suffering of thousands. CIRM could also use the results to ask the legislature or the people of California, by ballot measure, for additional funding.
The disease team round is the first major effort involving international partners, Canada and the United Kingdom. Organizations in those countries are collaborating with California partners and adding many more millions to the research largess.
All of the grants in tier one were approved, although application 1471 had conditions attached because of a change in the employment of a co-PI in the United Kingdom.
Concerns About Size of Disease Team Round
Some CIRM directors seem to be concerned about the overall size of the disease team package and the original budget of $210 million.
There may well be an effort to trim the overall size, which would mean that some grants in tier one are removed. Normally all grants in tier win ultimate approval from directors, but they have the ability to do whatever they want.
There may well be an effort to trim the overall size, which would mean that some grants in tier one are removed. Normally all grants in tier win ultimate approval from directors, but they have the ability to do whatever they want.
City of Hope Wins Initial Appeal
Directors of the California stem cell agency this morning gave a positive nod to an attempt to win approval of an application from the City of Hope in the agency's disease team round.
The board approved, on a unanimous vote, a motion to move the application into the first tier of grants expected to be approved later today.
The grant was proposed by Karen Aboody of City of Hope in Duarte, Ca., to study development of treatments for brain tumors.
Aboody filed an extraordinary petition to overturn a negative decision by CIRM reviewers, who gave the application a score of 43 on a scale of 100.
CIRM Vice Chairman Duane Roth said he would support the grant because information in the review was incorrect. Another director concurred with Roth's comments.
The size of the grant was not immediately available.
(Editor's note: The vote tally is based on votes that were audible on the board Web audiocast. The ultimate figure may vary slightly.)
The board approved, on a unanimous vote, a motion to move the application into the first tier of grants expected to be approved later today.
The grant was proposed by Karen Aboody of City of Hope in Duarte, Ca., to study development of treatments for brain tumors.
Aboody filed an extraordinary petition to overturn a negative decision by CIRM reviewers, who gave the application a score of 43 on a scale of 100.
CIRM Vice Chairman Duane Roth said he would support the grant because information in the review was incorrect. Another director concurred with Roth's comments.
The size of the grant was not immediately available.
(Editor's note: The vote tally is based on votes that were audible on the board Web audiocast. The ultimate figure may vary slightly.)
CIRM Directors Nix Buck Appeal
Directors of the California stem cell agency turned back an attempt to win approval of a $17 million application from the Buck Institute on a stem cell research proposal involving Parkinsons disease.
The board rejected, on a 6-11 vote with one abstention, a motion to move the application into the first tier of grants expected to be approved later today.
The grant was proposed by Xianmin Zeng of Buck and co-PI Mahendra Rao, vice president of Invitrogen and former head of the stem cell group at National Institute of Aging.
Scientific reviewers gave the application a score of 53 and did not recommend it for funding.
Zeng filed an “extraordinary petition” and personally appeared before the board this morning. She said the criticisms by reviewers were minor or technical and have already been addressed or are being addressed.
The motion to move ahead on the grant was offered by CIRM Director Joan Samuelson, who has Parkinsons.
(Editor's note: The vote tally is based on votes that were audible on the board Web audiocast. The ultimate figure may vary slightly.)
The board rejected, on a 6-11 vote with one abstention, a motion to move the application into the first tier of grants expected to be approved later today.
The grant was proposed by Xianmin Zeng of Buck and co-PI Mahendra Rao, vice president of Invitrogen and former head of the stem cell group at National Institute of Aging.
Scientific reviewers gave the application a score of 53 and did not recommend it for funding.
Zeng filed an “extraordinary petition” and personally appeared before the board this morning. She said the criticisms by reviewers were minor or technical and have already been addressed or are being addressed.
The motion to move ahead on the grant was offered by CIRM Director Joan Samuelson, who has Parkinsons.
(Editor's note: The vote tally is based on votes that were audible on the board Web audiocast. The ultimate figure may vary slightly.)
Buck Institute Application Being Discussed
The board of the California stem cell agency has resumed its discussion of disease team grants and loans. Currently it is considering an effort by Xianmin Zeng of the Buck Institute for Age Research to overturn a negative decision on her application by science reviewers.
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