Directors of the California stem cell agency have gone into executive session to discuss confidential information related to applications for $167 million grants and loans in the agency's disease team round.
The CIRM board moved into closed door discussions tonight shortly after the CIRM staff presented a brief overview of the round. It is not clear when the board will return to open session.
The agency has called a news conference for 11 a.m. PDT tomorrow to formally announce the awards and publicly identify the winners.
Tuesday, October 27, 2009
Advisory
If you are having difficulty hearing the audiocast of the meeting of the CIRM board, so are we. We are told that they are working on improving the quality.
Trounson's Report to Directors Posted by CIRM
The California stem cell agency has posted the slides that its president, Alan Trounson, will use to brief directors this afternoon on the state of CIRM.
They include his assessment and summary of recent stem cell research worldwide, his priorities and upcoming rounds for new grants.
Also on tap is a briefing by Geoff Lomax, senior officer for medical and ethical standards, on CIRM's Compliance Program. It is a presentation that CIRM grant recipients and their allied institutions should pay close attention to.
CIRM is expected to have about $1 billion in grants in place by the end of this week. Close monitoring of that cash and the performance of the recipient institutions and scientists is critical to CIRM's credibility.
They include his assessment and summary of recent stem cell research worldwide, his priorities and upcoming rounds for new grants.
Also on tap is a briefing by Geoff Lomax, senior officer for medical and ethical standards, on CIRM's Compliance Program. It is a presentation that CIRM grant recipients and their allied institutions should pay close attention to.
CIRM is expected to have about $1 billion in grants in place by the end of this week. Close monitoring of that cash and the performance of the recipient institutions and scientists is critical to CIRM's credibility.
Brighter Financial Outlook for CIRM
The California stem cell agency began 2009 with an alarming and surprising report about its financial condition. Today the picture is much brighter.
John Robson, vice president for CIRM operations, is scheduled to brief the agency's directors this afternoon about the current state of CIRM finances.
His best news will be about the $118 million CIRM received from the recent California bond sale. The cash will provide funding up to about June of 2011. Unless something truly catastrophic happens, California is likely to sell billions in more bonds between now and then, some of which will keep CIRM research funds flowing.
In response to a query, Don Gibbons, CIRM's chief communications officer, also told us a few days ago that $14.8 million of previous CIRM(state) debt has been reclassified as tax-exempt bonds. That means lower interest costs for the state.
You can find Robson's Power Point presentation (slide 36) here.
John Robson, vice president for CIRM operations, is scheduled to brief the agency's directors this afternoon about the current state of CIRM finances.
His best news will be about the $118 million CIRM received from the recent California bond sale. The cash will provide funding up to about June of 2011. Unless something truly catastrophic happens, California is likely to sell billions in more bonds between now and then, some of which will keep CIRM research funds flowing.
In response to a query, Don Gibbons, CIRM's chief communications officer, also told us a few days ago that $14.8 million of previous CIRM(state) debt has been reclassified as tax-exempt bonds. That means lower interest costs for the state.
You can find Robson's Power Point presentation (slide 36) here.
Coverage Advisory
Assuming all goes with our Internet connection here in Mazatlan, we will bring you coverage this afternoon and evening of today's meeting of the board of directors of the California Institute for Regenerative Medicine, otherwise known as the the California stem cell agency. The main order of business tonight is discussion and possible action on $167 million in disease team research. The meeting begins 4:30 p.m. PDT.
Monday, October 26, 2009
How the Lucky 11 Made Their Way: A $200 Million Tale
Seventy-three pilgrims started out on California's disease team trail last March, looking to share $210 million. Only 11 have finished, unless the men and women who control $3 billion decide differently.
The initial number of stem cell argonauts was substantially less than predicted by Alan Trounson, president of the California stem cell agency, which is financed by $3 billion borrowed by the state.
Last January, Trounson told CIRM directors that he anticipated more than 100 applicants. The prizes were alluring: up to $20 million each.
But only 73 teams filed “pre-applications,” Trounson said in April. Thirty-two of those were invited to submit full applications following CIRM's new grant triage process, which involved scientific specialists from outside California and CIRM staff.
In June, Trounson reported to directors that eight of the 32 invitees had commercial partners or were led by a business. Nine involved international collaborations, down from 18 in preliminary process. (CIRM reported scores on only 31 applications. Presumably one of the 32 did not apply or failed to qualify for some other reason.)
CIRM is ballyhooing the international aspects of the disease team round, whose original California budget was $210 million with up to 12 successful teams. The 11 likely winners account for only $167 million. But funds from the United Kingdom and Canadian teams will boost the combined total to $200 million, according to CIRM.
The results of the disease team round could be an important indicator of CIRM-industry relations. Some businesses have expressed dismay in the past with CIRM after their applications were denied, sometimes appearing at board meetings to vent their concerns. They are generally rebuffed by directors.
Trounson and others, however, have been talking for months about improving ties with the biotech. The updated strategic plan(also up for a final vote this week) calls for closer links. And Trounson has created a new position (yet to be filled), vice president for research and development, to help encourage more amicable relations. He is hoping to attract a candidate with industry experience.
CIRM reviewers rejected 20 disease team applications. Based on our latest look at the agenda, none have sought to overturn the result via the agency's “extraordinary petition” process. But those appeal letters often show up late publicly. Any applicant can also appear before the board and ask for reconsideration of reviewers' decisions for any reason. Few have.
Only four applications received scientific scores above 80. The highest was 90. The other seven ranged in the 70s. Rejected applicants fell below that line, although their scores are not released publicly. The general ranking of the unsuccessful applicants can be determined by examining the listing of the grants. CIRM has made a practice of ordering all the application summaries by their score. For example, application 1480 is the first to fall below the 70 cutoff. If CIRM follows past practice, 1480 has a much higher score than the last application, 1449, listed on the summary.
Sometimes CIRM directors have discussed whether the difference between a score of 70 and 68 has any significance. Those discussions usually come up when they are considering moving an application out of the “not recommended” category. Given that there is more cash available, some directors may move to approve an application just below the cutoff line.
Directors, with the exception of those on the grant review group, do not have access to the full application. Nor are the names of the individuals or institutions disclosed to directors, although considerable information is contained in the review summaries that provide clues to applicants' identities.
Directors also are barred from voting or even discussing applications in which they have a conflict of interest. Usually directors vote on the top-tier grants as a block, officially recording their votes with this language, “Yes, except for those on which I have a conflict.”
Since many of the 29 directors come from institutions that often have applications before CIRM, the votes of the “non-conflicted” board members (mainly patient advocate representatives) are very important in order to complete legal action on the applications.
CIRM has a supermajority quorum requirement – 65 percent – written into state law by Prop. 71, which created the stem cell agency. The quorum is based on those eligible to vote. While quorum and attendance problems have hampered the board with some frequency in the past, we suspect that will not be the case this week. CIRM Chairman Robert Klein has more than once emphasized the importance of the disease team round in terms of producing results that will help CIRM find funding to continue its work beyond the 10 years it can issue bonds.
The initial number of stem cell argonauts was substantially less than predicted by Alan Trounson, president of the California stem cell agency, which is financed by $3 billion borrowed by the state.
Last January, Trounson told CIRM directors that he anticipated more than 100 applicants. The prizes were alluring: up to $20 million each.
But only 73 teams filed “pre-applications,” Trounson said in April. Thirty-two of those were invited to submit full applications following CIRM's new grant triage process, which involved scientific specialists from outside California and CIRM staff.
In June, Trounson reported to directors that eight of the 32 invitees had commercial partners or were led by a business. Nine involved international collaborations, down from 18 in preliminary process. (CIRM reported scores on only 31 applications. Presumably one of the 32 did not apply or failed to qualify for some other reason.)
CIRM is ballyhooing the international aspects of the disease team round, whose original California budget was $210 million with up to 12 successful teams. The 11 likely winners account for only $167 million. But funds from the United Kingdom and Canadian teams will boost the combined total to $200 million, according to CIRM.
The results of the disease team round could be an important indicator of CIRM-industry relations. Some businesses have expressed dismay in the past with CIRM after their applications were denied, sometimes appearing at board meetings to vent their concerns. They are generally rebuffed by directors.
Trounson and others, however, have been talking for months about improving ties with the biotech. The updated strategic plan(also up for a final vote this week) calls for closer links. And Trounson has created a new position (yet to be filled), vice president for research and development, to help encourage more amicable relations. He is hoping to attract a candidate with industry experience.
CIRM reviewers rejected 20 disease team applications. Based on our latest look at the agenda, none have sought to overturn the result via the agency's “extraordinary petition” process. But those appeal letters often show up late publicly. Any applicant can also appear before the board and ask for reconsideration of reviewers' decisions for any reason. Few have.
Only four applications received scientific scores above 80. The highest was 90. The other seven ranged in the 70s. Rejected applicants fell below that line, although their scores are not released publicly. The general ranking of the unsuccessful applicants can be determined by examining the listing of the grants. CIRM has made a practice of ordering all the application summaries by their score. For example, application 1480 is the first to fall below the 70 cutoff. If CIRM follows past practice, 1480 has a much higher score than the last application, 1449, listed on the summary.
Sometimes CIRM directors have discussed whether the difference between a score of 70 and 68 has any significance. Those discussions usually come up when they are considering moving an application out of the “not recommended” category. Given that there is more cash available, some directors may move to approve an application just below the cutoff line.
Directors, with the exception of those on the grant review group, do not have access to the full application. Nor are the names of the individuals or institutions disclosed to directors, although considerable information is contained in the review summaries that provide clues to applicants' identities.
Directors also are barred from voting or even discussing applications in which they have a conflict of interest. Usually directors vote on the top-tier grants as a block, officially recording their votes with this language, “Yes, except for those on which I have a conflict.”
Since many of the 29 directors come from institutions that often have applications before CIRM, the votes of the “non-conflicted” board members (mainly patient advocate representatives) are very important in order to complete legal action on the applications.
CIRM has a supermajority quorum requirement – 65 percent – written into state law by Prop. 71, which created the stem cell agency. The quorum is based on those eligible to vote. While quorum and attendance problems have hampered the board with some frequency in the past, we suspect that will not be the case this week. CIRM Chairman Robert Klein has more than once emphasized the importance of the disease team round in terms of producing results that will help CIRM find funding to continue its work beyond the 10 years it can issue bonds.
CIRM Board Meeting Available on Internet, $167 Million to be Handed Out
This week's board meetings of the California stem cell agency, during which the panel will give away $167 million, can be heard by interested parties via an audiocast on the Internet.
The actual public meetings tomorrow and Wednesday will be in Los Angeles with a remote teleconference location at ValleyCare Health Systems in Pleasanton in Northern California.
Specific instructions for the audiocast can be found on the agenda, along with the address in Pleasanton.
A news conference Wednesday will be available on the Web at this link, which will not be live until about 11 a.m.
The actual public meetings tomorrow and Wednesday will be in Los Angeles with a remote teleconference location at ValleyCare Health Systems in Pleasanton in Northern California.
Specific instructions for the audiocast can be found on the agenda, along with the address in Pleasanton.
A news conference Wednesday will be available on the Web at this link, which will not be live until about 11 a.m.
CIRM Hopes for Big Media Splash on Disease Team Grants
The California stem cell agency today began trumpeting this week's disease team grants to the mainstream media, proclaiming that it means $200 million for researchers in California, the United Kingdom and Canada.
CIRM issued an advisory to news outlets, presumably globally, that a news conference will held at 11 a.m. PDT on Wednesday at the Luxe Hotel on Sunset Boulevard in Los Angeles. Six winning scientists will be available to answer questions, CIRM said, although the awards have not yet been approved by the CIRM board.
That, obviously, is a technicality. Grant reviewers have already made the de facto decisions, approving 11. Legally, however, the CIRM board has final say. It begins a two-day meeting at the Luxe tomorrow.
CIRM has promised the appearance of six government officials, including one each from the UK and Canada. Also on hand will be patients living with diseases targeted by the awards. Those are the folks who are going to be the selling point for TV coverage. They are much more sympathetic and appealing than say, for example, Herb Schultz, a senior adviser to the California governor and one of the six government officials who will be on the scene.
For those of you unfamiliar with PR drum-beating, the CIRM news advisory is the easiest part of the process. Phone calls will be made along with additional emails. Information specific to various areas will be fed to reporters and editors. Promises about exclusive interviews will be tendered. Whatever it takes. And that is as it should be if CIRM is going to make the most out of what it views as a critical round of grants that may have a lot to do with building support for its continued existence.
CIRM is barred from spending money out of state. Cash for the research in the UK and Canada will come from those countries, but the winning scientists have joined together in teams.
The news conference will be webcast at the following link: http://www.cirm.ca.gov/Disease_Team_Press_Conference
It will not be live until shortly before 11 a.m. Reporters not on the scene will be able to email questions to the news conference.
CIRM issued an advisory to news outlets, presumably globally, that a news conference will held at 11 a.m. PDT on Wednesday at the Luxe Hotel on Sunset Boulevard in Los Angeles. Six winning scientists will be available to answer questions, CIRM said, although the awards have not yet been approved by the CIRM board.
That, obviously, is a technicality. Grant reviewers have already made the de facto decisions, approving 11. Legally, however, the CIRM board has final say. It begins a two-day meeting at the Luxe tomorrow.
CIRM has promised the appearance of six government officials, including one each from the UK and Canada. Also on hand will be patients living with diseases targeted by the awards. Those are the folks who are going to be the selling point for TV coverage. They are much more sympathetic and appealing than say, for example, Herb Schultz, a senior adviser to the California governor and one of the six government officials who will be on the scene.
For those of you unfamiliar with PR drum-beating, the CIRM news advisory is the easiest part of the process. Phone calls will be made along with additional emails. Information specific to various areas will be fed to reporters and editors. Promises about exclusive interviews will be tendered. Whatever it takes. And that is as it should be if CIRM is going to make the most out of what it views as a critical round of grants that may have a lot to do with building support for its continued existence.
CIRM is barred from spending money out of state. Cash for the research in the UK and Canada will come from those countries, but the winning scientists have joined together in teams.
The news conference will be webcast at the following link: http://www.cirm.ca.gov/Disease_Team_Press_Conference
It will not be live until shortly before 11 a.m. Reporters not on the scene will be able to email questions to the news conference.
Sunday, October 25, 2009
California Courts and CIRM: Both Troubled by Technology Problems
The Sacramento Bee today carried an instructive piece that has implications for governmental enterprises that engage in major outside contracting and need complex computerized systems to monitor data and dollars.
That includes the California's $3 billion stem cell research effort. CIRM would be out of business without its outside contractors, which it is compelled to use because of a legal cap of 50 on staff size. The agency is also wrestling with a computer system to monitor the performance of its grantees and manage its multi-year grants, which will total nearly $1 billion by the end of this week.
The Bee's article by Robert Lewis is a fine piece of investigative reporting. Lewis chronicled the ins-and-outs of an effort to computerize the state's court system. The project began in 2001 and now faces costs close to $2 billion, but it is years away from completion.
The original cost projections appear to be unknown. The Bee quotes a court spokesman as saying costs estimates “at junctures where critical decisions were made” do not exist. How much has been spent so far? Court officials could not provide an answer.
Lewis' article notes that the state court project ballooned without the scrutiny that other state computer systems face. That's because the courts are an independent branch of government. CIRM is not an independent branch of government, but it receives even less normal state oversight, which usually comes from either the governor or the legislature.
Lewis does not identify a particular point where the the state court effort went wrong, although the court system severed ties with one major contractor in midstream. The project seems to have grown willy-nilly with differing goals, lack of a cohesive plan and huge no-bid contracts. Court officials also apparently ignored advice that called for a “business case” justification that would spell out the project's objectives.
CIRM's grant management system is small change compared to the court boondoggle. However, CIRM directors were told this year that the critically needed grant managements program is “at risk.”
The history of the CIRM project does not instill confidence. In October 2007, CIRM directors were told that the “complete cost” of the system would be $757,000. By the following spring, CIRM was seeking additional help at a cost of $85,000. By this year, the original contractor, Grantium, no longer was working on the project. Other contractors had been hired, at a cost of more than $350,000. Just last month, CIRM advertised on its site for more programming assistance. CIRM has made no public disclosure of all the costs of the system since the beginning of the Grantium contract.
In July, John Robson, vice president of operations for CIRM, differed with our reports of “disarray” in the grants management system. Robson, who did not join CIRM until after Grantium was selected, said the current system provides all the necessary information but is labor and time intensive. That is not a small consideration given the tiny staff (40 something) at CIRM. Robson also predicted that the current grants management system will save money compared to Grantium.
Robson made his comments to us following a meeting of the CIRM directors' Finance Subcommittee at which they asked for a detailed breakdown of spending on the grants management system. So far, that information has not been forthcoming.
That includes the California's $3 billion stem cell research effort. CIRM would be out of business without its outside contractors, which it is compelled to use because of a legal cap of 50 on staff size. The agency is also wrestling with a computer system to monitor the performance of its grantees and manage its multi-year grants, which will total nearly $1 billion by the end of this week.
The Bee's article by Robert Lewis is a fine piece of investigative reporting. Lewis chronicled the ins-and-outs of an effort to computerize the state's court system. The project began in 2001 and now faces costs close to $2 billion, but it is years away from completion.
The original cost projections appear to be unknown. The Bee quotes a court spokesman as saying costs estimates “at junctures where critical decisions were made” do not exist. How much has been spent so far? Court officials could not provide an answer.
Lewis' article notes that the state court project ballooned without the scrutiny that other state computer systems face. That's because the courts are an independent branch of government. CIRM is not an independent branch of government, but it receives even less normal state oversight, which usually comes from either the governor or the legislature.
Lewis does not identify a particular point where the the state court effort went wrong, although the court system severed ties with one major contractor in midstream. The project seems to have grown willy-nilly with differing goals, lack of a cohesive plan and huge no-bid contracts. Court officials also apparently ignored advice that called for a “business case” justification that would spell out the project's objectives.
CIRM's grant management system is small change compared to the court boondoggle. However, CIRM directors were told this year that the critically needed grant managements program is “at risk.”
The history of the CIRM project does not instill confidence. In October 2007, CIRM directors were told that the “complete cost” of the system would be $757,000. By the following spring, CIRM was seeking additional help at a cost of $85,000. By this year, the original contractor, Grantium, no longer was working on the project. Other contractors had been hired, at a cost of more than $350,000. Just last month, CIRM advertised on its site for more programming assistance. CIRM has made no public disclosure of all the costs of the system since the beginning of the Grantium contract.
In July, John Robson, vice president of operations for CIRM, differed with our reports of “disarray” in the grants management system. Robson, who did not join CIRM until after Grantium was selected, said the current system provides all the necessary information but is labor and time intensive. That is not a small consideration given the tiny staff (40 something) at CIRM. Robson also predicted that the current grants management system will save money compared to Grantium.
Robson made his comments to us following a meeting of the CIRM directors' Finance Subcommittee at which they asked for a detailed breakdown of spending on the grants management system. So far, that information has not been forthcoming.
Friday, October 23, 2009
The Lucky 11 and $167 Million in Stem Cell Research Cash
The California stem cell agency has pinpointed 11 likely winners of grants and loans up to $20 million each in the agency's ambitious disease team round, which was once projected at $210 million.
The awards are scheduled to be formally approved next week by the CIRM board of directors at a two-day meeting in Los Angeles at the Luxe Hotel. CIRM's Grants Working Group decided earlier that 11 proposals merited funding. The CIRM board almost never rejects a recommendation for funding by its reviewers.
The cost of the 11 applications is $167 million, well below the $210 million budgeted for the disease team round. Twenty other proposals were rejected by reviewers who gave them scientific scores of less than 70 on a scale of one to 100. Some patient advocates for the rejected research, which includes projects involving Huntington's Disease and spinal cord injury, are likely to make a pitch at the CIRM board meeting for funding of some of the rejected applications.
The CIRM board has final authority to make the grants, although it is loath to overrule its scientific reviewers.
Names of the recipients are not scheduled to be released until after board action, which could come on Tuesday or Wednesday. However, the public summaries of the reviews generally contain enough information to determine the identity of the winners, if you are well-informed about stem cell research or willing to scratch around on the Internet.
For example, the review summary of the top-ranked application – with a score of 90 for $14.6 million for stem cell therapy for AIDS – said,
The names of the applicants are not raised during the CIRM board discussion, which is public. The idea is the board members should be blind to the institutions seeking the funds. But some of the board members are well-versed enough in stem cell science to be able to identify applicants without an Internet search.
The earlier de facto decisions, however, are made behind closed doors by scientific reviewers and some CIRM board members. The statements of the economic interests and potential professional conflicts of scientific reviewers are filed with CIRM but are not made public, a practice that has triggered public complaints by a few researchers. Others grumble in private, wary of making their views publicly known because CIRM controls $3 billion in grant money that might not come their way if they are too cranky.
On tap for next week's meeting is discussion of a CIRM survey of its scientific reviewers regarding public disclosure of their financial interests. The results are expected to be negative, and the CIRM board is not likely to go against the wishes of its reviewers. Some CIRM directors fear the loss of reviewers if they are forced to make public their financial interests.
The Little Hoover Commission, the state's good government agency, recommended the survey because of the power of the reviewers over the public purse.
Some of the applications at next week's meeting are expected to involve loans to businesses, the opening foray into what is projected to be a $500 million program. CIRM directors are expected to go along with today's decisions on loan practices by their Finance Subcommittee.
In response to a query, Don Gibbons, CIRM's chief communications officer, said that the subcommittee approved both staff recommendations concerning evaluation of recourse loans and changes in the loan administration policy.
He said the panel also approved the “hybrid recommendation” in its financial review of loan applications. A CIRM document said,
The awards are scheduled to be formally approved next week by the CIRM board of directors at a two-day meeting in Los Angeles at the Luxe Hotel. CIRM's Grants Working Group decided earlier that 11 proposals merited funding. The CIRM board almost never rejects a recommendation for funding by its reviewers.
The cost of the 11 applications is $167 million, well below the $210 million budgeted for the disease team round. Twenty other proposals were rejected by reviewers who gave them scientific scores of less than 70 on a scale of one to 100. Some patient advocates for the rejected research, which includes projects involving Huntington's Disease and spinal cord injury, are likely to make a pitch at the CIRM board meeting for funding of some of the rejected applications.
The CIRM board has final authority to make the grants, although it is loath to overrule its scientific reviewers.
Names of the recipients are not scheduled to be released until after board action, which could come on Tuesday or Wednesday. However, the public summaries of the reviews generally contain enough information to determine the identity of the winners, if you are well-informed about stem cell research or willing to scratch around on the Internet.
For example, the review summary of the top-ranked application – with a score of 90 for $14.6 million for stem cell therapy for AIDS – said,
“Reviewers noted that the investigators have already successfully navigated many of the regulatory hurdles with the FDA and RAC through previous clinical trials in hematopoietic transplantation in HIV patients.”Regarding another application that sought $20 million for cell therapy for diabetes, the review summary said,
“The principal investigator (PI) has experience in encapsulation and has led the efforts that resulted in recent publications in top tier journals. The world-renowned immunology collaborator is well published, has experience in translational immunology and clinical trial design, and will lead a group of established immunologists at the collaborating institution.”The summaries also contain the names of reviewers who were excused from examining the application because of conflicts of interest, both professional and financial, additional information that can help identify winners.
The names of the applicants are not raised during the CIRM board discussion, which is public. The idea is the board members should be blind to the institutions seeking the funds. But some of the board members are well-versed enough in stem cell science to be able to identify applicants without an Internet search.
The earlier de facto decisions, however, are made behind closed doors by scientific reviewers and some CIRM board members. The statements of the economic interests and potential professional conflicts of scientific reviewers are filed with CIRM but are not made public, a practice that has triggered public complaints by a few researchers. Others grumble in private, wary of making their views publicly known because CIRM controls $3 billion in grant money that might not come their way if they are too cranky.
On tap for next week's meeting is discussion of a CIRM survey of its scientific reviewers regarding public disclosure of their financial interests. The results are expected to be negative, and the CIRM board is not likely to go against the wishes of its reviewers. Some CIRM directors fear the loss of reviewers if they are forced to make public their financial interests.
The Little Hoover Commission, the state's good government agency, recommended the survey because of the power of the reviewers over the public purse.
Some of the applications at next week's meeting are expected to involve loans to businesses, the opening foray into what is projected to be a $500 million program. CIRM directors are expected to go along with today's decisions on loan practices by their Finance Subcommittee.
In response to a query, Don Gibbons, CIRM's chief communications officer, said that the subcommittee approved both staff recommendations concerning evaluation of recourse loans and changes in the loan administration policy.
He said the panel also approved the “hybrid recommendation” in its financial review of loan applications. A CIRM document said,
“Under this proposal, CIRM staff would review and evaluate the information provided by CIRM’s delegated underwriter or financial consultant and the Grants Working Group, determine whether an applicant is eligible for a recourse loan or a non-recourse loan, and negotiate any conditions.”Under certain conditions, however, the staff's determination could be reviewed by the Finance Subcommittee.
Thursday, October 22, 2009
CIRM Directors Review Loan Program Changes
If you are connected to a biotech firm in California considering borrowing money from the state stem cell agency, now is the time to take a look at some important elements dealing with how to get the cash.
They will be considered tomorrow at an 8 a.m. teleconference meeting of the CIRM directors Finance Subcommittee. Public meeting locations are in San Francisco, Irvine, Menlo Park, Los Angeles, San Diego and Waco, Texas. Specific address can be found on the agenda.
We have not had a chance to read the background material carefully but wanted to call attention to its availability. One of the documents appears to have been posted only today. The two others seem to have been posted two days ago.
Here are the documents in question: criteria for evaluation of eligibility for a recourse loan, financial review process for loans and changes in the CIRM loan administration policy.
They will be considered tomorrow at an 8 a.m. teleconference meeting of the CIRM directors Finance Subcommittee. Public meeting locations are in San Francisco, Irvine, Menlo Park, Los Angeles, San Diego and Waco, Texas. Specific address can be found on the agenda.
We have not had a chance to read the background material carefully but wanted to call attention to its availability. One of the documents appears to have been posted only today. The two others seem to have been posted two days ago.
Here are the documents in question: criteria for evaluation of eligibility for a recourse loan, financial review process for loans and changes in the CIRM loan administration policy.
Nature's Stem Cell Web Site Folds Tent
Nature Reports Stem Cells, an online publication of Nature magazine, is closing its doors after more than a two-year run.
The move is a genuine loss to the field. Edited by Monya Baker, the site carried high quality content that was accessible to all. Baker also wrote a blog called “The Niche,” which gave her an opportunity to move quickly as events demanded. Here is the text of a note that Baker sent to us concerning the folding of Nature Reports Stem Cell.
“Well, my life has had less excitement than a hurricane, but I'm still feeling a little tossed about.
“I’m sad to announce that Nature Reports Stem Cells and the Niche will cease operations this week. Happily, our feature stories, interviews, commentaries, research highlights and more will remain available on an archived site and available through searching Nature’s website.
“When we launched in June 2007, we wanted to see how Nature Publishing Group (NPG) could build online communities by providing original content freely available to all members of a fragmented community as well as the interested public. The topic could not have been better: stem cell research was then – and is still – expanding and exciting. It requires highly varied experts to think and work together. Unfortunately, the business of scientific publishing is more difficult than the choice of topic. I will remain with NPG as technology editor of Nature and Nature Methods. Nature and its sister titles remain committed, as ever, to publishing new research and news about stem cells.
“I’ve enjoyed learning from my NPG colleagues and particularly editor-at-large Natalie DeWitt during Nature Reports’ run. Of course, our best content and biggest successes are due to significant participation and support of the stem cell community, who gave generously of their time and insight. David, I really appreciated your blog and coverage. Stay dry, please!”
The move is a genuine loss to the field. Edited by Monya Baker, the site carried high quality content that was accessible to all. Baker also wrote a blog called “The Niche,” which gave her an opportunity to move quickly as events demanded. Here is the text of a note that Baker sent to us concerning the folding of Nature Reports Stem Cell.
“Well, my life has had less excitement than a hurricane, but I'm still feeling a little tossed about.
“I’m sad to announce that Nature Reports Stem Cells and the Niche will cease operations this week. Happily, our feature stories, interviews, commentaries, research highlights and more will remain available on an archived site and available through searching Nature’s website.
“When we launched in June 2007, we wanted to see how Nature Publishing Group (NPG) could build online communities by providing original content freely available to all members of a fragmented community as well as the interested public. The topic could not have been better: stem cell research was then – and is still – expanding and exciting. It requires highly varied experts to think and work together. Unfortunately, the business of scientific publishing is more difficult than the choice of topic. I will remain with NPG as technology editor of Nature and Nature Methods. Nature and its sister titles remain committed, as ever, to publishing new research and news about stem cells.
“I’ve enjoyed learning from my NPG colleagues and particularly editor-at-large Natalie DeWitt during Nature Reports’ run. Of course, our best content and biggest successes are due to significant participation and support of the stem cell community, who gave generously of their time and insight. David, I really appreciated your blog and coverage. Stay dry, please!”
Wednesday, October 21, 2009
Rick Smacks Mazatlan, Blogger Escapes Damage
It is a fine, warm, sunny afternoon here in Mazatlan. Tropical Storm Rick inflicted nary a scratch on Hopalong or its crew, but others were not as fortunate.The newspaper Noroeste reports that 20,000 are without power. Some may be without water. No water is available at our marina, but we have plenty in our tanks on Hopalong.
The eye of Rick passed over us at about 8 a.m. MDT after a windy, rainy, rolly night. Then the wind kicked up again with gusts as high as 55 miles an hour in our marina, which is sheltered. One boat at a nearby marina reported gusts to more than 70. Rick dissipated rapidly as he moved inland, but continues to bring rain to communities in the mountains to our east.
Some medium-sized branches, palm fronds and coconuts are on the ground here. An unmanned, 60-foot, ferro-cement sailboat, Griffin, broke loose at a nearby marina when bolts on a dock cleat failed. Fortunately it came to rest on a piling before careening into other boats. Sailors on other vessels then lassoed Griffin, so to speak, and secured it once again.
Surf flooded the oceanfront floors of a condo nearby and a plate glass window blew out. Facing fell off an upper story of another recently built condo and the ceilings started to come down. Sheets of corrugated metal lay in the streets along with large pieces of roofing tile. One dinghy was reported flying through the air at the peak of the storm while it was tethered to a sailboat. Another small powerboat sunk at a dock.
Hopalong fared just fine. No damage or leaks that we know of. Now the task of drying out lines, repacking, etc., begins. Temperatures will start to climb tomorrow. All is well. We think.
Tuesday, October 20, 2009
Tropical Storm Rick Takes Measure of Blogger and Boat
The California Stem Cell Report is a bit damp and tired from preparations for what is now Tropical Storm Rick, which is scheduled to hit our berth here in Mazatlan late Wednesday morning.
Currently (11 p.m. MDT), Rick is predicted to have maximum sustained winds of about 60 miles an hour with higher gusts. That is down sharply from a couple of days ago. Then forecasters from the National Hurricane Center predicted that a hurricane would slam into mainland Mexico 100 miles or so to our north. Now Rick is much farther south and severely downgraded in intensity. But such are the vagaries of science.
Winds are currently about 20 miles an hour. The temperature is 72 degrees. Rain is falling steadily with four to six inches or more expected. Mazatlan does not handle rain well. The water collects in many streets and runs off very slowly, closing them to traffic. Normal services, such as electricity and running, potable water, may suffer outages. Also the Internet, if you consider that a normal service. Outlying towns could be hit much harder.
Our preparations involved removing everything from the boat that could fly away in the wind and storing it on land. That included such things as sails, awnings, shades and five-gallon jugs filled with diesel. We added extra lines to secure our vessel, Hopalong, to the dock. All hatches and ports were checked for leaks. The preparations, including adding food and water, took the better part of three days, partly because of the heat.
One interesting sidelight of the hurricane was an increase in traffic on the California Stem Cell Report. Our web statistics service, WebStat, reported some odd upticks. When we dug deeper into the numbers, we found the jumps were coming from searches on the terms “hurricane” and “Mazatlan.” Guess it pays to talk about the weather even if you can't do anything about it.
Currently (11 p.m. MDT), Rick is predicted to have maximum sustained winds of about 60 miles an hour with higher gusts. That is down sharply from a couple of days ago. Then forecasters from the National Hurricane Center predicted that a hurricane would slam into mainland Mexico 100 miles or so to our north. Now Rick is much farther south and severely downgraded in intensity. But such are the vagaries of science.
Winds are currently about 20 miles an hour. The temperature is 72 degrees. Rain is falling steadily with four to six inches or more expected. Mazatlan does not handle rain well. The water collects in many streets and runs off very slowly, closing them to traffic. Normal services, such as electricity and running, potable water, may suffer outages. Also the Internet, if you consider that a normal service. Outlying towns could be hit much harder.
Our preparations involved removing everything from the boat that could fly away in the wind and storing it on land. That included such things as sails, awnings, shades and five-gallon jugs filled with diesel. We added extra lines to secure our vessel, Hopalong, to the dock. All hatches and ports were checked for leaks. The preparations, including adding food and water, took the better part of three days, partly because of the heat.
One interesting sidelight of the hurricane was an increase in traffic on the California Stem Cell Report. Our web statistics service, WebStat, reported some odd upticks. When we dug deeper into the numbers, we found the jumps were coming from searches on the terms “hurricane” and “Mazatlan.” Guess it pays to talk about the weather even if you can't do anything about it.
Sunday, October 18, 2009
Hurricane Rick Plays Hob with Stem Cell Report
A 180-mile-an-hour hurricane in the Pacific Ocean means that we will be focused this week on preparations for the storm and not on items for the California Stem Cell Report. We are currently in a Mazatlan marina on our sailboat, Hopalong, on which we have lived for the last 11 years. Hurricane Rick is expected to hit the mainland of Mexico Wednesday or Thursday at hurricane force, but down from its current velocity to only 100 miles an hour or so.
Current predictions say the landfall will be north of us, maybe a couple of hundred miles, but the reliability of the forecasts is considerably less than 100 percent.
So we will be stripping the topsides of the boat, removing sails, adding dock lines, putting in supplies, arranging for alternative housing ashore and so forth today, Monday and Tuesday. If all goes well, we may have some fresh CIRM stuff next weekend.
Here is a link to Hurricane Rick's track as of this writing. Mazatlan is located on the mainland due east of the tip of Baja.
CIRM On Track to Hit $1 Billion Mark
The board of directors of the California stem cell agency late this month is expected to approve $210 million for disease team grants and loans, the largest ever research round for the five-year-old enterprise.
The amount will push CIRM's grant total to about $1 billion, the bulk of which has gone to institutions with representatives on its board of directors. The agency has authority to spend another $2 billion, which it generates through California state bonds. When that runs out, the agency will need to find additional funding if it is to continue.
The meeting Oct. 27-28 in Los Angeles will also mark the first ever loans made by the agency, which has plans to build the loan program to $500 million. The purpose of the loans is to assist biotech businesses that could not otherwise receive funding because they are in what as known as a “valley of death” financially. The expectation is that the loans will generate $100 million despite loan failure rates as high as 50 percent. Any profit is expected to be recycled as more loans or grants.
Prior to the board meeting, the directors' Finance Subcommittee is scheduled on Friday to consider some basic matters concerning the loan program. The recommendations of the panel will go before the board at its meeting at the end of the month.
No background information has yet been posted concerning those matters, which range from criteria for certain loans to unspecified changes in loan administration policies.
Also on tap for the full board meeting is a discussion of the yet-to-be released results of a survey of the scientific grant reviewers concerning whether they would be willing to publicly disclose their financial interests. They are members of the Grants Working Group, which makes the de facto decisions on CIRM grants.
The Little Hoover Commission, the state's good government agency, recommended the survey because of the power of the scientific reviewers, who perform their work behind closed doors. Questions have been raised about conflicts on the part of the reviewers, in private by some researchers, but some in public.
It is commonplace for scientists to disclose financial interests in publication of research papers, but some CIRM directors fear that public disclosure of reviewer interests would result in the loss of some reviewers, who would resign rather than be subject to public scrutiny.
Also on the table for the meeting is the update to CIRM's strategic plan, which would officially set CIRM on a course for closer relationships with the biotech industry. The agency is currently engaged in a $100,000 search to fill a newly created vice president of research and development. The post has a salary range that tops out at $332,000 and is aimed at attracting candidates from industry.
The amount will push CIRM's grant total to about $1 billion, the bulk of which has gone to institutions with representatives on its board of directors. The agency has authority to spend another $2 billion, which it generates through California state bonds. When that runs out, the agency will need to find additional funding if it is to continue.
The meeting Oct. 27-28 in Los Angeles will also mark the first ever loans made by the agency, which has plans to build the loan program to $500 million. The purpose of the loans is to assist biotech businesses that could not otherwise receive funding because they are in what as known as a “valley of death” financially. The expectation is that the loans will generate $100 million despite loan failure rates as high as 50 percent. Any profit is expected to be recycled as more loans or grants.
Prior to the board meeting, the directors' Finance Subcommittee is scheduled on Friday to consider some basic matters concerning the loan program. The recommendations of the panel will go before the board at its meeting at the end of the month.
No background information has yet been posted concerning those matters, which range from criteria for certain loans to unspecified changes in loan administration policies.
Also on tap for the full board meeting is a discussion of the yet-to-be released results of a survey of the scientific grant reviewers concerning whether they would be willing to publicly disclose their financial interests. They are members of the Grants Working Group, which makes the de facto decisions on CIRM grants.
The Little Hoover Commission, the state's good government agency, recommended the survey because of the power of the scientific reviewers, who perform their work behind closed doors. Questions have been raised about conflicts on the part of the reviewers, in private by some researchers, but some in public.
It is commonplace for scientists to disclose financial interests in publication of research papers, but some CIRM directors fear that public disclosure of reviewer interests would result in the loss of some reviewers, who would resign rather than be subject to public scrutiny.
Also on the table for the meeting is the update to CIRM's strategic plan, which would officially set CIRM on a course for closer relationships with the biotech industry. The agency is currently engaged in a $100,000 search to fill a newly created vice president of research and development. The post has a salary range that tops out at $332,000 and is aimed at attracting candidates from industry.
CIRM-China Agreement?
The $3 billion California stem cell agency has reached a collaborative research agreement with China, according to a news report on the Internet.
Here is what Richard Daverman of ChinaBio posted this morning,
CIRM has a number of collaborative agreements in place that include such countries as Spain, Canada and Germany. The arrangements provide for creation of international teams of researchers who bid jointly for grants. CIRM funds only research in California. The other countries put up their own cash.
Here is what Richard Daverman of ChinaBio posted this morning,
“In a story postdated to Monday, October 19, 2009, The California Institute for Regenerative Medicine (CIRM) revealed it has signed an agreement to collaborate on stem cell research with China’s Ministry of Science and Technology.As of this writing, we could find no other reports on the subject. We are querying CIRM concerning the item.
“The announcement was little more than a headline. Details will most likely be released on Monday.
“CIRM was established in 2004 with a $3 billion budget earmarked for funding research on stem cells. CIRM’s charter required that the money would be spent over a ten-year period, and grants would be given only to California-based institutions, both public and private. It is not clear how CIRM will cooperate with MOST, given the second provision.”
CIRM has a number of collaborative agreements in place that include such countries as Spain, Canada and Germany. The arrangements provide for creation of international teams of researchers who bid jointly for grants. CIRM funds only research in California. The other countries put up their own cash.
Friday, October 16, 2009
Square 1 Wins CIRM Biotech Loan Pilot Project
The California stem cell agency has signed a $250,000 contract with Square 1 bank to perform a financial review of the firms seeking the first-ever CIRM loans in a program that could reach $500 million or so.In response to a query, Don Gibbons, chief communications officer for CIRM, said today that the fee-for-service arrangement covered only this year's $210 million disease team round, which is budgeted for 12 awards.
Next Friday, the CIRM directors' Finance Subcommittee is scheduled to consider financial review procedures.
Originally CIRM had hoped to have more than one firm available to perform reviews because of the possibility of conflicts of interest. But last month, the agency decided to go with one firm on a pilot project basis.
At a meeting Sept. 15, CIRM Chairman Robert Klein told directors,
“By having a pilot contract, we can learn a great deal, the lender can learn, and we can be in a position in December or early next year of bringing back something that has gone back to the (directors) Finance Committee again and has more experience in it on the implementation side rather than getting ourselves into a large master contract without that case study value on a very limited and controlled basis.”Klein said the number of possible loans in the disease team round is “very small.”
John Robson, vice president for CIRM operations, said the next possible round of loans(early translation RFA) would not come up until the middle of next year. He said that would allow the staff to develop a more robust proposal that would engage more than one underwriter.
Chris Woolley(see photo), president of the life sciences division of Square 1 in San Diego, offered the original bid on behalf of his firm. Woolley is a past president of the San Diego Venture Group and formerly served on the board of Biocom, an industry group in that area.
Here is a link to Woolley's original proposal earlier this year.
Thursday, October 15, 2009
CIRM Tackles $500 Million Biotech Loan Issues
A key panel of directors of the California stem cell agency next week will wrestle with a few fundamental issues concerning its ambitious, $500 million biotech loan program.
Matters such as the process for financial review of loan applications, unspecified changes in the loan administration policy and criteria for eligibility for recourse loans are on the table for a teleconference meeting of the directors' Finance Subcommittee.
Biotech firms interested in participating in the loan program would be well-advised to sit in on the Oct. 23 session at one of eight teleconference locations.
CIRM's lending effort, which will use borrowed funds (bonds) to make the loans, is slated to get underway with this year's $210 million disease team effort, the largest ever research round by CIRM.
CIRM plans to loan money to risky enterprises that otherwise could not secure financing. Loan failure rates of up to 50 percent in the program have been predicted by CIRM. However, CIRM projections estimate that the effort will generate $100 million in profits that can be recycled into additional grants or loans.
So far, no background information has been posted by the agency concerning the issues to be discussed Oct. 23. at next week's meeting.
Interested parties can participate in the session at seven locations in California and one in Waco, Texas, where a CIRM director is expected to located. The locations in California include San Francisco, Irvine, Hillsborough, Menlo Park, Palo Alto, Los Angeles and San Diego.
Specific addresses can be found on the agenda.
Matters such as the process for financial review of loan applications, unspecified changes in the loan administration policy and criteria for eligibility for recourse loans are on the table for a teleconference meeting of the directors' Finance Subcommittee.
Biotech firms interested in participating in the loan program would be well-advised to sit in on the Oct. 23 session at one of eight teleconference locations.
CIRM's lending effort, which will use borrowed funds (bonds) to make the loans, is slated to get underway with this year's $210 million disease team effort, the largest ever research round by CIRM.
CIRM plans to loan money to risky enterprises that otherwise could not secure financing. Loan failure rates of up to 50 percent in the program have been predicted by CIRM. However, CIRM projections estimate that the effort will generate $100 million in profits that can be recycled into additional grants or loans.
So far, no background information has been posted by the agency concerning the issues to be discussed Oct. 23. at next week's meeting.
Interested parties can participate in the session at seven locations in California and one in Waco, Texas, where a CIRM director is expected to located. The locations in California include San Francisco, Irvine, Hillsborough, Menlo Park, Palo Alto, Los Angeles and San Diego.
Specific addresses can be found on the agenda.
Wednesday, October 14, 2009
CIRM Hires Levin to Help Find New VP
The California stem cell agency has hired the self-styled “boutique” executive search firm of Levin & Company, Inc., to help find a vice president for research, a new position created in the wake of the sudden departure of Marie Csete as chief scientific officer earlier this year.According to CIRM, Levin has signed a $100,000 contract with the agency. Levin beat out Korn/Ferry International, McCormack & Farrow, Caliber Associates, Russell Reynolds Associates, Spencer Stuart and The A-list.
Csete announced her resignation in June and subsequently told Nature magazine that her advice was not respected.
CIRM President Alan Trounson created the new research and development position with an eye to attracting candidates with more commercial research backgrounds. CIRM's salary range for the position tops out at $332,000.
In its proposal, the firm said,
“While we recognize that CIRM may have limitations on what it can offer (such as a bonus), we have had demonstrated experience in recruiting for clients with similar restrictions, such as early stage companies which are unable to offer bonuses, or international clients which cannot provide an equity package.”Levin has a long history in the life sciences industry. In its proposal, it said it had completed search assignments for CEOs for the following stem cell-connected firms: Osiris Therapeutics, Cellerant Therapeutics, StemCells, Inc., and ViaCell.
The firm said its CEO, Christos Richards (see photo), would personally lead the search, personally interview each finalist and negotiate the final package.
Levin projected a timetable of four to six months from the beginning of the search (Aug. 24) to the start date of the vice president. It said the period could be shorter but said “a search taking longer than six months leaves the potential for a dissatsified client.”
Levin, which has its corporate office in Boston, also has offices in San Francisco, Los Angeles and Pennsylvania.
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