Wednesday, October 28, 2009
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.
Looking at CIRM Grant Appeals Issues
Here are links to documents relating to the California stem cell agency and complaints about fairness in its grant review process.
Text of CIRM policy on appeals via "extraordinary petition."
An October 2008 examination of transparency and conflict of interest issues
Consumer Watchdog Identifies Businesses Rejected for CIRM Grants
First ever successful conflict appeal, December 2008
CIRM's August 2008 proposal for a reconsideration procedure
Transcript of August 2008 CIRM Meeting
Proposal by CIRM Director Jeff Sheehy on grant appeals, July 2008.
First mainstream media article ( July 2008) about complaints about fairness in CIRM grant-making
Cascade LifeSciences Seeks Reconsideration
Text of Cascade's Reconsideration Letter
CIRM Response to Cascade
Transcript of June 2008 CIRM Meeting Involving Cascade
Transcript of the January 2008 CIRM directors meeting, which heard the first public appeal of a scientific review. Search on the term "luben," which is the misspelling of the name of Bertram Lubin, president of Childrens Hospital Oakland Research Institute, who appeared before the directors seeking reconsideration.
Nature magazine article April 30, 2008, in which Lubin comments on CIRM
California Stem Cell Report account of part of the January meeting involving the Lubin appeal.
Text of CIRM policy on appeals via "extraordinary petition."
An October 2008 examination of transparency and conflict of interest issues
Consumer Watchdog Identifies Businesses Rejected for CIRM Grants
First ever successful conflict appeal, December 2008
CIRM's August 2008 proposal for a reconsideration procedure
Transcript of August 2008 CIRM Meeting
Proposal by CIRM Director Jeff Sheehy on grant appeals, July 2008.
First mainstream media article ( July 2008) about complaints about fairness in CIRM grant-making
Cascade LifeSciences Seeks Reconsideration
Text of Cascade's Reconsideration Letter
CIRM Response to Cascade
Transcript of June 2008 CIRM Meeting Involving Cascade
Transcript of the January 2008 CIRM directors meeting, which heard the first public appeal of a scientific review. Search on the term "luben," which is the misspelling of the name of Bertram Lubin, president of Childrens Hospital Oakland Research Institute, who appeared before the directors seeking reconsideration.
Nature magazine article April 30, 2008, in which Lubin comments on CIRM
California Stem Cell Report account of part of the January meeting involving the Lubin appeal.
Tuesday, October 27, 2009
Weissman's $20 Million Proposal Dodges Rejection
A $20 million grant application from reknown scientist Irv Weissman of Stanford tonight avoided disaster as CIRM directors overturned a decision by scientific reviewers to reject the proposal.
The application was moved, 14-2 vote with two directors abstaining, into the top tier of disease team grants that are headed for approval by the directors tomorrow morning.
Another $20 million application from Stanford's Gary Steinberg was also moved into the first tier on a separate vote, which was either 13-3 or 12-4. One director's vote was inaudible on the Web audiocast.
The Steinberg and Weissman applications bring to 13 the number of grants in the first tier for a total of $207 million. That is just under the $210 million budgeted for the disease team effort, the largest research grant round in CIRM history.
Both applications were the subject of an “extraordinary petition,” along with four other applications. One of those efforts was not successful tonight. No director made a motion to move a $12 million proposal by Aileen Anderson of UC Irvine to the first tier.
(Weissman's petition can be found here, Steinberg's here, Anderson's here. The other petitions are from Judith Shizuru of Stanford(here), Karen S. Aboody of the City of Hope(here) in Duarte, Ca., and Xianmin Zeng of the Buck Institute(here) in Novato, a town north of of San Francisco.)
The directors have recessed until tomorrow morning. They did not take up the other petitions tonight as they worked their way through the grants that CIRM's grant reviewers said were not worthy of funding. Weissman's application received a scientific score of 65, below the cutoff line of 70. Steinberg's and Anderson's scores were not available.
Regarding the Weissman application, CIRM Chairman Robert Klein said some of the reviewers may have been less than objective because they do not believe that cancer stem cells exist. The subject is a matter of some scientific dispute. CIRM President Alan Trounson disagreed with Klein on the possibility of prejudice but said that the grant could be worthy of funding.
Director Ted Love, who served as CIRM's chief scientific officer during the review, said the board could feel comfortable funding the grant or not. He said he did not think it would be “unwise” to fund the application.
Weissman's name was not mentioned during the discussion, but some commented about respect for the principal investigator. The United Kingdom is also involved in the grant, providing an additional $4.3 million, according to Trounson.
The board is scheduled to resume deliberations at 8:30 a.m. PDT tomorrow in Los Angeles. CIRM has scheduled an 11 a.m. news conference to formally announce the grant winners. The meeting will be audiocast on the Web. Directions for listening are on the agenda.
The application was moved, 14-2 vote with two directors abstaining, into the top tier of disease team grants that are headed for approval by the directors tomorrow morning.
Another $20 million application from Stanford's Gary Steinberg was also moved into the first tier on a separate vote, which was either 13-3 or 12-4. One director's vote was inaudible on the Web audiocast.
The Steinberg and Weissman applications bring to 13 the number of grants in the first tier for a total of $207 million. That is just under the $210 million budgeted for the disease team effort, the largest research grant round in CIRM history.
Both applications were the subject of an “extraordinary petition,” along with four other applications. One of those efforts was not successful tonight. No director made a motion to move a $12 million proposal by Aileen Anderson of UC Irvine to the first tier.
(Weissman's petition can be found here, Steinberg's here, Anderson's here. The other petitions are from Judith Shizuru of Stanford(here), Karen S. Aboody of the City of Hope(here) in Duarte, Ca., and Xianmin Zeng of the Buck Institute(here) in Novato, a town north of of San Francisco.)
The directors have recessed until tomorrow morning. They did not take up the other petitions tonight as they worked their way through the grants that CIRM's grant reviewers said were not worthy of funding. Weissman's application received a scientific score of 65, below the cutoff line of 70. Steinberg's and Anderson's scores were not available.
Regarding the Weissman application, CIRM Chairman Robert Klein said some of the reviewers may have been less than objective because they do not believe that cancer stem cells exist. The subject is a matter of some scientific dispute. CIRM President Alan Trounson disagreed with Klein on the possibility of prejudice but said that the grant could be worthy of funding.
Director Ted Love, who served as CIRM's chief scientific officer during the review, said the board could feel comfortable funding the grant or not. He said he did not think it would be “unwise” to fund the application.
Weissman's name was not mentioned during the discussion, but some commented about respect for the principal investigator. The United Kingdom is also involved in the grant, providing an additional $4.3 million, according to Trounson.
The board is scheduled to resume deliberations at 8:30 a.m. PDT tomorrow in Los Angeles. CIRM has scheduled an 11 a.m. news conference to formally announce the grant winners. The meeting will be audiocast on the Web. Directions for listening are on the agenda.
Correction
The “public appeal” item on Oct. 27, 2009, incorrectly said that extraordinary petitions filed by six grant applicants were not available on the CIRM Web site. The petitions were not noted on the CIRM board agenda but could be found three layers down on six of the 20 summaries of the grants rejected by reviewers.
Weissman's Grant and Appeal Now Being Discussed
Currently being discussed by the CIRM board is a rejected grant (1485) by noted Stanford scientist Irv Weissman.
Advisory
The meeting of the California stem cell agency board has resumed with much improved clarity. Up for discussion are the $167 million in disease team grants and loans.
Six Rejected Grant Applicants Make Public Appeal to CIRM Board
Six research teams that lost out in CIRM's closed door reviews of their applications for up to $20 million dollars are now seeking to overturn the decisions.
The rejected applicants include three from Stanford(Irv Weissman, Judith Shizuru and Gary Steinberg), one from the City of Hope (Karen S. Aboody) in Duarte, Ca., one from UC Irvine(Aileen Anderson) and one from the Buck Institute(Xianmin Zeng) in Novato, a town north of of San Francisco.
Their “extraordinary petitions” are not yet available on the board's agenda, but their existence was confirmed by John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca. Simpson was attending the meeting in Los Angeles and supplied the applicants' identities from CIRM documents available at the session.
We queried him about the petitions after hearing a partial comment on the Web audiocast of the meeting, which has been largely muddled at our location in Mazatlan.
Simpson also said that one key board member told him that the six petitions raise “substantive scientific issues.” The efforts to overturn the negative results raise some other interesting issues because CIRM budgeted $210 million for the disease team grant round while reviewers only approved $167 million.
The extraordinary petition process is relatively new at CIRM. It was created in September 2008 in response to public appearances by rejected applicants at CIRM board meetings. None have been successful using that method and none have been successful in using the extraordinary petition process.
A number of board members have been clearly uncomfortable with the public presentations by unhappy applicants. They have also been loath to overturn the decisions of the Grants Working Group and the scientists who are members of it.
The issue bubbled up in June 2008, leading to an extended public board discussion of the appeal or reconsideration process. CIRM allows "appeals" only in the case of conflicts of interest on the part of reviewers. However, reviewers do not have to publicly disclose their economic or professional interests.
The extraordinary petition process requires the applicant to file a request for reconsideration five days prior to a directors meeting. CIRM's president will then evaluate it and make a finding on whether it has merit.
Here is an account of how the petition process worked last January.
(Editor's note: An earlier version of this item incorrectly said the petitions were not available on the CIRM Web site.)
The rejected applicants include three from Stanford(Irv Weissman, Judith Shizuru and Gary Steinberg), one from the City of Hope (Karen S. Aboody) in Duarte, Ca., one from UC Irvine(Aileen Anderson) and one from the Buck Institute(Xianmin Zeng) in Novato, a town north of of San Francisco.
Their “extraordinary petitions” are not yet available on the board's agenda, but their existence was confirmed by John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca. Simpson was attending the meeting in Los Angeles and supplied the applicants' identities from CIRM documents available at the session.
We queried him about the petitions after hearing a partial comment on the Web audiocast of the meeting, which has been largely muddled at our location in Mazatlan.
Simpson also said that one key board member told him that the six petitions raise “substantive scientific issues.” The efforts to overturn the negative results raise some other interesting issues because CIRM budgeted $210 million for the disease team grant round while reviewers only approved $167 million.
The extraordinary petition process is relatively new at CIRM. It was created in September 2008 in response to public appearances by rejected applicants at CIRM board meetings. None have been successful using that method and none have been successful in using the extraordinary petition process.
A number of board members have been clearly uncomfortable with the public presentations by unhappy applicants. They have also been loath to overturn the decisions of the Grants Working Group and the scientists who are members of it.
The issue bubbled up in June 2008, leading to an extended public board discussion of the appeal or reconsideration process. CIRM allows "appeals" only in the case of conflicts of interest on the part of reviewers. However, reviewers do not have to publicly disclose their economic or professional interests.
The extraordinary petition process requires the applicant to file a request for reconsideration five days prior to a directors meeting. CIRM's president will then evaluate it and make a finding on whether it has merit.
Here is an account of how the petition process worked last January.
(Editor's note: An earlier version of this item incorrectly said the petitions were not available on the CIRM Web site.)
CIRM Board Recesses for Confidential Grant Review
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.
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.
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.
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