"I'm impressed that CIRM is following through on monitoring the huge disease team grants and has actually curtailed the funding of one that didn't meet a key milestone. I hope that makes the other grant holders nervous! Too many scientists (in my humble opinion) forget that they need to do what they said they'd do- or - if the first plan fails, have the expertise and desire to adapt and find another way to reach the goals."
Wednesday, March 21, 2012
Stem Cell Scientist Impressed by CIRM Oversight Over Huge Grants
A California stem cell researcher, who must remain anonymous, made the following emailed comment today on the progress report on the $230 million in disease team grants from the California stem cell agency and termination of a $19 million grant.
More Discussion Upcoming of CIRM Spending Plans
TThe board of the California stem cell agency is now at lunch and will resume its meeting at about 1 p.m. PDT with more discussion of its spending plans and priorities for the next five years.
Future Spending Plans of California Stem Cell Agency Coming Up
The governing board of the $3 billion California stem cell agency is expected momentarily to discuss its plans for spending its remaining $800 million.
Key issues involve shifting funds away from basic research to research more oriented towards more directly producing therapies.
The meeting can be heard on the Internet by following the directions on the agenda.
Key issues involve shifting funds away from basic research to research more oriented towards more directly producing therapies.
The meeting can be heard on the Internet by following the directions on the agenda.
CIRM Hires New PR Chief
The $3 billion California stem cell agency announced today that it has hired Kevin McCormack, currently media relations manager at California Pacific Medical Center in San Francisco, as its new director of communications.
CIRM Chairman Jonathan Thomas told the agency's directors at their meeting this morning in Sacramento that the appointment comes "not a moment too soon." Thomas told directors last June that the agency was engaged in a "communications war." Directors have been concerned about the lack of media coverage of the agency, which is largely below the radar of the mainstream media.
Thomas said that McCormack has "lots of experience" in media crisis management and "pressure cooker situations."
McCormack also served as media relations manager, Division of Research at Kaiser Permanente, and was a health/medical producer at KRON-TV in San Francisco.
The agency did not immediately release McCormack's salary. He will begin work April 2.
CIRM Chairman Jonathan Thomas told the agency's directors at their meeting this morning in Sacramento that the appointment comes "not a moment too soon." Thomas told directors last June that the agency was engaged in a "communications war." Directors have been concerned about the lack of media coverage of the agency, which is largely below the radar of the mainstream media.
Thomas said that McCormack has "lots of experience" in media crisis management and "pressure cooker situations."
McCormack also served as media relations manager, Division of Research at Kaiser Permanente, and was a health/medical producer at KRON-TV in San Francisco.
The agency did not immediately release McCormack's salary. He will begin work April 2.
Tuesday, March 20, 2012
California Stem Cell Agency Pulls $19 Million Grant
The California stem cell agency has terminated a $19 million grant to a UC San Francisco researcher involved in the agency's ambitious attempts to push stem cell therapies into clinics.
The agency said the research effort led by Mitchel Berger, chairman of the department of neurological surgery at UCSF, "did not meet a go/no-go milestone" stipulated in the grant. His research was funded in 2010 to treat brain tumors with genetically modified neural brain cells. No further explanation for the termination was provided by CIRM in a report prepared for tomorrow's meeting of the CIRM governing board. The agency estimated the cancellation would save $13 million.
The California Stem Cell Report has asked Berger and his co-PIs for comment on the CIRM action. The other researchers are Evan Snyder of Sanford-Burnham and Webster Cavanee of the Ludwig Cancer Institute. Their remarks will be carried verbatim when they are received.
The CIRM action was disclosed in the progress report on the $230 million disease team effort launched by the agency in 2009. The amount climbed to more than $250 million with contributions from partnering countries. Three of the 14 funded applicants – Irv Weissman and Gary Steinberg, both of Stanford, and Karen Aboody of the City of Hope – were approved only after they appealed to the CIRM board to overturn rejections by grant reviewers. (See here , here and here for their written appeals. See here and here for coverage of the 2009 board action.)
One other disease team grant was modified to limit its scope and revise its funding. No savings were announced by CIRM. The PI on the $20 million project is Dennis Carson of UC San Diego. Co-PIs are Catriona Jamieson, also of UC San Diego, and John Dick of the University Health Network of Canada. The research is aimed at leukemia.
The actions on the disease team grants were not entirely unexpected. From their inception, CIRM directors have been told not to expect all the grants to finish successfully.
Ellen Feigal, senior vice president for research and development at CIRM, prepared the 19-page update on the disease team efforts. The grants are aimed at generating an investigational new drug application with the FDA within the four-year term of the grant.
She said that the funding decisions were made following evaluation of the projects by panels of clinical development advisors. Their recommendations were then considered by CIRM staff.
Feigal's report laid out accomplishments of the research so far and discussed changes in direction.
She said two companies have been formed since the grants were awarded to commercialize the hoped-for products. She said that in June 2011 Aboody founded TheraBiologics Inc., Newport Beach, Ca., of which she is chief scientific officer and director. Another company, Regenerative Patch Technologies, Glendale, Ca., was created by the team working on an hESC treatment for age-related macular degeneration. That $16 million grant involves Mark Humayan and David Hinton of USC, Dennis Clegg of UC Santa Barbara and Peter Coffey, formerly with University College, London, but now at UC Santa Barbara. The effort has generated seven patent filings.
The Feigal update also discussed the efforts of companies involved in other disease team grants. The lack of CIRM funding for biotech firms has been a bone of contention with industry and troublesome for some CIRM directors.
CIRM indicated the projects involving the firms were moving on schedule with no major difficulties reported. The companies involved are ViaCyte of San Diego, Calimmune of Tucson, Az., and Sangamo Inc. of Richmond, Ca.
The agency said the research effort led by Mitchel Berger, chairman of the department of neurological surgery at UCSF, "did not meet a go/no-go milestone" stipulated in the grant. His research was funded in 2010 to treat brain tumors with genetically modified neural brain cells. No further explanation for the termination was provided by CIRM in a report prepared for tomorrow's meeting of the CIRM governing board. The agency estimated the cancellation would save $13 million.
The California Stem Cell Report has asked Berger and his co-PIs for comment on the CIRM action. The other researchers are Evan Snyder of Sanford-Burnham and Webster Cavanee of the Ludwig Cancer Institute. Their remarks will be carried verbatim when they are received.
The CIRM action was disclosed in the progress report on the $230 million disease team effort launched by the agency in 2009. The amount climbed to more than $250 million with contributions from partnering countries. Three of the 14 funded applicants – Irv Weissman and Gary Steinberg, both of Stanford, and Karen Aboody of the City of Hope – were approved only after they appealed to the CIRM board to overturn rejections by grant reviewers. (See here , here and here for their written appeals. See here and here for coverage of the 2009 board action.)
One other disease team grant was modified to limit its scope and revise its funding. No savings were announced by CIRM. The PI on the $20 million project is Dennis Carson of UC San Diego. Co-PIs are Catriona Jamieson, also of UC San Diego, and John Dick of the University Health Network of Canada. The research is aimed at leukemia.
The actions on the disease team grants were not entirely unexpected. From their inception, CIRM directors have been told not to expect all the grants to finish successfully.
Ellen Feigal, senior vice president for research and development at CIRM, prepared the 19-page update on the disease team efforts. The grants are aimed at generating an investigational new drug application with the FDA within the four-year term of the grant.
She said that the funding decisions were made following evaluation of the projects by panels of clinical development advisors. Their recommendations were then considered by CIRM staff.
Feigal's report laid out accomplishments of the research so far and discussed changes in direction.
She said two companies have been formed since the grants were awarded to commercialize the hoped-for products. She said that in June 2011 Aboody founded TheraBiologics Inc., Newport Beach, Ca., of which she is chief scientific officer and director. Another company, Regenerative Patch Technologies, Glendale, Ca., was created by the team working on an hESC treatment for age-related macular degeneration. That $16 million grant involves Mark Humayan and David Hinton of USC, Dennis Clegg of UC Santa Barbara and Peter Coffey, formerly with University College, London, but now at UC Santa Barbara. The effort has generated seven patent filings.
The Feigal update also discussed the efforts of companies involved in other disease team grants. The lack of CIRM funding for biotech firms has been a bone of contention with industry and troublesome for some CIRM directors.
CIRM indicated the projects involving the firms were moving on schedule with no major difficulties reported. The companies involved are ViaCyte of San Diego, Calimmune of Tucson, Az., and Sangamo Inc. of Richmond, Ca.
Stem Cell Agency Proposes 7 Percent Budget Hike, Seeks $50 Million in Private Funds
The California stem cell agency is proposing an operational budget of $17.8 million for the coming fiscal year, an increase of 7.2 percent over estimated spending for the current year ending June 30.
Financial documents (proposed budget and finance report) prepared for tomorrow's CIRM governing board meeting also showed that CIRM hopes to snag "$50 million in new, outside financial commitment for CIRM programs." This would represent the first major effort in recent years by CIRM to solicit private funds. The "draft goal" is in keeping with the agency's move to build a base of non-governmental funding.
Currently it is financed with cash that the state, which is mired in a financial crisis, must borrow. While CIRM's budget is increasing, the general fund budget for the entire state has plummeted from $103 billion in 2007-2008 to $87 billion this year.
The proposed CIRM budget also disclosed the agency will be facing substantial new costs – $1 million annually – for rent beginning in November 2015. CIRM has been operating rent-free since 2005 because of an $18 million recruitment package put together by the city of San Francisco.
The largest item in the proposed budget is salaries and benefits at $11 million, up from a projected $9.3 million for this year. The agency, which is administering $1.3 billion in grants involving hundreds of researchers, projects an increase in staff to 59. The agency currently has 51 employees, according to the finance report.
Outside contracts are the second largest expense at $3.4 million ($3 million this year) with grant reviews, meetings and workshops at $2.2 million(no comparable figure for this year).
By law, the stem cell agency operates under a budget cap of 6 percent of bond proceeds under the terms of Proposition 71, the ballot initiative that created CIRM.
In addition to tomorrow's review, the budget will be examined by the directors Finance Subcommittee April 2 before coming back for final approval in late May.
(Editor's note: An earlier version of this item incorrectly stated that the rent costs would rise to $1 million beginning in 2016. In fact, the increase will begin in November 2015. CIRM has revised the start date.)
Financial documents (proposed budget and finance report) prepared for tomorrow's CIRM governing board meeting also showed that CIRM hopes to snag "$50 million in new, outside financial commitment for CIRM programs." This would represent the first major effort in recent years by CIRM to solicit private funds. The "draft goal" is in keeping with the agency's move to build a base of non-governmental funding.
Currently it is financed with cash that the state, which is mired in a financial crisis, must borrow. While CIRM's budget is increasing, the general fund budget for the entire state has plummeted from $103 billion in 2007-2008 to $87 billion this year.
The proposed CIRM budget also disclosed the agency will be facing substantial new costs – $1 million annually – for rent beginning in November 2015. CIRM has been operating rent-free since 2005 because of an $18 million recruitment package put together by the city of San Francisco.
The largest item in the proposed budget is salaries and benefits at $11 million, up from a projected $9.3 million for this year. The agency, which is administering $1.3 billion in grants involving hundreds of researchers, projects an increase in staff to 59. The agency currently has 51 employees, according to the finance report.
Outside contracts are the second largest expense at $3.4 million ($3 million this year) with grant reviews, meetings and workshops at $2.2 million(no comparable figure for this year).
By law, the stem cell agency operates under a budget cap of 6 percent of bond proceeds under the terms of Proposition 71, the ballot initiative that created CIRM.
In addition to tomorrow's review, the budget will be examined by the directors Finance Subcommittee April 2 before coming back for final approval in late May.
(Editor's note: An earlier version of this item incorrectly stated that the rent costs would rise to $1 million beginning in 2016. In fact, the increase will begin in November 2015. CIRM has revised the start date.)
Correction
The "coverage" item yesterday incorrectly said the CIRM governing board meeting would be today. In fact, the session is tomorrow in Sacramento.
Monday, March 19, 2012
The AP on the California Stem Cell Agency: No Cures, Hazy Future
The Associated Press news service, whose reports circulate worldwide, has taken the measure of the $3 billion California stem cell agency, declaring that it has produced no cures and that it "faces an uncertain future."
The piece by science writer Alicia Chang asked whether the agency is "still relevant" nearly eight years after it was created by California voters and whether it will exist after the money for new grants runs out in about five years.
She wrote,
Here are excerpts from the piece:
Roger Noll, professor emeritus of economics at Stanford, was quoted as saying that "CIRM's legacy has yet to be written."
The piece by science writer Alicia Chang asked whether the agency is "still relevant" nearly eight years after it was created by California voters and whether it will exist after the money for new grants runs out in about five years.
She wrote,
"Midway through its mission, with several high-tech labs constructed, but little to show on the medicine front beyond basic research, the California Institute for Regenerative Medicine faces an uncertain future."Chang's piece carries more weight than those in most publications. The AP is the backbone of news coverage in the United States. Its news feeds appear automatically on hundreds, perhaps thousands of web sites in this country. Her article will also serve as a baseline in the future as other reporters examine the stem cell agency.
Here are excerpts from the piece:
"So what have Californians received for their money so far?Chang wrote,
"The most visible investment is the opening of sleek buildings and gleaming labs at a dozen private and public universities built with matching funds. Two years ago, Stanford University unveiled the nation's largest space dedicated to stem cell research - 200,000 square feet that can hold 550 researchers.
"There are no cures yet in the pipeline and CIRM has shifted focus, channeling money to projects with the most promise of yielding near-term results."
"Several camps that support stem cell research think taxpayers should not pay another cent given the state's budget woes.The article quoted UC Davis stem cell researcher Paul Knoepfler as favoring another bond measure to keep CIRM afloat, although he said he recognizes the average Californian may disagree.
"'It would be so wrong to ask Californians to pony up more money,' said Marcy Darnovsky of the Center for Genetics and Society, a pro-stem cell research group that opposed Proposition 71, the state ballot initiative that formed CIRM."
Roger Noll, professor emeritus of economics at Stanford, was quoted as saying that "CIRM's legacy has yet to be written."
"'CIRM spent a lot of money and there's a lot of stuff going on, but it's too early to know whether it was worth it,' Noll said."Chang concluded with these four paragraphs:
"David Jensen, who runs the blog California Stem Cell Report, said Californians have benefited, but whether it will be worth the $6 billion the state has to pay back remains unclear.
"'The agency's responsibility is now to get the biggest bang for the buck, which is no easy task given the tentative nature of much of the science involved,'" he said in an email.
"Some think CIRM has left a mark whether or not it will exist in the future.
Its 'legacy will be felt in part by the stimulus that it has had on stem cell' research in California, said Fred Gage of the Salk Institute for Biological Studies."
Coverage of Wednesday's Stem Cell Board Meeting
The California Stem Cell Report has found its cyberspace connection again on Isla Taboga about 10 miles offshore of Panama City. We expect to bring you live coverage via an Internet audiocast of Wednesday's meeting of the board of the California stem cell agency. The directors are scheduled to discuss a progress report on the agency's ambitious, $250 million disease team program and the termination of one grant. Directors are also expected to consider the agency's proposed budget for the coming year, its plans for its next few years of life and its plans to give away $3 million for stem cell programs for high school students. The meeting begins at 9 a.m. PDT.
http://www.cirm.ca.gov/summaries-review-applications-rfa-11-04-cirm-creativity-awards
http://www.cirm.ca.gov/summaries-review-applications-rfa-11-04-cirm-creativity-awards
Sunday, March 11, 2012
Researcher Alert: California Stem Cell Agency To Alter How It Administers Grants
Stem cell researchers and institutions throughout the state are likely to be affected by proposed changes – to be discussed online publicly Tuesday – dealing with how the California stem cell agency will handle its $3 billion in grants.
An important online session – open to all interested parties – comes up then, but advance registration is required.
The proposals are wide-ranging and detailed. The nearly 500 recipients of CIRM grants should examine them closely in addition to any persons seriously interested in California stem cell affairs. The changes deal with such subjects as milestones for research grants, indirect costs, travel costs, withholding payments for failure to file a progress report and much, much more.
Here is a link to the main page for all this, which has instructions on how to register for the online session along with links to the changes and their rationale.
(Editor's note: This item was filed from the Rio Sabana in the Darien in Panama when we found a weak Internet cellular link. We are still underway so postings are unlikely between now and later this month.)
An important online session – open to all interested parties – comes up then, but advance registration is required.
The proposals are wide-ranging and detailed. The nearly 500 recipients of CIRM grants should examine them closely in addition to any persons seriously interested in California stem cell affairs. The changes deal with such subjects as milestones for research grants, indirect costs, travel costs, withholding payments for failure to file a progress report and much, much more.
Here is a link to the main page for all this, which has instructions on how to register for the online session along with links to the changes and their rationale.
(Editor's note: This item was filed from the Rio Sabana in the Darien in Panama when we found a weak Internet cellular link. We are still underway so postings are unlikely between now and later this month.)
Thursday, March 01, 2012
CSCR On Hold Until March 20 or Thereabouts
The California Stem Cell Report will go dark until late this month. This blogger will be off sailing the Perlas Islands south of Panama and the Congo River in the Darien.
Wednesday, February 29, 2012
Conflict of Interest: California Stem Cell Agency Releases More Documents in Sladek Violation
The California stem cell agency today released its letter to leaders of the California legislature concerning the conflict of interest violation by the scientist who was then chairman of the panel that makes the de facto decisions on hundreds of millions of dollars in research grants.
The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.
The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.
Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."
The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.
The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,
As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.
The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."
The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership
The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.
The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.
Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."
The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.
The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,
"While preparing the public summary for Basic Biology III Awards Application No. RB3-02119, CIRM staff discovered that Dr. Sladek had co-authored two papers in the last three years with a researcher on the application. Although the researcher’s name was included on the CIRM conflict of interest form, Dr. Sladek did not disclose these publications to CIRM."As reported earlier, Sladek's participation did not affect the outcome on the application, which was not recommended for funding.
As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.
The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."
The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership
Tuesday, February 28, 2012
Conflict of Interest: Chair of California Stem Cell Agency Grant Review Group Resigns
A conflict of interest on a grant application before the $3 billion California stem cell agency last year led to the resignation of the grant review committee's longstanding chairman, John Sladek of the University of Colorado.
The incident occurred last April but was not publicly disclosed by CIRM until the California Stem Cell Report (CSCR) raised a question earlier this month.
Sladek is professor of neurology, pediatrics and neuroscience at the University of Colorado in Denver and a former president of Cal Lutheran University in the Los Angeles area. He had served on the stem cell agency's grant review group since 2005 and as its chairman from 2009 until April of last year.
Responding to an email from CSCR, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., outside counsel to the stem cell agency, said that CIRM's staff uncovered the conflict in April after the grant review session was concluded on March 17. Harrison described it as a "technical violation."
He said,
Harrison continued,
In December, the CIRM board of directors approved, on a unanimous voice vote of the 21 directors present out of 29, a resolution commending Sladek for serving in "exemplary fashion."
The stem cell agency disclosed specifics of the conflict of interest violation after the California Stem Cell Report discovered a vague reference to it in the transcript of the January meeting of the Citizens Financial Oversight and Accountability Committee, the only state entity specifically charged with oversight of the agency and its directors.
Members of the committee had raised questions about conflicts of interests at CIRM. At one point, Harrison said,
Asked about the report to the legislature, Harrison said CIRM wrote a letter to the legislative leadership about the incident. We have asked for a copy of the letter, which we will carry when we receive it.
As of this writing, the review summary for the grant application (RB3-02119) in question was not available on the CIRM web. Normally all the summaries are posted. We have queried the agency concerning its absence.
Harrison also said that in the seven-year history of CIRM no other instances exist of grant review committee members having been determined to be in a conflict of interest after participation in a review.
Our comment: CIRM is to be commended for taking care of this situation quickly last April. Sladek correctly resigned promptly. However, failure to disclose the incident at the time does not reflect well on the California stem cell agency nor does it inspire confidence in the agency's now improving openness and transparency.
CIRM is an enterprise that has substantial built-in conflicts of interests – all legal courtesy of Prop. 71, the ballot initiative that created CIRM. Institutions linked to CIRM directors have received $1.1 billion of the $1.2 billion the agency has given away. A display of reticence in this conflict-of-interest case does little to quell the suspicions of those who have criticized the agency for "cronyism," including the journal Nature and some in the biotech business community and elsewhere. As for the description of the incident as a "very technical" violation, that amounts to a bit of PR. Either it is a violation or it isn't.
Sladek's violation is the sort of thing not well understood by the public. Most public attention is focused on financial conflicts of interest in science. However, professional conflicts of interest involving scientists are among the most invidious. The California Stem Cell Report regularly hears complaints and suspicions about such dealings at CIRM: Big-name scientists receiving favored treatment, academic researchers unfairly evaluating applications from business researchers, younger researchers being shunted to background and more. All this as a billion dollars worth of applications have been evaluated behind closed doors with no public disclosure of the economic or professional interests of the reviewers. The stem cell agency would do well to improve its openness and transparency, particularly as it moves into ticklish and expensive relationships with industry. The first step would be to post on its web site the disclosure forms filed by its grant reviewers but withheld from the public by CIRM.
The incident occurred last April but was not publicly disclosed by CIRM until the California Stem Cell Report (CSCR) raised a question earlier this month.
Sladek is professor of neurology, pediatrics and neuroscience at the University of Colorado in Denver and a former president of Cal Lutheran University in the Los Angeles area. He had served on the stem cell agency's grant review group since 2005 and as its chairman from 2009 until April of last year.
Responding to an email from CSCR, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., outside counsel to the stem cell agency, said that CIRM's staff uncovered the conflict in April after the grant review session was concluded on March 17. Harrison described it as a "technical violation."
He said,
"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application."Harrison said,
"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window."Harrison said Sladek's conflict did not violate the state's political reform act nor did he have a financial interest in the application.
Harrison continued,
"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."Asked for comment, Sladek said that Harrison's account was accurate and that he had nothing to add. (Both Harrison's and Sladek's verbatim comments can be found here.)
In December, the CIRM board of directors approved, on a unanimous voice vote of the 21 directors present out of 29, a resolution commending Sladek for serving in "exemplary fashion."
The stem cell agency disclosed specifics of the conflict of interest violation after the California Stem Cell Report discovered a vague reference to it in the transcript of the January meeting of the Citizens Financial Oversight and Accountability Committee, the only state entity specifically charged with oversight of the agency and its directors.
Members of the committee had raised questions about conflicts of interests at CIRM. At one point, Harrison said,
"We have also had occasion where we have had a conflict of a very technical nature on the grants working group which we addressed pursuant to our procedure and reported to the legislature."It was that remark that triggered the request for more details.
Asked about the report to the legislature, Harrison said CIRM wrote a letter to the legislative leadership about the incident. We have asked for a copy of the letter, which we will carry when we receive it.
As of this writing, the review summary for the grant application (RB3-02119) in question was not available on the CIRM web. Normally all the summaries are posted. We have queried the agency concerning its absence.
Harrison also said that in the seven-year history of CIRM no other instances exist of grant review committee members having been determined to be in a conflict of interest after participation in a review.
Our comment: CIRM is to be commended for taking care of this situation quickly last April. Sladek correctly resigned promptly. However, failure to disclose the incident at the time does not reflect well on the California stem cell agency nor does it inspire confidence in the agency's now improving openness and transparency.
CIRM is an enterprise that has substantial built-in conflicts of interests – all legal courtesy of Prop. 71, the ballot initiative that created CIRM. Institutions linked to CIRM directors have received $1.1 billion of the $1.2 billion the agency has given away. A display of reticence in this conflict-of-interest case does little to quell the suspicions of those who have criticized the agency for "cronyism," including the journal Nature and some in the biotech business community and elsewhere. As for the description of the incident as a "very technical" violation, that amounts to a bit of PR. Either it is a violation or it isn't.
Sladek's violation is the sort of thing not well understood by the public. Most public attention is focused on financial conflicts of interest in science. However, professional conflicts of interest involving scientists are among the most invidious. The California Stem Cell Report regularly hears complaints and suspicions about such dealings at CIRM: Big-name scientists receiving favored treatment, academic researchers unfairly evaluating applications from business researchers, younger researchers being shunted to background and more. All this as a billion dollars worth of applications have been evaluated behind closed doors with no public disclosure of the economic or professional interests of the reviewers. The stem cell agency would do well to improve its openness and transparency, particularly as it moves into ticklish and expensive relationships with industry. The first step would be to post on its web site the disclosure forms filed by its grant reviewers but withheld from the public by CIRM.
Conflict of Interest: Text of CIRM and Sladek Comments
Here are the verbatim statements from James Harrison, outside counsel to the California stem cell agency, and John Sladek concerning Sladek's conflict of interest and resignation as chair of the agency's grant review group.
Harrison made these initial remarks first and provided a few other details later.
Harrison made these initial remarks first and provided a few other details later.
"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application.Sladek's response to a question for comment:
"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window.
"It should be noted, however, that Dr. Sladek's participation in the review of the application would not have constituted a conflict of interest under the Political Reform Act's conflict of interest standards because Dr. Sladek did not have a financial interest in the application. In addition, the amount of funding involved - approximately $3,000 of salary per year for three years, less than one percent of the total award - was not material, and Dr. Sladek did not stand to receive any financial benefit from the application. Finally, Dr. Sladek's participation in the review did not affect the outcome because the application was not recommended, or approved, for funding.
"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."
"Mr. Harrison’s account is accurate and there really isn’t anything to add other than I was pleased to serve CIRM and California for several years and wish them well as they pursue such an important mission with respect to the potential for therapeutic applications to human disease and disorders. Thank you for your inquiry."
Monday, February 27, 2012
Trounson Talks Stem Cells in Qatar
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| Qatar Conference Center |
Alan Trounson is one of a number of international stem cell notables at the session at the new Qatar Conference Center in the tiny nation in the Persian Gulf. The country is putting on the conference as a means of developing its own stem cell research capabilities.
Qatar had a gross national product of $129 billion in 2010, with a per capita income of $138,000, according to the U.S. State Department. The population is about 1.7 million, more than 75 percent of whom are foreigners with temporary residence status.
In addition to Trounson, other California and CIRM-connected researchers are speaking at the conference in the Qatar center, which just opened in December. They include David Baltimore, Nobel Laureate and a former director of the stem cell agency. A company Baltimore co-founded, Calimmune, of Tucson, Az., is sharing in a $20 million CIRM grant. Other CIRM grant recipients or representatives of recipient companies appearing at the conference are Irv Weissman of Stanford; Deepak Srivastava of the Gladstone Institute, and Ann Tsukamoto Weissman of Stem Cells Inc. of Newark, Ca.
Social activities at the conference include sand dune "bashing" in off-road vehicles, camel tracking along with a look at their "robot jockeys" and a visit to the original Arabic Oryx farm.
Sunday, February 26, 2012
California Stem Cell Agency Waiting Until April for More Cash
The state of California plans to sell $2 billion in bonds next Thursday, but the California stem cell agency, which is entirely dependent on state borrowing, will have to wait until later this spring to see more cash.
J.T. Thomas, chairman of the stem cell agency, said he expected to see CIRM benefit from the next bond sale in April. The agency currently has sufficient funds to operate until about June, plus an arrangement with the state for continued funding if a timely bond sale is not completed.
The $3 billion stem cell agency was created in 2004 through a ballot initiative that authorized its funding through the sale of state bonds over a 10-year period. The interest on the bonds raises the total cost of the agency to taxpayers to about $6 billion. Likewise, the cost of a $20 million grant is actually more like $40 million.
Financially beleaguered California's interest costs have sharply increased in recent years as the state has borrowed $53.8 billion from 2007 to 2010. This year, interest costs will come to about $5.4 billion, nearly 6 percent of the state budget. Nine years ago, it was $2.1 billion or 2.9 percent, according a piece by Randall Jensen (no relation to this writer) of the Bond Buyer newspaper.
The expense of borrowing shrinks the amount of state money available for public schools, helping the medically indigent and other state purposes.
Next Thursday's bond sale will go to refinance debt at lower rates. This year, Gov. Jerry Brown and state Treasurer Bill Lockyer plan to sell only $5.2 billion in general obligation bonds, roughly one-fourth of what the state issued in 2009.
J.T. Thomas, chairman of the stem cell agency, said he expected to see CIRM benefit from the next bond sale in April. The agency currently has sufficient funds to operate until about June, plus an arrangement with the state for continued funding if a timely bond sale is not completed.
The $3 billion stem cell agency was created in 2004 through a ballot initiative that authorized its funding through the sale of state bonds over a 10-year period. The interest on the bonds raises the total cost of the agency to taxpayers to about $6 billion. Likewise, the cost of a $20 million grant is actually more like $40 million.
Financially beleaguered California's interest costs have sharply increased in recent years as the state has borrowed $53.8 billion from 2007 to 2010. This year, interest costs will come to about $5.4 billion, nearly 6 percent of the state budget. Nine years ago, it was $2.1 billion or 2.9 percent, according a piece by Randall Jensen (no relation to this writer) of the Bond Buyer newspaper.
The expense of borrowing shrinks the amount of state money available for public schools, helping the medically indigent and other state purposes.
Next Thursday's bond sale will go to refinance debt at lower rates. This year, Gov. Jerry Brown and state Treasurer Bill Lockyer plan to sell only $5.2 billion in general obligation bonds, roughly one-fourth of what the state issued in 2009.
Thursday, February 23, 2012
The Afterlife of the California Stem Cell Agency: Venture Philanthropy and Big Pharma
The $3 billion California stem cell agency, which is facing its possible demise in five years, is exploring an afterlife that dips into "venture philanthropy" on a national level as well as investment ties with Big Pharma.
The Golden State's unprecedented research program laid out those possibilities in a "transition plan" sent this week to Gov. Jerry Brown and the state legislature. The plan was required under a law passed two years ago. The agency's future direction was also aired at a meeting last month in Los Angeles.
The California Institute for Regenerative Medicine(CIRM) will run out of funds for new grants in 2017. Its only real source of funding is cash that the state borrows (bonds). CIRM says that only $864 million remains for new research awards, and some of its recent grant rounds exceed $200 million. The current position of the agency is that it is "premature" to consider asking voters in financially strapped California to approve another multi-billion dollar bond measure.
The venture philanthropy effort involves creation of a nonprofit organization. CIRM Chairman Jonathan Thomas said in January that he is "test-driving (the proposal) with some high net worth donors we know to be interested in the stem cell space." Thomas was addressing the Citizens Financial Accountability and Oversight Committee, the only state entity specified charged with overseeing the agency and its directors. He said,
The Alliance for Regenerative Medicine is an industry-dominated lobbying group, based in Washington, D.C. The group's executive director and co-founder is Michael Werner, a longtime pharma and health industry lobbyist, who is also a partner in the influential Washington law firm of Holland and Knight.
The "biopharma investment fund" proposed by CIRM is less well developed. CIRM said it plans to explore opportunities with companies to fund stem cell research in California. The transition document uses as an example an $85 million deal between Pfizer and UC San Francisco, which gives the company special access to biomedical research.
The transition plan also touches on other issues such as winding down grants after its new grant money runs out, along with protecting intellectual property.
The plan could be considered a marketing tool for the agency's afterlife efforts. The document devotes a good portion of its nine pages to recounting the history of CIRM and touting its accomplishments.
Thomas used the occasion of the submission of the plan as a springboard for a piece yesterday on the CIRM research blog.He concluded his item by quoting from the plan itself. CIRM's achievements during the past seven years, he wrote, "will allow California to continue world (stem cell) leadership in the coming decades."
The Golden State's unprecedented research program laid out those possibilities in a "transition plan" sent this week to Gov. Jerry Brown and the state legislature. The plan was required under a law passed two years ago. The agency's future direction was also aired at a meeting last month in Los Angeles.
The California Institute for Regenerative Medicine(CIRM) will run out of funds for new grants in 2017. Its only real source of funding is cash that the state borrows (bonds). CIRM says that only $864 million remains for new research awards, and some of its recent grant rounds exceed $200 million. The current position of the agency is that it is "premature" to consider asking voters in financially strapped California to approve another multi-billion dollar bond measure.
The venture philanthropy effort involves creation of a nonprofit organization. CIRM Chairman Jonathan Thomas said in January that he is "test-driving (the proposal) with some high net worth donors we know to be interested in the stem cell space." Thomas was addressing the Citizens Financial Accountability and Oversight Committee, the only state entity specified charged with overseeing the agency and its directors. He said,
"We're busily putting together in conjunction with a national organization called the Alliance for Regenerative Medicine the plans for a nonprofit venture philanthropy fund."He said it would "would accept applications for awards from researchers and companies all over the country, not just those funded by CIRM, but those funded by NIH or the New York Stem Cell Foundation or the state of Maryland or whatever."
The Alliance for Regenerative Medicine is an industry-dominated lobbying group, based in Washington, D.C. The group's executive director and co-founder is Michael Werner, a longtime pharma and health industry lobbyist, who is also a partner in the influential Washington law firm of Holland and Knight.
The "biopharma investment fund" proposed by CIRM is less well developed. CIRM said it plans to explore opportunities with companies to fund stem cell research in California. The transition document uses as an example an $85 million deal between Pfizer and UC San Francisco, which gives the company special access to biomedical research.
The transition plan also touches on other issues such as winding down grants after its new grant money runs out, along with protecting intellectual property.
The plan could be considered a marketing tool for the agency's afterlife efforts. The document devotes a good portion of its nine pages to recounting the history of CIRM and touting its accomplishments.
Thomas used the occasion of the submission of the plan as a springboard for a piece yesterday on the CIRM research blog.He concluded his item by quoting from the plan itself. CIRM's achievements during the past seven years, he wrote, "will allow California to continue world (stem cell) leadership in the coming decades."
Tuesday, February 21, 2012
IOM's Lagging Effort for Comments on the $3 Billion California Stem Cell Agency
With the $700,000 Institute of Medicine inquiry into the performance of the California stem cell agency half complete – at least publicly – the blue-ribbon panel seems to be coming up short on comments from outside of the agency itself.
The major public effort by the IOM to secure comments is the passive posting of forms to be filled out on the IOM web site.
How many responses has the IOM received on those forms? The IOM has not disclosed that information despite two inquiries earlier this month by the California Stem Cell Report.
The prestigious institute is undertaking the study of $3 billion agency under contract with CIRM, which is paying the IOM $700,000. Some CIRM directors have expressed hope that the IOM findings will help build support for another multi-billion dollar state bond measure to renew financing for CIRM. It is scheduled to run out of money for new grants in five years.
So far, the IOM panel has held two public meetings, one in Washington, D.C., and one in the San Francisco area. The final California hearing is scheduled for April 10 in Irvine with the last public meetings scheduled for later this year in Washington.
So far, the panel has heard only from CIRM employees or directors as well as researchers who have received tens of millions of dollars in CIRM grants. The IOM has not heard publicly from a single independent witness.
The IOM has posted on its web site forms seeking comments from the public, grant recipients, beneficiary institutions and businesses. However, passive postings of forms are unlikely to generate more than a relative handful of responses. To produce significant numbers requires aggressive and targeted follow-up.
It is also unclear exactly what the IOM is doing to seek information from biotech businesses and unsuccessful grant applicants. Some businesses have complained publicly about the tiny share of funding that industry has received. And some CIRM directors have expressed concern for several years about the inadequacies of business funding.
On Feb. 12, the California Stem Cell Report queried the IOM about its efforts at outreach, asking for specifics on what is being done. Christine Stencel, a spokeswoman for the IOM, replied,
On Feb. 15, the California Stem Cell Report followed up with these additional questions,
The major public effort by the IOM to secure comments is the passive posting of forms to be filled out on the IOM web site.
How many responses has the IOM received on those forms? The IOM has not disclosed that information despite two inquiries earlier this month by the California Stem Cell Report.
The prestigious institute is undertaking the study of $3 billion agency under contract with CIRM, which is paying the IOM $700,000. Some CIRM directors have expressed hope that the IOM findings will help build support for another multi-billion dollar state bond measure to renew financing for CIRM. It is scheduled to run out of money for new grants in five years.
So far, the IOM panel has held two public meetings, one in Washington, D.C., and one in the San Francisco area. The final California hearing is scheduled for April 10 in Irvine with the last public meetings scheduled for later this year in Washington.
So far, the panel has heard only from CIRM employees or directors as well as researchers who have received tens of millions of dollars in CIRM grants. The IOM has not heard publicly from a single independent witness.
The IOM has posted on its web site forms seeking comments from the public, grant recipients, beneficiary institutions and businesses. However, passive postings of forms are unlikely to generate more than a relative handful of responses. To produce significant numbers requires aggressive and targeted follow-up.
It is also unclear exactly what the IOM is doing to seek information from biotech businesses and unsuccessful grant applicants. Some businesses have complained publicly about the tiny share of funding that industry has received. And some CIRM directors have expressed concern for several years about the inadequacies of business funding.
On Feb. 12, the California Stem Cell Report queried the IOM about its efforts at outreach, asking for specifics on what is being done. Christine Stencel, a spokeswoman for the IOM, replied,
"The IOM has been obtaining and compiling lists of organizations and people to circulate the questionnaires as widely as possible among target groups. For example, IOM has sent a notice to some 300 stakeholder groups encouraging participation."Other specifics were not forthcoming. (The full text of the questions and responses can be found here.)
On Feb. 15, the California Stem Cell Report followed up with these additional questions,
"Regarding the 300 stakeholder groups, how are those defined? Please give me a few examples.As of this writing, the IOM has not responded to those questions. We will carry its response verbatim when we receive it.
"Based on your response, is it correct to say that the IOM is not sending out questionnaires directly to all CIRM grant applicants, including those who were rejected?
"Is it correct to say that no special effort -- other than that described in your response -- is being made to seek responses from stem cell businesses?
"The failure to provide numbers on the responses so far would indicate that the numbers are so small that the IOM is choosing not to disclose them. If that is not the case, please email me the numbers."
Text of IOM Statement on Efforts at Soliciting Comment on CIRM
Here is the text of the questions submitted Feb. 12 by the California Stem Cell Report to the Institute of Medicine concerning its attempts to secure comments on the operation of the $3 billion California stem cell agency along with the IOM response.
The response from Christine Stencel, a spokeswoman for the IOM, follows these questions from the California Stem Cell Report.
The response from Christine Stencel, a spokeswoman for the IOM, follows these questions from the California Stem Cell Report.
"I will be writing a piece on Wednesday dealing with the online surveys that IOM has posted. For that piece, please tell me very, very specifically what the IOM is doing to generate responses. For example, is the IOM buying ads in newspapers or online, asking the public to fill out the forms? Is it hiring a polling firm to call households for responses? Also please tell me exactly what is being done to generate responses on all the other surveys that have been posted.The IOM response on Feb. 15:
"Additionally, please tell me how many responses that the IOM has received so far in each category on the survey forms for CIRM grantees, industry partners and leadership. Thank you."
"The IOM has been obtaining and compiling lists of organizations and people to circulate the questionnaires as widely as possible among target groups. For example, IOM has sent a notice to some 300 stakeholder groups encouraging participation. We do not have the resources to hire a polling firm or place ads.The California Stem Cell Report then asked the following questions on Feb. 15.
"The purpose of these questionnaires is to extend the committee's information gathering beyond in-person meetings and the standard listing of an email address or phone number for the study on the project website. Not all people who might have useful experiences or perspectives on CIRM may be able to attend the in-person meetings and not all may visit the project website and find the study contact information. This is a proactive effort to reach more people.
"Anyone who knows of individuals or organizations with information on CIRM that would be useful for the committee's knowledge can share the links to the questionnaires with them. This will help spread the word and get the committee insights they need.
"I don't have information on the number of responses so far. Ultimately, as noted at the top of each survey, the responses will be aggregated and de-identified and placed in the public access file in addition to being shared with the committee.
"I trust this will be useful for your readers."
"Thank you for your response. A few follow-up questions:The IOM had not responded to the follow-up questions as of this writing on Feb. 21.
Regarding the 300 stakeholder groups, how are those defined? Please give me a few examples.
"Based on your response, is it correct to say that the IOM is not sending out questionnaires directly to all CIRM grant applicants, including those who were rejected?
"Is it correct to say that no special effort -- other than that described in your response -- is being made to seek responses from stem cell businesses?
"The failure to provide numbers on the responses so far would indicate that the numbers are so small that the IOM is choosing not to disclose them. If that is not the case, please email me the numbers. Thank you."
Friday, February 17, 2012
ACT's Top Scientist Sells $1.5 Million in Company Stock
The mainstream media waxed enthusiastic last month when a California hESC clinical trial reported positive results dealing with blindness.
The report was first published account of a human trial of embryonic stem cell based therapy and involved Advanced Cell Technology, which is headquartered in Santa Monica, Ca. Despite a glowing reception of the trial's results, the firm is years away from being able to market the therapy at a profit – if it ever can do so.
The firm's chief scientific officer, Robert Lanza, moved quickly, however, to capture some monetary gain from the news, which was announced in a press release Jan. 23 by ACT.
On Jan. 23 and 24, Lanza sold 7.7 million shares in ACT for $1.5 million, according to SEC documents. He sold the stock at 18 and 19 cents a share. That compares to an ACT price of about 8 cents at the end of 2011. Lanza still holds 26 million shares in the firm. The acquisition price of the stocks is unknown.
There is nothing to suggest anything untoward about Lanza's sale. But it is a reminder that creating a successful stem cell therapy is about making money. Without a profit, there will be no therapy, as Geron reminded everyone last November when it dropped its longstanding hESC trial.
The California Stem Cell Report has asked Lanza if he has any comments about the sale of the stock. We will carry his remarks verbatim when we receive them.
The Seeking Alpha web site appears to have been the first to report the sale. Here is their complete item.
The report was first published account of a human trial of embryonic stem cell based therapy and involved Advanced Cell Technology, which is headquartered in Santa Monica, Ca. Despite a glowing reception of the trial's results, the firm is years away from being able to market the therapy at a profit – if it ever can do so.
The firm's chief scientific officer, Robert Lanza, moved quickly, however, to capture some monetary gain from the news, which was announced in a press release Jan. 23 by ACT.
On Jan. 23 and 24, Lanza sold 7.7 million shares in ACT for $1.5 million, according to SEC documents. He sold the stock at 18 and 19 cents a share. That compares to an ACT price of about 8 cents at the end of 2011. Lanza still holds 26 million shares in the firm. The acquisition price of the stocks is unknown.
There is nothing to suggest anything untoward about Lanza's sale. But it is a reminder that creating a successful stem cell therapy is about making money. Without a profit, there will be no therapy, as Geron reminded everyone last November when it dropped its longstanding hESC trial.
The California Stem Cell Report has asked Lanza if he has any comments about the sale of the stock. We will carry his remarks verbatim when we receive them.
The Seeking Alpha web site appears to have been the first to report the sale. Here is their complete item.
"Advanced Cell Technology, Inc. (ACTC.OB): ACTC is a development-stage biotech focused on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. On Wednesday, Chief Science Officer Robert Lanza filed SEC Form 4 indicating that he sold 7.7 million shares for $1.5 million, ending with 26.0 million shares after that sale. ACTC shares have rallied strongly since the beginning of the year, up from 8.2 cents at the end of last year to currently in 14-15c range after rising above 20c just earlier this week."
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