A second teleconference location has been added to where the public can participate in tomorrow's meeting of the directors of the California stem cell agency, which will be covered live via the Internet by the California Stem Cell Report.
The actual meeting will be in Los Angeles at Cedars-Sinai, but interested parties can weigh in from sites at Stanford and UC San Francisco. The meeting will also be audiocast on the Internet.
Here are specific addresses from the agenda for the teleconference locations.
Stanford School of Medicine
Li Ka Shing Center for Learning and Knowledge/291
Campus DriveLK3CO2 3rd Floor/MC5216/
Stanford CA 94305-5101
UCSF School of Medicine
513 Parnassus Avenue, Room S224
San Francisco, CA 94143
Here are instructions for the audiocast:
To access the live event or archive, use this URL:
https://im.csgsystems.com/cgi-bin/confCast
Enter Conference ID# 224434 then click Go.
Wednesday, December 07, 2011
Tuesday, December 06, 2011
California Stem Cell PR and Spongy Voter Mandates
Some connected to the California stem cell agency, notably its founding father Robert Klein, are fond of declaring that the $3 billion enterprise has an immutable mandate from voters to pursue its endeavors.
Well, mandates come and go.
That lesson was learned once again this morning with the results of a Field Poll that showed that another big ticket effort, the California high speed rail project which was approved by 53 percent of voters, has lost not only its luster but its support. According to the poll, 64 percent of voters would now like another chance to vote on it. And 59 percent would reject it.
The reasons for the change of heart? Severe economic conditions in California, increased mainstream media coverage of high speed rail's deficiencies and bungling by its management.
While a San Francisco Chronicle columnist last summer called CIRM "the high speed rail of medicine," the stem cell agency has not suffered from the same sort of heavy and critical media attention. CIRM is all but invisible to the public. But agency is now is embarking on an ambitious PR effort to raise its profile and to move forward to win voter approval of another multibillion bond measure. Otherwise it will run out of funds in 2017.
CIRM must tread carefully with its new communications campaign. It has a legitimate responsibility to better inform Californians, and its PR could be more robust(which is a sort of the word of the day at CIRM).
But downsides do exist. With a possible ballot measure coming up, some ungenerous folks might construe aggressive CIRM PR as electioneering at taxpayer expense, including its subsidies of patient advocate activities, such as attendance at conventions. Even without a looming election campaign, the high speed rail project's $12.5 million PR effort attracted negative attention in at least two major newspapers just this week(see here and here).
Klein, who led the campaign that created CIRM and served as its chairman for seven years, is now gone, but his footprints remain. The agency, however, cannot assume that voter support seven years ago, in a much, much different world, translates to support today.
Well, mandates come and go.
That lesson was learned once again this morning with the results of a Field Poll that showed that another big ticket effort, the California high speed rail project which was approved by 53 percent of voters, has lost not only its luster but its support. According to the poll, 64 percent of voters would now like another chance to vote on it. And 59 percent would reject it.
The reasons for the change of heart? Severe economic conditions in California, increased mainstream media coverage of high speed rail's deficiencies and bungling by its management.
While a San Francisco Chronicle columnist last summer called CIRM "the high speed rail of medicine," the stem cell agency has not suffered from the same sort of heavy and critical media attention. CIRM is all but invisible to the public. But agency is now is embarking on an ambitious PR effort to raise its profile and to move forward to win voter approval of another multibillion bond measure. Otherwise it will run out of funds in 2017.
CIRM must tread carefully with its new communications campaign. It has a legitimate responsibility to better inform Californians, and its PR could be more robust(which is a sort of the word of the day at CIRM).
But downsides do exist. With a possible ballot measure coming up, some ungenerous folks might construe aggressive CIRM PR as electioneering at taxpayer expense, including its subsidies of patient advocate activities, such as attendance at conventions. Even without a looming election campaign, the high speed rail project's $12.5 million PR effort attracted negative attention in at least two major newspapers just this week(see here and here).
Klein, who led the campaign that created CIRM and served as its chairman for seven years, is now gone, but his footprints remain. The agency, however, cannot assume that voter support seven years ago, in a much, much different world, translates to support today.
Researcher Alert: CIRM Making Changes in Grant Administration
The California stem cell agency is readying a long list of changes that will affect all of its 453 grant recipients and all future awards.
Many of the changes are minor. Some have been requested by grantees. Others are aimed at dealing with issues posed by larger grants. Some reflect the agency's move to more streamlined reporting.
Amy Lewis, CIRM's grant management officer, has prepared an introductory memo along with the proposed changes for discussion at Thursday's board meeting in Los Angeles. She said the proposal is in its early stages and will not require a vote this week.But it would behoove those affected to carefully check the grant administration policy to see how it might alter their lives.
Many of the changes are minor. Some have been requested by grantees. Others are aimed at dealing with issues posed by larger grants. Some reflect the agency's move to more streamlined reporting.
Amy Lewis, CIRM's grant management officer, has prepared an introductory memo along with the proposed changes for discussion at Thursday's board meeting in Los Angeles. She said the proposal is in its early stages and will not require a vote this week.But it would behoove those affected to carefully check the grant administration policy to see how it might alter their lives.
Former iPierian Exec Joins California Stem Cell Agency as CFO
A former executive at a California stem cell firm has been named as the first chief financial officer of the seven-year-old, $3 billion California stem cell agency, it was announced today.
Matthew Plunkett, former vice president and chief financial officer of iPierian Inc., has been at work at CIRM since late last month. The agency said in a news release today that Plunkett is overseeing "budgeting, forecasting, financial compliance and reporting, and implementation of the industry loan award program."
Plunkett will also "play a key role in securing opportunities to leverage CIRM funds with additional outside capital," said CIRM Chairman Jonathan Thomas.
Plunkett worked for iPierian from 2009 until last April. While he was at the firm, it received $7 million in grants from CIRM. The South San Francisco business has a unique connection to CIRM. Major investors in iPierian, including John Doerr of Kleiner Perkins Caulfield Byers of Menlo Park, pumped nearly $6 million into the 2004 ballot campaign that created CIRM. That amounted to 25 percent of the total contributed to the campaign, which was headed by Robert Klein, who later became the first chairman of the stem cell agency.
CIRM has said no connection exists between the contributions and subsequent awards to iPierian.
The agency has needed a chief financial officer for some time. It has sometimes struggled with routine budget matters, although that problem seems to have been largely solved even before Plunkett was hired. Plunkett will report to both the agency's chairman, Jonathan Thomas, and CIRM President Alan Trounson, in a continuation of the troublesome dual executive arrangement at the stem cell agency.
Prior to joining iPierian, Plunkett worked for Oppenheimer/CIBC World Markets from 2000 to 2009. In his last position there, he was managing director/head of West Coast biotechnology. He holds Ph.D. in organic chemistry from UC Berkeley.
Plunkett, who is earning $260,004 annually, began work on Nov. 28. Today's press release on his hiring came after the California Stem Cell Report inquired on Saturday about progress in filling the position.
Here is a link to a brief article in the San Francisco Business Times about the Plunkett announcement.
(An earlier version of this item incorrectly said Plunkett started work on Nov. 11 based on his resume which said "11/11.")
 |
| Matthew Plunkett, CIRM CFO CIRM Photo |
Plunkett will also "play a key role in securing opportunities to leverage CIRM funds with additional outside capital," said CIRM Chairman Jonathan Thomas.
Plunkett worked for iPierian from 2009 until last April. While he was at the firm, it received $7 million in grants from CIRM. The South San Francisco business has a unique connection to CIRM. Major investors in iPierian, including John Doerr of Kleiner Perkins Caulfield Byers of Menlo Park, pumped nearly $6 million into the 2004 ballot campaign that created CIRM. That amounted to 25 percent of the total contributed to the campaign, which was headed by Robert Klein, who later became the first chairman of the stem cell agency.
CIRM has said no connection exists between the contributions and subsequent awards to iPierian.
The agency has needed a chief financial officer for some time. It has sometimes struggled with routine budget matters, although that problem seems to have been largely solved even before Plunkett was hired. Plunkett will report to both the agency's chairman, Jonathan Thomas, and CIRM President Alan Trounson, in a continuation of the troublesome dual executive arrangement at the stem cell agency.
Prior to joining iPierian, Plunkett worked for Oppenheimer/CIBC World Markets from 2000 to 2009. In his last position there, he was managing director/head of West Coast biotechnology. He holds Ph.D. in organic chemistry from UC Berkeley.
Plunkett, who is earning $260,004 annually, began work on Nov. 28. Today's press release on his hiring came after the California Stem Cell Report inquired on Saturday about progress in filling the position.
Here is a link to a brief article in the San Francisco Business Times about the Plunkett announcement.
(An earlier version of this item incorrectly said Plunkett started work on Nov. 11 based on his resume which said "11/11.")
Monday, December 05, 2011
The Back Story on Baylis and the Ethics of Geron's hESC Trial
Last week Canadian bioethicist Francoise Baylis raised ethical questions about Geron's abandonment of its hESC clinical trial in an article that, it turned out, has a bit of a history.
When we notified her that we had written about her piece and its implications for the California stem cell agency, Baylis replied with a thank you and said,
When we notified her that we had written about her piece and its implications for the California stem cell agency, Baylis replied with a thank you and said,
"As an aside, you might be interested to know that I sought to publish a version of this commentary as a letter to the editor in a peer reviewed stem cell science journal and received the following response: I and two experts 'found the overall tone and presentation of the letter inappropriately strong and confrontational. As a result, it does not seem appropriate for us to offer to consider it further.'In that piece, Baylis also wrote about Geron's position that the results with four clinical trial participants would "be a fair reflection of what would have happened if we had completed the study(with 10).” She said,
"In my view, this was an unfortunate editorial decision as I believe the stem cell science community needs to engage with this issue. Moreover, I know of responsible stem cell researchers who share my point of view. Beside which, I disagree with the characterization of the piece as confrontational ...
"Another posting of mine on The Mark News makes the same point, but in a more journalistic style."
"I want to suggest, however, that this is an ethically problematic response to a situation that could have been anticipated, and thus avoided. Failure to name the problem in this way leaves future participants in safety studies of novel hESC interventions at risk of abandonment whenever a private biotech company decides to end a trial mid-stream for business reasons."Our take? The California Stem Cell Report agrees that the decision by the unnamed journal was unfortunate, to put it mildly. Baylis' comments were neither inappropriate nor confrontational, but they did raise questions that could well make some persons uncomfortable. Nonetheless, the questions were the sort that the general public and patient advocates raise in one form or another in their dealings with the enterprises that develop therapies and drugs. Either the questions are addressed now or later -- when they may well have to be dealt with under much more difficult circumstances when things go awry.
Conflict of Interest: Harvard Researcher Resigns from IOM Inquiry into California Stem Cell Agency
One of the members of the Institute of Medicine panel conducting a 17-month investigation into the $3 billion California stem cell agency has resigned because of a conflict of interest involving a San Diego stem cell firm.
David Scadden, co-director of the Harvard Stem Cell Institute, withdrew last week after conferring with IOM officials concerning his connection to Fate Therapeutics, which lists him as a scientific founder.
In an email to the California Stem Cell Report, Scadden said,
We have queried the IOM about whether Scadden will be replaced on the now 13-member panel.
David Scadden, co-director of the Harvard Stem Cell Institute, withdrew last week after conferring with IOM officials concerning his connection to Fate Therapeutics, which lists him as a scientific founder.
In an email to the California Stem Cell Report, Scadden said,
"I have a relationship with a start-up company in CA and, after discussion, with the IOM, we concluded that it would constitute a conflict of interest. I would have enjoyed helping out, but didn't want to compromise the perception of objectivity of the report."Fate Therapeutics does not hold an award from the California stem cell agency. It is not known whether the company has applied for CIRM funding. The agency does not release the names of applicants that are not approved.
We have queried the IOM about whether Scadden will be replaced on the now 13-member panel.
Saturday, December 03, 2011
Strategy at CIRM: New Sources of Cash, More Funding Transparency, Better PR?
The California stem cell agency is huddling with industry, scientists and public as it wades through a revision of its strategic plan to determine how to spend its remaining $1.4 billion before the cash runs out.
CIRM officials have held at least 10 meetings with a variety of groups, including three public sessions. The next public hearing is Thursday in Los Angeles at the CIRM board meeting.
The revision comes as the agency wrestles with the increasing need to generate results that will resonate with California voters. CIRM's original $3 billion, which consists of cash borrowed by the state, will run out in roughly 2017. The agency is considering mounting a ballot campaign for another multibillion dollar bond measure. The agency is also under examination by the prestiguous Institute of Medicine and is likely to hear recommendations for changes from that report next fall.
Ellen Feigal, senior vice president for research and development, summarized stakeholder comments so far on CIRM's plans in a 13-page documment prepared for the meeting at Cedars-Sinai. She identified several key themes from stakeholders, including the need to find "alternate funding resources," presumably non-public financing. Feigal also cited a need to make the grant funding process more transparent, apparently reflecting complaints from industry. But she noted that stakeholders have said the agency has made "great initial progress" in its first seven years.
Here are four of the five themes Feigal identified. The fifth dealt mentioned CIRM's progress.
Feigal will come back to the board in January with a draft revision. It is scheduled to be approved March 21. The final plan will be shipped off to the IOM panel studying CIRM. It is scheduled to conclude its work next fall.
Interested parties can email their comments on the plan to CIRM (info@cirm.ca.gov) or speak at CIRM board meetings. The specific address for Thursday's meeting can be found on the agenda. A teleconference location is also available at UC San Francisco, where members of public can take part.
CIRM officials have held at least 10 meetings with a variety of groups, including three public sessions. The next public hearing is Thursday in Los Angeles at the CIRM board meeting.
The revision comes as the agency wrestles with the increasing need to generate results that will resonate with California voters. CIRM's original $3 billion, which consists of cash borrowed by the state, will run out in roughly 2017. The agency is considering mounting a ballot campaign for another multibillion dollar bond measure. The agency is also under examination by the prestiguous Institute of Medicine and is likely to hear recommendations for changes from that report next fall.
Ellen Feigal, senior vice president for research and development, summarized stakeholder comments so far on CIRM's plans in a 13-page documment prepared for the meeting at Cedars-Sinai. She identified several key themes from stakeholders, including the need to find "alternate funding resources," presumably non-public financing. Feigal also cited a need to make the grant funding process more transparent, apparently reflecting complaints from industry. But she noted that stakeholders have said the agency has made "great initial progress" in its first seven years.
Here are four of the five themes Feigal identified. The fifth dealt mentioned CIRM's progress.
- "CIRM needs to become more aggressive in finding alternate funding resources and to implement greater creativity in identifying the types of organizations that may be able to contribute to the sustainability of CIRM's work"
- "Robust public affairs tactics are necessary, and CIRM needs to better communicate the organizational initiatives, as well as educate the public more broadly."
- "Greater transparency in the funding process is needed, and there is a great need for the process to be less bureaucratic and easier to navigate."
- "CIRM needs to provide greater opportunities for networking and breed collaborative projects that unite academic and industry as well as researchers across geographic reasons."
Feigal will come back to the board in January with a draft revision. It is scheduled to be approved March 21. The final plan will be shipped off to the IOM panel studying CIRM. It is scheduled to conclude its work next fall.
Interested parties can email their comments on the plan to CIRM (info@cirm.ca.gov) or speak at CIRM board meetings. The specific address for Thursday's meeting can be found on the agenda. A teleconference location is also available at UC San Francisco, where members of public can take part.
Luring Stem Cell Researchers to California: A $5.6 Million Bid
The $3 billion California stem cell agency has played a role in bringing two star researchers to the Golden State through its $44 million recruitment program and is about ready to bring in a third.
Next Thursday in Los Angeles, CIRM's governing board is expected to approve a $5.6 million grant to an unidentified scientist to lure him or her to an unidentified California institution.
The funds will go for the researcher's efforts to develop "a regeneration-based functional restoration treatment for spinal cord injury," according to a summary of reviewer comments on the CIRM web site. The grant was scored at 86 by scientific reviewers.
The summary quoted the researcher as saying,
Next Thursday in Los Angeles, CIRM's governing board is expected to approve a $5.6 million grant to an unidentified scientist to lure him or her to an unidentified California institution.
The funds will go for the researcher's efforts to develop "a regeneration-based functional restoration treatment for spinal cord injury," according to a summary of reviewer comments on the CIRM web site. The grant was scored at 86 by scientific reviewers.
The summary quoted the researcher as saying,
"We recently made breakthrough discoveries in identifying key biological mechanisms stimulating the re-growth of injured axons in the adult nervous system, which led to unprecedented extents of axon regeneration in various CNS injury models. While our success was compelling, we found that many regenerated axons were stalled at the lesion sites by the injury-induced glial scars. Furthermore, it is unclear whether the regenerated axons can form functional synaptic connections when they grow into the denervated spinal cord. This proposed research program is aimed at solving these obstacles by using human stem cell technologies."The summary said,
"The PI was described by reviewers as a superb scientist and emerging leader with outstanding accomplishments and exceptional promise. The candidate has already made key contributions to the understanding of mechanism underlying axonal regeneration that have significantly advanced the field of neuroregeneration. He/she has been extremely productive, publishing a number of seminal papers in the highest profile journals including Science, Nature, Neuron and Nature Neuroscience."The stem cell agency's recruitment efforts have helped to bring Peter Coffey ($4.9 million from CIRM)from the UK to UC Santa Barbara and Robert Wechsler-Reya ($6 million)- to Sanford Burnham in La Jolla from Duke University.
California Stem Cell Agency and Geron: Ethical Issues with Sale of hESC Trial
A Canadian bioethicist is raising ethical questions about Geron's hESC trial that have implications for the attempt by the California stem cell agency to salvage the once-vaunted effort.
Writing yesterday on the Hastings Center Bioethics Forum, Francoise Baylis of Dalhousie University said,
Baylis noted that Stephen Kelsey, chief medical officer of the Menlo Park, Ca., firm, has been quoted as saying that the results of Geron trial – now with five patients instead of the projected 10 – "will be a fair reflection of what would have happened if we had completed the study."
Baylis wrote,
Writing yesterday on the Hastings Center Bioethics Forum, Francoise Baylis of Dalhousie University said,
"It is one thing to close a trial to further enrollment for scientific reasons, such as a problem with trial design, or for ethical reasons, such as an unanticipated serious risk of harm to participants. It is quite another matter to close a trial for business reasons, such as to improve profit margins."Geron last month said it was ending the trial because of financial reasons and to pursue development of its cancer treatments. CIRM awarded Geron a $25 million loan just last May and was surprised by the Geron move. The $3 billion state research program is now attempting to find a buyer/partner for Geron's hESC business.
Baylis noted that Stephen Kelsey, chief medical officer of the Menlo Park, Ca., firm, has been quoted as saying that the results of Geron trial – now with five patients instead of the projected 10 – "will be a fair reflection of what would have happened if we had completed the study."
Baylis wrote,
"This statement is deeply problematic, however."Baylis, a professor and the Canada Research Chair in the departments of philosophy and of obstetrics and gynecology at Dalhousie, continued,
"No clinical trial should involve too few or too many participants. It is important that the trial not be underpowered and thus unable to generate scientific knowledge. It is equally important than no more research participants than necessary be exposed to potential research risks. If only five participants were needed to generate the scientific knowledge, then why would Geron and the F.D.A. have agreed to expose additional persons to the potential harms of trial participation?She concluded,
"On the other hand, if Kelsey’s statement is false, and the findings from five research participants will be underpowered, then they may have been exposed to the potential harms of trial participation without the potential for benefit in the form of scientific knowledge."
"In either case, the scenario forces us to consider what measures should be taken with respect to future trials funded in the private sector so that participants are not left stranded. Perhaps regulators and institutional review boards should critically examine whether a company has both the financial (and other) resources and the will to complete a trial under review before granting regulatory or ethics approval. If there are doubts about this, then either the trial should not be approved, or there should be stringent disclosure requirements so that prospective research participants are aware of the possibility that research may stop mid-trial for financial reasons."
Friday, December 02, 2011
Researcher Alert: CIRM Readying $57 Million in New Opportunities
The California stem cell agency is proposing to pump $30 million into new research involving reprogrammed adult stem cells and another $27 million into fresh efforts to speed development of clinical therapies.
In a memo prepared for the CIRM directors meeting next week in Los Angeles, the agency's staff said the $30 million effort could generate "disease-in-a-dish models" that "have the potential to make drug discovery faster, more efficient and more personalized to individual patients."
The "disease-in-a-dish" plan was dubbed a "human pluripotent stem cell (hPSC) initiative" by the staff. The goal is to generate high quality stem cell-based tools for use by the researchers and drug developers.
The proposal includes four elements, one of which is collaboration with the NIH to develop cell lines from patients with Huntington’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. No cost was specified on that effort. Also recommended to directors was a $4 million disease line award round, a $16 million core hiPSC derivation round and a $10 million stem cell bank round. The RFAs would go out in May of next year with funding expected early in 2013.
The staff memo on the initiative did not mention human embryonic stem cells, but a spokeswoman for the agency said they were not excluded from the effort.
The other new grant proposals up next week grew out of a recommendations from a blue-ribbon panel that CIRM organized last year to examine its operations. One element in the plan is a $12 million "bridging fund" that would apply only to current CIRM-funded projects in three areas: disease team grants, some early translational projects and clinical development projects. The bridging fund would provide up to $3 million for up to one year for each recipient, if CIRM President Alan Trounson approves the project. Trounson would be assisted in his evaluation by staff and external consultants, if necessary.
The second part of the response to the review panel's finding is an "external innovation initiative" to support collaborative efforts of CIRM grantees to work with teams that CIRM said are "making extraordinary progress outside California."
The $15 million program would provide awards as often as two times a year. The maximum amount on each award was not specified.
Ellen Feigal, CIRM's vice president of research and development, said in a memo to directors that examples of potential projects included collaborative efforts with the NIH and work with the Harvard Stem Cell Institute and its disease-focused programs.
Some of the latest CIRM initiatives are open to biotech businesses. Others are open only to non-profit or academic researchers.
(Editor's note: An earlier version of this item did not include the sentence dealing with human embryonic stem cells.)
In a memo prepared for the CIRM directors meeting next week in Los Angeles, the agency's staff said the $30 million effort could generate "disease-in-a-dish models" that "have the potential to make drug discovery faster, more efficient and more personalized to individual patients."
The "disease-in-a-dish" plan was dubbed a "human pluripotent stem cell (hPSC) initiative" by the staff. The goal is to generate high quality stem cell-based tools for use by the researchers and drug developers.
The proposal includes four elements, one of which is collaboration with the NIH to develop cell lines from patients with Huntington’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. No cost was specified on that effort. Also recommended to directors was a $4 million disease line award round, a $16 million core hiPSC derivation round and a $10 million stem cell bank round. The RFAs would go out in May of next year with funding expected early in 2013.
The staff memo on the initiative did not mention human embryonic stem cells, but a spokeswoman for the agency said they were not excluded from the effort.
The other new grant proposals up next week grew out of a recommendations from a blue-ribbon panel that CIRM organized last year to examine its operations. One element in the plan is a $12 million "bridging fund" that would apply only to current CIRM-funded projects in three areas: disease team grants, some early translational projects and clinical development projects. The bridging fund would provide up to $3 million for up to one year for each recipient, if CIRM President Alan Trounson approves the project. Trounson would be assisted in his evaluation by staff and external consultants, if necessary.
The second part of the response to the review panel's finding is an "external innovation initiative" to support collaborative efforts of CIRM grantees to work with teams that CIRM said are "making extraordinary progress outside California."
The $15 million program would provide awards as often as two times a year. The maximum amount on each award was not specified.
Ellen Feigal, CIRM's vice president of research and development, said in a memo to directors that examples of potential projects included collaborative efforts with the NIH and work with the Harvard Stem Cell Institute and its disease-focused programs.
Some of the latest CIRM initiatives are open to biotech businesses. Others are open only to non-profit or academic researchers.
(Editor's note: An earlier version of this item did not include the sentence dealing with human embryonic stem cells.)
Tuesday, November 29, 2011
Stem Cell Agency Provides Early Access to Multimillion Dollar Proposals Coming Before its Directors
Could this be a trend?
The California stem cell agency, working under the direction of a new chairman, has once again posted a handsome amount of background material well in advance of its regular board meeting – in this case the Dec. 8 session at Cedars-Sinai in Los Angeles.
For the past several years, the agency has failed to post in a timely fashion important information on many decisions to be made by agency directors, making it virtually impossible for interested parties to plan to attend meetings or prepare thoughtful suggestions or recommend possible changes.
That situation has begun to change under Chairman Jonathan Thomas, a Los Angeles bond financier, who controls the board agenda and who was elected to his post at the end of June. In August, the agency also posted in a timely fashion a healthy dollop of information on matters to come before the board.
For December's meeting, the agenda contains links to information on a proposed $5.6 million recruitment award to lure a star researcher to the Golden State, an update on CIRM's proposed changes in its strategic plan, two new initiatives totalling $27 million that would accelerate progress to the clinic, grant administration changes that could affect the hundreds of CIRM grant recipients and proposed new scientific members for the group that makes the de facto decisions on which scientists receive CIRM cash.
We will have more on the details of all this later, but readers who have a special interest might want to dip in early. All the background information can be found via the agenda, which also says a remote site in San Francisco will be available for participation of those who cannot make it to Los Angeles.
The California stem cell agency, working under the direction of a new chairman, has once again posted a handsome amount of background material well in advance of its regular board meeting – in this case the Dec. 8 session at Cedars-Sinai in Los Angeles.
For the past several years, the agency has failed to post in a timely fashion important information on many decisions to be made by agency directors, making it virtually impossible for interested parties to plan to attend meetings or prepare thoughtful suggestions or recommend possible changes.
That situation has begun to change under Chairman Jonathan Thomas, a Los Angeles bond financier, who controls the board agenda and who was elected to his post at the end of June. In August, the agency also posted in a timely fashion a healthy dollop of information on matters to come before the board.
For December's meeting, the agenda contains links to information on a proposed $5.6 million recruitment award to lure a star researcher to the Golden State, an update on CIRM's proposed changes in its strategic plan, two new initiatives totalling $27 million that would accelerate progress to the clinic, grant administration changes that could affect the hundreds of CIRM grant recipients and proposed new scientific members for the group that makes the de facto decisions on which scientists receive CIRM cash.
We will have more on the details of all this later, but readers who have a special interest might want to dip in early. All the background information can be found via the agenda, which also says a remote site in San Francisco will be available for participation of those who cannot make it to Los Angeles.
Sunday, November 27, 2011
Hype, Geron and Stem Cell Research: A Hard-eyed View from the North
From Canada last week came a stem cell "reality check" that pulled together a professional football quarterback, a Yankee baseball pitcher, a Republican presidential hopeful and Geron.
What do they all have in common? Stem cell therapy, answered Timothy Caulfield, a Canadian academic, writing on the Canadian version of the Huffington Post. Declaring that stem cell treatments are being ballyhooed as a "miracle cure" and "elixir of life," Caulfield wrote,
Caulfield wrote that Geron's abandonment of hESC research "underscores the cavernous gap between the well-publicized (and completely legitimate) promise of stem cell research and actual, efficacious, therapies."
He said the California company's decision "generated both shock and anger. And for the patients hoping for a near-future cure, it was nothing less than heartbreaking."
Caulfield continued,
 |
| Timothy Caulfield, U. of Alberta Photo |
"But does it actually work? I think not -- at least not yet."Caulfield is not one of your stereotypical opponents of stem cell research. In fact, he describes himself as a "believer" in the likelihood of development of effective stem cell therapies. Caulfield also springs from a deep academic background. He is research director of the Health Law Institute at the University of Alberta and has published a plethora of scholarly articles related to stem cell research.
Caulfield wrote that Geron's abandonment of hESC research "underscores the cavernous gap between the well-publicized (and completely legitimate) promise of stem cell research and actual, efficacious, therapies."
He said the California company's decision "generated both shock and anger. And for the patients hoping for a near-future cure, it was nothing less than heartbreaking."
Caulfield continued,
"Not only did the company decide to stop this particular trial, it decided to get out of the field of stem cell therapies altogether. So definitive was the decision that Geron gave back millions of public research dollars(to the California stem cell agency)."Caulfield warned, however,
"We need to be careful not to over-interpret the Geron pull out. This is one company and one trial. There are now a few other clinical experiments in the pipeline (emphasis on a few), such as one to treat a form of blindness. And we must remember that not all things that are called 'stem cell therapies' are the same. "Caulfield continued with his "reality check,"
"First, ignore the hype. I believe there is little evidence that any of the often advertised stem cell therapies, embryonic or otherwise, work. Yes, there are a handful of decades-old treatments ….Caulfield concluded,
"(Peyton) Manning, (Bartolo) Colon and (Rick)Perry may have had a positive experience (the placebo effect is a powerful thing, after all), but, to date, I believe good clinical evidence simply does not exist.
"Second, despite the hope of many, it isn't going to be easy to make money off stem cell research -- at least with a treatment that is scientifically legitimate, appropriately tested and approved by the relevant regulatory agencies (three characteristics missing from most of the stem cell therapies currently offered in clinics around the world). "Economic growth has often been one of the ways that the huge public investment in stem cell research has been justified. Just a few weeks ago, for example, the UK government announced that it was committing millions in a stem cell research centre with the hope that it will help drive the UK economic recovery.
"But the ability of emerging stem cell technologies to stimulate the economy and create jobs is far from certain. Indeed, economics is the explicit reason for the Geron pull out. The company press release stated that the decision was made after a strategic review of the costs, timelines and 'clinical, manufacturing and regulatory complexities associated' with this kind of research. In other words, stem cell research is not, from the perspective of this company, worth it."
"I don't mean to be a downer. In fact, I believe that stem cell research holds tremendous potential. I remain fully confident that, one day, therapies will emerge. But the inappropriate hype associated with this area hurts policy debates, leads to unmet expectations, and has the potential to mislead the public about the actual state of the science. The Geron story is a sober reminder that promise is not reality, even in a field as exciting as stem cell research."
The CIRM 'Debt' to George Bush and Disgraced Korean Researcher
It was brief but pointed comment on the differences in the stem cell world of 2004 compared to the stem cell world of 2011.
Larry Ebert, a patent attorney, made the remark on his blog, IPBiz. He was writing about an observation on this website that without George Bush and his restrictions on federal hESC research, there would have been no California stem cell agency.
Ebert said,
Consider Woo Suk duly credited.
Larry Ebert, a patent attorney, made the remark on his blog, IPBiz. He was writing about an observation on this website that without George Bush and his restrictions on federal hESC research, there would have been no California stem cell agency.
Ebert said,
"IPBiz notes that when the California voters voted Prop. 71 in, scientists thought Huang Woo Suk's work on hESC was real. In 2011, the current state of the art is still not up to what Huang Woo Suk falsely reported in the journal Science. Californiastemcellreport should give Huang Woo Suk some credit for the passage of Prop. 71."
Consider Woo Suk duly credited.
Wednesday, November 23, 2011
California Stem Cell Agency Takes Initiative in PR 'War'
Jonathan Thomas, chairman of the $3 billion California stem cell agency, took to the blogosphere today with an item promoting CIRM's progress, declaring that it is a record of which Californians can be proud.
In his debut performance as a blogger, Thomas declared that the agency has 43 research projects that are in various stages of moving towards clinical trials. He wrote on CIRM's research blog,
The document also explains the laborious process for creating a therapy before it can be brought to market and actually used to treat patients. The document said,
Today's blog posting by Thomas and, more particularly the "Fueling Hope" document, will be useful to CIRM in dealing with the overblown expectations of rapid cures that were generated by the hype of the 2004 ballot initiative campaign that created the stem cell research program.
The campaign generated impressions among voters that cures – specifically human embryonic stem cell cures – were just around the corner and that the Bush Administration, with its restrictions on hESC research, was the only thing standing in the way. Indeed, without George Bush, there would be no state stem cell agency since his stand against hESC created an apparent need for alternative funding. For voters who expected instant cures, however, CIRM must be a sad disappointment since it has developed no therapy that is being used to treat people.
Managing expectations is a critical task for CIRM, which will run out of funds in 2017 and which is expected to be asking voters for another multibillion dollar bond measure sometime in the next few years.
In his debut performance as a blogger, Thomas declared that the agency has 43 research projects that are in various stages of moving towards clinical trials. He wrote on CIRM's research blog,
"Given that it normally takes a decade or longer for a basic science discovery to reach clinical trials, 43 projects seemed to me like quite an achievement – an achievement that the people of California should take pride in supporting. Not only is CIRM driving stem cell science in our state, but through our national and international collaborations California has become a stem cell hub that accelerates stem cell progress worldwide."Thomas, a Los Angeles bond financier, pointed to a new document from CIRM, titled "Funding therapies: Fueling Hope." It summarizes some of the agency's work and touts the "incredible potential" of stem cells.
The document also explains the laborious process for creating a therapy before it can be brought to market and actually used to treat patients. The document said,
"Altogether, carrying out the basic research, translational work and preclinical data leading up to a clinical trial can take a decade or longer, and that's just to start the clinical trial. CIRM’s funding approach speeds that timeline by providing stable funding that eliminates pauses in the research to raise new funds, by strategically funding areas thought to be barriers to the clinic and by forming teams of researchers who work in parallel rather than sequentially to reach clinical trials faster."When Thomas was elected chairman of the agency last June, he told directors that the agency was in a "communications war" in which its record was not fully appreciated by the public. He made telling the CIRM story one of his top priorities.
Today's blog posting by Thomas and, more particularly the "Fueling Hope" document, will be useful to CIRM in dealing with the overblown expectations of rapid cures that were generated by the hype of the 2004 ballot initiative campaign that created the stem cell research program.
The campaign generated impressions among voters that cures – specifically human embryonic stem cell cures – were just around the corner and that the Bush Administration, with its restrictions on hESC research, was the only thing standing in the way. Indeed, without George Bush, there would be no state stem cell agency since his stand against hESC created an apparent need for alternative funding. For voters who expected instant cures, however, CIRM must be a sad disappointment since it has developed no therapy that is being used to treat people.
Managing expectations is a critical task for CIRM, which will run out of funds in 2017 and which is expected to be asking voters for another multibillion dollar bond measure sometime in the next few years.
A Look Inside the CIRM-Geron Loan Documents
The $25 million loan that the California stem cell agency awarded to Geron was the largest ever made by the research enterprise.
Directors approved the loan last May during a hearing that was a major departure from its usual procedures. The loan agreement was signed Aug. 1., about three months before Geron announced that it was abandoning the hESC business.
Geron last week repaid the $6.42 million that it had received from CIRM up to that point. Geron also paid the agency $36,732.33 in interest. CIRM additionally received 537,893 warrants to buy Geron stock at $3.98, CIRM told the California Stem Cell Report. Geron closed at $1.50 yesterday. The warrants expire in 10 years.
Last summer the California Stem Cell Report requested copies of the loan documents, which can be found at the end of this item, although the agency blacked out much of the information.
In a note accompanying the documents, Ian Sweedler, deputy legal counsel to CIRM, said,
CIRM-Geron 8-1-11 Loan Agreement
CIRM 7-28-11 Geron Loan Term Letter
Geron-CIRM Loan Agreement Appendix B
Geron-CIRM Loan Timetable Appendix C
Directors approved the loan last May during a hearing that was a major departure from its usual procedures. The loan agreement was signed Aug. 1., about three months before Geron announced that it was abandoning the hESC business.
Geron last week repaid the $6.42 million that it had received from CIRM up to that point. Geron also paid the agency $36,732.33 in interest. CIRM additionally received 537,893 warrants to buy Geron stock at $3.98, CIRM told the California Stem Cell Report. Geron closed at $1.50 yesterday. The warrants expire in 10 years.
Last summer the California Stem Cell Report requested copies of the loan documents, which can be found at the end of this item, although the agency blacked out much of the information.
In a note accompanying the documents, Ian Sweedler, deputy legal counsel to CIRM, said,
"Geron requested and justified redactions to the milestone document, to those parts that describe specific activities, plans and data within the overall project. Geron asserted and justified a claim that these details meet the legal standard for trade secrets that are exempt from production. For the milestones, Geron agreed to leave enough unredacted to give a sense of the intent, at a level of detail that is not confidential. For example, it will be possible to see that a milestone refers to enrolling a certain number of patients, but not what that number is, or other specifics about that stage of the project. There are also accompanying comments with technical details and alternative approaches considered. For these comments, we were unable to find a way to leave any meaningful text that would not disclose trade secret information. The comments have therefore been completely redacted.Here are the loan documents.
"Geron similarly justified redaction of information about how it will divide funds among different aspects of the project. They explained that their internal costs, processes, and sequences are confidential, competitive trade secret information. The redacted versions therefore show the amount of funding CIRM will provide, but not when and how Geron will allocate that to different activities."
CIRM-Geron 8-1-11 Loan Agreement
CIRM 7-28-11 Geron Loan Term Letter
Geron-CIRM Loan Agreement Appendix B
Geron-CIRM Loan Timetable Appendix C
Tuesday, November 22, 2011
The Ins and Outs of CIRM's Push to Keep the Geron hESC Effort Alive
The $3 billion California stem cell agency has confirmed that it is looking for companies to take over Geron's hESC business, but remained vague on the details of just what it is proposing as well as any financial incentives.
A certain ambiguity may appropriate because Prop. 71, the ballot initiative that created CIRM seven years ago, constrains the state research effort, which is engaged in an aggressive push to bring stem cell therapies into the marketplace.
After last week's New Scientist article in which CIRM President Alan Trounson said he was talking to at least three companies, the California Stem Cell Report emailed this inquiry to the agency:
With some crafty lawyering, however, CIRM might be able to move its $25 million Geron loan over to a some sort of new entity if the clinical trial remains virtually identical.
The agency might also find a way to use a newly created $30 million "strategic partnership" program to support a deal involving Geron's stem cell program. CIRM's new program is industry friendly and aimed at early stages of clinical development.
However, by law, only a public vote of the 29-member board of directors can approve a loan or grant. That vote is taken in what is supposed to be a blind process in which the names of the applicants are not known. However, it is clear from last May's approval of the Geron loan that the directors knew the identity of the applicant although it was not announced publicly until after the formal 16-1 vote. The agency's procedures also call for action prior to the board vote by its grant review group, which makes the de facto decisions on grants.
The timeline on normal award rounds is lengthy – more than a year from concept to finish – and may not be appropriate in this case. Plus the rounds are open to more than one applicant.
CIRM's current award rounds for business involve loans not grants. The loan policy was developed, in part, because businesses objected to the financial hooks in grants. Originally, the loan program was created to fund business projects that otherwise could not find funding. The program was originally slated to run as high as $500 million. The interest was expected to finance additional research.
The agency also has geographic constraints. It cannot pay for work outside of California. So that would mean that a potential buyer probably would need a substantial presence in California unless the agency could put together a deal in which Geron is still in the game and doing some of the work.
The agency can receive warrants in loan deals but does not make stock investments. It probably cannot legally directly buy a stake in a company and thus provide a cash infusion.
A new arrangement for Geron's hESC business would need some likelihood of a substantial stream of cash over the next several years, based on what Geron said last week. But the current environment for early stage biotech investment is quite difficult. And then there is the FDA, which authorized the clinical trial and is likely to have something to say about who operates it.
Whether CIRM can overcome all these obstacles would seem to be problematic. But, of course, Geron is also shopping its business around. And some buyers might be attracted by a bargain basement price enhanced by the expectation of continued cash from the California stem cell agency.
A certain ambiguity may appropriate because Prop. 71, the ballot initiative that created CIRM seven years ago, constrains the state research effort, which is engaged in an aggressive push to bring stem cell therapies into the marketplace.
After last week's New Scientist article in which CIRM President Alan Trounson said he was talking to at least three companies, the California Stem Cell Report emailed this inquiry to the agency:
"Re Trounson's comments about CIRM trying to find an enterprise to pick up the Geron hESC business, what form is that taking? Are CIRM officials contacting companies, asking them to consider the Geron business? Are promises being made that Geron's loan would be passed along to a new company? Are CIRM officials giving any sort of assurance that the new enterprise would be looked on favorably in terms of possible CIRM financing help, even a wink or some such thing?"In response, Maria Bonneville, executive director to the CIRM board, said yesterday,
"Dr. Trounson is encouraging companies to take a hard look at the potential of this project. If any companies express a solid desire to continue the project, they would be thoroughly vetted through CIRM's existing procedures."The stem cell agency is limited by law in what it can do encourage a deal for Geron's orphan business. Nonetheless it will have to move quickly if it wants to keep Geron's hESC team intact. Otherwise, those folks will be heading for more secure employment.
With some crafty lawyering, however, CIRM might be able to move its $25 million Geron loan over to a some sort of new entity if the clinical trial remains virtually identical.
The agency might also find a way to use a newly created $30 million "strategic partnership" program to support a deal involving Geron's stem cell program. CIRM's new program is industry friendly and aimed at early stages of clinical development.
However, by law, only a public vote of the 29-member board of directors can approve a loan or grant. That vote is taken in what is supposed to be a blind process in which the names of the applicants are not known. However, it is clear from last May's approval of the Geron loan that the directors knew the identity of the applicant although it was not announced publicly until after the formal 16-1 vote. The agency's procedures also call for action prior to the board vote by its grant review group, which makes the de facto decisions on grants.
The timeline on normal award rounds is lengthy – more than a year from concept to finish – and may not be appropriate in this case. Plus the rounds are open to more than one applicant.
CIRM's current award rounds for business involve loans not grants. The loan policy was developed, in part, because businesses objected to the financial hooks in grants. Originally, the loan program was created to fund business projects that otherwise could not find funding. The program was originally slated to run as high as $500 million. The interest was expected to finance additional research.
The agency also has geographic constraints. It cannot pay for work outside of California. So that would mean that a potential buyer probably would need a substantial presence in California unless the agency could put together a deal in which Geron is still in the game and doing some of the work.
The agency can receive warrants in loan deals but does not make stock investments. It probably cannot legally directly buy a stake in a company and thus provide a cash infusion.
A new arrangement for Geron's hESC business would need some likelihood of a substantial stream of cash over the next several years, based on what Geron said last week. But the current environment for early stage biotech investment is quite difficult. And then there is the FDA, which authorized the clinical trial and is likely to have something to say about who operates it.
Whether CIRM can overcome all these obstacles would seem to be problematic. But, of course, Geron is also shopping its business around. And some buyers might be attracted by a bargain basement price enhanced by the expectation of continued cash from the California stem cell agency.
Sunday, November 20, 2011
California Stem Cell Agency Trying to Line Up Buyers for Geron hESC Business
The president of the $3 billion California stem cell agency, Alan Trounson, says it is in talks with at least three firms in an effort to salvage Geron's orphan stem cell business.
Andy Coghlan of New Scientist magazine reported Trounson's remarks in an article on Friday headlined, "Is there life for stem cells after Geron."
The Menlo Park, Ca., firm last Monday abandoned its stem cell therapy development program and terminated a much-heralded clinical trial that was the first-ever in the nation for an hESC therapy. The California stem cell agency loaned the firm $25 million just last May as part of its push towards bringing therapies to market. Geron last week paid back the $6 million of the loan that it had received up to that date.
Details were sketchy in New Scientist about CIRM's attempt to serve as a stem cell matchmaker. Coghlan had only this to say,
Last week, several names surfaced in the media of a number of possible buyer/partners/backers for Geron's stem cell business. They included Pfizer, which is involved with Peter Coffey of UC Santa Barbara in another possible hESC trial; BioTime of Alameda, Ca., which has a number of Geron alums, and Teva Pharamaceutical of Israel. UC Irvine researcher Hans Kierstead, whose work led to the Geron spinal trial, was also in the mix, according to a report in the Orange County Register. Pat Brennan, who interviewed Kierstead, wrote that the researcher said "he is exploring alternative funding to continue the trials." Keirstead, who is on the scientific advisory board of California Stem Cell of Irvine, Ca., also said the trial may well go overseas.
The California Stem Cell Report queried the firms identified last week concerning their intentions towards Geron. All declined to comment specifically. Michael West, CEO of BioTime, also said,
Brokering a deal for Geron's stem cell business places the California stem cell agency in a novel position and will test its business skills. CIRM's activities have been largely devoted to awarding grants and loans. Its loan to Geron was only approved by directors just six months ago. The loan agreement was not actually signed until August.
Under CIRM's procedures, companies receiving loans are supposed to be vetted during a private due diligence process. However, one might question the quality of that due diligence given Geron's withdrawal from the business only three months after the loan was finalized.
The key question, in trying to attract buyers for Geron's orphan stem cell project, will be not so much about whether it is good science but whether it is a good business.
Andy Coghlan of New Scientist magazine reported Trounson's remarks in an article on Friday headlined, "Is there life for stem cells after Geron."
The Menlo Park, Ca., firm last Monday abandoned its stem cell therapy development program and terminated a much-heralded clinical trial that was the first-ever in the nation for an hESC therapy. The California stem cell agency loaned the firm $25 million just last May as part of its push towards bringing therapies to market. Geron last week paid back the $6 million of the loan that it had received up to that date.
Details were sketchy in New Scientist about CIRM's attempt to serve as a stem cell matchmaker. Coghlan had only this to say,
"Alan Trounson, the institute's president, told New Scientist that CIRM is now talking to at least three other possible backers to take over the spinal trial. 'We'll have to wait and see, but it's important that it happens in a short time [because] once it gets beyond a couple of months, it gets very difficult to hold people together,' he said."Coghlan noted that Geron, in addition to the spinal therapy clinical trial, had three other hESC possible trials lined up for diabetes, heart disease and arthritis.
Last week, several names surfaced in the media of a number of possible buyer/partners/backers for Geron's stem cell business. They included Pfizer, which is involved with Peter Coffey of UC Santa Barbara in another possible hESC trial; BioTime of Alameda, Ca., which has a number of Geron alums, and Teva Pharamaceutical of Israel. UC Irvine researcher Hans Kierstead, whose work led to the Geron spinal trial, was also in the mix, according to a report in the Orange County Register. Pat Brennan, who interviewed Kierstead, wrote that the researcher said "he is exploring alternative funding to continue the trials." Keirstead, who is on the scientific advisory board of California Stem Cell of Irvine, Ca., also said the trial may well go overseas.
The California Stem Cell Report queried the firms identified last week concerning their intentions towards Geron. All declined to comment specifically. Michael West, CEO of BioTime, also said,
"I think the commentary you heard was a deduction based on my prior role at Geron, our being so geographically close to Geron, and, of course, our entire focus on hES cells and reprogramming. I will only add that I continue to believe passionately in the cause. More than ever, we have an historic opportunity to impact the practice of medicine. That is about as far as I can go."West founded Geron and has served as president of Advanced Cell Technology of Santa Monica, Ca., which is conducting an hESC trial at UCLA involving eye disease.
Brokering a deal for Geron's stem cell business places the California stem cell agency in a novel position and will test its business skills. CIRM's activities have been largely devoted to awarding grants and loans. Its loan to Geron was only approved by directors just six months ago. The loan agreement was not actually signed until August.
Under CIRM's procedures, companies receiving loans are supposed to be vetted during a private due diligence process. However, one might question the quality of that due diligence given Geron's withdrawal from the business only three months after the loan was finalized.
The key question, in trying to attract buyers for Geron's orphan stem cell project, will be not so much about whether it is good science but whether it is a good business.
Thursday, November 17, 2011
Geron hESC Withdrawal 'Real Blow' to California Stem Cell Agency, Says CGS
In a sharp-edged analysis of Geron's abandonment of stem cell research, the Center for Genetics and Society yesterday described the action as a "real blow" to the California stem cell agency.
Written by Pete Shanks, a regular contributor to the Berkeley center's Biopolitical Times, the piece chronicled some of the history and hype involving Geron and hESC research. The center has long taken a skeptical view of the California stem cell agency and Geron. Shanks wrote,
Written by Pete Shanks, a regular contributor to the Berkeley center's Biopolitical Times, the piece chronicled some of the history and hype involving Geron and hESC research. The center has long taken a skeptical view of the California stem cell agency and Geron. Shanks wrote,
"Geron has been in trouble for a while. Former CEO Thomas Okarma, who left abruptly in February, was the subject of ridicule for his repeated announcements that ESC-based clinical trials would begin "next year" — that is, 2005, 2006, 2007, 2008 — and the trial they eventually came up with was so dubious that Arthur Caplan called it "nuts and hugely risky." Even experts in the field thought that targeting spinal cord injury in the first ESC trial was dubious, though some seem to be more willing to be critical now it has ended.Shanks also wrote,
"And that was on the scientific and perhaps commercial merits. The ethical problems were much worse, since the trial was intended for people who had recently suffered damage to their spinal cords. Bioethicist Laurie Zoloth (who was once on Geron's ethics advisory board, and basically approved of the study), noted at the time of its announcement that:
"'True informed consent in this very vulnerable population, people who have suffered a devastating and life-changing injury a week prior to being asked to enter the first clinical trial for such long-awaited, highly publicized and desperately needed treatment, is hard to obtain and will need to be carefully thought through.'"
"What of CIRM's role? After Geron's announcement, they issued a remarkably bland press statement, followed by an internal memo that expressed deep disappointment (the California Stem Cell Report has the text). It's a real blow to them: Geron was the first private company to receive funds from CIRM to run a clinical trial using ESCs.
"This was a loan, not a grant, and was only made, as the indefatigable David Jensen (publisher of the California Stem Cell Report) discovered, after a 'major departure from longstanding procedures.' The proposal received a low score (66/100) that was not publicly revealed until Jensen specifically asked for it. And the other applicants who might have competed for those funds rather surprisingly all withdrew.
"The suspicion arises that CIRM, or some people within it, badly wanted the trial to proceed in the hope that it would give them a therapeutic success to boast about. If so, the decision just backfired."
Wednesday, November 16, 2011
CIRM Chairman on Geron: Agency in for the Long Haul
Commenting on Geron's decision to abandon hESC research, the chairman of the California stem cell agency, Jonathan Thomas, says the agency knew "the road to new therapies would be arduous, and that for each success, there would be setbacks as well."
In a memo Monday to the agency's 29 board members, Thomas reiterated that Geron maintains the decision had nothing to do with safety concerns. He said the company's action underscores the agency's commitment to long-term development of stem cell therapies.
Thomas also said the $3 billion agency will retain the stock warrants it received from Geron, but did not disclose their numbers. We have queried CIRM for more details. CIRM loaned Geron $25 million, which was paid back by Geron on Monday.
A copy of the Thomas memo was provided to the California Stem Cell Report. Here is the full text.
In a memo Monday to the agency's 29 board members, Thomas reiterated that Geron maintains the decision had nothing to do with safety concerns. He said the company's action underscores the agency's commitment to long-term development of stem cell therapies.
Thomas also said the $3 billion agency will retain the stock warrants it received from Geron, but did not disclose their numbers. We have queried CIRM for more details. CIRM loaned Geron $25 million, which was paid back by Geron on Monday.
A copy of the Thomas memo was provided to the California Stem Cell Report. Here is the full text.
"Dear Board Members:
"Earlier this afternoon, we learned that Geron made a decision to discontinue its stem cell research program, including the CIRM-funded clinical trial involving spinal cord injury. Geron made this decision in order to shift its focus to its oncology program. Geron has assured us that its decision to discontinue the trial had nothing to do with safety concerns; the cells have been well-tolerated and the patients have experienced no adverse effects. Geron will continue to follow all enrolled patients and has committed to accrue data and update the FDA and the medical community regarding the patients’ progress.
"In addition, Geron has returned CIRM’s funds, with accrued interest. CIRM will maintain the warrants it received.
"Of course, we remain committed to funding clinical development of stem cell therapies. We have always recognized that the road to new therapies would be arduous, and that for each success, there would be setbacks as well. We also know that companies make decisions for business reasons, and that it is not unusual for a company to pursue a new strategy, as Geron has done. CIRM, by contrast, is focused on its long-term goal of delivering therapies and cure to patients, and today’s events underscore the importance of CIRM’s long-term commitment to funding therapy development.
"This trial represented the first-ever clinical trial of human embryonic stem cells and we expected that it would be challenging. We share the frustration of all the patients for whom this trial offered great hope. I spoke personally with both Don and Roman Reed to express my commitment to the on-going search for therapies.
"Although we are deeply disappointed by Geron’s decision, we are grateful that Geron has established a regulatory pathway for human embryonic stem cell therapies and we are confident in the potential of stem cells to treat patients suffering from chronic disease and injury.
"Here is a link to CIRM’s press release: http://www.cirm.ca.gov/PressRelease_2011-11-14"
Tuesday, November 15, 2011
Possible Buyers for Geron's Stem Cell Business: BioTime, Pfizer, Celgene
The mainstream media is climbing all over the Geron story today with more analysis and a discussion of firms that might snag the San Francisco area firm's orphan stem cell business.
Reporter Peter Loftus of the Wall Street Journal mentioned Pfizer, which is involved an hESC project with researcher Peter Coffey, who was lured from the UK this fall to UC Santa Barbara. Among the incentives was a $4.9 million grant from the California stem cell agency, which also financed Geron to the tune of $25 million.
Matthew Perrone of The Associated Press had this to say about buyers:
The AP also wrote,
Here are more excerpts from today's coverage.
Gretchen Vogel of Science magazine wrote,
Reporter Peter Loftus of the Wall Street Journal mentioned Pfizer, which is involved an hESC project with researcher Peter Coffey, who was lured from the UK this fall to UC Santa Barbara. Among the incentives was a $4.9 million grant from the California stem cell agency, which also financed Geron to the tune of $25 million.
Matthew Perrone of The Associated Press had this to say about buyers:
"Analysts say Geron's stem cell business could be acquired by Alameda, Calif.-based BioTime, a company founded by former Geron scientists. Other potential acquirers could include larger pharmaceutical companies like Celgene Corp., Pfizer Inc. and Teva Pharmaceuticals, which have dabbled in stem cells without making major investments."BioTime's shares were up 7 percent today, closing at $4.52. Geron's shares were down as much as 28 percent and hit a five-year low. It closed at $1.71, down 22 percent.
The AP also wrote,
"Joseph Pantginis, an analyst with Roth Capital Partners, said it would have taken five to ten years before Geron's lead stem cell product reached the market.Charo had close ties early on with the $3 billion California stem cell agency, which loaned $25 million to Geron just six months ago. The loan was part of an aggressive effort to produce clinical results that will help extend the agency's life beyond 2017, when funds are expected to run out. Currently CIRM is financed through California state bonds, which will need to be approved by voters again if CIRM is to continue.
"'This is still very much a fledgling space and some people would even consider stem cells to be a science experiment, so there's still a long way to go,' said Pantginis.
"University of Wisconsin professor Alta Charo said Geron's move 'may suggest that a different business model is needed, one with a longer timeline for return on investment.'"
Here are more excerpts from today's coverage.
Gretchen Vogel of Science magazine wrote,
"Some observers had reservations about the trial from the start, worrying that the animal results were not strong enough to justify a human trial. But many had been pulling for the company nonetheless. 'It's with a sense of loss that I see this news,' says Roger Pedersen of the University of Cambridge in the United Kingdom, who was one of the researchers to receive funding from Geron in the mid-1990s to attempt to derive hES cells. He says the company may be reacting not only to the long timeline to bring cell therapies to the clinic, but also to a possible weakening of its intellectual property portfolio. The development of induced pluripotent stem (iPS) cells, which are adult cells genetically reprogrammed to resemble embryonic ones, means that Geron's exclusive licenses may be worth less. 'Advances in the stem cell field are disruptive innovations that have the potential to supercede earlier innovations, hES cells being one of those. I don't know if Geron looks at it that way, but I do,' Pedersen says."Ben Hirschler and Kate Kelland of Reuters reported:
"A decision by one of the biggest names in stem cell research to throw in the towel will not stop other pioneering work that could yet produce cures for blindness and help mend broken hearts.Sarah Boseley of The Guardian in the UK wrote:
Scientists were shocked by U.S. biotech company Geron Corp's decision on Monday to quit embryonic stem cell research -- a move it blamed on a lack of money and the complexities of getting regulatory approval....
"Robert Lanza, chief scientific officer of ACT, is not giving up hope on the embryonic front but said Geron's exit put more pressure on his firm to succeed.
"'Of course, it's the second mouse that often gets the cheese,' he said."
"The dream of Superman actor Christopher Reeve and others of paralysed people being able to walk again after injections of stem cells has receded, following the announcement by biotech company Geron in the US that it is to abandon the first-ever human trial of its kind."Jef Akst of The Scientist magazine wrote:
"'It’s certainly going to have a very chilling effect,' said Robert Lanza, chief scientific officer at Advanced Cell Technology, the only other company currently engaged in clinical trials involving hESCs. 'There’s a lot of exciting potential here in this field, and it would just be a real shame for this not to move ahead full steam.'...The Financial Times of London altered its original story by Andrew Jack without notifying its readers that the story was changed or why. The old version began.
"One thing working in the field’s favor is the fact that Geron helped pave the regulatory way for other stem cell therapies, said Sheng Ding, a stem cell biologist at the Gladstone Institutes and the University of California, San Francisco. 'Geron’s past efforts had cleared out a FDA path for pluripotent stem cells,” he wrote in an email to The Scientist."
"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."The new version, posted at least 12 hours later, begins:
"Geron, the Californian biotech company, is abandoning its pioneering embryonic stem cell work, after concluding that the costs and length of further development were too great."Matthew Herper of Forbes published a comment from Jamie Thomson of the University of Wisconsin, whose hESC discoveries were financed in part by Geron. Thomson wrote,
"Geron’s decision to discontinue their stem cell work reflects how genuinely difficult it is to build a business around embryonic stem cell-based transplantation therapies. They also chose a particularly challenging target for the first therapeutic application. They are to be commended, however, for blazing a trail that others can follow in getting the first clinical trial approved by the FDA, as such approvals should be easier in the future."Herper continued,
"Thomson initially shied away from the idea of building businesses around embryonic stem cells or their successors, induced pluripotent stem cells, which don’t involve destroying embryos. (He told me three years ago, 'I really believe personally that the value of these cells is not in transplantation,' and that '90% of the value of these cells will be in things that don’t make the front pages.') When Thomson did decide to become an entrepreneur, it was through a Madison, Wisconsin-based startup called Cellular Dynamics International, which uses the cells to create better ways of testing the safety and effectiveness of experimental drugs. Drug giants including Roche, Pfizer, and AstraZeneca have taken their own steps toward embracing stem-cell-based research. This field is slowly gaining steam just as the one Geron is abandoning its own attempts to heal the lame."Brian Orelli on the MotleyFool investment web site wrote,
"Geron is giving up on stem cells. That's like Krispy Kreme Doughnuts without glazed treats, or Apple without Macintosh."Adam Feuerstein on thestreet.com wrote:
"Geron's decision to shut down its embryonic stem cell research programs is a blow to the controversial research field and a painful reminder that only dreamers and fools invest in embryonic stem cell stocks....But does anyone believe that Geron would jettison stem-cell research if the ongoing clinical trial in spinal cord injury were helping patient recover neurological or motor function?"
Subscribe to:
Posts (Atom)