Text of Comments Reacting to IOM Report on California Stem Cell Agency
By Dr. Matthew Watson
Here is the full text or the essential
elements of comments sought by the California Stem Cell Report on the
Institute of Medicine report that recommended sweeping changes at the
California stem cell agency. Consumer Watchdog and the Center for
Genetics and Society put their comments in the form of news releases,
which contained redundant material.
of California's Little Hoover Commission:
“CIRM initiated the Institute of
Medicine review, which is to its credit. The Institute of
Medicine took a scrupulous and rigorous approach to its review of the
California Institute of Regenerative Medicine and in its report,
notes CIRM’s many achievements and accomplishments.“The Institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009. The
institute graciously acknowledged the commission’s work, which
clearly is as relevant now as it was in 2009.“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”
director at Consumer Watchdog of Santa Monica, Ca.(full press release here):
“Consumer Watchdog Thursday welcomed
a report from the prestigious Institute of Medicine (IOM) calling for
sweeping reforms in governance at California’s stem cell agency and
an end to the board’s built-in conflicts of interest.
“The report said that 'far too many
board members represent organizations' that receive funding or
benefit from the stem cell agency. The IOM said that the board’s
oversight function should be separated from the day-to-day management
of the California Institute for Regenerative Medicine (CIRM).
“'The IOM's critical report echoes
what every independent evaluator has said in the past,' said John
M. Simpson, Consumer Watchdog’s Stem Cell Project director.
'As we have repeated from the beginning, CIRM suffers from built-in
conflicts of interest and needs to separate the board's oversight
function from day-to-day management.'
“'It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,' Simpson said.”
executive director of the Center for Genetics and Society in
Berkeley, Ca.(full press release here):
“The Center for Genetics and Society,
a nonprofit policy research and advocacy organization, welcomed the
report on the California stem cell agency released today by the
Institute of Medicine and called for stronger protections for the interests of Californians as
the agency continues its disbursement of public funds.
“CIRM is nearing the end of the
billions of dollars of public funding allocated to it in
2004. The agency is currently considering how to extend
its operations after the money runs out. CGS Associate Executive
Director Marcy Darnovskysaid, “Given the agency’s
shortcomings and the state’s budgetary problems, it would be wrong
to ask Californians to give it more public money. If the agency
acquires new funds from industry sources or venture firms, it must
recognize that it has ongoing obligations to the people of
California.”“She continued, 'CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2008 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.'
“'Today’s report from the IOM
reaffirms the significance of the conflicts of interest and
structural flaws that were built into the stem cell program from the
beginning, and that continue to threaten its credibility and
effectiveness. These are serious problems that the Center for
Genetics and Society and other public interest voices pointed out
even before the agency was approved by the 2004 ballot measure on
which backers spent some $35 million.
“'Many aspects of these early
concerns remain directly relevant,' Darnovsky said. 'There is
still no way for elected officials to provide oversight because the
measure that created CIRM requires a 70% vote by both houses – more
than a supermajority. The agency’s governing board is still tainted
by its built-in conflicts of interest, and still includes no
representation of the public beyond disease advocates. Members of the
agency’s powerful Working Groups, including the one that reviews
grant applications, are still not required to publicly disclose their
individual financial interests.'”
Source:
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December 9th, 2012
IOM Proposals for Overhaul at CIRM Win High Marks
By Dr. Matthew Watson
The Institute of Medicine's
recommendations for major changes at the California stem cell agency
today received generally high marks from independent observers and
critics.
suggestions from California's Little Hoover Commission, the
state's good government agency. Asked for comment, Stuart Drown, the
commission's executive director, said,
“The institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009."
“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”
asked the agency's first president, Zach Hall, for his thoughts. Here
is the full text of what Hall, who was one of the peer reviewers on
the IOM study, had to say,
“The IOM Committee and its staff have
done an impressive job. The report recognizes the scientific
value and achievements of the CIRM and, at the same time, makes
cogent recommendations that, if taken seriously, will further improve
the quality and the public credibility of the Institute. The
committee and staff deserve the thanks of the scientific community
and all California citizens for their careful and thoughtful work.”
director for Consumer Watchdog of Santa Monica, Ca., said,
“It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,”
director of the Center for Genetics and Society of Berkeley, Ca.,
welcomed the recommendations. But she said,
“Given the agency’s shortcomings
and the state’s budgetary problems, it would be wrong to ask
Californians to give it more public money. If the agency acquires new
funds from industry sources or venture firms, it must recognize that
it has ongoing obligations to the people of California.”
“CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2009 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.”
queried most of the 10 patient advocates on the agency's governing
board for comment. Their roles could be altered in a major way by the
IOM recommendations. None of the advocates have yet responded.
full text of all the above comments is available here.)
Source:Stem Cell Therapy
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December 9th, 2012
Coverage of the IOM Report: Light but a Column with a Cutting Edge
By Dr. Matthew Watson
News coverage has been light so far
today of the Institute of Medicine's recommendations for an overhaul
at the $3 billion California stem cell agency. But a Pulitzer Prize-winning columnist from the Los Angeles Times took a sharp knife to the agency's press release on the IOM report.
Michael Hiltzik, who is a regular critic of the agency, asked,
"So how did CIRM react to the report? Even before the review panel's conference call with the press was completed, the agency issued a news release stating that the panel had 'praised' the agency 'for its ground breaking work in helping advance the science of stem cell research.'"If you wanted to know about the committee's criticisms, the first mention of those was in paragraph 9 of the news release. It quoted board Chairman Jonathan Thomas as promising to 'work on establishing a process to enable us to consider how best to proceed with reviewing the recommendations.'
"By my count, that's seven steps it will take before actually acting on the recommendations.
"As it happens, the panel's recommendations, which include creating a majority of independent board members without any potential conflicts of interest, track very closely to recommendations made by several previous outside reviews of CIRM, especially a 2009 study by the state's Little Hoover Commission.
"CIRM rejected almost every one, and it looks to be preparing to circle the wagons again against sensible improvements in the way it does business."
Chang popped up in two different forms on the Washington
Post web site and in Ottowa and Spokane, among other places. Chang
was on board for the IOM news conference and had this to say about
CIRM from one of the IOM study group members.
“'They’re not broken but they’re
bent,' said Sharon Terry, president of the nonprofit Genetic Alliance
who was part of the panel. 'They need some correction.'”
“California has transformed into a
powerhouse player in stem cell research, but the taxpayer-funded
institute responsible for that needs an overhaul, a report released
Thursday found.”
Ottowa and Spokane and beyond, started this way,
cell agency needs more independent oversight and recommends a
restructuring to avoid the appearance of conflict of interest.”
Business, who is one of perhaps two reporters who regularly cover
the stem cell agency, wrote,
“A review of California's stem cell
research funding agency proposed changes to the agency's governing
structure and commercial goals while praising its results so far. The
124-page report from the Institute
of Medicine recycles many conflict of interest and
intellectual property concerns that have dogged the San
Francisco-based” agency.
Angeles also had a story.
Source:Stem Cell Therapy
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December 9th, 2012
More IOM-CIRM Coverage: One Story Notes Major 2007 Conflict Flaps at Stem Cell Agency
By Dr. Matthew Watson
Additional coverage emerged this morning,
including stories in the Los Angeles Times, the Nature web site and
Businessweek. on a blue-ribbon report that recommended sweeping changes
at the the $3 billion California stem cell agency
circulation newspaper, Eryn Brown's story was headlined,
"Stem cell
agency board criticized for conflicts of interest."
"The board of California's stem cell
funding agency is rife with conflicts of interest and should be
restructured to improve the integrity of its grant-making process,
according to a new report from independent experts convened by the
national Institute of Medicine."“
Fikes' article was the only piece in all the coverage to mention two major conflict-of-interest flaps at the agency in 2007.
John Reed, head of Sanford-Burnham in La Jolla, who tried to influence CIRM staff
in connection with a grant to his organization, triggering
an investigation by the state's political ethics commission. (Reed's
actions were first disclosed by the California Stem Cell Report.) The
other case involved inappropriate actions by four members of the
29-member board in an $85 million round. Ten applications were dumped
from the round because of the directors' actions. The conflict
issues were so rampant that only eight of the directors present at a
December 2007 meeting could discuss the issues.
had a thorough piece that said the agency “received a mixture of
praise and hard-to-enact recommendations from an august scientific
body.” She also wrote,
“It’s unclear what effect the
report will have. Many of these recommendations run counter to
requirements enshrined in the legislation that created CIRM, and the
board of CIRM has heard similar recommendations before and failed to
act on them.”
Greg Miller wrote that IOM report "praises the California Institute for
Regenerative Medicine (CIRM) as a 'bold social innovation' that
provided a creative new source of funding that has turned the state
into an international hub of stem cell research. But the IOM panel
authoring the report also concluded that the funding agency’s
organization and governance is not optimal."
Alicia Chang mentioned yesterday. The AP story also appeared on the San
Francisco Chronicle and Sacramento Bee web sites and was also carried internationally on other web sites. The Chronicle also had a staff story by Erin Allday.
(An earlier version of this item did not contain the last sentence regarding the Allday story.)
Source:Stem Cell Therapy
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December 9th, 2012
IOM Recommends Sweeping Changes at California Stem Cell Agency
By Dr. Matthew Watson
A blue-ribbon study of the $3 billion
California stem cell agency today said the program has “achieved
many notable results,” but recommended sweeping changes to remove
conflict of interest problems, clean up a troubling dual-executive
arrangement and fundamentally change the nature of the governing
board.
study by the Institute of Medicine (IOM) would strip the board of its ability to approve individual
grants, greatly strengthen the role of the agency's president,
significantly alter the role of patient advocates on the governing
board and engage the biotech industry more vigorously.
 |
| Harold Shapiro, chairman of IOM-CIRM panel Princeton University Photo |
Princeton University and chairman of the IOM study panel, said,
Institute for Regenerative Medicine) has done a remarkably good job”
in giving the state a prominent position in regenerative medicine.
But he said the stem cell field has “evolved”and CIRM needs to
change with it.
report said,
“The challenge of moving its research programs
closer to the clinic and California’s large biotechnology sector is
certainly on CIRM’s agenda, but substantial achievements in this
arena remain to be made.”
of CIRM, which paid the IOM $700,000. The IOM is a prestigious
non-profit organization that was created in 1970 to provide
authoritative advice to policy makers and the public.
study, Robert Klein, then chairman of the CIRM board, and other board
members said that they hoped the study would lead to
another multibillion dollar state bond issue to support the
agency(see here and here). Duane Roth, a San Diego businessman and co-vice chairman of
the CIRM governing board, was the lone no vote on the study. He
warned directors that that they could not “go in just sort of blind
trust that (the IOM is) going to reach the conclusion you want them
to reach.”
grants in four years. Currently California remains in the throes of
state budgetary problems, and the agency has put on hold talk of another bond
election. It has also broached the possibility of
seeking private funding.
develop a full-blown “sustainability platform” and plans that would
spell out its likely financial structure and future rules on grants
and their administration, including intellectual property.
complaints about CIRM's operation that were aired even before the
agency was officially created by voters in 2004. One of those
involves the built-in conflicts of interests on the CIRM governing
board. As of September, 92 percent of the $1.7 billion handed out by the agency had gone to institutions linked to persons serving on the 29-member board.
“Far too many board members
represent organizations that receive CIRM funding or benefit from
that funding. These competing personal and professional
interests compromise the perceived independence of the ICOC(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”
has led to mass resignations of the agency's grant reviewers. The
IOM said,
“Recent controversy surrounding the
Cancer Prevention and Research Institute of Texas grants process
illustrates the importance of rigorous scientific review free from
inherent or perceived conflict and the consequences when these
boundaries appear to be breached.”
“Because the committee was not
charged with reviewing CIRM's past funding decisions, it did not
identify any specific cases of conflict.”
The IOM surveyed members of the board (ICOC) about conflicts of interest. The report said,
"While a majority of respondents stated
that personal interests did not play a role in their work on
the ICOC, some responses were more equivocal. One respondent replied that it was 'hard
to tell' given that 'so many decisions take place off camera in secret meetings,' while another
acknowledged that ICOC members are human, and of course their decisions are influenced by
personal beliefs and interests."
interest, the IOM recommended that the CIRM governing board not be
allowed to approve individual grants. Instead, the board would be
given a slate of applications that would be approved as a block. All
CIRM board members would be removed from the grant review committee
and the grant review process would be turned over to the president of
the agency, currently Alan Trounson.
the board consist of “independent” members and said that the
board should not be increased beyond its current 29 members, although
it could be shrunk.
revised to deal with personal conflicts, which could have a major
impact on the 10 patient advocate members of the board but also
other directors and possibly staff who have family members with health issues. The report said,
“California law focuses primarily on
financial conflicts of interest, but the committee believes that
personal conflicts of interest arising from one’s own or a family
member’s affliction with a particular disease or advocacy on behalf
of a particular disease also can create bias for board members.
Studies in psychology and behavioral economics show that conflict of
interest leads to unconscious and unintentional 'self-serving bias'
and to a 'bias blind spot' that prevents recognition of one’s own
bias. Bias distorts evaluation of evidence and assessment of what is
fair.”
involved in operational matters, including the chair and the two
vice-chairs. The report said,
“The board should transfer management
responsibilities to management so it can provide truly independent
oversight and evaluation of management, strategic planning, and broad
direction for resource allocation.”
a 2009 study by California's Little Hoover Commission, the state's good
government agency. It noted that CIRM rejected most of the commission's recommendations. The IOM also cited recommendations by the agency's own “external review” panel in 2010 and suggestions
this year from the first performance audit of the agency, which cost
CIRM $234,944.
require either legislative approval or another ballot initiative.
However, changes in the Prop. 71, the ballot initiative that created CIRM, require a politically difficult super, supermajority
vote (70 percent) of the both houses of the legislature and the
signature of the governor. The requirement was written into the
10,000-word initiative and has been used by CIRM to block legislation
that it did not favor.
other IOM recommendations:
- Greater engagement with industry to
commercialize stem cell research. Noting that industry has received
only 6 percent of the agency grants, the report said business
representation on CIRM working groups and other committees “should
be enhanced to leverage industry’s expertise and resources in
product development, manufacturing, and regulatory approval in
support of the ultimate goal of bringing therapies to patients.” - Elimination of the current process in
which applicants rejected by reviewers appeal publicly to the
governing board. Noting that 32 percent of “extraordinary
petitions” have been successful, the report said they “undermine
the credibility and independent work” of grant reviewers. Instead
appeals would heard only by staff behind closed doors. - Creation of a new scientific advisory
board, appointed by the CIRM president with a majority from outside
of California, instead of multiple advisory groups. The report said,“Such an external board would be
invaluable in vetting ideas for new RFAs, suggesting RFAs that
otherwise would not have been considered, and helping CIRM maintain
an appropriate balance in its research portfolio. Input from this
board would help CIRM make fundamental decisions about dealing with
challenges that cut across particular diseases, decide which
discoveries should progress toward the clinic, and determine how best
to engage industry partners in developing new therapies.” - Funding of programs on bioethics and
regulatory problems. The report said,“It is difficult for researchers to
find appropriate funding for stem cell-specific ethics and policy
work, and filling this funding gap is well within CIRM’s budget.”
earlier, Duane Roth, co-vice chairman of the agency, was the only no
vote on the board when it authorized the IOM study in 2010. The IOM today said,
“The critical tasks performed by the
vice chairs should be reassigned to management. In particular, the
important tasks of government relations and corporate relations both
should be carried out by staff reporting to the president rather than
by the vice chairs of the board.”
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December 9th, 2012
Excerpts from the IOM Report on the California Stem Cell agency
By Dr. Matthew Watson
Here are excerpts from the $700,000 Institute of Medicine (IOM) report on the $3 billion California stem cell
agency -- the California Institute of Regenerative Medicine (CIRM).
structure, scientific program, and policies are critical to better
serving California taxpayers who elected to devote funding to promote
stem cell research in the state. The necessary changes outlined by
the IOM committee, if enacted by the state and/or the institute,
would help to instill confidence among the scientific community and
California residents in the vital work that CIRM is accomplishing.”
that overall, CIRM has done a very good job of initially establishing
and then updating the strategic plans that have set priorities for
and guided its programs, and of taking advantage of its guaranteed
flow of $300 million a year for 10 years to establish a sustainable
position in regenerative medicine for California. The challenge of
moving its research programs closer to the clinic and California’s
large biotechnology sector is certainly on CIRM’s agenda, but
substantial achievements in this arena remain to be made.
achievements to date, as well as the largely positive independent
reports covering various aspects of its operations, no one would
claim that CIRM is a perfect organization or that it should adhere
slavishly to its initial form of organization, set of regulations, or
pattern of priorities. The field of regenerative medicine has
advanced rapidly since November 2004, and CIRM itself has seen the
need to alter its activities and approaches in some areas. The
committee believes the same should be true of its governance
structure, some of its administrative practices, and its use of
external perspectives on strategic scientific priorities and on the
evaluation of other key policies, such as intellectual property, to
ensure that they continue to encourage the development and deployment
of new treatments.”
the administrative structure of CIRM established in Proposition 71
had the advantage of protecting the institute’s ongoing operations
from outside interference in an ethically controversial arena, they
also made it difficult to modify the organization’s structure in
response to experience and/or changing circumstances. Moreover, these
protections, whatever their benefits, appear to some to shield CIRM
from the normal accountability mechanisms in place for state
agencies.”
represent organizations that receive CIRM funding or benefit from
that funding. These competing personal and professional
interests compromise the perceived independence of the ICOC,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board. Neither the board
chair nor board members should serve on any working group. The board
itself should include representatives of the diverse constituencies
that have an interest in stem cell research, but no institution or
organization should be guaranteed a seat.”
conflicts of interest has persisted for as long as CIRM has existed.
The IOM committee would be less concerned about individual board
members with actual or perceived conflicts of interest if the board
membership included more truly independent members. The majority of
board members should be independent, with no competing or conflicting
personal or professional interest. Broader representation from a
wider variety of stakeholders will inject new perspectives into the
panel and will help to dispel the perception of conflicts of
interest.
of interest definitions to include non-financial interests, such as
the potential for personal conflicts of interest to arise from one’s
own affliction with a disease or personal advocacy on behalf of that
disease. CIRM policies for managing conflicts of interest should
apply to that broader definition.”
governing board) functions both as an executor and as an
overseer—competing duties that compromise the ICOC’s critical
role of providing independent oversight and strategic
direction. The IOM committee recommends that CIRM’s operations
be separated from its oversight. The board should delegate more
authority and responsibility for day-to-day affairs to the
president and senior management, and the ICOC’s three working
groups should report to senior management within CIRM, rather than to
the ICOC. The moves would permit the board to better focus its energy
and collective talent on strategic planning, overseeing financial
performance, ensuring legal compliance, assessing the
president’s performance, and devising a plan for preserving and
expanding its considerable assets to permit the institute to continue
its important work after the bond measures end.”
challenge teams to have filed a request to begin clinical trials or
to have completed early-stage trials in patients within four years,
the committee feels these ambitious goals are unrealistic. New
therapies take more time to progress to federal approval, and
early-stage clinical trials are beset by a staggeringly high
failure rate. Rather than judging success by simply tallying the
number of active clinical trials, the IOM committee suggests
that CIRM also continue its focus on underlying biological mechanisms
that drive the success or failure of a promising therapy and on
careful design of clinical trials. Advances in these areas will
help the entire field progress, even if a specific drug candidate
is not approved."
expenditures are supporting approximately 3,400 jobs and their
innovative efforts have also attracted substantial additional private
and institutional resources to this research arena in California
CIRM’s long-term impact on such critical aspects of the California
economy as state tax revenues and health care costs beyond the
shorter-term and temporary impact of its direct expenditures cannot
be reliably estimated at this point in CIRM’s history.... (T)he
estimate of the Analysis Group (2008) that the CIRM program alone
would support about 3,400 jobs as long as it was allocating about
$300 million per year in research and development grants appears
quite reasonable to the committee. To put this estimate in context,
however, total employment in California is roughly 16 million, and
NIH alone provides more than $3.5 billion per year to California
research institutions.”
specify who will have the power and authority to assert and enforce
in the future rights retained by the state in CIRM-funded
intellectual property. CIRM should seek to clarify which state
agencies and actors will be responsible for the exercise of
discretion currently allocated to CIRM and the ICOC (the CIRM
governing board) over future determinations on issues regarding
march-in rights, access plans, and revenue-sharing rights that might
arise years after CIRM's initial funding period has passed.... (T)he
ICOC should reconsider whether its goal of developing cures would be
better served by harmonizing CIRM’s IP policies wherever possible
with the more familiar policies of the Bayh-Dole Act(federal IP law).
Source:Stem Cell Therapy
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December 9th, 2012
Text of CIRM Chairman’s Comments on the IOM Report
By Dr. Matthew Watson
Here is the text of comments on the IOM study of CIRM from J.T. Thomas, chairman of the agency.
"We deeply appreciate all the hard work of the IOM committee in compiling long and detailed report and the IOM clearly put considerable thought into compiling it. This has just been released so our Board and our staff has not had a chance to look at it yet, let alone digest its findings and recommendations, so it’s premature for us to offer any opinions. We are looking forward to the IOM presentation at the next meeting of our board, the Independent Citizens Oversight Committee (ICOC) where we’ll have a chance to talk with the IOM directly about the report. After that we’ll put together a process on how best to proceed so that we can respond in as thoughtful a manner to the recommendations as the IOM did in making them."
Source:Stem Cell Therapy
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December 9th, 2012
Collapse of Big Pharma Deal Involving California Stem Cell Agency
By Dr. Matthew Watson
A ballyhooed deal has blown apart that
would have hooked up – for the first time – Big Pharma and the $3
billion California stem cell agency.
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.
when Viacyte, Inc., of San Diego, received a $10.1 million award to
help finance a clinical trial for a diabetes treatment involving
Viacyte and GlaxoSmithKline.
“We have recently been informed that
GSK was not able to obtain the final approval required due to
business reasons in the context of GSK's overall research and
development portfolio and investment needs and not as a result of any
scientific or technical assessment of ViaCyte's program.”
the Glaxo decision.
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.
Viacyte and CIRM was trumpeted in October, when Viacyte was awarded
the $10 million. Officials of the stem cell agency said the award
was a “watershed” for CIRM. Jason Gardner, head of the Glaxo stem
cell unit and who attended the meeting, told the California Stem Cell
Report that the arrangement was a partnership and that the company
intended to develop a sustainable pipeline.
business-connected deal that has collapsed for the $3 billion agency
within the last 13 months. In November 2011, Geron abandoned its
clinical trial for spinal injuries. CIRM had loaned Geron $25 million
for the trial just three months earlier. The company paid the money
back with interest.
agency remain “extremely positive” about the Viacyte research and
“strongly recommended” that the company receive the additional $3
million. The memo said that trial has a “strong potential” to be
commercialized.
Source:Stem Cell Therapy
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December 9th, 2012
$80 Million in Grants, Money for Viacyte and Blue-Ribbon Report on California Stem Cell Agency
By Dr. Matthew Watson
Directors of the California stem cell
agency are expected to give away $80 million next week to 20
fortunate researchers in addition to exploring a “commercialization
and industry engagement plan.”
research effort.
“career development of physician scientists working in
translational stem cell research.”
“This award will fund promising
physician scientists in the critical early stages of their careers as
independent investigators and faculty members establishing their own
laboratories and programs.”
comments and application scores should be available sometime this
week. The bare-bones agenda lacked elaboration on the
commercialization plan.
hear a presentation on the blue-ribbon report by the Institute of
Medicine for which the agency is paying $700,000. The report has been
17 months in the making and is scheduled to be released this
Thursday.
table, although the agency has yet to produce background material
laying out any details. The subjects include:
- More money – no amount yet specified
– for Viacyte, Inc, of San Diego, which has received more than $36
million from CIRM. - An update of the agency's response to
the only performance audit conducted at the agency. The audit
identified 27 areas where improvement is needed, but the governing
board has not discussed the results publicly since they were
disclosed last May. - Approval of the concept plan for
another round of basic biology grants and adoption of conflict of
interest code changes.
Interested parties will be able to take part at the meeting location in Los Angeles and teleconference locations in La Jolla, Oakland and UCSF. If you are interested in
the teleconference locations, you will need to contact the agency for more specific directions than are provided on the agenda.
Source:Stem Cell Therapy
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December 9th, 2012
Extra, Extra! CIRM Staffers Blog the World Stem Cell Summit
By Dr. Matthew Watson
Years ago, I worked with an editor who
used to advise his lagging scribes to put their noses in their
typewriters and peck.
noses in what passes today for typewriters and are pecking away
furiously. Their subject is the World Stem Cell Summit, which has
received only slight coverage in the mainstream media.
Francisco's King Street filed -- on the agency's blog -- three fulsome
items on doings at the summit, which is taking place in West Palm
Beach, Fla. Yesterday they filed four. Photos and charts were
included. More coverage is expected tomorrow.
 |
| CIRM staffers blogging the World Stem Cell Summit covered UC Davis researcher Paul Knoepfler discussing patient advocacy and its role in funding stem cell research. |
The CIRM writers are doing double-duty
in at least one case. Geoff Lomax, the agency's senior officer for
its standards group, is additionally speaking on a panel at the session. A
handful of other CIRM officials are also appearing at the conference,
which ends tomorrow.
sending state employees across the country is to gather the latest
information on stem cell science and issues and to make contacts. It
is a bit of a bonus for the public to have the CIRM attendees also
file stories on the sessions.
attention. One dealt with patient advocates and their role in
energizing and helping to drive funding for research. Another item
discussed what appear to be growing issues with dubious stem cell treatments and the damage they can do to the field in general.
cell scam like this:
- “Claims of miracle cures for
diseases - “Single treatments or cells that
can treat any type of disease - “Lack of objective information,
evidence (such as published medical reports) that a treatment is
effective - “Treatment by a doctor who is
not trained or certified to treat the specific disease - “No system exists to collect
information and follow up with patients”
Source:Stem Cell Therapy
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December 9th, 2012
Update on Move To Curb Researcher Appeals at California Stem Cell Agency
By Dr. Matthew Watson
Directors of the $3 billion California
stem cell agency are still mulling details of changes in their
free-wheeling and sometimes emotional appeals process for grant applications
that are rejected by the agency's reviewers.
for the second time to discuss the likely alterations. Kevin McCormack, spokesman for the agency, said
the group made no decisions. Another meeting will be held later at a
date to be determined. The task force's recommendations will then go
before the full board, probably in late January.
have asked for “more details regarding the process that would be
employed if the appeals and extraordinary petition processes were
merged.”
appeals process. Early in its existence, the agency said appeals of
reviewer decisions could be based only on conflicts of interest.
However, researchers have a right under state law to speak to the
governing board in public on any issue whatsoever. As some
researchers began to use that avenue to ask for reconsideration of
their applications, the CIRM board created what it called
“extraordinary petitions” in an effort to control the process and
limit appeals. Both the “appeals” and “extraordinary petitions”
are, in fact, appeals but on different grounds and employing different
mechanisms.
after directors complained about “arm-twisting” and “emotionally charged presentations” in connection with a record number of
appeals earlier this year.
transcript of the session should be available on the CIRM web site
within the next two weeks. It will be found under the meetings
section of the web and then under the heading for the task force's
November session.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Hkq7zcXyMsQ/update-on-move-to-curb-researcher.html
Stem Cell Therapy
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December 9th, 2012
Stem Cell Board Members Lubin and Sheehy Honored
By Dr. Matthew Watson
A couple of members of the governing
board of the $3 billion California stem cell agency were honored for
their work this month.
 |
| Jeff Sheehy UCSF Photo |
communications manager and nationally known HIV/AIDS advocate, who
has served on the CIRM board since its inception. He was named by POZ
magazine as one of the top 100 “soldiers” in the fight against
HIV/AIDS.
Sheehy on the agency's blog yesterday. She said,
“Jeff once told me
that when he joined CIRM’s board eight years ago, he didn’t see a
role for stem cells in an HIV/AIDS treatment. Now, CIRM has committed
$40 million toward HIV/AIDS projects and two teams of researchers
from City
of Hope and UCLA are
working toward clinical trials.”
House to commemorate World AIDs day Dec. 1.
 |
| Bert Lubin Childrens Hospital Photo |
Childrens Hospital in Oakland, where he has worked since 1973, a
remarkable achievement in today's world of transitory employment. The
San Francisco Business Times named Lubin as the “most admiredCEO” in the San Francisco Bay Area. The newspaper said that since
he took charge at Childrens in 2009,
“He recruited a new senior management
team, chopped away at the pediatric hospital’s operating deficit
and worked to heal relationships with the local community and
governmental and political leaders that were deeply frayed...”
long volunteered at Childrens gives him high marks as well, citing
several encounters where he exceeded the usual CEO effort.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/9b9s3mW2ebM/stem-cell-board-members-lubin-and.html
Stem Cell Therapy
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December 2nd, 2012
Diane Winokur, Veteran ALS Patient Advocate, Named to California Stem Cell Agency Board
By Dr. Matthew Watson
Longtime ALS patient advocate Diane
Winokur of San Francisco, who has lost two sons to the disease, has
been appointed to the governing board of the $3 billion California
stem cell agency.
Serrano Sewell, who resigned from the 29-member panel earlier this
year after serving since the agency's inception. CIRM has 10 patient advocates
on its board.
 |
| Diane Winokur Photo -- Legal Momentum |
She sat for five years on the governing board of the national ALS
advocacy group and currently serves on the board for the California
state group, the Golden West chapter. She also served for six years on the board of
trustees for the Sanford- Burnham Institute in La Jolla, which has received $37 million from the stem cell agency. She left Sanford in 2011.
CIRM board to successfully seek approval of an $18 million ALS grant
that was rejected by the agency's reviewers. Researcher Clive
Svendsen of Cedars-Sinai in Los Angeles appealed the denial to the
full board and was supported in emotional testimony by other patient
advocates as well, including persons with the affliction.(See here for video of some of the testimony.)
million, including the Svendsen grant, for research directly related
to ALS.
West issued a press release Nov. 21, lauding the Winokur appointment
by California Lt. Gov. Gavin Newsom. The release quoted Lucie Bruijn,
chief scientist of The ALS Association, as saying,
"Her
contributions have been invaluable and she will be a tremendous asset
in moving the ALS research field forward through CIRM
funding."
on Winokur's appointment in addition to a press release. CIRM
Chairman J.T. Thomas said,
“Her knowledge, expertise and
leadership will be a tremendous addition to the ICOC (the stem cell
agency governing board) and help guide us in our work.”
Ca., described Winokur in a 2008 blog item as “small, elegant, full
of energy, an exclamation point of a person.”
(Editor's note: Based on information from CIRM and Golden West, an earlier version of this item incorrectly stated that Winokur is a current member of the Sanford-Burnham board.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/dITcyP7WJbs/diane-winokur-veteran-als-patient.html
Stem Cell Therapy
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December 2nd, 2012
Knoepfler Award Update: More than a Baker’s Dozen Nominated
By Dr. Matthew Watson
As of this week, 14 persons have been
recommended for the Knoepfler “Stem Cell Person of the Year”
Award.
Knoepfler, the UC Davis stem cell scientist and blogger, who is
putting up $1,000 for the winner of the honor.
field. Risk-taking is one important criteria.
“It’s something that I’m hoping I
can do every year. It would also be a reward for risk taking,
creativity and be breaking with tradition and be something new in
that regard.”
attention outside of Knoepfler's blog. A few days after he introduced
the award on his blog, UC Davis decided to put out a press release and video on it. The California Stem Cell Report followed with an item. Then CIRM blogged it as well.
about the award in the mainstream media, but things could change.
Source:Stem Cell Therapy
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December 2nd, 2012
California Stem Cell Agency Still in Talks on $40 Million for StemCells, Inc.
By Dr. Matthew Watson
The California stem cell agency and
StemCells, Inc., are still trying to reach agreement on a deal in
which the company would receive $40 million from the state's
taxpayer-funded research effort.
in matching funds required from the Newark, Ca., firm under the terms
of the two awards approved in July and September. The latter award
was okayed on a 7-5 vote by the governing board after it was rejected
twice by the agency's reviewers.
Report queried the agency about the status of the awards. Kevin
McCormack, the agency's spokesman, replied,
“We are still in talks with them over
the terms of the funding. Hopefully, we'll have an agreement soon.”
applications after they are approved by the agency's governing board
to be sure that all conditions are being met. However, in the case of
the September award to StemCells, Inc., CIRM's governing board took
the unusual step of publicly stating that the firm must demonstrate
it has the $20 million in matching funds before it receives any
payments from CIRM. The board did not take that sort of public
position on the $20 million grant approved earlier in the summer,
although matching funds are required in that case as well.
stem cell agency, Robert Klein, appeared twice before the board to
lobby for approval of the second award to StemCells, Inc., which is a
publicly traded firm.. It was the first such appearance by Klein
before his former colleagues since leaving the agency in June 2011.
attracted attention from the Los Angeles Times last month. Pulitzer
Prize-winning columnist Michael Hiltzik wrote that the process was “redolent of cronyism.” He said a “charmed relationship”
existed among StemCells, Inc., its “powerful friends” and the
stem cell agency.
Source:Stem Cell Therapy
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November 25th, 2012
Texas Flap Looms Over California Stem Cell Agency’s Grant Appeals
By Dr. Matthew Watson
In nine days, the California stem cell
agency plans to take another crack at finding ways to curb its
free-wheeling appeal process involving scientists whose applications
for millions have been rejected by reviewers.
to researchers who need the cash to keep their labs running and remain in good standing with their host institutions.
record-breaking number of researchers made public appeals featuring
emotional patient advocates. Even the former chairman of the agency,
Robert Klein, made a two-time pitch for one applicant. Board members
later complained publicly about “arm-twisting,” lobbying and“emotionally charged presentations.”
meeting in Oakland -- with teleconferencing sites in San Francisco,
Irvine, Palo Alto, Seattle and Rochester, N.Y. -- contains few clues
on what the panel is hoping to specifically accomplish in next week's
90-minute session.
the transcript from the Oct. 24 meeting, during which CIRM President
Alan Trounson described the problem as “very critical.” He said,
“I think this is a very serious
matter that could really bite us very hard in a similar way to what's
happened in Texas. Unless we come up with some kind of process that
really addresses the science, it's a very large concern.”
mass resignations of reviewers at that state's $3 billion cancer
research effort. Questions have been raised about integrity of its grant review process and the program's political and biotech industry
relationships. James Drew of the Dallas Morning News produced a bit of an overview this week. In another piece, Eric Berger of the
Houston Chronicle provided quotes from emails from the infighting on
a controversial $18 million grant.
be also discussed at the agency's board meeting Dec. 12 in Los Angeles.
The board hopes to wrap up its action by late January.
to the agency at info@cirm.ca.gov.
Source:Stem Cell Therapy
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November 25th, 2012
Pomeroy Moving On, Will Leave Stem Cell Board
By Dr. Matthew Watson
Claire Pomeroy, one of the longtime
members of the governing board of the $3 billion California stem cell agency,
will be leaving her position at UC Davis and the stem cell board next
June.
dean of the medical school. In a telephone interview, she told the
California Stem Cell Report that she is examining a “few select
opportunities” to work at a national level on health reform and
health policy issues.
 |
| Claire Pomeroy UC Davis photo |
Washington, D.C., working on health issues on behalf of the
University of California during the transition period before she
leaves her position in California.
shortly before the Golden State's stem cell agency was created in
2004. At that time, UC Davis had what she called a “fledgling”
stem cell research effort. Today the school has chalked up $128 million in
grants from the stem cell agency, ranking fifth among institutions
funded by the agency.
agency “catalyzed development of our program,” which she said has
risen to “national prominence.”
agency board was also instrumental in attracting a $100 million grant
from the Moore Foundation to start a new school of nursing at UC
Davis in 2009. Through her service on the board, she met Ed Penhoet,
who also served on the board and was one of the co-founders of Chiron
and then president of the Moore Foundation. Subsequently, Penhoet
called her for lunch to discuss her thoughts on nursing education,
and developments moved on from there.
nation's largest grant for nursing education, according to the Moore Foundation.
Source:Stem Cell Therapy
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November 25th, 2012
‘The Knoepfler Award:’ Recognizing Risk and Those Who Make a Difference
By Dr. Matthew Watson
A UC Davis stem cell researcher-blogger has announced a “stem cell person of the year” award
complete with a $1,000 cash prize that he is putting up himself.
stem cell scientist in the U.S. actively blogging on the subject,
said he has decided to put his money where his mouth is.
including one for a scientist. Three days after the item aappeared, UC Davis
featured Knoepfler in a press release that included a video of
Knoepfler explaining the effort.
 |
| Paul Knoepfler UC Davis photo |
He said he wanted to go beyond “old
fashioned awards” given by “stodgy committees.” Knoepfler said he
is seeking to recognize that stem cell research is “transcending the
lab.”
is “to advance the stem cell field and give credit to those who
make a real difference.”
“The criteria are that the person
made a truly outstanding difference in the stem cell field for 2012.
The winner could be a scientist, a patient advocate, someone in
industry, a student, a physician…really anyone who has made the
field better. For non-scientist nominees I’m particularly
interested in those who took personal risks or gave of themselves to
help others. For scientists I am looking for outstanding scientific
achievement and in particular out-of-the-box thinking. Folks in any
country are eligible.”
Self-nominations are permissible. Knoepfler plans to pick five
finalists and interview them by phone. He also plans an online vote
that he said “may” influence his decision.
Source:Stem Cell Therapy
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November 25th, 2012
California Stem Cell Agency Blogs on Geron Clinical Trial
By Dr. Matthew Watson
The California stem cell agency
published an article online last week concerning the hESC clinical
trial that Geron abandoned last year, dealing mainly with one of the
participants in the program.
about whether the $3 billion research program is likely to fund the
trial once again, should BioTime, Inc., of Alameda, Ca., be
successful in acquiring the assets of once was the first hESC
clinical trial in the United States. The agency loaned Geron $25
million a few months before the company cancelled the trial.
manager, simply wrote,
“They (BioTime) would need to apply
for a loan if they want CIRM to financially support the continued
trial.”
BioTime could apply for has a deadline of Dec. 18 for letters of
intent. In addition to a loan, a grant is also a possibility.
enrolled in the clinical trial shortly before Geron said it was
dropping the effort for financial reasons. Adams interviewed Sharify
before an audience of scientists.
“Katie told me that it would be
impossible not to hope that a trial would help her, but that by the
time she made the decision to participate she knew she was doing it
to further science, not necessarily to further her own recovery. She
told the audience, 'I was part of something that was bigger than me,
and bigger than all of you.'”
UC Davis also wrote about the BioTime-Geron deal last week. Noting
that Geron's decision a year ago left many “upset to put it
mildly,” Knoepfler said the “idea of BioTime buying the Geron
stem cell program is a great one that provides new hope on many
levels.”
Source:Stem Cell Therapy
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November 25th, 2012
Researcher Alert: Keeping Tabs on the Stem Cell Exchequer
By Dr. Matthew Watson
The California stem cell agency has
posted the dates for meetings of its board of directors for 2013
with most of the sessions scheduled for the San Francisco Bay Area.
Diego in August, and another in Los Angeles 13 months from now. The
other five are in Northern California. Not yet on the schedule is a board workshop in early January that will be open to the public.
and others? The board controls the purse strings to $3 billion for research grants and determines what areas are to be funded. Astute scientists would do well to take in the sessions.
They offer insights into board thinking and opportunities to deal
with the agency staff and directors on an informal basis. Only a
handful of researchers – or less – attend the meetings on a
regular basis, but have been well-served by the time spent.
Source:Stem Cell Therapy
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November 25th, 2012