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Archive for the ‘Stem Cells’ Category

Stem Cell Agency Board Sticks with More Financial Disclosure

Sunday, May 27th, 2012


The governing board of the $3 billion
California stem cell agency today rejected a proposal that would have
restricted transparency surrounding the financial interests of its
directors and top executives.

On a unanimous voice vote, the board
decided it would stick with the more complete disclosure rules that it
has operated under since 2005. CIRM staff had offered changes that would have narrowed the amount of economic
information that the board members and the executives would have been
required to disclose.
The directors' Governance Subcommittee, however, on May 3 rejected the plan. Sherry Lansing, a former
Hollywood film studio CEO and chair of the subcommittee, said at the time,

"I personally feel strongly that
because of CIRM's unique mission and the agency's incredibly
long-standing commitment to transparency, i believe that we should
continue to set an example by requiring the broadest disclosure for
members of the board and high level staff."

Retention of existing disclosure
rules comes at a time when more conflicts may arise. The agency is
moving to engage the biotech industry more closely as it pushes to
develop stem cell therapies. Already one case of conflict has arisen this
year dealing with industry. It involves a "special advisor"
to CIRM who was nominated to become director of a firm sharing in a
$14.5 million grant. She also was working for the firm. (See here and
here.)
The CIRM board also has built-in
conflicts of interest, written into the law by Proposition 71, which
created the agency. About 92 percent of the $1.3 billion awarded so
far has gone to institutions tied to members of the CIRM governing
board. Board members are not permitted, however, to vote on or
discuss grants to their institutions. But it is fair to say that if
California voters had foreseen that nearly all of the grants would
have gone to directors' institutions, they would not have
approved creation of the stem cell agency.
As the California Stem Cell Report remarked earlier, it is a good
move for CIRM to retain more transparency rather than less. As one of
the Moss Adams staffers said today – in a different context –
during the presentation of the first-ever performance audit of CIRM,

"When people have to fill a void
in information, they assume the worst."

Source:
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CIRM Directors Pleased with Performance Audit Findings

Sunday, May 27th, 2012


The $3 billion California stem cell
agency received a "very favorable" performance audit report
compared to other government agencies, CIRM directors were told
today.

Representatives of Moss Adams, which
was paid $234,944 by CIRM for the study, made the comments during a
presentation today to the agency's 29 directors. During their
comments, CIRM executives and directors focused on the favorable
aspects of the findings of the six-month study.
CIRM Chairman J.T. Thomas said the
report showed that CIRM is "doing better than being on the right
track." Co-vice chairman Art Torres said,

 "Comparatively we
have done very well."

The report praised the professionalism
of the CIRM staff – "a high caliber group" – and noted
the seven-year-old agency is both "ramping up and ramping down"
at the same time – a reference to the end of state bond funding for
CIRM in 2017.
Prior to the presentation, CIRM
President Alan Trounson said the staff would review the findings and
come up with a plan for the board at its July meeting. The agency is
already implementing some of the recommendations.
The audit was required by a recent
state law that also allowed CIRM to hire more than 50 persons, a cap
imposed by Proposition 71, which created the agency. The audit found a need for improvement in 27 areas and made recommendations. Of the 20 recommendations with the highest priority,
half involved how CIRM manages its information, much of which is
needed for good decision-making. The audit did not assess the
scientific performance of the agency.
The Moss Adams report, performed by the
Seattle firm's San Francisco office, said,

"CIRM board members and senior
management do not receive regularly updated, enterprise-level
performance information. The ability to evaluate performance against
strategic goals is critical to effective leadership and program
monitoring, evaluation, and reporting. CIRM does not currently have a
formal performance reporting program."

In addition to decision-making
information, Moss Adams called for improvements in the agency's
long-troubled grants management system, better grant outcome
tracking, development of a results-based communications plan,
creation of a comprehensive, formal business development plan,
formulation of a comprehensive information technology plan that would
include steps to establish clear responsibility for CIRM's website
and improved monitoring of invention disclosure forms from grantee
institutions.
Last week, in a long overdue move, the
agency hired a director for information technology, who is expected
to solve many of the problems cited in the audit.
State law requires another performance audit in a few years. 

Source:
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Live Coverage of Tomorrow’s California Stem Cell Meeting

Sunday, May 27th, 2012


The California Stem Cell Report will
provide live coverage of tomorrow's meeting of the governing board of
the $3 billion California stem cell agency. Directors are expected to
make major decisions about the agency's future direction, hear the results
of the first-ever performance audit and award about $95 million in
grants or loans.

The meeting will be held near the San
Francisco airport with another public teleconference location at UC
San Francisco
. Los Angeles will also have two public teleconference
locations. Another will be in La Jolla.
The meeting will be audiocast live on
the Internet, which the California Stem Cell Report will monitor from its
base in Panama near the Pacific entrance to the Panama Canal.
Instructions for listening in on the
audiocast can be found on the agenda along with specific addresses
for the public teleconference locations. The meeting is scheduled to
begin at 9 a.m. PDT.  

Source:
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Michael J. Fox Backs Away From Stem Cell Cure for Parkinson’s

Sunday, May 27th, 2012


It was not exactly a case of "Back
to the Future,
" the hit movie starring Michael J. Fox,
but it did offer a reflection on the past.

It involves the actor's
changing views on stem cell research in connection with Parkinson's
disease, which he has had since the 1990s.
Fox's 2004 Ad
Early on, Fox was well-known for his
support of human embryonic stem cell research. ABC News
recently described him as having become "one of the country’s
most visible advocates for stem cell research." In California, Fox was a prominent promoter of the ballot initiative, Proposition 71,
that created the $3 billion California stem cell agency in 2004. "
He filmed a TV commercial that was
aired widely during the 2004 campaign to create the stem cell agency,
declaring,

 "It could save the life of someone you love."

Today he is considerably less
confident. In an interview last week with ABC, he cited "problems
along the way." Fox said,

“It’s not so much that [stem cell
research has] diminished in its prospects for breakthroughs as much
as it’s the other avenues of research have grown and multiplied and
become as much or more promising. So, an answer may come from stem
cell research but it’s more than likely to come from another area.”

Source:
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Third Researcher Appealing Grant Rejection to Stem Cell Agency Board

Sunday, May 27th, 2012


The director of robotics and biosurgery
at UC Davis is appealing rejection of his application for a
$4.9 million grant from the California stem cell agency.

The scientist, W. Douglas Boyd,
noted that his proposal was given a scientific score of 67, which was
one point below the cutoff for most grants approved by CIRM's
Grants Working Group
. Thirteen grants fell in the 68 to 53
range, including Boyd's. Reviewers approved four in that range,
including two with scores of 53.
Boyd's letter was brief, focusing on a
letter of support from an Indiana firm, Cook Biotech, Inc.,
that would supply the "material and technical expertise to
create a new bioengineered cardiac patch
material."
The appeal letter, along with other
appeals(see here and here), will be given to CIRM directors in the agenda material for their meeting tomorrow in San Francisco. The
board does not have to act on the petitions or discuss them.
Researchers can also appear before the board to make a case.

Claire Pomeroy, CEO of the UC
Davis Health
Systems, is a member of the CIRM board. She
will be barred from taking part in any discussion of Boyd's
application or voting on it.

Source:
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Stem Cell Agency Hires Tech Chief to Solve a Myriad of Problems

Sunday, May 27th, 2012


In a move that was long overdue, the $3
billion California stem cell agency last week hired a director of
information technology to straighten out key problems ranging from
its grants management system to how it handles its website.

The new hire comes as the CIRM
governing board faces the results of its first-ever performance audit, which is markedly critical of how the agency handles its
information. Half of the audit's 20 highest priority recommendations for improvement focus on information deficiencies, including
critical information necessary for CIRM executives to determine the
agency's performance.
Solving those problems will fall on
the shoulders of Bill Gimbel, who is no stranger to CIRM. He has been
working with the agency as an information technology advisor since
2010 through a contract with Infonetica, Inc., of Pleasanton, Ca., according to CIRM spokesman Kevin McCormack.  Gimbel is now the first staff person in a chief technology position at CIRM since October 2007, when about 25 percent of CIRM employees left.
Bill Gimbel
A graduate of MIT, Gimbel, who will be
paid $180,000 annually, has a broad range of experience in computer
technology and software dating back to 1992. According to his
Linkedin web site, he was most recently director of IT at Infonetica.
He lists himself as owner of aptReader, an app for reference books.
He has also worked for LearningExpress and Scholastic, Inc.
The stem cell agency has been wrestling with information technology issues for years. The critical grants
management system has been an issue at least since 2007, when
directors were told its costs would not exceed $757,000. No figures
for the total spent since then have been made public by CIRM, which
is attempting to build a custom system, but the amount clearly and
easily surpasses the 2007 estimate, based on some of the outside
consulting costs. Although the agency hopes to resolve many of the
problems by the end of this calendar year, the grant system was the
target of considerable attention by Moss Adams, the firm that
prepared the performance audit.
Over the years, CIRM directors have received
intermittent, sketchy CIRM staff reports about the grants management
system, but the Moss Adams discussion is the most
comprehensive.
Among other things, the Moss Adams report said in bureaucratically delicate language,

 "Integration
of website content management has not been an integral part of the
GMS (grants management system) development process, which could
result in suboptimal operational efficiency and effectiveness.

"Grants management system
development is effectively managed at a tactical level, but it lacks
dedicated, strategic governance and oversight, which has resulted in
an elongated development process and requirements conflicts."

Moss Adams said,

"The new grants management system
intellectual property module, currently under development, does not
include provisions to address commercialization activity."

The performance audit additionally
said,

"CIRM board members and senior
management do not receive regularly updated, enterprise-level
performance information. The ability to evaluate performance against
strategic goals is critical to effective leadership and program
monitoring, evaluation, and reporting. CIRM does not currently have a
formal performance reporting program."

Moss Adams continued on other
information technology topics:

"Data and document access are
inefficient as a result of CIRM operating without a document
management system.....In most cases, CIRM staff cannot access
information without human interface. Information is stored in
multiple locations, which are not linked or indexed."

The audit said that the agency has
tried to solve its information problems without a plan. 

 "CIRM’s
information system needs have been met by a variety of tools,
including in-house developed applications, off-the-shelf
applications, databases, and spreadsheets, most of which are not
integrated," the audit stated.

One of the effects of all this is much
wasted time when CIRM's tiny staff tries to extract information from
the hodge-podge of systems. It is time that cannot be spared as the
workload increases in the next few years, as it is certain to do. 
CIRM's 29-member board is scheduled to consider the performance audit at its meeting this Thursday. 

Source:
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San Diego Biotech Firm Appeals Rejection of Cancer Stem Cell Grant

Sunday, May 20th, 2012


A San Diego biotech firm, Eclipse
Therapeutics
, whose multimillion dollar grant application was
rejected by reviewers at the California stem cell agency, is asking
the agency's board to overturn the decision next Thursday.
Eclipse, a spinoff from
Biogen Idec, said it is reducing its request from $3.5 million
because it has raised $2 million since it applied for the grant six
months ago. However, its appeal did not state specifically how much
it was now requesting from CIRM. The research involves cancer stem cells.
The company's appeal said that
during the period following submission of its application, it has accomplished all of the activities that CIRM had identified
as the first milestone in the research project. Eclipse also said it
has accomplished a number of activities in milestones two and three.
The firm said that it is now accelerating its IND filing by one year.
Eclipse was formed in March 2011 with
$2 million in seed funding from City Hill Ventures, also of San
Diego, according to a Bioworld article by Marie Powers. The
co-founders are Peter Chu, now president of Eclipse, and Christopher
Reyes
, chief scientific officer. Chu and Reyes ran Biogen Idec's
cancer stem cell program. They are also the applicants for the CIRM
grant.
Their appeal carried a routine cover
letter to the CIRM board from CIRM President Alan Trounson. He made
no comment on the worthiness of the request. On
an earlier appeal from Stuart Lipton of Sanford-Burnham, Trounson's
cover letter said Lipton's letter was "without merit."
Eclipse said its proposal received a
scientific score of 58 out of 100 from CIRM reviewers. CIRM, however, has not released the company's score. Two other proposals with scores of 53
were approved by reviewers.
For several years, CIRM has been
sharply criticized for its failure to fund businesses in a
significant way. It is currently moving to engage them more closely.
If Eclipse's appeal is successful, it will be one of less than 20
business to be funded without a nonprofit partner. Businesses have
received only about 4 percent of CIRM's $1.3 billion in awards to 494enterprises.
Appeals from rejected applicants
are included in the agenda material presented to the CIRM board, but
the board does not have to act on them or discuss them. Researchers
can also appear before the board to make a case.

Source:
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Painful Decisions Coming Up at Stem Cell Agency

Sunday, May 20th, 2012


The
Sacramento Bee
today ran a piece by yours truly in its California
Forum
section.

Here
is an excerpt. You can find the entire article here.

"They're
talking about pain at the $3 billion 
California stem
cell agency. And mortality. But not the end of life as you and I know
it.

"They're
talking about the pain that comes from cutting off millions of
dollars for scientists. They're talking about what will happen when
the state stops borrowing money to finance 
stem
cell research
 –
a final-breath moment that arrives in about five years....

"CIRM's
changing priorities create 'stark tension,' said one board
member, Michael Friedman, CEO of the City of Hope in the Los Angeles
area, in January. 'We're going to have to make some really
painful and difficult decisions,' he told directors.

"CIRM's
success – or lack of it – will play a critical role in its future
finances, whether they are based on another bond measure or private
support."

Source:
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Burnham’s Lipton Appeals Rejection of $5 Million Grant Application

Sunday, May 20th, 2012


Sanford-Burnham researcher Stuart
Lipton
is seeking to overturn rejection of his application for a $5
million grant from the California stem cell agency, declaring that
reviewers misinterpreted the proposal and relied partly on
"grantsmanship" instead of science.
Lipton's proposal deals with strokes
and is one of 22 rejected by CIRM's reviewers in a $95 million
round that comes before the agency's directors next Thursday.
Lipton's letter to CIRM yesterday said
some of the reviewers' criticism was "completely unfounded,"
"incorrect" or "in error." The two-page letter
went into specific scientific detail.
In a cover letter to the CIRM board,
CIRM President Alan Trounson said Lipton's appeal was "without
merit." He did not go into details but said CIRM staff is
prepared to discuss it next Thursday.
The scientific score on Lipton's grant
was not disclosed by CIRM, but it appears to be between 62 and 53.
Two grants ranked at 53 were approved by reviewers. Appeals from
rejected scientists are included in the agenda material presented by
the board, but the board does not have to act on them or discuss them.
Researchers can also appear before the board to make a case.
Kristiina Vuori, president of
Sanford-Burnham, is a member of the CIRM board. She will be barred
from taking part in any discussion of Lipton's application or voting
on it.

Source:
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CIRM’s Improving Openness

Sunday, May 20th, 2012


The California stem cell agency this
week once again posted in a timely fashion important information
dealing with matters to be decided next Thursday by directors of the
$3 billion stem cell agency.
The agency's actions are a marked
improvement in openness and transparency compared to the practices
prior to the election last June of J.T. Thomas as chairman of the
CIRM board. Previously, background material on multimillion dollar
matters was not available much of the time until shortly before the directors meeting, making it virtually impossible for interested
parties or the public to comment or attend the sessions. Even CIRM directors would complain from time to time about the laggard performance.
According to the agenda, next week's meeting in San Francisco
will include approval of $95 million in new grants, consideration of
the first-ever performance audit of  which made 27
recommendations for improvement, action on the first-ever CIRM directors' code of conduct along with conflict of interest rules, changes in its loan policy and consideration of the agency's
strategy for the next five years.
In addition to the meeting site in San
Francisco, a public teleconference location will be available at UC
San Francisco
, two in Los Angeles and one in La Jolla. Specific
addresses can be found on the meeting agenda.

Source:
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Scripps CEO Joins Stem Cell Agency Board; Love Leaves

Sunday, May 20th, 2012


Michael Marletta
Scripps Photo

State Treasurer Bill Lockyer has
appointed Michael Marletta, president and CEO of the Scripps Research
Institute
, to the 29-member board of directors of the $3 billion
California stem cell agency.

Marletta fills the seat of Floyd Bloom,
also a Scripps executive, who resigned last year. Scripps has
received $45.3 million in funding from CIRM.
In a letter yesterday to the stem cell
agency, Lockyer said Marletta is a member of the National Academy of
Science, American Academy of Arts and Sciences
and the Institute of
Medicine.
Marletta joined Scripps in 2011 and became president in
January.
Prior to that, he was at the University
of California, Berkeley
, where he once served as chairman of the
department of chemistry, among other roles. An item on the Scripps
web site said Marletta "focused his research on the intersection
of chemistry and biology. He is acknowledged as a pioneer in
discovering the role of nitric oxide, a critical player in
communication between cells."
The CIRM board has another vacancy to
fill. Ted Love resigned last month after serving on the board since
its inception in December 2004. CIRM said Love, executive vice
president of Onyx Pharmaceuticals, resigned for personal reasons.
State Controller John Chiang is considering a number of candidates to
replace him. Love was the only African-American on the board.

Source:
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Conflict of Interest: CIRM to End Contract with Consultant Linked to Grant Recipient

Sunday, May 20th, 2012


The California stem cell agency will
not renew a contract with a "special advisor" who has been
nominated to the board of directors of a firm that is sharing in a $14.5 million grant from the agency.
She is Saira Ramasastry, managing
partner of LifeSciences Advisory, LLC, of Emerald Lake Hills, Ca.
Ramasastry has worked for CIRM since May of 2010. Last month, she was
nominated to the board of Sangamo BioSciences, Inc., of Richmond, Ca.
Her responsibilities with CIRM have included "industry analysis
and consultation." Sangamo cited her experience with CIRM in its
press release on her nomination. She was also employed as a
consultant by Sangamo, according to the firm.
Ramasastry's dual roles raise obvious
conflict of interest questions. The case highlights the issues
that can arise between CIRM and the biotech industry as the agency
moves to engage industry more closely. CIRM's response additionally
demonstrates a lack of awareness of the potential for serious
mischief or worse when dealing with consultants.
The California Stem Cell Report asked
CIRM on May 6 for comment on the Sangamo-Ramasastry matter. The
questions included whether Ramasastry disclosed to CIRM her work for
Sangamo and whether CIRM took any action per the agency's conflict of
interest code. CIRM did not respond to the question of whether
Ramasastry ever disclosed her ties to Sangamo, which expects to
receive $5.2 million from the CIRM grant if it runs a full four
years.
Here is the text of CIRM's reply today
from spokesman Kevin McCormack.

"Saira Ramasastry was an
independent contractor. As required by law, we do ask independent
consultants to complete Form 700s(statements of economic interests)
if they participate in an agency decision making role. Her role did
not fall into that category - she was identified as a 'special
advisor' in connection with our external review process - and so she
did not have to fill out a Form 700. Her contract with CIRM comes to
an end at the end of June, and she will not be elected to Sangamo's
board of directors until July. Obviously once she is a member of the
Sangamo board she will not be consulting or advising CIRM because of
our strict conflict of interest rules."

(Editor's note: The board election is
June 21, according to the company, not July.)
Our take: CIRM is heavily dependent on
outside contractors. Expenditures for their services are the second
largest item in CIRM's operational budget, exceeded only by salaries
and benefits of regular employees. The responsibilities of outside
contractors cover a wide range of sensitive tasks including computer
system security, development of software that deals with proprietary
information from grant recipients, analysis of confidential business
operations of grant and loan applicants and much more.
The agency needs to know who their
consultants are working for besides CIRM. Whether they make decisions
for CIRM is beside the point. Gathering information that is not
normally accessible to the public can be extremely valuable to
businesses and their competitors as well as applicants for
CIRM's $3 billion. In Ramasastry's case, she was privy to a great
deal of confidential or economically useful information during her work on CIRM's external
review and likely much more.
The use of California's Form 700 is
hardly adequate to assess conflict of interest issues involving
private consultants. The form was developed in the 1970s to deal with
elected officials primarily and provides only the grossest sort of
look at financial holdings and income.
CIRM's current move to embrace industry
requires more scrutiny of conflicting interests – not less. NextThursday the CIRM board will deal with some of its conflict ofinterest rules. It is fine opportunity to ask for a sharper analysis
of conflict issues and consultants with an eye to strengthening CIRM
regulations and ensuring protection of the agency and its grantees'
work – not to mention the interests of the people of California.

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$95 Million in California Stem Cell Grants: Preview the Spending

Sunday, May 20th, 2012


For those interested in how the
California stem cell agency is going to spend its next $95 million,
you can check out short digests today of the 19 research grant applications, including reviewer comments, that are virtually certain of receiving the cash. 
The applications came in what CIRM
calls its "early translational III" round, which is
scheduled to be acted on by the CIRM board May 24 in San Francisco.
Digests of reviewer comments are
part of the directors' meeting agenda. They include scientific
scores, a statement from the applicant and a summary of what
reviewers had to say during their closed door sessions. But you won't
find the names of the applicants, their institutions or businesses.
The stem cell agency conceals the names of the winners until after
the board acts. Names of the unlucky ones are not disclosed by CIRM.
The agency says it does not want to embarrass anybody including the
institutions involved.
However, persons familiar with the area
of science involved may well be able to discern at least some of the
names of applicants from the information contained in the summaries.
Scientific scores of the successful
applicants ranged from 88 to 53. Nine grants scored higher than 53
but were rejected by reviewers(the Grants Working Group). The panel
turned down 22 applications overall. The CIRM board has final
authority on applications, but has almost never rejected a positive
decision by reviewers. Sometimes, however, it will overrule a
negative decision.
One successful application that was
scored at 53 involved ALS. The $1.7 million proposal was approved
for "programmatic reasons," according to the summary.
Often, programmatic motions for approval are made by CIRM board
members sitting on the review panel. However, the summary did not
disclose who made the motion or the vote. The summary said,

"The programmatic reasons provided
were that ALS is a devastating disease that is not well-represented
in CIRM's portfolio."

The other successful application that
scored at 53 sought $6.3 million for research involving heart
disease. The summary did not clearly identify the specific reason for
approving the grant on a programmatic motion. But it said,

 "The
GWG (grants working group) ... advised as a condition for funding
that the applicant consult additional vector specialists with
translational and clinical experience to select a more appropriate
vector to move this program towards the clinic." 

Again CIRM withheld the vote on the
motion and the name of the person who made the motion.
Applicants who have been rejected by
reviewers can appeal to the full board. So far no appeals have been
publicly posted by CIRM. The success rate on such appeals is mixed.
The translational round was open to
both academics and businesses, which have received a tiny fraction of
CIRM's $1.3 billion in spending so far. Some businesses have
complained publicly and, as well, to a panel of the Institute of
Medicine
that is evaluating CIRM's performance.
The California Stem Cell Report
yesterday asked CIRM for the number of businesses that applied in the
translational round, including the pre-application process, which is
used to whittle down the total number of applications. The request included total numbers as well. CIRM spokesman
Kevin McCormack declined to produce the figures prior to the CIRM
board meeting, saying they "won't be ready" until after the
session.   

Source:
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IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

Sunday, May 20th, 2012


The $3 billion California stem cell
agency is laboring under a range of problems that include protection of
its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month
study said yesterday.
The performance audit by the Moss Adams accounting
firm of Seattle, Wash., made 27 recommendations for improvements,
including more effort to ease strain connected to the agency's
controversial dual executive arrangement. The study said that the
nearly eight-year-old agency has many "opportunities" to
"enhance performance reporting and decision making, strengthen
effectiveness and efficiency, retain essential human resources and
leverage technology."
In response to the report, the stem
cell agency said, "(M)anagement concurs with the findings and
recommendations....The recommendations are focused and constructive.
CIRM is already implementing many of these recommendations, and we
will be investigating the others in the coming months."
The performance audit is the first ever
made of the California Institute for Regenerative Medicine. The
audit is required by state law and was commissioned by the agency at
a cost of $234,944. For years, the agency for years had resisted calls for a
performance audit until it sought legislative approval in 2010 for
removal of a 50-person cap on its staff. Originally, the performance
audit legislation would have put the study in the hands of the only
state body charged with oversight of the agency and its board. CIRM,
however, was successful in lobbying to have that provision removed.
The 54-page report identified once
again a number of issues that have troubled the stem cell agency for
some years. Moss made 12 top priority recommendations, many of which
dealt with information technology and grants management. Many of the
recommendations focused on providing better and faster information on
performance outcomes, which the audit said has been slow to come and
hard to generate.
The report said,

"Key performance information is
not readily available to CIRM leadership and other stakeholders on an
ongoing basis. CIRM board members and senior management do not
receive regularly updated, enterprise-level performance information.
The ability to evaluate performance against strategic goals is
critical to effective leadership and program monitoring, evaluation,
and reporting."

The audit stated,

"CIRM does not effectively
communicate outcome-based performance internally or externally. As
such, CIRM does not focus on performance metrics as part of its
(staff) meeting process."

The report additionally said,

"CIRM does not have an integrated
financial information system....The use of spreadsheets results in
labor intensive processes to generate reports and respond to
information inquiries, since data must be pulled from multiple
spreadsheets, a process that may be prone to error. ...Spreadsheets
are not linked to each other or a master report. CIRM does not have a
comprehensive list of spreadsheets or instructions for how to
maintain the files or generate reports from them."

Moss Adams said that CIRM needed to do
a better job in "bond forecasting," a reference to the
California state bonds that finance virtually every aspect of the
agency's operations. CIRM directors were caught by surprise a few
years ago when they suddenly learned the agency was up against a
major cash crunch.
Some of the recommendations will
require more work from CIRM grantees and their technology transfer
offices in an effort to track intellectual property and grant outcomes.
The report also recommended a speed-up in CIRM's review of progress
reports from grant recipients, which have been lagging completion by
several months.
The dual executive arrangement, which
was written into law by Prop. 71, has troubled CIRM since nearly day
one. CIRM's own external review panel also identified it as problem
two years ago. The executive structure is virtually impossible to
change because of the political difficulty in making alterations in
the ballot initiative.
Moss-Adams said,

"The working relationship between
the chairman’s office and the president’s office has vastly
improved over the past year, but there are still opportunities for
improvement."

The performance audit recommended,

"Make every effort to manage and
operate as one cohesive organization, while recognizing the varying
roles, responsibilities, and authorities that exist with positions in
both the chairman’s office and president’s office."

One of the top 12 recommendations
involved CIRM's public relations/communications effort. CIRM
Chairman J.T. Thomas told directors last June that the agency was in
a "communications war."
Moss-Adams said,

"CIRM does not have a
communication plan, and there is lack of clarity on how to address
mission-based communication to CIRM’s various target audiences,
especially the general public....The best way to facilitate
results-based communications is to 1) quantify goals and outcomes in
CIRM’s strategic plan and 2) report on achievement of those goals
and outcomes by enhancing CIRM’s annual report with additional
performance-based information."

Another performance assessment of the
stem cell agency is also underway. It is being conducted by the
prestigious Institute of Medicine and is costing CIRM $700,000. That
report is expected this fall.
CIRM's board of directors is scheduled
to consider the Moss Adams report at its meeting May 24.
Our take: While the findings and
recommendations of the performance audit were delicately worded in
many cases, they brought out issues that need to be addressed, many
of which have been around for a great deal of time. At their meeting
next week, CIRM directors should act very directly on the
recommendations. They can do that by requiring a written report each
month from CIRM Chairman J.T. Thomas and CIRM President Alan Trounson
on the specific steps that they are taking to implement the
performance audit's recommendations. Otherwise, the inevitable drift
will set in.

Source:
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California Budget Slashing Misses Stem Cell Agency

Sunday, May 20th, 2012


The $3 billion California stem cell
agency dodged the governor's financial knife today.
This morning, Gov. Jerry Brown
announced sweeping cuts throughout California state government as he
attempted to close a new, $15.7 billion deficit. A report in the Los
Angeles Times
 said the governor was "grabbing any spare change available." But this afternoon, in response to a
query, Kevin McCormack, CIRM's spokesman, said,

"The answer is no, we won't be
affected."

The question arose because California's
financial picture is much bleaker than it was just four months ago.
And the stem cell agency's only real source of cash is money borrowed
by the state -- general obligation bonds.
Under Prop. 71, which created the
agency in 2004, the bond funds flow directly to the agency without
intervention by the legislature or the governor. However, Brown has
been chary of additional bond sales since they create an increasing
burden in the form of interest costs. Those costs must be financed
out of money that otherwise might go to the University of
California
, K-12 schools and medical help for the poor.
Under an agreement arrived at last year, CIRM has what amounts to a $225 million line of credit with the
state, which should take care of its needs until January. The cash is
coming from short-term borrowing by the state instead of bonds.

The Brown Administration has cut back
on bond borrowing and intends to cut more this fall. According to the state Department of Finance, the cost of borrowing
has declined $173 million this fiscal year, down to $5.2 billion.
CIRM's share of the debt service is more than $200,000 a day.  

Source:
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StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

Sunday, May 13th, 2012


StemCells, Inc., said today it has
applied for as much as $40 million in funding from the California
stem cell agency for two projects dealing with Alzheimer's disease
and cervical spinal cord injury.
The announcement came in a news release
dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board
of the $3 billion California stem cell agency. Funding for
businesses in the disease team round is expected to come through a
loan.
StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM)
for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

Applications in the round were reviewed
behind closed doors in April. CIRM also has a policy of not releasing the
names of applicants until its board acts and then only if an
applicant is approved. CIRM says it does not want to embarrass firms
that do not win approval. That includes individual researcher names
as well as the names of such institutions as the University of
California
.
During discussion of grant applications by the CIRM board, directors are not told the names of the applicants,
just the number of the application. If board members have conflicts
of interest on specific applications, they are barred from voting on
and discussing the application. The names of applicants have
occassionally slipped out. Sometimes their identities can also be
discerned by information contained in the summaries of the reviews of
the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.
Most companies seeking funding from
CIRM do not identify themselves in advance, although they do if they
appeal a negative decision by reviewers. The board has ultimate
authority for approval of grants but has almost never rejected a
recommendation for funding by reviewers.
StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage
of Salk and David Anderson of Caltech. Weissman and Gage have won
substantial grants from CIRM. 
StemCells Inc.'s stock price closed at
92 cents yesterday. Its 52-week high was $8.20, and its 52 week low
was 70 cents.
Here is a link to an analyst's report
on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

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Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

Sunday, May 13th, 2012


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co
.
to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

Source:
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Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency

Sunday, May 13th, 2012


A "special
advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a
firm that is sharing in a $14.5 million grant from the state research
enterprise.
She is Saira Ramasastry, managing partner of Life Sciences Advisory, LLC, of
Emerald Lake Hills, Ca., and who also has worked as a consultant to
Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010,
when she served as a consultant for the panel that CIRM hired to
review its operations. The panel strongly recommended that CIRM
engage industry more warmly. Since then Ramasastry's contracts with
CIRM have totalled $65,000. Her current $25,000 contract describes
her work for CIRM as "industry analysis and consultation."
Ramasastry's
website says she serves as "a special advisor to CIRM in
industry engagement initiatives and strategic projects." Her
firm also offers expertise to life sciences firms in "strategic
alternatives advisory, strategic options analysis, tailored business
development solutions and innovative financing strategies."
In a news release April 30 announcing her nomination, Sangamo said Ramasastry has worked as a consultant to the Richmond, Ca., company. William Ringo, chairman of Sangamo's board of
directors, said,

 "Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

Sangamo's board is
scheduled to vote on Ramasastry's nomination on June 21. 
The California
Stem Cell Report
has asked Ramasastry if she has any comment for
publication. We are also querying CIRM and Sangamo. Their comments
will be carried verbatim when we receive them.
Our take?
Ramasastry's consulting work with both CIRM and Sangamo demonstrates
again the tiny size of the world of stem cell science. It also raises
questions about conflicts of interest involving CIRM and industry. Can
a consultant in such a position serve two masters and serve them both
equally well? CIRM's interests are not necessarily the same as
Sangamo's, which is a publicly traded firm working diligently to
generate profit and financial returns for its shareholders. To do
that, it needs capital from its financial "backers,"
including CIRM. The stem cell agency, however, is in the business of
getting the results that it wants from Sangamo. If not, the grant
can be cancelled. Working for both the stem cell agency, whose
paramount obligation is to the people of California, and a recipient
of the agency's millions is incompatible.

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Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure

Sunday, May 6th, 2012


A key panel of directors of the $3
billion California stem cell agency yesterday voted unanimously to
retain full public disclosure of the financial interests of its
directors and top executives.
The director's Governance Subcommittee
bypassed a proposal that would have substantially weakened disclosure at a time when the agency is moving closer to industry in an effort
to develop cures.
"Because of CIRM's unique mission
and the agency's longstanding commitment to transparency," said
Kevin McCormack, the agency's spokesman, "they believed that
CIRM should continue to set an example by requiring the broadest
disclosure of members of the board and high level staff."
Currently CIRM board members and top
executives must disclose all their investments and income – in a
general way – along with California real property that they hold.
Under the rejected changes, disclosures would have instead been
required only "if the business entity or source of income is of
the type to receive grants or other monies from or through
the California Institute for Regenerative Medicine." 
The proposed changes would also have
relieved CIRM officials of reporting investment in or income from
venture capital or other firms that may be engaged in financing
biotech or stem cell enterprises, since the firms do not receive cash
from CIRM or engage in biomedical research.

The subcommittee's action will go before the full CIRM board later this month, where it is expected to be ratified. 

Our take? The Governance Subcommittee
took the right action and is to be commended for going beyond the
letter of the law. The integrity and credibility of CIRM are
paramount. As the California Stem Cell Report wrote last week, narrowing disclosure would only have engendered suspicion and
unnecessarily raised questions about the conduct of the agency as it
embarks on an aggressive push for stem cell cures.

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Researcher Alert: First Look at Proposed Rules for California’s Stem Cell Bank

Sunday, May 6th, 2012


The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.

The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."

The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.

To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,

"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine
which is also creating a repository for iPSC lines and
derived materials."

Baum also said,

"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."

Baum provided the
following summary of the $30 million banking initiative:

"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses
for the public meeting locations can be found on the agenda.

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