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Category Archives: Stem Cell Therapy

Burnham's Lipton Appeals Rejection of $5 Million Grant Application


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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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CIRM's Improving Openness


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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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CIRM’s Improving Openness


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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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


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.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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Scripps CEO Joins Stem Cell Agency Board; Love Leaves


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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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


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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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