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Category Archives: Stem Cells

CIRM's Improving Openness

Posted: May 20, 2012 at 3:56 pm


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.

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

Posted: May 20, 2012 at 3:56 pm


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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Scripps CEO Joins Stem Cell Agency Board; Love Leaves

Posted: May 20, 2012 at 3:56 pm


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.

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

Posted: May 20, 2012 at 3:56 pm


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

Posted: May 20, 2012 at 3:56 pm


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

Posted: May 20, 2012 at 3:56 pm


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.  

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Stem Cell Market & Cord Blood Banking Industry Research Reports at 10% Discount – Limited Period Offer

Posted: May 17, 2012 at 8:16 am

DALLAS, May 15, 2012 /PRNewswire/ --

ReportsnReports.com announces a Flat 10% Discount on ALL market research reports by BioInformant WorldWide, LLC through June 20, 2012. Whether stem cells are to be studied functionally or based on source tissues, our database of reports on stem cells is sure to meet your research requirements.

Here is a list of reports on which you get a Flat 10% Discount through June 20, 2012:

The stem cell research products market (excluding stem cell antibodies) was valued at $1.28 billion for the full year 2011 and is projected to increase to $2.10 billion by 2016. The total market for all types of stem cell products - including stem cell research products, stem cell antibodies, and stem cell therapies - was valued at $5.72 billion for the full year 2011. This report identifies, defines, and quantifies each market segment within the stem cell product industry.

This research helps you with data and analysis on rate of entrants to the cord blood banking industry, revenue distinctions among existing banks, effect of new entrants for existing competitors, leveraging global tactics for growth and more.

As of 2012, 510 cord blood banks are active in 97 countries around the world. This database contains nearly 7000 global cord blood industry contacts from top 15 countries and around 9 categories.

This market research report focuses on recent advances in MSC research applications, explores research priorities by market segment, highlights individual labs and end-users of MSC research products, explores the competitive environment for MSC research products, and provides 5-year growth and trend analysis.

This study explores the complex IP landscape affecting development of human embryonic stem cell products, providing clear guidance for companies that want to enter the product area.

Explore information on applications, application priorities, patents, projected 5-years market growth, Competitors covering suppliers of neural stem & progenitor cell products and their products offered, Specialty pharmaceutical companies in neural stem & progenitor cell therapies, Breakdown of stem cell research activity by cell type, Potential end-users of neural stem cell products, Product ideas & suggestions and more.

This report uses end-user surveys of expectant parents and technology-derived data to determine the factors involved in parental-decision making. More than 1,200 expectation parents in the U.S., Canada, Europe and other international regions answered a detailed survey between November 2008 and January 2009.

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Stem Cell Market & Cord Blood Banking Industry Research Reports at 10% Discount - Limited Period Offer

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Advanced Cell Technology reports positive early results from embryonic stem cell trial

Posted: May 17, 2012 at 8:16 am

By Chelsea Conaboy, Globe Staff

Researchers at the University of California, Los Angeles, and Advanced Cell Technology of Marlborough have become the first to publish a study involving the use of embryonic stem cells in humans.

The study, published online in the British medical journal The Lancet and involving just two patients, was designed to test the safety of injecting the cells into patients with degenerative eye conditions. In both patients, the cells behaved as expected after four months, with no safety concerns arising, the researchers reported today, and the patients reported improvement in their vision.

The study provides a boost for the beleaguered field of embryonic stem cell research but must be view cautiously, said Dr. George Q. Daley, director of the Stem Cell Transplantation Program at Childrens Hospital Boston and a faculty member at the Harvard Stem Cell Institute.

Were all enthusiastic to see actual trials of cells based on human embryonic stem cells, but it really is far too preliminary to conclude anything other than that more studies are warranted, he said. What we have to do is temper our hope with real skepticism.

The researchers injected one eye of each patient with specialized eye cells derived from embryonic stem cells, which promote the health of photoreceptors in the eye. One, an adult woman, had Stargardt disease, a form of inherited juvenile macular degeneration. The other had age-related macular degeneration.

Dr. Robert Lanza, an author of the study and chief scientific officer at Advanced Cell Technology, a publicly traded company that funded the research, said the fact that the patients both reported improvements in their vision was a bonus, though he acknowledged that some of the change could be attributed to the placebo effect, or the patients own expectation for improvement as a result of the study.

The patient with Stargardt disease could detect hand motion before the injection. Within two weeks afterward, she could count fingers, the study said. She also reported improvements in her ability to detect color with the injected eye. There was no change in her other eye, the study said. The other patient showed improvement in reading a vision chart.

In these advanced patients it would be hard to expect much improvement but were surprised, Lanza said.

The patients were the first two in a set of trials that will study the use of the cells in a total of 24 people. The researchers injected the first patient in a separate trial in Europe on Friday.

Excerpt from:
Advanced Cell Technology reports positive early results from embryonic stem cell trial

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QualityStocks News – International Stem Cell Scientists to Present Pre-Clinical Research Results at Gene and Cell …

Posted: May 17, 2012 at 8:16 am

Scottsdale, AZ (PRWEB) May 16, 2012

QualityStocks would like to highlight International Stem Cell Corporation, a publicly traded company focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs).

In the companys news yesterday,

International Stem Cell Corp. announced that several of its leading scientists will be presenting experimental results from three of ISCOs pre-clinical therapeutic programs at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinsons disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinsons.

Secondly, the differentiation of hpSC and embryonic stem cells into cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases, stated Dr. Ruslan Semechkin, Vice President of Research and Development.

About QualityStocks

QualityStocks, based in Scottsdale, Arizona, is a free service that collects data from hundreds of Small-Cap and Micro-Cap online Investment Newsletters into one Daily Newsletter Report. QualityStocks is dedicated to assisting emerging public companies with their investor communication efforts and connecting subscribers with companies that have huge potential to succeed in the short and long-term future.

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Verastem, Inc. Reports First Quarter 2012 Financial Results

Posted: May 15, 2012 at 3:12 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Verastem, Inc., (NASDAQ: VSTM - News) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, today reported financial results for the quarter ended March 31, 2012 and also commented on certain corporate accomplishments and plans.

"We continue to build value by progressing the discovery and development of drugs targeting cancer stem cells and adding key advisors," said Christoph Westphal, M.D., Ph.D., Chairman, President and Chief Executive Officer of Verastem, Inc. "Henri Termeers insight and extensive experience has been a great asset to Verastem. As Lead Director, Henri will play an integral role in guiding Verastems vision for the next generation of cancer treatments. The addition of Dr. Max Wicha to our Scientific Advisory Board adds significant expertise in translational medicine which will shape our programs as we progress towards clinical development over the next 12 months.

Recent Accomplishments

Our significant recent accomplishments include the following:

First Quarter 2012 Financial Results

As of March 31, 2012, Verastem had cash, cash equivalents, short-term investments and long-term investments of $109.3 million compared to $56.8 million on December 31, 2011.

Net loss for the three months ended March 31, 2012 (the 2012 Quarter) was $6.9 million, or $0.47 per share applicable to common shareholders, as compared to $1.2 million, or $1.06 per share, for the three months ending March 31, 2011 (the 2011 Quarter). Net loss includes stock-based compensation expense of $1.5 million and $54,000 for the 2012 Quarter and 2011 Quarter, respectively. Net loss for the 2012 Quarter includes a non-cash charge of $431,000 related to the revaluation of a warrant that we have agreed to issue to Poniard Pharmaceuticals, Inc. (Poniard) upon achievement of a milestone under a license agreement.

Research and development expense for the 2012 Quarter was $4.8 million compared to $675,000 for the 2011 Quarter. The $4.1 million increase from the 2011 Quarter to the 2012 Quarter principally resulted from an increase of $1.4 million in contract research organization expense, an increase of $1.4 million for personnel costs, including stock-based compensation of $856,000, an increase of $482,000 in license fee expense primarily related to the revaluation of a warrant that we have agreed to issue to Poniard upon achievement of a milestone and an increase of $315,000 for laboratory supplies.

General and administrative expense for the 2012 Quarter was $2.1 million compared to $471,000 for the 2011 Quarter. The $1.7 million increase from the 2011 Quarter to the 2012 Quarter principally resulted from an increase of $973,000 for personnel costs, including stock-based compensation of $620,000, an increase of $274,000 in professional fees primarily related to additional legal and accounting fees for being a publicly traded company, an increase of $157,000 in consulting fees and an increase of $96,000 in insurance primarily related to being a publicly traded company.

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Verastem, Inc. Reports First Quarter 2012 Financial Results

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