1. Stem Cells

Category Archives: Stem Cells

Two Additional Appeals Rejected in Disease Team Round

Posted on by


The governing board of the California stem cell agency last night rejected appeals by two applicants -- OncoMed Pharmaceuticals of Redwood City and Albert Wong of Stanford -- in the $200 million disease team round.

Both petitions generated little discussion. You can find more on their petitions here and here.

The board also approved changes in its intellectual property and grant administration rules. Both proposals will now enter the state's official administrative law process for more comment and possible change.

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

CIRM Board Eyes Florida Researcher for $6.7 Million Grant

Posted on by


The board of the California stem cell agency is discussing a proposal to award $6.7 million to recruit a Florida scientist to the Parkinson's Institute in Sunnyvale, Ca.

The scientist is Dennis Steindler of the University of Florida. The recruitment award received a score of 57, although the scores ranged from 30 to 75.  Jeff Sheehy, a member of the grant review group and CIRM board member, said the score reflected two extremely divergent positions by two reviewers.

The board has awarded four grants in its recruitment round over the past couple of years, but this is the first extended discussion of an award recommended by reviewers. It is also the first to have a representative of the applicant institution speaking publicly for the grant.

CIRM directors have now moved into executive session to discuss matters they prefer to air in private.

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

StemCells, Inc., Hails $40 Million in Awards from California Stem Cell Agency

Posted on by


StemCells, Inc., was quick this morning
with a press release about winning a $20 million award last night from the
California stem cell agency.

The publicly traded, Newark, Ca., firm
also pointed out that the CIRM board in July awarded another $20
million to the business.
The news release hailed the awards as
validating its science and business. Martin McGlynn, who personally
appeared before the CIRM board last night, said,

 "CIRM's approval of two
awards to StemCells illustrates the tremendous promise of
our neural stem cell technology and the high degree of confidence in
the world class team of scientists and clinicians who will be working
to translate this technology into potential treatments and cures for
these devastating diseases." 

On the Alzheimer's award last night,
McGlynn said,

 "With the recent spate of late-stage clinical
failures in Alzheimer's disease, it is clear that the field could
benefit from alternative approaches to lessen the huge burden on
families, caregivers and our healthcare system.

He continued,

"Our recently reported preclinical
data, which showed that our neural stem cells restored memory and
enhanced synaptic function in two animal models relevant to
Alzheimer's disease, shows our approach has promise. We greatly
appreciate the support from CIRM, which should help us accelerate our
efforts to test our HuCNS-SC cells in Alzheimer's disease."

The news release did not note that the
board has required that the firm must show proof that it has access
to $20 million in matching funds prior to receiving cash from the
agency on the Alzheimer's grant. The California Stem Cell Report is
asking CIRM whether that requirement extends to the earlier grant as
well.
One of the analysts who follows the
company released a special report on the firm this morning. Stephen
Dunn of LifeTech Capital said,

 “We are reiterating our strong
speculative buy with a price target of $4.50 as StemCells Inc.
continues to distinguishing themselves as one of the most advanced
players in the stem cell space.”

At the time of this writing, the firm's
stock was trading at $2.20 up seven cents. Its 52 week high is $2.67
and its 52 week low is 59 cents.  

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

California Stem Cell Agency: A New Board Member and a New Vacancy

Posted on by


The chairs are shifting a tad on the
governing board of the $3 billion California stem cell agency as a
French immigrant is added, a Latino leaves and a veteran patient
advocate is reappointed.


Coming on board for next week's meeting
is Anne-Marie Duliege, chief medical officer of Affymax Inc., of
Palo Alto, a publicly traded biopharmaceutical company that deals
with kidney disease. Leaving is David Serrano Sewell, who has been
named to the state Medical Board by Gov. Jerry Brown. Reappointed is
Jeff Sheehy, an HIV/AIDs patient advocate who may be the most public face
of patient advocates on the stem cell agency.
Anne-Marie Duliege
Affymax Photo

State Controller John Chiang appointed
Duliege to the CIRM post, saying, 

“Dr. Duliege brings
first-hand knowledge of what is required to take a drug from research
phase through FDA approval.”

In May, Duliege made a presentation to
the Bioscience Forum in South San Francisco called “Beating the
Odds,” a discussion of Affymax's first commercial product.
According to information posted by the group, Duliege led the way by
shepherding it through a 10-month gauntlet at the FDA.
Duliege has been with Affymax since
2007. Her prior positions included time at Chiron and Genentech. She
is a practicing physician, working part-time, and received her
medical degree from Paris Medical School.
Affymax has had a previous tie to the
stem cell agency. Ted Love, one of the initial members of the CIRM board, also sits on the Affymax board of directors. Indeed, Duliege fills the seat
vacated by Love when he resigned from the CIRM board. The position must be
filled by an officer of a California life science company.  
David Serrano Sewell
CIRM Photo

Serrano Sewell, who has also served on
the CIRM board since its inception, is apparently resigning to accept
an appointment to the board that regulates
California physicians. Apparently – because the stem cell agency
has not confirmed that he is leaving, although this morning it placed a resolution honoring him on the agenda for next week's meeting.  That almost invariably means a board member is departing.

Serrano Sewell, an attorney for the
city of San Francisco, was one of 10 patient advocate members on the
29-member board. Sewell was apppointed by the California lieutenant
governor. His seat will remain vacant until the current lieutenant
governor, Gavin Newsom, makes an appointment, who must also be a patient advocate.
Jeff Sheehy
CIRM Photo

Sheehy was reappointed recently by
state Senate President Pro Tem Darrell Steinberg. Sheehy is a
communications manager at UC San Francisco and a nationally known
HIV/AIDS advocate. He is co-chairman of CIRM's Science Subcommittee
and vice chairman of the grants review group. Sheehy leads the
discussion of grant applications when they come before the full board
in public session.

With the latest shuffling, the board has essentially lost its only African-American member – Ted Love.
Eugene Washington, dean of the UCLA medical school, is a member of
the board but never attends the meetings. Instead he sends a
surrogate. Serrano Sewell's departure brings the number of Hispanics
to three, co-vice chairman Art Torres, Francisco Prieto and Marcy
Feit. No Asians sit on the board.

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

StemCells, Inc., Wins Another $20 Million From California Stem Cell Agency

Posted on by


Following a second impassioned pitch by its former chairman, Robert Klein, the governing board of the California stem cell agency approved a $20 million award to a financially strapped biotech firm, StemCells, Inc., of Newark, Ca.

Approval came on a 7-5 vote with the condition that the company demonstrate it has access to $20 million in matching funds prior to funding.  It is the second $20 million award that the company has received in the disease team round, which now totals $214 million. Another disease team application has been tabled and will not be considered until October.

The current CIRM chairman, J.T. Thomas, a Los Angeles bond financier, asked for the financial proof because he said some concerns were expressed during an executive session that CIRM would now "account for such a large part of the assets of the company." Martin McGlynn, CEO of StemCells, Inc., also told the board that the company might have to drop its Alzheimer's research if it did not receive the CIRM award.

The StemCells, Inc., application was rejected twice by reviewers. The original rejection came before the July meeting at which Klein first appeared (see here and here). The proposal was then sent back for re-review, during which it was rejected again.

However, the 29-member board narrowly approved the application following discussion tonight and following its rejection of another Alzheimer's research proposal from USC. Both applicants produced a number of witnesses, including patients, on behalf of their appeals.

The re-review on the StemCells, Inc., application said in reference to a statement by Klein to board in July,

“The reviewers did not feel there was compelling data for neuron migration in the submitted manuscript. This is the manuscript specifically referenced at the ICOC (CIRM governing board) meeting (in July) that prompted the call for additional analysis. The manuscript is not yet accepted, it is 'potentially acceptable' but requires 'major revisions' according to the journal editor note. In addition, however, the studies in this manuscript used mouse NSCs, not the human NSCs proposed for the disease team award....”

In July, Klein said, “....(W)e have brand-new data that demonstrates and totally contradicts the key weakness on which it was downgraded.” 

A footnote: The CIRM staff said that as a result of two StemCells application, a proposal is being prepared to limit applications to one per entity in later rounds.

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

Nearly $6 Million Sought: Four Scientists Seek to Overturn Rejection by CIRM Reviewers

Posted on by


Four researchers are appealing
rejection of their proposals to win millions of dollars from the
California stem cell agency just as the agency is moving to curb such
reconsideration efforts by scientists.

The latest appeals come in what the
agency calls its basic biology round. The agency's governing board
meets next Wednesday and Thursday to hand out as much as $35 million
to as many as 25 scientists competing for the research dollars.
The four appeals follow a record outpouring last month of attempts at reconsideration in another
round. One upshot has been a proposal that would tighten the review process. That plan also comes before directors next week.
In three of the latest appeals, the
applications were given scientific scores that exceeded those of some
proposals that were approved by reviewers. The lower scoring
proposals were given the go-ahead on the basis of “programmatic
review,” which one CIRM document says is designed to allow
“consideration of issues beyond scientific merit, such as disease
representation and societal impact.” 
The latest appeals – formally known
as extraordinary petitions – were filed by Michael Teitell of UCLA,
Deborah Lieu of UC Davis, Tony Hunter of Salk and Hanna Mikkola, also
of UCLA. In all, their applications seek nearly $6 million from CIRM.
Hunter's $1.8 million application had the highest scientific score, 70,  of the four appeals. It ranked above three grants approved by reviewers. 
In his appeal, Hunter said “no major scientific issues were found” by reviewers concerning his application. He also reported new data involving a “major concern” of reviewers. Hunter said the information was developed after the application was submitted April 25.

In the case of Lieu, reviewers
said she was “relatively inexperienced.” Lieu's appeal said she
has “24 publications with over 6 years of experience in the
differentiation of cardiac muscle cells from human pluripotent stem
cells, 12 publications (3 co-corresponding author) on human
pluripotent stem cells and their cardiac derivatives, and 3
publications on the engineering of pacemaker cells” in addition to
other related professional experience.
She is seeking $1.3 million. Her
application received a score of 68, ranking it above two other grants
approved by reviewers and equal to a third also approved by
reviewers.
Mikkola said her application built on work previously funded by CIRM. She also cited new data that the
reviewers did not have access to. Mikkola's application for $1.4 million
received a score of 65, which ranks it above one grant approved by
reviewers.
Teitell's letter to the board also cited new data that is scheduled to published in November that deals with one of the concerns of reviewers. Teitell additionally disputed some of the critical information in the summary of reviewer comments.

He is seeking $1.4 million. CIRM did not release a score on his application, although it appears to be below 63, the lowest score disclosed publicly by the agency.

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

Bob Klein, "Lobbying" and Reader Reaction

Posted on by


A robust discussion has arisen
concerning Bob Klein and his appearance last month before the
governing board of the $3 billion California stem cell agency, a body
that he once chaired and an enterprise that he once oversaw.

The comments were triggered by the original "unseemly performance" item on the California Stem Cell Report and a subsequent comment by Francisco Prieto, a longtime member of the board.
The comments discussed whether Klein
was manipulated and whether he was engaged in so-called “revolving
door” activity – the practice of former government officials,
such as Klein, becoming paid representatives of enterprises that were
involved with their former agency.
The comments raise a number of
interesting questions that we will discuss on the California Stem
Cell Report during the next few days.
You can read the remarks by going to this item and scrolling down to the end of the piece.
(Editor's note: Our apologies to some
of those who commented for the delay in posting their remarks.)

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

Researcher Alert: Troubling CIRM Grant Appeal Process Up for Revision

Posted on by


Directors of the California stem cell
agency next week are expected to make unspecified changes in how
scientists can appeal denials of their applications for millions of
dollars in research grants.

The move follows a jam-packed and
emotional meeting last month in which the CIRM governing board faced a record outpouring of appeals of negative decisions by grant
reviewers. The board is the ultimate arbiter on applications. While it almost never overturns positive decisions by reviewers, it sometimes
approves applications that they have rejected. 
No details of the proposed changes in
the appeal process are yet available for the meeting Sept. 5-6 in
Burlingame, Ca. All that is known at this point is the following item
from the board agenda: “consideration of modifications to the
extraordinary petition policy and adoption of additional
information policy.” Extraordinary petitions are the key vehicle
for appeals.
The appeals process has long troubled the CIRM board. It has made changes in the procedures, but last
month's high stakes, $243 million round posed new challenges and
consumed so much time that the board was unable to complete action on
several items.
As a result of the July appeals, the
board sent five applications back for re-review. (See here, here and
here.) Some of those are expected to come up next week and others at
the end of October. The board agenda, however, did not specify which
applications would be considered next week. Nor did it specify how many additional appeals have been filed in the round that was up for
approval in July.

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

USC Researchers Appeal Rejection of $20 Million Proposal

Posted on by


Researchers from the University of
Southern California are making a pitch to overturn rejection of their
$20 million grant application by reviewers in one of the signature
commercialization rounds of the California stem cell agency.

The appeal by Roberta Diaz Brinton and
Lon Schneider will be taken up one week from tomorrow by the
governing board of the $3 billion state enterprise.
The USC application deals with Alzheimer's. It came in the $243
million disease team round that was considered last month during a
record-breaking outpouring of appeals and a day of emotion-filled
appearances by patients. CIRM directors adjourned their meeting
without completing action on a number of items, leaving open the possibility of additional appeals such as the one from USC.
The Brinton-Schneider application
received a score of 63 from reviewers. They said in a letter to
the board,

“We are submitting the petition at
this time as we are new to the CIRM ICOC(governing board) process and after listening
to the July 26 ICOC meeting deliberations now understand that the
petition process allows the ICOC to further consider our proposal.
We noted that the proposal scored one point above ours and another
two points below ours, each utilized the extraordinary petition
strategy to gain ICOC review which resulted in funding approval in
the former, and reconsideration in the latter instance.”

Their statement reinforced a concern
expressed by CIRM Director Oswald Steward, director of the Reeve Center at UC Irvine,  at last month's board
meeting about fairness in the grant process. He said,

“I'm not really quire sure that all
of the applicants clearly understood that they could come back to us
to address the criticisms(of reviewers).”

Concerns about whether all applicants fully understand the appeal process have surfaced on a number of occasions over the last several years. The CIRM board, however, is generally reluctant to overturn negative recommendations by reviewers. It also almost never reverses positive recommendations.

Next week the board is scheduled to
make unspecified changes in the appeal process. No further details on
those changes have yet been released by the agency although the
meeting is just four business days away.
In the Brinton-Schneider letter to the
CIRM board, the scientists defended their scientific approach and
responded to criticism by reviewers, especially those related to
sedation. Reviewers expressed reservations about over-sedation, which
the researchers said were erroneous.
It is not clear whether other scientists will
be making appeals during next week's board meeting.

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

Stem Cell Agency Moving to Curb Free-Wheeling Appeals by Researchers

Posted on by


The $3 billion California stem cell
agency on Tuesday released details of proposed, major changes in how
scientists are allowed to appeal decisions when their
applications for millions of dollars are rejected by grant reviewers.

The agency posted on its web site a 4 ½ page plan to curb the free-wheeling pitches that reached a record level at last month's governing board meeting. Some of the changes
would formalize ad hoc procedures that have emerged over the last
several years. The plan would also make it clearer exactly what can
and cannot be done or expected under the agency's appeal process,
which is poorly understood by at least some researchers.
The agency's proposal, due to be acted
on at the CIRM board meeting next Wednesday and Tuesday, is heavily
nuanced, dealing with such matters as “supplemental information,”
an “additional analysis option,” “criteria for material dispute
of fact,” “criteria for material new information” – not to
mention the old standby – “extraordinary petition.”
CIRM also reiterates in a footnote its
distinction between an “appeal” and an “extraordinary
petition.” However, it is a distinction without a difference except
to those in thrall of bureaucratic jargon. Both are appeals. Their
purpose is to provide a method for overturning reviewers' decision under certain conditions.
Details on CIRM's proposed changes came
only four business days prior to next week's governing board meeting
– a little late to generate thoughtful comment and constructive
suggestions from those most likely to be affected by the changes –
the 500 or so recipients of $1.6 billion in CIRM funding. Before final action on the changes, the board may well want to send out the proposal to all of its grant recipients and ask them for written comment that could then be considered at a public meeting of its Science Subcommittee.
The CIRM board has been bedeviled by
the appeal process for more than four years, including the
presentations at its public meetings by scientists. Ironically, the
first such public appearance was made by Bert Lubin, who is now a member of the CIRM
board  and CEO of Childrens Hospital in Oakland, Ca..
As the California Stem Cell Report
wrote at the time, the pitch by Lubin, who was unsuccessful,
disturbed some board members. Gerald Levey, then dean of the UCLA
medical school and a member of the board, said,

"I don't think we can run a board
this way. If we do, it would be chaos." 

Lubin was later quoted in the journal
Nature as saying that his rejected application did not come from “the
in crowd” of stem cell researchers or organization.

“So a project that was really going
to go into patients was essentially triaged.”

A final note: CIRM's proposal for changes in
the appeal process also uses language that obfuscates exactly what
researchers can do under state law. The document says that scientists
“may” make oral and written comments to the board, which is a
state government entity. In fact, state law makes it clear that
researchers as well as any member of the public have the “right”
to comment. The board legally cannot prevent them from speaking or
making comments. And the board, to its credit, has always allowed
ample public comment even when it slows the board's work.  

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

An Unseemly Performance: Former Chair of Stem Cell Agency Promotes $20 Million Research Proposal

Posted on by


Bob Klein is nearly an icon in the
history of the $3 billion California stem cell. And when he appeared
before its governing board last month and aggressively touted a $20
million grant proposal already rejected by agency reviewers, his
actions raised eyebrows.

Robert Klein
Elie Dolgin/Nature photo
Klein's comments carried unusual
weight, given that they were supported by his unique and influential
relationship with the California Institute for Regenerative
Medicine(CIRM). He and his associates wrote the 10,000-word ballot
initiative that created the stem cell agency in 2004. He ran the $35
million electoral campaign that convinced voters to buy into the
idea. Klein raised millions on behalf of the effort. He personally
provided the campaign $3 million. And he was the first chairman of
the agency, leaving that office only 13 months ago, when he was
designated chairman emeritus.
The meeting last month marked Klein's
first public appearance before the board on behalf of a specific
application.. He heralded the applicant, StemCells, Inc., as unique
and the “best” in United States with a “huge body of
experience.”

(The full text of his testimony can be found here.)
Irv Weissman
Stanford Photo
StemCells Inc. is a publicly traded company based in Newark, Ca., that was founded by renown Stanford
scientist Irv Weissman, who sits on its board. Weissman also played
an important role in the Prop. 71 ballot campaign that created the
stem cell agency. StemCells, Inc.'s application was turned down by
CIRM reviewers who gave it a score of 61, but the company appealed the action to the agency's governing board. Following the appearance by Klein, Weissman and others, the CIRM board sent the application back for more review.
The board will reconsider it next month or in October.
One California stem cell researcher,
who requested anonymity, said it is “highly inappropriate for Bob
Klein to be advocating for any grant application from a public
company.”
The scientist said,

 “He has
considerable influence with the ICOC(the CIRM governing board), and
is closely associated with biotech in the Bay Area. Even if he
doesn't make a lot of money himself from this, then he certainly has
friends who will.  Irv Weissman would be one of those friends."

In response to questions asked on Aug. 7 by the
California Stem Cell Report, Klein today defended his actions.  He was asked if he had “any sort of
financial ties” to firms or individuals that would benefit from
approval of the award. Klein, who is a real estate investment banker and also an attorney, said he has
“no financial interest” in the firm or individuals that might
benefit.
Klein also indicated his appearance was
entirely appropriate. He defined his role as a patient advocate –
not as a lobbyist who is paid for advocating on behalf of a company.
Klein said he had “a particular responsibility to contribute my
background knowledge and experience.”
Klein said he hoped other former board
members would follow his example. He said,

“(I)t would be a tragedy if the
expertise of board members built up over six or more years is lost.”

(The full text of his response can be found here.)
Klein's appearance came at a propitious
time for financially strapped StemCells, Inc. The company's
financial information shows that it is losing $5.4 million a quarter
as of the end of June and had only $9 million in cash on hand. It
also had liabilities of $11.6 million, up substantially from $8.5
million in September of last year.
The researcher who criticized Klein's efforts as inappropriate also said,

"StemCells Inc has been on the
stock market for 20 years, without producing anything of value for
the investors.  The stock price has been sinking fast:  it
was 60 cents this June; last year at this time, it was around $5 a
share.   

“On July 17, when the CIRM Disease
Team Award review results became available, the stock rose from 87
cents to $1.80 – a person who could anticipate the outcome of the
CIRM applications could have made considerable money in that 24 hour
period.”

Weissman's role
with the StemCells, Inc., is more than scientific. According to the
company's financial statements, he holds 88,612 shares. His wife,
Ann Tsukamoto, is executive vice president of the firm. She holds
185,209 shares in the firm.
Weissman played a significant role in
the Prop. 71 campaign. He did the “billionaire circuit,” raising
money for the initiative, according to an article by Diana Kapp in
San Francisco magazine. Among other things, Weissman worked the
exclusive Bohemian Grove in Northern California and “pitched”
Bill Bowes, a co-founder of Amgen, who, along with his wife, gave
$1.3 million to the campaign. Weissman was the key to securing a
$400,000 contribution from Microsoft's Bill Gates. Weissman also plumped for Prop. 71 in a TV campaign ad.
In addition to StemCells, Inc., Klein
and Weissman supported a successful attempt last month to overturn
reviewers' rejection of another $20 million application by Judith Shizuru
of Stanford. The application received a score of 53 from reviewers.
One of the application's problems cited
by reviewers was the availability of antibodies for the study. The
antibodies were developed by Systemix, a company founded by Weissman.
Systemix was acquired by Novartis in 1997 for about $70 million.
Weissman said he has “negotiated back” rights to key antibodies,
which he said are now held by Stanford.
Klein said that reviewers believed the
research was “a showstopper” but did not think the documentation
was adequate. He told the CIRM directors that they now have a letter
with proprietary information that supports the grant application.
Our take: The stem cell agency has long
labored under the perception that it is something of an insiders'
club. Even the prestigious journal Nature warned in 2008 about what
it called “cronyism” at CIRM. If anything, the situation is worse today,  four years later. Enterprises associated with persons on the CIRM board of directors have received more than 90 percent of the funds handed out by the agency. Klein's efforts last month
reinforce the not-so-pleasant image of the stem cell agency as an
old boy's club and create an impression – at the very least – of
unseemly insider influence.

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

CIRM Board Member Prieto Defends Klein's Right to Appear Before Board

Posted on by


A member of the governing board of the
California stem cell agency, Francisco Prieto, has commented
in an email about the “unseemly performance” item concerning the
agency's former chairman, Robert Klein. Prieto is a
Sacramento physician who serves as a patient advocate member of the
board. He has been on the board since its inception. Here are his
remarks.

“I wanted to comment on this piece
from the perspective of another patient advocate.  While I think
you know that I did not always agree with Bob Klein during his tenure
on the ICOC(the agency's governing board), I would strongly defend
his right to appear and give his opinions to the Board.  He is a
private citizen now, albeit one with considerable experience and
expertise, and I think his greatest vested interest in this case
stems (you should pardon the expression) from being the child of a
parent with Alzheimers.  As you point out, some eyebrows may be
raised, and I can imagine that some board members might be swayed in
either direction by his testimony, but  he is a passionate and
committed advocate, and he has the right to advocate before us.”

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

Text of Klein's Comments Supporting Rejected Applications

Posted on by


Robert Klein, who served 6 ½ years as the first chairman
of the $3 billion California stem cell agency,  testified before the agency's board for the first time on July 26, 2012. Klein, a real
estate investment banker and attorney, spoke on behalf of two applicants whose
grants had been rejected by the agency's reviewers. The appearance
has raised questions about the propriety of Klein's actions.

Here is a link to an item on his appearance. Here is the text of
his comments as reported in the transcript of the meeting.

“As the board knows, I've never addressed any grant from the
floor. It is critical here to understand that we have here
StemCells, Inc., which is the only company in North America
and, for that matter, maybe in the world, that has had two stem cell
therapies in the brain with these specific neural stem cells. They
have a huge body of experience here. 

“Secondly, one of the fundamental issues here that it (the
company's grant application) was downgraded on was the issue of the
fundamental concept, the platform concept, of injecting two focal
injections in the brain, in the hippocampus of the brain. It's
important to note that I've sat on three (CIRM)peer reviews where the
scientists really affirmed this specific approach with extremely high
scores, three different views. All right.

“So it's very important to realize we have a standard deviation
here of 12 (on the review scores). These scientists were completely
split. With some recusals on that panel, if you have 12 or 13 that
can really vote, three or four very low scores can bring it out of
the funding category all the way down. It is in the region where
this board is looking where the other three peer reviews, right,
early translation, the one before that was the planning grant review,
that the hippocampus was a good platform.

“Then they said the key weakness was you can't show migration.
Dr. Laferla (a co-PI on the application) has told me that
today the Journal of Neuroscience accepted the publication of
the data demonstrating migration. It was stated previously in the
application, but it wasn't accepted for publication. It now is.
That is the fundamental weakness that they identified in this
approach.  

“So we have a reaffirmed approach to the hippocampus by three
different peer review groups and a substantial portion of these
reviewers along with data dealing with the weak point. I'm sorry it
happened today. The data was out there, accepted for publication
today, means that it should definitely fall into this category. And,
of course, Dr. (Alan) Trounson (president of CIRM) wouldn't
have been able to review that in process because he was recused from
this grant by his own voluntary recusal. So the progress of this
data being accepted for publication is new information today. 

“If I look at the entire history of CIRM, as Leeza (Gibbons,
a CIRM director) says, building up to this point, we have reaffirmed
this approach from the very beginning with Dr. Laferla, with multiple
scientific approvals, and board approval, and we have the best
company in North America with the greatest experience with these
neural stem cells, with the best researcher we have for the potential
to address this disease, and we have brand-new data that demonstrates
and totally contradicts the key weakness on which it was downgraded.”

Here is the text of Klein's remarks on
behalf of a second application, also rejected by CIRM reviewers.

“This is the only other disease team grant I will address. Very
specifically, this was a disease team grant that I was on the peer
review in the planning grant stage. There are some fundamental
issues here. Is the international company on which the one antibody
that's not coming from Stanford, the two for sorting are
coming from Stanford, is the other antibody coming from this
international company a commitment that you can rely on? 

“The reviewers said this was a showstopper. That's the word they
used. They made a decision this was a showstopper because they did
not believe the company because they thought that the documentation
was inadequate. You now have a letter that goes into great
proprietary depth about the depth of this company's commitments
written by the head of development and translation internationally
for the company. 

“If we cannot depend on company commitments of this type, and
you will review the letter in executive session, if you have one, I
will not understand how we'll be able to collaborate with companies
with proprietary products and processes where they're making
commitments to academic institutions of the highest standard. I
believe this company is going to perform. I was on an hour call to
confirm with eight members of that company their level of commitment,
and I am completely convinced by that point. 

“The review is completely factually wrong on this issue about
the other two antibodies for sorting this. Dr. (Irv) Weissman
has just said they have not only been developed, they have been used
in clinical trials. There's data on them. And they are, in fact,
being thawed under FDA direction to reuse in this trial. 

“So I believe there's a major factual difference. Remember with
Karen Aboody there was a major factual error that was pivotal
in elevating that, and we found tremendous performance on that grant
by Karen Aboody of City of Hope. 

“So you have a decision to make. As a risk issue, do we believe
this company? Finally, this is broader than SCID. 

“Donald Kohn has written a letter that's in the public
domain that I suggest you read. It makes it very clear that opening
the niche for repopulating the immune system without chemotherapy and
radiation is a key contribution to every form of genetically modified
stem cells for an entire range of childhood diseases and other
genetic diseases in addition to therapies like sickle cell or aids. 

“I suggest that that profound contribution that can be made to
the field is a risk that is worth taking early on because of his
contribution to so many other areas. You have 12 other letters from
North America's leading pediatric geneticists that fundamentally
provide extraordinary support for this position and this approach.”

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

Text of Klein's Response to Questions Concerning His Advocacy on Rejected Grant Applications

Posted on by


Here is the text of Robert Klein's response today to the California Stem Cell Report concerning his appearance before the governing board of the California stem cell agency July 26, 2012. Klein, former chairman of the agency, real estate investment banker and attorney, promoted two applications seeking $20 million each from the agency. Both applications had been rejected by the agency's reviewers. Here is a link to an item on the subject.

"Dear David,
"You have posed two
questions related to my continuing role as a Patient Advocate in
contributing information to the Board of the California Institute for
Regenerative Medicine, in an effort to optimize decisions on medical
and scientific grants and loans for research that could mitigate
and/or cure chronic diseases or injuries. 

"Q: Do you have any sort
of financial ties to StemCells Inc. or any of the individuals or
firms that would benefit from approval of those awards by the ICOC(the CIRM governing board)?
"A: I have no financial
interest in StemCells Inc. or any of the individuals or firms that
would benefit from approval of those awards by the ICOC. In fact, I
have no financial interest in any biomedical research company.

"Q: Do you think it is
appropriate for the former chairman of the ICOC to lobby that body on
behalf of awards to specific companies or individuals?
"A: First, it is
fundamental that the terms be defined to properly respond to your
question. A “Patient Advocate” is a member of a patient family or
a medical/scientific care /support group who advocates for medical
and scientific advances that might potentially mitigate and/or cure a
patient’s chronic disease or injury. A “Patient Advocate” is
not paid for his/her advocacy, unless they are staff members of a
non-profit institution dedicated to a specific disease or group of
diseases or injuries. 

"Second, a “lobbyist”
is a paid representative of a company or a for-profit institution(s)
with a financial interest in the outcome of a governmental decision. 

"I am serving as a
Patient Advocate in my presentations to the Board of the California
Institute for Regenerative Medicine. As the former Chairman of the
Board, I have a particular responsibility to contribute my background
knowledge and experience for the Board to consider, along with all
new information, in reaching their best decision. I hope other former
Board members, who possess a wealth of scientific, medical, and
institutional knowledge that can benefit the Board, would consider
the value they can contribute to future decisions. As Board terms
expire, it will be important not to lose that institutional knowledge
and medical/scientific expertise that has been built up over the last
seven plus years of the Agency’s existence. 

"In an outline format,
I would suggest the following areas where the knowledge of former
Board members can be especially valuable in optimizing the input for
Board decisions in the future. 

"A number of Board
members have participated in up to 20 or more Peer Review meetings,
some of which cover multiple days. Current grant or loan requests
represent the result of scientific and medical advancement that has
been intensely vetted in prior peer reviews; the information gained
in those peer reviews should not be lost, when a subsequent grant or
loan request – built on the earlier research outcomes – is
considered. Each peer review session has the benefit of different
specialists and scientists and/or biotech representatives with
unique backgrounds and areas of expertise. The value of the prior
contributions may be pivotal, in considering a later application,
developed from the earlier medical or research advances funded
through CIRM’s grants or loans. The current peer review,
scientific staff presentation, and Board expertise, is not the limit
of the Board’s information, in reaching the best current decision.
To the extent the Board can draw from prior peer reviews (unique
insights), prior scientific staff presentations, and prior Board
expertise, additional information that can enhance a potential
decision, the Board has the opportunity to optimize its decision
making process. This is particularly valuable, when there is a high
standard deviation – a substantial split – in the scoring
positions from the current peer review. 

"Beyond peer review
participation, Board members have intensely engaged in another 35
plus Working Group sessions on Facilities and Standards, in addition
to more than 70 Board meetings and over 125 Subcommittee meetings,
as of August 2012. Retiring Board members possess a treasury of
information on policy development, process, federal and state laws
and regulations, and the regulations of the agency, as well as in
depth information on research facilities and capabilities throughout
California, the nation, and the world. It takes a substantial length
of time for a new Board member to gain a comprehensive knowledge in
all of these areas and each Board member will develop unique
insights, which it would be a tragedy to lose. As Chairman, I
frequently reached back to consult with former Board members on
areas of their special expertise and I would hope that all current
and future Board members utilize the significant asset in developed
knowledge of the prior Board members. To the extent prior members
can be available for public meetings, this would be a substantial
benefit to the agency to broadly inform the Board, the scientific
staff, and the public. 

"The Board has a
unique contribution to make on programmatic resource allocations and
risk management of the research and clinical investments in each
disease area. The opportunities in some disease areas for major
advancement are numerous, whereas there are major diseases and/or
critical research areas where the potential, high-value advancement
options are relatively limited. For Board members who have
participated in over 20 peer reviews and 70 Board meetings, the
programmatic perspective on the opportunities in each disease area
has been highly developed. Concurrently, those Board members or
former Board members have substantial knowledge that is of critical
value in reaching programmatic decisions on the number of
opportunities for advancement in any specific disease area and the
relative risk that needs to be taken to accomplish meaningful
breakthroughs in advancing the research and clinical opportunities
in a disease and/or injury area. 

"I hope these examples
of how former Board members can contribute to the current Board’s
information in reaching decisions on the best medical/scientific
grants and loans are helpful. As I stated earlier, it would be a
tragedy if the expertise of Board members built up over six or more
years is lost. The field is extremely complicated and the Board needs
the opportunity to consider all of the information available. The
Board can choose to accept or reject any past advice or opinions
gained from prior peer review sessions or Board meetings, but the
Board should have access to the full spectrum of information and the
treasury of scientific and medical advice the agency has received
since its inception.

"There are areas that I
have not addresses in this short response, such as the institutional
value of applicants being able to rely upon prior scientific and/or
policy direction, in their current applications. From a historical
perspective, prior Board members and/or the Chairman can have
significant information that is relevant to these evaluations,
especially if the individual Board member served on a special Task
Force , Subcommittee or peer review. These more complicated areas of
individual contribution by former Board members I can address in a
future communication; but, this specific subject – alone – could
comprise several pages and I would like to obtain critical advice and
perspective from other former Board members and the scientific
community before discussing this area in greater detail.
"Bob Klein
"Chair Emeritus
"California Institute
for Regenerative Medicine"

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

$70 Million Research Proposal Up Next Week at California Stem Cell Agency

Posted on by


Directors of the $3 billion California
stem cell agency will hold a special, teleconference meeting next
Tuesday to deal with business that was put off last month, including
a new, $70 million research round.
The meeting is necessary because directors could not finish their business July 26 after they lost the supermajority quorum required to do business. They delayed action on a number of
matters, including the translational research proposal, which is
scheduled to be posted as an RFA next month.
The governing board also had discussed
dealing with changes in its intellectual property rules at next week's meeting, but that proposal is not on Tuesday's agenda. The next meeting of the board is Sept. 5 and 6 in San Francisco. The
agency has confirmed that it will be a two-day session.
At least one new appeal is expected to
come up in September in the $243 million disease team round that
consumed so much time in July.
Next week meeting involves a host of
locations throughout California. The public is entitled to
participate in the session from any of those sites. The specific
addresses can be found on the agenda.

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

CSCR Reading List: A Look at the Grant Appeal Process at the California Stem Cell Agency

Posted on by


Here is a list of articles from the California Stem Cell Report as well as CIRM documents dealing with the grant appeal process at the California stem cell agency. The list was prepared on Aug. 16, 2012. To read the entire articles, click on the links.

Articles from the California Stem Cell Report

Aug. 7, 2012
A tiny opening exists for scientists
who failed to win approval last month of their bids for $20 million
research awards from the California stem cell agency.
July 26, 2012
Directors of the California stem cell
agency today approved $151 million in research awards aimed at
commercializing stem cell research and pushing therapies into
clinical treatment....Five of the applications involving appeals were
sent back by the board for more review. (See here, here and here.)
They will be considered again in early September or October.
July 24, 2012
The California stem cell agency's
latest grant round – which is budgeted for $243 million – has
drawn an extraordinary and record outpouring of appeals from more
than half of the scientists rejected by the grant reviewers. Nine of
the 15 applicants who were turned down have filed appeals to the
governing board for its meeting
Thursday in Burlingame. No other CIRM grant round
has drawn as high a percentage of appeals, formally known as
extraordinary petitions. (See here
for a story on the previous record for percentage of
appeals.)
Aug. 10, 2010

Emotionalism and Potential Favoritism Cited as Need for Changes in CIRM Grant Appeals
Passion and favoritism, democracy and gamesmanship – all are part of the ongoing discussion among directors of the $3 billion California stem cell agency as they try to fix what some of them call a “broken” grant appeal process.

July 19, 2010
UC Davis Scientist Praises CIRM Appeals Change
A stem cell researcher at UC Davis today said a change in the CIRM grant appeals procedure makes “a lot of sense.” Writing on his blog in regard to "extraordinary petitions," Paul Knoepfler said, “I think the proposed change makes a lot of sense and would greatly improve the process. Sometimes the reasons in the petitions are clearly not meritorious and as it now stands, they end up wasting CIRM's time. The last time CIRM received 9 petitions as well, which represented a remarkably large fraction of the total applications. A stricter process would discourage the submission of large numbers of petitions, an important issue given that the number of petitions received by CIRM continues to grow.”

CIRM Finally Discloses Grant Appeal Proposals
The California stem cell agency early today belatedly posted a two-page memo on proposed changes in how it will deal with appeals by scientists whose grant applications have been rejected by reviewers.

July 18, 2010
Sticky, Troubling Appeals by Rejected Researchers Targeted by Stem Cell Agency
A key step in the process for awarding billions of dollars in research grants is “broken,” according to many directors of the California stem cell agency, and major changes are looming that will affect hundreds of scientists.

June 22, 2010
Immunology Grants: CIRM Gives $25 Million to 19 Researchers
Directors of the California stem cell agency today approved $25 million for immunology research, overturning four negative decisions by its grant reviewers. Directors faced a record nine public petitions to reverse its reviewers. After some grumbling, the directors, who see only a summary of the application and reviewer comments, okayed the four.

June 19, 2010
More Grant Appeals Filed: Yamanaka Invoked
The California stem cell agency has set another benchmark, although this is one that it may not want to trot out at international stem cell gatherings. Eight scientists whose applications were rejected for funding by the CIRM grants working group and scientific reviewers are seeking to overturn those decisions at the agency's board meeting in San Diego on Tuesday. It is the largest number of “extraordinary petitions” ever filed and amounts to more than one out of every four applications that were turned down. The total number of applications received was 44. Fifteen were approved. Some of the researchers are likely to appear at the board meeting and make a personal pitch.

May 18, 2010
Competing for California Stem Cell Cash: Rules of the Game Coming Under Scrutiny
Every California stem cell scientist and researcher looking to join the field – be they from academia or business – should pay very close attention to a meeting next week of a key group of directors of the $3 billion California stem cell agency. They plan to discuss possible changes in how scientists compete for stem cell cash, which is no small matter since CIRM has another $2 billion to hand out over the next several years.

CIRM documents

Pre-application review – CIRM report (Jan. 2010) on the process

Extraordinary petition policy – Version as of 5/25/10

Appeal policy – Version as of 5/25/2010

Transcript of July 20, 2010, meeting of CIRM directors Science Subcommittee. Discussion of petitions begins on page 40.

Transcript of the June 22, 2010, CIRM directors meeting. Discussions of extraordinary petitions begin on pages 24 and 67.

Transcript of 5/25/10 Science Subcommittee meeting dealing with appeals issue. Discussion begins on page 99.

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

International Stem Cell Corporation Announces Start of Marketing Collaboration with John Mauldin for Skin Care Products

Posted on by

OCEANSIDE, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB:ISCO),http://www.internationalstemcell.com, announced today that it had launched the first phase of its previously announced joint marketing campaign with John Mauldin, the founder and Chairman of Millennium Wave Investments, to market Lifeline Skin Care’s (LSC) new topical skin care products to more than one million of Mauldin’s subscribers. This launch follows ISCO’s earlier successful release to its own investor base and to the general public through its website,http://www.lifelineskincare.com.

“Having seen a strong demand from our investors and followers, we have been working diligently to increase both our marketing and production capabilities. John Mauldin’s participation will support the continuation of our rapid progress”

Mauldin, a best-selling writer, author of a monthly investment newsletter, and recognized marketing expert, provides LSC with the skills and a platform to enable LSC to continue expanding its sales while keeping marketing cost per customer lower than would be possible with a traditional media campaign.

Lifeline Skin Care’s exclusive patent pending skin rejuvenation serums contain extracts from ISCO’s proprietary “parthenogenetic” stem cells created from unfertilized eggs. The stem cell extract was discovered during ISCO’s therapeutic research that revealed the extract’s potential applications in skin cell rejuvenation. Independent third party testing indicates that both the day and the night serums now being offered have significant positive effects on the look and feel of the skin.

“Having seen a strong demand from our investors and followers, we have been working diligently to increase both our marketing and production capabilities. John Mauldin’s participation will support the continuation of our rapid progress,” says Dr. Ruslan Semechkin, CEO of Lifeline Skin Care.

John Mauldin adds, “I’m pleased to be involved with LSC and to help these truly revolutionary skin care products reach a broader audience. This new collaboration gives me the ability to offer these unique LSC products to my loyal client base.”

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and has developed and is now marketing a line of skin care products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website,http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments, product introduction plans and related support, the potential benefits of planned products, anticipated sales growth for recently introduced products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Key Words: Stem cells, parthenogenesis, biotechnology, skin care, anti-aging

International Stem Cell Corporation to Present Ethical and Technical Qualities of Human Parthenogenetic Stem Cells at the Center for Ethics in Science

Posted on by

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, will lead a free public discussion highlighting the ethical considerations and medical advantages surrounding the derivation of human stem cells from unfertilized human eggs using ISCO's patented technology known as parthenogenesis. The discussion, sponsored by The Center for Ethics in Science and Technology, will take place on Wednesday, January 5th from 5:30-7:00 pm at the Reuben H. Fleet Science Center Community Forum, 1875 El Prado, San Diego, CA. Jeffrey Janus, Senior VP, will be the featured speaker in a program moderated by Michael Kalichman, Ph.D., Director of the Research Ethics Program at UC San Diego and co-founder and director of the Center of Ethics in Science and Technology.

ISCO's patented method of parthenogenesis results in pluripotent human stem cell lines having the positive characteristics of embryonic stem cells without the damage or destruction of a viable human embryo.

In preparation for the discussion, Dr. Kalichman and Mr. Janus will be interviewed on Monday, January 3, on XETV channel 6 at 7:25 am, and on the radio show "These Days" broadcast on KPBS, 89.5 FM at 9:20 am.

Registration for the free event can be made at http://www.ethicscenter.net.

In addition to the ethical advantages of not requiring the destruction of a viable human embryo, parthenogenetic stem cells possess unique qualities allowing them to be immune matched to millions of persons, giving them the potential to be used in many future stem cell based therapeutic applications. ISCO has derived ten parthenogenetic stem cell lines in Russia using Western-style informed consent processes, and is now setting up processes in the United States. However, the ethical and regulatory requirements involved in obtaining unfertilized human eggs in the U.S. present challenges to ISCO and other researchers working in stem cell field. ISCO's hope is to conform to these complicated regulatory and ethical frameworks so clinical-grade human parthenogenetic stem cells may be derived in the U.S. and used to create a bank of parthenogenetic stem cells that may be used by millions of persons of different sexes and racial groups.

According to Dr. Kalichman, "Success in scientific development often depends on both public understanding of science and on understanding by scientists of public concerns. The participation of ISCO in the proposed public forums is praiseworthy as a way to meet both of these goals."

"In addition to the ethical considerations, human parthenogenetic stem cells offer a potentially superior solution to stem-cell based therapies because they allow immune-matching that may alleviate immune rejection problems that are likely to hamper other stem cell therapies. This is especially important when the patients have a genetically-based disease, and cannot use their own stem cells," says Jeffrey Janus. "ISCO is one of the few therapeutic research organizations pursing the utilization of these unique cells because of not only the ethical advantages, but also because of these important medical considerations."

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at ISCO's website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology
, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Jeffrey Janus, Senior Vice President
760-940-6383
jjanus@intlstemcell.com

Some breast cancer tumors may not originate from stem cells?

Posted on by

Surprise breast cancer source by Jennifer Welsh,TheScientist.com, September 2, 2010. First paragraph:

Some breast cancer tumors may not originate from stem cells as previously believed, according to a study published in the September 3rd issue of Cell Stem Cell. The discovery is an important step in the development of treatments for these cancers.

This news story is based on the publication: BRCA1 Basal-like Breast Cancers Originate from Luminal Epithelial Progenitors and Not from Basal Stem Cells by Gemma Molyneux and 11 co-authors, including Matthew J Smalley, Cell Stem Cell 2010(Sep 3); 7(3): 403-417. OA article [Full text] [PubMed citation].

A commentary: Cancer Cell of Origin: Spotlight on Luminal Progenitors by Christine L Chaffer and Robert A Weinberg, Cell Stem Cell 2010(Sep 3); 7(3): 271-272. [PubMed citation].

Stem Cell Blowback from Proposition 71

Posted on by


Proposition 71 last week once again
stood in the way of action by the $3 billion California stem cell
agency.

This time it was a bit of minutia
embedded in state law that prevented the agency's governing board
from going forward. The result is that the board will have to hold
another meeting in August to approve matters that need to be acted on
in a timely fashion.
The minutia involves the supermajority
quorum requirement for the board, the percentage of board members
needed to conduct business legally. Proposition 71, the 10,000-word
ballot initiative that created the agency in 2004, stipulates that 65
percent of the 29 members of the board be present for action.
Here is what happened: Late last
Thursday afternoon, CIRM directors were moving fast after a long day
of dealing with $151 million in research awards. But as they
attempted to act on proposed changes in the agency's important
intellectual property rules, one of the board members left the
meeting, presumably to catch a flight. The result was that the
meeting quickly ended after it was decided to deal with the IP
proposal and another matter during a telephonic meeting this month.
The quorum problem has plagued the CIRM
board since its inception, although the situation has eased since
J.T. Thomas, a Los Angeles bond financier, was elected chairman in
2011. A few years back, the board also changed its rules to allow a
limited number of board members to participate in meetings by
telephone, reducing the pressure on board members to physically
attend meetings.
The obvious solution would be to change
the quorum to 50 percent, a reasonable standard. However, the board
is legally barred from doing that. To make the change would require a super, supermajority vote, 70 percent of
each house of the state legislature and the signature of the
governor. That is another bit that is embedded in state law, courtesy of Proposition 71. To attempt to win a  70 percent legislative vote would involve a political process
that could be contentious and also involve some horse-trading that
the stem cell agency would not like to see.
Why does the 65-percent quorum
requirement exist? Normally, one would think such internal matters
are best left to the governing board itself. It is difficult to know
why former CIRM Chairman Bob Klein and his associates wrote that
requirement into law. But it does allow a minority to have effective
veto power over many actions by the governing board.
Of course, there is another way to look
at the problem: CIRM board members could change their flights and
stick around until all the business is done. But that would ignore
the reality that all of them are extremely busy people and have
schedules that are more than full.
All of this goes to one of the major policy issues in California -- ballot box budgeting and the use of initiatives that are inflexible and all but impossible to change, even when the state is in the midst of a financial crisis in which the poor, the elderly and school children are the victims. One California economist has called the situation "our special hell."

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


  1. Stem Cells