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Archive for the ‘Stem Cells’ Category

Cash and Favors: Robert Klein Gives $21,630 to the California Stem Cell Agency

Sunday, May 12th, 2013

A seemingly innocuous $21,630 gift to
the California stem cell agency has kicked up new questions about a
controversial $20 million research award and generated a wave of
special favors for the donor that stretched out to include a gold
mining multimillionaire from Canada.

Robert Klein
Elie Dolgin/Nature photo

The gift was made last May by Robert
Klein
, chairman of the stem cell agency from 2004 to July 2011, but has never
been publicly reported to the agency's governing board as required by
its own regulations. 

In July, two months after he donated the cash, Klein made an unusual appearance before his old board and  pitched it to override rejection by scientific grant
reviewers of a $20 million application by StemCells, Inc., of  Newark, Ca.  The board subsequently asked for a reevaluation of the proposal, which was again rejected by reviewers. Klein persisted at a September meeting, and the 29-member board decided, on a 7-5 vote,  to go along with him. It was the
first time in its eight-year history that the board has approved an
application that was rejected twice by its scientific reviewers, who scored the proposal at 61 out of 100. 
Klein's donation to the agency, formally known as the California Institute for Regenerative Medicine (CIRM), included more than the cash, which financed trips to a prestigious stem cell conference in Japan for six of the agency's science officers in June 2012. He also arranged the waiver of roughly $3000 to $4000 for their registration fees for the annual meeting of the International Society for Stem Cell Research. Nine agency executives and other staffers were already attending at taxpayer expense, but the six could not attend because of travel budget cuts at the $3 billion agency. (The total of 15 amounted nearly one-third of the agency's staff.)

Klein's donation triggered a number of
special favors from the agency, according to documents provided by CIRM to the California Stem Cell Report under a state Public Records Act request.  Klein wanted to meet with the six science officers, who have a wide range of responsibilities, including managing and developing grant and loan programs, participating in reviews of applications and evaluating research progress. CIRM President Alan Trounson obliged. At the meeting in Japan, the six science officers received a memo approved by Trounson instructing them to meet
privately “one-on-one” with their benefactor and to give him special access to their activities. The meetings were
actually scheduled to also include a third person, Rob McEwen,  who is one of the 100 richest persons in Canada, a $20 million donor to a stem
cell center in Toronto and CEO of the gold mining company bearing his name.

The memo indicated
that the science officers – all California state employees –
should be helpful by identifying areas of “special importance” to
Klein and “other donors.” The CIRM documents show no objection
from the agency to instructions from another member of the public --
Klein aide Melissa King -- to provide her and Klein with written
summaries about the science officers' activities at the convention
along with “details” about their work at CIRM. Email addresses of
the six were also provided to Klein, who may have additionally
received their cell phone numbers although that is not entirely
clear.

At Klein's request, Trounson also
invited McEwen to a closed-door session in Japan involving the
agency's international partners, a session at which presumably
valuable, little known scientific information might be mentioned and
future directions charted. Trounson specifically told McEwen in an
email that it was Klein who asked that the executive be invited to the
session.
Both the agency and Klein deny any
wrongdoing in connection with the donation, which was the only
private contribution to CIRM in the 2011-12 fiscal year. Both say
there was no connection between the donation last May 16 and the
StemCells, Inc., application, which was rejected by reviewers one
month earlier during closed-door meetings April 18-20, 2012.
CIRM's gift regulations bar donations
from persons who have applied for funding or who intend to apply for
funding, but the rules do not speak to gifts from persons who lobby
on behalf of funding for others. The rules require that the governing
board of the agency be informed at a public meeting of gifts accepted
by Trounson on behalf of CIRM. Trounson is required to identify the
donor and conditions imposed by acceptance of the gift. Trounson did
neither prior to Klein's appearance last July on behalf of StemCells,
Inc.
At the July meeting, Trounson
recused himself from public discussions of the StemCells, Inc.,
application, although he did not offer an explanation. However, his
action was connected to his relationship with stem cell scientist Irv Weissman of
Stanford University, who founded the publicly traded company, currently sits on its board
and holds 124,608 shares of the firm. Trounson was a guest once at
Weissman's ranch for four days in July 2011, CIRM said in response to
a question this week.
In the wake of the California Stem Cell Report's inquiries, Kevin McCormack, the agency's senior director
for public communications, said last week that the agency plans to
report the donation to the governing board at its meeting in
the San Francisco Bay Area later this month.
McCormack said the failure to report
the donation prior to the board's consideration of StemCells, Inc.'s,
application was “due to the lack of additional donations, a
transition in CIRM’s finance office and an oversight."(See thefull text of McCormack's statement here.) 
Asked whether
the agency is concerned about the appearance of Klein's donation and
the subsequent board action, McCormack replied,

“No, the two items are entirely
separate with no connection. Item 1  involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research.  The science officers had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend.  Item 2 is an ICOC (board) decision to fund
a research project that they felt had promise and was important for
the people of California.”

As for the special treatment of Klein
in the wake of his donation, the agency did not respond to inquiries
asking for an explanation.
Klein said in
an email that his donation was not connected to StemCells, Inc. He said that as late as June he had “no idea”
that the its application had been rejected by reviewers. Klein said that he committed to the donation
in “April or May.”  (The full text of Klein's comments re the application can be found here and here.)

Prior to leaving CIRM in 2011, Klein was a non-voting  member of the CIRM grant review committee, which consists of out-of-state scientists and seven CIRM board members. His service on the committee included the period when it approved a planning grant for StemCells, Inc., to prepare its application for the $20 million.

Klein noted that he did not pick the six science officers for the Japan trip. One of them was the lead science officer on the award round involving StemCells, Inc. A second was also heavily involved, according to  the transcript of the July 2012 board meeting. Science officers, however, do not vote on or score applications. Klein characterized the CIRM staff as recommending against approval of the grant so “they were clearly not influenced” by his donation.

Klein said his meetings with the six
science officers were aimed at determining whether they believed the
cost of attending the stem cell convention justified what they
learned at the meeting. He said a second goal was to aid universities
and other researchers, mainly in Canada, “in advancing their
contributions from an existing donor or donors.” Canada is one of
CIRM's research partners.

Klein defended the involvement of
McEwen, who Klein said has contributed to the stem cell group conducting the meeting. Klein said McEwen does not engage in technical
discussions and added,

“On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual.”

Private funding of activities by state
employees has stirred up controversy over the years in California.
The most recent example was Gov. Jerry Brown's much-reported trip to
China this spring, which was financed by private donations. Articles
in the Los Angeles Times and The Sacramento Bee both noted that
private funding arrangements have plenty of critics.
Columnist George Skelton of the Times
wrote,

 “It just looks unseemly — a pack of lobbyists and other
favor-seekers paying big bucks to traipse after the governor,
schmoozing and gaining invaluable access.”

Reporter David Siders carried a quote in The Bee
from Jock
O'Connell,
international trade adviser for the economics
consulting firm Beacon Economics, who said,

“They're donating because they want
to curry favor with the incumbent administration."

Asked whether CIRM planned to accept
donations for trips in the future, McCormack replied that the agency
is “always open to donations from generous supporters” provided
they meet the state's legal requirements.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FefPhO0IEiY/cash-and-favors-robert-klein-gives.html

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The Klein Donation: Text of Robert Klein’s Comments on Special Treatment by CIRM

Sunday, May 12th, 2013

Here is the text of comments from
Robert Klein, former chairman of the California stem cell agency,
concerning his $21,630 donation to the agency and subsequent actions
by the agency. Klein's comments May 1 came in response to questions
from the California Stem Cell Report(CSCR) on April 30. The text of
the inquiry from CSCR precedes Klein's response. Here is a link to the story on the matter.

CSCR to Klein:

"I have sent the following to CIRM
asking for their response and am offering the same opportunity to
you. Here is what I sent the agency:
'The documents that I have received so
far show that after Klein gave CIRM $21,000 the agency instructed six
of its science officers to give him special access to their
activities and apparently did not object to additional instructions
from another member of the public, Melissa King, to provide Klein and
her with written summaries about their activities at the ISSCR
convention and “details” about their work at CIRM. Email
addresses of the six were also provided to Klein, who may have
additionally received their cell phone numbers although that is not
entirely clear. The CIRM documents show that the six were told to
engage in one-on-one sessions with Klein, which actually included a
third person, a wealthy Canadian mining company executive. One
document indicates that the science officers should assist in
fundraising for CIRM by identifying areas of “special importance”
to Klein and 'other donors.'
"'Additionally, Alan Trounson, at
Klein's request, invited the mining executive to a closed door
session involving the agency's international partners, a session at
which presumably valuable, little known scientific information would
be discussed and future directions charted. Trounson specifically
told the executive that it was Klein who asked that executive be
invited to the session, adding to Klein's clout in any business or
other dealings that Klein might have with the executive.'

My questions to CIRM deal with the
special treatment that was provided in connection with your donation.
I would ask you if you think that state agencies should provide this
sort of extraordinary treatment for individuals who donate to the
agency. At the very least, doesn't this raise questions about the
integrity of the agency and doubts in the public mind about whether
it can be fair and even-handed in its activities?

Klein's response:

"In April or May of 2012 I committed
to contribute a charitable donation to CIRM to cover the travel costs
for 5-7 additional science officers to attend the International Stem
Cell Conference in Japan.  It is important to CIRM that their
science officers understand the cutting edge research being developed
around the world so that CIRM does not fund redundant research; but,
to the contrary, the science officers understand how to create
networks between California scientists and scientists in other
foreign countries who are doing complementary research that can
potentially accelerate the advancements of therapies for patients. I
do not hold any financial interest in biotech companies. I have
historically been involved in encouraging international collaboration
to advance medical therapies; for patients, every day of delay in the
development of a therapy is a delay they cannot afford. To
conceptually document the value of additional scientists traveling to
these meetings, it was discussed that there should be conceptual,
bullet point summaries about the value for CIRM obtained through the
scientists discussions at the international conference.  The
idea was to create bullet points of information about a few of the
most meaningful scientific concepts and contacts the science officers
benefitted from each day of attendance at the conference. I did not
participate in the selection of the science officers who attended and
I did not play any part in determining what activities they
participated in. There were two fundamental goals to the very short
one-on-one sessions that were arranged at "down time" that
would not conflict with their other activities. The first goal was to
conceptually understand if each of the science officers believed that
the benefit to the agency was sufficient to justify the cost of their
attending, when considering the learning and contacts they had gained
which might accelerate research and therapies for patients. The
second goal was to assist universities and non-profits, principally
in Canada - a research partner of CIRM - in advancing their
contributions from an existing donor or donors.

"The Canadian mining executive had an
important history in contributing to the International Stem Cell
Society and to Canadian non-profit research institutions. This
individual has an expert background in mining and a passionate
personal commitment to medical research; but, he does not engage in
technical discussions of research. On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual grants. The value of international
collaboration and the benefits of collaborating with new
international partners is discussed. Scientific theories and
individual grants are not discussed and new scientific information is
not presented. I attended this session of international partners to
support international collaboration; again, I do not hold any
financial interest in any biotech organizations. Additionally, I do
not have any business or financial relationship with the Canadian
mining executive. The Canadian executive, based upon family and
friends who have had chronic disease, is a significant donor to
non-profit research institutions in Canada. All of my activities, the
donation and the encouragement to develop information to validate the
future benefits of science officers traveling to international stem
cell conferences were focused on benefitting California patients with
chronic illness or injury and the agency formed through Proposition
71."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SBGFem2qPWo/the-klein-donation-text-of-robert.html

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hESC Research Totals $458 Million out of $1.8 Billion from California Stem Cell Agency

Sunday, May 5th, 2013

The California stem cell agency today
said that it has awarded $458 million to fund research involving
human embryonic stem cells (hESC) out of a total of $1.8 billion it
has given away during the past eight years.

The amount is of some interest because
the key reason that the agency now exists is the perceived
need in 2004 to fund hESC research in the wake of the Bush
Administration restrictions on federal funding in that area. The
restrictions created a national uproar in the scientific and patient
advocate community, which feared that promising therapies would never
be developed.
The $35 million ballot campaign to
create the agency focused hard on hESC research to the virtual
exclusion of any mention of adult stem cell research. Opposing the
effort were such forces as the anti-abortion movement and the
Catholic church. But this month LifeNews.com carried a mildly
approving item that pointed to the agency's turn towards adult stem
cell research.
When the Obama administration lifted
the Bush restrictions, some questions were raised about the need for
the California effort, which is costing state taxpayers $6 billion,
including interest. But those concerns received little public
attention and quickly died out.
Funding for the agency comes through
state bonds. Cash for new awards is scheduled to run out in 2017. The
agency is looking at developing a public-private effort for thefuture that would need a $50 to $200 million “public investment”
and major private funding.
Amy Adams, CIRM's communications
manager, provided the $458 million figure following publication of
this item yesterday on the California Stem Cell Report.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iQOiBLaIRNc/hesc-research-totals-458-million-out-of.html

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‘Praise’ for California Stem Cell Agency from Unlikely Corner

Sunday, May 5th, 2013

The California stem cell agency this
month received what some might consider a gesture of approval from a
longtime foe – LifeNews.com.

LifeNews is a site devoted to
anti-abortion efforts and information and is sharply opposed to research
involving human embryonic stem cells.
So it was with some surprise that we
read a tacit endorsement of recent CIRM activities in an April 22 piece written by Gene Tame out of Sacramento. It said the most recent
$32 million grant round from CIRM “demonstrates – again – where
the future of stem cell reserch lies.”
Tame wrote,

“CIRM has been steadily moving away
from its original mission to give preferential
treatment
 to funding for human embryonic stem cell research
(hESCR). Instead, after adopting a renewed
emphasis
 on translating research into clinical trials, CIRM
has more and more shifted the bulk of its grants towards funding
research utilizing adult stem cells and other alternatives to hESCR,
such as induced
pluripotent stem cells
 (iPSCs).”

Tame continued,

“(T)he lack, once again, of funding
for hESCR only serves to highlight how old and dated that approach to
finding treatments and cures increasingly seems.”

Tame is correct in his assertion that
the stem cell agency has moved a considerable distance from its
reason for being – research involving human embryonic stem cells.
In 2004, the ballot campaign to create the agency pitched voters hard
on hESC research and made no real mention of adult stem cells.
Instead, it focused on the threat from the Bush Administration with its
restrictions on hESC research, which have been lifted by the Obama
Administration.
.
In 2010, a study by a Georgia Tech
academic, Aaron Levine, reported that through 2009 only 18 percent of California's dollars went for grants that were "clearly" not eligible for federal funding under the Bush restrictions. 
At the date of the study, CIRM had not
publicly disclosed statistics on its funding of hESC research.
Today, however, its web site shows that only about 240 of the 595 awards that it has handed out are going for hESC research. CIRM has not made public the dollar value of
those 240 awards, but it has given away a total of $1.8 billion. (Following publication of this item, the agency told the California Stem Report that it has funded $458 million in hESC research.) 
A footnote: Levine was a member of the
blue-ribbon Institute of Medicine panel that recommended sweeping
changes at CIRM.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hxYse4K5TpU/praise-for-california-stem-cell-agency.html

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Stem Cell Agency Provides More Cost Detail on Future Plans

Sunday, April 28th, 2013

The California stem cell agency today clarified the size of the assumed "public investment" in its rough outline of its plan for future activities. 


In response to a query from the California Stem Cell Report, Don Gibbons, a spokesman for the agency, said,

"This hypothetical range of public investment ($50 million to $200 million) is thought of as a one-time investment, with hope of private investments in multiples of that with the fund recharging to some extent based on revenue."

Gibbons also said the agency did not want to indicate what it was prepared to pay for the study.  He said, 

 "We have not wanted to post the budget range because we want honest estimates of what folks think the budget should be rather than having them penciling estimates that max out the budget."


Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/rXqOoGO0Z0k/stem-cell-agency-provides-more-cost.html

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California Stem Cell Agency Seeks Lobbyist Bids

Sunday, April 28th, 2013

The California stem cell agency has put
out a bid for a private lobbyist to watch out for its interests in
Sacramento, perhaps severing a longtime relationship with one of the
Capitol's more prestigious power brokers.
The $3 billion agency has had
a contract since 2005 with Nielsen Merksamer Parrinello Gross &
Leoni LLP
of Sacramento, which reported lobbying revenue last
year of more than $5 million. That made it one of the top revenue producers among California lobbyists.
The agency's contract is tiny, however.
It started at $49,900 for five months in 2005 on a no-bid contract with Nielsen, although the annual figure is now $49,999.  The agency's request this month for bids calls for a boost to $65,000 annually.
Nielsen Merksamer is very active in
health care lobbying. Its biotech/pharmaceutical clients have included Genentech, Merck &
Co
. and Pfizer. The firm also played a role in the drafting of and
campaign for Proposition 71 in 2004. In 2009, at the behest of
Robert Klein, then chairman of the agency, it produced a legal memo
that Klein used to help box in the agency governing board on taking a
position on the Little Hoover Commission report recommending major
changes at the enterprise.
The stem cell agency is one of the few
agencies that hires a private lobbyist, which has raised some
eyebrows. Nearly all agencies handle legislative relations
internally.
Deadline for bids is May 3.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/0HfVYv0XVQg/california-stem-cell-agency-seeks.html

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Deadline This October: California Stem Cell Agency Seeking Detailed Public-Private Plan for its Future

Sunday, April 28th, 2013

The $3 billion California stem cell
agency, which is currently scheduled to go out of business in a few
years, hopes to come up with a detailed plan by this fall for a novel
public-private arrangement that would extend its life.

The rough outlines of the proposal
assume $50 to $200 million in “public investment,” although it is
not clear whether that would be a one-time figure or an annual amount
from presumably the state budget or perhaps another state bond
measure. The concept includes additional private funding of a
yet-to-be-determined nature. (The agency later said that the public investment figures would be a one-time event.)
The broad sketch of the agency's latest
thinking about how to regenerate itself was found in an RFP posted four days ago on its website.
CIRM is seeking a consultant who would
flesh out the general concepts that it has offered. Work would
begin in mid June and be completed in four months, close to the ninth
anniversary of the agency, formally known as the California
Institute for Regenerative Medicine.
The RFP did not contain a figure
for the cost of the study, but said that the price would be part of
the criteria for evaluating bids.
CIRM was created in November 2004 when
California voters approved Proposition 71, a ballot initiative. Since
then it has awarded $1.8 billion to 595 recipients. It is funded by
money borrowed by the state (bonds), but cash for new grants is
scheduled to run out in 2017. Interests costs on the bonds raise the
total cost of the agency to roughly $6 billion.
CIRM said in the RFP that the plan for
its future should provide

“...an in-depth analysis of various
public-private funding models with potential to attract private
sector investment to, and facilitate further development of the most
promising CIRM-supported research projects; and recommend a single
preferred approach for achieving this goal, complete with details
relating to the recommended structure and an operational plan.”

The RFP also contained a just-released,
$31,750 study by CBT Advisors of Cambridge, Mass, that examined
mechanisms for financing translational research, which is the key
focus nowadays at the stem cell agency. Such research is aimed at
pushing laboratory findings into the marketplace.
Among other things, the CBT report,
whose lead author was Steve Dickman, said,

“The nature of CIRM as a state agency
is perhaps the biggest weak point (and) has to be addressed politically
and cleared up as soon as possible or raising money will be
unnecessarily challenging.”

The CBT study did not address how that
might be done, which could be a considerable task. Proposition 71
modified the state constitution and state law and can be altered only
by a super, super majority vote of the legislature or by another
ballot initiative.
California is the first state to
provide billions for stem cell research by using borrowed money. It
also is unique in California state government in that its funding
flows directly to the agency and cannot be altered by the governor or
the legislature.
Translating all that into some sort of
public-private arrangement would be novel among state government
departments and could well require legislative or voter approval.
The California Stem Cell Report has
queried the agency concerning the frequency of the assumed “public
investment” and CIRM's budget for the RFP. We will report that
information when we receive it.  (The agency later declined to disclose what it was prepared to pay for the study.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bdJQjlhAoPM/deadline-this-october-california-stem.html

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California Stem Cell Agency Budget Up 4.6 Percent, Topping $17 Million

Sunday, April 21st, 2013

During the past couple of years, the California stem cell agency has vastly improved the way it
budgets the relatively tiny amount it spends on operational expenses.

At one point a few years back, its
operational budget was often all but incoherent to the public and to
at least some members of its governing board. (See here, here and
here.) But times have changed. The process for its operational
budget, which amounts to about $17 million for the 2013-14 fiscal
year, is now more transparent and better organized.
The long overdue improvements can be
credited to the hiring of Matt Plunkett in December 2011 as its first
chief financial officer in its eight-year history, as well as the
efforts of CIRM directors Michael Goldberg and Marcy Feit. Goldberg,
a venture capitalist, is chairman of the board's Finance Subcommittee
and Feit, CEO of Valley Healthcare in Pleasanton, Ca., is vice chair. Plunkett, however,
left the agency suddenly last summer and the agency has no plans to
replace him. CIRM Chairman J.T. Thomas says Plunkett put new
financial systems in place that can be operated without a CFO.
Interested readers can get a glimpse of
what is upcoming for CIRM spending beginning in July in documents prepared for the Monday meeting of the governing board's Finance
Subcommittee meeting. The agenda, however, lacks a much-needed
explanation and justification for the spending. All that is presented
now for the public are raw numbers and a PowerPoint presentation,
which is no substitute for a nuanced, written overview.
Nonetheless, here are the basics. The
budget proposed for 2013-14 stands at $17.4 million, up 4.6 percent, according to California Stem Cell Report calculations, or $771,000 from forecast expenditures for the current year. The
budget represents the cost of overseeing $1.8 billion in grants and
loans and preparing new proposals and reviews of applications for
hundreds of millions of dollars in additional awards.
The largest budget component is for
personnel – $12.1 million, up from $10.7 million. Second largest
is outside contracting at $2 million, down from $2.9 million for the
current year, continuing a trend away from outside contracts, which
once were burgeoning.
One interesting area includes “reviews,
meetings and workshops,”- which are expected to cost $1.8 million
this year. Next year, they are budgeted for $2 million. Some might
look askance at those sorts of expenditures for “meetings.”
However, that includes the fees and expenses for scientific reviewers
for multi-day meetings in the San Francisco area, which is a high
cost area, and other large gatherings. However, the figure does not
include travel for reviewers, who come from out of the state and even
from overseas.
Examples of the meeting costs include a
three-day grant review session last September at the Claremont Hotel
in Oakland that cost $44,019. A two-day meeting at the same hotel for
the 29-member CIRM governing board cost $34,424. (These figures and others involving outside contracts can be found on the agenda of the
board's Governance Subcommittee meeting April 10.)
The agency also dissected the budget
from different perspectives on expenditures. The spending plan
includes $2.0 million for the office of Chairman Thomas and $1.6
million for the office of President Alan Trounson. Comparable
figures for actual spending this fiscal year were not provided,
however, by CIRM for the Finance Subcommittee meeting. The size of
the chairman's budget reflects the controversial dual executive nature of management at CIRM, which has come under repeated
criticism, including from the recent blue-ribbon report by the
Institute of Medicine
.. However, the arrangement is locked into state
law as the result of the ballot measure, Proposition 71, that created
the stem cell agency in 2004.
Legal expenses are budgeted at $2.2
million with public relations and communications running slightly
more than $1 million. The scientific office, as one might expect,
consumes much larger amounts, with basic research, translational
research, grants review and grants administration budgeted at $4.7
million. The development side of the scientific office, which
focuses on pre–clinical and clinical research, is slated for $3.4
million. The agency did not offer comparable figures for the current
year.
Under Proposition 71, the agency can
legally spend only 6 percent of its $3 billion in bond funding for operational
expenses. At one time the agency had a 50-person staff cap, but that
was altered several years ago by the legislature. The most recent
figures show it has 54 employees. However, this month's budget
documents did not list the number of staff for this year or next.
The stem cell agency also reported that
it expects to spend an additional $1 million a year for rent
beginning in 2015, when a free rent deal provided through the city of
San Francisco expires. The city put together a $18 million package to
attract the CIRM headquarters in a bidding war with other California
cities. The agency has never produced a public accounting of whether
it has received full value on the package.
The proposed budget is likely to be
approved by the Finance panel next week without significant changes
and then by the full board late in May.
The public can participate in the
Finance meeting at two locations in San Francisco one each in Irvine,
Pleasanton, La Jolla and Berkeley. Specific locations can be found onthe agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4WgoKJd8w08/california-stem-cell-agency-budget-up.html

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Meager California Biotech Representation in Governor’s China Trip

Sunday, April 21st, 2013

California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

Some 90 persons were involved in the governor's delegation, but representation was meager from California's renown biotech sector and none at all from the $3 billion California stem cell agency, which has a collaboration underway with Chinese scientists. It may have been the only state agency with a formal collaboration agreement with China prior to Brown's visit.
According to many reports, the Chinese government regards growth of its biotech industry as one of its core economic efforts. Within that sector, biomedicine ranks as the most important and fastest growing, according to an Italian Trade Commission report. Stem cell research is especially important, according to this Canadian study. Indeed, some scientists in China are eyeing a Nobel Prize in the field (See here or here.)
California would seem to be well placed to take advantage of that situation, given its substantial biotech industry and community, which is only rivaled by Massachusetts. Add to that the existence of the unique California stem cell agency, which has funded a $1.5 million study by Holger Willenbring at UC San Francisco that also involves research by Lijian Hui at the Shanghai Institutes for Biological Sciences, which is separately funded by that country to the tune of nearly $1 million.
A look at the list of those traveling to China with the governor showed two representatives who could be considered from biotech: Joe Panetta, head of BioCom, a life science industry organization in Southern California, and Michel Baudry, dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences in Pomona, Ca..
We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

(Following the posting of this item, Ron Leuty of the San Francisco Business Times gave us a heads up on the latest on the site. He reported in March that Joinn Laboratories, a Chinese contract research organization, purchased the site. Leuty said that its plans are vague about future development, but that it may lease some of the space.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/x57uSahTPNI/meager-california-biotech.html

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StemCells, Inc., Nails Down Controversial, $19 Million Award from California Stem Cell Agency

Sunday, April 14th, 2013

The stock price of StemCells, Inc.,
price today jumped as much as 9 percent after the company disclosed
it had finally concluded an agreement with the California stem cell
agency for a $19.3 million forgivable loan for research twice rejected by the agency's scientific reviewers..

The stem cell agency governing board seven months ago approved the loan to the Newark, Ca., firm. But the
cash was withheld until the financially strapped company could
demonstrate that it could match the size of the loan, as promised in
its application.
The StemCells, Inc., (SCI) application
was nixed two times in 2012 by the agency's scientific reviewers who gave it a
score of 61. In a controversial move, the 29-member board approved the award in early September on a 7-5 vote after former agency
chairman Robert Klein intervened publicly on behalf of the firm. It was the first time that Klein had lobbied the board publicly on behalf of an application. It was also the first time that the board
approved an application that was rejected twice by its reviewers, a
panel of internationally recognized stem cell scientists.
In a press release, Martin McGlynn,
CEO of StemCells, Inc., said,

"With CIRM's support, we are now
able to lay the groundwork that could result in the world's first
neural stem cell trial in Alzheimer's patients."

Both the company and the $3 billion
state research agency were tight-lipped about the nature of the
matching funds from the company, which reported losses of $28.5
million in 2012 on revenues of $1.4 million.
In a brief response to questions from the
California Stem Cell Report, McGlynn said, 

 “At this time, we
do not intend to elaborate any further on the contents of our press
releases or public filings pertaining to the SVB (Silicon Valley Bank) or CIRM(the stem cell agency) loans.”

Earlier this week, the company reported receiving a $10 million loan from Silicon Valley Bank. Both McGlynn
and the stem cell agency did not answer a question about whether
those funds are being used to back the award from California
taxpayers.
The agency confirmed that the firm was
providing $19.3 million in matching resources. But Kevin McCormack,
senior director of public communications, did not provide any
specifics on the nature of the match. He only said,

“The matching  requires
them to demonstrate they have enough funds necessary to
fund SCI’s share going forward as well as their own
operations and other commitments.”

The award was originally for $20
million. We have queried the agency about the smaller figure
announced today.
The company's stock price rose as high as $1.87 earlier today after closing at $1.71 yesterday. It stood at
$1.77 at the time of this writing. Its 52 week high is $2.67, and its
52 week low is $0.59. The loan from Silicon Valley Bank gives the
bank warrants to purchase 293,531 shares of the company at $1.70 over
the next 10 years.
The 10-year loan from CIRM is low risk for the
company, which said its “obligation to repay the loan will be
contingent upon the success” of the research. If a product is
developed, it will take years before it could hit the market.
The award to StemCells, Inc., put
the stem cell agency in a touchy situation involving the company's decision last month to reject an additional $20 million award from
the agency.( It was the first time a recipient has rejected an award.) Neither the company nor the agency would give a reason for
the rejection of the loan for a spinal injury project . However, the
award also required a $20 million match, which undoubtedly tested the company's resources.
The spinal injury application was
scored at 79 by agency reviewers and was routinely approved by the
board. With its withdrawal by the company, the agency, which prides
itself on funding only the best science, was left supporting research
(StemCells, Inc.'s Alzheimer's project) judged significantly inferior
by reviewers with its score of 61.
In response to a question about that
situation, CIRM's McCormack said,

“Our goal is to always fund the best,
most promising science. This is not the first time that our board has
voted to fund a project that the Grants Review Group had not
recommended (this has happened in around 2% of cases) The board did
so for a number of reasons, not the least of which is that this was
the first disease team application that had a goal of  moving a
promising stem cell therapy for Alzheimer's towards clinical
trials.”

The round in question, however, had another application dealing with Alzheimer's which was scored at 63,
two points higher than the one from StemCells, Inc. Reviewers also did not recommend funding that application.
The action last September by the
agency board came only after it publicly said the funds would not be
distributed until the StemCells, Inc., could show it could provide
the match, still another first for the agency.
The award triggered a column in
the Los Angeles Times by Pulitzer Prize winning writer Michael
Hiltzik
, who said in October that  the
process was “redolent of cronyism.”
 He said a “charmed
relationship” existed among StemCells, Inc., its “powerful
friends” and the stem cell agency.
StemCells, Inc., was founded by
Stanford researcher Irv Weissman, who was a major fundraiser for
Proposition 71, which created the stem cell agency in 2004. Klein
headed the ballot campaign, which spent more than $30 million to win
voter approval. Weissman sits on board of directors of StemCells,
Inc., and holds 124,608 shares in the firm, including 8,630 he reported this month receiving.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/34J6wy7wpLY/stemcells-inc-nails-down-controversial.html

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Modest Approval from Long-time Stem Cell Agency Critic

Sunday, April 14th, 2013

Of all California's newspapers, The
Sacramento Bee
, the only daily paper in the state capital, has long
been the most critical – editorially – of the Golden State's $3
billion stem cell research agency.

Today, however, the newspaper gave a
modest nod of approval to the agency's modest efforts to clean up its
built-in conflicts of interest, which have been cited as a major flaw
by the prestigious Institute of Medicine.
The headline on the Bee's editorial today said,

“Stem cell agency finally addresses
potential for conflicts”

The piece said that Jonathan Thomas,
chairman of the agency, “has taken important steps in
reducing the potential for conflicts within this agency.”
The editorial continued,

 “He hasn't
gone as far as we would like, or that independent outside reviewers
have recommended....But he's achieved what's possible, at least for
now, and the board may empower him to go further.”

The Bee referred to action last month
in which the agency's governing board decided, among other things,
that 13 of the 15 board members linked to recipient institutions
could not vote on any grants, although they could participate in
discussion of applications. Twenty-nine persons sit on the board. In
a $700,000 report commissioned by the agency, the Institute of
Medicine recommended a fully independent board.
The Sacramento newspaper said, 

“We
think Thomas and the oversight board should go further and adopt the
Institute of Medicine recommendations. But that is politically
unlikely. As is now obvious, it will be up to the Legislature to
fully remove representatives of funding-eligible institutions from
being involved in decisions about grants that could come back to
them.

“Thomas, to his credit, recognizes
that his compromise may not be the perfect solution. He wants to test
out the new policy for a year, and see how it works. There's a lot
riding on the outcome. CIRM is expected to run out of funds in 2017,
and while philanthropy and foundation money could extend that for a
few years, supporters of California stem cell research clearly want
to go back to the ballot to seek additional funding. To make that
case, CIRM supporters can't afford any more scandals about insider
dealing. The next year will reveal whether it is on the right track.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/NowG2d8N5CM/modest-approval-from-long-time-stem.html

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StemCells, Inc., Rejects $20 Million from California Stem Cell Agency

Sunday, April 7th, 2013

When does a financially struggling
biotech company turn down a $20 million “forgivable loan?”

When it is StemCells, Inc., of Newark,
Ca., and the cash is being offered by the $3 billion California stem
cell agency. The research program has handed out nearly 600 awards, and it is the first time that a recipient has rejected funding.
That's the latest development in a stem
cell saga that began publicly last July and that involved unusual personal lobbying by the former chairman of the Golden State's stem cell research agency. The high point of the saga may have come in
September when the agency's governing board finished awarding
StemCells, Inc., $40 million in two different awards. But there was a
catch. StemCells Inc., had to match that figure with $40 million of
its own.
Late last month, StemCells, Inc., threw
in the towel on the $20 million awarded on its cervical spinal cord
injury application. In comments to analysts March 21, Rodney Young,
chief financial officer of the publicly traded company, said:

“The funding would have been in the
form of a forgivable loan, however, we have elected not to borrow
these funds from CIRM(the stem cell agency).”

According to the Seeking Alpha transcript of the conference call with analysts, Young said,

“You may also recall that last
September, CIRM approved a separate application under the same
disease team program for Alzheimer's disease, which was also for up
to $20 million in the form of a loan. We remain in confidential
negotiations with CIRM regarding the terms and conditions that would
attach to this loan.”

The company provided no explanation for
rejecting the cash, either in the conference call transcript or in
its press release.
During the conference call, StemCells,
Inc., reported continuing losses. For 2012, net losses totaled $28.5
million compared to $21.3 million in 2011. Revenue for 2012 was $1.4
million compared to $1.2 million in the previous year.
The awards last year to StemCells,
Inc., founded by Stanford's eminent researcher Irv Weissman, stirred
up a bit of a ruckus. The spinal injury award was handed out
routinely in July. Scientific reviewers gave it a score of 79 and
recommended funding. It was another matter on the Alzheimer's
application. It was scored at 61. Reviewers said it did not merit
funding. But the company publicly appealed to the full board, which sent the
application back for more examination. It was rejected again.
Nonetheless, in September, the 29-member board approved the award on
a 7-5 vote, bypassing a rival Alzheimer's application scored at 63.
It was the first time in the eight-year-history of the agency that
its board approved an application that was rejected twice by
reviewers.
Approval came only after strong
lobbying by Robert Klein, former chairman of the board. Klein was
also chairman of the ballot campaign that created the agency, and
Weissman, who holds stock in StemCells, Inc., and sits on its board,
was a major fundraiser for the campaign. 
The Los Angeles Times' Pulitzer
Prize-winning columnist, Michael Hiltzik, wrote in October that
 the process was “redolent of cronyism.” He said a
“charmed relationship” existed among StemCells, Inc., its
“powerful friends” and the stem cell agency.
As for the remaining $20 million award,
Martin McGlynn, CEO of StemCells, Inc., expects “quick” action on
finally securing the cash.
Here is an exchange that came during
the March conference call between McGlynn and analyst Kaey Nakae of
Ascendiant Capital Markets.

Nakae: “Okay. Just 2 more questions.
I guess the first one, as it relates to CIRM.
In deciding to decline the funding for spinal cord yet continuing to
pursue the funding for Alzheimer's, is there a difference in what
you're getting from them in terms of potential terms and conditions
that allow you to proceed on one and not the other, or is it the fact
that you're already in human with -- in spine, and still very
preclinical with Alzheimer's?”

McGlynn: :”I think you're very
definitely -- you're getting at some important criteria when one
considers how to fund programs whether you use debt or equity,
etcetera. So I wouldn't disagree with anything that you've outlined
or surmised. But I just would pray your indulgence until we're
finished, the negotiations with CIRM, which are coming to a close and
we expect those to resolve pretty quickly with regards to the
Alzheimer's program. And then quite frankly, we can be way more
forthcoming and way more disclosive with regards not only to our
decisions, but to our thinking.”

StemCells, Inc., was trading at about $1.65 at the time of this writing, down slightly from the previous
day. Its 52-week high is $2.67 and its 52-week low $0.59.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zYvykN1XE6k/stemcells-inc-rejects-20-million-from.html

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More about Funding for Personalized Medicine Research

Sunday, March 31st, 2013

A post entitled Funding for Personalized Medicine Research, dated January 31, 2012, provided information about the participation of the Cancer Stem Cell Consortium (CSCC) in the Large-Scale Applied Research Project Competition of Genome Canada, in collaboration with the first phase of the Personalized Medicine Signature Initiative of the Canadian Institutes of Health Research (CIHR).

On March 26, 2013, it was announced that 17 projects will be supported. A list of these project is available (PDF). One of the 17 projects is entitled "Innovative chemogenomic tools to improve outcome in acute myeloid leukemia". The Project leader is Guy Sauvageau of the Institute for Research in Immunology and Cancer (IRIC) at the Université de Montréal. The Project co-leader is Josée Hébert of the Centre de Recherche Hôpital Maisonneuve-Rosemont, Montréal. One of the aims of this project is to develop new models for tracking cancer stem cells that are left behind after a patient is treated.

Source:
http://cancerstemcellnews.blogspot.com/2013/03/more-about-funding-for-personalized.html

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California Stem Cell Directors to Finalize IOM Response Next Week

Sunday, March 17th, 2013

Directors of the California stem cell
agency will meet March 19 in Burlingame to complete action on
their response to blue-ribbon recommendations for sweeping changes at
the eight-year-old research enterprise.

CIRM Chairman J.T. Thomas last week
told the San Diego U-T editorial board that he regarded approval as
“largely ministerial.”
Thomas has been visiting newspaper
editorial boards around the state, touting his plan, which was
initially approved by the board in January. The main focus has been
on its provisions dealing with conflicts of interest, which would
have 13 of the 29 governing board members voluntarily remove themselves from
voting on any grant applications. The 13 are linked to recipient
institutions. Two other board members linked to recipient
institutions also sit on the board.
About 90 percent of the $1.8 billion
that has been awarded by the CIRM board has gone to institutions
linked to past and present members of the board.
In December, the Institute of Medicine cited major
problems with conflicts at the stem cell agency. It recommended
creation of a new, independent majority on the board, which would
mean that some members would lose their seats. The IOM report also
recommended a host of additional changes that have become eclipsed by
the controversy about conflicts, which were built into the board by
Proposition 71, the ballot measure that created it in 2004.
An analysis in January by the
California Stem Cell Report of the IOM report, which CIRM
commissioned at a cost of $700,000, showed that agency's response fell far short of what the IOM proposed to improve the agency's
performance.
Also on the agenda for the March 19 is
approval of applications in a $30 million effort by the agency
involving reprogrammed adult stem cells. The agency said the goal of
the initiative is “to generate and ensure the availability of high
quality disease-specific hiPSC resources for disease modeling, target
discovery and drug discovery and development for prevalent,
genetically complex diseases.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FH7dzoNWS8c/california-stem-cell-directors-to.html

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Cyberspace Makeover at California Stem Cell Agency

Sunday, March 17th, 2013

California's $3 billion stem cell
agency has performed a well-done makeover on its most important
public face – its web site, which is chock-a-block full of useful
information for researchers and the unwashed alike.

At cirm.ca.gov, one can find the very
words of its directors as they wrestle with everything from grant
approvals to conflicts of interest. Scientists can be seen telling
the story of their accomplishments. Money can be followed, and
summaries of reviews of grant applications read, both those approved
and those that did not pass muster.
The web site of the California
Institute of Regenerative Medicine
 (the formal name of the agency) is the place where the stem cell program
really meets the public. News stories are important, but infrequent.
Day to day, however, thousands of interested persons seek out
information that the folks at CIRM HQ, just a long throw from the San
Francisco Giants
ballpark, bring to cyberspace.
Each month, said Amy Adams, major domo
of the web site, 15,000 to 17,000 “unique viewers”
visit online. She told the California Stem Cell
Report
in an email,

“We're up about 25 percent year over
year in unique viewers to the site. A lot of that growth comes from
search, and the rest is from traffic driven through our blog and
Facebook.” 

The numbers are not huge compared to
those chalked up by major media sites. But they are significant
given that there are only a few thousand people worldwide who are
deeply and regularly interested in stem cell research. Many more,
however, are stimulated to look into the subject from time to time,
either because of news stories, personal, disease-related concerns or simple interest in cutting edge science. Engaging those
readers, who can spread the CIRM story, and winning their approval is
critical for the agency as it faces the need to raise more millions
as it money runs out in the next few years.
CIRM has mounted much information online over
its short life. So much that good tools are needed to navigate the
site. Decisions about what should go on the home page are critical.
With the makeover, the agency now has a long-needed, home-page link to its
meetings , especially those of its governing board, which are the
single most important events at the agency.
The redesign is crisp and clean. The
new, white background makes it easier to read and is comfortable for
readers long conditioned to the black-on-white print of the books,
newspapers and magazines. The video image on the home page is larger,
which helps attract viewers. The site has long had a carload of
videos, some of which contain powerful and emotional stories from
patients.
Adams used CIRM staffers to test the
new features. She reported,

“I've had people inside CIRM (who
have been beta testing this site) tell me that they are finding
content they'd never seen before because the site is so much easier
to navigate.”

Adams and the CIRM communications team
also have pulled together important information on each grant on a
single page, including progress reports. You can find a sample here on a $1 million grant to Stanford's Helen Blau.
Adams said,

 “Now people can not only
read about what our grantees are hoping to accomplish, they can read
about what has actually been accomplished with our funding.”

Adams said another new feature is
downloadable spread sheets of information that can be manipulated by
readers offline. She said,

“Most places on the site where you
see tables, you can now download those tables to Excel. You'll notice
the small Excel icon at the lower left of the table. This feature has
long been available for the searchable grants table. Now you'll see
it on all the tables of review reports (see here for
example http://www.cirm.ca.gov/application-reviews/10877)
on the disease fact sheets (see
here http://www.cirm.ca.gov/about-stem-cells/alzheimers-disease-fact-sheet)
and other places throughout the site. This is part of an effort to
make our funding records more publicly available.”

CIRM's search engine for its web site
still needs work. A search using the term “CIRM budget 2012-2013”
did not produce a budget document on the first two pages of the
search results. A search on the term “Proposition 71,” the ballot
initiative that created CIRM, did not provide a direct link to its
text on the first two pages of search results.
Also missing from the web site, as far
as I can tell, is a list of the persons who appointed the past and
present board members as well as the dates of the board members'
terms of office. The biographies on some of the 29 governing board
members come up short. In the case of Susan Bryant, her bio does not
mention that she is interim executive vice chancellor and provost at
UC Irvine. Links also could be added to board members statements of economic interest. A list of CIRM staff members (only slightly more than 50
persons) and their titles could be added.
As for CIRM's count of visitors, CIRM
uses Google Analytics tools. Adams said,

“A unique visitor is Google's
definition (it's one of the metrics they provide). It's a visit from
a unique IP (internet protocol) address. So, if you visit our site
multiple times from one IP address during a day, you count as a
single unique visitor. (Editor's note: It is possible to have
more than one visitor from the same IP address.)

“We get ~23,000-25,000 visits per
month, or ~16,000-18,000 unique visitors. Page views are on the order
of 65,000 a month.”

Our take: The redesign of the web site
is a worthy effort and enhances CIRM's relationships with all those
who come looking for information. The agency is to be commended and
should continue its work to improve the site and its connections with
the public.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1OuvEMC2aTs/cyberspace-makeover-at-california-stem.html

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San Diego Newspaper Hails Stem Cell Agency and IOM Response

Sunday, March 17th, 2013

The $3 billion California stem cell
agency hit it big in San Diego today, finally scoring an editorial
that said “arguably” the agency's largess has made the state “the
world leader in medical research.”

The San Diego U-T, the largest
circulation newspaper in the area, said the big headline about the
eight-year-old agency is “the potential for transformative medical
breakthroughs.”
The editorial noted that the agency has
long been criticized in connection with conflicts of interest. About
90 percent of the $1.8 billion the agency has awarded has gone to
institutions linked to current and past members of its board of
directors.
But the agency “is finally taking the
criticism seriously,” the newspaper said. It cited proposals that
would, if approved later this month, have 13 members of the agency's
governing board voluntarily abstain from voting on any grants that come before
the board. Twenty-nine persons sit on the board. The thirteen are
connected to recipient institutions. Two other board members are
linked to recipient institutions.
The stem cell business is no small
matter in San Diego, which is one of California's hotbeds of biotech
and stem cell research. The stem cell agency has awarded about $338
million to San Diego area institutions and businesses. Four
executives from San Diego area institutions sit on the CIRM board.
The newspaper's editorial said,

“There
remains a residue of cynicism about CIRM. Critics say the agency
board did the minimum necessary to avoid an intervention by the
Legislature – and also acted to buff the agency’s image should it
seek more bond funding from California voters before its present
funding runs out in 2017, as is now projected.

“These views
may have some merit. But on balance, we think the California
Institute for Regenerative Medicine
has – at long last –
responded properly to the fair criticism it faced. Instead of being
exasperated by CIRM, more people should be excited about the great
work it is doing.”

The editorial followed a meeting
involving the editorial board of the newspaper, CIRM Chairman
Jonathan Thomas and Larry Godlstein, director of the UC San Diego stem
cell program. The meeting was part of a CIRM campaign to generate
newspaper support for the agency's response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. The San Diego editorial is the most effusive so far.
The newspaper's biotech reporter,
Bradley Fikes, sat in on the meeting and Saturday posted video excerpts from the discussion, including a brief written summary of the content of each clip.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/WHLDfisWzQI/san-diego-newspaper-hails-stem-cell.html

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Public Banned from ‘Best Stem Cell Meeting in the World’

Sunday, March 10th, 2013

“The best stem cell meeting in the
world” is underway today in San Francisco – conducted at taxpayer
expense – but the public is barred from attending.

More than 500 persons are at the meeting at an undisclosed location, including some
representatives of biotech firms. And the meeting is even being
written about on the internet by a blogger. But the $3 billion
California stem cell agency says the public is not allowed in because
some of the information is “proprietary.”
CIRM President Alan Trounson addressed
the meeting earlier this week and declared it was “the best stem
cell meeting in the world,” according to UC Davis researcher Paul
Knoepfler
, who is reporting from the session on his blog.
The attendees consist almost entirely
of the recipients of taxpayer-funded grants given by the stem cell agency  although a number of
businesses have been brought in.. CIRM, which is paying for the gathering,  says of the annual sessions,

 “The purpose of meeting is to bring together investigators funded
by CIRM, to highlight their research, and encourage scientific
exchange and collaboration.”

Kevin McCormack, spokesman for the
agency, today said the public was barred from the meeting, which ends tomorrow, because “so
many presentations/talks (are) using proprietary information.”
That rationale is nothing new in the
world of science. But there is no chance of maintaining secrecy about anything that is
truly proprietary when hundreds of people have access to it in
this sort of forum. No penalties exist for disclosure, plus the whole
point of the session is to share information.
Yesterday we wrote briefly about the importance of transparency and openness in government, and make no mistake about
it, the stem cell agency is a government operation. We doubt that
anything egregious is underway at the session, but closing it to the
public is a reminder about where the agency's priorities lie.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uiwodYaNIP8/public-banned-from-best-stem-cell.html

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Good News, Bad News and the California Stem Cell Agency

Sunday, March 10th, 2013

A few weeks ago an anonymous reader
admonished the California Stem Cell Report to be more positive about
the $3 billion agency and its efforts to develop the cures that its
backers promised California voters more than eight years ago.

The comment was thoughtful and pointed
out that “almost all the time” the agency “has done the right
thing.” The reader made the remarks in the context of continuing
coverage of the Institute of Medicine (IOM) report that found there
were major flaws in CIRM's operations. (The reader's comment can be found here at the end of the post.)
Given the reader's remarks, it seems a
good time to review the operating principles and biases of the
California Stem Cell Report.
Bias No. 1: Openness and transparency
come first in any government operation. They are
fundamental to the integrity of all government enterprises. Bias No.
2: The California stem cell agency is generally doing a good job at
funding stem cell research. We generally favor all manner of stem cell research. 
Regarding our operating principles, the
goal is report news and information about the agency along with
analysis and explanation. One key to understanding what this blog
does is to understand what news is. News by definition is almost
always “bad” as opposed to “good.” News deals with the
exceptional. It is not news that millions of drivers commute to work
safely each day on California freeways. It is news when one is killed
in a traffic accident.
The California Stem Cell Report also
tries to fill information voids. We understand that the stem cell
agency believes certain information is not in their best interests to
disclose. Such is always the case with both private and public
organizations. However, it is generally in the public interest to see
more information rather less, particularly information that an
organization would rather not see become public.
Analysis and explanation of what the stem cell agency does is rare in the California media and even less seen
nationally or internationally. This blog focuses primarily on the
public policy aspects of the agency – not the science. The agency
is an unprecedented experiment that brings together big science, big
government, big academia, big business, religion, morality, ethics,
life and death in single enterprise – one that operates outside the
normal constraints of state agencies. No governor can cut CIRM's
budget. Nor can the legislature. Even tiny changes in Proposition 71,
which created CIRM, require either another vote of the people or the
super, super-majority vote of both houses of the legislature and the signature of the governor. All of
this is the result of the initiative process – a well-intended tool
that has been abused and that has also created enormous problems for the
state of California that go well beyond the stem cell agency.
Then there is the funding of the
agency, which basically lives off the state's credit card. All the
money that goes for grants is borrowed and roughly doubles the actual
expense to taxpayers.
Since January 2005, we have posted
3,452 items on the stem cell agency because we believe the California
Institute for Regenerative Medicine (CIRM)
is an important enterprise
– one that deserves more attention that it receives in the
mainstream media. Our readership includes persons at the NIH, the
National Academy of Sciences, most of the major stem cell research
centers in California, academic institutions in the Great Britain,
Canada, Norway, Germany, Russia, China, Australia, Singapore and
Korea – not to mention the agency itself and scientific journals.
We do not attempt to replicate what the
California stem cell agency itself does, which is to post online a
prodigious amount of positive stories and good news about the agency.
To do so would serve no useful public purpose and would simply be
repetitive. That said, there is room to acknowledge the work that the
agency does, particularly the staff, but also the board. We try to
point that out from time to time.
The California Stem Cell Report also
welcomes and encourages comments, anonymous and otherwise. Directors
and executives of the agency have a standing invitation to comment at
length and have their remarks published verbatim, something almost
never seen in the mainstream media.
Finally, given the questions raised by
the Institute of Medicine about disclosure of potential conflicts of
interests, the author of this blog and his immediate family have no
financial interests in any biotech or stem cell companies, other than
those that may be held by large mutual funds. We have no relatives
working in the field. We do have the potential personal conflicts,
cited generally by the IOM in connection with some CIRM board
members, involving relatives who have afflictions that could be
possibly be treated with stem cell therapies in the distant future.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GRJeamu0RXw/good-news-bad-news-and-california-stem.html

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LA Times: Stem Cell Agency Conflict-of-Interest Response Only a Bandage

Sunday, March 3rd, 2013

The Los Angeles Times yesterday modestly praised the $3 billion California stem cell agency for
taking some limited steps to deal with its longstanding conflict of
interest issues.

But the newspaper, which has the largest circulation in the state, said that was more was
needed if the agency plans to have a life after 2017, when funds for
new awards run out.
The Times editorial said,

“After years of resisting all
criticisms of its operations, the California Institute for
Regenerative Medicine
is finally listening — a little.“

The editorial continued,

“Yet the agency isn't exactly
embracing an ethical overhaul. It's doing just enough to address the
criticisms without triggering any oversight from the Legislature. The
modifications are more a bandage than a cure. Like a bandage, they
will probably do, but only for a limited time.”

The board plans to have 13 board
members with ties to recipient institutions voluntarily refrain from
voting on any grants that come before the board, not just the ones to
their institutions.
The Times said December's blue-ribbon
report from the Institute of Medicine identified the make-up of the
board as the “single biggest problem” at the agency. The
editorial cited figures prepared by the California Stem Cell Report
that show that about 90 percent of the $1.8 billion that the board
has awarded has gone to institutions linked to current or past
members of the board. Fifteen out of the 29 current board members
have ties to recipient institutions.
The editorial concluded,

“If the stem cell institute is just a
temporary agency that will last until its public funding runs out —
it plans to give its last grants with existing funds in 2017 — its
planned reforms will probably be enough. But if the institute wants
to be a permanent part of the research landscape — and possibly ask
for more public funding — voluntary recusals are an inadequate
patch. The agency's leaders should admit that the original setup was
flawed and seek a true fix. “

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4TPMCEI6hDg/la-times-stem-cell-agency-conflict-of.html

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CIRM Director Prieto on Disclosure of Reviewer Financial Interests

Sunday, March 3rd, 2013

A member of the governing board of the
$3 billion California stem cell agency is weighing in on an item on
the California Stem Cell Report that called for public disclosure of the financial interests of the scientific reviewers, who make 98
percent of the decisions on awards by the agency.

Francisco Prieto, a Sacramento
physician and a patient advocate member of the board, said in an email:

“ It seems to me there's a bit
of 'damned if we do and damned if we don't' here. If the ICOC (the
agency governing board) decides to listen to some of the members of
the public who come to our meetings and overrule a recommendation of
the Grants Working Group(GWG), we're slammed for letting emotion trump
science, or bowing to special interests. If we just accept the
rankings of the GWG and approve all their recommendations, we're
criticized for not being truly independent.  I think we don't do
it often (for good reason) but should and do retain the right to look
at other factors besides those our scientific reviewers do, and make
our own decisions about funding. We are ultimately responsible, not
the scientific reviewers. 

“As for the issue of their
disclosure of personal conflicts of interest, from what I've read of
the NIH processes, ours are no less strict. The NIH requires that
reviewers disclose any conflicts to their institutions which I
believe must disclose them to the NIH, but I have not seen anything
requiring them to disclose all their personal financial & other
interests publicly, as we (ICOC members) have to.  When we were
assembling our group of reviewers initially, the fear was that many
of the best scientists would turn us down if we required them to make
the kind of personal disclosures we have to. I don't know how many we
might actually lose if that were the case, but as you know we do
require them to disclose to CIRM, and they have to leave the room
when any application for which they have a conflict is discussed.”

Our take: Prieto is right about the
board being perched on the horns of a dilemma, which has a lot to do
with Proposition 71, which created the agency, and American
scientific traditions, which place an extraordinary value on the
“integrity” of the review process. In this case, integrity refers
to adherence to reviewers' scientific judgments.
Proposition 71 placed the legal
authority for grant approvals in the hands of the CIRM board, which
has overridden decisions by reviewers in only 2 percent of the cases
since 2005. However, that was enough, with at least one high profile
case coupled with public appeals, to cause the Institute of Medicine
to raise concerns about the integrity of the CIRM grant review
process. Traditionally, peer reviewers are deemed to be the most
capable of making the scientific decisions about grant applications,
rather than a board appointed by University of California chancellors
and elected state officials.
Yet, if the board concedes the
decisions to the grant reviewers, state law is likely to require
public disclosure of their financial interests, a move that the board
has opposed for years. Former CIRM Chairman Robert Klein repeatedly
advised the board during its public grant approval processes that
reviewers' actions were only ”recommendations” and that the board
was actually making the decisions. However, it has long been apparent
that the reviewers were making the de facto decisions. A CIRM memo in
January confirmed that, producing the 98 percent figure.
The issues involving disclosure by
reviewers, integrity of peer reviews, the language of Proposition 71
and state law are difficult and may, in some cases, be at odds.
However, it makes little difference
what the NIH is doing. It is a much different organization and has
had a history of conflict of interest problems that it has been
trying to work through.
The trend in the academic and
scientific research community has been towards more public disclosure
rather than less because of many well-documented instances of
problems. What is at stake is the public's faith in scientific
research and the integrity of public institutions.
Our thanks to Prieto for his comments
on this important subject.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/OlA8vhJTIsA/cirm-director-prieto-on-disclosure-of.html

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