Live Audiocast Available for Next Week's CIRM-IOM Meetings

The California stem cell agency will
provide a live audiocast of next week's critical discussions of
action on the sweeping recommendations proposed for the agency by the
Institute of Medicine.
Instructions for hooking into the
telephonic arrangement can be found on the agendas for Wednesday and
Thursday. Also expected to be posted soon on the Wednesday agenda are
recommendations by CIRM Chairman J.T. Thomas.
The audiocast will only provide the
opportunity to listen and no opportunity to provide testimony. If you
are interesting in making suggestions or comments ahead of the
meeting, email them to info@cirm.ca.gov. The public can also testify at the board meeting.
The meeting is scheduled for the
Claremont Hotel in the Berkeley hills across the bay from CIRM's San
Francisco headquarters.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XiZzHp3Zp_s/live-audiocast-available-for-next-weeks.html

Patient Advocate Says IOM Recommendations Would 'Destroy' California Stem Cell Agency

California's “beloved,” $3 billion
stem cell research program should not be altered despite
recommendations from the most prestigious scientific organization of
its kind. So says longtime patient advocate Don Reed of Fremont, Ca.

Reed says the recommendations by the
Institute of Medicine (IOM) are a “threat” that would “destroy” an
agency that “is like nothing else on earth.” Reed is urging other
patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does
business.
Reed and CIRM's Amy Adams
World Stem Cell Summit photo
Reed is a fixture in stem cell circles
nationally and in California and has been a regular at the stem cell
agency's public meetings since 2004. He is also vice president of
Americans for Cures, a private stem cell lobbying group created by
Robert Klein when he was chairman of the stem cell agency,  formally known as the California Institute for Regenerative
Medicine(CIRM)
.
Reed has written twice about the IOM
report on his blog with duplicate publication on the Huffington Post.
Yesterday, he said IOM “defies” the voters' will when they
created the stem cell agency in 2004. On Dec. 19, he said the
$700,000, 17-month study was “staggeringly misguided.” He wrote,

“If its recommendations were enacted,
they would silence stem cell patient advocate involvement, eliminate
public debate on funding proposals, and delegate the real decisions
to secret proceedings by an out-of-state-controlled board.”

Reed described the stem cell agency as
“fantastic” and wrote,

“So why mess with it, in such a
brutal and insulting manner?”

This writer has known Reed since the
early days of the stem cell agency and respects him. But in this
case he has many of his facts wrong. To mention just a few key
points: Patient advocates would not be silenced; their role would be
changed. Public comment would not be eliminated. Scientists could
still appeal negative decisions by reviewers to the full board if
they so choose, although the “extraordinary petition” process
would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.
While Bob Klein has not been heard from
publicly on the IOM report, some of Reed's comments reflect Klein's
past positions against altering the agency. Klein, an attorney and
real estate investment banker, might well be considered the father of
the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the
qualifications for the chairman, which fit only one person in
California. It was no surprise when he won the post.
In years past, Klein has been extraordinarily protective of the ballot measure, at one point boxing
in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.
In 2010, he was the prime
advocate for commissioning the IOM report which he expected
to serve as the basis for continued funding of the agency. It will
run out of cash for new grants in 2017.
To keep the money rolling in, Klein
said the IOM report would constitute a “gold standard” that would
generate increased enthusiasm for the research.
According to the transcript of the Aug.18, 2010, governing board meeting, Klein declared,

“(We will) never convince the people
that are adamant against us. But for the public and for the
constituent groups that are reasoned and prepared to look at
evidence, this is a very important validation that they can look to
to separate out what is a false claim from real performance.”

Also writing yesterday about the IOM
study was Bradley Fikes of the San Diego U-T, the dominant daily
newspaper in that area.
He summarized Reed's latest item as well as this on the California Stem Cell Report yesterday. Fikes
plans to file his own story within the next few days.
Feel free to file your own comments by
clicking on the word “comment” below or with the stem cell agency
at info@cirm.ca.gov. Anonymous
comments are permitted on this blog.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/wX7BEi46lc8/patient-advocate-says-iom.html

Nature Biotechnology: California Stem Cell Agency Receives 'Stinging Rebuke'

The headline this week in Nature
Biotechnology
read: “IOM smacks down California Institute of
Regenerative Medicine.”
The story by Senior Editor Laura
DeFrancesco
said that the $3 billion California stem cell agency
“received a stinging rebuke of much of the way it has been carrying
out its business by a group of independent reviewers.”
At the same time, DeFranesco wrote that
the blue-ribbon, Institute of Medicine panel “praised the courage
and vision of the individuals who spearheaded the program as well as
those toiling in the CIRM office in San Francisco.”
The Nature Biotechnology piece covered
familiar ground for many readers, summarizing the IOM's sweepingrecommendations last month, including those dealing with the built-in
conflicts of interest on the agency's 29-member governing board.
DeFrancesco wrote that is unclear
whether the agency will move to adopt any of the recommendations from
the panel, many of which have been rejected in the past.
Some members of the CIRM governing
board last month bristled at some of the recommendations. The board is scheduled to discuss the IOM report, for
which it paid $700,000, at a public meeting Jan. 23 in Berkeley.
Patient advocates are already organizing a turn-out to lobby against
some recommendations.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bJIhSwMvwx8/nature-biotechnology-california-stem.html

California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations

Two days next week at the posh
Claremont Hotel in the Berkeley hills could settle the fate of
California's $3 billion stem cell agency.

At 9 a.m. next Wednesday, the governing
board of the state research effort will begin a critical, two-day
public session. On the table will be the $700,000, blue-ribbon
report from the prestigious Institute of Medicine (IOM). The study
recommends sweeping changes in the structure and operations of the
California Institute of Regenerative Medicine (CIRM), as the stem
cell agency is formally known.
The IOM report alone poses major
challenges for the agency. But the recommendations are freighted with
even more significance. Below the surface lies the hard fact of
CIRM's dwindling resources and possible demise. In less than four
years – without either renewed public support or private
contributions – the research effort will begin a shriveling,
downward spiral.
Claremont Hotel

The IOM report places a special burden
on the agency governing board. The board paid the IOM to evaluate its
performance. In 2010, then CIRM Chairman Robert Klein trumpeted the
value of an IOM study, saying it would serve as a springboard for a
new, multibillion-dollar state bond measure for the agency(see here and here). Given the
state's difficult financial condition – not to mention the position
of potential private sector investors – winning approval of that
kind of investment will be more than difficult. 

California's major newspapers already have editorially backed the IOM proposals. Indeed, if the
directors choose to ignore the major IOM recommendations, they will
hand opponents a devastating weapon, one that could be used to convince voters to reject
any proposal for continued funding. The board
would also give private investors more major reasons to say no to
CIRM pitches for cash.
Under Klein's leadership, the 29-member
board has rejected similar proposals for changes in the past. When
the IOM presented the study to the board just last month, the
reception was not much different. Several board members bristled. One
influential board member, Sherry Lansing, chair of the University of
California
board of regents, said the directors' “hands are tied”
because some of the recommendations might require a vote of the people. Her comments echoed similar statements from Klein in 2009,
when he said board members would violate their oath of office if they
supported recommendations for changes that he opposed.
The IOM discussion in December,
however, was relatively brief and less than definitive. Klein has
been off the board since June 2011, replaced by Los Angeles bond
financier Jonathan Thomas, who is regarded as a welcome change by a
number of board members.
Nonetheless, the recommendations of the IOM could mean that some members of the board would lose their seats; others would lose important roles in the grant-award process or
within the agency itself. Conflict of interest rules would be
tightened. In some ways, the board would lose power, which would be
shifted to the president. The board would no longer vote on
individual applications – only a slate recommended by reviewers.
Applicants for CIRM awards would be directly affected, being barred
from making the sort of direct and public appeals that clogged the
CIRM board meetings last year. And that would be just the beginning.
Thomas, the CIRM chairman, is expected
to make his recommendations for action on the report, although they
have not yet been posted on the CIRM web site. Under what might be considered “normal” leadership, Thomas would be testing sentiment
among board members via personal conversations and phone calls.
However, in California that would be illegal – a violation of open
meeting laws that bar what are called “serial meetings” at nearly
all public agencies.
Thomas' task is not easy. Rounding up a
majority vote for anything significant among 29 strong-minded
individuals is not simple. But it is even more difficult when facing
a board that has a tradition of consensus management and
oversight.
The site of next week's meetings is
interesting. The nearly 100-year-old, iconic Claremont hotel has a
troubled financial history. It was up for sale for $80 million last
spring but there were no takers. In the early 20th century, the
property on which it is located was lost and won in a checkers game
in Oakland, or so the story goes.
The stakes are also high for the
California stem cell agency. Moves next week by directors could
easily determine whether CIRM becomes nothing more than an
interesting scientific footnote or establishes a path that will lead
it to long-lasting leadership in regenerative medicine.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SS09uwQmVDQ/california-stem-cell-face-off-cirm.html

BioTime Buys Geron's Stem Cell Assets, Including hESC Clinical Trial

Geron Corp., which pioneered the first
clinical trial of an hESC therapy, today sold its stem cell
business to another San Francisco Bay Area firm whose two top
executives were once CEOs at Geron.

Michael West
BioTime photo
The total value of the complex deal was
not clear from the public statements released by Geron and the
acquiring firm, BioTime, Inc., of Alameda, but an unidentified
outside investor is adding $10 million to transaction.
In a telephone interview this evening,
Michael West, CEO of BioTime, said that as a result of the deal his
firm will hold 600 patents and patent applications involving stem
cells. He said the aggregation should help in attracting financial
interest in the firm and its efforts.
West founded Geron in 1990. BioTime
Acquistion Corp
., the BioTime subsidiary that is picking up the Geron
assets, is headed by Tom Okarma, who was Geron's CEO from 1999 to
2011.
After Okarma left the firm in 2011,
Geron abruptly jettisoned its stem cell business along with the
clinical trial. Geron has been looking since then for a buyer for the
assets.
Tom Okarma
Geron photo
Only a few months prior to the Geron
decision in 2011, the California stem cell agency had signed a $25
million loan agreement with Geron to support the clinical trial. The
company paid back with interest the amount of the loan that it had
received.
Information from the two companies did
not specify whether BioTime will begin seeking additional
participants in the clinical trial. Nor did BioTime indicate whether
it would seek additional funding from the state stem cell agency.
However, West said during the telephone
interview that he has an “open mind” about working with CIRM.
Last year, agency officials indicated an interest in continuing to
support the clinical trial. West said BioTime had already hired some
employees that were laid off by Geron, including its patent attorney.
He said that he hoped to reassemble at least part of Geron's now
scattered stem cell team.
According to the Geron press release,
when the deal is officially concluded in September, “it is
anticipated that Geron stockholders would own approximately 21% of
BAC, BioTime would own approximately 72%, and a private investor
would own approximately 7% after an additional $5 million investment
in BAC.”
For its new operations, BioTime has
leased space in Menlo Park that Geron once used for its stem cell
business.
Both firms are publicy traded.
BioTime's stock price closed at $3.45 today and had a 52-week high of
$6.35 and a low of $2.67. Geron closed at $1.60 and had a 52-week
high of $2.99 and a low of 91 cents.

Here is a link to an article in the San
Francisco Business Times
about the deal. Here are links to the
BioTime press release, a BioTime FAQ and the Geron press release.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/TBbR-z7OPWc/biotime-buys-gerons-stem-cell-assets.html

BioTime Stock Jumps 22 Percent in Two Days in Wake of Geron Deal

The stock price of Biotime, Inc., of
Alameda, Ca., shot up more than 12 percent today following the
announcement of a complex deal that will give it the stem cell assets
of Geron Corp., the first firm to launch a clinical trial for an hESC
therapy.

Geron stock price Jan. 2-8
Google chart
BioTime stock closed at $3.88, up
43 cents or 12.46 percent. That followed a 9.6 percent gain
yesterday. Geron's stock closed at $1.63, up three cents or 1.9
percent.
News coverage of the deal was light
with our tracking showing only one story so far today on The Scientist magazine web site.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/mQRu0qUrqwM/biotime-stock-jumps-22-percent-in-two.html

Roman Reed is Stem Cell Person of 2012; Leigh Turner Runner-up

Roman Reed, a Fremont, Ca., patient advocate, this week was named Stem
Cell Person of 2012
by the Knoepfler Stem Cell Lab at UC Davis, which
cited Reed for energizing a new generation of
advocacy.

Roman Reed (left) and Paul Knoepfler
Knoepfler Lab photo
UC Davis stem cell scientist Paul
Knoepfler
awarded Reed $1,000 from his personal funds. The ceremonial
check appears to be close to four-feet long in a photo taken in
Knoepfler's lab.
Knoepfler wrote on his blog that Reed
made a “tremendous difference” in 2012. The researcher said,

“One of the most notable was
catalyzing the TJ Atchison Spinal Cord Injury Research Act in
Alabama, which provides $400,000/year in funding for research. Of
course, TJ and many others who helped make this possible also deserve
great credit and have my admiration, but Roman provided key
leadership. Here in California, Roman’s Law supported its 11th
year of grants all eligible for all forms of stem cell research.
Roman informs me that it funded $749,00 overall and approximately
$200,000 in stem cell funding. 

“In addition, Roman in 2012 mentored
and energized a whole new generation of advocacy from young,
energetic leaders: TJ Atchison, Katie Sharify, Richard Lajara
and Tory Minus.”

Knoepfler personally made the decision on the award,
but also conducted an advisory poll that Reed won. Knoepfler wrote,

Leigh Turner
U of Minn photo

“Only 6% behind Roman was the amazing
activist Ted Harada followed by Roman’s dad the remarkable Don
Reed
, the wonderful Judy Roberson, and the super Katie Sharify nearly
all tied for third. Next after them was the relative new kid in stem
cell town, Leigh Turner.”

Knoepfler named Turner, an associate
professor at the Center for Bioethics at the University of Minnesota,
as the official runner-up in the contest, No. 2 behind Reed.
Knoepfler wrote,

“Leigh took the courageous,
outside-the-box step in 2012 of contacting the FDA to investigate
Celltex when he perceived patients could be at risk. As “thanks”
for his action, he was put under enormous pressure and there was talk
of possible litigation against him. Pressure was applied to his
employer, the University of Minnesota. We’ll never know for sure,
but from everything that I know I believe that Leigh’s actions
directly led to prompt FDA action, which otherwise might not have
happened at all or until much later. In my opinion, Leigh’s act of
courage, helped make hundreds of patients safer in a direct way and
indirectly may have set a higher standard for the field of stem cell
treatments.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QfG7CijBsy4/roman-reed-is-stem-cell-person-of-2012.html

San Diego Newspaper Calls for Major Changes at California Stem Cell Agency

The San Diego U-T today ran an
editorial that was headlined “Stem cell research institute must fix itself.”

The editorial was written in response
to findings by the Institute of Medicine that the $3 billion
California stem cell should make sweeping changes to deal with issues
ranging from conflicts of interest to management structure.
The San Diego U-T editorial came as part of
a unanimous reaction so far from California newspapers.
The San Diego paper said,

“We hope we
are wrong in thinking that, given the number of times the same
criticisms of CIRM have come up over the past seven years, the agency
doesn’t really take them seriously.

“If that is
the agency’s attitude, it could well be a fatal error. CIRM has
enough money remaining from the original $3 billion to continue
awarding research grants for another four years. But it will either
have to go back to California voters in 2014 or 2016 for another bond
issue to continue its operations or find a different source of
funding.

“Whichever
CIRM decides, whoever is asked to foot the bill, either taxpayers or
the private sector will demand transparency and accountability. We
hope CIRM can demonstrate it.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/aZWF_3ieMCY/san-diego-newspaper-calls-for-major.html

Reverse Engineering Grandpa

Stem cells are rarely the subject of
cartoons, but one popped last week from Bizarro.

The cartoon appeared in the San
Francisco Chronicle
 and elsewhere, including the
Bizarro web site
. The image was of a petri dish in a lab with
tiny maternal speck giving parental advice to an even tinier speck:
"You can be anything you want to be when you grow up."
Artist Dan Piraro said the cartoon was his favorite of the
week because of its “strangeness.”
Piraro wrote on his blog,

“To use a term common in the
vernacular of geneticists, it’s creepy cool.”

The cartoon did not differentiate
between embryonic and adult cells, much less reprogrammed adult
cells. Using reprogrammed cells in the cartoon would have been even
creepier and cooler, giving new meaning to the 1947 song, “I Am My
Own Grandpa.”
(See here and here.)

(A nod to "Bob" for calling our attention to the cartoon.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/gXXLRtG2Sx4/reverse-engineering-grandpa.html

Exploring the Straw Man Argument Against IOM Reforms at California Stem Cell Agency

Constitutional objections to some of
the Institute of Medicine's sweeping recommendations for changes at
the $3 billion California stem cell agency amount to little more than
a straw man, at least based on a legal memo produced earlier by the
agency.

The legal objections to structural reforms at the
agency were initially advanced in 2009 when the stem cell agency was
fighting an unwelcome analysis of its activities by the state's good
government agency, the Little Hoover Commission. The objections were
voiced again at a meeting earlier this month by some governing board
members, particularly Sherry Lansing, who is also chairwoman of the
University of California regents. Her comments came within minutes of
the start of the Institute of Medicine's (IOM) presentation to the
board.
She said directors' hands “are tied”
because of requirements in Proposition 71, the ballot initiative that
created the stem cell agency, which is formally known as the
California Institute for Regenerative Medicine(CIRM). While Lansing
did not elaborate, some of the initiative is written into the state
constitution, which can only be amended by a vote of the people.
However, Proposition 71 can also be amended by a 70 percent vote of
each house of the Legislature and the signature of the governor,
which is no small task to achieve.
The 2009 legal memo (see the full text
below) dealt with the recommendations of the Little Hoover
Commission, some of which were cited and echoed by the IOM. The legal
memo contended that the legislature was barred from making major
changes in the structure of the stem cell agency governing board
because the changes supposedly would not “enhance the ability of
the (agency) to further the purposes of the grant and loan programs.”
The argument was that only the people could make “non-enhancing”
changes. The vague “enhancement” requirement was written into
Proposition 71 by its authors, one of whom is James Harrison, the
outside counsel to the board, who was also the lead author on the
2009 memo. Harrison is revisiting the supposed constitutional issues in the wake of the IOM study.
However, the objections cited in his earlier memo are dubious and easily overcome. The meaning of “enhance” is
so vague as to permit wide interpretations. Certainly, removing
public suspicion about conflicts of interest would seem to help move
the agency forward. Straightening out the muddled management
structure of the agency, with its overlapping responsibilities for
the chairman and president, would certainly seem to enhance the
functioning of the agency. Assuring that the governing board has the
full ability to exercise strong oversight over the conduct of the
agency would certainly seem to be an enhancement and long overdue.
At least that is what the most
prestigious body of its sort says. The Institute of Medicine studied
the agency for 17 months under a $700,000 contract with CIRM. The
IOM's charge was to evaluate the performance of the agency and make
recommendations for improvements. The IOM recommendations echoed
findings not only of the Little Hoover Commission, but some in two
earlier studies also funded by the agency.
For CIRM directors now to reject the
IOM findings and turn away would be to indicate that their earlier
admiration and respect for the IOM was something of a sham or, more
likely, now inconvenient.
As for removing ambiguity about what
does or does not enhance the agency's mission, the 29-member board
could simply adopt a resolution declaring that all the IOM
recommendations would enhance the CIRM mission.
One of major obstacles to acting on the
earlier recommendations for changes was Robert Klein, the first
chairman of the agency board. Klein, an attorney and real estate investment
banker, also directed the writing of Proposition 71 and wrote
portions of it himself. He would often make numerical code citations
to the initiative during agency board meetings.
Klein is now gone from the board,
leaving in 2011 at the end of his term. He was replaced by Jonathan
Thomas
, a Los Angeles bond financier, who has ushered in a new and
different era at the stem cell agency. Some might say a more
reasonable era. He says he and governing board
take the IOM study seriously. 
The report is scheduled for discussion
Jan. 23 at a public workshop at the Claremont Hotel in Berkeley, Ca.,
the day before the regular board meeting. .
The IOM's recommendations have won theeditorial endorsement of all the California newspapers that have so
far written about them. The newspapers believe that the proposals
would indeed enhance the agency's mission and are, in fact, necessary
if the agency is to survive beyond 2017, when the money for new
grants runs out.
Directors of the stem cell agency are
currently mulling the future of their efforts. If they are to be
successful in raising additional hundreds of millions of dollars –
be they private or public – the directors must confront the
findings of the IOM in a forthright manner. And they must move to
dispel the cloud that now hangs over the stem cell agency.
(Editor's note: The full text of the
2009 legal memo can be found below. Also below is another related
legal memo from Americans for Cures, a stem cell lobbying group
sponsored by Robert Klein at the same time he was chairman of the
stem cell agency. Despite the language on the Americans for Cures
memo, it is a public record. It became a public document when Klein
submitted it to the Little Hoover Commission.) 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8TDUJVXl3rw/exploring-straw-man-argument-against.html

Boxing in the California Stem Cell Board

Robert Klein is much admired for his
prodigious efforts on behalf of stem cell research, including his
service as the first chairman of the $3 billion California stem cell
agency.

Klein was adept at many tasks, such as
directing the ballot campaign that resulted in passage of Proposition
71
in 2004 and creation of of the agency. One of Klein's less
publicly recognized skills was putting the governing board of the
agency in a box from time to time.
The 29 members of that board could well
be headed for another box – this time in connection with their
position on the Institute of Medicine's sweeping recommendations for major changes at the stem cell agency.
Here is how that could work based on a
similar situation in 2009 involving Klein and the Little Hoover
Commission
, the state's good government agency.
Klein did not welcome the inquiry by
the commission, which was requested by state lawmakers who had butted
heads with Klein. He knew that the commission would come up with
recommendations that he would find odious.
So even before the Hoover report was
released in its final form, Klein had the board's outside counsel,
James Harrison, prepare a legal memo on a draft version of the study.
Harrison's memo said many of the most far-reaching recommendations of
the commission would require a vote of the people – a more costly
and unlikely proposition than a vote of the legislature.
Harrison's memo was dated June 23,
2009. The commission report was released June 26, 2009. On June 30, 2009, Klein warned directors in an email that support of some of the
proposals would violate their oath of office. The first time a
subcommittee of directors had to a chance to react publicly came on
July 16, 2009. The full board did not have the Hoover report on its
agenda until Aug. 6, 2009. By that time, they were thoroughly boxed
in.
Their choices were minimal, even if
they disagreed with Klein. To do anything other than go along with
him would mean rejection of a 10-page legal opinion from Harrison,
which could be interpreted as no-confidence vote on Harrison and
possibly Klein. Board members were not interested in losing
Harrison, who has been valuable asset to the board since day one.
Overthrowing Klein was even less likely in 2009.
Harrison is currently revisiting his
2009 memo in the wake of the Institute of Medicine recommendations,
which echo some of the major Hoover proposals. The board has also
scheduled a workshop for Jan. 23 that will discuss the IOM proposals.
If Harrison produces another legal memo
that is as explicit as the 2009 document, CIRM directors will have
few choices.  The best procedure may well be for Harrison
to continue his work on the memo until after the Jan. 23 meeting.
Directors could then decide on initial steps in connection with the
IOM recommendations and ask Harrison how they can proceed legally, although the task is really more of a political challenge than a legal
one.
Directors paid $700,000 for the IOM's evaluation and advice. It is a prestigious body with virtually no critics in the scientific community. It would be odd, to say the least, for CIRM directors to now reject major recommendations from the blue-ribbon panel only because the proposals might require a statewide vote. The response is likely to be from some: Well, stem cell directors, let's have a statewide vote, and we expect you to support the IOM changes if you plan to seek additional state funding. 
Placing another stem cell measure on the ballot -- with or without related additional funding for the agency -- would bring into play a host of issues, including possible elimination of the agency. Not to mention disturbing existing stakeholder relationships and raising uncertainty in the scientific and biotech business communities. 
Directors believe the agency has made a major contribution both to California and to science. So does the IOM. The directors need to move forward on the IOM recommendations if they are to continue their research efforts beyond 2017, when cash for new grants runs out.  And putting the board in a box is not the best way to give them the room they need to maneuver. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Dh4v5HREt6Y/boxing-in-california-stem-cell-board.html

Southern California Newspaper Tackles Stem Cell Agency and UC Irvine Grants

The Orange County Register today zeroed
in on the $3 billion California stem cell agency and its relationship
to the local University of California campus in the wake of sweeping
recommendations for changes at the eight-year-old agency.

The article by Melody Petersen was
headlined “Ties to stem cell board lucrative.”
Petersen began her article with story of the $20 million award to StemCells, Inc., earlier this year and
the firm's partnership with Frank LaFerla of UC Irvine, which is located in Orange County.
The award was rejected twice by
reviewers at the stem cell agency but the governing board of the
agency (CIRM) approved it on a 7-5 vote in September following
lobbying on behalf of the company by the board's former chairman,
Robert Klein, and others.
Petersen said the award was not the first time that questions have been raised about stem cell agency grants. She said that the 17-month study by the prestigious Institute of
Medicine (IOM)
and some of its findings, particularly those dealing
with conflicts of interest, echoed criticisms that have been raised for years.
She wrote,

“Repeated independent reviews of the
agency, including one by the (IOM) released this month, have found
that its board is rife with conflicts of interest. In fact, of the
$1.7 billion that the agency has awarded so far, about 90 percent has
gone to research institutions with ties to people sitting on the
board, according to an analysis by David Jensen at the California
Stem Cell Report
, which closely follows the agency's operations.

While the agency has yet to produce a
cure, Petersen said,

“What's clear already is that the
money has transformed stem cell research in California and poured
hundreds of millions of dollars into the state's universities,
including UC Irvine.”

She noted that the CIRM governing board
is dominated by members from the UC system, including two professors
at UC Irvine.
Peterson continued,

“Before Proposition 71 (the measure
that created the agency) passed, UC Irvine had less than ten stem
cell scientists, who received about $1.5 million in funding each
year. Now, after receiving $100 million in grants from the state
agency, the university has sixty scientists working to advance stem
cell research and teaching. It touts itself as one of the top stem
cell research centers in the world. In 2010, it opened an $80 million
four-story stem cell research center with the agency picking up $27
million of the cost.

“As UC Irvine has won increasing
amounts of taxpayer money, its two professors who sit on the agency's
board have risen in status on campus.

Susan Bryant
UC Irvine photo

“Professor Susan Bryant, an expert in
regenerative medicine, was dean of the School of Biological Sciences
when she was named to the agency's board in 2004. She was then
promoted to vice-chancellor of research. In July, she was named the
university's interim executive vice-chancellor and provost, its
second most powerful administrator.

“When Professor Oswald Steward, a
stem cell scientist, joined the agency's board in 2004, he was
director of UCI's Reeve-Irvine Research Center for Spinal Injury.
Since then, the scientists working in his center have received
millions of dollars in grants from the agency. In May, the university
rewarded Steward with an additional title: senior associate dean of
research for the School of Medicine.”

“The two professors are prohibited
from receiving any agency funds for their own scientific work. But so
much money has been funneled into the stem cell field in California
that it can be difficult to show their continued scientific efforts
are not somehow benefiting. For example, Bryant co-authored a
scientific article in 2009 with nine other scientists about the
genetics of salamanders, which can regenerate limbs. In the report,
the group recognized the state agency for partially funding their
work. Bryant said that the money was received by another scientist in
the group who was not employed by UC Irvine. She said the state
agency has never given a grant for research involving salamanders. 'I
have never-ever benefited from CIRM funding,' Bryant said using the
agency's acronym.

Os Steward
UC Irvine photo

“Steward said he stopped his stem
cell research when he joined the board in 2004. His board position,
he said, 'has prevented me from taking on lines of research I
otherwise would do.'

Tom Vasich, a campus spokesperson,
said Bryant and Stewart's positions on the agency's board played no
part in their promotions and success at the school.”

Petersen additionally reported that
Steward and Bryant are not allowed to vote on grants to UC Irvine.
Petersen pointed out that the
University of California has 16 members on the 29-member board. One
of those is the chairwoman of the UC Regents, Sherry Lansing.
Petersen also noted that three of the UC officials, including
Steward, hold seats on the board as patient advocates.

Petersen is a recent addition to the
Register's staff, joining it in November as an investigative
reporter. She worked as a business reporter for the New York Times and authored  "Our Daily Meds," a book about the pharmaceutical industry. She shared in the top award in newspaper financial journalism when she was at the San Jose Mercury News.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/41IPNEUfHpo/southern-california-newspaper-tackles.html

California Editorial Unamity: Stem Cell Agency Needs Revamp

With the addition of another editorial
this week, reaction among California newspapers so far has been
unanimous that the $3 billion California stem cell agency should heed
the sweeping recommendations of the prestigious Institute of
Medicine.

The Riverside Press-Enterprise added its voice yesterday, declaring,

“Good intentions do not justify poor
practice.”

Like others, the newspaper said that
the agency “needs to revamp its governance structure to avoid
potential conflicts of interest and boost public confidence in the
agency.”
The Riverside paper focused on the conflicts of interest at the organization, which has seen about
90 percent of its funding go to institutions with ties to directors, but also supported other recommendations, including elimination of the dual executive arrangement at the research effort. 
The editorial said,

“An agency spending Californians’
money has no business being cavalier about good government practice
and ethical safeguards — no matter how promising the potential
therapies might be. The stem-cell institute is not a private fiefdom,
but a taxpayer-supported undertaking. Yet many on the stem-cell
institute’s board objected this month to the report’s
recommendations.

“The agency also said that Prop. 71’s
provisions mean that enacting many of the proposed fixes would
require either a supermajority vote of the Legislature or another
ballot measure. That prospect should warn Californians about the
dangers of voting for complex, costly, politically driven initiatives
that have little to do with fundamental state duties.

“Still, the stem-cell agency cannot
just sit on these recommendations without damaging its credibility.
The search for medical breakthroughs does not justify ignoring vital
safeguards for spending taxpayer dollars.”

For a look at other editorials, see here and here.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/70xi8-waM7k/california-editorial-unamity-stem-cell.html

Balloting Begins on Stem Cell Person of the Year

The nominations are in. Voting has
begun, with about 1,000 ballots cast so far. But only one vote truly
counts. That belongs to Paul Knoepfler, who is running the The Stem
Cell Person of the Year
contest and will pony up $1,000 of his
hard-earned cash to honor the winner.
On Monday, Knoepfler announced 16 finalists out of 30 nominees. They range from scientists to patients
to advocates. Voting began instantly and will continue until Dec. 31
at 11:59 p.m. Votes will count for something, but Knoepfler makes it clear that they are only advisory. He makes the decision.
This is Knoepfler's first year at the
contest. The UC Davis stem cell researcher, patient advocate and
blogger wants to recognize someone who made a difference and took
some risks in doing so.
You can find the entire list of
candidates on Knoepfler's blog, but we wanted to note that they have
a father and son competing against each other – Don Reed and his
son, Roman. (Could be tense around the holiday tables in the
Reeds' households.) Also on the list is Jeanne Loring of Scripps,
whose nominator said engages the wider community with great
effectiveness. I once heard Loring say that every stem cell
researcher should have a spiel that could be delivered in five
minutes in a taxi and that would not only explain stem cell research,
but persuade the cab driver of its virtues.
All of the nominees have much to
recommend them. Knoepfler will be chewing his fingernails before this
is all over.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/_Zshc3lQops/balloting-begins-on-stem-cell-person-of.html

Meager Coverage of Yesterday's Bristling IOM-CIRM Meeting

Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem
cell agency and representatives of the prestigious Institute of
Medicine(IOM).

Only two pieces appeared, one in the
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes
of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
One of the recommendations of the IOM
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
Fikes wrote,

"'I'm a
colon cancer survivor,' said Art Torres, vice chairman of the
oversight committee, and a patient advocate designate. 'Does having
colon cancer make me biased?'
Jeff
Sheehy
, another patient advocate designate, protested what he called
a 'defenestration' of patient advocates, whose interests often span
multiple diseases.”

Ron Leuty of the San Francisco Business
Times
skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
Fikes also had a piece on ViaCyte,
which is in his area, receiving another $3 million from CIRM.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sTuRbsA7d_w/meager-coverage-of-yesterdays-bristling.html

Two More Editorials: The California Stem Cell Agency Should Heed IOM Recommendations for Reform

Two other major California newspapers
today said the $3 billion California stem cell agency needs to “clean
up its act” if it wants to be successful in continuing its efforts
at turning stem cells into cures.

The editorials appeared in the Los Angeles
Times
, the state's largest circulation newspaper at more than
700,000, and the San Jose Mercury News in California's Silicon Valley.
The Mercury News has a reported circulation of nearly 600,000,
although that figure includes other Bay Area newspaper owned by the
same chain.
Both editorials focused on the 17-month evaluation of the agency by the prestigious Institute of Medicine (IOM) as did earlier editorials in The Sacramento Bee and the San Francisco Chronicle. The IOM recommended sweeping reforms at the agency that would alter its structure and target conflicts of interest. 

“The $700,000 spent on the
study...will be wasted if the institute's oversight board fails to
heed the (IOM) committee's
criticisms,
 which echo the findings of the Little Hoover
Commission
and other groups over the years.”

The editorial continued,

“The 29-member board is made up
almost entirely of representatives of advocacy groups and research
institutions that have a direct interest in how the money is spent.”

The Times cited the California Stem
Cell Report'
s calculations that about 90 percent of the $1.7 billion awarded by CIRM has gone to institutions linked to current and former members of its governing board. 
The Times noted an award to a Northern California firm that has stirred some criticism. The editorial said,

“The board also overrode the advice
of its scientific advisors — twice on a single application when it
considered a grant for a well-connected company, StemCells Inc. based
in Newark, Calif. The board granted the company $20 million after Robert Klein, the driving force behind the passage of Proposition 71,
which created and funded the agency in 2004, and its former head,
lobbied so intensively for the company that one board member
described it as 'arm-twisting.'"

The Times concluded,

“The agency has used more than half
of its funding and one day will almost certainly want to ask
taxpayers for more. It should remember that voters will look for
evidence of public accountability as well as respected research.”

The San Jose paper sounded a similar
note about the agency. Its editorial said,

“(I)f it wants to survive...it
should heed the Institute of Medicine's advice to eliminate conflicts
of interest on its board -- and do it before awarding the remaining
$1.2 billion of the $3 billion voters approved for stem cell
research.”

But the paper said the stem cell agency
should not be provided any more state funding.

“Long-term funding was never the
intent when Proposition 71 passed in 2004. It was supposed to
kick-start research at a time when federal funding was blocked and to
establish California as a major player in the rapidly advancing
medical field. 

“The agency could continue to bring
value to the state as an advocate and funder of research, but only if
it can attract private donors, partners and investors. For that to
happen, it will need a board that passes the ethics test, with more
independent experts and industry executives free of conflicts. 

“At the outset, stem cell advocates
took immense pride in structuring the agency to keep it relatively
free of legislative interference despite the use of public money.
Politicians kept their hands off, which was good. But the agency
created its own inappropriate influences in the way it constituted
its board. Now it needs to clean up its act.“

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hjDmQPb6wDs/two-more-editorials-california-stem.html

LA Times: On the California Stem Cell Agency and Wasting $700,000

The headline on the Los Angeles
Times
 web site this afternoon read,

"Is California's stem cell program
preparing to waste $700,000?"

The question was raised by Pulitzer
Prize-winning columnist Michael Hiltzikwhowas commenting on the presentation today by the
prestigious Institute of Medicine's (IOM) on its sweeping
recommendations for changes at the state stem cell agency. 
Hiltzik wrote, 

"If you're betting that
the California
stem cell agency will spurn key recommendations of a
blue-ribbon review panel that criticized its leadership and
management structures, you might want to double that bet. Several
board members showed overt hostility to the panel's recommendations
during a public meeting today."

Harold Shapiro, chairman of the IOM
panel and former president of Princeton University, delivered
the briefing. The group's study took 17 months and cost the stem cell
agency $700,000.
Hiltzik's piece summarized the IOM
proposals, which echoed many criticisms that have been aired for
years in California.  Hiltzik wrote, 

"CIRM Chairman Jonathan
Thomas
 glided over those issues when he introduced Shapiro.
Thomas observed that the Institute of Medicine report included many
statements "validating CIRM, its process, what it was able to
achieve," which is a bit like launching the investigation of a
plane crash by focusing on all the planes that land safely every day.
Thomas did mention that the Institute of Medicine had made numerous
recommendation about how to "take something which is already a
great experience and improve it even further." 

"Shapiro got only a few minutes
into his presentation before board members started interrupting him
with objections to the Institute of Medicine's recommendation for a
majority of independent members."

Hiltzik concluded, 

"Thomas promised to stage a public
workshop on the Institute of Medicine report soon and to subject them
to 'lengthy discussion.' 

"Does that sound as if the board
will be taking seriously the advice that it change the way it does
business? Stay tuned, but don't hold your breath."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/9CY8_m5Reqo/la-times-on-california-stem-cell-agency.html

Appeals at the California Stem Cell Agency: Worthwhile or Worthless?

Jon Shestack, a patient advocate member
of the governing board of the California stem cell agency, weighed in
today on the virtues of the grant application appeal process at the
$3 billion research enterprise.

His remarks came in a “comment”
filed on the Duchenne item that appeared yesterday on this site. (His
full comment can be found at the end of that item.)
Shestack said that the handling of the
$6 million CIRM grant involving Duchenne research is “a casebook
study on why the special(extraordinary) petition is worthwhile. There
was indeed new and relevant information that only became available
after grant review. Scientific staff and leadership flagged it.”
The utility of the petitions is one of
the reasons that we ran the story about Duchenne and the team at
UCLA. The extraordinary petition process is currently under fire by
both the Institute of Medicine and the stem cell agency itself, which
has appointed a task force to come up with changes. But, while the
petition process is certainly less than perfect, so is the peer
review/grant review process.
The Duchenne application is not the
only “case study.” An application by Karen Aboody of the City of
Hope
is often cited as another case. There are undoubtedly others.
The petition process was adopted
several years ago by the board as a tool to manage willy-nilly
appearances of scientists before the CIRM governing board whose
applications were rejected by reviewers. Now the Institute of
Medicine has recommended the petitions be abandoned, saying they
undermine the integrity of grant review process. The IOM cited a
major controversy in Texas involving its cancer research agency as an
example of how grant reviews or the lack of them can go bad – not
to mention conflict of interest problems there. CIRM has already
started to look for better solutions regarding appeals. Many of its directors
are troubled by emotional presentations from patients in
connection with petitions and the lack of adequate information to
make informed decisions on the spot about the contested matters.
Whether appeals can be put in a tidy,
scientific box is debatable. Researchers have the right, under state
law, to address the board on any issue whatsoever. And at least some
of them will continue to do so -- regardless of any appeals changes --  when millions of dollars and their
careers are at stake.
Opinions and decisions of CIRM
reviewers are not holy writ. They can and do make mistakes, as we
all do. In making changes in the appeals process, the goal of the
agency should be to devise a public and transparent process rather
than enshroud it in more secrecy. CIRM also should find a way to do
a much better job of communicating to applicants the availability of
appeals and precisely how to appeal when it becomes necessary.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ROhqJSUEC28/appeals-at-california-stem-cell-agency.html

ViaCyte Wins Another $3 Million from California Stem Cell Agency

The California stem cell agency, which
has awarded ViaCyte, Inc., $36 million, today pumped another $3
million in the firm following the collapse of an alliance between the
San Diego firm and GlaxoSmithKline.

The now failed ViaCyte-Glaxo-CIRM
arrangement was ballyhooed by the CIRM in October because it would
have been the first deal involving Big Pharma and the stem cell
agency. The resources of Big Pharma are needed to pursue the
expensive path of turning stem cell research into cures.
Meeting in Los Angeles, the CIRM
governing board approved the additional funds on a 13-0 vote with two abstentions.  The action came following a closed door session to discuss how the funds would be spent. No details were provided publicly on that matter.

ViaCyte
has also told Biocentury that it is pursuing even more funding after
the alliance with Glaxo broke down. CIRM President Alan Trounson said ViaCyte is likely to receive another $3 million from the Juvenile Diabetes Research Foundation. Trounson also said that other sources are being examined as well. 

Patricia Olson, executive director of
CIRM, scientific activities said the agency's advisors continue to have faith in ViaCyte's effort to develop a treatment for diabetes. The company plans to start a clinical trial on its product in
2014.
The ViaCyte-Glaxo-CIRM deal was cause for
celebration last fall. Alan Trounson, CIRM's president, said the
deal would “resound” globally. He told directors,

 “This is
verification of our program. To have (the head of Glaxo regenerative
medicine program) join us through a partnership arrangement with GSK
means that a project that we've shepherded from the basic science
through to the preclinical work and is heading to the clinic we're
now going to do in partnership with a very major organization.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/qtxtQt3nhU0/viacyte-wins-another-3-million-from.html

Winners From Today's Awards by the California Stem Cell Agency

The 12 winners in the latest round of grants from the California stem cell agency all come from institutions linked to directors on the agency's governing board. Board members with conflicts of interest are not allowed to vote on the grants or participate in the debate. Since the inception of the agency, more than 90 percent of its awards have gone to institutions linked to the directors. Here is a link to the CIRM press release on today's meeting.

Here is the list of researchers who won awards today.

New Faculty Physician Scientist Translational Research Awards

RN3-06530Robert BalohCedars-Sinai Medical Center $3,031,737.00
RN3-06378Reza ArdehaliUniversity of California, Los Angeles $2,930,388.00
RN3-06504Jason PomerantzUniversity of California, San Francisco $3,084,000.00
RN3-06396Mana ParastUniversity of California, San Diego $3,013,252.00
RN3-06425Tracy GrikscheitChildren's Hospital of Los Angeles $3,408,000.00
RN3-06532Tippi MacKenzieUniversity of California, San Francisco $2,661,742.00
RN3-06479Ann Capela ZoveinUniversity of California, San Francisco $3,084,000.00
RN3-06529Alan ChengStanford University $3,091,595.00
RN3-06455Ali NsairUniversity of California, Los Angeles $3,004,315.00
RN3-06460Emanual MaverakisUniversity of California, Davis $2,964,000.00
RN3-06510Michelle MonjeStanford University $2,800,536.00
RN3-06525Ophir KleinUniversity of California, San Francisco $3,084,000.00
Total   $36,157,565.00

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QdM4BZ5hPnc/winners-from-todays-awards-by.html