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Stem Cell Agency Adds Fresh Details to IOM Response

♫ Sunday, January 27th, 2013

The California stem cell agency today
issued a press release touting “dramatic changes” at the agency in response to critical recommendations by the Institute of Medicine.

The press release contained a few more
details about the changes than were released in the Power Point
presentation yesterday. Here is the text of those details.
  • “The 13 Board members appointed from
    institutions eligible for funding from the stem cell agency, such as
    those in the University of California system, would no longer vote on
    any grants brought before the Board but would instead abstain
  • “All members of the Board would
    be able to participate in discussions on applications but only
    patient advocates and independent members of the Board would be able
    to vote on funding issues (members would continue to refrain from
    any discussion of specific applications from their institutions)
  • “Patient Advocates would
    continue to be members of the Grants Working Groups but would not
    vote on individual applications
  • “Programmatic review, aimed at
    balancing the agency’s portfolio, would take place at public Board
    meetings where members have a chance to make changes to
    recommendations from the Grants Working Group
  • “Industry involvement would
    increase, where appropriate, on the Grants Working Group, and also
    feature in a newly constituted Scientific Advisory Board; the
    structure and membership of this group is still under discussion
  • “Appeals on applications not
    recommended for funding will be handled by science staff who will
    evaluate them, determine if they merit further review by the Grants
    Working Group, and ultimately make recommendations to the Board.
    Staff will also be allowed to advocate for additional grants not
    recommended for funding by the Grants Working Group that they
    believe should be considered in programmatic review
  • “The Chair and President would
    share a division of responsibilities with the President supervising
    all scientific operations and internal operational responsibilities.
    In addition the Chief Financial Officer would report to the
    President. The Chair would handle the ‘external affairs’ aspect
    of the agency, things such as financial sustainability to raise
    additional funds, state legislative relations, bond financing,
    public communications etc.
  • “IOM recommendation on the
    creation of a Scientific Advisory Board to provide counsel on such
    issues as funding priorities and portfolio strategy will be
    implemented by staff
  • “IOM recommendations on
    Intellectual Property will be referred to the agency’s IP
    subcommittee which will review and report back to the full board
    with options and recommendations
  • “IOM recommendations on
    Sustainability: Chair, working with the President, will develop a
    plan to address this and present to the Board when ready

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/MHSytXHG-zU/stem-cell-agency-adds-fresh-details-to.html

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Nature on the IOM and the California Stem Cell Agency

♫ Sunday, January 27th, 2013

The journal Nature today said on its
web site that the California stem cell agency plans to make a “few
changes” in response to a critical report from the Institute of
Medicine(IOM).

A short piece by Monya Baker on the agency's response yesterday summarized
some of the IOM recommendations and the CIRM response. Baker wrote,
She said,

"Other IOM recommendations were only
indirectly addressed by (CIRM Chairman J.T.) Thomas’ plan. The IOM report had stated
that the board should restrict itself to an 'oversight' role
rather than an 'operational' role. Thomas’s recommendations
instead described ways to avoid overlapping duties. His own role as
chair is to handle 'external affairs' whereas CIRM’s president
will be to handle scientific and internal affairs."

Baker also carried the favorable
comments from John M. Simpson of Consumer Watchdog.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/JU2zXAO4Q1Q/nature-on-iom-and-california-stem-cell.html

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California Stem Cell Agency to Pitch Newspaper Editorial Boards

♫ Sunday, January 27th, 2013

The California stem cell agency is
planning an editorial road show with major California newspapers to
explain its new plan to deal with the recommendations of the
Institute of Medicine(IOM) for major changes at the agency.

In what might be called the kickoff to the campaign, the agency this afternoon issued a press release hailing the plan as making “dramatic changes.”

The agency could have a tough audience.
The newspapers editorializing on the subject were unanimously in
favor of the IOM recommendations. One said the agency needs to clean
up its act. They warned of a loss of public trust along with losing the
possibility of continued financial support. (For a sample, see here
and here.)

CIRM Chairman J.T. Thomas said during
today's meeting that a public relations foray was in the works
following board action on his proposals yesterday. He said,

“The opportunity is ripe.”

His comments came after CIRM Director
Jeff Sheehy, a UCSF communications manager, urged engaging the
editorial boards.
Thomas' plan meets only a portion of
the IOM recommendations and sidestepped a call for
creating a new majority on the board of independent members. The IOM
said “far too many” board members – at least 13 – are tied to
institutions that receive money from CIRM. Thomas' plan would have
the 13 voluntarily restrain from voting on any grants for any
institution.
A compilation by the California Stem
Cell Report shows that roughly 90 percent of the $1.7 billion awarded
by directors has gone to institutions with links to the directors.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sN7GVoQPGjA/california-stem-cell-agency-to-pitch.html

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Roll Call Vote on the Thomas Plan Dealing with IOM Recommendations

♫ Sunday, January 27th, 2013

Here is the roll call vote yesterday on the plan to deal with the findings of the Institute of Medicine
concerning the California stem cell agency. The vote was 23-0 with
one abstention. The board has 29 seats. Not all board members were in attendance,
and it is not entirely clear whether all the board members in attendance
voted. Among other things, the plan calls for members with links to
institutions that could benefit from CIRM awards to voluntarily refrain from
voting on any applications for funding – not just those to their
institutions. The roll call was provided by a spokesman for the
agency.

Yes votes
David Brenner, dean of the UC San
Diego medical school.
Anne Marie Duliege , vice president of
Affymax
Michael Freidman, CEO City of Hope
Michael Goldberg, executive chairman of Nodality, Inc., and DNAnexus, appointed as executive officer of a commercial life science entity
Sam Hawgood, dean of the UC San
Francisco medical school
Steve Juelsgaard, former executive
vice president of Genentech, appointed as executive officer of a
commercial life science entity
Sherry Lansing, chairwoman of the UC
board of regents, appointed as patient advocate
Jacob Levin, assistant vice
chancellor, research, UC Irvine, and alternate for Sue Bryant,
interim provost at UC Irvine
Bert Lubin, CEO of Childrens Hospital,
Oakland
Robert Price, associate vice
chancellor for research, political science professor, alternate for
the UC Berkeley chancellor
Francisco Prieto, Sacramento physician
and patient advocate member of the board
Robert Quint, San Jose physician and
patient advocate member
Duane Roth, San Diego businessman,
appointed as executive officer of a commercial life science entity
Joan Samuelson, patient advocate member
Jeff Sheehy, patient advocate member
Jon Shestack, patient advocate member
Os Steward, patient advocate member and
head of the Reeve-Irvine Research Center at UC Irvine
Jonathan Thomas, chairman of the board
and Los Angeles bond financier
Art Torres, patient advocate member
Kristiina Vuori, interim CEO of
Sanford Burnham Research Institute
Diane Winokur, patient advocate member

Claire Pomeroy, dean of the UC Davis medical school
Shlomo Melmed, senior vice president for academic affairs, Cedars Sinai
Abstaining
Michael Marletta, CEO of Scripps
Research

(Editor's note: Based on information provided by CIRM, an earlier version of this item incorrectly reported that the vote was 21-0. It also contained errors on three names. All have been corrected. Thanks for the heads up on the misspellings from a board member who will remain unnamed.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DYyBzk0Er5g/roll-call-vote-on-thomas-plan-dealing.html

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Meager, Meager Coverage of Yesterday’s IOM-Stem Cell Meeting

♫ Sunday, January 27th, 2013

The $3 billion California stem cell
agency seemed all but invisible this morning in terms of mainstream
media coverage.

Only one major outlet reported on
the watershed events yesterday at the CIRM governing board meeting at
the Claremont Hotel in Oakland – at least from what our Internet
searches show.
The piece was written by Bradley Fikes
in the San Diego U-T, the dominant daily newspaper in that area,
which is a major biotech center. The major media in the San Francisco
Bay area, home to the stem cell agency and also a biotech center, were absent from the coverage.
Fikes wrote a straight forward account
of the meeting, saying that the governing board voted “ to
accept in concept proposed
changes to reduce conflicts of interest on the agency's
governing committee.”
Fikes wrote the story based on the audiocast of the meeting. He probably would not have written his daily piece without the availability of the audiocast. 
Some of those connected with the stem
cell agency often wonder about the lack of mainstream coverage of its doings,
particularly the lack of favorable coverage.
Much of it has to do with the shriveled
state of the media business, which is understaffed and overworked
compared to 15 years ago. Specialized science reporters are all but
an extinct species. Also, the mainstream media has traditionally
ignored the affairs of most state agencies.
Speaking as a former editor at a major
Northern California newspaper, I would not have sent a reporter to
cover this week's two-day CIRM board meetings. It would have consumed
too much valuable time with little likelihood of a major story,
especially when weighed against other story possibilities. There was
no guarantee that the board would have even acted. The events and
their significance could be better handled in a roundup story later
with more perspective, perhaps keying on the board's meeting in
March, where details of yesterday's action will be fleshed out. The
fact is that many, very important events occur within state
government every day that never receive media attention. Some don't
even see the light of day until a catastrophe occurs.
All of this may be deplorable in the
eyes in stem cell agency backers and others, but it is the reality of
today's news business.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8q4FDQb-BUk/meager-meager-coverage-of-yesterdays.html

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Reaction to IOM: California Stem Cell Directors Approve Plan on Conflicts of Interest and More

♫ Sunday, January 27th, 2013

Directors of the $3 billion California
stem cell agency today approved a far-reaching plan aimed at resolving long-standing
conflict of interest issues involving the agency's governing board
and also at helping to maintain credibility with the public.

Jonathan Thomas
CIRM photo
The framework of the proposal by CIRM
Chairman J.T. Thomas moved forward on a 23-0 vote with one
abstention. He laid out the plan in response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. Details will be worked out and come back to the board in March. 
Acknowledging that many board members
were not pleased with the IOM criticism of the agency, Thomas said, 

“This is one of those times that we must move forward and compromise.” 

He
said issues such conflicts of interest have “stolen focus” from
the good scientific work that the agency has funded.
Thomas was reacting to the $700,000 IOM
study commissioned by CIRM governing board. The IOM recommendations
called for removing conflict
of interest problems, cleaning up a troubling dual-executive arrangement
and fundamentally changing the nature of the governing board. The IOM proposals would strip the board of its ability to approve individual grants,
greatly strengthen the role of the agency's president, significantly
alter the role of patient advocates on the governing board and engage
the biotech industry more vigorously.
Thomas' plan, which would be put in
place for up to a one-year trial period, would not do all that the
IOM wanted, but would move strongly in that direction.
State Controller John Chiang, chairman
of the only state entity with financial oversight over CIRM, endorsed
most of the proposal, said deputy controller Ruth Holton-Hodson. She
told CIRM directors that Thomas' plan was thoughtful and positive,
although Chiang did not support continued involvement of the chairman
in day-to-day operations.
The Thomas plan, which would not require legislative approval, would:
  • Have 13 members of the 29-member board
    refrain from voting on specific grant applications. The 13 would be from institutions that could benefit from CIRM grants. They would be
    allowed to participate in discussions. Thomas said this would deal
    with financial conflict of interest questions. 
  • Increase industry participation of
    industry in grant application review and step up business involvement
    internally at CIRM, including development of RFAs.
  • Redirect all scientific appeals to
    staff to evaluate for possible re-review before they go to the full
    board.
  • Move “programmatic” review of
    grants to public sessions of the full board instead of being held
    behind closed doors during grant review sessions. Patient advocate
    directors now sitting on the grant review group would no longer be
    allowed to vote during the closed-door review sessions, but they
    could participate in the discussion.

It appears, however, that the Thomas
plan would do little to deal with the dual-executive problems identified
by the IOM.

Consumer Watchdog's John M. Simpson, a
long observer of the stem cell agency, welcomed the response by
CIRM. Writing on his blog, Simpson said,

 "It looks like
the message is finally getting through to California's stem cell
agency board....
Part of what is driving the new
approach is the realization that CIRM will need to find a new source
of funding -- possibly going back to the voters -- if it is to
continue.  As Thomas told the board today, 'If we don't
have credibility, we won't have a chance of sustaining the agency.'"

During the lengthy debate this
afternoon, one director after another said they did not agree with
all that the IOM had to say, but said maintaining credibility and
trust was the key to the sustainability of the organization.
CIRM will run out of money for new
grants in less than four years. Thomas said he is working on a plan
to continue the agency's effort into the future. Details of that will
be disclosed later, he said.

(Editor's note: An earlier version of this item, based on incorrect information from CIRM, said the vote was 21-0. The correct figure is 23-0.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Phybdqb0SV0/iom-california-stem-cell-directors.html

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Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations

♫ Sunday, January 20th, 2013

The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, yesterday outlined how
he intends to proceed next week when the agency's governing board
considers the far-reaching recommendations of a blue-ribbon Institute
of Medicine panel.

Writing on the agency's blog, Thomas
said,

“While some of the IOM’s
recommendations are administrative in nature and can be implemented,
others are much more complex and would require changes in (governing)
board policy or legislative changes.” 

Jonathan Thomas, chairman of CIRM governing board at far right. Art
Torres (center), co-vice chair and former state Democratic party chairman,
who would  play key role in dealing with lawmakers. Robert Klein is at the
 left in this 2011 meeting, Klein's last as chairman of the agency and the one
 in which Thomas was elected chairman. 
He continued,

“My goal is to strive to reach
consensus on a course of action on the 23rd. However, if the board
isn’t able to choose a course of action at this time we will
continue the conversation and bring it up at future board meetings
until we reach agreement.”

It is worth noting that Thomas did not
mention the possibility of having to ask the people of California to
amend the state constitution, which would require a statewide election. Opponents to change at the agency have
used that possibility to discourage action. (See here and here.) An
election would be costly, politically difficult and could open the
door to additional unwelcome changes at the eight-year-old research
enterprise.
Thomas' desire for a consensus among
the 29 board members – instead of a simple majority – could be a
stumbling block as the board becomes snarled internally, perhaps for
months or more. The board normally meets only about once a month and
has a full slate of regular business on those occasions. The agency
will run out of money for new grants in less than four years, and
action on the IOM recommendations seems a necessary prelude to
winning continued financial support.
While four years would appear to an ample
period of time, making the sort of changes the IOM recommends would
require legislative action, which probably would take a minimum of a
year. Timing is important as well. The current leaders in the state
Senate and Assembly will be termed out in 2014. Starting all over
with novice leadership, changes in key committee chairmanships and so
forth would make the task even more difficult. Then there is the need
to address strategies for continued financial support. Should the
agency seek a new statewide bond measure (the current funding
mechanism)? If so campaign committees need to be formed, electoral
strategies planned and tested and tens of millions of dollars raised
for campaign expenses. If private funds instead are to be raised to
the tune of hundreds of millions of dollars(the agency spends about
$300 million a year), such an effort would also require considerable time.
To keep the funding pipeline full, all of this should be completed
well before the money runs out in 2017.
Dilly-dallying this year in drawn-out, fruitless debate over
the IOM proposals would be an unfortunate beginning should CIRM
directors actually want to continue the existence of the
organization.
In his blog item, Thomas sounded this
final note.

“It’s likely the debate will be
passionate – everyone involved in this work cares deeply about it –
and there will undoubtedly be disagreements, but ultimately we all
share the same goal, a desire to make sure that whatever we decide
helps make the stem cell agency even stronger and more effective, and
is in the best interests of the people of California.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xriRP02aekU/stem-cell-agency-chair-pressing-for.html

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StemCells, Inc., Still Looking for $40 Million from California Stem Cell Agency

♫ Sunday, January 20th, 2013

Remember StemCells, Inc., and the $40
million it was awarded by the California stem cell agency.
The Newark, Ca., firm, founded by
eminent Stanford researcher Irv Weissman, received an award of $20
million last July and then again in September. Nearly five months
later, however, the stem cell agency has yet to cut a check for the
company, a spokesman for the agency told the California Stem Cell
Report in response to a query.
The hang-up is the $40 million in
matching funds that the company promised the agency. The stem cell
agency has yet to be satisfied that StemCells, Inc., can actually
produce the match, although the spokesman did not offer details.
The StemCells, Inc., awards were
unusual in a number of ways. It was the first time that former CIRM
Chairman Robert Klein lobbied the CIRM governing board on behalf of a
company(see here and here). It was the first time that the governing
board approved an application that had been rejected twice by grant
reviewers. It was the first time that the board said explicitly in a
public session that it wanted proof of the matching funds as a
condition of the award.
It was the first time that a CIRM award
to a company received a careful and critical scrutiny from a major
California newspaper. Michael Hiltzik, a Pulitzer Prize-winning
business columnist and author, wrote in October in the Los Angeles
Times that the award was “redolent of cronyism.” He referred
particularly to longstanding ties between Klein and Weissman.
The CIRM board vote on the StemCells,
Inc., grant in September was 7-5, which amounted to 12 out of 29
members of the board.
In December, a blue-ribbon panel of the
Institute of Medicine (IOM) recommended that the agency tighten its
conflict of interest standards to avoid such perceptions as have been
generated by the StemCells, Inc., awards. The IOM said,

“(C)om­peting personal and
professional interests com­promise the perceived independence of
the (governing board), introduce potential bias into the board’s decision
making, and threaten to undermine confidence in the board.”

Concerns about conflicts of interest have long been of concern to observers of the stem cell agency for years. Indeed, the prestigious journal Nature in 2008 warned of "cronyism" at the $3 billion research enterprise.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5BdZ8FguJp8/stemcells-inc-still-looking-for-40.html

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Patient Advocate Says IOM Recommendations Would ‘Destroy’ California Stem Cell Agency

♫ Sunday, January 20th, 2013

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

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UC Davis Stem Cell Researcher: ‘Ivory Tower’ IOM Recommendations Harmful to California Stem Cell Agency

♫ Sunday, January 20th, 2013

The $3 billion California stem cell
agency has funded in the neighborhood of 500 to 600 scientists and
institutions, reviving and starting careers and stimulating
construction of $1 billion in new research labs around the state.

None of those recipients, as far as we
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.
UC Davis researcher Paul Knoepfler, who
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.
“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient,  used to describe the recommendations. He predicted “extremely negative repercussions” that “would
actually make CIRM less effective and less responsive to patients and
California citizens.”
He wrote that the IOM report, which
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”
He defended the CIRM governing board,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,

“Far too many board mem­bers
represent organizations that receive CIRM funding or benefit from
that funding. These com­peting personal and professional
interests com­promise the perceived independence of the ICOC,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board."

Knoepfler said,

“(The) IOM itself admits there is no
evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”

Knoepfler also wrote,

“Interestingly, highlighting the
extremely sensitive nature of this issue, while I’ve been talking
with many bigwigs about this, at this point no one is wiling to go on
the record with an opinion about it except one courageous soul, Don
Reed (see
his piece here).”

There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.
California scientists, however, should
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/pW_1A2nkyrM/uc-davis-stem-cell-researcher-ivory.html

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

♫ Sunday, January 20th, 2013

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

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

♫ Sunday, January 20th, 2013

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

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

♫ Sunday, January 13th, 2013

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

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Nature Biotechnology: California Stem Cell Agency Receives ‘Stinging Rebuke’

♫ Sunday, January 13th, 2013
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

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

♫ Sunday, January 13th, 2013

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

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

♫ Sunday, January 13th, 2013

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

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Reverse Engineering Grandpa

♫ Sunday, January 13th, 2013

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

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

♫ Sunday, December 23rd, 2012

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.) 
Legal Memo from California Stem Cell Agency on Little Hoover Recommendations 2009
Legal memo from Americans for Cures regarding the Little Hoover Commission Report 2009 

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

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Boxing in the California Stem Cell Board

♫ Sunday, December 23rd, 2012

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

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

♫ Sunday, December 23rd, 2012

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

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