Stem Cell Therapy – StemCell Therapy

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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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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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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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