header logo image


Page 69«..1020..68697071..8090..»

Archive for the ‘Stem Cell Therapy’ Category

Stem Cell Therapy – Let Your Own Stem Cells Make Wrinkles Virtually Disappear! Free postage – Video

Tuesday, December 11th, 2012


Stem Cell Therapy - Let Your Own Stem Cells Make Wrinkles Virtually Disappear! Free postage
Stem Cell Therapy - Let Your Own Stem Cells Make Wrinkles Virtually Disappear!From:Deals2uTVViews:0 0ratingsTime:02:01More inHowto Style

Visit link:
Stem Cell Therapy - Let Your Own Stem Cells Make Wrinkles Virtually Disappear! Free postage - Video

Read More...

Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’

Sunday, December 9th, 2012
Jonathan Thomas
CIRM Photo

Jonathan Thomas, the Los Angeles bond
financier who is chairman of the $3 billion California stem cell agency, has
weighed in at more length on the sweeping recommendations from the
Institute of Medicine for changes at the agency.

He wrote a piece for the agency's blog
that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press
release yesterday that said the IOM “praises the agency as a 'bold
social innovation.'”
Thomas did acknowledge that the report
“highlighted some areas and made some recommendations about where
and how we might improve our performance.” 
Thomas concluded by saying the agency
takes the report seriously and will, over the next few months,
consider how best to respond.
Nearly needless to say, other observers
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html

Read More...

IOM Proposals for Overhaul at CIRM Win High Marks

Sunday, December 9th, 2012

The Institute of Medicine's
recommendations for major changes at the California stem cell agency
today received generally high marks from independent observers and
critics.

Many of the proposals echoed
suggestions from California's Little Hoover Commission, the
state's good government agency. Asked for comment, Stuart Drown, the
commission's executive director, said,

“The institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009."

He continued,

“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”

The California Stem Cell Report also
asked the agency's first president, Zach Hall, for his thoughts. Here
is the full text of what Hall, who was one of the peer reviewers on
the IOM study, had to say,

“The IOM Committee and its staff have
done an impressive job.  The report recognizes the scientific
value and achievements of the CIRM and, at the same time, makes
cogent recommendations that, if taken seriously, will further improve
the quality and the public credibility of the Institute. The
committee and staff deserve the thanks of the scientific community
and all California citizens for their careful and thoughtful work.” 

John M. Simpson, stem cell project
director for Consumer Watchdog of Santa Monica, Ca., said,

“It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,” 

Marcy Darnovsky, associate executive
director of the Center for Genetics and Society of Berkeley, Ca.,
welcomed the recommendations. But she said,

“Given the agency’s shortcomings
and the state’s budgetary problems, it would be wrong to ask
Californians to give it more public money. If the agency acquires new
funds from industry sources or venture firms, it must recognize that
it has ongoing obligations to the people of California.” 

She continued,

 “CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2009 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.” 

The California Stem Cell Report also
queried most of the 10 patient advocates on the agency's governing
board for comment. Their roles could be altered in a major way by the
IOM recommendations. None of the advocates have yet responded.
(The full text or nearly
full text of all the above comments is available here.)  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/yyZ0TAisMZQ/iom-proposals-for-overhaul-at-cirm-win.html

Read More...

More IOM-CIRM Coverage: One Story Notes Major 2007 Conflict Flaps at Stem Cell Agency

Sunday, December 9th, 2012

Additional coverage emerged this morning,
including stories in the Los Angeles Times, the Nature web site and
Businessweek. on a blue-ribbon report that recommended sweeping changes
at the the $3 billion California stem cell agency

In the Times, California's largest
circulation newspaper, Eryn Brown's story was headlined,

"Stem cell
agency board criticized for conflicts of interest."

The article began,

"The board of California's stem cell
funding agency is rife with conflicts of interest and should be
restructured to improve the integrity of its grant-making process,
according to a new report from independent experts convened by the
national Institute of Medicine."“

In the San Diego U-T, reporter Bradley
Fikes
' article was the only piece in all the coverage to mention two major conflict-of-interest flaps at the agency in 2007.
One involved then CIRM board member
John Reed, head of Sanford-Burnham in La Jolla, who tried to influence CIRM staff
in connection with a grant to his organization, triggering
an investigation by the state's political ethics commission. (Reed's
actions were first disclosed by the California Stem Cell Report.) The
other case involved inappropriate actions by four members of the
29-member board in an $85 million round. Ten applications were dumped
from the round because of the directors' actions. The conflict
issues were so rampant that only eight of the directors present at a
December 2007 meeting could discuss the issues.
(See here, here and here.)
On the Nature news blog, Monya Baker
had a thorough piece that said the agency “received a mixture of
praise and hard-to-enact recommendations from an august scientific
body.” She also wrote,

“It’s unclear what effect the
report will have. Many of these recommendations run counter to
requirements enshrined in the legislation that created CIRM, and the
board of CIRM has heard similar recommendations before and failed to
act on them.”

On the web site of the journal Science,
Greg Miller wrote that IOM report "praises the California Institute for
Regenerative Medicine
(CIRM) as a 'bold social innovation' that
provided a creative new source of funding that has turned the state
into an international hub of stem cell research. But the IOM panel
authoring the report also concluded that the funding agency’s
organization and governance is not optimal."
Businessweek carried the AP story by
Alicia Chang mentioned yesterday. The AP story also appeared on the San
Francisco Chronicle
and Sacramento Bee web sites and was also carried internationally on other web sites.  The Chronicle also had a staff story by Erin Allday.  
(An earlier version of this item did not contain the last sentence regarding the Allday story.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/yk8zuHF6IKA/more-iom-cirm-coverage-one-story-notes.html

Read More...

Text of Comments Reacting to IOM Report on California Stem Cell Agency

Sunday, December 9th, 2012

Here is the full text or the essential
elements of comments sought by the California Stem Cell Report on the
Institute of Medicine report that recommended sweeping changes at the
California stem cell agency. Consumer Watchdog and the Center for
Genetics and Society
put their comments in the form of news releases,
which contained redundant material.

From Stuart Drown, executive director
of California's Little Hoover Commission:

“CIRM initiated the Institute of
Medicine review, which is to its credit.  The Institute of
Medicine took a scrupulous and rigorous approach to its review of the
California Institute of Regenerative Medicine and in its report,
notes CIRM’s many achievements and accomplishments.

“The Institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009. The
institute graciously acknowledged the commission’s work, which
clearly is as relevant now as it was in 2009.

“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”

From John M. Simpson, stem cell project
director at Consumer Watchdog of Santa Monica, Ca.(full press release here):

“Consumer Watchdog Thursday welcomed
a report from the prestigious Institute of Medicine (IOM) calling for
sweeping reforms in governance at California’s stem cell agency and
an end to the board’s built-in conflicts of interest. 

“The report said that 'far too many
board members represent organizations' that receive funding or
benefit from the stem cell agency. The IOM said that the board’s
oversight function should be separated from the day-to-day management
of the California Institute for Regenerative Medicine (CIRM). 

“'The IOM's critical report echoes
what every independent evaluator has said in the past,' said John
M. Simpson, Consumer Watchdog’s Stem Cell Project director.
'As we have repeated from the beginning, CIRM suffers from built-in
conflicts of interest and needs to separate the board's oversight
function from day-to-day management.'

“'It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,' Simpson said.”

From Marcy Darnovsky, associate
executive director of the Center for Genetics and Society in
Berkeley, Ca.(full press release here):

“The Center for Genetics and Society,
a nonprofit policy research and advocacy organization, welcomed the
report on the California stem cell agency released today by the
Institute of Medicine and called for stronger protections for  the interests of Californians as
the agency continues its disbursement of public funds.

“CIRM is nearing the end of the
billions of dollars of public funding allocated to it in
2004. The agency is currently considering how to extend
its operations after the money runs out. CGS Associate Executive
Director Marcy Darnovskysaid, “Given the agency’s
shortcomings and the state’s budgetary problems, it would be wrong
to ask Californians to give it more public money. If the agency
acquires new funds from industry sources or venture firms, it must
recognize that it has ongoing obligations to the people of
California.”

“She continued, 'CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2008 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.' 

“'Today’s report from the IOM
reaffirms the significance of the conflicts of interest and
structural flaws that were built into the stem cell program from the
beginning, and that continue to threaten its credibility and
effectiveness. These are serious problems that the Center for
Genetics and Society and other public interest voices pointed out
even before the agency was approved by the 2004 ballot measure on
which backers spent some $35 million. 

“'Many aspects of these early
concerns remain directly relevant,' Darnovsky said. 'There is
still no way for elected officials to provide oversight because the
measure that created CIRM requires a 70% vote by both houses – more
than a supermajority. The agency’s governing board is still tainted
by its built-in conflicts of interest, and still includes no
representation of the public beyond disease advocates. Members of the
agency’s powerful Working Groups, including the one that reviews
grant applications, are still not required to publicly disclose their
individual financial interests.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iu4DrhoewYo/text-of-comments-reacting-to-iom-report.html

Read More...

Coverage of the IOM Report: Light but a Column with a Cutting Edge

Sunday, December 9th, 2012

News coverage has been light so far
today of the Institute of Medicine's recommendations for an overhaul
at the $3 billion California stem cell agency. But a Pulitzer Prize-winning columnist from the Los Angeles Times took a sharp knife to the agency's press release on the IOM report.

Michael Hiltzik, who is a regular critic of the agency, asked,

 "So how did CIRM react to the report? Even before the review panel's conference call with the press was completed, the agency issued a news release stating that the panel had 'praised' the agency 'for its ground breaking work in helping advance the science of stem cell research.'"If you wanted to know about the committee's criticisms, the first mention of those was in paragraph 9 of the news release. It quoted board Chairman Jonathan Thomas as promising to 'work on establishing a process to enable us to consider how best to proceed with reviewing the recommendations.' 

"By my count, that's seven steps it will take before actually acting on the recommendations. 

"As it happens, the panel's recommendations, which include creating a majority of independent board members without any potential conflicts of interest, track very closely to recommendations made by several previous outside reviews of CIRM, especially a 2009 study by the state's Little Hoover Commission.

"CIRM rejected almost every one, and it looks to be preparing to circle the wagons again against sensible improvements in the way it does business."

The Associated Press story by Alicia
Chang 
popped up in two different forms on the Washington
Post
web site and in Ottowa and Spokane, among other places. Chang
was on board for the IOM news conference and had this to say about
CIRM from one of the IOM study group members.

“'They’re not broken but they’re
bent,' said Sharon Terry, president of the nonprofit Genetic Alliance
who was part of the panel. 'They need some correction.'”

Chang's story originally began,

“California has transformed into a
powerhouse player in stem cell research, but the taxpayer-funded
institute responsible for that needs an overhaul, a report released
Thursday found.”

Another version, that appeared in
Ottowa and Spokane and beyond, started this way,
“A report says California’s stem
cell agency needs more independent oversight and recommends a
restructuring to avoid the appearance of conflict of interest.”
Ron Leuty of the San Francisco
Business, who is one of perhaps two reporters who regularly cover
the stem cell agency, wrote,

“A review of California's stem cell
research funding agency proposed changes to the agency's governing
structure and commercial goals while praising its results so far. The
124-page report from the Institute
of Medicine
 recycles many conflict of interest and
intellectual property concerns that have dogged the San
Francisco-based” agency.

Stephanie O'Neill at KPCC radio in Los
Angeles also had a story.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XpN8S2N2-iw/coverage-of-iom-report-light-but-column.html

Read More...

IOM Recommends Sweeping Changes at California Stem Cell Agency

Sunday, December 9th, 2012

A blue-ribbon study of the $3 billion
California stem cell agency today said the program has “achieved
many notable results,” but recommended sweeping changes to remove
conflict of interest problems, clean up a troubling dual-executive
arrangement and fundamentally change the nature of the governing
board.

The recommendations from the 17-month
study by the Institute of Medicine (IOM) 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.
Harold Shapiro, chairman of
IOM-CIRM  panel
Princeton University Photo

Harold Shapiro, former president of
Princeton University and chairman of the IOM study panel, said,
“Overall, CIRM (the California
Institute for Regenerative Medicine
) has done a remarkably good job”
in giving the state a prominent position in regenerative medicine.
But he said the stem cell field has “evolved”and CIRM needs to
change with it.
As for turning research into cures, the
report said,

 “The challenge of moving its research programs
closer to the clinic and California’s large biotechnology sector is
certainly on CIRM’s agenda, but substantial achievements in this
arena remain to be made.”

Asked for comment, J.T. Thomas, chairman of the CIRM governing board, said it was premature to offer an opinion on the report, which will be presented to directors Dec. 12 at their Los Angeles meeting. (See here for the full text of Thomas' remarks.)
The study was conducted at the behest
of CIRM, which paid the IOM $700,000. The IOM is a prestigious
non-profit organization that was created in 1970 to provide
authoritative advice to policy makers and the public.
In 2010, when directors authorized the
study, Robert Klein, then chairman of the CIRM board, and other board
members said that they hoped the study would lead to
another multibillion dollar state bond issue to support the
agency(see here and here). Duane Roth, a San Diego businessman and co-vice chairman of
the CIRM governing board, was the lone no vote on the study. He
warned directors that that they could not “go in just sort of blind
trust that (the IOM is) going to reach the conclusion you want them
to reach.”
The agency will run out cash for new
grants in four years. Currently California remains in the throes of
state budgetary problems, and the agency has put on hold talk of another bond
election. It has also broached the possibility of
seeking private funding.
The IOM report said the agency should
develop a full-blown “sustainability platform” and plans that would
spell out its likely financial structure and future rules on grants
and their administration, including intellectual property.
The study echoed concerns and
complaints about CIRM's operation that were aired even before the
agency was officially created by voters in 2004. One of those
involves the built-in conflicts of interests on the CIRM governing
board. As of September, 92 percent of the $1.7 billion handed out by the agency had gone to institutions linked to persons serving on the 29-member board.
The report 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(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”

The IOM cited an ongoing scandal in Texas dealing with that state's $3 billion cancer agency. The flap
has led to mass resignations of the agency's grant reviewers. The
IOM said,

“Recent controversy surrounding the
Cancer Prevention and Research Institute of Texas grants process
illustrates the importance of rigorous scientific review free from
inherent or perceived conflict and the consequences when these
boundaries appear to be breached.”

However, the IOM press release said,

“Because the committee was not
charged with reviewing CIRM's past funding decisions, it did not
identify any specific cases of conflict.”

The IOM surveyed members of the board (ICOC) about conflicts of interest. The report said,

 "While a majority of respondents stated
that personal interests did not play a role in their work on
the ICOC, some responses were more equivocal. One respondent replied that it was 'hard
to tell' given that 'so many decisions take place off camera in secret meetings,' while another
acknowledged that ICOC members are human, and of course their decisions are influenced by
personal beliefs and interests."

To help deal with conflicts of
interest, the IOM recommended that the CIRM governing board not be
allowed to approve individual grants. Instead, the board would be
given a slate of applications that would be approved as a block. All
CIRM board members would be removed from the grant review committee
and the grant review process would be turned over to the president of
the agency, currently Alan Trounson.
The IOM recommended that a majority of
the board consist of “independent” members and said that the
board should not be increased beyond its current 29 members, although
it could be shrunk.
Conflict of interest rules should be
revised to deal with personal conflicts, which could have a major
impact on the 10 patient advocate members of the board but also
other directors and possibly staff who have family members with health issues. The report said,

“California law focuses primarily on
financial conflicts of interest, but the committee believes that
personal conflicts of interest arising from one’s own or a family
member’s affliction with a particular disease or advocacy on behalf
of a particular disease also can create bias for board members.
Studies in psychology and behavioral economics show that conflict of
interest leads to unconscious and unintentional 'self-serving bias'
and to a 'bias blind spot' that prevents recognition of one’s own
bias. Bias distorts evaluation of evidence and assessment of what is
fair.”

The IOM said that the board is much too
involved in operational matters, including the chair and the two
vice-chairs. The report said,

“The board should transfer management
responsibilities to management so it can provide truly independent
oversight and evaluation of management, strategic planning, and broad
direction for resource allocation.”

The IOM repeatedly and favorably cited
a 2009 study by California's Little Hoover Commission, the state's good
government agency. It noted that CIRM rejected most of the commission's recommendations. The IOM also cited recommendations by the agency's own “external review” panel in 2010 and suggestions
this year from the first performance audit of the agency, which cost
CIRM $234,944.
Many of the IOM's recommendations would
require either legislative approval or another ballot initiative.
However, changes in the Prop. 71, the ballot initiative that created CIRM, require a politically difficult super, supermajority
vote (70 percent) of the both houses of the legislature and the
signature of the governor. The requirement was written into the
10,000-word initiative and has been used by CIRM to block legislation
that it did not favor.
Here is brief rundown on some of the
other IOM recommendations:
  • Greater engagement with industry to
    commercialize stem cell research. Noting that industry has received
    only 6 percent of the agency grants, the report said business
    representation on CIRM working groups and other committees “should
    be enhanced to leverage industry’s expertise and resources in
    product development, manufacturing, and regulatory approval in
    support of the ultimate goal of bringing therapies to patients.”
  • Elimination of the current process in
    which applicants rejected by reviewers appeal publicly to the
    governing board. Noting that 32 percent of “extraordinary
    petitions” have been successful, the report said they “undermine
    the credibility and independent work” of grant reviewers. Instead
    appeals would heard only by staff behind closed doors.
  • Creation of a new scientific advisory
    board, appointed by the CIRM president with a majority from outside
    of California, instead of multiple advisory groups. The report said,“Such an external board would be
    invaluable in vetting ideas for new RFAs, suggesting RFAs that
    otherwise would not have been considered, and helping CIRM maintain
    an appropriate balance in its research portfolio. Input from this
    board would help CIRM make fundamental decisions about dealing with
    challenges that cut across particular diseases, decide which
    discoveries should progress toward the clinic, and determine how best
    to engage industry partners in developing new therapies.”
  • Funding of programs on bioethics and
    regulatory problems. The report said,“It is difficult for researchers to
    find appropriate funding for stem cell-specific ethics and policy
    work, and filling this funding gap is well within CIRM’s budget.”
One final note: As mentioned
earlier, Duane Roth, co-vice chairman of the agency, was the only no
vote on the board when it authorized the IOM study in 2010. The IOM today said,

“The critical tasks performed by the
vice chairs should be reassigned to management. In particular, the
important tasks of government relations and corporate relations both
should be carried out by staff reporting to the president rather than
by the vice chairs of the board.”

For more excerpts from the report, see this item.
,  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/O67cWrCCsco/iom-recommends-sweeping-changes-at.html

Read More...

Text of CIRM Chairman’s Comments on the IOM Report

Sunday, December 9th, 2012

Here is the text of comments on the IOM study of CIRM from J.T. Thomas, chairman of the agency. 

"We deeply appreciate all the hard work of the IOM committee in compiling  long and detailed report and the IOM clearly put considerable thought into compiling it. This has just been released so our Board and our staff has not had a chance to look at it yet, let alone digest its findings and recommendations, so it’s premature for us to offer any opinions. We are looking forward to the IOM presentation at the next meeting of our board, the Independent Citizens Oversight Committee (ICOC) where we’ll have a chance to talk with the IOM directly about the report. After that we’ll put together a process on how best to proceed so that we can respond in as thoughtful a manner to the recommendations as the IOM did in making them."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/YkRTcgnXNqU/text-of-cirm-comments-on-iom-report.html

Read More...

Excerpts from the IOM Report on the California Stem Cell agency

Sunday, December 9th, 2012

Here are excerpts from the $700,000 Institute of Medicine (IOM) report on the $3 billion California stem cell
agency -- the California Institute of Regenerative Medicine (CIRM).

Overall Comments
“Improvements to CIRM’s governance
structure, scientific program, and policies are critical to bet­ter
serving California taxpayers who elected to devote funding to promote
stem cell research in the state. The necessary changes outlined by
the IOM committee, if enacted by the state and/or the institute,
would help to instill confidence among the scientific community and
California residents in the vital work that CIRM is accomplishing.”
“It is the committee’s judgment
that overall, CIRM has done a very good job of initially establishing
and then updating the strategic plans that have set priorities for
and guided its programs, and of taking advantage of its guaranteed
flow of $300 million a year for 10 years to establish a sustainable
position in regenerative medicine for California. The challenge of
moving its research programs closer to the clinic and California’s
large biotechnology sector is certainly on CIRM’s agenda, but
substantial achievements in this arena remain to be made.
“Despite its demonstrable
achievements to date, as well as the largely positive independent
reports covering various aspects of its operations, no one would
claim that CIRM is a perfect organization or that it should adhere
slavishly to its initial form of organization, set of regulations, or
pattern of priorities. The field of regenerative medicine has
advanced rapidly since November 2004, and CIRM itself has seen the
need to alter its activities and approaches in some areas. The
committee believes the same should be true of its governance
structure, some of its administrative practices, and its use of
external perspectives on strategic scientific priorities and on the
evaluation of other key policies, such as intellectual property, to
ensure that they continue to encourage the development and deployment
of new treatments.”
“While the restrictions on amending
the administrative structure of CIRM established in Proposition 71
had the advantage of protecting the institute’s ongoing operations
from outside interference in an ethically controversial arena, they
also made it difficult to modify the organization’s structure in
response to experience and/or changing circumstances. Moreover, these
protections, whatever their benefits, appear to some to shield CIRM
from the normal accountability mechanisms in place for state
agencies.”
Conflicts of Interest
“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. Neither the board
chair nor board members should serve on any working group. The board
itself should include representatives of the diverse constituencies
that have an interest in stem cell research, but no institution or
organiza­tion should be guaranteed a seat.”
“The problematic perception of
conflicts of interest has persisted for as long as CIRM has existed.
The IOM committee would be less concerned about individual board
members with actual or perceived conflicts of interest if the board
membership included more truly independent members. The majority of
board members should be independent, with no competing or conflicting
personal or professional interest. Broader representation from a
wider variety of stakeholders will inject new perspectives into the
panel and will help to dispel the perception of conflicts of
interest.
“CIRM also should revise its conflict
of interest definitions to include non-financial interests, such as
the potential for personal conflicts of interest to arise from one’s
own affliction with a disease or personal advocacy on behalf of that
disease. CIRM policies for managing conflicts of interest should
apply to that broader definition.”
Structure and Governance
“Currently, the ICOC (the agency's
governing board) functions both as an executor and as an
overseer—competing duties that compromise the ICOC’s critical
role of pro­viding independent oversight and strategic
direc­tion. The IOM committee recommends that CIRM’s operations
be separated from its over­sight. The board should delegate more
author­ity and responsibility for day-to-day affairs to the
president and senior management, and the ICOC’s three working
groups should report to senior management within CIRM, rather than to
the ICOC. The moves would permit the board to better focus its energy
and collective talent on strategic planning, overseeing financial
perfor­mance, ensuring legal compliance, assessing the
president’s performance, and devising a plan for preserving and
expanding its considerable assets to permit the institute to continue
its important work after the bond measures end.”
Unrealistic Goals
“While the latest round of awards
challenge teams to have filed a request to begin clinical trials or
to have completed early-stage trials in patients within four years,
the committee feels these ambi­tious goals are unrealistic. New
therapies take more time to progress to federal approval, and
early-stage clinical trials are beset by a stagger­ingly high
failure rate. Rather than judging suc­cess by simply tallying the
number of active clini­cal trials, the IOM committee suggests
that CIRM also continue its focus on underlying biological mechanisms
that drive the success or failure of a promising therapy and on
careful design of clini­cal trials. Advances in these areas will
help the entire field progress, even if a specific drug candi­date
is not approved." 
Economic Impact
“In the short term, CIRM’s
expenditures are supporting approximately 3,400 jobs and their
innovative efforts have also attracted substantial additional private
and institutional resources to this research arena in California
CIRM’s long-term impact on such critical aspects of the California
economy as state tax revenues and health care costs beyond the
shorter-term and temporary impact of its direct expenditures cannot
be reliably estimated at this point in CIRM’s history.... (T)he
estimate of the Analysis Group (2008) that the CIRM program alone
would support about 3,400 jobs as long as it was allocating about
$300 million per year in research and development grants appears
quite reasonable to the committee. To put this estimate in context,
however, total employment in California is roughly 16 million, and
NIH alone provides more than $3.5 billion per year to California
research institutions.”
Intellectual Property
“CIRM should propose regulations that
specify who will have the power and authority to assert and enforce
in the future rights retained by the state in CIRM-funded
intellectual property. CIRM should seek to clarify which state
agencies and actors will be responsible for the exercise of
discretion currently allocated to CIRM and the ICOC (the CIRM
governing board) over future determinations on issues regarding
march-in rights, access plans, and revenue-sharing rights that might
arise years after CIRM's initial funding period has passed.... (T)he
ICOC should reconsider whether its goal of developing cures would be
better served by harmonizing CIRM’s IP policies wherever possible
with the more familiar policies of the Bayh-Dole Act(federal IP law).

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Td6TGOVGYNo/excerpts-from-iom-report-on-california.html

Read More...

Collapse of Big Pharma Deal Involving California Stem Cell Agency

Sunday, December 9th, 2012

A ballyhooed deal has blown apart that
would have hooked up – for the first time – Big Pharma and the $3
billion California stem cell agency.

The breakdown of the arrangement was
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.
The deal was first announced Oct. 25
when Viacyte, Inc., of San Diego, received a $10.1 million award to
help finance a clinical trial for a diabetes treatment involving
Viacyte and GlaxoSmithKline.
The CIRM background memo said this week, however,

“We have recently been informed that
GSK was not able to obtain the final approval required due to
business reasons in the context of GSK's overall research and
development portfolio and investment needs and not as a result of any
scientific or technical assessment of ViaCyte's program.”

The memo gave no further details about
the Glaxo decision.
CIRM staff proposed that Viacyte, which
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.
The arrangement involving Glaxo,
Viacyte and CIRM was trumpeted in October, when Viacyte was awarded
the $10 million. Officials of the stem cell agency said the award
was a “watershed” for CIRM. Jason Gardner, head of the Glaxo stem
cell unit and who attended the meeting, told the California Stem Cell
Report
that the arrangement was a partnership and that the company
intended to develop a sustainable pipeline.
It was the second significant
business-connected deal that has collapsed for the $3 billion agency
within the last 13 months. In November 2011, Geron abandoned its
clinical trial for spinal injuries. CIRM had loaned Geron $25 million
for the trial just three months earlier. The company paid the money
back with interest.
CIRM staff said that advisors to the
agency remain “extremely positive” about the Viacyte research and
“strongly recommended” that the company receive the additional $3
million. The memo said that trial has a “strong potential” to be
commercialized.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/p-E0ivzGfr0/collapse-of-big-pharma-deal-involving.html

Read More...

Extra, Extra! CIRM Staffers Blog the World Stem Cell Summit

Sunday, December 9th, 2012

Years ago, I worked with an editor who
used to advise his lagging scribes to put their noses in their
typewriters and peck.

Well, the folks at the California stem cell agency have their
noses in what passes today for typewriters and are pecking away
furiously. Their subject is the World Stem Cell Summit, which has
received only slight coverage in the mainstream media.
Today, the stem “cellists” from San
Francisco's King Street filed -- on the agency's blog -- three fulsome
items on doings at the summit, which is taking place in West Palm
Beach, Fla. Yesterday they filed four. Photos and charts were
included. More coverage is expected tomorrow.
CIRM staffers blogging the World Stem Cell Summit
covered UC Davis researcher Paul Knoepfler discussing
patient advocacy and its role in funding stem cell research. 

The CIRM writers are doing double-duty
in at least one case. Geoff Lomax, the agency's senior officer for
its standards group, is additionally speaking on a panel at the session. A
handful of other CIRM officials are also appearing at the conference,
which ends tomorrow.

The primary purpose, we presume, of
sending state employees across the country is to gather the latest
information on stem cell science and issues and to make contacts. It
is a bit of a bonus for the public to have the CIRM attendees also
file stories on the sessions.
A couple of the items caught my
attention. One dealt with patient advocates and their role in
energizing and helping to drive funding for research. Another item
discussed what appear to be growing issues with dubious stem cell treatments and the damage they can do to the field in general.
Lomax summarized the signs of a stem
cell scam like this:
  • “Claims of miracle cures for
    diseases
  • “Single treatments or cells that
    can treat any type of disease
  • “Lack of objective information,
    evidence (such as published medical reports) that a treatment is
    effective
  • “Treatment by a doctor who is
    not trained or certified to treat the specific disease
  • “No system exists to collect
    information and follow up with patients”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/usBXfuFwqy4/extra-extra-cirm-staffers-blog-world.html

Read More...

$80 Million in Grants, Money for Viacyte and Blue-Ribbon Report on California Stem Cell Agency

Sunday, December 9th, 2012

Directors of the California stem cell
agency are expected to give away $80 million next week to 20
fortunate researchers in addition to exploring a “commercialization
and industry engagement plan.”

The subjects are on tap for the Dec. 12 meeting in Los Angeles of the governing board of the $3 billion
research effort.
The $80 million grant round is aimed at
“career development of physician scientists working in
translational stem cell research.”
The RFA said

“This award will fund promising
physician scientists in the critical early stages of their careers as
independent investigators and faculty members establishing their own
laboratories and programs.” 

Summaries of the grant reviewers
comments and application scores should be available sometime this
week. The bare-bones agenda lacked elaboration on the
commercialization plan.
Directors are additionally scheduled to
hear a presentation on the blue-ribbon report by the Institute of
Medicine
for which the agency is paying $700,000. The report has been
17 months in the making and is scheduled to be released this
Thursday.
Other interesting matters are on the
table, although the agency has yet to produce background material
laying out any details. The subjects include:
  • More money – no amount yet specified
    – for Viacyte, Inc, of San Diego, which has received more than $36
    million from CIRM.
  • An update of the agency's response to
    the only performance audit conducted at the agency. The audit
    identified 27 areas where improvement is needed, but the governing
    board has not discussed the results publicly since they were
    disclosed last May.
  • Approval of the concept plan for
    another round of basic biology grants and adoption of conflict of
    interest code changes.

Interested parties will be able to take part at the meeting location in Los Angeles and teleconference locations in La Jolla, Oakland and UCSF. If you are interested in
the teleconference locations, you will need to contact the agency for more specific directions than are provided on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/RU_xC86oAyw/80-million-in-grants-money-for-viacyte.html

Read More...

Update on Move To Curb Researcher Appeals at California Stem Cell Agency

Sunday, December 9th, 2012

Directors of the $3 billion California
stem cell agency are still mulling details of changes in their
free-wheeling and sometimes emotional appeals process for grant applications
that are rejected by the agency's reviewers.

A special task force of directors met last week
for the second time to discuss the likely alterations. Kevin McCormack, spokesman for the agency, said
the group made no decisions. Another meeting will be held later at a
date to be determined. The task force's recommendations will then go
before the full board, probably in late January.
McCormack said members of the panel
have asked for “more details regarding the process that would be
employed if the appeals and extraordinary petition processes were
merged.”
The agency has an odd, bifurcated
appeals process. Early in its existence, the agency said appeals of
reviewer decisions could be based only on conflicts of interest.
However, researchers have a right under state law to speak to the
governing board in public on any issue whatsoever. As some
researchers began to use that avenue to ask for reconsideration of
their applications, the CIRM board created what it called
“extraordinary petitions” in an effort to control the process and
limit appeals. Both the “appeals” and “extraordinary petitions”
are, in fact, appeals but on different grounds and employing different
mechanisms.
The task force was created in September
after directors complained about “arm-twisting” and “emotionally charged presentations” in connection with a record number of
appeals earlier this year.
Here is a link to an item about the task force's first meeting. Here is a link to an agency summary of the task force's deliberations prior to last week's meeting. The
transcript of the session should be available on the CIRM web site
within the next two weeks. It will be found under the meetings
section of the web and then under the heading for the task force's
November session.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Hkq7zcXyMsQ/update-on-move-to-curb-researcher.html

Read More...

Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’

Sunday, December 9th, 2012
Jonathan Thomas
CIRM Photo

Jonathan Thomas, the Los Angeles bond
financier who is chairman of the $3 billion California stem cell agency, has
weighed in at more length on the sweeping recommendations from the
Institute of Medicine for changes at the agency.

He wrote a piece for the agency's blog
that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press
release yesterday that said the IOM “praises the agency as a 'bold
social innovation.'”
Thomas did acknowledge that the report
“highlighted some areas and made some recommendations about where
and how we might improve our performance.” 
Thomas concluded by saying the agency
takes the report seriously and will, over the next few months,
consider how best to respond.
Nearly needless to say, other observers
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html

Read More...

IOM Proposals for Overhaul at CIRM Win High Marks

Sunday, December 9th, 2012

The Institute of Medicine's
recommendations for major changes at the California stem cell agency
today received generally high marks from independent observers and
critics.

Many of the proposals echoed
suggestions from California's Little Hoover Commission, the
state's good government agency. Asked for comment, Stuart Drown, the
commission's executive director, said,

“The institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009."

He continued,

“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”

The California Stem Cell Report also
asked the agency's first president, Zach Hall, for his thoughts. Here
is the full text of what Hall, who was one of the peer reviewers on
the IOM study, had to say,

“The IOM Committee and its staff have
done an impressive job.  The report recognizes the scientific
value and achievements of the CIRM and, at the same time, makes
cogent recommendations that, if taken seriously, will further improve
the quality and the public credibility of the Institute. The
committee and staff deserve the thanks of the scientific community
and all California citizens for their careful and thoughtful work.” 

John M. Simpson, stem cell project
director for Consumer Watchdog of Santa Monica, Ca., said,

“It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,” 

Marcy Darnovsky, associate executive
director of the Center for Genetics and Society of Berkeley, Ca.,
welcomed the recommendations. But she said,

“Given the agency’s shortcomings
and the state’s budgetary problems, it would be wrong to ask
Californians to give it more public money. If the agency acquires new
funds from industry sources or venture firms, it must recognize that
it has ongoing obligations to the people of California.” 

She continued,

 “CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2009 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.” 

The California Stem Cell Report also
queried most of the 10 patient advocates on the agency's governing
board for comment. Their roles could be altered in a major way by the
IOM recommendations. None of the advocates have yet responded.
(The full text or nearly
full text of all the above comments is available here.)  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/yyZ0TAisMZQ/iom-proposals-for-overhaul-at-cirm-win.html

Read More...

Text of Comments Reacting to IOM Report on California Stem Cell Agency

Sunday, December 9th, 2012

Here is the full text or the essential
elements of comments sought by the California Stem Cell Report on the
Institute of Medicine report that recommended sweeping changes at the
California stem cell agency. Consumer Watchdog and the Center for
Genetics and Society
put their comments in the form of news releases,
which contained redundant material.

From Stuart Drown, executive director
of California's Little Hoover Commission:

“CIRM initiated the Institute of
Medicine review, which is to its credit.  The Institute of
Medicine took a scrupulous and rigorous approach to its review of the
California Institute of Regenerative Medicine and in its report,
notes CIRM’s many achievements and accomplishments.

“The Institute’s recommendations
for much-needed changes to CIRM’s governance structure to provide
greater efficiency, clarity and accountability reinforce the
recommendations the Little Hoover Commission made in 2009. The
institute graciously acknowledged the commission’s work, which
clearly is as relevant now as it was in 2009.

“Then and now, the Commission’s
recommendations are aimed at improving CIRM’s ability to meet its
goals for the good of all who can benefit from stem cell research,
and to ensure that California taxpayers’ dollars are put to their
most efficient use to that end.”

From John M. Simpson, stem cell project
director at Consumer Watchdog of Santa Monica, Ca.(full press release here):

“Consumer Watchdog Thursday welcomed
a report from the prestigious Institute of Medicine (IOM) calling for
sweeping reforms in governance at California’s stem cell agency and
an end to the board’s built-in conflicts of interest. 

“The report said that 'far too many
board members represent organizations' that receive funding or
benefit from the stem cell agency. The IOM said that the board’s
oversight function should be separated from the day-to-day management
of the California Institute for Regenerative Medicine (CIRM). 

“'The IOM's critical report echoes
what every independent evaluator has said in the past,' said John
M. Simpson, Consumer Watchdog’s Stem Cell Project director.
'As we have repeated from the beginning, CIRM suffers from built-in
conflicts of interest and needs to separate the board's oversight
function from day-to-day management.'

“'It's long past time to make the
changes the report calls for, but given the spin the agency put on
its response -- saying the report praises the 'agency as a bold
innovation' -- shows it's business as usual. This sort of behavior
will only ensure that CIRM doesn't get another round of public
funding,' Simpson said.”

From Marcy Darnovsky, associate
executive director of the Center for Genetics and Society in
Berkeley, Ca.(full press release here):

“The Center for Genetics and Society,
a nonprofit policy research and advocacy organization, welcomed the
report on the California stem cell agency released today by the
Institute of Medicine and called for stronger protections for  the interests of Californians as
the agency continues its disbursement of public funds.

“CIRM is nearing the end of the
billions of dollars of public funding allocated to it in
2004. The agency is currently considering how to extend
its operations after the money runs out. CGS Associate Executive
Director Marcy Darnovskysaid, “Given the agency’s
shortcomings and the state’s budgetary problems, it would be wrong
to ask Californians to give it more public money. If the agency
acquires new funds from industry sources or venture firms, it must
recognize that it has ongoing obligations to the people of
California.”

“She continued, 'CIRM has not
responded in a meaningful way to many previous public interest
suggestions or to independent reviews, including the one in 2008 by
the state’s Little Hoover Commission. We hope the agency will not
continue that pattern.' 

“'Today’s report from the IOM
reaffirms the significance of the conflicts of interest and
structural flaws that were built into the stem cell program from the
beginning, and that continue to threaten its credibility and
effectiveness. These are serious problems that the Center for
Genetics and Society and other public interest voices pointed out
even before the agency was approved by the 2004 ballot measure on
which backers spent some $35 million. 

“'Many aspects of these early
concerns remain directly relevant,' Darnovsky said. 'There is
still no way for elected officials to provide oversight because the
measure that created CIRM requires a 70% vote by both houses – more
than a supermajority. The agency’s governing board is still tainted
by its built-in conflicts of interest, and still includes no
representation of the public beyond disease advocates. Members of the
agency’s powerful Working Groups, including the one that reviews
grant applications, are still not required to publicly disclose their
individual financial interests.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iu4DrhoewYo/text-of-comments-reacting-to-iom-report.html

Read More...

Coverage of the IOM Report: Light but a Column with a Cutting Edge

Sunday, December 9th, 2012

News coverage has been light so far
today of the Institute of Medicine's recommendations for an overhaul
at the $3 billion California stem cell agency. But a Pulitzer Prize-winning columnist from the Los Angeles Times took a sharp knife to the agency's press release on the IOM report.

Michael Hiltzik, who is a regular critic of the agency, asked,

 "So how did CIRM react to the report? Even before the review panel's conference call with the press was completed, the agency issued a news release stating that the panel had 'praised' the agency 'for its ground breaking work in helping advance the science of stem cell research.'"If you wanted to know about the committee's criticisms, the first mention of those was in paragraph 9 of the news release. It quoted board Chairman Jonathan Thomas as promising to 'work on establishing a process to enable us to consider how best to proceed with reviewing the recommendations.' 

"By my count, that's seven steps it will take before actually acting on the recommendations. 

"As it happens, the panel's recommendations, which include creating a majority of independent board members without any potential conflicts of interest, track very closely to recommendations made by several previous outside reviews of CIRM, especially a 2009 study by the state's Little Hoover Commission.

"CIRM rejected almost every one, and it looks to be preparing to circle the wagons again against sensible improvements in the way it does business."

The Associated Press story by Alicia
Chang 
popped up in two different forms on the Washington
Post
web site and in Ottowa and Spokane, among other places. Chang
was on board for the IOM news conference and had this to say about
CIRM from one of the IOM study group members.

“'They’re not broken but they’re
bent,' said Sharon Terry, president of the nonprofit Genetic Alliance
who was part of the panel. 'They need some correction.'”

Chang's story originally began,

“California has transformed into a
powerhouse player in stem cell research, but the taxpayer-funded
institute responsible for that needs an overhaul, a report released
Thursday found.”

Another version, that appeared in
Ottowa and Spokane and beyond, started this way,
“A report says California’s stem
cell agency needs more independent oversight and recommends a
restructuring to avoid the appearance of conflict of interest.”
Ron Leuty of the San Francisco
Business, who is one of perhaps two reporters who regularly cover
the stem cell agency, wrote,

“A review of California's stem cell
research funding agency proposed changes to the agency's governing
structure and commercial goals while praising its results so far. The
124-page report from the Institute
of Medicine
 recycles many conflict of interest and
intellectual property concerns that have dogged the San
Francisco-based” agency.

Stephanie O'Neill at KPCC radio in Los
Angeles also had a story.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XpN8S2N2-iw/coverage-of-iom-report-light-but-column.html

Read More...

More IOM-CIRM Coverage: One Story Notes Major 2007 Conflict Flaps at Stem Cell Agency

Sunday, December 9th, 2012

Additional coverage emerged this morning,
including stories in the Los Angeles Times, the Nature web site and
Businessweek. on a blue-ribbon report that recommended sweeping changes
at the the $3 billion California stem cell agency

In the Times, California's largest
circulation newspaper, Eryn Brown's story was headlined,

"Stem cell
agency board criticized for conflicts of interest."

The article began,

"The board of California's stem cell
funding agency is rife with conflicts of interest and should be
restructured to improve the integrity of its grant-making process,
according to a new report from independent experts convened by the
national Institute of Medicine."“

In the San Diego U-T, reporter Bradley
Fikes
' article was the only piece in all the coverage to mention two major conflict-of-interest flaps at the agency in 2007.
One involved then CIRM board member
John Reed, head of Sanford-Burnham in La Jolla, who tried to influence CIRM staff
in connection with a grant to his organization, triggering
an investigation by the state's political ethics commission. (Reed's
actions were first disclosed by the California Stem Cell Report.) The
other case involved inappropriate actions by four members of the
29-member board in an $85 million round. Ten applications were dumped
from the round because of the directors' actions. The conflict
issues were so rampant that only eight of the directors present at a
December 2007 meeting could discuss the issues.
(See here, here and here.)
On the Nature news blog, Monya Baker
had a thorough piece that said the agency “received a mixture of
praise and hard-to-enact recommendations from an august scientific
body.” She also wrote,

“It’s unclear what effect the
report will have. Many of these recommendations run counter to
requirements enshrined in the legislation that created CIRM, and the
board of CIRM has heard similar recommendations before and failed to
act on them.”

On the web site of the journal Science,
Greg Miller wrote that IOM report "praises the California Institute for
Regenerative Medicine
(CIRM) as a 'bold social innovation' that
provided a creative new source of funding that has turned the state
into an international hub of stem cell research. But the IOM panel
authoring the report also concluded that the funding agency’s
organization and governance is not optimal."
Businessweek carried the AP story by
Alicia Chang mentioned yesterday. The AP story also appeared on the San
Francisco Chronicle
and Sacramento Bee web sites and was also carried internationally on other web sites.  The Chronicle also had a staff story by Erin Allday.  
(An earlier version of this item did not contain the last sentence regarding the Allday story.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/yk8zuHF6IKA/more-iom-cirm-coverage-one-story-notes.html

Read More...

IOM Recommends Sweeping Changes at California Stem Cell Agency

Sunday, December 9th, 2012

A blue-ribbon study of the $3 billion
California stem cell agency today said the program has “achieved
many notable results,” but recommended sweeping changes to remove
conflict of interest problems, clean up a troubling dual-executive
arrangement and fundamentally change the nature of the governing
board.

The recommendations from the 17-month
study by the Institute of Medicine (IOM) 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.
Harold Shapiro, chairman of
IOM-CIRM  panel
Princeton University Photo

Harold Shapiro, former president of
Princeton University and chairman of the IOM study panel, said,
“Overall, CIRM (the California
Institute for Regenerative Medicine
) has done a remarkably good job”
in giving the state a prominent position in regenerative medicine.
But he said the stem cell field has “evolved”and CIRM needs to
change with it.
As for turning research into cures, the
report said,

 “The challenge of moving its research programs
closer to the clinic and California’s large biotechnology sector is
certainly on CIRM’s agenda, but substantial achievements in this
arena remain to be made.”

Asked for comment, J.T. Thomas, chairman of the CIRM governing board, said it was premature to offer an opinion on the report, which will be presented to directors Dec. 12 at their Los Angeles meeting. (See here for the full text of Thomas' remarks.)
The study was conducted at the behest
of CIRM, which paid the IOM $700,000. The IOM is a prestigious
non-profit organization that was created in 1970 to provide
authoritative advice to policy makers and the public.
In 2010, when directors authorized the
study, Robert Klein, then chairman of the CIRM board, and other board
members said that they hoped the study would lead to
another multibillion dollar state bond issue to support the
agency(see here and here). Duane Roth, a San Diego businessman and co-vice chairman of
the CIRM governing board, was the lone no vote on the study. He
warned directors that that they could not “go in just sort of blind
trust that (the IOM is) going to reach the conclusion you want them
to reach.”
The agency will run out cash for new
grants in four years. Currently California remains in the throes of
state budgetary problems, and the agency has put on hold talk of another bond
election. It has also broached the possibility of
seeking private funding.
The IOM report said the agency should
develop a full-blown “sustainability platform” and plans that would
spell out its likely financial structure and future rules on grants
and their administration, including intellectual property.
The study echoed concerns and
complaints about CIRM's operation that were aired even before the
agency was officially created by voters in 2004. One of those
involves the built-in conflicts of interests on the CIRM governing
board. As of September, 92 percent of the $1.7 billion handed out by the agency had gone to institutions linked to persons serving on the 29-member board.
The report 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(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”

The IOM cited an ongoing scandal in Texas dealing with that state's $3 billion cancer agency. The flap
has led to mass resignations of the agency's grant reviewers. The
IOM said,

“Recent controversy surrounding the
Cancer Prevention and Research Institute of Texas grants process
illustrates the importance of rigorous scientific review free from
inherent or perceived conflict and the consequences when these
boundaries appear to be breached.”

However, the IOM press release said,

“Because the committee was not
charged with reviewing CIRM's past funding decisions, it did not
identify any specific cases of conflict.”

The IOM surveyed members of the board (ICOC) about conflicts of interest. The report said,

 "While a majority of respondents stated
that personal interests did not play a role in their work on
the ICOC, some responses were more equivocal. One respondent replied that it was 'hard
to tell' given that 'so many decisions take place off camera in secret meetings,' while another
acknowledged that ICOC members are human, and of course their decisions are influenced by
personal beliefs and interests."

To help deal with conflicts of
interest, the IOM recommended that the CIRM governing board not be
allowed to approve individual grants. Instead, the board would be
given a slate of applications that would be approved as a block. All
CIRM board members would be removed from the grant review committee
and the grant review process would be turned over to the president of
the agency, currently Alan Trounson.
The IOM recommended that a majority of
the board consist of “independent” members and said that the
board should not be increased beyond its current 29 members, although
it could be shrunk.
Conflict of interest rules should be
revised to deal with personal conflicts, which could have a major
impact on the 10 patient advocate members of the board but also
other directors and possibly staff who have family members with health issues. The report said,

“California law focuses primarily on
financial conflicts of interest, but the committee believes that
personal conflicts of interest arising from one’s own or a family
member’s affliction with a particular disease or advocacy on behalf
of a particular disease also can create bias for board members.
Studies in psychology and behavioral economics show that conflict of
interest leads to unconscious and unintentional 'self-serving bias'
and to a 'bias blind spot' that prevents recognition of one’s own
bias. Bias distorts evaluation of evidence and assessment of what is
fair.”

The IOM said that the board is much too
involved in operational matters, including the chair and the two
vice-chairs. The report said,

“The board should transfer management
responsibilities to management so it can provide truly independent
oversight and evaluation of management, strategic planning, and broad
direction for resource allocation.”

The IOM repeatedly and favorably cited
a 2009 study by California's Little Hoover Commission, the state's good
government agency. It noted that CIRM rejected most of the commission's recommendations. The IOM also cited recommendations by the agency's own “external review” panel in 2010 and suggestions
this year from the first performance audit of the agency, which cost
CIRM $234,944.
Many of the IOM's recommendations would
require either legislative approval or another ballot initiative.
However, changes in the Prop. 71, the ballot initiative that created CIRM, require a politically difficult super, supermajority
vote (70 percent) of the both houses of the legislature and the
signature of the governor. The requirement was written into the
10,000-word initiative and has been used by CIRM to block legislation
that it did not favor.
Here is brief rundown on some of the
other IOM recommendations:
  • Greater engagement with industry to
    commercialize stem cell research. Noting that industry has received
    only 6 percent of the agency grants, the report said business
    representation on CIRM working groups and other committees “should
    be enhanced to leverage industry’s expertise and resources in
    product development, manufacturing, and regulatory approval in
    support of the ultimate goal of bringing therapies to patients.”
  • Elimination of the current process in
    which applicants rejected by reviewers appeal publicly to the
    governing board. Noting that 32 percent of “extraordinary
    petitions” have been successful, the report said they “undermine
    the credibility and independent work” of grant reviewers. Instead
    appeals would heard only by staff behind closed doors.
  • Creation of a new scientific advisory
    board, appointed by the CIRM president with a majority from outside
    of California, instead of multiple advisory groups. The report said,“Such an external board would be
    invaluable in vetting ideas for new RFAs, suggesting RFAs that
    otherwise would not have been considered, and helping CIRM maintain
    an appropriate balance in its research portfolio. Input from this
    board would help CIRM make fundamental decisions about dealing with
    challenges that cut across particular diseases, decide which
    discoveries should progress toward the clinic, and determine how best
    to engage industry partners in developing new therapies.”
  • Funding of programs on bioethics and
    regulatory problems. The report said,“It is difficult for researchers to
    find appropriate funding for stem cell-specific ethics and policy
    work, and filling this funding gap is well within CIRM’s budget.”
One final note: As mentioned
earlier, Duane Roth, co-vice chairman of the agency, was the only no
vote on the board when it authorized the IOM study in 2010. The IOM today said,

“The critical tasks performed by the
vice chairs should be reassigned to management. In particular, the
important tasks of government relations and corporate relations both
should be carried out by staff reporting to the president rather than
by the vice chairs of the board.”

For more excerpts from the report, see this item.
,  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/O67cWrCCsco/iom-recommends-sweeping-changes-at.html

Read More...

Excerpts from the IOM Report on the California Stem Cell agency

Sunday, December 9th, 2012

Here are excerpts from the $700,000 Institute of Medicine (IOM) report on the $3 billion California stem cell
agency -- the California Institute of Regenerative Medicine (CIRM).

Overall Comments
“Improvements to CIRM’s governance
structure, scientific program, and policies are critical to bet­ter
serving California taxpayers who elected to devote funding to promote
stem cell research in the state. The necessary changes outlined by
the IOM committee, if enacted by the state and/or the institute,
would help to instill confidence among the scientific community and
California residents in the vital work that CIRM is accomplishing.”
“It is the committee’s judgment
that overall, CIRM has done a very good job of initially establishing
and then updating the strategic plans that have set priorities for
and guided its programs, and of taking advantage of its guaranteed
flow of $300 million a year for 10 years to establish a sustainable
position in regenerative medicine for California. The challenge of
moving its research programs closer to the clinic and California’s
large biotechnology sector is certainly on CIRM’s agenda, but
substantial achievements in this arena remain to be made.
“Despite its demonstrable
achievements to date, as well as the largely positive independent
reports covering various aspects of its operations, no one would
claim that CIRM is a perfect organization or that it should adhere
slavishly to its initial form of organization, set of regulations, or
pattern of priorities. The field of regenerative medicine has
advanced rapidly since November 2004, and CIRM itself has seen the
need to alter its activities and approaches in some areas. The
committee believes the same should be true of its governance
structure, some of its administrative practices, and its use of
external perspectives on strategic scientific priorities and on the
evaluation of other key policies, such as intellectual property, to
ensure that they continue to encourage the development and deployment
of new treatments.”
“While the restrictions on amending
the administrative structure of CIRM established in Proposition 71
had the advantage of protecting the institute’s ongoing operations
from outside interference in an ethically controversial arena, they
also made it difficult to modify the organization’s structure in
response to experience and/or changing circumstances. Moreover, these
protections, whatever their benefits, appear to some to shield CIRM
from the normal accountability mechanisms in place for state
agencies.”
Conflicts of Interest
“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. Neither the board
chair nor board members should serve on any working group. The board
itself should include representatives of the diverse constituencies
that have an interest in stem cell research, but no institution or
organiza­tion should be guaranteed a seat.”
“The problematic perception of
conflicts of interest has persisted for as long as CIRM has existed.
The IOM committee would be less concerned about individual board
members with actual or perceived conflicts of interest if the board
membership included more truly independent members. The majority of
board members should be independent, with no competing or conflicting
personal or professional interest. Broader representation from a
wider variety of stakeholders will inject new perspectives into the
panel and will help to dispel the perception of conflicts of
interest.
“CIRM also should revise its conflict
of interest definitions to include non-financial interests, such as
the potential for personal conflicts of interest to arise from one’s
own affliction with a disease or personal advocacy on behalf of that
disease. CIRM policies for managing conflicts of interest should
apply to that broader definition.”
Structure and Governance
“Currently, the ICOC (the agency's
governing board) functions both as an executor and as an
overseer—competing duties that compromise the ICOC’s critical
role of pro­viding independent oversight and strategic
direc­tion. The IOM committee recommends that CIRM’s operations
be separated from its over­sight. The board should delegate more
author­ity and responsibility for day-to-day affairs to the
president and senior management, and the ICOC’s three working
groups should report to senior management within CIRM, rather than to
the ICOC. The moves would permit the board to better focus its energy
and collective talent on strategic planning, overseeing financial
perfor­mance, ensuring legal compliance, assessing the
president’s performance, and devising a plan for preserving and
expanding its considerable assets to permit the institute to continue
its important work after the bond measures end.”
Unrealistic Goals
“While the latest round of awards
challenge teams to have filed a request to begin clinical trials or
to have completed early-stage trials in patients within four years,
the committee feels these ambi­tious goals are unrealistic. New
therapies take more time to progress to federal approval, and
early-stage clinical trials are beset by a stagger­ingly high
failure rate. Rather than judging suc­cess by simply tallying the
number of active clini­cal trials, the IOM committee suggests
that CIRM also continue its focus on underlying biological mechanisms
that drive the success or failure of a promising therapy and on
careful design of clini­cal trials. Advances in these areas will
help the entire field progress, even if a specific drug candi­date
is not approved." 
Economic Impact
“In the short term, CIRM’s
expenditures are supporting approximately 3,400 jobs and their
innovative efforts have also attracted substantial additional private
and institutional resources to this research arena in California
CIRM’s long-term impact on such critical aspects of the California
economy as state tax revenues and health care costs beyond the
shorter-term and temporary impact of its direct expenditures cannot
be reliably estimated at this point in CIRM’s history.... (T)he
estimate of the Analysis Group (2008) that the CIRM program alone
would support about 3,400 jobs as long as it was allocating about
$300 million per year in research and development grants appears
quite reasonable to the committee. To put this estimate in context,
however, total employment in California is roughly 16 million, and
NIH alone provides more than $3.5 billion per year to California
research institutions.”
Intellectual Property
“CIRM should propose regulations that
specify who will have the power and authority to assert and enforce
in the future rights retained by the state in CIRM-funded
intellectual property. CIRM should seek to clarify which state
agencies and actors will be responsible for the exercise of
discretion currently allocated to CIRM and the ICOC (the CIRM
governing board) over future determinations on issues regarding
march-in rights, access plans, and revenue-sharing rights that might
arise years after CIRM's initial funding period has passed.... (T)he
ICOC should reconsider whether its goal of developing cures would be
better served by harmonizing CIRM’s IP policies wherever possible
with the more familiar policies of the Bayh-Dole Act(federal IP law).

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Td6TGOVGYNo/excerpts-from-iom-report-on-california.html

Read More...

Page 69«..1020..68697071..8090..»


2024 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick