Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’
By Dr. Matthew Watson
 |
| 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.
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.'”
“highlighted some areas and made some recommendations about where
and how we might improve our performance.”
takes the report seriously and will, over the next few months,
consider how best to respond.
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html
Stem Cell Therapy
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December 9th, 2012
IOM Proposals for Overhaul at CIRM Win High Marks
By Dr. Matthew Watson
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.
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."
“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.”
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.”
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,”
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.”
“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.”
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.
full text of all the above comments is available here.)
Source:Stem Cell Therapy
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December 9th, 2012
Text of Comments Reacting to IOM Report on California Stem Cell Agency
By Dr. Matthew Watson
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.
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.”
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.”
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:Stem Cell Therapy
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December 9th, 2012
More IOM-CIRM Coverage: One Story Notes Major 2007 Conflict Flaps at Stem Cell Agency
By Dr. Matthew Watson
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
circulation newspaper, Eryn Brown's story was headlined,
"Stem cell
agency board criticized for conflicts of interest."
"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."“
Fikes' article was the only piece in all the coverage to mention two major conflict-of-interest flaps at the agency in 2007.
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.
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.”
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."
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:Stem Cell Therapy
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December 9th, 2012
Coverage of the IOM Report: Light but a Column with a Cutting Edge
By Dr. Matthew Watson
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."
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.'”
“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.”
Ottowa and Spokane and beyond, started this way,
cell agency needs more independent oversight and recommends a
restructuring to avoid the appearance of conflict of interest.”
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.
Angeles also had a story.
Source:Stem Cell Therapy
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December 9th, 2012
IOM Recommends Sweeping Changes at California Stem Cell Agency
By Dr. Matthew Watson
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.
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 |
Princeton University and chairman of the IOM study panel, said,
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.
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.”
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.
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.”
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.
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.
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.
“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.”
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.”
“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."
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 board consist of “independent” members and said that the
board should not be increased beyond its current 29 members, although
it could be shrunk.
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.”
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.”
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.
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.
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.”
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.”
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December 9th, 2012
Text of CIRM Chairman’s Comments on the IOM Report
By Dr. Matthew Watson
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:Stem Cell Therapy
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December 9th, 2012
Excerpts from the IOM Report on the California Stem Cell agency
By Dr. Matthew Watson
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).
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.”
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.
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.”
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.”
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.”
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.
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.”
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.”
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."
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.”
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:Stem Cell Therapy
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December 9th, 2012
Collapse of Big Pharma Deal Involving California Stem Cell Agency
By Dr. Matthew Watson
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.
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.
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.
“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 Glaxo decision.
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.
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.
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.
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:Stem Cell Therapy
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December 9th, 2012
Extra, Extra! CIRM Staffers Blog the World Stem Cell Summit
By Dr. Matthew Watson
Years ago, I worked with an editor who
used to advise his lagging scribes to put their noses in their
typewriters and peck.
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.
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.
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.
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.
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:Stem Cell Therapy
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December 9th, 2012
$80 Million in Grants, Money for Viacyte and Blue-Ribbon Report on California Stem Cell Agency
By Dr. Matthew Watson
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.”
research effort.
“career development of physician scientists working in
translational stem cell research.”
“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.”
comments and application scores should be available sometime this
week. The bare-bones agenda lacked elaboration on the
commercialization plan.
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.
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:Stem Cell Therapy
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December 9th, 2012
Update on Move To Curb Researcher Appeals at California Stem Cell Agency
By Dr. Matthew Watson
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.
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.
have asked for “more details regarding the process that would be
employed if the appeals and extraordinary petition processes were
merged.”
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.
after directors complained about “arm-twisting” and “emotionally charged presentations” in connection with a record number of
appeals earlier this year.
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.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Hkq7zcXyMsQ/update-on-move-to-curb-researcher.html
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December 9th, 2012
An all natural skincare serum based on stemcells science – Video
By Sykes24Tracey
An all natural skincare serum based on stemcells science
Independent clinical trials show DRAMATIC results - 25% fewer wrinkles,30% more moisture and 10% more elasticity...in just 28 days! Our breakthrough serum revitalizes the skin at the cellular level, to restore and maintain the skin #39;s youthful vibrance. DermaStem is a mocha-hued fusion of natural oils that blends invisibly into the skin. This all-natural serum contains a velvety emulsion of the world #39;s most restorative ingredients. This revolutionary product works to reduce the signs of premature aging by supporting the work of skin stem cells, the natural renewal system of the skin. For order online or more information,please contact us at http://www.myonline.stemtechbiz.com or email to fusioncreations@gmail.com.From:Tony Lim Careen SeeViews:1 0ratingsTime:06:48More inHowto Style
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December 7th, 2012
WISE Surgical Solutions LLC Announces Project Hope: Helping People with Debilitating Conditions Including Arthritis …
By Dr. Matthew Watson
With millions of people in aggregate suffering from debilitating disease, reduced mobility, or relentless pain associated with various conditions, stem cell medicine is available now through WISE Surgical Solutions LLC by direct flight from some major cities to our Joint Commission International Accredited Johns Hopkins affiliated Punta Pacifica Hospital in Panama.
New York (PRWEB) December 06, 2012
Cathy Nenninger, Chief Executive Officer of WISE Surgical Solutions LLC, shared why this offering is important. When I ran wound centers up and down the east coast, I used to get calls from patients and family members desperate for treatments to help alleviate severe symptoms of ailments such as these. It was heartbreaking that we were not able to provide any type of help or hope to these patients. Granted, while the response and success of stem cell treatment in patients varies greatly and by disease, patients who are in extreme discomfort or experiencing reduced function or quality of life deserve to know that they have options available to them.
A significant element of PROJECT HOPE, continues Ms. Nenninger, is the opportunity for community funding of the treatment. Often, families and communities want to help someone by making donations that will collectively fund a surgery or procedure which in itself can add another chore to the already stressed world of a Care Captain (person seeking help for another); Our goal is to make the process easy. For more information on Project Hope, call (631) 942-6040 or for a quote for service, fill out a medical history form available at http://www.WISESurgicalSolutions.com.
WISE Surgical Solutions LLC is based out of New York and caters to companies and patients seeking quality healthcare at an affordable price inclusive of travel. Offerings include medical, dental and surgical procedures of most types, in-vitro fertilization (IVF) and stem cell medicine. Community & group funding as well as financing options are available for patients. Media relations inquiries can be directed to (631) 909-8538 or emailed to surgsolutions(at)optimum(dot)net.
Cathy M. Nenninger, MBA Wise Surgical Solutions LLC (631) 942-6040 Email Information
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December 6th, 2012
Kell – ASD – 3 day after Stem Cell Treatment Part 2 – Video
By Sykes24Tracey
Kell - ASD - 3 day after Stem Cell Treatment Part 2
For more information about ASD and Stem Cell Therapy, please visit worldstemcells.com © 2012 World Stem Cells LLCFrom:WorldStem CellsViews:2 2ratingsTime:17:14More inScience Technology
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December 5th, 2012
Making Stem Cell Thearpy Safer – Mayo Clinic – Video
By daniellenierenberg
Making Stem Cell Thearpy Safer - Mayo Clinic
Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. Study Author, Dr. Timothy Nelson provides and overview.From:mayoclinicViews:45 0ratingsTime:02:04More inScience Technology
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December 5th, 2012
Precision StemCell's Neural Reprogrammed Stem Cell Therapy Yields Better-Than-Expected Results for ALS Patients
By JoanneRUSSELL25
GULF SHORES, Ala., Dec. 4, 2012 /PRNewswire/ --More than 75 percent of amyotrophic lateral sclerosis (ALS) patients who received neural reprogrammed stem cell therapy have shown a positive response to the procedure. The groundbreaking technique was introduced to the United States this year by Precision StemCell (http://www.precisionstemcell.com), an outpatient imaging and image-guided treatment facility located in Gulf Shores, Ala.
The procedure is performed by Dr. Jason R. Williams, a board-certified radiologist with extensive training in image-guided procedures. Under his care, 14 out of 18 patients diagnosed with ALS, also known as Lou Gehrig's disease, have shown signs of recovery.
"The improvements are mild, with patients reporting improved movement, breathing and speech, but we still have a long way to go," Dr. Williams stated. "Only time will tell how this therapy will affect the patients' long-term prognosis."
In Precision StemCell's neural reprogrammed stem cell therapy, fat-derived stem cells are injected into the spine of the patient. Dr. Williams uses a drug called selegeline, which has been shown to be a pre-inducer of adipose-derived stem cells into neural-like cells. Dr. Williams contends that the therapy is probably one of the largest advances seen in ALS therapy. "Before we started this therapy, I would have been happy just to see the progression of the disease halted, but to see some actual improvement, that was just shocking," he said
The first patient treated with the technique was Frank Orgel who continues to see improvement since his first treatment seven months ago. Eight years ago, Orgel's quality of life had declined to the point that he could not move his left arm or leg, walk or even stand on his own. The therapy has allowed Orgel to stand without assistance, and he continues to work with a physical therapist to regain the ability to walk. Another patient, Dexter Johnson, previously walked with a cane. After the treatment, Johnson has been able to walk without his cane for the majority of the time and he has been able to walk at a much faster pace.
The Precision StemCell center focuses on advanced imaging techniques, which include a 3T Open MRI, a low-dose 64-Slice CT Scanner, ultrasound and fluoroscopy, also known as real-time x-ray. The center is headed by Dr. Williams, who specializes in image-guided procedures, had already been performing magnetic resonance imaging (MRI), computed tomography (CT), ultrasound and fluoroscopy-guided stem cell injections for joint and orthopedic conditions.
In addition to their current work on advanced stem cell harvesting and processing with image-guided stem cell injections, Precision StemCell staff are planning to conduct further research so as to develop even more advanced techniques such as adding gene therapy to the current neural reprogramming platform. "Our therapy techniques not only hold promise for ALS patients, but also for people with other neural-related conditions such as Parkinson's and spinal cord injuries," said Dr. Williams. "There are several candidate genes that we plan to add to the adipose-derived stem cells and study in the mouse model. Though we are happy with our initial progress, our goal is to develop an effective cure."
About Precision StemCell
Located in Gulf Shores, Alabama, Precision StemCell conducts stem cell procedures using advanced imaging techniques, which include an Open 3T MRI, a low-dose 64-Slice CT scanner, ultrasound, and real time x-ray (fluoroscopy). Headed by Jason Williams, MD, a board-certified radiologist with extensive training in image-guided procedures, the facility performs advanced stem cell harvesting and processing with image-guided stem cell injections.
Contact:
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December 5th, 2012
.Rejuvenare Stem Cell Therapy 888-988-5456 – Video
By JoanneRUSSELL25
.Rejuvenare Stem Cell Therapy 888-988-5456
Rejuvenare Autologous Adult Stem Cell Therapy welcome video asks and answers questions on whether someone is a candidate for stem cell therapy. More can be found at http://www.rejuvenare.comFrom:rejuvenareViews:2 0ratingsTime:01:01More inPeople Blogs
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December 3rd, 2012
NeoStem to Present at Multiple Conferences in December
By Sykes24Tracey
NEW YORK, Dec. 3, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that the Company and its subsidiary, Progenitor Cell Therapy ("PCT"), will present at multiple conferences in December.
World Stem Cell Summit
RedChip Small-Cap Equities Virtual Conference
Cell Therapy Manufacturing (Informa Life Sciences' 3rd Annual VIC Congress 2012)
American Society of Hematology Annual Meeting and Exposition ("ASH")
NeoStem's abstract on VSELTM Technology titled "A Lin-CD45-CD34+ Population of Extracellular Vesicles in Human Blood That Mimics Very Small Embryonic-Like Stem Cells (VSELs) by Flow Cytometry" has been selected for publication online in December in conjunction with the ASH Annual Meeting and Exposition, December 8-11, 2012. The abstract will be available at http://bloodjournal.hematologylibrary.org/site/misc/ASH_Meeting_Abstracts_Info.xhtml.
About NeoStem, Inc.
NeoStem, continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift occurring in medicine. We anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy industry. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, PCT, with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe that, with our expertise and research capabilities and collaborations, we will achieve our mission of becoming a premier cell therapy company.
Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert to create a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we are well positioned to succeed.
For more information, please visit http://www.neostem.com.
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NeoStem to Present at Multiple Conferences in December
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December 3rd, 2012
Biotechnology: Things you should know about Gene Therapy
By Dr. Matthew Watson
Introduction
Genetic disorders are becoming common nowadays due to stressful modern lifestyle. Latest technologies are the added values to create many genetic disorders. To overcome the disorders, Gene therapy is a blessing. In order to compensate abnormal genes and make a good gene, genetic material is introduced into cells. In this way, mutated gene will act as a normal gene. Let us see in detail.
Ways to insert the gene
There are indirect ways need to be followed to make a gene to function as if it is inserted directly does not function. Carrier also called as vector is used to deliver the gene. In the place of vectors, virus play the role as they are getting modified and hence people are not affected with new diseases when it is integrated into the chromosome of the human cell.
The vectors need to get injected to specific tissue in the body or outwardly patient’s cell is removed and exposed to the vector. In either of the ways need to be again returned to the patient. Successful treatment makes proper genes and genetic disorders get solved.
Gene therapy for treating cancer
Cancer is the dangerous disease and there are many ways to cure cancer including surgery, chemotherapy, and radiation. But cancerous cells in due course again spread and hence it is a deadly disease. Gene therapy is the best way discovered nowadays for treating cancer.
Let us see the basic fundamentals of cells. cells include packets of data in genes, created either from DNA or RNA. Sequence is there for DNA and if it is in the order, there will be no problem. But at the same time If there is disorder occurs in portion of the genes either turning or changing the position, cells lost their control and abnormal growth is seen which result in cancerous tumors. It can spread in mouth, breast, lung etc.,
Specialists in Gene therapy analyze the patient’s criticality first and follow the treatment procedures. One way is they replace missing or mutated genes into wholesome genes. Inserting totally new genes for fighting cancer, placing DNA into cancerous cells to undergo chemotherapy and radiation or injecting bad gene to destroy them etc., Mesothelioma type of cancers are not at all responded in formal therapies and hence one need to undergo gene therapy essentially. Need to have consultations with doctors to overcome their deadly disease.
Gene therapy importance
Doctors decide whether gene therapy is suitable by the following approaches. If genetic disorders are from mutations in one or more genes or whether a normal copy of the gene that is available in the patient is enough to fix the problems in the affected cells, then doctors determine that gene therapy will be more helpful rather than going for traditional methods.
Conclusion
Genetic engineering is a vast topic. Latest Science innovations in the field of genetic engineering yields for gene therapy. Doctors and scientists together working to find out whether gene therapy is the best suitable way for treating deadly diseases like cancer and others. Let us salute for the positive force of gene therapy.
Source:
http://www.biotechblog.org/entry/biotechnology-gene-therapy/
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December 2nd, 2012