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Category Archives: Stem Cell Therapy
Some California Stem Cell Board Members Bristle at IOM Recommendations
Posted: December 12, 2012 at 6:52 pm
Some directors of the $3 billion California stem cell agency today sharply challenged recommendations by the Institute of Medicine(IOM) concerning conflicts of interest and the role of patient advocates on the governing board.
Much of the criticism came from the 10 patient advocate members on the board, whose roles would be significantly altered under the IOM recommendations. Jeff Sheehy, a patient advocate for HIV/AIDs and vice chairman of the agency's grant review group, said he saw no evidence in the IOM report for its recommendations regarding patient advocates. He said,
"If you had some here, I would be more comfortable."
He continued,
"We are not all powerful. We are a minority on the (29-member) board."
Jonathan Shestack, another patient/adovcate director, said the IOM's conclusions on "conflicts of interest could not possibly be more incorrect than they are." He said,
"Advocates are here to advocate."
Harold Shapiro, chairman of the IOM study, said, "We are not against patient advocates." He said that the IOM supports advocates and that its recommendations could increase the role of patient advocates, albeit in a different manner.
Shapiro added that conflicts of interest do not necessary bar participation by board members. He said, however, they must be disclosed and managed.
Director Robert Price of UC Berkeley said,
"We have gone to great lengths to manage conflicts of interest."
The IOM recommended that all board members be removed from the grant review process, which would be turned over to the CIRM president. The board would only vote on a slate of applications, not individual grants. More disclosure would be required of personal conflicts of interest, including health matters, that the board said research has shown can create bias.
The IOM 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.”
More than 90 percent of the $1.7 billion that the CIRM board has awarded has gone to institutions that are represented on the CIRM governing board.
J.T. Thomas, chairman of the CIRM board, said that the agency takes the recommendations "very seriously" and that they would discussed further at a board workshop in early January. The workshop is scheduled to be public but the date and location has not been announced. Thomas said the recommendations will receive "lengthy discussion" thereafter and review by appropriate subcommittees of directors.
No one from the public commented during the roughly 90 minute discussion. Eighteen out of 29 board members were present at the beginning of today's meeting.
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IOM Report: Many Major Changes at Stem Cell Agency Require Legislation
Posted: December 12, 2012 at 5:34 pm
As the Institute of Medicine began its presentation today to the governing board of the $3 billion California stem cell agency, one of its key directors, Sherry Lansing, pointed out that some of the IOM recommendations require legislative action and perhaps a vote of the people.
Her essential point was that the agency is hamstrung by the very measure that created it in 2004. She did not elaborate on her comment, but here is a look at some of matters she was talking about. (Lansing is chairwoman of the UC board of regents and former CEO of a Hollywood film studio.)
The ballot measure locked in management minutia and more, and then slapped on tight restrictions that make it nearly politically impossible to alter even such matters as who is in charge of production of the annual report. (By order of law, the chairman, in case you are wondering.)
And if the 29-member governing board -- so sized and specified to every nit and nat by the ballot measure -- wants to make the sweeping changes recommended by the IOM, agency directors face a formidable task in California's Capitol.
Many of
the most important recommendations for the California stem cell
agency require a vote of the California legislature and
signature of the governor. The IOM's choice of words – that these proposals “may” need legislation – is conservative. There is little doubt that legislative action would be needed to fully implement the recommendations below.
The vote needed is no simple majority. It is a rare, super,
super-majority (70 percent) of each house. The requirement was also written into state law by Proposition 71, the 10,000-word ballot initiative
that created the stem cell agency. The 70 percent requirement gives extraordinary power to minority viewpoints that must be dealt with to win passage of legislation. In the state Senate, for example, it would take only 13 senators to block a bill.
super-majority (70 percent) of each house. The requirement was also written into state law by Proposition 71, the 10,000-word ballot initiative
that created the stem cell agency. The 70 percent requirement gives extraordinary power to minority viewpoints that must be dealt with to win passage of legislation. In the state Senate, for example, it would take only 13 senators to block a bill.
With that background, here are direct quotes from the IOM report on its legislative recommendations.
Separate Operations from Oversight
The board should focus on strategic
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
management. The chair and the board should delegate day-to-day
management responsibilities to the president. Each of the three
working groups should report to management rather than to the ICOC.
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
management. The chair and the board should delegate day-to-day
management responsibilities to the president. Each of the three
working groups should report to management rather than to the ICOC.
Change the Composition and Structure of
the Board and Working Groups
the Board and Working Groups
CIRM should put systems in place to
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community. The terms of board
members should be staggered to balance fresh perspectives with
continuity.
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community. The terms of board
members should be staggered to balance fresh perspectives with
continuity.
The chair and other ICOC members should
be prohibited from serving on the working groups. During the
reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.
be prohibited from serving on the working groups. During the
reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.
Revise Conflict of Interest
Definitions and Policies
Definitions and Policies
CIRM should revise its definitions of
conflict of interest to recognize conflicts arising from nonfinancial
interests, such as the potential for conflict arising from an
individual’s interest in a specific disease, and should reassess
its policies for managing conflict of interest in light of this
broader definition.
conflict of interest to recognize conflicts arising from nonfinancial
interests, such as the potential for conflict arising from an
individual’s interest in a specific disease, and should reassess
its policies for managing conflict of interest in light of this
broader definition.
Restructure the Grant Review and
Funding Process
Funding Process
CIRM should restructure the grant
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC should remain
responsible for oversight and articulation of an overall strategic
plan. However, grant management, funding recommendations, and grant
administration should be the responsibility of the CIRM scientific
staff, reporting to the president. This restructuring would help
mitigate concerns related to conflicts of interest and would also put
the review and funding process in the hands of those best equipped to
make those decisions.
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC should remain
responsible for oversight and articulation of an overall strategic
plan. However, grant management, funding recommendations, and grant
administration should be the responsibility of the CIRM scientific
staff, reporting to the president. This restructuring would help
mitigate concerns related to conflicts of interest and would also put
the review and funding process in the hands of those best equipped to
make those decisions.
The committee recommends several
changes pertaining to the development and approval of RFAs,
composition of the Grants Working Group, reordering of rankings by
CIRM staff, notification of applicants, and process for making final
decisions.
changes pertaining to the development and approval of RFAs,
composition of the Grants Working Group, reordering of rankings by
CIRM staff, notification of applicants, and process for making final
decisions.
Enhance Industry Representation in Key
Aspects of CIRM Organization
Aspects of CIRM Organization
Industry representation on the ICOC,
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group 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.
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group 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.
Consider Harmonizing Intellectual
Property Policies with Policies of Bayh-Dole Act
Property Policies with Policies of Bayh-Dole Act
As
other sources of funding for stem cell research become available and
as the field of regenerative medicine advances from the laboratory to
the clinic, the 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.
other sources of funding for stem cell research become available and
as the field of regenerative medicine advances from the laboratory to
the clinic, the 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.
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Stem Cell Therapy and Medical Tourism: Of Promise and Peril? – Video
Posted: December 12, 2012 at 1:40 am
Stem Cell Therapy and Medical Tourism: Of Promise and Peril?
From:harvardstemcellViews:2 0ratingsTime:01:15:50More inScience Technology
Excerpt from:
Stem Cell Therapy and Medical Tourism: Of Promise and Peril? - Video
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Gordon Camp (Parkinson’s Disease) Stem Cell Therapy – Video
Posted: December 12, 2012 at 1:40 am
Gordon Camp (Parkinson #39;s Disease) Stem Cell Therapy
New Project 46From:OmarGonzalezMDViews:5 0ratingsTime:06:29More inScience Technology
More here:
Gordon Camp (Parkinson's Disease) Stem Cell Therapy - Video
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Photo Release — GIOSTAR and the Government of India to Enter $2 Billion Stem Cell Therapy Program – Official State …
Posted: December 12, 2012 at 1:40 am
SAN DIEGO, Dec. 10, 2012 (GLOBE NEWSWIRE) -- The Global Institute Of Stem-cell Therapy And Research (GIOSTAR) announced today a collaborative treatment plan to serve the local population suffering from a genetic disease, Sickle Cell Anemia. President and CEO, Mr. Deven Patel and his team met with Honorable Chief Minister Shri Arjun Munda of State of Jharkhand, India in November 2012 to address the local population's medical needs.
A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=16184.
As a follow-up, a government delegation representing the state of Jharkhand, India; Chief Minister, Principal Health Secretary, Chief Secretary and many other officials are visiting GIOSTAR in San Diego on December 14, 2012 to finalize the proposed two (2) billion U.S. dollar contract to be serviced over the next 15 years.
Bob Filner, Mayor of San Diego and City Council Members are among the invited guests for this state visit along with representatives from Belize and the island nation of Saint Vincent and the Grenadines.
Two hundred (200) jobs are estimated to be created in San Diego and it is expected that the dialog would include an economic development program between City of San Diego and State of Jharkhand, India.
GIOSTAR is a Global Private Funding (Global) incubated company. "Global is a private equity firm that focuses on funding projects and initiatives that are job-creation centric rather than just profit centric. We believe that a venture that draws the best minds and hearts to a unified goal, driven by a unified vision tends to be far stronger and less prone to failure than one driven by just profit. We invest in people, not the business," said Dr. Sam Senev, Chairman and CEO of Global. Senev added that GIOSTAR is a showcase client focused on both serving mankind through quality of life and job creation.
GIOSTAR, headquartered in San Diego, California (USA), was formed with the vision to provide stem cell based therapy to aid those suffering from degenerative or genetic diseases around the world. We are the leaders in developing innovative stem cell based technology.
The Chairman and Cofounder of GIOSTAR, Dr. Anand Srivastava and our team of scientists and clinicians have been associated with leading universities and research institutions throughout USA. GIOSTAR team has extensive research and clinical experience in the field of Stem cell, which is documented by several publications in revered scientific journals.
GIOSTAR in July 2011, inaugurated the world's first dedicated stem cell treatment hospital, a 125-bed, contemporary facility with the most advanced on-site stem cell laboratory. This hospital is fully operational. GIOSTAR is developing the world's largest, a three hundred thousand square-foot (300,000SF) state-of-the-art, Stem Cell Treatment Hospital in the Surat Civil Hospital Campus in collaboration with the government of Gujarat. Negotiations are ongoing with China, Philippines, Bahamas, Belize, Thailand, Ukraine and the Middle East to open regional stem cell treatment hospitals and satellite clinics throughout those countries and regions. "We are expanding the GIOSTAR footprint and is in negotiations to open locations near Austin Texas, Phoenix Arizona, and Savannah South Carolina" said Michael Andersen, Vice President of Venture Management at Global. Global and Empyrean West, EB-5 administrators, plan to invest over one hundred and eighty million ($180M) in economic development investments for GIOSTAR projects.
The Global Institute of Stem Cell Therapy and Research company logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=16183.
Posted in Stem Cell Therapy
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Stem Cell Therapy for Animals Q
Posted: December 10, 2012 at 5:40 pm
Stem Cell Therapy for Animals Q A at Animal Clinic of
- Captured Live on Ustream at http://www.ustream.tvFrom:HawaiiWellnessDirViews:1 0ratingsTime:39:36More inPeople Blogs
Originally posted here:
Stem Cell Therapy for Animals Q
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123Triad : fatgraftforumcom – Video
Posted: December 10, 2012 at 5:40 pm
123Triad : fatgraftforumcom
123Triad is proud to design website for http://www.fatgraftforum.com Autologous fat grafting is rapidly becoming the standard in the field of Plastic Surgery and the demand for knowledge and advances in fat grafting have significantly increased. The International Fat Grafting Forum will present renowned physicians from all over the world to promote the advancement of fat grafting technology and techniques including the ongoing debate on stem cell therapy.From:123triadorgViews:2 0ratingsTime:00:36More inScience Technology
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123Triad : fatgraftforumcom - Video
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MissouriCuresEvents_Oct2012_Dr.MarieCsete – Video
Posted: December 10, 2012 at 5:40 pm
MissouriCuresEvents_Oct2012_Dr.MarieCsete
"The stem cell therapy race: roadblocks to the finish line", as presented by Dr. Marie Csete at The Danforth Center on behalf of Missouri Cures Education Foundation #39;s Speaker Series in October, 2012.From:MissouriCuresEventsViews:4 0ratingsTime:51:36More inNonprofits Activism
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MissouriCuresEvents_Oct2012_Dr.MarieCsete - Video
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Robert Toves Testimonial (Parkinson’s Disease) Stem Cell Therapy – Video
Posted: December 10, 2012 at 5:40 pm
Robert Toves Testimonial (Parkinson #39;s Disease) Stem Cell Therapy
Robert Toves is a patient at Integra Medical Center, Mr.Toves suffers of Parkinson #39;s disease and has come to try Dr.Gonzalez method of stem cell therapy, just less than an hour after the stem cell therapy great results seem to show.From:OmarGonzalezMDViews:8 0ratingsTime:05:58More inScience Technology
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Robert Toves Testimonial (Parkinson's Disease) Stem Cell Therapy - Video
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Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’
Posted: December 9, 2012 at 8:01 am
 |
| 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.'”
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.”
“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.
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.)
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
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