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Category Archives: Stem Cell Therapy

Researcher Alert: First Look at Proposed Rules for California's Stem Cell Bank


The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.

The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."

The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.

To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,

"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine which is also creating a repository for iPSC lines and
derived materials."

Baum also said,

"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."

Baum provided the
following summary of the $30 million banking initiative:

"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses
for the public meeting locations can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Posted in Stem Cell Therapy, Stem Cells | Comments Off on Researcher Alert: First Look at Proposed Rules for California's Stem Cell Bank

Researcher Alert: First Look at Proposed Rules for California’s Stem Cell Bank


The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.

The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."

The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.

To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,

"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine which is also creating a repository for iPSC lines and
derived materials."

Baum also said,

"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."

Baum provided the
following summary of the $30 million banking initiative:

"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses
for the public meeting locations can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Posted in Stem Cell Therapy, Stem Cells | Comments Off on Researcher Alert: First Look at Proposed Rules for California’s Stem Cell Bank

ACT and CIRM Together on Eye Research Webinar


Executives of Advanced Cell Technology,
which has been repeatedly rejected for funding by the $3 billion
California stem cell agency, will participate this week in the agency's Internet "webinar" on research involving the human eye.
ACT, which is engaged in the only hESC
clinical trial in the nation, was held up earlier this month (see
here and here) at an Institute of Medicine hearing as a prime example
of the California's agency's failure to fund the stem cell industry
in any significant way.
Gary Rabin, CEO of ACT
Nonetheless, three ACT execs are scheduled to be online for the CIRM session on Wednesday: Gary Rabin, the CEO of
ACT; Matthew Vincent, director of business development, and Edmund
Mickunas, vice president of regulatory affairs. The webinar will deal with regulatory issues
with the FDA and clinical trials involving the eye.
Also on the panel are Samuel Barone,
medical officer with the FDA, and Mark Humayun, professor of
opthamology at USC, who is the PI on a $16 million macular
degeneration grant from CIRM.
So what is the significance of ACT's
participation in the CIRM event? If the relationship between ACT and
CIRM has been touchy, this sort of cooperation is probably a good
sign for both. For one, CIRM could have hardly staged the webinar
without ACT, given the subject matter. But if the agency did not
want to engage ACT, it could have simply done nothing about setting
up a webinar in which the firm would participate.
Does this mean that ACT is going to
receive a handsome grant or loan from CIRM? CIRM has established
procedures (RFAs, peer review, etc.) for approval of funding, and ACT
would have to go through that process unless CIRM does something very
unusual.
Wednesday's event is aimed at researchers and
is likely to be technical. Persons interested in taking part must
register in advance.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Posted in Stem Cell Therapy, Stem Cells | Comments Off on ACT and CIRM Together on Eye Research Webinar

Researcher Alert: First Look at Proposed Rules for California’s Stem Cell Bank


The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.

The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."

The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.

To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,

"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine which is also creating a repository for iPSC lines and
derived materials."

Baum also said,

"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."

Baum provided the
following summary of the $30 million banking initiative:

"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses
for the public meeting locations can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Posted in Stem Cell Therapy | Comments Off on Researcher Alert: First Look at Proposed Rules for California’s Stem Cell Bank

Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure


A key panel of directors of the $3
billion California stem cell agency yesterday voted unanimously to
retain full public disclosure of the financial interests of its
directors and top executives.
The director's Governance Subcommittee
bypassed a proposal that would have substantially weakened disclosure at a time when the agency is moving closer to industry in an effort
to develop cures.
"Because of CIRM's unique mission
and the agency's longstanding commitment to transparency," said
Kevin McCormack, the agency's spokesman, "they believed that
CIRM should continue to set an example by requiring the broadest
disclosure of members of the board and high level staff."
Currently CIRM board members and top
executives must disclose all their investments and income – in a
general way – along with California real property that they hold.
Under the rejected changes, disclosures would have instead been
required only "if the business entity or source of income is of
the type to receive grants or other monies from or through
the California Institute for Regenerative Medicine." 
The proposed changes would also have
relieved CIRM officials of reporting investment in or income from
venture capital or other firms that may be engaged in financing
biotech or stem cell enterprises, since the firms do not receive cash
from CIRM or engage in biomedical research.

The subcommittee's action will go before the full CIRM board later this month, where it is expected to be ratified. 

Our take? The Governance Subcommittee
took the right action and is to be commended for going beyond the
letter of the law. The integrity and credibility of CIRM are
paramount. As the California Stem Cell Report wrote last week, narrowing disclosure would only have engendered suspicion and
unnecessarily raised questions about the conduct of the agency as it
embarks on an aggressive push for stem cell cures.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Posted in Stem Cell Therapy | Comments Off on Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure

ACT and CIRM Together on Eye Research Webinar


Executives of Advanced Cell Technology,
which has been repeatedly rejected for funding by the $3 billion
California stem cell agency, will participate this week in the agency's Internet "webinar" on research involving the human eye.
ACT, which is engaged in the only hESC
clinical trial in the nation, was held up earlier this month (see
here and here) at an Institute of Medicine hearing as a prime example
of the California's agency's failure to fund the stem cell industry
in any significant way.
Gary Rabin, CEO of ACT
Nonetheless, three ACT execs are scheduled to be online for the CIRM session on Wednesday: Gary Rabin, the CEO of
ACT; Matthew Vincent, director of business development, and Edmund
Mickunas, vice president of regulatory affairs. The webinar will deal with regulatory issues
with the FDA and clinical trials involving the eye.
Also on the panel are Samuel Barone,
medical officer with the FDA, and Mark Humayun, professor of
opthamology at USC, who is the PI on a $16 million macular
degeneration grant from CIRM.
So what is the significance of ACT's
participation in the CIRM event? If the relationship between ACT and
CIRM has been touchy, this sort of cooperation is probably a good
sign for both. For one, CIRM could have hardly staged the webinar
without ACT, given the subject matter. But if the agency did not
want to engage ACT, it could have simply done nothing about setting
up a webinar in which the firm would participate.
Does this mean that ACT is going to
receive a handsome grant or loan from CIRM? CIRM has established
procedures (RFAs, peer review, etc.) for approval of funding, and ACT
would have to go through that process unless CIRM does something very
unusual.
Wednesday's event is aimed at researchers and
is likely to be technical. Persons interested in taking part must
register in advance.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Posted in Stem Cell Therapy | Comments Off on ACT and CIRM Together on Eye Research Webinar