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

Posted: May 6, 2012 at 3:57 pm


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

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

Posted: May 6, 2012 at 3:57 pm


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

ACT and CIRM Together on Eye Research Webinar

Posted: May 6, 2012 at 3:57 pm


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

Complex cancer industry trial literature is too confusing for patients to understand

Posted: May 6, 2012 at 3:56 pm

By J. D. Heyes

Have you ever read something so complex and confusing that it frustrated you to
the point of distraction? Well, a new study has found that cancer trial
literature causes that kind of frustration - and may be misleading to patients
as well.

According to Prof. Mary Dixon-Woods, professor of Medical Sociology at the
University of Leicester Department of Health Sciences in Great Britain, a
number of cancer patients found information leaflets describing cancer trials
too long, too incomprehensible and too intimidating.

"These information sheets are poorly aligned with patients' information
needs and how they really make decisions about whether to join a cancer
trial," said Dixon-Woods, lead author of the research http://www.eurekalert.org/pub_releases/2012-03/uol-cti032612.php,
which was published in the international journal Sociology of Health and
Illness.

"Some patients did find them very useful, but many others paid them little
attention. They preferred to rely on discussions they had with their doctor to
make up their minds," she said. Read more…

Source:
http://feeds.feedburner.com/integratedmedicine

Posted in Integrative Medicine | Comments Off on Complex cancer industry trial literature is too confusing for patients to understand

Another > $100M month for companies in the cell therapy space

Posted: May 6, 2012 at 3:56 pm

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Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


..


So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


--Lee


p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


Source:
http://feeds.feedburner.com/CellTherapyBlog

Posted in Regenerative Medicine | Comments Off on Another > $100M month for companies in the cell therapy space

Gene Hunt Is On for Mental Disabilities in Children

Posted: May 6, 2012 at 3:56 pm

By Ewen Callaway of Nature magazine

[More]

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Source:
http://rss.sciam.com/sciam/topic/gene-therapy

Posted in Gene therapy | Comments Off on Gene Hunt Is On for Mental Disabilities in Children

Processed EHR text can be used to develop CDS tools Read more: Processed EHR text can be used to develop Clinical decision support tools with automated text processing

Posted: May 6, 2012 at 3:56 pm

See on Scoop.itinPharmatics

Free text in electronic health records, with the help of natural language processing (NLP) technology, can be used to create accurate clinical decision support (CDS) tools, according to a study published this week in the Journal of the American Medical Informatics Association

See on jamia.bmj.com

Source:
http://microarray.wordpress.com/feed/

Posted in Genetic medicine | Comments Off on Processed EHR text can be used to develop CDS tools Read more: Processed EHR text can be used to develop Clinical decision support tools with automated text processing

Why mHealth hasn’t created an Instagram (yet)

Posted: May 6, 2012 at 3:56 pm

See on Scoop.itinPharmatics

Read about why a Qualcomm Life executive says mobile health doesn’t yet have an Instagram, and why it eventually will.

See on http://www.medcitynews.com

Source:
http://microarray.wordpress.com/feed/

Posted in Genetic medicine | Comments Off on Why mHealth hasn’t created an Instagram (yet)

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

Posted: May 6, 2012 at 3:56 pm


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

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

Posted: May 6, 2012 at 3:56 pm


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

Page 2,772«..1020..2,7712,7722,7732,774..2,7802,790..»