Collapse of Big Pharma Deal Involving California Stem Cell Agency

Posted on December 9, 2012 by Fredricko

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

The breakdown of the arrangement was
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.

The deal was first announced Oct. 25
when Viacyte, Inc., of San Diego, received a $10.1 million award to
help finance a clinical trial for a diabetes treatment involving
Viacyte and GlaxoSmithKline.

The CIRM background memo said this week, however,

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

The memo gave no further details about
the Glaxo decision.

CIRM staff proposed that Viacyte, which
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.

The arrangement involving Glaxo,
Viacyte and CIRM was trumpeted in October, when Viacyte was awarded
the $10 million. Officials of the stem cell agency said the award
was a “watershed” for CIRM. Jason Gardner, head of the Glaxo stem
cell unit and who attended the meeting, told the California Stem Cell
Report that the arrangement was a partnership and that the company
intended to develop a sustainable pipeline.

It was the second significant
business-connected deal that has collapsed for the $3 billion agency
within the last 13 months. In November 2011, Geron abandoned its
clinical trial for spinal injuries. CIRM had loaned Geron $25 million
for the trial just three months earlier. The company paid the money
back with interest.

CIRM staff said that advisors to the
agency remain “extremely positive” about the Viacyte research and
“strongly recommended” that the company receive the additional $3
million. The memo said that trial has a “strong potential” to be
commercialized.

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

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

Posted on December 9, 2012 by Fredricko

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

Well, the folks at the California stem cell agency have their
noses in what passes today for typewriters and are pecking away
furiously. Their subject is the World Stem Cell Summit, which has
received only slight coverage in the mainstream media.

Today, the stem “cellists” from San
Francisco's King Street filed -- on the agency's blog -- three fulsome
items on doings at the summit, which is taking place in West Palm
Beach, Fla. Yesterday they filed four. Photos and charts were
included. More coverage is expected tomorrow.

CIRM staffers blogging the World Stem Cell Summit
covered UC Davis researcher Paul Knoepfler discussing
patient advocacy and its role in funding stem cell research.

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

The primary purpose, we presume, of
sending state employees across the country is to gather the latest
information on stem cell science and issues and to make contacts. It
is a bit of a bonus for the public to have the CIRM attendees also
file stories on the sessions.

A couple of the items caught my
attention. One dealt with patient advocates and their role in
energizing and helping to drive funding for research. Another item
discussed what appear to be growing issues with dubious stem cell treatments and the damage they can do to the field in general.

Lomax summarized the signs of a stem
cell scam like this:

“Claims of miracle cures for
diseases
“Single treatments or cells that
can treat any type of disease
“Lack of objective information,
evidence (such as published medical reports) that a treatment is
effective
“Treatment by a doctor who is
not trained or certified to treat the specific disease
“No system exists to collect
information and follow up with patients”

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

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

Posted on December 9, 2012 by Fredricko

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

The subjects are on tap for the Dec. 12 meeting in Los Angeles of the governing board of the $3 billion
research effort.

The $80 million grant round is aimed at
“career development of physician scientists working in
translational stem cell research.”

The RFA said

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

Summaries of the grant reviewers
comments and application scores should be available sometime this
week. The bare-bones agenda lacked elaboration on the
commercialization plan.

Directors are additionally scheduled to
hear a presentation on the blue-ribbon report by the Institute of
Medicine for which the agency is paying $700,000. The report has been
17 months in the making and is scheduled to be released this
Thursday.

Other interesting matters are on the
table, although the agency has yet to produce background material
laying out any details. The subjects include:

More money – no amount yet specified
– for Viacyte, Inc, of San Diego, which has received more than $36
million from CIRM.
An update of the agency's response to
the only performance audit conducted at the agency. The audit
identified 27 areas where improvement is needed, but the governing
board has not discussed the results publicly since they were
disclosed last May.
Approval of the concept plan for
another round of basic biology grants and adoption of conflict of
interest code changes.

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

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

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

Posted on December 9, 2012 by Fredricko

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

A special task force of directors met last week
for the second time to discuss the likely alterations. Kevin McCormack, spokesman for the agency, said
the group made no decisions. Another meeting will be held later at a
date to be determined. The task force's recommendations will then go
before the full board, probably in late January.

McCormack said members of the panel
have asked for “more details regarding the process that would be
employed if the appeals and extraordinary petition processes were
merged.”

The agency has an odd, bifurcated
appeals process. Early in its existence, the agency said appeals of
reviewer decisions could be based only on conflicts of interest.
However, researchers have a right under state law to speak to the
governing board in public on any issue whatsoever. As some
researchers began to use that avenue to ask for reconsideration of
their applications, the CIRM board created what it called
“extraordinary petitions” in an effort to control the process and
limit appeals. Both the “appeals” and “extraordinary petitions”
are, in fact, appeals but on different grounds and employing different
mechanisms.

The task force was created in September
after directors complained about “arm-twisting” and “emotionally charged presentations” in connection with a record number of
appeals earlier this year.

Here is a link to an item about the task force's first meeting. Here is a link to an agency summary of the task force's deliberations prior to last week's meeting. The
transcript of the session should be available on the CIRM web site
within the next two weeks. It will be found under the meetings
section of the web and then under the heading for the task force's
November session.

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