Multimillion Dollar Carrots for Stem Cell Research in California

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Directors of the California stem cell
agency approved an $80 million business-friendly plan that will
dangle multimillion dollar carrots before biotech firms in an effort
to push therapies into the marketplace.

The upfront payment effort will allow
CIRM to take part in early stage clinical trials at no risk and could
generate a list of achievements that will be useful in creating
support for fresh funding after CIRM's money runs out in 2017.
The proposal is the first-ever from
CIRM that involves no upfront payments. Instead, recipients will have
to meet agreed-upon criteria to receive either grants or loans.
A CIRM staff document said,

“The major development milestone and
success criteria will be mutually agreed upon between CIRM and the
applicant at the beginning of the project(s) and at a minimum will
require completion of a clinical trial that shows some level of
biological activity/clinical efficacy and safety. The advantage to
CIRM of this...is that CIRM funds will only be applied to projects
that are successful.”

The proposal was wrapped into what the
agency calls its strategic partnership plan, which also has a more
conventional aspect, providing loans and grants in advance.
As part of the program, the CIRM board
also today approved a $6.4 million award to Sangamo BioSciences of
Richmond, Ca., to help develop a therapy for
beta-thalassemia. The firm will have to match the amount of the
award.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uJidDBHhPdI/multimillion-dollar-carrots-for-stem.html

Sacramento Bee: Ongoing Conflict Problems No Help for Future Funding of Stem Cell Agency

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The Sacramento Bee says conflict of
interest problems continue to trouble the California stem cell agency
despite its assertions that it has “turned a page” on the issues.
In an editorial Saturday, The Bee said
that CIRM Chairman Jonathan Thomas “has vowed to be aggressive in
avoiding conflicts in dispersing millions of public dollars for stem
cell research. Yet serious conflicts continue to be
revealed involving CIRM.”
The Bee cited articles on the
California Stem Cell Report earlier this month about a $21,630 gift
by its former chairman, Robert Klein, and the employment by Klein of
Vice Chairman Art Torres. The Bee said the situation “throws
into question a $20 million grant awarded last year to StemCells
Inc., a company that wants to transplant neural stem
cells to treat Alzheimer's
disease.” (See here, here and here)
The Bee also cited the case of Lee
Hood, an internationally renown scientist who violated the agency's conflict of interest policy. Hood failed to disclose to CIRM a
conflict involving an application that he was reviewing on behalf of
the agency. The Bee said the agency's failure to detect the conflict
was “serious oversight."
Eight readers commented on the
editorial and agency, generally unfavorably about CIRM.
But reader “bchild” said,

“It took a couple years for them to start funding projects and it may take years to see results. Wall
Street got 1.5 trillion and the promise of 10x that if they get
into trouble again, the scientists (and their business buds) just
want a couple billion...In the end who do you trust more with
public money? At least there is the appearance of public benefit
here..."

The Bee concluded,

“None of this helps CIRM's reputation
in being fair and impartial in spending $3 billion in public funds.
It surely won't help the institute's standing with the Legislature
and the public, should it need help staying in operation when its
funding is exhausted in a few years.”

The editorial was also carried by at least one other paper in the McClatchy chain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/BZeSccFCbBU/sacramento-bee-ongoing-conflict.html

Replicating Oregon Cloning in California: Views on the Legality

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Oregon's stem cell cloning achievement
has triggered some discussion about whether it could be replicated
legally in California, which bans paying for eggs as was done in
Oregon.

Stanford researcher Irv Weissman said
it is “not true” that Oregon's stem cell research would be
illegal in California. Leftovers from IVF clinics could be used, he said.
But in response Oregon researcher
Shoukhrat Mitalipov said that “SCNT (the process he used) did not
work with discarded human eggs.”
He added,

 “SCNT worked with eggs from
healthy young volunteers (paid of course). IVF patients (whether paid
or not) have reproductive health problems and may not provide
acceptable quality eggs for SCNT.” 

Weissman said,

 "Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done properly without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors for stem cell research to properly perform their research
and could not find them without providing compensation.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/IimgOYxndkg/replicating-oregon-cloning-in.html

California Stem Cell Agency: 5 Percent Budget Increase for Coming Fiscal Year

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Directors of the California stem cell
agency today approved a $17.4 million operating budget for the fiscal
year beginning July 1, an increase of 5.1 percent over spending for
the current year.

As usual, the agency tries to portray
its budget as a decrease in spending. Directors were told that it
represented a 3 percent decline from the current year. However, the
comparison is not made to actual spending for this year. Instead, the
staff compares the 2013-14 budget to budget figures proposed last
May, which are now no more than time-worn ephemera.
Most of the budget goes for salaries
and benefits ($12.2 million ) with outside contracting running next
($2 million). (See here for details.) The budget projects 59 employees for next year
compared to 57 currently. CIRM staff said the number of employees is expected to remain about
the same until 2017 or so when its workload is projected to diminish.
The agency is expected to run out of
money for new grants in 2017, but it is working on a plan to develop
a combination of private and public funding to continue its work.
The spending plan reflects the cost of
overseeing about $1.8 billion in nearly 600 grants and loans plus
developing new research proposals that are likely to be funded in the
next few years. The operational budget is capped by law at 6 percent
of the amount of funds the agency distributes over its lifetime.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GJSQ_B3ck_8/california-stem-cell-agency-5-percent.html

A Patent War on iPS: One Researcher's View

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As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.

But questions do exist whether those
efforts can surmount barriers that have to do with patents and
ownership of the intellectual property.
UC Davis stem researcher and blogger
Paul Knoepfler discussed some of the problems in a post yesterday. He wrote,

“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.

“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results.

“A search for “cellular
reprogramming produced more than 1,000
results.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..

“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.

“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?

“I don’t think so.

“This could get really messy.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZX0PoUag-pE/a-patent-war-on-ips-one-researchers-view.html

Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State

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The good news out of Oregon is that
some diligent scientists in the Beaver State have accomplished a
major advance in stem cell research --- the cloning of human stem
cells.

That bad news is that their research
would have been illegal in California, and probably will be banned
for decades, if not longer – thanks to Proposition 71 of 2004.
The proposition was the ballot
initiative that created the $3 billion California stem cell agency,
which is hailed internationally as being one of the world leaders in
financing stem cell science. Unfortunately, the 10,000-word
initiative also contains language that was aimed at winning voter
approval of the measure -- not promoting good science.
The team writing the initiative, led by
Robert Klein, the former and first chairman of the stem cell agency,
put in a provision that made it illegal to pay women for their eggs.
The Oregon researchers paid women $3,000 to $7,000 each for their eggs, reflecting the current market rate based on prices paid in
connection with IVF. In some cases for IVF, the compensation is
dramatically higher. (See here and here.) Stem cell researchers in
recent years in the United States have found that they cannot secure
an adequate number of donors without matching IVF donor compensation.
While compensation for eggs is a matter
of some controversy, strong cases have been made that women
should make their own decisions about selling their eggs – not the what some call the nanny state. Of course, that should occur under well-regulated
situations. But Proposition 71 backers wanted to remove any possible
campaign objections by opponents of stem cell research, and so they
inserted the ban along with management minutia and other dubious
material.
Can't that be changed, one might ask?
Not without a herculean effort. That means another ballot measure or
a super, super majority vote in the California legislature plus the
signature of the governor. Imagine a measure on the ballot to
allow women to sell their eggs. The uproar would be heard
internationally. In 2004, when Proposition 71 was approved, it would
have been better to leave the compensation issue unaddressed. Then it
could have been dealt with through regulation or normal legislation,
both of which are far more flexible than ballot measures that alter
the state Constitution and state law.
Our quick and limited survey of the
news coverage indicated that many of the mainstream media stories
omitted the price of the eggs, which may suggest that the issue of
compensation is becoming moot.
In related news about the Oregon
accomplishment, UC Davis stem cell researcher Paul Knoepfler has
posted a good look at the some of the misinformation that is
surfacing on the Internet about the research, including its
implications.
He said,

“Keep in mind that on day one of the
iPS cell era in the stem cell field we had a huge number of
misconceptions because we simply had so much to learn. Same is true
here.”

Jessica Cussins over at the
Berkeley-based Biopolitical Times also has a solid roundup of the
coverage of the Oregon research and the analysis of its significance.
Here are links to two blog items from
the California stem cell agency on the Oregon research, including one
dealing with “cloning hysteria” and a more general look.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A4AXZfPs3dc/oregon-style-stem-cell-cloning-research.html

Weissman Says Oregon-style Stem Cell Research Could be Done in California

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Stanford researcher Irv Weissman says it
is “not true” that Oregon's stem cell research could not be done
legally in California.

Weissman said, 

"Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors to properly perform their research
and could not find them without providing compensation.
We have queried Shoukhrat Mitalipov in
Oregon concerning his views on Weissman's comments. We welcome other
comments as well. Comments can be filed directly by clicking on the word "comment" at the end of this item or you can email them to djensen@californiastemcellreport.com. 
We should also note the comment from
researcher Paul Knoepfler of UC Davis who notes that SCNT cloning is
permissible in California, which is what was done in Oregon. The
state does ban reproductive cloning, however.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/vlJ5XeK4AOU/weissman-says-oregon-style-stem-cell.html

WARF hESC Patent Update: Seven Years and Challenge Still Underway

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Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.

Loring did not mention it in the Q&A
but she is the key figure in the ongoing challenge to the WARF
(Wisconsin Alumni Research Foundation) patents on human embryonic
stem cells. Her effort began in 2006 but has dropped out of the news.
We asked her for an update on the case.
Here is the text of what she replied,

“Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds. 

“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents.  Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.

“This is Dan's summary of the current
situation:

"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology." 

“The 'narrowing' of the patents has
had an unexpected consequence.  Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”

In the Q&A on Knoepfler's blog,
which also involved an interesting discussion of IPS research,
Loring said,

“Patents
on fundamental things --
genes, human embryonic stem cells, iPS cells --
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.

“Patents
are supposed to stimulate investment in development.  Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?

“But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells.  One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.

“There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs.  I’m paying attention to the patent 'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves.  It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/fXlAaqQbBAs/warf-hesc-patent-update-seven-years-and.html

Patient Advocate Reed Defends Klein Donation to Stem Cell Agency

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The California Stem Cell Report today
received the following email from Don Reed, a patient advocate, who
has long been involved in California stem cell agency affairs. Reed
is vice president of public policy for Americans for Cures
Foundation, a position he has held for some years. Americans for
Cures is the personal lobbying organization created by Robert Klein,
former chairman of the California stem cell agency. Reed said his
opinions below are his own and may or may not reflect those of the
foundation.

“I must take issue with your entry,
'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May
05, 2013.

“When
Bob Klein donated $21,630 to the California stem cell program (to
allow scientists to attend a research conference in Japan) he was
doing exactly what he always does: advancing research to ease
suffering and save lives.  The scientists needed a way to attend
a top-level conference. Believing in the benefits of researchers
sharing thoughts, Bob paid for their trip.

“Unfortunately,
your article appears to imply corrupt motivations.

“'A
seemingly innocuous…gift…generated a wave of special favors for
(Klein) that stretched out to include a gold mining multimillionaire
from Canada.'.
A 'wave of special favors?'  The article
states that 'Klein wanted to meet with the six science officers…'
 and to get their impressions on the conference.

“Is
that not natural? First, would it not be helpful to hear from the
scientists if the trip was worth the time and expense? Second, Bob
Klein works in real estate, a full-time job. He does not have the
scientist’s automatic involvement to keep him up to speed on
everything new in regenerative research. But he wants to know the
latest: what is working, what is not. He is always eager for a chance
to speak one-on-one with an expert.

“He met with a Canadian
millionaire? Why is this shocking? The millionaire supports stem cell
research; so does Bob. California is working closely with Canada on
several projects; they pay their scientists, we pay ours; more bang
for the buck. If there is a person with the resources and will to
advance Canadian research, it is natural that Bob would want to
develop a deeper interest in the shared research.

“And why
should Klein be criticized for supporting a research project
attempting to alleviate Alzheimer’s? He saw his own mother die of
the disease, after losing the ability  to recognize her own son.
 I am familiar with that particular Alzheimer’s project, and
it had some amazing results, restoring memory to laboratory rats.
This was a water maze test, and the rats recovered the memory of a
pathway out of the water, which they had forgotten. To the best of my
knowledge, no one else in the world had achieved memory return, and
the project deserved the most serious consideration.  Yes, the
board of directors voted against the Grants Working Group; it is not
only their right but their responsibility to exercise judgment, and
not merely be a rubber stamp for the GWG.

“There is also the
matter of free speech. Anybody else in California can come to the
meetings of the program and voice their opinion—why should Klein be
denied the right to voice his opinion?

“Bob Klein owns no
stem cell stock, no biomedical enterprises. Financially, supporting
stem cell research has cost him a great deal. This is the man who led
the fight to build the California stem cell program, donating roughly
six million dollars, taking out loans on his house to help finance
Proposition 71. And, for six years (without salary) he worked
full-time as Chair of the Board of the oversight committee.
Physically and emotionally, it has been an exhausting decade for him.
He has not profited in any way, except to see the advancement of
research for cure.

“Passing a $3 billion stem cell program
in the midst of a recession was like relocating Mount
Everest—seemingly impossible, but he did it anyway. He moved the
mountain. Thousands of people helped, but one man made it possible.
Without Bob Klein, California would not have the greatest stem cell
program in the world: challenging diseases considered incurable since
the dawn of time. That he should continue to support it, with his
dollars, time, energy and creativity, is commendable.

“Sometimes
a good deed is just that: no sinister motivations, no secret
agendas-- just a positive action which benefits all.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hW_Zc6qeDYY/patient-advocate-reed-defends-klein.html

Stem Cell Agency Approves $36 million to Recruit Six Scientists to California

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The California stem cell agency today
awarded $36 million to six scientists to lure them to the Golden
State, in what was the agency's largest-ever recruiting round.

The awards more than doubled the amount
of CIRM has spent on recruitment. Until today, the agency had awarded
only $23.2 million for four awards.
Today's awards ranged from $7.5 million
to $4.8 million. The agency did not immediately identify the recipients. However, testimony at the meeting indicated that two of the institutions involved were UC San Francisco and the Gladstone Institute (the $7.5 million award) and UC Santa Cruz (a $5.4 million award). (The agency later released the list, which can be found here. Here is a link to the CIRM press release.)

The differences in the size of the awards had to do with the overhead charges that are levied by the institutions at which the scientists would work, CIRM staff said. The "direct costs" of the research for each grant was $4.5 million.

Six applications were considered in the
latest round, including one that was scored at 75 that was rejected by grant reviewers. However, CIRM staff recommended that application, which involved UC San Francisco and Gladstone, be funded. (See here and here.)
Previous winners of the recruitment awards were Robert Wechsler-Reya, Sanford-Burnham; Dennis Steindler,
The Parkinson's Institute; Andrew McMahon, USC, and Peter Coffey, UC
Santa Barbara.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4jJo64qAjcY/stem-cell-agency-approves-36-million-to.html

$36 Million Recruitment: Names of Researchers Being Lured to California

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Here are the names of the researchers being recruited to California by the California stem cell agency with $36 million in awards. The sixth asked not to be revealed since he/she has yet to tell the current institution and are in
negotiations with their new institution

·      Hiromitsu
Nakauchi of the University of Tokyo, who would be moving to Stanford
University
·      Barry
R. Stripp of Duke moving to Cedars-Sinai Medical Center
·      Richard
Gregory of Harvard and Children’s Hospital, Boston moving to UC
Santa Cruz
·      Eric
Ahrens of Carnegie Mellon moving to UC San Diego

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Kbc3TScH6ds/36-million-recruitment-names-of.html

Nature Reports on Lee Hood Conflict Case

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The journal Nature and genomeweb.com
today picked up the story from the California Stem Cell Report about
the conflict of interest case at the California stem cell agency involving renown scientist Lee Hood of
Seattle, Wash.

Science news aggregators on the
Internet also relayed various versions of the story. The facts were
first reported on this blog yesterday. The matter involved a $24
million application for a genome project involving Irv Weissman of
Stanford. Hood was one of the reviewers in the round. Hood and
Weissman are longtime friends and own property together in Montana.
They have also have a number of professional relationships.
In piece by Ewen Callaway, Nature
additionally referred to ongoing conflict of interest issues at the agency,
including the findings of an Institute of Medicine study. Harold Shapiro, head of the study, said the agency directors make "proposals to themselves, essentially, regarding what should be funded. They cannot exert independent oversight." 
The genomeweb item was also brief and
did not mention the IOM study.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xBpF71FS1Ys/nature-reports-on-lee-hood-conflict-case.html

California Stem Cell Agency to Court Patient Groups This Summer

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Jonathan Thomas, chairman of the California stem cell agency, said this morning that he and a team from the agency will begin a round of meetings this summer with patient advocate groups throughout the state.

He said the effort is aimed at keeping the groups up to speed on developments at CIRM. While Thomas did not mention it to the agency's governing board, it is also critical that the agency have strong support from patient advocate groups as it tries to develop new sources of funding, either public or private.

The agency will run out of cash for new grants in 2017 and hopes to have a plan for the future before the board later this year. Its initial assumptions include as much as $200 million in onetime public funding with more cash coming from the private sector.

Currently the agency is funded by state bonds at a cost of about $6 billion, including interest. It spends roughly $300 million a year on grants and loans for research.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/lra474LHezU/california-stem-cell-agency-to-court.html

Klein, StemCells, Inc., and $31,000 in Consulting Fees for Torres

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The Robert Klein-StemCells, Inc.,
affair has taken another turn with the disclosure that a vice
chairman of the California stem cell agency was paid at least $31,000
over a two-year period by Klein and also voted on behalf of Klein's
effort to win approval of a $20 million award for StemCells, Inc.

Art Torres received what he reported were
consulting fees during 2011 and 2012 from firms controlled by Klein, former chairman of
the agency. In 2012, Torres backed Klein's
efforts to override grant reviewers' rejection of the $20 million
application from the Newark, Ca., publicly traded firm.
Art Torres, center, with Bob Klein, left, at Klein's last meeting in
2011 as chairman of the California stem cell agency.
 Incoming chairman Jonathan Thomas is at right. 

The 29-member board of the California
Institute for Regenerative Medicine (CIRM), as the agency is formally
known, narrowly voted 7-5 last September for the award. It was the
first time that the board has approved an application rejected twice
by its scientific reviewers. It was also the first time that Klein
has lobbied the board on behalf of a specific application since
stepping down in June 2011. He was elected chairman in 2005 as the
agency was just beginning its work and is an iconic figure to many in
the California stem cell community.

Asked for comment last week by the
California Stem Cell Report, Torres said,

"My decision to support an award
to StemCells, Inc. to explore the use of neural stem cell
transplantation to treat Alzheimer's disease was based on the merits
of the application and the hope it offers to patients who suffer from
Alzheimer's, a disease that affects millions, including Bob Klein's
late mother. I have no financial interest in StemCells, Inc. nor does
Bob Klein, and my decision to support the award has no connection
whatsoever to the work I do with Bob Klein."

Kevin McCormack, senior director for
public communications at CIRM, said that Torres' statement would be
the only comment on the matter from the agency.
Klein did not respond to questions,
declaring that personal issues were occupying his time.
The California Stem Cell Report's
questions to all three dealt with the propriety of Torres' employment
by both CIRM and Klein while Klein was asking the board to award a
business $20 million. The governing board has a code of conduct that
declares members should “maintain the highest standards of
integrity and professionalism.” However, it does not speak to
questions of appropriate employment by CIRM directors outside of the
agency.
In January 2012, Torres authored a document discussing CIRM's conflict of interest rules. He said they
are intended “to eliminate even the appearance of impropriety.”
He also referred to CIRM's policy on “incompatible activities”
for employees. It deals with activities that could “discredit”
the agency or that are “inimical” to it. However, it does not
specifically deal with the type of situation involving Torres and
Klein, who is a real estate investment banker and attorney. The policy additionally does not address cases where a
governing board member is also an employee of the agency.
Torres' economic disclosure statements,
which are required by state law, contain only broad ranges for compensation, and the amount could be significantly higher than
$31,000. Torres reported that in 2011 he was paid between $10,001 and
$100,000 by both Klein Financial Corp. and K CP Cal, which share the
same address as Klein's offices in Palo Alto. In 2012, Torres reported receiving between $10,001 and $100,000 from K CP Cal and
between $1,001 and $10,000 from Klein Ventures LLC, which also has
the same address.
Torres reported that the payments were
consulting fees and that the firms dealt with real estate. He did not
respond to requests for more details.
Torres earns $225,000 a year in his part-time role as one of two vice chairmen for the agency. Under the
arrangement, he works four days a week.
Torres was chairman of the state
Democratic Party and a longtime state legislator. He was nominated
for vice chairman in 2009 by state Treasurer Bill Lockyer, among
others.
Last week, another financial
arrangement involving Klein surfaced in connection with the
StemCells, Inc., application. Klein gave the agency $21,000 last May,two months before he pitched the board on the StemCells, Inc.,application. The donation was not reported to the board prior to
Klein's appearances before the panel. The agency's regulations
require such gifts to be reported to the board but do not specify a
time frame. Following inquiries from the California Stem Cell Report,
the agency said it would report the donation at the agency board
meeting next week.
Klein's donation financed a trip by six
CIRM science officers to Japan for an international stem cell
conference. The agency directed the officers to give special access
to Klein. Two of the officers were heavily involved in the grant
round that included the StemCells, Inc., application, which scientific reviewers scored at 61 on a scale of 100.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7zwWISe_LMA/klein-stemcells-inc-and-31000-in.html

Text of CIRM Comments on Lee Hood Questions

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Here is the full text of the statement
today by Kevin McCormack, senior director for public communications
at the California stem cell agency, in connection with the conflict
of interest issue involving Lee Hood, president of Institute for
Systems Biology of Seattle, Wash. See here for a story on the matter.

McCormack's comments came in response
to the following questions from the California Stem Cell Report.

“Did (CIRM President Alan) Trounson
recruit Hood to serve on the grants working group?

“Does CIRM perform any sort of
serious examination of the statements of interests of its scientific
reviewers prior to specific review sessions. The conflict involving
Weissman and Hood was easily detected by a Google search. The first
two entries on the search term "lee hood irv weissman"
raise serious red flags. Additionally, I imagine it is more than
common knowledge among many in the scientific community that
these two scientists are longtime friends.”

Here is McCormack's reply,

“Alan helps recruit many reviewers,
including in this case Dr. Hood, but he is not involved in assigning
reviewers to individual applications. Furthermore he expects all
reviewers to declare whatever conflicts they have.  

“Yes, we do a serious examination of
statements of interest from all our reviewers. However, this conflict
was not identified by the reviewer either in the financial disclosure
statement or identified in the conflict of interest list. Normally we
do not check Google for all possible combinations of 15 GWG reviewers
times about 200 individuals listed in these applications. That would
be about 3000 independent Google searches to identify a possible
conflict. While this relationship may be known to some it certainly
was not known to the CIRM staff who checked the conflicts. If it had
been they would have raised it before the meeting.

“It's also important to point out
that Dr. Hood was a new member of this review panel and was not
familiar with our conflict of interest rules. This was clearly a case
of a new reviewer making an innocent error.

“Finally, CIRM’s rules are stricter
than state law, and this would not have been a conflict under
California conflict of interest law.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1ndmVIt2OlQ/text-of-cirm-comments-on-lee-hood.html

The Klein Donation: Text of Robert Klein's Response re StemCells, Inc.

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Here is the text of the initial
response from Robert Klein, chairman of the California stem
cell agency until July 2011, to questions from the California Stem Cell Report (CSCR)
concerning his $21,630 donation to the agency. The questions posed by
CSCR on precede the response by Klein. Here is a link to a story on
the matter.


CSCR to Klein:

“Why did you give the agency the
money?
“Did you place on conditions on its
use?
“Did anyone connected with the agency
indicate in advance  that your donation would be desired? If so
who? Who did you deal with primarily on the donation -- Trounson,
Thomas or...?
“The donation came one month after
grant reviewers rejected StemCells Inc.'s Alzheimer's application. Do
you think it was appropriate to make the donation and then ask the
board twice to override its reviewers?
“Do you think the donation and
subsequent action on StemCells, Inc.'s Alzheimer's application will
negatively color the perception of future efforts by CIRM at private
fundraising?”

Klein's response:
“In April or May of 2012 I committed
approximately $20,000 as a contribution to CIRM to cover the travel
expenses of staff to the International Stem Cell Society
meeting in Japan. My commitment to ensure scientific staff can
participate in international meetings dates back many years. In 2011
I wrote the following explanation of its importance in obtaining the
knowledge to accelerate the drive of scientific research to reach
patients with chronic disease.
            Leverage
Leading Edge Science
           
“Travel by CIRM staff members and leadership permits CIRM to stay
in contact with, and understand, the leading edge advances of
scientists all over the world, and to leverage those advances by
creating a platform for collaborations between these leading
scientists and their peers in California. Currently, CIRM has
collaboration agreements with 15 foreign governments pursuant to
which these governments have pledged $134,380,000 in commitments to
fund the work of their scientists on join teams with California
scientists to develop therapy candidates and to advance therapies to
human trials. Although a significant amount of this commitment is
currently pending scientific peer review and not all of it will be
awarded as part of a successful application, every dollar in
funding by a foreign government magnifies the scientific impact of
California’s taxpayer dollars. If just $40 million is awarded each
year over ten years, it would provide California with $400 million of
scientific leverage.
  •     It
    is critical to understand that there are unpublished scientific
    discoveries in progress in each of these nations. Often, publication
    may trail a scientific discovery by nine months or more.
  •     The
    travel requested by CIRM provides a critical link for the timely
    transmission of valuable new information. California cannot afford to
    lose the opportunity to harness discoveries in other countries to
    advance the development of therapies in California and to capture the
    opportunity to advance therapies for patients instead of using
    California taxpayer dollars to duplicate discoveries already mastered
    in other countries.
  •      While
    CIRM’s scientific staff works with scientists in other countries to
    capture the scientific knowledge for the benefit of California’s
    therapy development teams, the Chairman’s Office works with
    international finance ministers, the premiers of international
    states, and foreign funding agencies to ensure funding allocations
    for these bilateral funding agreements. These discussions often
    involve face-to-face negotiations in foreign nations and states, in
    addition to meetings at international conferences, all of which are
    supported by extensive staff work in California.
  •      CIRM
    issued its first co-funding awards early in 2009. Over the last two
    years, these agreements have yielded $57 million in international
    funds actually approved through peer review. This $57 million
    represents participation by only the first five countries and one
    international state with which CIRM established a collaboration. Now,
    CIRM has agreements with nine countries and two international states
    and an additional three countries will be added in the near future.
  •     Even
    if CIRM were only to obtain $30 million per year in international
    matching funds, the ratio of return on CIRM’s $206,920 travel
    expenditures would be approximately 145 to 1.
  •    Proposition 71 specifically anticipated
    and directs CIRM to develop leverage and global leadership to capture
    the benefit for patients.
Keeping on the Cutting Edge of Stem
Cell Science
"CIRM’s over 20 MDs and/or PhDs
science officers on the grant review staff at CIRM reach out
nationally and internationally through conferences that may include
10-20 meetings per day and workshops of 8-12 hours per day to grasp
the leading edge of this pre-publication, dynamic
revolution in medical knowledge. In order to ensure that the
every research dollar is optimally deployed to advance therapies to
save lives or rescue the quality of life for patients, it is critical
that CIRM staff remain on the cutting edge of new discoveries.
International conferences and workshops provide a critical
opportunity for massive and decisive transfers of information, which
ensures that California is funding the right research.
“I principally corresponded with Dr.
Trounson on the issue covering the travel expenses for the staff for the reasons stated above. I had no input into the selection
of scientific staff. In May and even in June when the conference
occurred I had no idea that there would be any disagreement on the
Alzheimer’s application of Stem Cells Inc. in August. At the Board
meeting I asked that there be consideration for the fact that three
other peer reviews had found the work leading up to this application
to be outstanding and they had ranked it highly. In addition, the
current peer review had not been briefed on the fact that they
downgraded the applicant for following the directions on material
points by the prior peer reviews. Finally, the standard deviation on
the 2012 peer review was extremely high and the re-review by the
three member committee resulted in a split decision. It is
particularly appropriate with a huge standard deviation,
demonstrating both strong support and opposition within the peer
review group, for the Board to make its own independent decision. 
Please recall that the staff recommended against approval so that
they clearly were not influenced by my commitment to a contribution
to the Agency, months before, for the benefit of scientific staff to
be able to attend an international science conference. Additionally,
Dr. Trounson, I believe, recused himself from the review of the Stem
Cells Inc. application, for unrelated reasons, so he was not
involved. I personally had served on the three prior peer reviews,
including one in the prior year that recommended this application for
a Disease Team approval. I know how strongly the scientists on those
three prior peer reviews supported funding this scientific research,
with the 2011 review specifically recommending this Disease Team for
approval. I believe it was extremely important for me to provide a
voice to those three scientific panels who disagreed with a portion
of the scientists on the 2012 scientific panel. Supporting the
scientific movement to human trials for Alzheimer’s has to be
eventually approved by the FDA; but, this loan will move the science
and the potential for clinical trials forward significantly and
hopefully obtain FDA approval. I believe all three of the Board’s
overrides of the peer review recommendations on the Disease Team
round in 2008 are leading directly to human trials in the United
States and/or United Kingdom. 92% of the all of the funds awarded by
CIRM have followed the recommendations of the peer review committee;
but, in those significant cases where the Board has made an
independent decision, there has been an extremely high success rate
particularly when there has been a high level of disagreement within
the Peer Review Board that was overridden and prior peer reviews
recommended and/or approved the scientific approach and concepts of
the applicant.”

(Editor's note:  The applications in this round were reviewed once in April 2012 by CIRM's full grant review group. StemCells, Inc.'s application was subject to a reevaluation after Klein's appeal in July 2012 and rejected again, but it was not a full review.  Klein may be referring also an earlier round that provided grants for planning to apply for the full $20 million.) 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/57qJcfMUql0/the-klein-donation-text-of-robert_5.html

The Klein Donation: Text of Stem Cell Agency's Key Responses

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Here is the text of the key comments
from the California stem cell agency in response to questions from
the California Stem Cell Report (CSCR) concerning the $21,630
contribution by Robert Klein. Here is a link to the full story on the matter.

CSCR to CIRM:

“Is CIRM concerned about the
appearance created by the donation from Bob Klein to enable scientific
staff to attend the ISSCR meeting in Yokohoma, coming one
month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application
and one month before the July Board meeting that led to the approval
of the award?”(Editor's note: It was actually two months before the board meeting.)

CIRM's response:

“No, the two items are entirely
separate with no connection. Item 1  involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research.  The science officers
 had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend.  Item 2 is an ICOC decision to fund a
research project that they felt had promise and was important for the
people of California.”

CSCR to CIRM:
"Please explain why the agency
could not finance the trip itself ."
CIRM's response:
"During the financial year 2011/12  the
Governor's Office issued an Executive Order requiring state agencies,
under the Governor's direct authority, to reduce out-of-state travel.
 Although CIRM was not required to participate, we nevertheless
imposed restrictions on out-of-state travel to meet the intent/spirit
of the Governor's request.  Accordingly, we made a decision to
reduce the number of our science staff who would be attending the
 conference.  Bob Klein's donation made it possible
for those staff to go." 

CSCR asked several questions re the
failure to report the Klein donation to the board as required by
agency rules.
CIRM's response:

“Under the Gift Policy, the President
had the authority to accept Mr. Klein’s generous offer as a 'Direct
payment or reimbursement by third parties for the costs of general
operation or grant management administrative activities.' (Gift
Policy, Sec. III(A)(2).)  Because CIRM receives gifts only
infrequently, CIRM staff determined that it would be more efficient
to report gifts to the Board on a semi-annual basis.  Mr.
Klein’s donation was the first gift CIRM had received in some
years.  Due to the lack of additional donations, a transition in
CIRM’s finance office, and an oversight, CIRM staff has not yet
presented a report including Mr. Klein’s gift.  Staff plans to
report Mr. Klein’s gift as part of the finance report at the May
Board meeting.  Because the President had the authority to
accept the gift pursuant to section III(A)(2) of the Gift Policy, it
did not require a commitment letter.  (See Gift Policy, Sec.
III(C)(1) ['A Commitment Letter is not required for gifts described
under III.A.2., 3. and 4.'].)  However, consistent with the
policy, Dr. Trounson sent Mr. Klein a letter of appreciation, a copy
of which we have already provided you.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/dQImAqKe0Ys/the-klein-donation-text-of-stem-cell.html

hESC Research Totals $458 Million out of $1.8 Billion from California Stem Cell Agency

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The California stem cell agency today
said that it has awarded $458 million to fund research involving
human embryonic stem cells (hESC) out of a total of $1.8 billion it
has given away during the past eight years.

The amount is of some interest because
the key reason that the agency now exists is the perceived
need in 2004 to fund hESC research in the wake of the Bush
Administration restrictions on federal funding in that area. The
restrictions created a national uproar in the scientific and patient
advocate community, which feared that promising therapies would never
be developed.
The $35 million ballot campaign to
create the agency focused hard on hESC research to the virtual
exclusion of any mention of adult stem cell research. Opposing the
effort were such forces as the anti-abortion movement and the
Catholic church. But this month LifeNews.com carried a mildly
approving item that pointed to the agency's turn towards adult stem
cell research.
When the Obama administration lifted
the Bush restrictions, some questions were raised about the need for
the California effort, which is costing state taxpayers $6 billion,
including interest. But those concerns received little public
attention and quickly died out.
Funding for the agency comes through
state bonds. Cash for new awards is scheduled to run out in 2017. The
agency is looking at developing a public-private effort for thefuture that would need a $50 to $200 million “public investment”
and major private funding.
Amy Adams, CIRM's communications
manager, provided the $458 million figure following publication of
this item yesterday on the California Stem Cell Report.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iQOiBLaIRNc/hesc-research-totals-458-million-out-of.html