1. Stem Cell Therapy

Category Archives: Stem Cell Therapy

California Stem Cell Agency Still in Talks on $40 Million for StemCells, Inc.

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The California stem cell agency and
StemCells, Inc., are still trying to reach agreement on a deal in
which the company would receive $40 million from the state's
taxpayer-funded research effort.

The sticking point is the $40 million
in matching funds required from the Newark, Ca., firm under the terms
of the two awards approved in July and September. The latter award
was okayed on a 7-5 vote by the governing board after it was rejected
twice by the agency's reviewers.
On Monday the California Stem Cell
Report queried the agency about the status of the awards. Kevin
McCormack, the agency's spokesman, replied,

“We are still in talks with them over
the terms of the funding. Hopefully, we'll have an agreement soon.”

He did not elaborate further.
CIRM staff normally reviews
applications after they are approved by the agency's governing board
to be sure that all conditions are being met. However, in the case of
the September award to StemCells, Inc., CIRM's governing board took
the unusual step of publicly stating that the firm must demonstrate
it has the $20 million in matching funds before it receives any
payments from CIRM. The board did not take that sort of public
position on the $20 million grant approved earlier in the summer,
although matching funds are required in that case as well.
The former chairman of the $3 billion
stem cell agency, Robert Klein, appeared twice before the board to
lobby for approval of the second award to StemCells, Inc., which is a
publicly traded firm.. It was the first such appearance by Klein
before his former colleagues since leaving the agency in June 2011.
Action on the StemCells, Inc., awards
attracted attention from the Los Angeles Times last month. Pulitzer
Prize-winning columnist Michael Hiltzik wrote that the process was “redolent of cronyism.” He said a “charmed relationship”
existed among StemCells, Inc., its “powerful friends” and the
stem cell agency.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/MeZfo2qdxDQ/california-stem-cell-agency-still-in.html

Knoepfler Award Update: More than a Baker's Dozen Nominated

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As of this week, 14 persons have been
recommended for the Knoepfler “Stem Cell Person of the Year”
Award.

The total was reported by Paul
Knoepfler, the UC Davis stem cell scientist and blogger, who is
putting up $1,000 for the winner of the honor.
Knoepfler announced his award plans earlier this month, declaring that he wanted to recognize scientists or others who “truly made a difference” in the stem
field. Risk-taking is one important criteria.
Knoepfler said,

“It’s something that I’m hoping I
can do every year. It would also be a reward for risk taking,
creativity and be breaking with tradition and be something new in
that regard.” 

The award has drawn some modest
attention outside of Knoepfler's blog. A few days after he introduced
the award on his blog, UC Davis decided to put out a press release and video on it. The California Stem Cell Report followed with an item. Then CIRM blogged it as well.
So far we have not detected any stories
about the award in the mainstream media, but things could change.
Deadline for entries is Dec. 17.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/cLYLc5HQUSY/knoepfler-award-update-more-than-bakers.html

Pomeroy Moving On, Will Leave Stem Cell Board

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Claire Pomeroy, one of the longtime
members of the governing board of the $3 billion California stem cell agency,
will be leaving her position at UC Davis and the stem cell board next
June.

Pomeroy yesterday announced her departure from Davis as vice chancellor for human health services and
dean of the medical school. In a telephone interview, she told the
California Stem Cell Report that she is examining a “few select
opportunities” to work at a national level on health reform and
health policy issues.
Claire Pomeroy
UC Davis photo
Pomeroy, 57, will be spending time in
Washington, D.C., working on health issues on behalf of the
University of California during the transition period before she
leaves her position in California.
Pomeroy came to UC Davis 10 years ago,
shortly before the Golden State's stem cell agency was created in
2004. At that time, UC Davis had what she called a “fledgling”
stem cell research effort. Today the school has chalked up $128 million in
grants from the stem cell agency, ranking fifth among institutions
funded by the agency.
She said that creation of the stem cell
agency “catalyzed development of our program,” which she said has
risen to “national prominence.”
Pomeroy's service on the stem cell
agency board was also instrumental in attracting a $100 million grant
from the Moore Foundation to start a new school of nursing at UC
Davis in 2009. Through her service on the board, she met Ed Penhoet,
who also served on the board and was one of the co-founders of Chiron
and then president of the Moore Foundation. Subsequently, Penhoet
called her for lunch to discuss her thoughts on nursing education,
and developments moved on from there.
The $100 million commitment was the
nation's largest grant for nursing education, according to the Moore Foundation.

Source:
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Texas Flap Looms Over California Stem Cell Agency's Grant Appeals

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In nine days, the California stem cell
agency plans to take another crack at finding ways to curb its
free-wheeling appeal process involving scientists whose applications
for millions have been rejected by reviewers.

It is a matter of considerable interest
to researchers who need the cash to keep their labs running and remain in good standing with their host institutions.
The stem cell agency's governing board this fall created a task force to deal with the appeals issue after a
record-breaking number of researchers made public appeals featuring
emotional patient advocates. Even the former chairman of the agency,
Robert Klein, made a two-time pitch for one applicant. Board members
later complained publicly about “arm-twisting,” lobbying and“emotionally charged presentations.”
The agenda for the Nov. 30 task force
meeting in Oakland -- with teleconferencing sites in San Francisco,
Irvine, Palo Alto, Seattle and Rochester, N.Y. -- contains few clues
on what the panel is hoping to specifically accomplish in next week's
90-minute session.
But interested researchers can check
the transcript from the Oct. 24 meeting, during which CIRM President
Alan Trounson described the problem as “very critical.” He said,

“I think this is a very serious
matter that could really bite us very hard in a similar way to what's
happened in Texas. Unless we come up with some kind of process that
really addresses the science, it's a very large concern.”

Trounson's Texas reference was to the
mass resignations of reviewers at that state's $3 billion cancer
research effort. Questions have been raised about integrity of its grant review process and the program's political and biotech industry
relationships. James Drew of the Dallas Morning News produced a bit of an overview this week. In another piece, Eric Berger of the
Houston Chronicle provided quotes from emails from the infighting on
a controversial $18 million grant.
Changes in California's grant appeal process may well
be also discussed at the agency's board meeting Dec. 12 in Los Angeles.
The board hopes to wrap up its action by late January.
Here is a link to an item with more specifics on material presented to the task force in October. Here is a link to an August 2012 list of articles and documents related to the CIRM appeals process.
Interested parties can address comments
to the agency at info@cirm.ca.gov.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5vUXCLMoJz8/texas-flaps-looms-over-california-stem.html

'The Knoepfler Award:' Recognizing Risk and Those Who Make a Difference

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A UC Davis stem cell researcher-blogger has announced a “stem cell person of the year” award
complete with a $1,000 cash prize that he is putting up himself.

Paul Knoepfler, who may be the only
stem cell scientist in the U.S. actively blogging on the subject,
said he has decided to put his money where his mouth is. 
Since announcing the contest in a Nov.13 blog item, Knoepfler has already received eight nominations,
including one for a scientist. Three days after the item aappeared, UC Davis
featured Knoepfler in a press release that included a video of
Knoepfler explaining the effort.
Paul Knoepfler
UC Davis photo

He said he wanted to go beyond “old
fashioned awards” given by “stodgy committees.” Knoepfler said he
is seeking to recognize that stem cell research is “transcending the
lab.”

The goal of the award, Knoepfler said,
is “to advance the stem cell field and give credit to those who
make a real difference.”
Knoepfler wrote,

“The criteria are that the person
made a truly outstanding difference in the stem cell field for 2012.
The winner could be a scientist, a patient advocate, someone in
industry, a student, a physician…really anyone who has made the
field better. For non-scientist nominees I’m particularly
interested in those who took personal risks or gave of themselves to
help others. For scientists I am looking for outstanding scientific
achievement and in particular out-of-the-box thinking. Folks in any
country are eligible.”

Deadline for nominations is Dec. 17.
Self-nominations are permissible. Knoepfler plans to pick five
finalists and interview them by phone. He also plans an online vote
that he said  “may” influence his decision.
Complete details are available on Knoepfler's blog. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/D_njqx1jc1U/the-knoepfler-award-recognizing-risk.html

Researcher Alert: Keeping Tabs on the Stem Cell Exchequer

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The California stem cell agency has
posted the dates for meetings of its board of directors for 2013
with most of the sessions scheduled for the San Francisco Bay Area.

One is expected to take place in San
Diego in August, and another in Los Angeles 13 months from now. The
other five are in Northern California. Not yet on the schedule is a board workshop in early January that will be open to the public.
Why is this of interest to researchers
and others? The  board controls the purse strings to $3 billion for research grants and determines what areas are to be funded. Astute scientists would do well to take in the sessions.
They offer insights into board thinking and opportunities to deal
with the agency staff and directors on an informal basis. Only a
handful of researchers – or less – attend the meetings on a
regular basis, but have been well-served by the time spent. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/YJowRDshtEY/researcher-alert-keeping-tabs-on-stem.html

California Stem Cell Agency Blogs on Geron Clinical Trial

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The California stem cell agency
published an article online last week concerning the hESC clinical
trial that Geron abandoned last year, dealing mainly with one of the
participants in the program.

The piece was studiously non-committal
about whether the $3 billion research program is likely to fund the
trial once again, should BioTime, Inc., of Alameda, Ca., be
successful in acquiring the assets of once was the first hESC
clinical trial in the United States. The agency loaned Geron $25
million a few months before the company cancelled the trial.
Amy Adams, CIRM's communications
manager, simply wrote,

“They (BioTime) would need to apply
for a loan if they want CIRM to financially support the continued
trial.”

The latest round of funding that
BioTime could apply for has a deadline of Dec. 18 for letters of
intent. In addition to a loan, a grant is also a possibility.
Adams focused on Katie Sharify, who was
enrolled in the clinical trial shortly before Geron said it was
dropping the effort for financial reasons. Adams interviewed Sharify
before an audience of scientists.
Adams wrote,

“Katie told me that it would be
impossible not to hope that a trial would help her, but that by the
time she made the decision to participate she knew she was doing it
to further science, not necessarily to further her own recovery. She
told the audience, 'I was part of something that was bigger than me,
and bigger than all of you.'”

Stem cell scientist Paul Knoepfler of
UC Davis also wrote about the BioTime-Geron deal last week. Noting
that Geron's decision a year ago left many “upset to put it
mildly,” Knoepfler said the “idea of BioTime buying the Geron
stem cell program is a great one that provides new hope on many
levels.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VlS7kYH6oy4/california-stem-cell-agency-blogs-on.html

Study of California Stem Agency Likely to be Released in About a Month

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The $700,000, Institute of Medicine performance study of the $3 billion California stem cell agency is expected to be
released in late November or early December, the IOM said today.

In response to a question last week
from the California Stem Cell Report, Christine Stencel, senior media
relations officer for the IOM in Washington, D.C., briefly discussed
the release plans and the impact of the East Coast super-storm.
Here is the text of her response:

“The DC area escaped the worst of
Sandy’s thumping but nonetheless our schedules and planning have
been somewhat thrown off as we’re playing catch up after two days
of being shut down and some of our committee members and reviewers
are in the areas that got the brunt of the storm. We’re not sure
whether the storm will cause any delays in peer review, but we’re
working toward the goal of publicly releasing the report in late
November or early December. The study staff is working with committee
members to determine the best release format but I anticipate there
will be a press briefing. I’ll send a media advisory when we’ve
got all the details worked out.”

The stem cell agency is paying for the
report, which is examining the performance of the agency. The IOM
began its work in the summer of 2011.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iNEFrnWvUO0/study-of-california-stem-agency-likely.html

Geron, BioTime Deal Moves Forward with Letter of Intent

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Geron Corp., which once pioneered human
embryonic stem cell research, is close to selling off its hESC business in a complicated deal involving two former CEOs of the company and
BioTime, Inc., of Alameda, Ca.

The two publicly traded firms yesterday
announced a “letter of intent” involving a transaction in which
BioTime would acquire the assets of Geron's hESC clinical trial that
the company suddenly abandoned last year. The firm also laid off 66 people,
about 40 percent of its staff.
Abandonment of the program came only a
few months after the $3 billion California stem cell agency loaned Geron $25 million to assist in the trial. The agency could
restore the loan for the trial, but the Geron-BioTime announcement
did not mention that possibility. The California Stem Cell Report has
asked the agency for comment.
The letter of intent came one year and
one day after Geron announced that it was giving up the hESC spinal injury trial because of financial reasons. The Menlo Park, Ca., firm
has been trying to sell its hESC assets since then. BioTime has
been the only firm to express public interest. The Geron trial was
the first hESC trial approved by the FDA.
The proposed deal involves Michael
West, who founded Geron and is now head of Biotime, and Tom Okarma,
who was CEO of Geron from 1999 to 2011. Okarma is now head of BioTime
Acquisition Corp.,(BAC) a subsidiary of BioTime.
Here is how yesterday's press release
described the deal in which BioTime would acquire Geron's
“intellectual property and other assets related to Geron’s
discontinued human embryonic stem cell programs.”

“ BioTime would contribute
to BAC $5 million in cash, $30 million of BioTime common
shares, warrants to purchase eight (8) million common shares
of BioTime at a pre-specified price, rights to use certain
human embryonic stem cell lines, and minority stakes in two of
BioTime’s subsidiaries. In addition, a private investor would
invest $5 million in cash in BAC. 

“Following consummation of the
potential transaction, Geron stockholders would receive
shares representing 21.4% of the common stock of BAC as well as
warrants to purchase 8 million shares of BioTime common
stock at a pre-specified price. BioTime would own
approximately 71.6%, and a private investor would own approximately
7.0% of the outstanding BAC common stock for their $5
million investment. BioTime would also receive
warrants that would enable it to increase its ownership in BAC by
approximately 2%, which would reduce the Geron stockholders’
ownership in BAC to 19.2%. BAC would also be committed to pay
to Geron royalties on the sale of products that are
commercialized in reliance upon Geron patents acquired by
BAC.”

Prior to release of the letter of
intent, an article earlier this week by Vickie Brower in The Scientist said,

“The offer couldn’t come at a
better time for Geron, which in recent months has started to feel
pressure from its shareholders to boost its stock price and move
products through the pipeline. Since last November, when the company
announced its decision to shutter its hESC and regenerative medicine
business and funnel its resources into developing telomerase-related
treatments for cancer, the stock price has dropped more than 50
percent to $1.30 a share. Geron claimed the move was simply to save
money, but many took the decision—which effectively terminated a
clinical trial of an hESC treatment for spinal cord injury—as a
setback for the entire field." 

News coverage of yesterday's
announcement was light. Here is a link to a piece by Ryan McBride on
Fierce Biotech.

Geron's stock price closed at $1.21
yesterday and rose to $1.24 in after hours trading. BioTime closed at
$2.97. No after hours trading was reported for BioTime.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/b-E7JaABIOI/geron-biotime-deal-moves-forward-with.html

BioTime Will Have to Compete for California Cash for Geron's Dormant Clinical Trial

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The California stem cell agency said
today it does not plan to reactivate the $25 million loan to assist
in Geron's spinal injury clinical trial despite an impending deal that would turn the effort over to BioTime, Inc.

Kevin McCormack, senior director for
public communications for the agency, said BioTime will have to
compete in an upcoming award round if it wants to win California
dollars.
Responding to a question from the
California Stem Cell Report, McCormack said,

“That (earlier) loan was specific to
Geron and when the trial was ended the loan ended too. Of course if
Biotime and Geron do complete their deal then Biotime would be free
to apply to us for a new disease team grant.”

McCormack later added that BioTime
could also compete in other appropriate rounds, including the
strategic partnership round just posted by CIRM. It provides for four
awards of up to $15 million. Funding could come as early as October
of next year. The strategic partnership round is a business-friendly
effort that is aimed at attracting “industry engagement and
investment.” The deadline for letters of intent is Dec. 18.
The stem cell agency made its $25
million loan to Geron in 2011 just a few months before the Menlo Park
firm abandoned its human embryonic stem cell trial for financial
reasons. (The full text of the loan agreement can be found here.) The company has repaid the loan with interest.
The company has tried to sell the
assets associated with the clinical trial since last November. The only public
interest that has surfaced has come from BioTime, Inc., of Alameda,
Ca. Michael West, founder of Geron, is the CEO of BioTime. Tom
Okarma, CEO of Geron from 1999 to 2011, is CEO of the BioTime
subsidiary that would assume the clinical trial.
News from clinical trial is expected to
be published soon, according to a story in the San Francisco Business
Times by Ron Leuty. He quoted CIRM President Alan Trounson as saying
that “some findings” from the trial would be published next month
in a medical journal.
Geron's stock traded at $1.24 at the
time of this writing today, up from $1.21 yesterday. BioTime's stock
stood at $2.99, up from $2.97.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/DS-6n2DoRy0/biotime-will-have-to-compete-for.html

Geron Weighs Biotime Bid for hESC Biz

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Geron, Inc., of Menlo Park, Ca., said
today it is assessing an offer by two of its former executives to buy
the human embryonic stem cell program that it abandoned nearly a year
ago.
Geron startled the stem cell world,
including the $3 billion California stem cell agency, when it
jettisoned the first clinical trial of an hESC therapy for financial
reasons. The agency had loaned the company $25 million just a few
months earlier. Geron repaid the loan with interest.
Geron has been mum until today about the Oct. 18 offer by Biotime, Inc., of Alameda, Ca., which is headed
by Michael West, who founded Geron in 1990. Tom Okarma, president of
Geron from 1999 to 2011, is involved with West on the deal and is now
working at Biotime.
Geron's remarks came during a
conference call on its third quarter earnings. A spokesman said the
company is working with Biotime to “assess the feasibility” of
the proposal. He said the proposed transaction is complex and the
company is seeking “additional important details.”
The spokesman declined to offer any
additional comments on the Biotime proposal when questioned following
his initial statement.  
See here and here for earlier stories on the California Stem Cell Report on the Biotime offer. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4JnJvoKwHpA/geron-weighs-biotime-bid-for-hesc-biz.html

Trounson Going Halftime in January and February

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BURLINGAME, Ca. -- The president of the $3 billion California stem cell agency, Alan Trounson, will be working half-time while living in Australia during January and February of next year.

Trounson told the governing board of the agency of his plans at the beginning of its meeting here morning. He said he needs to spend more time with his family, which lives in Melbourne.

Trounson has an 11-year-old son with whom Trounson said he hasn't spend much time in the last 18 months.  Trounson said he intends to teach his son to surf. Trounson's daughter also will be getting married in February.

Meanwhile, directors are currently discussing approval of grants in its $20 million-plus strategic partnership round.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Qvgdz9k9XZ0/trounson-going-halftime-in-january-and.html

California Stem Cell Agency First: Big Pharma Hook Up

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BURLINGAME, Ca. – For the first
time, a Big Pharma company has hooked into the $3 billion California
stem cell agency, a move that the agency described as a “watershed”
in its efforts to commercialize stem cell research.

The involvement of GlaxoSmithKline
comes via a partnership with ViaCyte, Inc., of San Diego, Ca., in a
clinical trial, partially financed with a $10.1 million grant today
from the stem cell agency. The trial involves a human embryonic stem
cell product that has “the potential to essentially cure patients
with type 1 diabetes and provide a powerful new treatment for those
with type 2 disease,” ViaCyte said. Scientific reviewers for the agency, formally known as the California Institute for Regenerative Medicine(CIRM),  “characterized the goal of the proposed therapy as as the 'holy grail' of diabetes treatments.”
CIRM Director Jeff Sheehy, who is co
vice chair of the agency's grant review group, said the ViaCyte product
could be manufactured on a large scale and basically involves “taking
(small) pouches and popping them into patients.”
The stem cell agency's award triggered
arrangements between ViaCyte and Glaxo that will bring in financial
and other support from Glaxo. The exact amount of cash was not
disclosed. CIRM said Glaxo will “co-fund and, assuming success,
conduct the pivotal trial and commercialize the product.” Under the terms of the grant, Glaxo and ViaCyte will have to meet CIRM milestones in order to secure continued funding. 
Following board approval, Jason
Gardner, head of the Glaxo stem cell unit, characterized the
arrangement as a partnership. He told the board that the company
intends to develop a “sustainable pipeline.”
Gardner credited CIRM President Alan
Trounson with being instrumental in helping to put the arrangement
together, beginning with their first meeting three years ago.
Trounson said the deal will resonate not only in California but
throughout the world.
Paul Laikind, president of ViaCyte,
also addressed the board, stressing the importance of CIRM's
financial support for his company over past years. It has received
$26.3 million (not including the latest grant) from California taxpayers at a time when stem cell
funding was nearly dried up. He noted that small companies such as ViaCyte do not have the resources to carry a product through the
final stages of clinical trials and subsequent production. Gardner also said,

“When the commercial funding avenues
have become much more risk averse, CIRM support (has ensured) that
promising, innovative cell therapy technologies are fully explored.”

In comments to the California Stem Cell
Report, Elona Baum, CIRM's general counsel and vice president for
business development, described the award as a “watershed” for
the eight-year-old agency, linking the agency with Big Phama for the
first time. Much of CIRM's current efforts are aimed at stimulating
financial commitments from large companies, which are necessary to
commercialize stem cell research.
Arrangements between Big Pharma and
small companies are not unusual and can vanish quickly. However, the
CIRM-ViaCyte-Glaxo deal sends a message to other Big Pharma companies
and smaller ones, perhaps clearing away concerns that have hindered
other deals that could involve the stem cell agency.
The stem cell agency is pushing hard to
fulfill the promises of the 2004 ballot campaign that created CIRM.
Voters were led to believe that stem cell cures were virtually around
the corner. None have been developed to date.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Jt1JalGURys/california-stem-cell-agency-first-big.html

Biotime-Geron Deal Attracts Interest from Brit Investor

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A British investment trust that has
invested in Geron says it is going to take an advantage of an offer
by an Alameda firm that is seeking to acquire Geron's human embryonic
stem cell assets.

Jonathan C. Woolf, managing director
of British & American Investment Trust PLC, said last week in a letter to its
shareholders that it is disappointed in Geron's performance and the abandonment of its hESC program last November. The sudden halt to the
program and its historic clinical trial also surprised the California
stem cell agency, which had loaned Geron $25 million just a few
months earlier. The agency has expressed an interest in continuing the trial.
Woolf said,

“We have been highly critical of
Geron management's decisions and strategy over the past 20 months, in
particular the decision in November 2011 to abruptly exit Geron's
regenerative medicine (stem cell) business in which it was the
acknowledged world leader. Since that time, Geron management has
attempted to sell or partner this business but to date has been
unable to announce any progress on this.”

Woolf's trust is not listed as a major
Geron shareholder by Morningstar, but Woolf said 17 percent of his firm's
investments are in the Menlo Park, Ca., company. The
specific size of the trust's holdings in Geron was not immediately
known.
Woolf pointed to the offer by Biotime,
Inc., of Alameda, Ca., as a way for Geron shareholders to benefit. On
Oct. 18, Biotime proposed a complicated deal in which it would
acquire Geron's hESC program. Biotime's president, Michael West,
founded Geron in 1990. The head of the Biotime subsidiary that would acquire
the Geron assets is Tom Okarma, who was CEO of Geron from 1999 to 2011. (Here are links to brief stories on the offer: Fiercebiotech, New Scientist.)
In his letter, Woolf noted Geron's
declining stock performance. He said he is “seriously concerned”
that Geron has failed to find a buyer for the assets. Woolf said,

“These now dormant and untended
assets are inevitably losing value as competitors make progress in
Geron's absence from the field and patent protection periods
decline.”

Woolf continued,

“We believe BioTime's proposals would
make Geron's stem cell assets in combination with those of BioTime
once again the world's leading stem cell business with sufficient
resources to recommence the discontinued programmes and develop the
business further into the medium term.”

Woolf urged Geron directors and other
Geron shareholders to work with Biotime to complete the deal. Geron
has not commented on the offer.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/va_Yea0dbF8/biotime-geron-deal-attracts-interest.html

Los Angeles Times: StemCells, Inc., Award 'Redolent of Cronyism'

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The Los Angeles Times this
morning carried a column about the “charmed relationship” between
StemCells, Inc., its “powerful friends” and the $3 billion
California stem cell agency.

The article was written by
Pulitzer prize winner and author Michael Hiltzik, who has been
critical of the agency in the past. The piece was the first in the major
mainstream media about a $20 million award to StemCells, Inc., that was approved in September by the agency's board. The bottom line of the
article? The award was “redolent of cronyism.”
Hiltzik noted that
StemCells, Inc., now ranks as the leading corporate recipient of cash
from the agency with $40 million approved during the last few months.
But he focused primarily
on September's $20 million award, which was approved despite being
rejected twice by grant reviewers – “a particularly
impressive” performance, according to Hiltzik. It was the first
time that the board has approved an award that was rejected twice by
reviewers.
Hiltzik wrote,

“What was the company's
secret? StemCells says it's addressing 'a serious unmet medical need'
in Alzheimer's research. But it doesn't hurt that the company also
had powerful friends going to bat for it, including two guys who were
instrumental in getting CIRM off the ground in the first place.”

The two are Robert Klein,
who led the ballot campaign that created the agency and became its
first chairman, and Irv Weissman of Stanford, who co-founded
StemCells, Inc., and sits on its board. Weissman, an internationally
known stem cell researcher, also was an important supporter of the
campaign, raising millions of dollars and appearing in TV ads. Klein,
who left the agency last year, appeared twice before the CIRM board
this summer to lobby his former colleagues on behalf of Weissman's
company. It was Klein's first appearance before the board on behalf
of a specific application.
The Times piece continued,

“But private enterprise
is new territory for CIRM, which has steered almost all its grants
thus far to nonprofit institutions. Those efforts haven't been
trouble-free: With some 90% of the agency's grants having gone to
institutions with representatives on its board, the agency has long
been vulnerable to charges of conflicts of interest. The last thing
it needed was to show a similar flaw in its dealings with private
companies too.”

Hiltzik wrote,

“(Weissman) has also
been a leading beneficiary of CIRM funding, listed as the principal
researcher on three grants worth a total of $24.5 million. The agency
also contributed $43.6 million toward the construction of his
institute's glittering $200-million research building on the Stanford
campus.”

CIRM board approval of the
$20 million for StemCells, Inc., came on 7-5 vote that also required
the firm to prove that it had a promised $20 million in matching
funds prior to distribution of state cash.
Hiltzik continued,

“The problem is that
StemCells doesn't have $20 million in spare funds. Its quarterly
report for the period ended June 30 listed about $10.4
million in liquid assets, and shows it's burning about $5 million per
quarter. Its prospects of raising significant cash from investors
are, shall we say, conjectural.

“As it happens, within
days of the board's vote, the
firm downplayed any pledge 'to raise a specific amount of
money in a particular period of time.' The idea that CIRM 'is
requiring us to raise $20 million in matching funds' is a
'misimpression,' it said. Indeed, it suggested that it might count
its existing spending on salaries and other 'infrastructure and
overhead' as part of the match. StemCells declined my request that it
expand on its statement. 

“CIRM spokesman Kevin
McCormack says the agency is currently scrutinizing StemCells'
finances 'to see what it is they have and whether it meets the
requirements and expectations of the board.' The goal is to set
'terms and conditions that provide maximum protection for taxpayer
dollars.' He says, 'If we can't agree on a plan, the award will
not be funded.'"

Hiltzik wrote,

“The agency shouldn't be
deciding on the spot what does or doesn't qualify as matching funds.
It should have clear guidelines in advance.

“Nor should the board
overturn the judgment of its scientific review panels without
clear-cut reasons....The record suggests that the handling of the
StemCells appeal was at best haphazard and at worst redolent of
cronyism.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6qvBfSLP3RE/los-angeles-times-stemcells-inc-award.html

Texas Science Flap Cited as California Stem Cell Agency Eyes its Own Processes

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OAKLAND, Ca. – Meeting against a
backdrop from Texas that involves conflicts of interest and mass
resignations of grant reviewers, a task force of the $3 billion
California stem cell agency today began a partial examination of its
own grant approval process, specifically focusing on appeals by
rejected applicants.

The president of the California
organization, Alan Trounson, told the task force that it was dealing
with a “very serious matter” that in some ways is similar to what
happened in Texas. He said the science community is “very much
concerned.”
The situation in Texas involves the
five-year-old Cancer Prevention and Research Institute, which like
the California stem cell agency, formally known as the California
Institute of Regenerative Medicine (CIRM), has $3 billion of borrowed
money to use to finance research.
The chief scientific officer of the
Texas organization, Nobel laureate Alfred Gilman, resigned Oct. 12
during a flap about its attempts “to simultaneously support basic
research and nurture companies.”
Gilman's departure was triggered by a
$20 million award made without scientific review. Reviewer
resignations followed with letters that accused the Texas group of
“hucksterism” and dishonoring the peer review process. (Writer Monya Baker has a good overview today in Nature.)
The situation in Texas came to a head
AFTER the governing board of the California research group created
its task force. The problems in Texas are bigger and not identical to
those in California, which mainly involve the free-wheeling nature of the appeal process, not an entire lack of scientific review.
Nonetheless, this past summer, directors of the California agency for
the first time approved an award that was rejected twice by
reviewers. The award went to StemCells, Inc., of Newark, Ca., which
now has won $40 million, ranking the company No. 1 in
awards to business from CIRM.
Earlier this month, Los Angeles Times
business columnist Michael Hiltzik characterized the StemCells, Inc.,
award as “redolent of cronyism.”
Today's session of the CIRM task force
focused primarily on an aspect of the agency's appeals process that
CIRM labels as “extraordinary petitions.” They are letters which
rejected applicants use to challenge decisions by grant reviewers.
The researchers follow up with public appearances before the
governing board, often trailing squads of patients making emotional
appeals.
Both researchers and patients have a
right under state law to appear before the CIRM board to discuss any
matter. CIRM, however, is trying to come up with changes in the
appeal process that will make it clear to researchers on what the
grounds the board might overturn reviewers' decisions. The agency is
also defining those grounds narrowly and aiming at eliminating
appeals based on differences in scientific opinion.
At today's meeting, CIRM Director Jeff
Sheehy, a patient advocate and co-vice chair of the grants review
group, said peer review is an “extraordinary way of analyzing
science, but it is not always perfect.” However, he also said that
“as a board we are not respecting input” from scientists and thus
allow the perception that we can be “persuaded against the judgment
of scientists.”
CIRM Director Oswald Steward, director
of the Reeve-Irvine Research Center at UC Irvine, agreed with a
suggestion by Sheehy that board must act with “discipline” when
faced with appeals by rejected applicants. Steward said, 

“The
process has gotten a little out of hand.”

It was a sentiment that drew no dissent
at today's 90-minute meeting.
Missing from today's meeting, which had
teleconference locations in San Francisco, Irvine, La Jolla and Palo
Alto, were any of the hundreds of California scientists whose
livelihoods are likely to be affected by changes in the grant
approval process. Also absent were California biotech businesses,
along with the only representative on the task force from CIRM's
scientific reviewers.
Our comment? When researchers and
businesses that have millions at stake fail to show up for key
sessions that set the terms on how they can get the money, it is a
sad commentary on their professional and business acumen.
Bert Lubin, a CIRM director and
chairman of the task force, indicated he would like to have two more
meetings of the task force prior to making recommendations to a full
board workshop in January with possible final action later that
month. Lubin, CEO of Children's Hospital in Oakland, said the matter
is “really important for the credibility of our whole
organization.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A3HGGTzzso8/texas-science-flap-cited-as-california.html

Yamanaka: 'Rejected, Slow and Clumsy'

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This week's announcement of the Nobel
Prize for Shinya Yamanaka brought along some interesting
tidbits, including who was “snubbed” as well as recollections
from the recipient.

Jon Bardin of the Los Angeles Times
wrote the “snubbed” piece and quoted Christopher Scott of
Stanford and Paul Knoepfler of UC Davis about the selection issues.
Bardin's piece mentioned Jamie Thomson and Ian Wilmut as scientists
who also could have been considered for the award but were not named.
Ultimately, Bardin wrote that the award committee was looking for a
“singular, paradigm shifting discovery,” which he concluded was
not the case with Thomson or Wilmut.
How Yamanaka arrived at his research
was another topic in the news coverage, much of it dry as dust.
However, Lisa Krieger of the San Jose Mercury News began her story
with Yamanaka's travails some 20 years ago. At the time, no one was returning his phone
calls as he looked for work, and he was rejected by
50 apparently not-so-farsighted American labs.
But that job search in 1993 came only after Yamanaka
decided he was less than successful as an orthopedic surgeon,
according to an account in JapanRealTime. “Slow and clumsy” was
how Yamanaka described himself.
And so he moved on to research. But
again he reported stumbling. In this case, he found a way to reduce
“bad cholesterol” but with a tiny complication – liver cancer.
That in turn sent him on a journey to learn how cells proliferate and
develop, which led him to the work that won the Nobel Prize.
Yamanaka said his original interest in
orthopedic medicine was stimulated by his father along with the treatments
for injuries young Yamanaka received while playing rugby and learning judo. The JapanRealTime account continued,

“'My father probably still thinks in
heaven that I’m a doctor,' he said in the interview(with Asahi
Shimbun last April). 'IPS cells are still at a research phase and
have not treated a single patient. I hope to link it to actual
treatment soon so I will be not embarrassed when I meet my father
someday.'”

And then there was, of course, the much-repeated story from the researcher who shared the Nobel with Yamanaka, John Gurdon. He has preserved to this day a
report from a high school biology teacher that said the 15-year-old
Gurdon's desire to become a scientist was “quite ridiculous.”
The teacher, who is unnamed, wrote,

“If he can’t learn simple
biological facts he would have no chance of doing the work of a
specialist, and it would be a sheer waste of time, both on his part
and of those who would have to teach him.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7J31SRIukpg/yamanaka-rejected-slow-and-clumsy.html

Yamanaka and the Frailty of Peer Review

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More than one back story exists on
Shinya Yamanaka and his Nobel Prize, but one that has received little
attention this week also raises questions about hoary practice of
peer review and publication of research – not to mention the
awarding of billions of dollars in taxpayer dollars.

The Yamanaka tale goes back to a 2010
article in the New Scientist magazine by Peter Aldous in which the
publication examined more than 200 stem cell papers published from
“2006 onwards.” The study showed an apparent favoritism towards
U.S. scientists. Also specifically reported were long delays in
publication of Yamanaka's papers, including in one case 295 days.
Here is part of what Aldous wrote,

“All's fair in love and war, they
say, but science is supposed to obey more noble ideals. New findings
are submitted for publication, the studies are farmed out to experts
for objective 'peer review' and the best research appears promptly
in the most prestigious journals. 

“Some stem cell biologists are crying
foul, however. Last year(2009), 14 researchers in this notoriously
competitive field wrote
to leading journals complaining of "unreasonable or
obstructive reviews". The result, they claimed, is that
'publication of truly original findings may be delayed or rejected.' 

“Triggered by this protest, New
Scientist scrutinised the dynamics of publication in the most
exciting and competitive area of stem
cell research, in which cells are 'reprogrammed' to
acquire the versatility of those of an early-stage embryo. In this
fast-moving field, where a Nobel prize is arguably at stake,
biologists are racing feverishly to publish their findings in top
journals. 

“Our analysis of more than 200
research papers from 2006 onwards reveals that US-based scientists
are enjoying a significant advantage, getting their papers published
faster and in more prominent journals (find
our data, methods and analyses here). 

“More mysterious, given his standing
in the field, is why two of Yamanaka's papers were among the 10 with
the longest lags. In the most delayed of all, Yamanaka reported that
the tumour-suppressing gene p53 inhibits the formation of
iPS cells. The paper took 295 days to be accepted. It was eventually
published by Nature in August 2009 alongside four similar
studies. 'Yamanaka's paper was submitted months before any of the
others,' complains Austin
Smith at the University of Cambridge, UK, who coordinated
the letter sent to leading journals. 

“Yamanaka suggests that editors may
be less excited by papers from non-US scientists, but may change
their minds when they receive similar work from leading labs in the
US. In this case, Hochedlinger submitted a paper similar to
Yamanaka's, but nearly six months after him. Ritu
Dhand, Nature's chief biology editor, says that each paper
is assessed on its own merits. Hochedlinger says he was unaware of
Yamanaka's research on p53 before publication.”

Last week, Paul Knoepfler of UC Davis
wrote of other issues dealing with peer review, but coincidentally
also dealing with iPS cells. What New Scientist and Knoepfler are
discussing is not an isolated situation. It is part of a continuum of
complaints, both serious and self-interested but exceedingly
pervasive. A Google search today on the term “problems with peer
review” turned up 10.1 million references.  Writing on Ars Technica last year, Jonathan Gitlin, science policy analyst at the National
Human Genome Research Institute,  summarized many of the issues, citing a “published” (our quotation marks)
study that said peer review doesn't work “any better than chance.”
Gitlin said,

“A common criticism is that peer
review is biased towards well-established research groups and the
scientific status quo. Reviewers are unwilling to reject papers from
big names in their fields out of fear, and they can be hostile to
ideas that challenge their own, even if the supporting data is good.
Unscrupulous reviewers can reject papers and then quickly publish
similar work themselves.” 

At the $3 billion California stem cell
agency, peer review is undergoing some modest, indirect examination
nowadays. The agency is moving towards tighter scrutiny of budgets
proposed by applicants. And, following a record wave of appeals this
summer by disgruntled applicants rejected during peer review, it is
also moving to bring the appeal process under more control.
As the agency tries to move faster and
more successfully towards development of commercial therapies, it may
do well to consider also the frailties of its peer review process and the
perils of scientific orthodoxy.   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/lESi4gQF2IA/yamanaka-and-frailty-of-peer-review.html

Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions

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The move by the $3 billion California
stem cell agency to curtail its free-wheeling grant appeal process
will undergo its first public hearing next week.

The proposals will mean that scientists
whose applications are rejected by reviewers will have fewer avenues
to pursue to overturn those decisions. The changes could take effect
as early as next year.
The move comes in the wake of a record
number of appeals this summer that left the board complaining about
“arm-twisting,” lobbying and “emotionally charged presentations.”
Among other things, the new "guidelines" attempt to define
criteria for re-review – “additional analysis” – of
applications involved in appeals, also called “extraordinary
petitions.” The plan states that re-review should occur only in
the case of a material dispute of fact or material new information.
(See the end of this item for agency's proposed definitions.)
In addition to alterations in the
appeal process, the CIRM directors' Application Review Task Force
will take up questions involving “ex parte communications.” The
agenda for the Oct. 24 meeting did not contain any additional
information on the issue but it likely deals with lobbying efforts on
grants outside of public meetings of the agency. We understand that
such efforts surfaced last summer involving the $$214 million disease
team round and Robert Klein, the former chairman of the stem cell
agency.
Klein appeared twice publicly before
the board on one, $20 million application by StemCells, Inc., the
first time a former governing board member has publicly lobbied his former
colleagues on an application. The application was rejected twice by reviewers – once
on the initial review and again later on a re-review – but it was
ultimately approved by directors in September on a 7-5 vote.
The board has long been troubled with
its appeal process but last summer's events brought the matter to a
new head. The issue is difficult to deal with because state law
allows anyone to address the CIRM governing board on any subject when
it meets. That includes applicants who can ask the board to approve
grants for any reason whatsoever, not withstanding CIRM rules. The board can also approve a grant
for virtually any reason although it has generally relied on
scientific scores from reviewers.
The proposals to restrict appeals are
designed to make it clear to scientists whose applications are
rejected by reviewers that the board is not going to look with favor
on those who depart from the normal appeals procedure.
While the board almost never has
overturned a positive decision by reviewers, in nearly every round it  approves some applications that have been rejected by reviewers. That has
occurred as the result of appeals and as the result of motions by
board members that did not result from public appeals.
Ten of the 29 board members are classified as patient advocates and often feel they must advance the cause of the
diseases that they have been involved with. Sometimes that means
seeking approval of applications with low scientific scores.
Here is how agency proposes to define
“material dispute of fact:”

“A material dispute of fact should
meet five criteria:(1) An applicant disputes the accuracy of a
statement in the review summary;(2) the disputed fact was significant
in the scoring or recommendation of the GWG(grant review group); (3) the dispute pertains
to an objectively verifiable fact, rather than a matter of scientific
judgment or opinion;(4) the discrepancy was not addressed through the
Supplemental Information Process and cannot be resolved at the
meeting at which the application is being considered; and
(5) resolution of the dispute could affect the outcome of the board’s
funding decision."

Here is how the agency proposes to
define “material new information:”

“New information should: (1)be
verifiable through external sources; (2) have arisen since the
Grants Working Group(grant review group) meeting at which the application
was considered; (3) respond directly to a specific criticism or
question identified in the Grants Working Group’s review; and (4)
be submitted as part of an extraordinary petition filed five business
days before the board meeting at which the application is
being considered."

Next week's hearing is scheduled for
Children's Hospital in Oakland with a teleconference location at UC
Irvine. Addresses can be found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6sbxGqQJ77Y/researcher-alert-stem-cell-agency-to.html

Tighter Controls on Stem Cell Grant Budgets Hits Quorum Bump

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SAN FRANCISCO – A move to tighten
budget controls on grants from the $3 billion California stem cell
agency stalled Monday, but it appears that the plan is headed for
ultimate approval.

The proposal was up for consideration
by the agency's directors' Science Subcommittee, which could not act
on it after it lost its quorum.
Members of the panel generally favored
the stronger budget controls, but had questions about the specifics
of implementing the plan during closed-door reviews of grant
applications. The proposal is likely to be altered to respond to
those concerns. It would then either come back to the Science
Subcommittee or go to the full board.
The plan would make it clear to
recipients of large grants that approval of an application by the
agency's governing board does not provide a carte blanche to
researchers. Ellen Feigal, senior vice president for research and
development, said it can be “extremely difficult” for CIRM staff
to deal with budget problems in grants following board approval.
The committee also approved a plan to
speed the application process on its next disease team round, which
is aimed at driving research into the clinic. The concept proposal
for that round is scheduled to come before directors later this
month. The round will be limited to “more mature stage” research
that is close to a clinical trial, if not in one. Feigal said 10 to
15 applications are expected.
Another proposal to add more millions
to CIRM's strategic partnership program was also approved.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/EqLIk55mLu4/tighter-controls-on-stem-cell-grant.html


  1. Stem Cell Therapy