BioTime Stock Jumps 22 Percent in Two Days in Wake of Geron Deal
By Dr. Matthew Watson
The stock price of Biotime, Inc., of
Alameda, Ca., shot up more than 12 percent today following the
announcement of a complex deal that will give it the stem cell assets
of Geron Corp., the first firm to launch a clinical trial for an hESC
therapy.
 |
| Geron stock price Jan. 2-8 Google chart |
43 cents or 12.46 percent. That followed a 9.6 percent gain
yesterday. Geron's stock closed at $1.63, up three cents or 1.9
percent.
with our tracking showing only one story so far today on The Scientist magazine web site.
Source:
Stem Cell Therapy
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January 13th, 2013
BioTime Buys Geron’s Stem Cell Assets, Including hESC Clinical Trial
By Dr. Matthew Watson
Geron Corp., which pioneered the first
clinical trial of an hESC therapy, today sold its stem cell
business to another San Francisco Bay Area firm whose two top
executives were once CEOs at Geron.
 |
| Michael West BioTime photo |
not clear from the public statements released by Geron and the
acquiring firm, BioTime, Inc., of Alameda, but an unidentified
outside investor is adding $10 million to transaction.
Michael West, CEO of BioTime, said that as a result of the deal his
firm will hold 600 patents and patent applications involving stem
cells. He said the aggregation should help in attracting financial
interest in the firm and its efforts.
Acquistion Corp., the BioTime subsidiary that is picking up the Geron
assets, is headed by Tom Okarma, who was Geron's CEO from 1999 to
2011.
Geron abruptly jettisoned its stem cell business along with the
clinical trial. Geron has been looking since then for a buyer for the
assets.
 |
| Tom Okarma Geron photo |
decision in 2011, the California stem cell agency had signed a $25
million loan agreement with Geron to support the clinical trial. The
company paid back with interest the amount of the loan that it had
received.
not specify whether BioTime will begin seeking additional
participants in the clinical trial. Nor did BioTime indicate whether
it would seek additional funding from the state stem cell agency.
interview that he has an “open mind” about working with CIRM.
Last year, agency officials indicated an interest in continuing to
support the clinical trial. West said BioTime had already hired some
employees that were laid off by Geron, including its patent attorney.
He said that he hoped to reassemble at least part of Geron's now
scattered stem cell team.
when the deal is officially concluded in September, “it is
anticipated that Geron stockholders would own approximately 21% of
BAC, BioTime would own approximately 72%, and a private investor
would own approximately 7% after an additional $5 million investment
in BAC.”
leased space in Menlo Park that Geron once used for its stem cell
business.
BioTime's stock price closed at $3.45 today and had a 52-week high of
$6.35 and a low of $2.67. Geron closed at $1.60 and had a 52-week
high of $2.99 and a low of 91 cents.
Francisco Business Times about the deal. Here are links to the
BioTime press release, a BioTime FAQ and the Geron press release.
Source:Stem Cell Therapy
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January 13th, 2013
Reverse Engineering Grandpa
By Dr. Matthew Watson
Stem cells are rarely the subject of
cartoons, but one popped last week from Bizarro.
Francisco Chronicle and elsewhere, including the
Bizarro web site. The image was of a petri dish in a lab with
tiny maternal speck giving parental advice to an even tinier speck:
"You can be anything you want to be when you grow up."
Artist Dan Piraro said the cartoon was his favorite of the
week because of its “strangeness.”
“To use a term common in the
vernacular of geneticists, it’s creepy cool.”
between embryonic and adult cells, much less reprogrammed adult
cells. Using reprogrammed cells in the cartoon would have been even
creepier and cooler, giving new meaning to the 1947 song, “I Am My
Own Grandpa.”(See here and here.)
(A nod to "Bob" for calling our attention to the cartoon.)
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/gXXLRtG2Sx4/reverse-engineering-grandpa.html
Boxing in the California Stem Cell Board
By Dr. Matthew Watson
Robert Klein is much admired for his
prodigious efforts on behalf of stem cell research, including his
service as the first chairman of the $3 billion California stem cell
agency.
directing the ballot campaign that resulted in passage of Proposition
71 in 2004 and creation of of the agency. One of Klein's less
publicly recognized skills was putting the governing board of the
agency in a box from time to time.
be headed for another box – this time in connection with their
position on the Institute of Medicine's sweeping recommendations for major changes at the stem cell agency.
similar situation in 2009 involving Klein and the Little Hoover
Commission, the state's good government agency.
the commission, which was requested by state lawmakers who had butted
heads with Klein. He knew that the commission would come up with
recommendations that he would find odious.
released in its final form, Klein had the board's outside counsel,
James Harrison, prepare a legal memo on a draft version of the study.
Harrison's memo said many of the most far-reaching recommendations of
the commission would require a vote of the people – a more costly
and unlikely proposition than a vote of the legislature.
2009. The commission report was released June 26, 2009. On June 30, 2009, Klein warned directors in an email that support of some of the
proposals would violate their oath of office. The first time a
subcommittee of directors had to a chance to react publicly came on
July 16, 2009. The full board did not have the Hoover report on its
agenda until Aug. 6, 2009. By that time, they were thoroughly boxed
in.
they disagreed with Klein. To do anything other than go along with
him would mean rejection of a 10-page legal opinion from Harrison,
which could be interpreted as no-confidence vote on Harrison and
possibly Klein. Board members were not interested in losing
Harrison, who has been valuable asset to the board since day one.
Overthrowing Klein was even less likely in 2009.
2009 memo in the wake of the Institute of Medicine recommendations,
which echo some of the major Hoover proposals. The board has also
scheduled a workshop for Jan. 23 that will discuss the IOM proposals.
that is as explicit as the 2009 document, CIRM directors will have
few choices. The best procedure may well be for Harrison
to continue his work on the memo until after the Jan. 23 meeting.
Directors could then decide on initial steps in connection with the
IOM recommendations and ask Harrison how they can proceed legally, although the task is really more of a political challenge than a legal
one.
Source:San Diego Newspaper Calls for Major Changes at California Stem Cell Agency
By Dr. Matthew Watson
The San Diego U-T today ran an
editorial that was headlined “Stem cell research institute must fix itself.”
to findings by the Institute of Medicine that the $3 billion
California stem cell should make sweeping changes to deal with issues
ranging from conflicts of interest to management structure.
a unanimous reaction so far from California newspapers.
“We hope we
are wrong in thinking that, given the number of times the same
criticisms of CIRM have come up over the past seven years, the agency
doesn’t really take them seriously.
“If that is
the agency’s attitude, it could well be a fatal error. CIRM has
enough money remaining from the original $3 billion to continue
awarding research grants for another four years. But it will either
have to go back to California voters in 2014 or 2016 for another bond
issue to continue its operations or find a different source of
funding.
“Whichever
CIRM decides, whoever is asked to foot the bill, either taxpayers or
the private sector will demand transparency and accountability. We
hope CIRM can demonstrate it.”
Source:Stem Cell Therapy
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December 23rd, 2012
California Editorial Unamity: Stem Cell Agency Needs Revamp
By Dr. Matthew Watson
With the addition of another editorial
this week, reaction among California newspapers so far has been
unanimous that the $3 billion California stem cell agency should heed
the sweeping recommendations of the prestigious Institute of
Medicine.
“Good intentions do not justify poor
practice.”
the agency “needs to revamp its governance structure to avoid
potential conflicts of interest and boost public confidence in the
agency.”
90 percent of its funding go to institutions with ties to directors, but also supported other recommendations, including elimination of the dual executive arrangement at the research effort.
“An agency spending Californians’
money has no business being cavalier about good government practice
and ethical safeguards — no matter how promising the potential
therapies might be. The stem-cell institute is not a private fiefdom,
but a taxpayer-supported undertaking. Yet many on the stem-cell
institute’s board objected this month to the report’s
recommendations.
“The agency also said that Prop. 71’s
provisions mean that enacting many of the proposed fixes would
require either a supermajority vote of the Legislature or another
ballot measure. That prospect should warn Californians about the
dangers of voting for complex, costly, politically driven initiatives
that have little to do with fundamental state duties.
“Still, the stem-cell agency cannot
just sit on these recommendations without damaging its credibility.
The search for medical breakthroughs does not justify ignoring vital
safeguards for spending taxpayer dollars.”
For a look at other editorials, see here and here.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/70xi8-waM7k/california-editorial-unamity-stem-cell.html
Stem Cell Therapy
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December 23rd, 2012
Balloting Begins on Stem Cell Person of the Year
By Dr. Matthew Watson
begun, with about 1,000 ballots cast so far. But only one vote truly
counts. That belongs to Paul Knoepfler, who is running the The Stem
Cell Person of the Year contest and will pony up $1,000 of his
hard-earned cash to honor the winner.
to advocates. Voting began instantly and will continue until Dec. 31
at 11:59 p.m. Votes will count for something, but Knoepfler makes it clear that they are only advisory. He makes the decision.
contest. The UC Davis stem cell researcher, patient advocate and
blogger wants to recognize someone who made a difference and took
some risks in doing so.
candidates on Knoepfler's blog, but we wanted to note that they have
a father and son competing against each other – Don Reed and his
son, Roman. (Could be tense around the holiday tables in the
Reeds' households.) Also on the list is Jeanne Loring of Scripps,
whose nominator said engages the wider community with great
effectiveness. I once heard Loring say that every stem cell
researcher should have a spiel that could be delivered in five
minutes in a taxi and that would not only explain stem cell research,
but persuade the cab driver of its virtues.
recommend them. Knoepfler will be chewing his fingernails before this
is all over.
Source:Stem Cell Therapy
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December 23rd, 2012
Exploring the Straw Man Argument Against IOM Reforms at California Stem Cell Agency
By Dr. Matthew Watson
Constitutional objections to some of
the Institute of Medicine's sweeping recommendations for changes at
the $3 billion California stem cell agency amount to little more than
a straw man, at least based on a legal memo produced earlier by the
agency.
agency were initially advanced in 2009 when the stem cell agency was
fighting an unwelcome analysis of its activities by the state's good
government agency, the Little Hoover Commission. The objections were
voiced again at a meeting earlier this month by some governing board
members, particularly Sherry Lansing, who is also chairwoman of the
University of California regents. Her comments came within minutes of
the start of the Institute of Medicine's (IOM) presentation to the
board.
because of requirements in Proposition 71, the ballot initiative that
created the stem cell agency, which is formally known as the
California Institute for Regenerative Medicine(CIRM). While Lansing
did not elaborate, some of the initiative is written into the state
constitution, which can only be amended by a vote of the people.
However, Proposition 71 can also be amended by a 70 percent vote of
each house of the Legislature and the signature of the governor,
which is no small task to achieve.
below) dealt with the recommendations of the Little Hoover
Commission, some of which were cited and echoed by the IOM. The legal
memo contended that the legislature was barred from making major
changes in the structure of the stem cell agency governing board
because the changes supposedly would not “enhance the ability of
the (agency) to further the purposes of the grant and loan programs.”
The argument was that only the people could make “non-enhancing”
changes. The vague “enhancement” requirement was written into
Proposition 71 by its authors, one of whom is James Harrison, the
outside counsel to the board, who was also the lead author on the
2009 memo. Harrison is revisiting the supposed constitutional issues in the wake of the IOM study.
so vague as to permit wide interpretations. Certainly, removing
public suspicion about conflicts of interest would seem to help move
the agency forward. Straightening out the muddled management
structure of the agency, with its overlapping responsibilities for
the chairman and president, would certainly seem to enhance the
functioning of the agency. Assuring that the governing board has the
full ability to exercise strong oversight over the conduct of the
agency would certainly seem to be an enhancement and long overdue.
prestigious body of its sort says. The Institute of Medicine studied
the agency for 17 months under a $700,000 contract with CIRM. The
IOM's charge was to evaluate the performance of the agency and make
recommendations for improvements. The IOM recommendations echoed
findings not only of the Little Hoover Commission, but some in two
earlier studies also funded by the agency.
IOM findings and turn away would be to indicate that their earlier
admiration and respect for the IOM was something of a sham or, more
likely, now inconvenient.
does or does not enhance the agency's mission, the 29-member board
could simply adopt a resolution declaring that all the IOM
recommendations would enhance the CIRM mission.
earlier recommendations for changes was Robert Klein, the first
chairman of the agency board. Klein, an attorney and real estate investment
banker, also directed the writing of Proposition 71 and wrote
portions of it himself. He would often make numerical code citations
to the initiative during agency board meetings.
leaving in 2011 at the end of his term. He was replaced by Jonathan
Thomas, a Los Angeles bond financier, who has ushered in a new and
different era at the stem cell agency. Some might say a more
reasonable era. He says he and governing board
take the IOM study seriously.
Jan. 23 at a public workshop at the Claremont Hotel in Berkeley, Ca.,
the day before the regular board meeting. .
far written about them. The newspapers believe that the proposals
would indeed enhance the agency's mission and are, in fact, necessary
if the agency is to survive beyond 2017, when the money for new
grants runs out.
currently mulling the future of their efforts. If they are to be
successful in raising additional hundreds of millions of dollars –
be they private or public – the directors must confront the
findings of the IOM in a forthright manner. And they must move to
dispel the cloud that now hangs over the stem cell agency.
2009 legal memo can be found below. Also below is another related
legal memo from Americans for Cures, a stem cell lobbying group
sponsored by Robert Klein at the same time he was chairman of the
stem cell agency. Despite the language on the Americans for Cures
memo, it is a public record. It became a public document when Klein
submitted it to the Little Hoover Commission.)
Source:Stem Cell Therapy
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December 23rd, 2012
Southern California Newspaper Tackles Stem Cell Agency and UC Irvine Grants
By Dr. Matthew Watson
The Orange County Register today zeroed
in on the $3 billion California stem cell agency and its relationship
to the local University of California campus in the wake of sweeping
recommendations for changes at the eight-year-old agency.
headlined “Ties to stem cell board lucrative.”
the firm's partnership with Frank LaFerla of UC Irvine, which is located in Orange County.
reviewers at the stem cell agency but the governing board of the
agency (CIRM) approved it on a 7-5 vote in September following
lobbying on behalf of the company by the board's former chairman,
Robert Klein, and others.
Medicine (IOM) and some of its findings, particularly those dealing
with conflicts of interest, echoed criticisms that have been raised for years.
“Repeated independent reviews of the
agency, including one by the (IOM) released this month, have found
that its board is rife with conflicts of interest. In fact, of the
$1.7 billion that the agency has awarded so far, about 90 percent has
gone to research institutions with ties to people sitting on the
board, according to an analysis by David Jensen at the California
Stem Cell Report, which closely follows the agency's operations.
cure, Petersen said,
“What's clear already is that the
money has transformed stem cell research in California and poured
hundreds of millions of dollars into the state's universities,
including UC Irvine.”
is dominated by members from the UC system, including two professors
at UC Irvine.
“Before Proposition 71 (the measure
that created the agency) passed, UC Irvine had less than ten stem
cell scientists, who received about $1.5 million in funding each
year. Now, after receiving $100 million in grants from the state
agency, the university has sixty scientists working to advance stem
cell research and teaching. It touts itself as one of the top stem
cell research centers in the world. In 2010, it opened an $80 million
four-story stem cell research center with the agency picking up $27
million of the cost.
“As UC Irvine has won increasing
amounts of taxpayer money, its two professors who sit on the agency's
board have risen in status on campus.
Susan Bryant
UC Irvine photo
“Professor Susan Bryant, an expert in
regenerative medicine, was dean of the School of Biological Sciences
when she was named to the agency's board in 2004. She was then
promoted to vice-chancellor of research. In July, she was named the
university's interim executive vice-chancellor and provost, its
second most powerful administrator.
“When Professor Oswald Steward, a
stem cell scientist, joined the agency's board in 2004, he was
director of UCI's Reeve-Irvine Research Center for Spinal Injury.
Since then, the scientists working in his center have received
millions of dollars in grants from the agency. In May, the university
rewarded Steward with an additional title: senior associate dean of
research for the School of Medicine.”
“The two professors are prohibited
from receiving any agency funds for their own scientific work. But so
much money has been funneled into the stem cell field in California
that it can be difficult to show their continued scientific efforts
are not somehow benefiting. For example, Bryant co-authored a
scientific article in 2009 with nine other scientists about the
genetics of salamanders, which can regenerate limbs. In the report,
the group recognized the state agency for partially funding their
work. Bryant said that the money was received by another scientist in
the group who was not employed by UC Irvine. She said the state
agency has never given a grant for research involving salamanders. 'I
have never-ever benefited from CIRM funding,' Bryant said using the
agency's acronym.
Os Steward
UC Irvine photo
“Steward said he stopped his stem
cell research when he joined the board in 2004. His board position,
he said, 'has prevented me from taking on lines of research I
otherwise would do.'
“Tom Vasich, a campus spokesperson,
said Bryant and Stewart's positions on the agency's board played no
part in their promotions and success at the school.”
Steward and Bryant are not allowed to vote on grants to UC Irvine.
University of California has 16 members on the 29-member board. One
of those is the chairwoman of the UC Regents, Sherry Lansing.
Petersen also noted that three of the UC officials, including
Steward, hold seats on the board as patient advocates.
Register's staff, joining it in November as an investigative
reporter. She worked as a business reporter for the New York Times and authored "Our Daily Meds," a book about the pharmaceutical industry. She shared in the top award in newspaper financial journalism when she was at the San Jose Mercury News.
Source:Stem Cell Therapy
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December 23rd, 2012
Meager Coverage of Yesterday’s Bristling IOM-CIRM Meeting
By Dr. Matthew Watson
Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem
cell agency and representatives of the prestigious Institute of
Medicine(IOM).
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
"'I'm a
colon cancer survivor,' said Art Torres, vice chairman of the
oversight committee, and a patient advocate designate. 'Does having
colon cancer make me biased?'
“Jeff
Sheehy, another patient advocate designate, protested what he called
a 'defenestration' of patient advocates, whose interests often span
multiple diseases.”
Times skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
which is in his area, receiving another $3 million from CIRM.
Source:Stem Cell Therapy
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December 16th, 2012
Two More Editorials: The California Stem Cell Agency Should Heed IOM Recommendations for Reform
By Dr. Matthew Watson
Two other major California newspapers
today said the $3 billion California stem cell agency needs to “clean
up its act” if it wants to be successful in continuing its efforts
at turning stem cells into cures.
Times, the state's largest circulation newspaper at more than
700,000, and the San Jose Mercury News in California's Silicon Valley.
The Mercury News has a reported circulation of nearly 600,000,
although that figure includes other Bay Area newspaper owned by the
same chain.
“The $700,000 spent on the
study...will be wasted if the institute's oversight board fails to
heed the (IOM) committee's
criticisms, which echo the findings of the Little Hoover
Commission and other groups over the years.”
“The 29-member board is made up
almost entirely of representatives of advocacy groups and research
institutions that have a direct interest in how the money is spent.”
Cell Report's calculations that about 90 percent of the $1.7 billion awarded by CIRM has gone to institutions linked to current and former members of its governing board.
“The board also overrode the advice
of its scientific advisors — twice on a single application when it
considered a grant for a well-connected company, StemCells Inc. based
in Newark, Calif. The board granted the company $20 million after Robert Klein, the driving force behind the passage of Proposition 71,
which created and funded the agency in 2004, and its former head,
lobbied so intensively for the company that one board member
described it as 'arm-twisting.'"
“The agency has used more than half
of its funding and one day will almost certainly want to ask
taxpayers for more. It should remember that voters will look for
evidence of public accountability as well as respected research.”
note about the agency. Its editorial said,
“(I)f it wants to survive...it
should heed the Institute of Medicine's advice to eliminate conflicts
of interest on its board -- and do it before awarding the remaining
$1.2 billion of the $3 billion voters approved for stem cell
research.”
should not be provided any more state funding.
“Long-term funding was never the
intent when Proposition 71 passed in 2004. It was supposed to
kick-start research at a time when federal funding was blocked and to
establish California as a major player in the rapidly advancing
medical field.
“The agency could continue to bring
value to the state as an advocate and funder of research, but only if
it can attract private donors, partners and investors. For that to
happen, it will need a board that passes the ethics test, with more
independent experts and industry executives free of conflicts.
“At the outset, stem cell advocates
took immense pride in structuring the agency to keep it relatively
free of legislative interference despite the use of public money.
Politicians kept their hands off, which was good. But the agency
created its own inappropriate influences in the way it constituted
its board. Now it needs to clean up its act.“
Source:Stem Cell Therapy
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December 16th, 2012
LA Times: On the California Stem Cell Agency and Wasting $700,000
By Dr. Matthew Watson
The headline on the Los Angeles
Times web site this afternoon read,
"Is California's stem cell program
preparing to waste $700,000?"
Prize-winning columnist Michael Hiltzik, whowas commenting on the presentation today by the
prestigious Institute of Medicine's (IOM) on its sweeping
recommendations for changes at the state stem cell agency.
"If you're betting that
the California
stem cell agency will spurn key recommendations of a
blue-ribbon review panel that criticized its leadership and
management structures, you might want to double that bet. Several
board members showed overt hostility to the panel's recommendations
during a public meeting today."
panel and former president of Princeton University, delivered
the briefing. The group's study took 17 months and cost the stem cell
agency $700,000.
proposals, which echoed many criticisms that have been aired for
years in California. Hiltzik wrote,
"CIRM Chairman Jonathan
Thomas glided over those issues when he introduced Shapiro.
Thomas observed that the Institute of Medicine report included many
statements "validating CIRM, its process, what it was able to
achieve," which is a bit like launching the investigation of a
plane crash by focusing on all the planes that land safely every day.
Thomas did mention that the Institute of Medicine had made numerous
recommendation about how to "take something which is already a
great experience and improve it even further."
"Shapiro got only a few minutes
into his presentation before board members started interrupting him
with objections to the Institute of Medicine's recommendation for a
majority of independent members."
"Thomas promised to stage a public
workshop on the Institute of Medicine report soon and to subject them
to 'lengthy discussion.'
"Does that sound as if the board
will be taking seriously the advice that it change the way it does
business? Stay tuned, but don't hold your breath."
Source:Stem Cell Therapy
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December 16th, 2012
Appeals at the California Stem Cell Agency: Worthwhile or Worthless?
By Dr. Matthew Watson
Jon Shestack, a patient advocate member
of the governing board of the California stem cell agency, weighed in
today on the virtues of the grant application appeal process at the
$3 billion research enterprise.
filed on the Duchenne item that appeared yesterday on this site. (His
full comment can be found at the end of that item.)
$6 million CIRM grant involving Duchenne research is “a casebook
study on why the special(extraordinary) petition is worthwhile. There
was indeed new and relevant information that only became available
after grant review. Scientific staff and leadership flagged it.”
the reasons that we ran the story about Duchenne and the team at
UCLA. The extraordinary petition process is currently under fire by
both the Institute of Medicine and the stem cell agency itself, which
has appointed a task force to come up with changes. But, while the
petition process is certainly less than perfect, so is the peer
review/grant review process.
only “case study.” An application by Karen Aboody of the City of
Hope is often cited as another case. There are undoubtedly others.
several years ago by the board as a tool to manage willy-nilly
appearances of scientists before the CIRM governing board whose
applications were rejected by reviewers. Now the Institute of
Medicine has recommended the petitions be abandoned, saying they
undermine the integrity of grant review process. The IOM cited a
major controversy in Texas involving its cancer research agency as an
example of how grant reviews or the lack of them can go bad – not
to mention conflict of interest problems there. CIRM has already
started to look for better solutions regarding appeals. Many of its directors
are troubled by emotional presentations from patients in
connection with petitions and the lack of adequate information to
make informed decisions on the spot about the contested matters.
scientific box is debatable. Researchers have the right, under state
law, to address the board on any issue whatsoever. And at least some
of them will continue to do so -- regardless of any appeals changes -- when millions of dollars and their
careers are at stake.
reviewers are not holy writ. They can and do make mistakes, as we
all do. In making changes in the appeals process, the goal of the
agency should be to devise a public and transparent process rather
than enshroud it in more secrecy. CIRM also should find a way to do
a much better job of communicating to applicants the availability of
appeals and precisely how to appeal when it becomes necessary.
Source:Stem Cell Therapy
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December 16th, 2012
ViaCyte Wins Another $3 Million from California Stem Cell Agency
By Dr. Matthew Watson
The California stem cell agency, which
has awarded ViaCyte, Inc., $36 million, today pumped another $3
million in the firm following the collapse of an alliance between the
San Diego firm and GlaxoSmithKline.
arrangement was ballyhooed by the CIRM in October because it would
have been the first deal involving Big Pharma and the stem cell
agency. The resources of Big Pharma are needed to pursue the
expensive path of turning stem cell research into cures.
governing board approved the additional funds on a 13-0 vote with two abstentions. The action came following a closed door session to discuss how the funds would be spent. No details were provided publicly on that matter.
ViaCyte
has also told Biocentury that it is pursuing even more funding after
the alliance with Glaxo broke down. CIRM President Alan Trounson said ViaCyte is likely to receive another $3 million from the Juvenile Diabetes Research Foundation. Trounson also said that other sources are being examined as well.
CIRM, scientific activities said the agency's advisors continue to have faith in ViaCyte's effort to develop a treatment for diabetes. The company plans to start a clinical trial on its product in
2014.
celebration last fall. Alan Trounson, CIRM's president, said the
deal would “resound” globally. He told directors,
“This is
verification of our program. To have (the head of Glaxo regenerative
medicine program) join us through a partnership arrangement with GSK
means that a project that we've shepherded from the basic science
through to the preclinical work and is heading to the clinic we're
now going to do in partnership with a very major organization.”
Source:Stem Cell Therapy
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December 16th, 2012
Winners From Today’s Awards by the California Stem Cell Agency
By Dr. Matthew Watson
The 12 winners in the latest round of grants from the California stem cell agency all come from institutions linked to directors on the agency's governing board. Board members with conflicts of interest are not allowed to vote on the grants or participate in the debate. Since the inception of the agency, more than 90 percent of its awards have gone to institutions linked to the directors. Here is a link to the CIRM press release on today's meeting.
Here is the list of researchers who won awards today.
New Faculty Physician Scientist Translational Research Awards
| RN3-06530 | Robert Baloh | Cedars-Sinai Medical Center | $3,031,737.00 |
| RN3-06378 | Reza Ardehali | University of California, Los Angeles | $2,930,388.00 |
| RN3-06504 | Jason Pomerantz | University of California, San Francisco | $3,084,000.00 |
| RN3-06396 | Mana Parast | University of California, San Diego | $3,013,252.00 |
| RN3-06425 | Tracy Grikscheit | Children's Hospital of Los Angeles | $3,408,000.00 |
| RN3-06532 | Tippi MacKenzie | University of California, San Francisco | $2,661,742.00 |
| RN3-06479 | Ann Capela Zovein | University of California, San Francisco | $3,084,000.00 |
| RN3-06529 | Alan Cheng | Stanford University | $3,091,595.00 |
| RN3-06455 | Ali Nsair | University of California, Los Angeles | $3,004,315.00 |
| RN3-06460 | Emanual Maverakis | University of California, Davis | $2,964,000.00 |
| RN3-06510 | Michelle Monje | Stanford University | $2,800,536.00 |
| RN3-06525 | Ophir Klein | University of California, San Francisco | $3,084,000.00 |
| Total | $36,157,565.00 |
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QdM4BZ5hPnc/winners-from-todays-awards-by.html
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December 16th, 2012
Constitutional Questions Raised on Sweeping Changes at the California Stem Cell Agency
By Dr. Matthew Watson
The outside counsel to the governing board of the California stem cell agency is preparing an opinion on whether some of the major changes recommended by the blue-ribbon Institute of Medicine(IOM) study might require a vote of the people.
More than three years ago, the same issue was raised and used by the agency to resist unwanted changes.
Kevin McCormack, agency spokesman, said today that James Harrison of Remcho Johansen & Purcell of San Leandro will perform the analysis. Harrison has been counsel to the CIRM board since its inception. He also wrote part of Proposition 71, which created the stem cell agency in 2004.
Harrison's analysis was disclosed after CIRM Director Sherry Lansing, who is also chairwoman of the University of California Board of Regents, said this morning that the board's "hands are tied" concerning some of the IOM proposals because they could require a vote of the people. Other members of the board bristled at the IOM recommendations.
In 2009, Harrison tackled a similar task in connection with related, proposed structural changes at the $3 billion stem cell research effort. In reaction to proposals by the Little Hoover Commission, the state's good government agency, Harrison said,
“The Little Hoover Commission’s proposals would effect drastic and disruptive changes to CIRM’s governance and operating systems. Such changes run counter to the voters’ intent, and do not further Proposition 71’s purposes.”
The California Stem Cell Report wrote at the time,
"The 10-page legal memo hung most of its arguments on a provision in Prop. 71 that states that it can only be amended by the legislature if the changes 'enhance the ability of the institute to further the purposes of the grant and loan programs.'
"Harrison's memo said the Hoover proposals (in question) could only be enacted through another ballot measure...."
The Little Hoover proposals dealt with the structure of the board and the conflicting responsibilities of the president and the chairman. The IOM has recommended major changes in both areas and approvingly cited the Hoover study .
Harrison's analysis will also delineate which IOM recommendations can be implemented by board action and which will require legislative approval.
cell agency $700,000, recommended a host of changes that critics for
years have said are needed. But the 17-month study also went beyond
what the critics had proposed. The IOM said that the 29-member
governing board should be stripped of power to approve individual grants.
Instead, the board would be limited to voting for or against a slate
of applications.
changes to remove conflict of interest problems, clean up a troubling
dual-executive arrangement and fundamentally change the nature of the
governing board. The recommendations would greatly strengthen the
role of the agency's president, significantly alter the role of
patient advocates on the governing board and engage the biotech
industry more vigorously.
the San Francisco Chronicle said that prompt and major changes are
needed at the agency.
recommendations clearly require either a rare, super, supermajority vote of
the legislature (70 percent) and the signature of the governor or
another ballot initiative, which is very unlikely. Achieving the 70
percent vote is exceedingly difficult except on the most
noncontroversial matters before the legislature. The requirement
permits only 13 members of the 40-member Senate to block any CIRM
legislation, giving minority viewpoints extraordinary power over the
content of any CIRM legislation.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6UqNIAVe5JY/constitutional-questions-raised-on.html
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December 16th, 2012
A Singular Scientific Story: Duchenne’s Disease, a Family and the California Stem Cell Agency
By Dr. Matthew Watson
including a tie to the $3 billion California stem cell agency,
surround a promising scientific development reported today by a
husband and wife research team at UCLA.
muscular dystrophy (DMD), an inherited disease that afflicts about
one in 3,600 boys and results in muscle degeneration and, eventually,
death.
 |
| Carrie Miceli UCLA photo |
Miceli, said they have discovered a promising FDA-approved drug that
could advance the fight against the affliction.
son, Dylan, with the disease. They have been studying the affliction
for some time, but their most recent and ambitious research plan was
rejected earlier this year by stem cell agency grant reviewers, a process that
normally kills an application. Undaunted, Miceli and Nelson appealed
to the full stem cell agency board last July. Backed by an emotional
presentation involving patient advocates, they won approval of a $6
million grant.
process known as an “extraordinary petition,” which the Institute
of Medicine (IOM) last week said should be abandoned because it undermines
the integrity of the CIRM grant review process.
 |
| Stan Nelson UCLA photo |
the CIRM board was moving to restrict its free-wheeling
appeals procedures.
journal Science Translational Medicine. However, the money was not used in the study reported today.
the (Duchenne) therapy currently being tested in clinical trials,”
according to a UCLA press release.
“(The researchers) hope this one-two
punch used in combination will overcome the genetic mutations that
cause DMD, restore a missing protein needed for proper muscle
function and allow those affected by the disease to lead relatively
normal lives.”“Their youngest son, Dylan, 11, was
diagnosed with DMD in 2004. While he’s still ambulatory – many
DMD patients require the use of wheelchairs by about age 10 – Dylan
can no longer run or climb stairs and he can’t shoot a basketball
over his head like other boys his age. Despite these
challenges, Miceli said Dylan remains a happy, funny and engaged boy,
full of life and passion.“'We entered into this field because
of the diagnosis of our son, but we hope our research can help many
others,' she said. 'There are drugs that can help manage the symptoms
of the disease, but nothing that changes its course dramatically.
We’re trying to correct the defect that causes DMD with highly
personalized genetic medicine.'”
used for “longer term studies of their drug combination therapy in
mouse models to ensure it can restore dystrophin levels to normal or
near normal levels. They also will explore whether DMD patients with
other mutations can benefit from the combination therapy.”
spokesman for the stem cell agency, said today's findings "are certainly
very encouraging." He continued,
"Clearly there is still a long way
to go before we know if this approach will work in people but we're
delighted that funding from the stem cell agency is helping the
researchers move their work forward....This is what voters set out to
do when they approved Proposition 71 to create the stem cell agency."
Source:Stem Cell Therapy
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December 16th, 2012
Some California Stem Cell Board Members Bristle at IOM Recommendations
By Dr. Matthew Watson
Some directors of the $3 billion California stem cell agency today sharply challenged recommendations by the Institute of Medicine(IOM) concerning conflicts of interest and the role of patient advocates on the governing board.
Much of the criticism came from the 10 patient advocate members on the board, whose roles would be significantly altered under the IOM recommendations. Jeff Sheehy, a patient advocate for HIV/AIDs and vice chairman of the agency's grant review group, said he saw no evidence in the IOM report for its recommendations regarding patient advocates. He said,
"If you had some here, I would be more comfortable."
He continued,
"We are not all powerful. We are a minority on the (29-member) board."
Jonathan Shestack, another patient/adovcate director, said the IOM's conclusions on "conflicts of interest could not possibly be more incorrect than they are." He said,
"Advocates are here to advocate."
Harold Shapiro, chairman of the IOM study, said, "We are not against patient advocates." He said that the IOM supports advocates and that its recommendations could increase the role of patient advocates, albeit in a different manner.
Shapiro added that conflicts of interest do not necessary bar participation by board members. He said, however, they must be disclosed and managed.
Director Robert Price of UC Berkeley said,
"We have gone to great lengths to manage conflicts of interest."
The IOM recommended that all board members be removed from the grant review process, which would be turned over to the CIRM president. The board would only vote on a slate of applications, not individual grants. More disclosure would be required of personal conflicts of interest, including health matters, that the board said research has shown can create bias.
The IOM report said,
“Far too many board members
represent organizations that receive CIRM funding or benefit from
that funding. These competing personal and professional
interests compromise the perceived independence of the ICOC(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”
More than 90 percent of the $1.7 billion that the CIRM board has awarded has gone to institutions that are represented on the CIRM governing board.
J.T. Thomas, chairman of the CIRM board, said that the agency takes the recommendations "very seriously" and that they would discussed further at a board workshop in early January. The workshop is scheduled to be public but the date and location has not been announced. Thomas said the recommendations will receive "lengthy discussion" thereafter and review by appropriate subcommittees of directors.
No one from the public commented during the roughly 90 minute discussion. Eighteen out of 29 board members were present at the beginning of today's meeting.
Source:Stem Cell Therapy
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December 16th, 2012
IOM Report: Many Major Changes at Stem Cell Agency Require Legislation
By Dr. Matthew Watson
As the Institute of Medicine began its presentation today to the governing board of the $3 billion California stem cell agency, one of its key directors, Sherry Lansing, pointed out that some of the IOM recommendations require legislative action and perhaps a vote of the people.
Her essential point was that the agency is hamstrung by the very measure that created it in 2004. She did not elaborate on her comment, but here is a look at some of matters she was talking about. (Lansing is chairwoman of the UC board of regents and former CEO of a Hollywood film studio.)
The ballot measure locked in management minutia and more, and then slapped on tight restrictions that make it nearly politically impossible to alter even such matters as who is in charge of production of the annual report. (By order of law, the chairman, in case you are wondering.)
And if the 29-member governing board -- so sized and specified to every nit and nat by the ballot measure -- wants to make the sweeping changes recommended by the IOM, agency directors face a formidable task in California's Capitol.
Many of
the most important recommendations for the California stem cell
agency require a vote of the California legislature and
signature of the governor. The IOM's choice of words – that these proposals “may” need legislation – is conservative. There is little doubt that legislative action would be needed to fully implement the recommendations below.
super-majority (70 percent) of each house. The requirement was also written into state law by Proposition 71, the 10,000-word ballot initiative
that created the stem cell agency. The 70 percent requirement gives extraordinary power to minority viewpoints that must be dealt with to win passage of legislation. In the state Senate, for example, it would take only 13 senators to block a bill.
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
management. The chair and the board should delegate day-to-day
management responsibilities to the president. Each of the three
working groups should report to management rather than to the ICOC.
the Board and Working Groups
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community. The terms of board
members should be staggered to balance fresh perspectives with
continuity.
be prohibited from serving on the working groups. During the
reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.
Definitions and Policies
conflict of interest to recognize conflicts arising from nonfinancial
interests, such as the potential for conflict arising from an
individual’s interest in a specific disease, and should reassess
its policies for managing conflict of interest in light of this
broader definition.
Funding Process
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC should remain
responsible for oversight and articulation of an overall strategic
plan. However, grant management, funding recommendations, and grant
administration should be the responsibility of the CIRM scientific
staff, reporting to the president. This restructuring would help
mitigate concerns related to conflicts of interest and would also put
the review and funding process in the hands of those best equipped to
make those decisions.
changes pertaining to the development and approval of RFAs,
composition of the Grants Working Group, reordering of rankings by
CIRM staff, notification of applicants, and process for making final
decisions.
Aspects of CIRM Organization
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group should be enhanced to leverage industry’s
expertise and resources in product development, manufacturing, and
regulatory approval in support of the ultimate goal of bringing
therapies to patients.
Property Policies with Policies of Bayh-Dole Act
other sources of funding for stem cell research become available and
as the field of regenerative medicine advances from the laboratory to
the clinic, the ICOC should reconsider whether its goal of developing
cures would be better served by harmonizing CIRM’s IP policies
wherever possible with the more familiar policies of the Bayh-Dole
Act.
Source:Stem Cell Therapy
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December 16th, 2012
Stem Cell Agency Chairman Says IOM Report ‘Quite Complimentary’
By Dr. Matthew Watson
 |
| Jonathan Thomas CIRM Photo |
Jonathan Thomas, the Los Angeles bond
financier who is chairman of the $3 billion California stem cell agency, has
weighed in at more length on the sweeping recommendations from the
Institute of Medicine for changes at the agency.
that said the 124-page report was “quite complimentary.” Thomas' article carried forward the theme of the stem cell agency's press
release yesterday that said the IOM “praises the agency as a 'bold
social innovation.'”
“highlighted some areas and made some recommendations about where
and how we might improve our performance.”
takes the report seriously and will, over the next few months,
consider how best to respond.
of the agency differ with Thomas' characterization of the report as
“quite complimentary.(See here and here.)
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/HmbrFtBzcs4/stem-cell-agency-chairman-says-iom.html
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December 9th, 2012