Bob Klein, "Lobbying" and Reader Reaction
By Dr. Matthew Watson
A robust discussion has arisen
concerning Bob Klein and his appearance last month before the
governing board of the $3 billion California stem cell agency, a body
that he once chaired and an enterprise that he once oversaw.
was manipulated and whether he was engaged in so-called “revolving
door” activity – the practice of former government officials,
such as Klein, becoming paid representatives of enterprises that were
involved with their former agency.
interesting questions that we will discuss on the California Stem
Cell Report during the next few days.
of those who commented for the delay in posting their remarks.)
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Nearly $6 Million Sought: Four Scientists Seek to Overturn Rejection by CIRM Reviewers
By Dr. Matthew Watson
Four researchers are appealing
rejection of their proposals to win millions of dollars from the
California stem cell agency just as the agency is moving to curb such
reconsideration efforts by scientists.
agency calls its basic biology round. The agency's governing board
meets next Wednesday and Thursday to hand out as much as $35 million
to as many as 25 scientists competing for the research dollars.
round. One upshot has been a proposal that would tighten the review process. That plan also comes before directors next week.
applications were given scientific scores that exceeded those of some
proposals that were approved by reviewers. The lower scoring
proposals were given the go-ahead on the basis of “programmatic
review,” which one CIRM document says is designed to allow
“consideration of issues beyond scientific merit, such as disease
representation and societal impact.”
as extraordinary petitions – were filed by Michael Teitell of UCLA,
Deborah Lieu of UC Davis, Tony Hunter of Salk and Hanna Mikkola, also
of UCLA. In all, their applications seek nearly $6 million from CIRM.
said she was “relatively inexperienced.” Lieu's appeal said she
has “24 publications with over 6 years of experience in the
differentiation of cardiac muscle cells from human pluripotent stem
cells, 12 publications (3 co-corresponding author) on human
pluripotent stem cells and their cardiac derivatives, and 3
publications on the engineering of pacemaker cells” in addition to
other related professional experience.
application received a score of 68, ranking it above two other grants
approved by reviewers and equal to a third also approved by
reviewers.
reviewers did not have access to. Mikkola's application for $1.4 million
received a score of 65, which ranks it above one grant approved by
reviewers.
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September 2nd, 2012
Stem Cell Agency Moving to Curb Free-Wheeling Appeals by Researchers
By Dr. Matthew Watson
The $3 billion California stem cell
agency on Tuesday released details of proposed, major changes in how
scientists are allowed to appeal decisions when their
applications for millions of dollars are rejected by grant reviewers.
would formalize ad hoc procedures that have emerged over the last
several years. The plan would also make it clearer exactly what can
and cannot be done or expected under the agency's appeal process,
which is poorly understood by at least some researchers.
on at the CIRM board meeting next Wednesday and Tuesday, is heavily
nuanced, dealing with such matters as “supplemental information,”
an “additional analysis option,” “criteria for material dispute
of fact,” “criteria for material new information” – not to
mention the old standby – “extraordinary petition.”
distinction between an “appeal” and an “extraordinary
petition.” However, it is a distinction without a difference except
to those in thrall of bureaucratic jargon. Both are appeals. Their
purpose is to provide a method for overturning reviewers' decision under certain conditions.
only four business days prior to next week's governing board meeting
– a little late to generate thoughtful comment and constructive
suggestions from those most likely to be affected by the changes –
the 500 or so recipients of $1.6 billion in CIRM funding. Before final action on the changes, the board may well want to send out the proposal to all of its grant recipients and ask them for written comment that could then be considered at a public meeting of its Science Subcommittee.
the appeal process for more than four years, including the
presentations at its public meetings by scientists. Ironically, the
first such public appearance was made by Bert Lubin, who is now a member of the CIRM
board and CEO of Childrens Hospital in Oakland, Ca..
wrote at the time, the pitch by Lubin, who was unsuccessful,
disturbed some board members. Gerald Levey, then dean of the UCLA
medical school and a member of the board, said,
"I don't think we can run a board
this way. If we do, it would be chaos."
Nature as saying that his rejected application did not come from “the
in crowd” of stem cell researchers or organization.
“So a project that was really going
to go into patients was essentially triaged.”
the appeal process also uses language that obfuscates exactly what
researchers can do under state law. The document says that scientists
“may” make oral and written comments to the board, which is a
state government entity. In fact, state law makes it clear that
researchers as well as any member of the public have the “right”
to comment. The board legally cannot prevent them from speaking or
making comments. And the board, to its credit, has always allowed
ample public comment even when it slows the board's work.
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September 2nd, 2012
USC Researchers Appeal Rejection of $20 Million Proposal
By Dr. Matthew Watson
Researchers from the University of
Southern California are making a pitch to overturn rejection of their
$20 million grant application by reviewers in one of the signature
commercialization rounds of the California stem cell agency.
Lon Schneider will be taken up one week from tomorrow by the
governing board of the $3 billion state enterprise.
million disease team round that was considered last month during a
record-breaking outpouring of appeals and a day of emotion-filled
appearances by patients. CIRM directors adjourned their meeting
without completing action on a number of items, leaving open the possibility of additional appeals such as the one from USC.
received a score of 63 from reviewers. They said in a letter to
the board,
“We are submitting the petition at
this time as we are new to the CIRM ICOC(governing board) process and after listening
to the July 26 ICOC meeting deliberations now understand that the
petition process allows the ICOC to further consider our proposal.
We noted that the proposal scored one point above ours and another
two points below ours, each utilized the extraordinary petition
strategy to gain ICOC review which resulted in funding approval in
the former, and reconsideration in the latter instance.”
expressed by CIRM Director Oswald Steward, director of the Reeve Center at UC Irvine, at last month's board
meeting about fairness in the grant process. He said,
“I'm not really quire sure that all
of the applicants clearly understood that they could come back to us
to address the criticisms(of reviewers).”
Concerns about whether all applicants fully understand the appeal process have surfaced on a number of occasions over the last several years. The CIRM board, however, is generally reluctant to overturn negative recommendations by reviewers. It also almost never reverses positive recommendations.
make unspecified changes in the appeal process. No further details on
those changes have yet been released by the agency although the
meeting is just four business days away.
CIRM board, the scientists defended their scientific approach and
responded to criticism by reviewers, especially those related to
sedation. Reviewers expressed reservations about over-sedation, which
the researchers said were erroneous.
be making appeals during next week's board meeting.
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September 2nd, 2012
Researcher Alert: Troubling CIRM Grant Appeal Process Up for Revision
By Dr. Matthew Watson
Directors of the California stem cell
agency next week are expected to make unspecified changes in how
scientists can appeal denials of their applications for millions of
dollars in research grants.
emotional meeting last month in which the CIRM governing board faced a record outpouring of appeals of negative decisions by grant
reviewers. The board is the ultimate arbiter on applications. While it almost never overturns positive decisions by reviewers, it sometimes
approves applications that they have rejected.
the appeal process are yet available for the meeting Sept. 5-6 in
Burlingame, Ca. All that is known at this point is the following item
from the board agenda: “consideration of modifications to the
extraordinary petition policy and adoption of additional
information policy.” Extraordinary petitions are the key vehicle
for appeals.
month's high stakes, $243 million round posed new challenges and
consumed so much time that the board was unable to complete action on
several items.
board sent five applications back for re-review. (See here, here and
here.) Some of those are expected to come up next week and others at
the end of October. The board agenda, however, did not specify which
applications would be considered next week. Nor did it specify how many additional appeals have been filed in the round that was up for
approval in July.
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September 2nd, 2012
CIRM Board Member Prieto Defends Klein’s Right to Appear Before Board
By Dr. Matthew Watson
California stem cell agency, Francisco Prieto, has commented
in an email about the “unseemly performance” item concerning the
agency's former chairman, Robert Klein. Prieto is a
Sacramento physician who serves as a patient advocate member of the
board. He has been on the board since its inception. Here are his
remarks.
“I wanted to comment on this piece
from the perspective of another patient advocate. While I think
you know that I did not always agree with Bob Klein during his tenure
on the ICOC(the agency's governing board), I would strongly defend
his right to appear and give his opinions to the Board. He is a
private citizen now, albeit one with considerable experience and
expertise, and I think his greatest vested interest in this case
stems (you should pardon the expression) from being the child of a
parent with Alzheimers. As you point out, some eyebrows may be
raised, and I can imagine that some board members might be swayed in
either direction by his testimony, but he is a passionate and
committed advocate, and he has the right to advocate before us.”
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August 26th, 2012
An Unseemly Performance: Former Chair of Stem Cell Agency Promotes $20 Million Research Proposal
By Dr. Matthew Watson
Bob Klein is nearly an icon in the
history of the $3 billion California stem cell. And when he appeared
before its governing board last month and aggressively touted a $20
million grant proposal already rejected by agency reviewers, his
actions raised eyebrows.
 |
| Robert Klein Elie Dolgin/Nature photo |
weight, given that they were supported by his unique and influential
relationship with the California Institute for Regenerative
Medicine(CIRM). He and his associates wrote the 10,000-word ballot
initiative that created the stem cell agency in 2004. He ran the $35
million electoral campaign that convinced voters to buy into the
idea. Klein raised millions on behalf of the effort. He personally
provided the campaign $3 million. And he was the first chairman of
the agency, leaving that office only 13 months ago, when he was
designated chairman emeritus.
first public appearance before the board on behalf of a specific
application.. He heralded the applicant, StemCells, Inc., as unique
and the “best” in United States with a “huge body of
experience.”
(The full text of his testimony can be found here.)
 |
| Irv Weissman Stanford Photo |
scientist Irv Weissman, who sits on its board. Weissman also played
an important role in the Prop. 71 ballot campaign that created the
stem cell agency. StemCells, Inc.'s application was turned down by
CIRM reviewers who gave it a score of 61, but the company appealed the action to the agency's governing board. Following the appearance by Klein, Weissman and others, the CIRM board sent the application back for more review.
The board will reconsider it next month or in October.
who requested anonymity, said it is “highly inappropriate for Bob
Klein to be advocating for any grant application from a public
company.”
“He has
considerable influence with the ICOC(the CIRM governing board), and
is closely associated with biotech in the Bay Area. Even if he
doesn't make a lot of money himself from this, then he certainly has
friends who will. Irv Weissman would be one of those friends."
California Stem Cell Report, Klein today defended his actions. He was asked if he had “any sort of
financial ties” to firms or individuals that would benefit from
approval of the award. Klein, who is a real estate investment banker and also an attorney, said he has
“no financial interest” in the firm or individuals that might
benefit.
entirely appropriate. He defined his role as a patient advocate –
not as a lobbyist who is paid for advocating on behalf of a company.
Klein said he had “a particular responsibility to contribute my
background knowledge and experience.”
members would follow his example. He said,
“(I)t would be a tragedy if the
expertise of board members built up over six or more years is lost.”
time for financially strapped StemCells, Inc. The company's
financial information shows that it is losing $5.4 million a quarter
as of the end of June and had only $9 million in cash on hand. It
also had liabilities of $11.6 million, up substantially from $8.5
million in September of last year.
"StemCells Inc has been on the
stock market for 20 years, without producing anything of value for
the investors. The stock price has been sinking fast: it
was 60 cents this June; last year at this time, it was around $5 a
share.
“On July 17, when the CIRM Disease
Team Award review results became available, the stock rose from 87
cents to $1.80 – a person who could anticipate the outcome of the
CIRM applications could have made considerable money in that 24 hour
period.”
with the StemCells, Inc., is more than scientific. According to the
company's financial statements, he holds 88,612 shares. His wife,
Ann Tsukamoto, is executive vice president of the firm. She holds
185,209 shares in the firm.
the Prop. 71 campaign. He did the “billionaire circuit,” raising
money for the initiative, according to an article by Diana Kapp in
San Francisco magazine. Among other things, Weissman worked the
exclusive Bohemian Grove in Northern California and “pitched”
Bill Bowes, a co-founder of Amgen, who, along with his wife, gave
$1.3 million to the campaign. Weissman was the key to securing a
$400,000 contribution from Microsoft's Bill Gates. Weissman also plumped for Prop. 71 in a TV campaign ad.
and Weissman supported a successful attempt last month to overturn
reviewers' rejection of another $20 million application by Judith Shizuru
of Stanford. The application received a score of 53 from reviewers.
by reviewers was the availability of antibodies for the study. The
antibodies were developed by Systemix, a company founded by Weissman.
Systemix was acquired by Novartis in 1997 for about $70 million.
Weissman said he has “negotiated back” rights to key antibodies,
which he said are now held by Stanford.
research was “a showstopper” but did not think the documentation
was adequate. He told the CIRM directors that they now have a letter
with proprietary information that supports the grant application.
labored under the perception that it is something of an insiders'
club. Even the prestigious journal Nature warned in 2008 about what
it called “cronyism” at CIRM. If anything, the situation is worse today, four years later. Enterprises associated with persons on the CIRM board of directors have received more than 90 percent of the funds handed out by the agency. Klein's efforts last month
reinforce the not-so-pleasant image of the stem cell agency as an
old boy's club and create an impression – at the very least – of
unseemly insider influence.
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August 26th, 2012
Text of Klein’s Response to Questions Concerning His Advocacy on Rejected Grant Applications
By Dr. Matthew Watson
Here is the text of Robert Klein's response today to the California Stem Cell Report concerning his appearance before the governing board of the California stem cell agency July 26, 2012. Klein, former chairman of the agency, real estate investment banker and attorney, promoted two applications seeking $20 million each from the agency. Both applications had been rejected by the agency's reviewers. Here is a link to an item on the subject.
"Dear David,
"You have posed two
questions related to my continuing role as a Patient Advocate in
contributing information to the Board of the California Institute for
Regenerative Medicine, in an effort to optimize decisions on medical
and scientific grants and loans for research that could mitigate
and/or cure chronic diseases or injuries.
"Q: Do you have any sort
of financial ties to StemCells Inc. or any of the individuals or
firms that would benefit from approval of those awards by the ICOC(the CIRM governing board)?
"A: I have no financial
interest in StemCells Inc. or any of the individuals or firms that
would benefit from approval of those awards by the ICOC. In fact, I
have no financial interest in any biomedical research company."Q: Do you think it is
appropriate for the former chairman of the ICOC to lobby that body on
behalf of awards to specific companies or individuals?
"A: First, it is
fundamental that the terms be defined to properly respond to your
question. A “Patient Advocate” is a member of a patient family or
a medical/scientific care /support group who advocates for medical
and scientific advances that might potentially mitigate and/or cure a
patient’s chronic disease or injury. A “Patient Advocate” is
not paid for his/her advocacy, unless they are staff members of a
non-profit institution dedicated to a specific disease or group of
diseases or injuries.
"Second, a “lobbyist”
is a paid representative of a company or a for-profit institution(s)
with a financial interest in the outcome of a governmental decision.
"I am serving as a
Patient Advocate in my presentations to the Board of the California
Institute for Regenerative Medicine. As the former Chairman of the
Board, I have a particular responsibility to contribute my background
knowledge and experience for the Board to consider, along with all
new information, in reaching their best decision. I hope other former
Board members, who possess a wealth of scientific, medical, and
institutional knowledge that can benefit the Board, would consider
the value they can contribute to future decisions. As Board terms
expire, it will be important not to lose that institutional knowledge
and medical/scientific expertise that has been built up over the last
seven plus years of the Agency’s existence.
"In an outline format,
I would suggest the following areas where the knowledge of former
Board members can be especially valuable in optimizing the input for
Board decisions in the future.
"A number of Board
members have participated in up to 20 or more Peer Review meetings,
some of which cover multiple days. Current grant or loan requests
represent the result of scientific and medical advancement that has
been intensely vetted in prior peer reviews; the information gained
in those peer reviews should not be lost, when a subsequent grant or
loan request – built on the earlier research outcomes – is
considered. Each peer review session has the benefit of different
specialists and scientists and/or biotech representatives with
unique backgrounds and areas of expertise. The value of the prior
contributions may be pivotal, in considering a later application,
developed from the earlier medical or research advances funded
through CIRM’s grants or loans. The current peer review,
scientific staff presentation, and Board expertise, is not the limit
of the Board’s information, in reaching the best current decision.
To the extent the Board can draw from prior peer reviews (unique
insights), prior scientific staff presentations, and prior Board
expertise, additional information that can enhance a potential
decision, the Board has the opportunity to optimize its decision
making process. This is particularly valuable, when there is a high
standard deviation – a substantial split – in the scoring
positions from the current peer review.
"Beyond peer review
participation, Board members have intensely engaged in another 35
plus Working Group sessions on Facilities and Standards, in addition
to more than 70 Board meetings and over 125 Subcommittee meetings,
as of August 2012. Retiring Board members possess a treasury of
information on policy development, process, federal and state laws
and regulations, and the regulations of the agency, as well as in
depth information on research facilities and capabilities throughout
California, the nation, and the world. It takes a substantial length
of time for a new Board member to gain a comprehensive knowledge in
all of these areas and each Board member will develop unique
insights, which it would be a tragedy to lose. As Chairman, I
frequently reached back to consult with former Board members on
areas of their special expertise and I would hope that all current
and future Board members utilize the significant asset in developed
knowledge of the prior Board members. To the extent prior members
can be available for public meetings, this would be a substantial
benefit to the agency to broadly inform the Board, the scientific
staff, and the public.
"The Board has a
unique contribution to make on programmatic resource allocations and
risk management of the research and clinical investments in each
disease area. The opportunities in some disease areas for major
advancement are numerous, whereas there are major diseases and/or
critical research areas where the potential, high-value advancement
options are relatively limited. For Board members who have
participated in over 20 peer reviews and 70 Board meetings, the
programmatic perspective on the opportunities in each disease area
has been highly developed. Concurrently, those Board members or
former Board members have substantial knowledge that is of critical
value in reaching programmatic decisions on the number of
opportunities for advancement in any specific disease area and the
relative risk that needs to be taken to accomplish meaningful
breakthroughs in advancing the research and clinical opportunities
in a disease and/or injury area.
"I hope these examples
of how former Board members can contribute to the current Board’s
information in reaching decisions on the best medical/scientific
grants and loans are helpful. As I stated earlier, it would be a
tragedy if the expertise of Board members built up over six or more
years is lost. The field is extremely complicated and the Board needs
the opportunity to consider all of the information available. The
Board can choose to accept or reject any past advice or opinions
gained from prior peer review sessions or Board meetings, but the
Board should have access to the full spectrum of information and the
treasury of scientific and medical advice the agency has received
since its inception.
"There are areas that I
have not addresses in this short response, such as the institutional
value of applicants being able to rely upon prior scientific and/or
policy direction, in their current applications. From a historical
perspective, prior Board members and/or the Chairman can have
significant information that is relevant to these evaluations,
especially if the individual Board member served on a special Task
Force , Subcommittee or peer review. These more complicated areas of
individual contribution by former Board members I can address in a
future communication; but, this specific subject – alone – could
comprise several pages and I would like to obtain critical advice and
perspective from other former Board members and the scientific
community before discussing this area in greater detail.
"Bob Klein
"Chair Emeritus
"California Institute
for Regenerative Medicine"
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August 26th, 2012
Text of Klein’s Comments Supporting Rejected Applications
By Dr. Matthew Watson
Robert Klein, who served 6 ½ years as the first chairman
of the $3 billion California stem cell agency, testified before the agency's board for the first time on July 26, 2012. Klein, a real
estate investment banker and attorney, spoke on behalf of two applicants whose
grants had been rejected by the agency's reviewers. The appearance
has raised questions about the propriety of Klein's actions.
Here is a link to an item on his appearance. Here is the text of
his comments as reported in the transcript of the meeting.
“As the board knows, I've never addressed any grant from the
floor. It is critical here to understand that we have here
StemCells, Inc., which is the only company in North America
and, for that matter, maybe in the world, that has had two stem cell
therapies in the brain with these specific neural stem cells. They
have a huge body of experience here.
“Secondly, one of the fundamental issues here that it (the
company's grant application) was downgraded on was the issue of the
fundamental concept, the platform concept, of injecting two focal
injections in the brain, in the hippocampus of the brain. It's
important to note that I've sat on three (CIRM)peer reviews where the
scientists really affirmed this specific approach with extremely high
scores, three different views. All right.
“So it's very important to realize we have a standard deviation
here of 12 (on the review scores). These scientists were completely
split. With some recusals on that panel, if you have 12 or 13 that
can really vote, three or four very low scores can bring it out of
the funding category all the way down. It is in the region where
this board is looking where the other three peer reviews, right,
early translation, the one before that was the planning grant review,
that the hippocampus was a good platform.
“Then they said the key weakness was you can't show migration.
Dr. Laferla (a co-PI on the application) has told me that
today the Journal of Neuroscience accepted the publication of
the data demonstrating migration. It was stated previously in the
application, but it wasn't accepted for publication. It now is.
That is the fundamental weakness that they identified in this
approach.
“So we have a reaffirmed approach to the hippocampus by three
different peer review groups and a substantial portion of these
reviewers along with data dealing with the weak point. I'm sorry it
happened today. The data was out there, accepted for publication
today, means that it should definitely fall into this category. And,
of course, Dr. (Alan) Trounson (president of CIRM) wouldn't
have been able to review that in process because he was recused from
this grant by his own voluntary recusal. So the progress of this
data being accepted for publication is new information today.
“If I look at the entire history of CIRM, as Leeza (Gibbons,
a CIRM director) says, building up to this point, we have reaffirmed
this approach from the very beginning with Dr. Laferla, with multiple
scientific approvals, and board approval, and we have the best
company in North America with the greatest experience with these
neural stem cells, with the best researcher we have for the potential
to address this disease, and we have brand-new data that demonstrates
and totally contradicts the key weakness on which it was downgraded.”
behalf of a second application, also rejected by CIRM reviewers.
“This is the only other disease team grant I will address. Very
specifically, this was a disease team grant that I was on the peer
review in the planning grant stage. There are some fundamental
issues here. Is the international company on which the one antibody
that's not coming from Stanford, the two for sorting are
coming from Stanford, is the other antibody coming from this
international company a commitment that you can rely on?
“The reviewers said this was a showstopper. That's the word they
used. They made a decision this was a showstopper because they did
not believe the company because they thought that the documentation
was inadequate. You now have a letter that goes into great
proprietary depth about the depth of this company's commitments
written by the head of development and translation internationally
for the company.
“If we cannot depend on company commitments of this type, and
you will review the letter in executive session, if you have one, I
will not understand how we'll be able to collaborate with companies
with proprietary products and processes where they're making
commitments to academic institutions of the highest standard. I
believe this company is going to perform. I was on an hour call to
confirm with eight members of that company their level of commitment,
and I am completely convinced by that point.
“The review is completely factually wrong on this issue about
the other two antibodies for sorting this. Dr. (Irv) Weissman
has just said they have not only been developed, they have been used
in clinical trials. There's data on them. And they are, in fact,
being thawed under FDA direction to reuse in this trial.
“So I believe there's a major factual difference. Remember with
Karen Aboody there was a major factual error that was pivotal
in elevating that, and we found tremendous performance on that grant
by Karen Aboody of City of Hope.
“So you have a decision to make. As a risk issue, do we believe
this company? Finally, this is broader than SCID.
“Donald Kohn has written a letter that's in the public
domain that I suggest you read. It makes it very clear that opening
the niche for repopulating the immune system without chemotherapy and
radiation is a key contribution to every form of genetically modified
stem cells for an entire range of childhood diseases and other
genetic diseases in addition to therapies like sickle cell or aids.
“I suggest that that profound contribution that can be made to
the field is a risk that is worth taking early on because of his
contribution to so many other areas. You have 12 other letters from
North America's leading pediatric geneticists that fundamentally
provide extraordinary support for this position and this approach.”
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August 26th, 2012
CSCR Reading List: A Look at the Grant Appeal Process at the California Stem Cell Agency
By Dr. Matthew Watson
Here is a list of articles from the California Stem Cell Report as well as CIRM documents dealing with the grant appeal process at the California stem cell agency. The list was prepared on Aug. 16, 2012. To read the entire articles, click on the links.
who failed to win approval last month of their bids for $20 million
research awards from the California stem cell agency.
agency today approved $151 million in research awards aimed at
commercializing stem cell research and pushing therapies into
clinical treatment....Five of the applications involving appeals were
sent back by the board for more review. (See here, here and here.)
They will be considered again in early September or October.
latest grant round – which is budgeted for $243 million – has
drawn an extraordinary and record outpouring of appeals from more
than half of the scientists rejected by the grant reviewers. Nine of
the 15 applicants who were turned down have filed appeals to the
governing board for its meeting
Thursday in Burlingame. No other CIRM grant round
has drawn as high a percentage of appeals, formally known as
extraordinary petitions. (See here
for a story on the previous record for percentage of
appeals.)
Emotionalism and Potential Favoritism Cited as Need for Changes in CIRM Grant Appeals
Passion and favoritism, democracy and gamesmanship – all are part of the ongoing discussion among directors of the $3 billion California stem cell agency as they try to fix what some of them call a “broken” grant appeal process.
July 19, 2010
UC Davis Scientist Praises CIRM Appeals Change
A stem cell researcher at UC Davis today said a change in the CIRM grant appeals procedure makes “a lot of sense.” Writing on his blog in regard to "extraordinary petitions," Paul Knoepfler said, “I think the proposed change makes a lot of sense and would greatly improve the process. Sometimes the reasons in the petitions are clearly not meritorious and as it now stands, they end up wasting CIRM's time. The last time CIRM received 9 petitions as well, which represented a remarkably large fraction of the total applications. A stricter process would discourage the submission of large numbers of petitions, an important issue given that the number of petitions received by CIRM continues to grow.”
CIRM Finally Discloses Grant Appeal Proposals
The California stem cell agency early today belatedly posted a two-page memo on proposed changes in how it will deal with appeals by scientists whose grant applications have been rejected by reviewers.
July 18, 2010
Sticky, Troubling Appeals by Rejected Researchers Targeted by Stem Cell Agency
A key step in the process for awarding billions of dollars in research grants is “broken,” according to many directors of the California stem cell agency, and major changes are looming that will affect hundreds of scientists.
June 22, 2010
Immunology Grants: CIRM Gives $25 Million to 19 Researchers
Directors of the California stem cell agency today approved $25 million for immunology research, overturning four negative decisions by its grant reviewers. Directors faced a record nine public petitions to reverse its reviewers. After some grumbling, the directors, who see only a summary of the application and reviewer comments, okayed the four.
June 19, 2010
More Grant Appeals Filed: Yamanaka Invoked
The California stem cell agency has set another benchmark, although this is one that it may not want to trot out at international stem cell gatherings. Eight scientists whose applications were rejected for funding by the CIRM grants working group and scientific reviewers are seeking to overturn those decisions at the agency's board meeting in San Diego on Tuesday. It is the largest number of “extraordinary petitions” ever filed and amounts to more than one out of every four applications that were turned down. The total number of applications received was 44. Fifteen were approved. Some of the researchers are likely to appear at the board meeting and make a personal pitch.
May 18, 2010
Competing for California Stem Cell Cash: Rules of the Game Coming Under Scrutiny
Every California stem cell scientist and researcher looking to join the field – be they from academia or business – should pay very close attention to a meeting next week of a key group of directors of the $3 billion California stem cell agency. They plan to discuss possible changes in how scientists compete for stem cell cash, which is no small matter since CIRM has another $2 billion to hand out over the next several years.
Pre-application review – CIRM report (Jan. 2010) on the process
Extraordinary petition policy – Version as of 5/25/10
Appeal policy – Version as of 5/25/2010
Transcript of July 20, 2010, meeting of CIRM directors Science Subcommittee. Discussion of petitions begins on page 40.
Transcript of the June 22, 2010, CIRM directors meeting. Discussions of extraordinary petitions begin on pages 24 and 67.
Transcript of 5/25/10 Science Subcommittee meeting dealing with appeals issue. Discussion begins on page 99.
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August 19th, 2012
$70 Million Research Proposal Up Next Week at California Stem Cell Agency
By Dr. Matthew Watson
stem cell agency will hold a special, teleconference meeting next
Tuesday to deal with business that was put off last month, including
a new, $70 million research round.
matters, including the translational research proposal, which is
scheduled to be posted as an RFA next month.
dealing with changes in its intellectual property rules at next week's meeting, but that proposal is not on Tuesday's agenda. The next meeting of the board is Sept. 5 and 6 in San Francisco. The
agency has confirmed that it will be a two-day session.
come up in September in the $243 million disease team round that
consumed so much time in July.
locations throughout California. The public is entitled to
participate in the session from any of those sites. The specific
addresses can be found on the agenda.
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August 19th, 2012
Researcher Alert: Opportunity for Fresh Appeal in $243 Million Disease Team Round
By Dr. Matthew Watson
A tiny opening exists for scientists
who failed to win approval last month of their bids for $20 million
research awards from the California stem cell agency.
board okayed $151 million for eight scientists during a day filled
with emotional testimony from patients, as well as appeals by
researchers seeking reconsideration of rejection by grant reviewers
at the California Institute for Regenerative Medicine. The board also
asked reviewers to take a fresh look at five applications in its signature disease team round.
eight applications, meaning that they are still pending. Normally the
board will approve -- as a group -- one set of applications. Then, at
the same meeting, it will vote to reject another set of applications.
On July 26, however, the hard-pressed directors late in the
afternoon lost the supermajority quorum (65 percent) required to do
business and adjourned without acting on all the applications.
rounds. In our recollection, it has happened only once before
although there may have been other occasions.
researchers to ask the board to act favorably at its Sept. 5-6 meeting in San Francisco on applications rejected by reviewers. Money
is available. The July 26 round was budgeted for $243 million.
by directors provided several clues to appropriate avenues for
reconsideration. They were interested in appeals, formally called
extraordinary petitions, that brought genuinely new information to
the table. Serious errors in the reviews – something more than
differences of opinion – were of interest. Wide variance in the
spread of scientific scores on specific applications, including the
preliminary scores, also triggered directors' interest.
be well-advised to listen to the audiocast of the meeting to hear the
discussion of appeals. The transcript of the meeting also should be
posted soon on the CIRM website, probably this week. The transcript
can be found via this page when it is posted. The audiocast
instructions can be found on the July 26 meeting agenda.
CIRM web site shows a Sept. 5-6 governing board meeting. However,
that schedule also shows other two day meetings earlier this year,
which actually have turned out to be only one day.)
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August 12th, 2012
Stem Cell Blowback from Proposition 71
By Dr. Matthew Watson
Proposition 71 last week once again
stood in the way of action by the $3 billion California stem cell
agency.
embedded in state law that prevented the agency's governing board
from going forward. The result is that the board will have to hold
another meeting in August to approve matters that need to be acted on
in a timely fashion.
quorum requirement for the board, the percentage of board members
needed to conduct business legally. Proposition 71, the 10,000-word
ballot initiative that created the agency in 2004, stipulates that 65
percent of the 29 members of the board be present for action.
Thursday afternoon, CIRM directors were moving fast after a long day
of dealing with $151 million in research awards. But as they
attempted to act on proposed changes in the agency's important
intellectual property rules, one of the board members left the
meeting, presumably to catch a flight. The result was that the
meeting quickly ended after it was decided to deal with the IP
proposal and another matter during a telephonic meeting this month.
board since its inception, although the situation has eased since
J.T. Thomas, a Los Angeles bond financier, was elected chairman in
2011. A few years back, the board also changed its rules to allow a
limited number of board members to participate in meetings by
telephone, reducing the pressure on board members to physically
attend meetings.
the quorum to 50 percent, a reasonable standard. However, the board
is legally barred from doing that. To make the change would require a super, supermajority vote, 70 percent of
each house of the state legislature and the signature of the
governor. That is another bit that is embedded in state law, courtesy of Proposition 71. To attempt to win a 70 percent legislative vote would involve a political process
that could be contentious and also involve some horse-trading that
the stem cell agency would not like to see.
requirement exist? Normally, one would think such internal matters
are best left to the governing board itself. It is difficult to know
why former CIRM Chairman Bob Klein and his associates wrote that
requirement into law. But it does allow a minority to have effective
veto power over many actions by the governing board.
at the problem: CIRM board members could change their flights and
stick around until all the business is done. But that would ignore
the reality that all of them are extremely busy people and have
schedules that are more than full.
created by Proposition 71, see here(cap on size of staff, which took legislation to remove), here (board cannot nominate its ownchairman), here (dual executive arrangement).
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$20 Million in Stem Cell Irony
By Dr. Matthew Watson
A bit of irony popped up this
week in the wake of approval of $151 million in awards by the
California stem cell agency.
StemCells, Inc., of Newark, Ca., which is also fighting hard for
another $20 million from the state research enterprise.
Stratton, general counsel for the firm, put some distance between his
company and the agency, which is handing out $3 billion in toto.
"We will take CIRM money last. We
don't want to be in a position where, years from now, we are actually
forced to sell [our products] in California at a loss."
StemCells, said in a press release,
“We are extremely grateful to CIRM
for its support.”
and CIRM, which is in the process of altering the intellectual
property rules that offended Stratton in 2008. The changes were due
to be approved last Thursday, but action was put off by the CIRM
board. It was overwhelmed as it dealt with the record pace of appeals
by researchers who were scrambling to overturn negative decisions by
grant reviewers.
million is one of those being appealed. The board will take it up
again in either September or late October, after it undergoes
additional scrutiny by the agency.
more friendly to business. They also can be made retroactive to cover
awards to business made in the past. CIRM directors expect to meet by
telephone, probably in August, to approve the new IP rules.
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Two More Disease Team Applications Sent Back for More Review
By Dr. Matthew Watson
Directors of the California stem cell agency today referred two additional research applications for $37 million in disease team funding back to reviewers for further consideration.
Both were the subjects of appeals by researchers whose proposals were rejected by grant reviewers.
One was from Timothy Hoey of OncoMed Pharmaceuticals in Redwood City, who sought $20 million. The other was from Henry Klassen of UC Irvine, who sought $17 million. (See here and here for their appeals.)
The board began the day by directing staff to come back to the board in early September. But with the large number of grants to be reassessed, it was acknowledged some might not be acted on until the board's meeting in late October.
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July 29th, 2012
News Coverage of CIRM Awards: Substantial but Not Extensive
By Dr. Matthew Watson
The California stem cell agency today
enjoyed substantial, if sparse, news coverage of the
approved by its board yesterday.
The Sacramento Bee carried solid stories on the grant awards. In the
case of the Chronicle, the story included compelling photos of
patients who spoke during emotional, tear-filled presentations.
from the past, when media outlets all but ignored the agency's
awards.
“For Melissa Biliardi of Santa
Maria, the (CIRM board) vote symbolizes hope. Her son, James
Birdsall, 32, was diagnosed four years ago with Huntington's disease.
The degenerative brain disorder could prove fatal over the next 10 to
15 years. There is currently no cure or treatment, but with the
grant, UC Davis researchers hope to deliver an effective therapy in
four years.
"'This is the most hope we've ever
had for a cure or treatment,' Biliardi said.”
“California's stem cell funding
agency on Thursday approved nearly $100 million in grants for
research into heart disease, cancer and spinal cord injuries, and to
the cheers of dozens of patients and their supporters, it also
awarded money to rare but devastating diseases with no cure.”
effectiveness of patients and patient advocates in telling the CIRM
story. Reporters are always looking for a warm human dimension –
especially to enhance a dry, bare-bones science and government story.
California Stem Cell Report, Kevin McCormack, spokesman for CIRM,
also mentioned radio news coverage in the San Francisco Bay Area. He
said the awards were covered in “two different stories on KCBS-AM
radio, one that ran several times yesterday and another that ran
several times today. KGO-AM radio also ran a story several tim, and,
of course, the best of all, today's KQED-FM Forum.”
nationally on Sirius radio, consisted of an hour-long look at CIRM,
with some calls from listeners. Guests on the show were CIRM
President, Alan Trounson, UC Davis stem cell researcher Jan Nolta and
yours truly, David Jensen.
story appeared in the Modesto Bee as well.
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July 29th, 2012
Disease Team Round Hits $151 Million with Final Action
By Dr. Matthew Watson
Directors of the California stem cell
agency approved an additional
$20 million disease team grant today before adjourning their
meeting. The grant brought the disease team round to a total of $151 million.
of Stanford. Scientist Irv Weissman and Robert
Klein, former chairman of the stem cell agency, both spoke on behalf
of her
appeal of a negative decision by grant reviewers.
chairman, J.T. Thomas, the board placed conditions on the grant
would stipulate Stanford pick up certain unknown, additional costs if
necessary.
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July 29th, 2012
Stem Cell Directors Approve $151 Million to Commercialize Stem Cell Research
By Dr. Matthew Watson
Directors of the California stem cell
agency today approved $151 million in research awards aimed at
commercializing stem cell research and pushing therapies into
clinical treatment.
Patients and researchers cheered when the action was announced.
The awards of up to $20 million each
were ratified by CIRM's governing board, which added two to the
six applications approved by reviewers. The original
six totalled $113 million. Directors budgeted $243 million
for today's round.
Five of the applications involving
appeals were sent back by the board for more review.
(See here, here and here.)
They will be considered again in early September or October.
second largest research round in CIRM's history,
surpassed only by an another, earlier $211 million “disease team”
round. The latest effort is aimed at bringing
proposed clinical trials to the FDA for approval or possibly starting
trials within four years. That deadline coincides roughly
with the date when CIRM is scheduled to run out of cash unless new
funding sources are developed.
private financing. It could also ask voters to approve another state
bond issue. (Bonds currently provide the only real source of cash for
CIRM.) In either case, the agency needs strong, positive
results from its grantees to support a bid for continued funding.
the 15 applicants who were rejected by reviewers appealed the
negative decisions. Two of the appeals were successful at today's meeting. It is a
good bet that at least some of those referred for more review
will be ratified by the board in September.
issues, ranging from technical science questions to inconsistencies
in CIRM's research approaches and mistakes by reviewers.
The outpouring
of appeals was the largest in CIRM history in terms of the
percentage of applicants seeking to overturn reviewer decisions.
another first in terms of the total initially approved by
reviewers. On occasion in the past, reviewers have not approved
enough awards to consume all the funds budgeted by the CIRM board.
But never before has the amount fallen so far short.
connected to persons on 29-member CIRM governing board, continuing a
trend that has existed throughout CIRM's history. Board members with
conflicts, however, are not allowed to vote or participate in the
CIRM press release can be found here.
(Editor's note: This item was updated from an earlier version and the figures increased as the CIRM board added another grant and took additional action.)
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July 29th, 2012
Harvard’s McMahon on His Way to USC
By Dr. Matthew Watson
 |
| Andy McMahon Harvard photo |
The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.
The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.
McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,
“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”
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StemCells, Inc., and Capricor Stave Off Rejection from Stem Cell Agency
By Dr. Matthew Watson
Two California stem cell firms today
won a reprieve from rejection in their bids for $40 million in
funding from the California stem cell agency.
and Capricor, Inc. of Beverly Hills. StemCells was founded by
Stanford researcher Irv Weissman. Capricor was formed to
commercialize research at Cedars of Sinai that had been previously
financed in part by the state's $3 billion enterprise. Frank
Litvack, who unsuccessfully vied for the chairmanship of the stem
cell agency in June 2011, is the recently appointed executive
chairman of Capricor.
their appeals of reviewers' negative decisions as well as testimony
at the board meeting today. The board will take up the applications, which seek $20 million each, again in early September.
Robert Klein, who was the first
chairman of the stem cell agency, appeared before his old board as a
member of the public on behalf of the StemCells appeal. He said new
evidence will be published soon in a scientific journal that supports
the StemCells approach. Klein also said that he was personally
involved in three CIRM grant reviews in which scientists affirmed the
company's approach. (Here are links to the appeal and to grant reviewer comments.)
information. Litvack, former CEO of Conor Medsystem, told the board
the firm has made considerable progress since CIRM's closed-door
review of applications last April, both in terms of management and
science. The firm's appeal said Litvack's appointment is part of the
management improvements at the firm.
board and former CEO of a Hollywood film studio, enthusiastically
recalled a presentation last year before the board about the results
of the initial research. She the firm has solved the problems cited by reviewers. She said,
“We have a fiduciary responsibility
to select the best science.”
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July 29th, 2012