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Category Archives: Stem Cell Therapy
California Stem Cell Agency: A New Board Member and a New Vacancy
Posted: September 2, 2012 at 3:58 pm
The chairs are shifting a tad on the
governing board of the $3 billion California stem cell agency as a
French immigrant is added, a Latino leaves and a veteran patient
advocate is reappointed.
Coming on board for next week's meeting
is Anne-Marie Duliege, chief medical officer of Affymax Inc., of
Palo Alto, a publicly traded biopharmaceutical company that deals
with kidney disease. Leaving is David Serrano Sewell, who has been
named to the state Medical Board by Gov. Jerry Brown. Reappointed is
Jeff Sheehy, an HIV/AIDs patient advocate who may be the most public face
of patient advocates on the stem cell agency.
Anne-Marie Duliege Affymax Photo |
State Controller John Chiang appointed
Duliege to the CIRM post, saying,
“Dr. Duliege brings
first-hand knowledge of what is required to take a drug from research
phase through FDA approval.”
In May, Duliege made a presentation to
the Bioscience Forum in South San Francisco called “Beating the
Odds,” a discussion of Affymax's first commercial product.
According to information posted by the group, Duliege led the way by
shepherding it through a 10-month gauntlet at the FDA.
the Bioscience Forum in South San Francisco called “Beating the
Odds,” a discussion of Affymax's first commercial product.
According to information posted by the group, Duliege led the way by
shepherding it through a 10-month gauntlet at the FDA.
Duliege has been with Affymax since
2007. Her prior positions included time at Chiron and Genentech. She
is a practicing physician, working part-time, and received her
medical degree from Paris Medical School.
2007. Her prior positions included time at Chiron and Genentech. She
is a practicing physician, working part-time, and received her
medical degree from Paris Medical School.
Affymax has had a previous tie to the
stem cell agency. Ted Love, one of the initial members of the CIRM board, also sits on the Affymax board of directors. Indeed, Duliege fills the seat
vacated by Love when he resigned from the CIRM board. The position must be
filled by an officer of a California life science company.
stem cell agency. Ted Love, one of the initial members of the CIRM board, also sits on the Affymax board of directors. Indeed, Duliege fills the seat
vacated by Love when he resigned from the CIRM board. The position must be
filled by an officer of a California life science company.
David Serrano Sewell CIRM Photo |
Serrano Sewell, who has also served on
the CIRM board since its inception, is apparently resigning to accept
an appointment to the board that regulates
California physicians. Apparently – because the stem cell agency
has not confirmed that he is leaving, although this morning it placed a resolution honoring him on the agenda for next week's meeting. That almost invariably means a board member is departing.
Serrano Sewell, an attorney for the
city of San Francisco, was one of 10 patient advocate members on the
29-member board. Sewell was apppointed by the California lieutenant
governor. His seat will remain vacant until the current lieutenant
governor, Gavin Newsom, makes an appointment, who must also be a patient advocate.
city of San Francisco, was one of 10 patient advocate members on the
29-member board. Sewell was apppointed by the California lieutenant
governor. His seat will remain vacant until the current lieutenant
governor, Gavin Newsom, makes an appointment, who must also be a patient advocate.
Jeff Sheehy CIRM Photo |
Sheehy was reappointed recently by
state Senate President Pro Tem Darrell Steinberg. Sheehy is a
communications manager at UC San Francisco and a nationally known
HIV/AIDS advocate. He is co-chairman of CIRM's Science Subcommittee
and vice chairman of the grants review group. Sheehy leads the
discussion of grant applications when they come before the full board
in public session.
With the latest shuffling, the board has essentially lost its only African-American member – Ted Love.
Eugene Washington, dean of the UCLA medical school, is a member of
the board but never attends the meetings. Instead he sends a
surrogate. Serrano Sewell's departure brings the number of Hispanics
to three, co-vice chairman Art Torres, Francisco Prieto and Marcy
Feit. No Asians sit on the board.
Eugene Washington, dean of the UCLA medical school, is a member of
the board but never attends the meetings. Instead he sends a
surrogate. Serrano Sewell's departure brings the number of Hispanics
to three, co-vice chairman Art Torres, Francisco Prieto and Marcy
Feit. No Asians sit on the board.
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Bob Klein, "Lobbying" and Reader Reaction
Posted: September 2, 2012 at 3:58 pm
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.
The comments were triggered by the original "unseemly performance" item on the California Stem Cell Report and a subsequent comment by Francisco Prieto, a longtime member of the board.
The comments discussed whether Klein
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.
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.
The comments raise a number of
interesting questions that we will discuss on the California Stem
Cell Report during the next few days.
interesting questions that we will discuss on the California Stem
Cell Report during the next few days.
You can read the remarks by going to this item and scrolling down to the end of the piece.
(Editor's note: Our apologies to some
of those who commented for the delay in posting their remarks.)
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
Posted: September 2, 2012 at 3:58 pm
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.
The latest appeals come in what the
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.
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.
The four appeals follow a record outpouring last month of attempts at reconsideration in another
round. One upshot has been a proposal that would tighten the review process. That plan also comes before directors next week.
round. One upshot has been a proposal that would tighten the review process. That plan also comes before directors next week.
In three of the latest appeals, the
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.”
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.”
The latest appeals – formally known
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.
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.
Hunter's $1.8 million application had the highest scientific score, 70, of the four appeals. It ranked above three grants approved by reviewers.
In his appeal, Hunter said “no major scientific issues were found” by reviewers concerning his application. He also reported new data involving a “major concern” of reviewers. Hunter said the information was developed after the application was submitted April 25.
In the case of Lieu, reviewers
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.
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.
She is seeking $1.3 million. Her
application received a score of 68, ranking it above two other grants
approved by reviewers and equal to a third also approved by
reviewers.
application received a score of 68, ranking it above two other grants
approved by reviewers and equal to a third also approved by
reviewers.
Mikkola said her application built on work previously funded by CIRM. She also cited new data that the
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.
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.
Teitell's letter to the board also cited new data that is scheduled to published in November that deals with one of the concerns of reviewers. Teitell additionally disputed some of the critical information in the summary of reviewer comments.
He is seeking $1.4 million. CIRM did not release a score on his application, although it appears to be below 63, the lowest score disclosed publicly by the agency.
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Stem Cell Agency Moving to Curb Free-Wheeling Appeals by Researchers
Posted: September 2, 2012 at 3:58 pm
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.
The agency posted on its web site a 4 ½ page plan to curb the free-wheeling pitches that reached a record level at last month's governing board meeting. Some of the changes
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.
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.
The agency's proposal, due to be acted
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.”
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.”
CIRM also reiterates in a footnote its
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.
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.
Details on CIRM's proposed changes came
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.
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 CIRM board has been bedeviled by
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..
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..
As the California Stem Cell Report
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,
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."
Lubin was later quoted in the journal
Nature as saying that his rejected application did not come from “the
in crowd” of stem cell researchers or organization.
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.”
A final note: CIRM's proposal for changes in
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.
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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USC Researchers Appeal Rejection of $20 Million Proposal
Posted: September 2, 2012 at 3:58 pm
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.
The appeal by Roberta Diaz Brinton and
Lon Schneider will be taken up one week from tomorrow by the
governing board of the $3 billion state enterprise.
Lon Schneider will be taken up one week from tomorrow by the
governing board of the $3 billion state enterprise.
The USC application deals with Alzheimer's. It came in the $243
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.
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.
The Brinton-Schneider application
received a score of 63 from reviewers. They said in a letter to
the board,
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.”
Their statement reinforced a concern
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,
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.
Next week the board is scheduled to
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.
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.
In the Brinton-Schneider letter to the
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.
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.
It is not clear whether other scientists will
be making appeals during next week's board meeting.
be making appeals during next week's board meeting.
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Researcher Alert: Troubling CIRM Grant Appeal Process Up for Revision
Posted: September 2, 2012 at 3:58 pm
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.
The move follows a jam-packed and
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.
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.
No details of the proposed changes in
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.
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.
The appeals process has long troubled the CIRM board. It has made changes in the procedures, but last
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.
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.
As a result of the July appeals, the
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.
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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PART 1: Lorna Tolentino admits undergoing stem cell treatment to keep vital organs rejuvenated
Posted: August 28, 2012 at 8:10 am
PART 1: Lorna Tolentino admits undergoing stem cell treatment to keep vital organs rejuvenated
Isang bihirang pagkakataon na nakausap uli ng PEP.ph (Philippine Entertainment Portal) sa isang mahabang interview ang multi-awarded actress na si Lorna Tolentino.
Naganap ang panayam noong nakaraang Huwebes, August 23, sa faculty office ng Central Colleges of the Philippines (CCP), kung saan ginanap ang taping ng weekly supernatural mystery drama series naThird Eye ng TV5.
During dinner break, nabanggit ni Lorna ang tungkol sa pinsang si Zsa Zsa Padilla, who was diagnosed with Stage 1 cancer of the kidney.
"Ka-text ko si Zsa Zsa. Four weeks daw siya doon, tapos saka babalik dito.
Four weeks after the operation, hindi pa siya puwedeng mag-work.
August 27 ang naiulat noon na schedule ng operasyon ni Zsa Zsa sa Cedars-Sinai Medical Center sa Los Angeles, California.
Sixteen hours and delay ng oras ng U.S. sa Pilipinas, kayat malamang na ngayong araw na ang operasyon ni Zsa Zsa.
Tatanggalin ang mala-golf ball sa laking namuong laman sa kanyang kidney.
Original post:
PART 1: Lorna Tolentino admits undergoing stem cell treatment to keep vital organs rejuvenated
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An Unseemly Performance: Former Chair of Stem Cell Agency Promotes $20 Million Research Proposal
Posted: August 26, 2012 at 3:55 pm
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 |
Klein's comments carried unusual
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.
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.
The meeting last month marked Klein's
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.)
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 |
StemCells Inc. is a publicly traded company based in Newark, Ca., that was founded by renown Stanford
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.
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.
One California stem cell researcher,
who requested anonymity, said it is “highly inappropriate for Bob
Klein to be advocating for any grant application from a public
company.”
who requested anonymity, said it is “highly inappropriate for Bob
Klein to be advocating for any grant application from a public
company.”
The scientist said,
“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."
In response to questions asked on Aug. 7 by the
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.
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.
Klein also indicated his appearance was
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.”
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.”
Klein said he hoped other former board
members would follow his example. He said,
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.”
(The full text of his response can be found here.)
Klein's appearance came at a propitious
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.
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.
The researcher who criticized Klein's efforts as inappropriate also said,
"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.”
Weissman's role
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.
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.
Weissman played a significant role in
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.
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.
In addition to StemCells, Inc., Klein
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.
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.
One of the application's problems cited
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.
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.
Klein said that reviewers believed the
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.
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.
Our take: The stem cell agency has long
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.
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.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Posted in Stem Cells, Stem Cell Therapy
Comments Off on An Unseemly Performance: Former Chair of Stem Cell Agency Promotes $20 Million Research Proposal
CIRM Board Member Prieto Defends Klein’s Right to Appear Before Board
Posted: August 26, 2012 at 3:55 pm
A member of the governing board of the
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.
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.”
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Posted in Stem Cells, Stem Cell Therapy
Comments Off on CIRM Board Member Prieto Defends Klein’s Right to Appear Before Board
Text of Klein’s Response to Questions Concerning His Advocacy on Rejected Grant Applications
Posted: August 26, 2012 at 3:55 pm
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"
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Posted in Stem Cells, Stem Cell Therapy
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