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Two More Disease Team Applications Sent Back for More Review
Posted: July 29, 2012 at 3:55 pm
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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Disease Team Round Hits $151 Million with Final Action
Posted: July 29, 2012 at 3:55 pm
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.
The award went to Judith Shizuru
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.
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.
At the suggestion of the current board
chairman, J.T. Thomas, the board placed conditions on the grant
would stipulate Stanford pick up certain unknown, additional costs if
necessary.
chairman, J.T. Thomas, the board placed conditions on the grant
would stipulate Stanford pick up certain unknown, additional costs if
necessary.
Here is a link to the CIRM press release on today's action.
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Stem Cell Directors Approve $151 Million to Commercialize Stem Cell Research
Posted: July 29, 2012 at 3:55 pm
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.
The awards are the
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.
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.
CIRM is currently exploring seeking
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.
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.
Today's action came after nine out of
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.
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.
The appeals were based on a variety of
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.
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.
The round also marked
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.
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.
Most of the awards went to enterprises
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
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
The full list of the winners and the
CIRM press release can be found here.
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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Harvard’s McMahon on His Way to USC
Posted: July 29, 2012 at 3:55 pm
 |
| 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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$18 Million Cedars Sinai ALS Proposal Headed for Approval
Posted: July 29, 2012 at 3:55 pm
The California stem cell agency today
cleared the way for approval of an $18 million grant to develop a new
cell-based therapy for treatment of ALS.
The agency's governing board moved the
application into a category that is expected to approved later today.
application into a category that is expected to approved later today.
The action came on an appeal by
researcher Clive Svendsen of Cedars Sinai. Also supporting the
application were a number of persons with ALS.
researcher Clive Svendsen of Cedars Sinai. Also supporting the
application were a number of persons with ALS.
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StemCells, Inc., and Capricor Stave Off Rejection from Stem Cell Agency
Posted: July 29, 2012 at 3:55 pm
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.
They are StemCells, Inc., of Newark
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.
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.
The CIRM board sent the firms' bids back for more scientific review based on
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.
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.)
The other application also involved new
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.
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.
Sherry Lansing, a member of the CIRM
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,
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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Rejected Grants May Be Sent Back for More Review
Posted: July 29, 2012 at 3:55 pm
California stem cell agency chairman J.T. Thomas has raised the possibility of sending some of the disease team applications back for additional review if the board feels that is necessary to consider new information and resolve scientific disputes.
Thomas discussed such a move at the beginning of the discussion of the $243 million disease team round. Nine out of 15 rejected applicants have appealed to the full board. Some have presented new information. Others have disputed the scientific work of reviewers.
The board used such a referral process for one application in the past. That grant was ultimately approved.
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Stem Cell Directors Order More Consideration on $20 Million UCLA Research Application
Posted: July 29, 2012 at 3:55 pm
Directors of the California stem cell
agency today deferred action on a $20 million proposal that was
rejected by its grant reviewers and sent it back for more consideration.
The move involved an application by
Stanley Nelson and M. Carrie Miceli of UCLA dealing with Duchenne
muscular dystrophy. They are parents of a child with the affliction,
which is usually fatal by age 25. The CIRM review summary said it is
“a devastating and incurable muscle-wasting disease caused by
genetic mutations in the gene that codes for dystrophin, a protein
that plays a key role in muscle cell health.”
Stanley Nelson and M. Carrie Miceli of UCLA dealing with Duchenne
muscular dystrophy. They are parents of a child with the affliction,
which is usually fatal by age 25. The CIRM review summary said it is
“a devastating and incurable muscle-wasting disease caused by
genetic mutations in the gene that codes for dystrophin, a protein
that plays a key role in muscle cell health.”
Nelson had filed an appeal seeking to
overturn reviewers' action. Five mothers and two fathers with
children suffering from the disease made emotional appeals to
CIRM directors on behalf of the application. Following their presentation, Art
Torres, co vice chairman of the CIRM board, responded equally
emotionally that the board is dedicated to finding therapies for such
afflictions as Duchenne muscular dystrophy
overturn reviewers' action. Five mothers and two fathers with
children suffering from the disease made emotional appeals to
CIRM directors on behalf of the application. Following their presentation, Art
Torres, co vice chairman of the CIRM board, responded equally
emotionally that the board is dedicated to finding therapies for such
afflictions as Duchenne muscular dystrophy
The board approved more review for the
application after it was disclosed that a company issued a press
release two days ago that showed that a drug involved in the
proposal was more effective than reviewers believed. Philip Pizzo, a
member of the board and dean of the Stanford medical school,
expressed caution about the press release, given its timing and
source. His comments came prior to the appearance of the parents.
application after it was disclosed that a company issued a press
release two days ago that showed that a drug involved in the
proposal was more effective than reviewers believed. Philip Pizzo, a
member of the board and dean of the Stanford medical school,
expressed caution about the press release, given its timing and
source. His comments came prior to the appearance of the parents.
The application is scheduled to be
brought back to the full board in September for further action.
brought back to the full board in September for further action.
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California Stem Cell Directors Open Meeting
Posted: July 29, 2012 at 3:55 pm
Today's session of the governing board of the $3 billion California stem cell agency has begun. The major item on the agenda is a $243 million grant round that has triggered a record pace for appeals by rejected applicants. At the request of the California Stem Cell Report, the agency has provided the conflict of interest list used by the agency to determine which directors will not be allowed today to vote or participate in the discussion of specific applications. The list can be found below. Conflict of Interest List -- CIRM Directors Meeting 7-26-12ound below.
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Short-term Borrowing to Continue to Provide California Stem Cell Cash
Posted: July 29, 2012 at 3:55 pm
The California stem cell agency will continue to be funded with short-term borrowing -- commercial paper -- provided through the state treasurer's office, J.T. Thomas, chairman of the agency's governing board, said today.
Until late last year, the $3 billion agency was funded through state bond funds, but California Gov. Jerry Brown is trying to reduce the state's long-term debt load, which has skyrocketed in the last decade.
Thomas told directors this morning that short-term funding comes at "the lowest possible interest rate." He said the arrangement leaves the agency in "very good shape."
The state will provide the funding to CIRM on a month-to-month basis in addition to providing a two month cushion, Thomas said.
At some point, the short-term debt is likely to covered by state bonds. As of June 30, CIRM
had $50.9 million on hand, down $42 million from April 30. During the fiscal year ending June 30, the agency paid out $232.7 million compared to $201.4 million in the previous fiscal year.
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