$18 Million Cedars Sinai ALS Proposal Headed for Approval
By Dr. Matthew Watson
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.
application into a category that is expected to approved later today.
researcher Clive Svendsen of Cedars Sinai. Also supporting the
application were a number of persons with ALS.
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July 29th, 2012
Rejected Grants May Be Sent Back for More Review
By Dr. Matthew Watson
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.
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July 29th, 2012
Stem Cell Directors Order More Consideration on $20 Million UCLA Research Application
By Dr. Matthew Watson
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.
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.”
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
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.
brought back to the full board in September for further action.
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July 29th, 2012
Short-term Borrowing to Continue to Provide California Stem Cell Cash
By Dr. Matthew Watson
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.
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July 29th, 2012
California Stem Cell Directors Open Meeting
By Dr. Matthew Watson
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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Companies selectively targeting cancer stem cells
By Dr. Matthew Watson
Today, I posted this to Twitter:
3 Innovative Cancer Treatments...But Which Is The Best Bet? seekingalpha.com/a/fjed $GSK $IMUC $VSTM #cancerSC via @seekingalpha — Jim Till (@jimtill) July 17, 2012
The article is about three companies that are working on treatments designed to target cancer stem cells (CSCs). The companies are OncoMed, Verastem and ImmunoCellular Therapeutics. The article is interesting.
Source:
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July 22nd, 2012
Royalty Rules at the California Stem Cell Agency: Business Friendly Changes Proposed
By Dr. Matthew Watson
If you are looking to follow the money
trail at the $3 billion California stem cell agency, next Thursday's meeting of its 29-member board of directors is a good place to start.
intellectual property rules, which are all about who gets paid and how much and when – should an agency-financed product generate
significant cash.
The key question about the proposed changes is whether they will generate an appropriate return for the state, given its $6 billion investment, including interest on the bonds that finance CIRM. The impact of the changes is not crystal clear. And the staff memo does not mention two important definition changes that appear to be quite business friendly.
created the stem cell agency, California voters were told that the
state would share as much as $1 billion or more in royalties. Eight
years later, no royalties have materialized since CIRM research has
not yet resulted in a commercial therapy.
directors will be asked to modify CIRM rules for royalties that CIRM
staff said "could be a disincentive" for business. A staff memo said the proposals would alter provisions that create "administrative challenges and uncertainty." The memo asserted
the proposed changes would ensure "a comparable economic
return to California" equal to the existing provisions.
However, the memo provided no explanation or evidence for how that
result would come about. The proposed changes could also be applied
retroactively with the agreement of CIRM and the grantee.
collaborators must share as much as 25 percent of their licensing
revenue in excess of $500,000, depending on the proportion of agency
funding for the product. The IP rules also contain a provision for
payments in the event of development of a "blockbuster" therapy.
The staff memo described how that would work.
“It provides that grantees and
collaborators must share revenues resulting from CIRM funded research
as follows: after revenues exceed $500,000, three times the grant
award, paid at a rate of 3% per year, plus upon earning
$250M(million) in a single calendar year, a onetime payment of three
times the award, plus upon earning revenues of $500M in a single
calendar year, an additional onetime payment of three times the award
and, finally, in the instance where a patented CIRM funded invention
or CIRM funded technology contributed to the creation of net
commercial revenue greater than $500M in a single calendar year, and
where CIRM awarded $5 million or more, an additional 1% royalty on
revenues in excess of $500 million annually over the life of the
patents.”
memo said, in order to maximize the amount businesses can "re-invest
in product development." The proportionality payment provision
would be changed to require only 15 percent of licensing revenues if
CIRM's investment is less than 50 percent and 25 percent if it is
more than 50 percent. Revenue sharing would be extended to "commercializing entities." No definition of "commercializing entities" was provided in the board agenda material, but a June version of the changes defined them as "A For-Profit Grantee and its Collaborator or Licensee that sells, offers for sale or transfers a Drug, product(s) or services resulting in whole or in part from CIRM-Funded Research."
enshrined in a 2011 state law. However, the law also provided that
they can be altered by the agency, the CIRM memo said, “if it
determined that it was necessary to do so either to ensure that
research and therapy development are not unreasonably hindered as a
result of CIRM’s regulations or to ensure that the State of
California has an opportunity to share in the revenues derived from
such research and therapy development.”
"The proposed amendments re-strike
the balance both to ensure that industry will partner with CIRM and
to ensure that the State has the opportunity to benefit from
successful therapy development."
go-ahead for posting the proposals as part of the official state
administrative rules process. They are subject to additional changes
in that process.
(Editor's note: The agency has now reposted the version of the text of the changes that was on the agenda earlier, saying that it was having problems with its web site. For the definitions of terms, however, it is still necessary to refer to the June documents.)
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July 22nd, 2012
UC Davis Researchers Score Big in $113 Million Stem Cell Award Round
By Dr. Matthew Watson
Scientists at the University of
California at Davis are set to win nearly half of $113 million
expected to be awarded next week by the California stem cell agency
as it pushes aggressively to turn research into marketplace cures.
virtually certain to approve awards to three researchers at UC Davis,
which operates its medical school and other research facilities in
nearby Sacramento. The other three expected winners are from UCLA,
Stanford and StemCells, Inc., of Newark, Ca., a publicly traded firm.
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
is close to the time 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 latest awards one week from tomorrow at a public meeting in Burlingame in the San Francisco area. The agency's policy is to
withhold the identities of applicants and winners until after formal
board action. The California Stem Cell Report, however, has pieced
together their identities from public records.
grant review summaries, listed in order of the CIRM scientific
scores:
- Vicki Wheelock, UC Davis, $19 million,
for development of a genetically modified cell therapy for
Huntington's disease, an inherited neurodegenerative disorder.
Scientific score 87. - Antoni Ribas, UCLA, $20 million, for
genetic reprogramming of cells to fight cancer. Scientific score 84. - Nancy Lane, UC Davis, $20 million, for
development of a small molecule to promote bone growth for the
treatment of osteoporosis. Scientific score 80. - John Laird, UC Davis, $14.2 million,
for development of mesenchymal stem cells genetically modified for
treatment of critical limb ischemia, which restricts blood flow in
the lower leg and can lead to amputation. Scientific score 79. - StemCells, Inc., (principal
investigator not yet known), $20 million, for development of human
neural stem cells to treat chronic cervical spinal cord injury. The
company, founded by Stanford scientist Irv Weissman, who serves on
its board, said earlier this year that it had filed two applications
in this round, one of which dealt with cervical cord spinal injury.
No other applicants filed a proposal for such research. Scientific score 79. - Robert Robbins, Stanford, $20 million,
development of a human embryonic stem cell treatment for end-stage
heart failure. Scientific score 68.
In the case of businesses, the awards
come in the form of loans. Grants go to nonprofits. One of the
reasons behind the varying mechanisms is the difference in CIRM's
intellectual property rules for businesses and nonprofits.
year approved the applications during closed door sessions. The full
CIRM board has ultimate authority on the applications, but it has
almost never rejected a positive action by the grant reviewers.
applications rejected by reviewers and approve any of them, which the
board has done in other rounds. In this round, three rejected
applications scored within seven points of the lowest rated
application approved by reviewers, which could lead some directors
to argue that the scores are not significantly different. One of the
three came from Alexandra Capela of StemCells, Inc., and was scored at 61. The other two and their scores are Clive Svendsen of
Cedars-Sinai, score 64, for ALS research, and Roberta Brinton of
USC, score 63, for an Alzheimer's project.
reviewer decisions to the full CIRM board in writing and in public
appearances before directors.
to apply for funding, CIRM told the California Stem Cell Report.
Applicants qualified by either winning a related planning grant from
CIRM last year or by being granted an exception to that requirement
by CIRM staff. Of the 22 researchers who ultimately applied(one
nonprofit dropped out), six came from biotech businesses. Three of
those qualified through exceptions. Three other businesses won
planning grants last year out of the eight businesses that applied.
negligible funding of stem cell firms and is moving to embrace
industry more warmly.
reviewers involves research with human embryonic stem cells, which
was the critical key to creation of the California stem cell agency.
California voters established the agency in 2004 on the basis that it
was needed because the Bush Administration had restricted federal
funding of human embryonic stem cell research.
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July 22nd, 2012
California’s $12.4 Million Stem Cell Recruitment Lure
By Dr. Matthew Watson
Directors of the California stem cell
agency next Thursday are likely to approve spending $12.4 million to
lure a couple of stem cell stars to the Golden State.
program that has brought three highly regarded scientists to three
California research institutions, all of which have representatives
on the CIRM board. (See here, here and here.)
identify the potential recipients in advance of the meeting or the
institutions that are recruiting them. However, if you have a modicum
of knowledge about the specific fields involved, it is likely that
you can identify them based on the information in CIRM's review summaries and some Internet searching.
$5.7 million award--would go a scientist who won raves from CIRM's
reviewers. The researcher was described as 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.”
The other grant was larger–$6.7
million–but reviewers raised a number of questions about the
candidate although they recommended it for funding. The review summary ranked the application at 57 and said,
“In summary, this is an application
from an established leader in NSC biology to pursue research focused
on disease mechanisms in PD. Strengths of the proposal include the
quality of the PI, the focus of the project on an interesting
hypothesis, and the leadership in basic science that the candidate
would bring to the applicant institution. Weaknesses included
deficiencies in the research plan, the limited track-record of the PI
in PD research and an institutional environment lacking adequate
support for basic science investigations.“
directors rejected a $6.3 million recruitment grant with a score of
76 sought by the Buck Institute, which is not represented on the
board.
on at a public CIRM board meeting in Burlingame, Ca.
(Editor's note: an earlier version of this item incorrectly said the total of both grants was $13.4 million.)
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July 22nd, 2012
Parsing Geron’s Stem Cell Foray: A Nature Journal Commentary
By Dr. Matthew Watson
Why did Geron "fail" in its
much ballyhooed pursuit of the first-ever human embryonic stem cell
therapy?
research scholar at Stanford, and Brady Huggett,
business editor of the journal Nature, took a crack at
answering that question in a commentary in the June edition of
Nature.
fall by Geron of its hESC business and the first-ever clinical trial
of an hESC therapy, Scott and Huggett scrutinized the history of the
company. The financial numbers were impressive. They wrote,
"How did Geron’s R&D program
meet such a demise? After all, the company raised more than $583
million through 23 financings, including two venture rounds, and
plowed more than half a billion dollars into R&D (about half of
that into hESC work) through 2010.
"There are problems with being at
the forefront of unknown territory. Of Geron’s development efforts,
the hESC trial was the most prominent, and fraught. Therapies based
on hESCs were new territory for the US Food and Drug
Administration (FDA), and it eyed Geron warily. The
investigational new drug application (IND), filed in 2008, was twice
put on clinical hold while more animal data were collected among
fears that nonmalignant tumors would result from stray hESCs that
escaped the purification process. Geron says it spent $45 million on
the application, and at 22,000 pages, it was reportedly the largest
the agency had ever received."
bet $25 million on the company just a few months before it pulled the
plug. Geron repaid all the CIRM money that it had used up to that point.
despite its vaunted stem cell patent portfolio. Scott and Huggett
reported that Geron received only $69 million from 1992 to 2010 from
collaborations, license and royalties. At the same time losses were
huge – $111 million in 2010.
was occurring while other biotech companies – such as Isis
and Alnylam – found ample financial support, revenue and
success.
final comment to Advanced Cell Technology, now the only
company in the United States with a clinical trial involving a human
embryonic stem cell therapy.
"Your technology may be
revolutionary, your team may be dedicated and you may believe. But it
does not matter if no one else will stand at your side."
agency obviously has learned something from its dealings with Geron.
The company's hESC announcement was an unpleasant surprise, to put it
mildly, coming only about three months after CIRM signed the Geron
loan agreement. Today, however, the agency has embarked on more,
equally risky ventures with other biotech enterprises. Indeed, CIRM
is forging into areas that conventional investment shuns. It is all
part of mission approved by California voters in 2004.
stem cells or even adult stem cells is alluring. And CIRM is feeling
much justifiable pressure to engage industry more closely. All the
more reason for CIRM's executives and directors to maintain a steely
determination to terminate research programs that are spinning their
wheels and instead pursue efforts that are making significant
progress in commercializing research and attracting other investors.
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June 24th, 2012
The California Stem Cell Agency and an HIV Cure: Pushing for a Clinical Trial in 2014
By Dr. Matthew Watson
The California stem cell agency's
leading efforts to find a cure for HIV – one tied to the famous "Berlin Patient" – received a plug today in a piece in the
state capital's largest circulation newspaper, The Sacramento Bee.
a $14 million CIRM grant to the City of Hope in Los Angeles that also
involves Sangamo BioSciences of Richmond, Ca. The team hopes to
launch a clinical trial by the end of next year.
now of San Francisco, who is the only person in the world known to
have been cured of HIV/AIDs. It came about as a side effect of a
blood transfusion carrying a rare mutation of a gene found almost
entirely among northern Europeans. Lesher, director of governmental
affairs for the Public Policy Institute in Sacramento, wrote,
"The
possibility of curing a global pandemic like AIDS with funding from
the California bond is exactly the kind of exciting potential that
inspired voters to approve Proposition 71 by
a wide margin. But the HIV research is also a good example of the
challenge facing the state's stem cell agency
as it tries to show voters that they made a good investment.
“None
of the research under way will reach patients until long after the 10
years of funding by the ballot measure runs out. With the HIV
project, researchers hope to be in human trials by 2014, but it is
likely to be at least 10 years before they can show it might work in
humans. And in the case of a stem cell cure
for AIDS, it would be many years after that before a treatment is
widely available.”
Sheehy, a prominent AIDS activist and a board member at the stem
cell agency,
described the effort as "the global home run. That's not in 10
years. … But this could be the beginning of something really
amazing."
"Nobody
thought stem cells might
be used to cure HIV when the bond (funding for the stem cell agency)
passed. Far from the embryonic stem cell treatments
that inspired the ballot measure, the HIV research involves a new and
growing integration of stem cell and
genetic science."
the ballot initiative that created the $3 billion California stem
cell agency trumpeted its devotion to human embryonic stem cell
research, which had been throttled by the Bush Administration. The
agency has veered away from hESC research, which now amounts
to less than $450 million out of the $1.4 billion in grants approved
since 2004.
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June 24th, 2012
$30 Million Round Attracts Strong Industry Interest; More Cash Coming?
By Dr. Matthew Watson
The California stem cell agency is
considering adding more cash to its upcoming $30 million award round
aimed at aiding projects that can complete – within the next four
years – a clinical trial for a therapy.
a Los Angeles bond financier, last month told agency directors that
there is "some real quality in the mix" among the firms
that have expressed initial interest. Depending on the judgment of
CIRM award reviewers later this year, Thomas said the board could
well be asked to increase the funding.
round has already exceeded expectations in terms of volume. CIRM told
the California Stem Cell Report that the agency has received
letters of intent from 37 enterprises, including 29 biotech
companies.
recommendations two years ago from an "external review"
panel that said that CIRM needed to do a better job of engaging the
biotech industry. The RFA for the round said the agency's intent is
to "enhance the likelihood that CIRM-funded projects will obtain
funding for phase III clinical trials" and attract additional
financing.
counsel and vice president for business development,, said in a news release earlier this spring,
“The Strategic Partnership Funding
Program represents a new era for CIRM, one that is increasingly
focused on moving therapies from the lab to the clinic, while still
recognizing the importance of maintaining investments in early stage
science,”
will provide grants or loans of up to $10 million to three
recipients. Applicants will have to match the size of the award. For
the first time, CIRM will also require applicants to demonstrate the
financial ability to carry the project forward.
Kevin McCormack said,
"We received 37 letters of intent
(LOIs), including 8 from non-profits and 29 from biotech companies.
Based on the information in the LOIs, and on discussions with
applicants, we were able to determine that some of the proposals were
for projects that were outside the scientific scope of the RFA and
that some of the applicants did not meet the minimum specified
criteria in the RFA for 'Commercial Validation.' We currently expect
to receive 10-15 applications for projects that appear to be
eligible."
review is scheduled for this fall by the directors' Intellectual
Property and Industry Subcommittee, which is co-chaired by
Stephen Juelsgaard, former executive vice president of Genentech,
and Duane Roth, CEO of CONNECT, a San Diego nonprofit
that supports technology and life sciences business development. The
others on the six-member panel are Chairman Thomas, Michael
Goldberg, a general partner at the MDV venture capital
firm, and two academics, Os Steward, chair and director of the
Reeve-Irvine Research Center for Spinal Cord Injury at UC
Irvine, and Susan Bryant, former vice chancellor for research,
also at UC Irvine.
validation says that applications must have "the financial
capacity to move the project through development or of being able to
attract the capital to do so. This may be evidenced by, for example,
(i) significant investment by venture capital firms, large
biotechnology or pharmaceutical companies and/or disease foundations;
(ii) a licensing and development agreement with a large biotechnology
or pharmaceutical company, or a commitment to enter into such an
agreement executed prior to the disbursement of CIRM funding; and/or
(iii) financial statements evidencing significant liquid assets."
reviews in September. The directors' Industry Subcommittee will meet
following the reviews. CIRM said funding would come no earlier than
January of next year.
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June 17th, 2012
Finding on ‘Evil’ Stem Cells Boosts Stem Cell Agency PR
By Dr. Matthew Watson
is struggling to spread the word about its good deeds, made a bit of
progress last week when it was praised – not once but three times –
on a widely followed national media outlet.
 |
| Jill Helms, Stanford photo |
Friday, the NPR program that is a favorite on PBS radio stations
around the country. It has 1.4 million listeners and 600,000 podcast downloads each week.
Stanford and a specialist in regenerative medicine, was the guest
last Friday. She talked about what Science Friday host Ira
Flatow called a "paradigm-shifting" finding that
cholestrol and fat are not the likely villains in clogging arteries.
Instead the villain is a stem cell – an evil one.
collaboration began as a result of a CIRM-sponsored meeting in Japan.
Although she and lead researcher Song Li, an associate professor of bioengineering at UC Berkeley, work nearly within shouting distance,
they had never met. She said,
 |
| Zhenyu Tang (at microscope) examines vascular stem cells in culture along with Aijun Wang (left) and Song Li. UC Berkeley/Zoey Huang photo |
"Even though he works just across
the (San Francisco) Bay from me - I met him at a meeting in Japan
that was sponsored by the California Institute for Regenerative
Medicine, or CIRM, and they fund a lot of stem cell research in
California."
"I will tell you that cancer is
certainly a disease that looks very much like a stem cell gone out of
control. And so if we understand what normally regulates a stem
cell's behavior, then we gain some crucial insights into what
regulates maybe a cancer cell's behavior. It's that kind of approach
that I think that CIRM is largely funding initiatives to try to
target human diseases, the big ones, and the ones that make us all
sort of quake in our shoes, and attempt to come up with new
therapies."
"Most basic scientists that work
in stem cells and in the area of stem cell are trying as hard as
possible to move this into translational therapies, things that can
be used in humans. And, of course, CIRM, our funding institution, is
very adamant about this being the trajectory. So, you know, I'll be
taking a stab at it about five to seven years. I think that the
ability to rapidly screen existing drugs for their ability to target
this cell population is why we think that it might have a shorter
course to getting into humans."
received a grant from the stem cell agency nor is she even one of the
featured players in CIRM's many videos. Song Li does have a $1.3million grant from the agency.
what the agency needs if it is to sell its efforts, which are almost
totally ignored by the mainstream media. However, the Science Friday
audience consists almost entirely of "true believers" in
the virtues of science and research. If CIRM is to accomplish its
PR-communications-marketing goals it also has to reach the unwashed
heathens, who are, however, unlikely converts. But most importantly,
CIRM needs to persuade fence-sitters. All of which will require a
long, hard and sometimes frustrating campaign.
NIH and the United States Army. According to CIRM's research blog post
on Li's work, his team included two researchers who were
part of Berkeley’s CIRM-funded training program.
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June 17th, 2012
Business-friendly Changes Proposed for Revenue Sharing by Stem Cell Agency
By Dr. Matthew Watson
The $3 billion California stem cell
agency, which hopes to generate income for the state through the sale
of stem cell therapies, is moving to make its profit-sharing rules
more friendly to business.
CIRM governing board.
has yet been commercialized. Its intellectual property regulations,
which determine payback criteria, were developed shortly after CIRM
was created in 2004. Ed Penhoet, one of the founders of
Chiron and now a venture capitalist, chaired the panel that worked
out the rules. He has since left the CIRM board.
rules in the case of a "blockbuster" therapy as "uneven"
and "lumpy." The memo said they "could be a
disincentive for the engagement of industry." Other rules were described as creating
"administrative challenges and uncertainty." The proposed changes, the memo said,
would address those issues and ensure a "comparable economic
return to California."
can take part in the discussion are located in San Francisco, La
Jolla, Los Angeles and Irvine. Specific addresses can be found on themeeting agenda.
full governing board and then into the state's administrative law
process before taking full effect.
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June 10th, 2012
Business Success Rate at Stem Cell Agency: Zero in Latest Round After 14 Fail
By Dr. Matthew Watson
California biotech companies chalked up
a zero in the latest funding round by the state's $3 billion stem
cell agency, although 14 tried to run a gauntlet that industry has
complained about for years.
translational research round went to 21 academic and nonprofit insitutions. No business received an award. One firm, Eclipse
Therapeutics of San Diego, appealed to the agency's governing board but was not successful despite having a higher scientific score
than at least two winners.
commercial enterprises – less than 4 percent of $1.4 billion handed
out so far – has been a matter of concern for some time for both
industry and some members of the CIRM governing board. Most
recently, industry executives complained at an April hearing of the
Institute of Medicine panel looking into CIRM's operations.
Even a 2010 review commissioned by CIRM said the agency needed to do
better by business.
simple matter of fairness or "good science," as CIRM
describes its funding goal. Without efforts by industry to turn
research into cures, CIRM will not be able to fulfill promises to
voters in 2004 when they approved creation of the stem cell agency.
CIRM last month approved a set of five-year goals that push more
aggressively for development of commercial products, but the goals
lacked such things as a financing round devoted solely to business
applicants.
applicants went through a three-step process, which is conducted
primarily behind closed doors. First came what CIRM calls
pre-applications. Those were reviewed by CIRM staff with the help of
outside advisors if necessary. Applicants who cleared that hurdle were allowed to apply for the full, peer-reviewed round. During that
process, the CIRM Grants Working Group reviews applications,
makes decisions and sends them to the full CIRM board for
ratification and possible changes. The board almost never has
rejected a grant approved by reviewers. But the board has ultimate
authority and sometimes funds applications that reviewers have
rejected. The applicants' names are withheld from the board and the
public during the process, although some of the board discussion and
the final vote is conducted in public. CIRM does not release the
names of rejected applicants unless they appeal.
pre-applications out of 167 were approved by staff, according to
CIRM. Thirty-eight came from nonprofits and academics out of the 153
such institutions that applied. Four out of 14 business
pre-applications advanced to full applications but none made the
final cut. All of the winning applications were linked to
institutions that have representatives on the CIRM governing board.
Those representatives are not allowed to vote on or take part in
discussion involving applications to their institutions.
grant review group is a scientific score. In last month's round,
scores of approved grants ranged from 88 to 53. However, eight grants
that were ranked above 53 were rejected by the board. One of those
higher-ranking applications came from San Diego's Eclipse
Therapeutics, which scored 58. The low-ranking grants were approved
for what CIRM describes as "programmatic" reasons.
California Stem Cell Report asked CIRM for figures on the
numbers of applications in the translational round, including those
for business. CIRM said the figures had not been compiled and would
not be available until after the awards were made on May 24. The
numbers were finally supplied yesterday.
their breakdown, is basic information that should be part of board's
decision-making process. The statistics should be routinely available
well in advance of the board's meeting. Indeed, the agency in its
earlier days used to routinely publish the figures. It may be now
that generating them is more time-consuming than necessary. The
recent performance evaluation of the agency said CIRM needs to make
major improvements in how it handles critical information needed for
its top management and board.
track record with business, the agency's directors should diligently
track industry's success rate on applications. If proposals ranked as
low as 53 are approved while higher ranking applications from
business are bypassed, it warrants more than cursory examination.
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June 10th, 2012
‘Ugly’ Stem Cell Headlines and a Stem Cell Essay Contest
By Dr. Matthew Watson
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June 10th, 2012
Two California Stem Cell Agency Directors Plump for Proposition 29
By Dr. Matthew Watson
Two directors of the $3 billion
California stem cell agency have popped up in the battle over the
anti-tobacco initiative on tomorrow's ballot in the Golden State.
Kristiina Vuori, who were the subjects of a column by Michael
Hiltzik of the Los Angeles Times dealing with Proposition
29, the "Son of CIRM" measure that would raise
$800 million for research by increasing the price of cigarettes by $1
a pack. In addition to serving on the CIRM board, Lansing heads her
own anti-cancer foundation and is chair of the board of the UC
regents. Vuori is head of the Sanford-Burnham Institute in La
Jolla.
measure that created the stem cell agency. The organization established by Proposition 29 would also be governed by a board that is run by
representatives of organizations almost certain to receive the bulk
of the funding, as is the case with CIRM.
Vuori said the Times and Hiltzik had fallen for "a smokescreen"
put up by tobacco companies which are spending something in the
neighborhood of $40 million to defeat the initiative. Lansing and
Vuori said the measure is needed to stop smoking by young people as
well as providing cash for research for tobacco-related diseases.
Young people are more sensitive to price increases of cigarettes than
adults, according to research.
in which Hiltzik opposed the measure because it would divert money
from more immediate state needs, including health and welfare
programs for children, education and the poor. (See here for thecolumn and here, here and here for related items.)
said,
"The...problem with Proposition 29
is its pigeonholing of the money for cancer research rather than for
immediate needs here in California that are absolutely dire. It’s
all well and good to say that cancer research benefits everyone, but
the real question is whether it should be the absolute top priority
for a state that can’t afford to keep its children fed or offer
them medical care in the here and now.
"Lansing and Vuori say the fact
that Prop. 29 'fails to provide funding for schools, roads or
affordable housing' is irrelevant, because it was 'was never intended
to solve these problems.'"In the context of the state’s
needs, this is a rather callous approach to take. Let’s spell out
why, so Lansing and Vuori won’t be so inclined to dismiss these
necessities of life so casually."
government cuts that have meant the loss of health coverage for
400,000 California children, eliminated welfare benefits for 578,000
poor California families and would mean an end to state college
student aid for 72,000 young people from less affluent families.
"That’s just the beginning of
what might be cut because the state needs money—and won’t be able
to lay its hands on the hundreds of millions of dollars that Lansing,
Vuori, and their research colleagues are angling for. They don’t
want voters to be reminded that there are competing demands for the
tobacco money, and they do so by failing to mention that they exist,
and also by presenting the spending on cancer research as the voters’
only choice.
"It’s the only choice because
the promoters of Proposition 29 designed it that way. Advocates of
programs like this love to pass them in via voter initiatives because
they leave no room to measure them against alternative needs."
carried a piece yesterday on Proposition 29 that drew 481 comments.
The article said,
"Organizers argued that the tax would have
less chance of passing if voters thought it would go into the state
coffers, and said that their only goal here was cutting down on
smoking."
of San Francisco and a keen observer of California politics,
predicted voter approval of the measure along with an increase in
cigarette smuggling from adjacent states and the sale of discount
smokes at the 58 Indian casino sites in the state.
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June 10th, 2012
Stem Cell Miracles and Campaign Promises : Thomas-Trounson vs. Hiltzik of the Times
By Dr. Matthew Watson
The Proposition 71 campaign of 2004,
which has filled the coffers of more than 500 researchers and
institutions with $1.4 billion, was the subject today of a discussion
about miracles.
miracles?
by Michael Hiltzik of the Los Angeles Times about the
"Son of CIRM" initiative, Proposition 29, on the June ballot. It
seeks to fund more medical research with $800 million handed out by
an organization patterned after the stem cell agency.
well of the agency and said the 2004 campaign promised miracles.
Thomas, chairman of CIRM, and Alan Trounson, president of
CIRM, said the campaign did not promise "miraculous cures."
on his blog, quoting from TV campaign ads featuring Christopher
Reeve and Michael J. Fox. Hiltzik also wrote,
"Joan Samuelson, a leading
Parkinson's patient advocate, is shown in another ad asserting,
'There are more Americans than I think we can count who are sick
now, or are going to be sick in the future, whose lives will be saved
by Prop. 71.' Shortly after the measure passed, Samuelson was
appointed to the stem cell program's board.
"Do these ads amount to promising
'miracles'? Given that the essence of scientific research is that no
one can predict the outcome, to assert as fact that 'lives will
be saved by Prop. 71' is plainly to promise something downright
extraordinary, if not outright miraculous.
"Yes, this is the language of
advertising, not research, but for Trounson and Thomas to pretend
that the ad campaign somehow promised merely 'good science' and not
specific outcomes, as their letter suggested, is (at least)
miraculously disingenuous."
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June 3rd, 2012
California Stem Cell Agency Fires Back at LA Times Columnist
By Dr. Matthew Watson
The top two leaders of the California
stem cell agency today took strong issue with a column in the Los
Angeles Times that spoke less than favorably about the history and
efforts of the state research enterprise.
Hiltzik mentioned California's $3 billion stem cell effort in a piece
May 27 about Proposition 29 on the June ballot. The "Son of CIRM" initiative,
tailored after the ballot measure that created the stem cell agency
in 2004, would provide $800 million annually for research into
tobacco-related illnesses. The money would be derived from a $1
dollar-a-pack tax on cigarettes.
"Proposition 71(the stem cell
initiative), you may recall, was sold to a gullible public via
candy-coated images of Christopher Reeve walking again
and Michael J. Fox cured of Parkinson's. The
implication was that these miracles would happen if voters approved a
$3-billion bond issue for stem cell research."
of the CIRM board and a Los Angeles bond financier, and CIRM
President Alan Trounson came in the form of a letter to the editor.
The letter was only four paragraphs long and may have been cut prior
to publication, which is common practice for letters to the editor.
We have asked CIRM about whether there is more to the letter. (Following publication of this item, CIRM spokesman Kevin McCormack said the complete text was published by the Times, which has a 150-word limit on letters. The CIRM letter was 148.)
"In his article opposing
Proposition 29, Michael Hiltzik makes a number of misleading
statements about Proposition 71, the voter-approved measure funding
stem-cell research.
"No ads for Proposition 71
promised miraculous cures. They promised good science, and that is
what is being funded, with more than 62 promising therapies for 40
different diseases on their way to clinical trials.
"The stem-cell agency has
conflict-of-interest rules as strict as any government agency. We
undergo state-mandated audits to ensure we follow all rules and
regulations, and the most recent one, completed just this month,
praised the agency for its performance.
"As for being 'an unwieldy
bureaucrac just 6% of the money we get goes to pay for staff; 94%
goes to fund research here in California, creating new jobs,
generating income for the state and, most important, helping find
treatments for deadly diseases."
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June 3rd, 2012
The Market’s Invisible Hand and Its Impact on Stem Cell Research
By Dr. Matthew Watson
agency intensifies its efforts this year to push cures into the
clinic, a Canadian academic is raising a host of serious questions
about the drive towards commercialization in scientific research.
in an article Monday in The Scientist magazine. It was written
by Timothy Caulfield, a Canada Research Chair in Health Law
and Policy, and a professor at the Faculty of Law and School of
Public Health, University of Alberta. He said,
"Commercialization has emerged as
dominant theme in both the advocacy of science and in the grant
writing process. But is this push good for science? What damage
might the market’s invisible hand do to the scientific process?"
played a role in commercial enterprises and that the goal-oriented
research has led to important developments. But he also wrote,
"There are many recent examples of
how commercialization plays out in top-down policy approaches to
science. The UK government recently justified a £220 million
investment in stem cell research on the pledge that it will help
stimulate an economic recovery. A 2009 policy document from
Texas made the optimistic prediction that stem cell research could
produce 230,000 regional jobs and $88 billion in state economic
activity. And President Obama’s 2011 State of the
Union address went so far as to challenge American researchers
to view this moment in time as 'our generation’s Sputnik
moment'—the opportunity to use science and innovation to drive the
economy, create new jobs, and compete with emerging economies, such
as China and India.
"The impact of this
commercialization pressure is still unfolding, but there is a growing
body of research that highlights the potential challenges, including
the possibility that this pressure could reduce collaborative
behavior, thus undermining scientific progress, and contribute to the
premature application of technologies, as may already be
happening in the spheres of stem cells and genetic
research. For example, might the controversial new Texas stem cell
research regulations, which allow the use of experimental adult
stem cell therapies without federal approval, be, at least in part, a
result of the government’s belief in the economic potential of
the field?
"Such pressure may also magnify
the growing tendency of research institutions and the media to hype
the potential near future benefits of research—another phenomenon
that might already be occurring in a number of domains and
could have the effect of creating a public expectation that is
impossible to satisfy.
"Furthermore, how will this trend
conflict with the emerging emphasis on an open approach to
science? A range of national and international policy entities, such
as the Organisation for Economic Co-operation and Development,
suggest 'full and open access to scientific data should be adopted as
the international norm.' Can policy makers have it both ways?
Can we ask researchers to strive to partner with industry and
commercialize their work and share their data and results
freely and as quickly as practical?"
the California stem cell agency is expected to make some hard
financial decisions about where its future spending will be targeted.
Just last week it approved a five-year plan with explicit goals for speeding stem cell research into the marketplace.
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June 3rd, 2012