California’s $70 Million ‘Alpha’ Stem Cell Clinic Plan Headed for Approval Next Week
By Dr. Matthew Watson
 |
| Alpha clinic organizational diagram Graphic by CIRM |
is likely to approve a $70 million plan to build a taxpayer-financed
chain of “Alpha” stem cell clinics in what could be a major step
towards making California the stem cell capital of the world,
at existing institutions or businesses to be funded at up to $11
million each over five years. Also proposed is a coordination and
information center that would receive $15 million over five years.
the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”
cell projects from the around the world as well as those
funded by the $3 billion California stem cell agency. The proposal
would be one of the largest single research efforts funded by the
agency, formally known as the California Institute for Regenerative
Medicine (CIRM) and use about 10 percent of its remaining cash.
of a sturdy foundation for the stem cell industry in California,
capitalizing on the burgeoning, international lure of stem cell
treatments. Indeed, one of the objectives of the information center
is to divert people from dubious treatments elsewhere.
in quality information about stem cell treatments, according to a CIRM document, which said,
“By providing this resource, the public and potential patients
would be better educated and informed, whether or not they should opt
to enroll in clinical trials or approved treatments at any of the
Alpha clinics.”
CIRM President Alan Trounson, a pioneer in IVF research and the IVF
business. His proposal has received early and heavy
attention on the CIRM website with a video, blog items and a white paper.
attention although a researcher from an institution that could be a
candidate for an Alpha clinic commented harshly in May on the California
Stem Cell Report, calling the proposal “an irresponsible waste”and a “boondoggle for some medical schools.” The researcher, who
asked that he/she not be identified, said,
“CIRM will pay for an unneeded
infrastructure that will be empty space and staff sitting on their
hands 99 percent of the time. Or worse yet, CIRM will pay but
the space will be used for other things, other clinic procedures paid
for by insurance.”
Medicine quoted Mahendra Rao, director of the Center for Regenerative
Medicine at the US National Institutes of Health (NIH), as applauding the concept. However, Rao said he doesn't
anticipate the approach being tried nationally soon.
“Rao regularly asks researchers
hoping to advance promising stem cell therapies whether they require
additional clinical infrastructure. 'So far, what they've told us is
they'll let us know if they need anything more than (the) programs
that we have already established,' he says.”
for Alpha clinics is not addressed in the CIRM concept plan. Also
absent is much discussion of the business aspects of the proposal. It
does mention “corporate sponsors” in passing. In a CIRM blog item
yesterday, Natalie DeWitt, special project director at the agency,
touched on business elements, declaring,
“(The proprosal) will yield better
clinical trial design, accelerated approval of high quality
treatments, and data and know-how to inform regulatory and
reimbursement decisions.”
for creating ways to generate profits for stem cell firms.
to bring substantial support from their own institutions and
“demonstrate the potential to bring in a pipeline of additional
stem cell-based therapeutic trials as well as future funding streams
to sustain the clinic.” Applicants would also be “evaluated in
their ability to create a positive 'brand' that would attract
clinical trials.”
reviewers, all of whom come from out-of-state, would have special
expertise to evaluate the business aspects of each applicant's
proposal along with their business track record.
25 at their meeting in Burlingame, Ca., is a request for approval of the concept, which
would be fleshed out for the RFA. The governing board almost always
approves staff concepts, although they may modify them slightly. A
number of directors come from institutions that are likely to be
applicants in the program. They can participate in voting on the
concept plan but would be barred from voting on any applications that
come in later. The two RFAs could go out as early as October with
approval of funding of applications one year from now.
site, members of the public can participate from two teleconference
locations in the Los Angeles area. The specific locations can be
found on the meeting agenda.
provide live coverage of the entire meeting, filing reports as
warranted based on the Internet audiocast.
document on the plan.
“To accelerate therapeutic
development and delivery of stem cell therapies, CIRM proposes
establishing the CIRM Alpha Stem Cell Clinics Network (CASC Network).
The network will be designed to support projects emanating from
CIRM’s funding pipeline, as well as scientifically outstanding stem
cell products being developed worldwide and brought to California.
Conceptually, the CASC Network is intended to be a sustainable
infrastructure designed to support academic- and industry-initiated
clinical trials, and delivery of therapies proven safe and
effective.”“The major thrusts (of the overall
plan) will be:
• Development of clinical capacity
and associated resources designed to support the effective
implementation and execution of clinical trials and delivery of
registered stem cell therapies
• Compilation of data and
information concerning clinical trial experience and therapy outcomes
to further inform the research, regulatory, and general community
about the status of investigational stem cell interventions and
long-term outcomes
• Dissemination of information to
the public and counseling of patients and potential trial subjects
about therapeutic options and clinical trials involving stem cells in
the network and elsewhere.”
“The long-term vision is for the
Alpha Clinics to expand and accommodate a broad array of stem
cell-based clinical trials, where the trial meets the scientific,
clinical trial design and ethical standards set forth by the Alpha
Clinics Network, as well as FDA approved treatments.”The coordinating and information center
would be expected to :
“Build relationships with
Accountable Care Organizations, and participate in initiatives for
informing coverage and payment decisions
“Design strategies to attract
investors and philanthropists to CASC network
“Create business plans, and marketing
and branding strategies for financial sustainability of the Alpha
Clinics Sites and (the coordination/information center)”.
Source:
Stem Cell Therapy
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July 21st, 2013
TV News Piece on Pay-for-Eggs Airs in Los Angeles, San Francisco
By Dr. Matthew Watson
yesterday picked up some mainstream media coverage, including a
two-minute, 24-second segment on two major television stations in Los
Angeles and San Francisco.
mainstream media has largely ignored the bill, with a couple of
exceptions. The piece is also exceptional because it appeared on TV
news, which reaches many more people than print media.
chief for KABC-TV in Los
Angeles, KGTV in
San Diego, KGO-TV in San
Francisco and KFSN-TV in Fresno, prepared the segment, which included on-camera interviews with both
supporters and opponents. The video appeared on KGO and KABC
and may well appear later on the other stations. It can be seen at
the end of this item.
Bonilla, D-Concord, would remove the ban in California on paying
women for their eggs for stem cell and other scientific research.
Women can already be paid for their eggs for fertility purposes.
another mainstream media outlet this morning, the San Diego U-T.
Writing in an op-ed column, Leah Campbell said she sold her eggs at
age 25 and has since become infertile as the result of problems her
doctors believe involved the process of providing the eggs.
“Six months (after providing the
eggs) my body began to fail me. I had always been a healthy and
active woman, but suddenly I was crippled by pain and unable to live
the life I had once enjoyed. I was soon diagnosed with stage IV
endometriosis, a disease my doctors now believe was pushed into
overdrive as a result of the potent hormones involved in my egg
donation protocols.”
“AB 926 may open the doors for
increased fertility research, but the potential costs for women’s
lives and health far outweigh any compensation that could ever be
offered.”
Source:Stem Cell Therapy
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July 14th, 2013
Shestack Resignation Letter: Heartfelt and Eloquent
By Dr. Matthew Watson
 |
| Jon Shestack(l) with J.T. Thomas, chairman of CIRM, at a 2012 board meeting California Stem Cell Report photo |
resigned this week as a director of the
California stem cell agency, was on board on Day One in December 2004
when the agency's work began with no offices, no desks, no chairs, no phones and
no ability to even write checks.
of his work in the autism community. He and his wife, Portia Iversen,
founded Cure Autism Now in 1995. A Hollywood film producer, Shestack
rattled cages at CIRM from time to time during his eight years of
service. And earlier this week, he wrote a heartfelt, eloquent
resignation letter, which he provided to the California Stem Cell
Report. The full text can be found below. Here are some excerpts.
“Over eight years there were moments
that were inspiring, some were contentious, and there was a bruising
number of meetings but through it all, the board was involved,
passionate and, will forever be for me, the gold standard when it
comes to integrity.
“The same goes double for the staff –
truly the most excellent, devoted, committed group of people I
have ever had the pleasure of working with.”
“When I started at CIRM, my sweet son
with autism was 12. Now he is 21. Over eight years our family has
learned more about how many are the challenges that await him and how
few the opportunities he has to look forward to. We have seen his
world get smaller and smaller. While my son is special to me. He is
not unique. There are thousands and thousands affected by mental
illness who need a better life.
“Sometimes feel that I have failed
these people, in particular those affected by autism or cerebral
palsy. Though CIRM ran first-rate workshops on these disorders, we
did not do all we could to follow up, put out disease-specific RFAs
and get in proposals that addressed the workshop recommendations. I
wish I had been more persuasive."
“In the movies, the third act is
where the hero takes stock of all the previous wins and losses, all
the hardships and lessons learned, and she puts all that knowledge
together in new, and surprising ways until victory is within reach!
As CIRM enters its third act, I hope it will do the same. I hope it
will challenge itself, always put the urgency of the mission
ahead of everything else and be willing to question the policies that
have been so successful in the past, and consider that new ones may
be needed for the future.
“And this is the future as I see it
for CIRM. We will have faith, but we will continue to earn our
miracles We will use our hearts and our minds to rip those miracles
out of the dreamy future and make them real today. We will seek out
the best scientists and encourage them to use all their wisdom, art
and discernment to bring us cures. And when we have done that, we
will do it again the next day. We will be optimistic, but not
satisfied. We will question authority, despise complacency and above
all love those among us in need of healing--this is the obligation
without end, whose reward is also without end.”
Source:Stem Cell Therapy
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July 14th, 2013
Veto Campaign Launched on California Pay-For-Eggs Bill
By Dr. Matthew Watson
pay-for-eggs bill have kicked off a campaign to urge Gov. Jerry Brown to veto the industry-backed legislation.
Berkeley yesterday posted a pitch on its website urging readers to
contact the governor's office by email, fax, phone or letter. The
target is a bill that would remove the ban in California on paying
women for their eggs for stem cell and other scientific research.
Women can already be paid for their eggs for fertility purposes.
director of the center, wrote,
“If you agree that more research on
short- and long-term risks is needed before expanding the market for
women’s eggs, please act quickly. Contact Governor Brown and ask
him to veto AB926.”
Alliance for Humane Biology, another San Francisco Bay area
organization.
Bonilla, D-Concord, has literally been cloaked in motherhood/reproductive issues. The measure has easily swept through the legislature and is now on its
way to the governor. The bill is sponsored by the AssociationFew if any stem cell or other research
organizations have been heard from during hearings on the bill. (For
more information, see here, here and here.)
complained in past years about the lack of eggs for research,
declaring that women want to be paid.
compensation for eggs in research funded by the $3 billion California
stem cell agency. However, the agency on July 24 will consider providing exceptions for stem cell lines derived from eggs that
involve compensation for women.
Source:Stem Cell Therapy
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July 14th, 2013
Sacramento Mental Health Advocate Appointed to Stem Cell Agency Board
By Dr. Matthew Watson
 |
| Al Rowlett Turning Point photo |
Rowlett has been named to the governing board of the $3 billion
California stem cell agency, it was announced today.
the 29-member panel. Shestack had served on the board since 2004,
when the agency was created by the Proposition 71 ballot initiative.
the CIRM board by California Assembly Speaker John Perez, D-Los
Angeles. Rowlett will fill one of the 10 patient advocate slots on
the board. He will be only African-American on the panel. The board
had also included one African-American, Ted Love, from 2004 to April
2012, when Love resigned.
governmental service. He is in his second term as a member of the Elk
Grove school board, the fifth largest school district in California.
He has worked for Turning Point since 1981.
serves on several other boards including Child Abuse Prevention
Center, California Institute of Mental Health and is a commissioner
for the United States Psychiatric Rehabilitation Association
Certification Program. In 2007, Rowlett won the National Association
of Social Work- California and California State University – Heart
of Social Work Award and the Asian Pacific Community Counseling –
Inspirational Mental Health Leadership Award.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/C2aH568yoco/sacramento-mental-health-advocate.html
Stem Cell Therapy
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July 14th, 2013
California Stem Cell Merger: Capricor and Niles Therapeutics
By Dr. Matthew Watson
benefiting from $27 million from the California stem cell agency,
this week announced that it is merging with Niles Therapeutic, Inc.,
of San Mateo.
 |
| Linda Marban Capricor photo |
for heart disease have been highlighted (see here and here) by the $3
billion state research agency, which is partially funding a clinical
trial for the firm. The firm sprang from work by Eduardo Marban of
Cedars-Sinai in Los Angeles, one of Capricor's founders. He received
$6.9 million for his early and current work. Capricor was awarded
$19.8 million more.
the publicly traded Niles announced on Monday that they were merging.
The new company will be known as Capricor Therapeutics, Inc., and will
be based in San Mateo.
with Capricor CEO Linda Marban as the new CEO.
two members from Niles and seven from Capricor, including its
executive chairman, Frank Litvack, who was an unsuccessful candidate for chairman of the stem cell agency board in 2011.
new company “should
have better access to capital, more potential for steady pipeline
development and more risk diversification."
press release said,
“Nile
will issue to Capricor stockholders shares of Nile common stock such
that Capricor stockholders will own approximately 90% of the combined
company's outstanding shares, and Nile stockholders will own
approximately 10%, calculated in each case on a fully-diluted basis
assuming the issuance of shares underlying options and warrants.
Options of Capricor will be assumed by Nile and become options to
acquire stock of Nile.”
"Capricor's
and Nile's product portfolios complement each other well, as our
therapies will address both the underlying causes and debilitating
effects of heart disease. Capricor's CDCs are allogeneic cardiac
derived stem cells that aim to attenuate and potentially improve
damage to the heart that can result in heart failure, while Nile's
cenderitide is intended to treat patients following hospital
discharge from an acute episode of heart failure."
recently. Its 52 week high was $0.20 and the 52-week low was $0.02.
Source:Stem Cell Therapy
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July 14th, 2013
Pay-for-Eggs Legislation: Strange Bedfellows and Existential Questions
By Dr. Matthew Watson
today generated a feature article that said the legislation has
“sparked an unusual lineup of partisans on both sides and resonates
far beyond” the Golden State.
Weekly, a news service specializing in California government and
political coverage, said,
“(C)omplicating the issue is
California’s role as a national leader in stem cell research, the
existential question of who or what constitutes a research subject,
and finally, the fact that compensation for fertility purposes is and
has been legal for years in California.”
(AB926) by Assemblywoman Susan Bonilla, D-Concord, that removes a ban
in California on paying women for eggs for scientific research.
Currently women can be paid in California for providing eggs for IVF.
The measure would not alter a ban on compensation for eggs in
research financed by the $3 billion California stem cell agency.
However, later this month, the agency will consider modifying its position somewhat.
is on its way to Gov. Jerry Brown. The industry association
sponsoring the bill expects the governor to sign it later this month
although the governor, as a general rule, does not make public
commitments on legislation.
and arguments on the bill and noted that it has received little
mainstream media attention.
 |
| Lisa Ikemoto UC Davis photo |
professor and bioethicist at UC Davis, on the sensitive nature of the
issue. Ikemoto said,
“On the fertility side, it’s
politically hard to touch because it’s all around family formation.
Nobody wants to restrict family formation. On the research side, when
the issue of payment for eggs came up, it was connected with human
embryonic stem cell research, and human embryonic stem cell research
was politicized from the outset.”
bedfellows opposing the bill. She said,
“Groups that fundamentally oppose
stem cell research such as the California Catholic Conference and
other pro-life groups are natural opponents of the bill, but they are
joined by a number of pro-choice groups who expressed concerns over
the limited research on the effects of egg donation on women’s
health.”
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/pskHpPceyco/pay-for-eggs-legislation-strange.html
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July 14th, 2013
"Comfort News" for California’s Stem Cell Research Effort
By Dr. Matthew Watson
enjoyed a spate of good financial and scientific news this week from
the biotech industry as the research effort pushes on with its
mission of turning stem cells into cures.
scheduled to make its last grants in less than three years and, given
the glacial pace of medical research, needs all the help it can get
by then to bring a stem cell therapy close to the marketplace – the
promise it made to voters when the agency was created nine years ago.
not only steady scientific progress but also a rosy outlook for the
industry, which has languished in past years as major investors
shunned the field. This week, CIRM garnered good news on both fronts.
even touted it on the agency's research blog in an item by
Neil Littman, CIRM's business development officer. He said it all
helps to leverage CIRM investments and create a favorable investment climate. The good news included yesterday's announcement that
Viacyte, Inc., of San Diego, Ca., has come up with $10.6
million needed to match a $10.1 million, much-ballyhooed award from CIRM last fall. The Viacyte financing
includes important support from Big Pharma, in the form of Johnson &
Johnson. CIRM has pumped a total of $39.4 million into Viacyte.
Cellular Dynamics International, Inc., of Madison, Wisc., yesterday
announced its price on its upcoming stock offering to raise up to $53
million. Cellular Dynamics scored $16 million from the agency last
March.
better outlook for biotech in general. John Carroll, editor of Fierce
Biotech, this week noted that there were only 11 biotech stock offerings last
year. He wrote,
“In the last 6 months, though, the
industry has seen a tremendous rebound, with almost twice that number
of IPOs in half the time. And there's no sign that the great leap
into the public market is waning, with 10 more IPOs in the queue.”
piece by Peter Winter on Bioworld headlined “Bubbleology and Biotech's Bull Run.”
call the “everybody's-doing-it dance" or the “lemming
syndrome,” depending on your point of view. The reality is that
big investors and venture capitalists are timid souls and need the
comfort of companionship-in-risk as they fork over tens or hundreds
of millions of dollars on something that may not pay off for a decade
or more. No one wants to be the out-front pioneer who winds up with
financial arrows in his or her back. Being in a crowd provides an
illusion of safety.
about how markets and investors are fickle. A piece of bad news can
translate quickly into major reversals as Apple has learned over the
last year. Nonetheless, the folks at the stem cell agency have to be feeling good today.
Source:Stem Cell Therapy
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July 14th, 2013
HIV Clinical Trial Hailed by California Stem Cell Agency
By Dr. Matthew Watson
California stem cell agency today scored what it called an “important
milestone” with the announcement of the start of a clinical trial
involving a therapy to help protect persons infected with HIV from
the effects of the virus.
trial is partially funded from a $20 million award from the stem cell
agency, which is known as CIRM, to researchers
at UCLA and Calimmune, a Tucson, Az.,
company. Calimmune's share of the award was $8.2 million.
Trounson, president of the $3 billion state agency, said in a
statement,
“CIRM
funding of this Phase l/ll trial is an important milestone for us.
One of our goals is to support research that moves the most promising
science out of the lab and into clinical trials in people. To be able
to do that with a disease as devastating as HIV/AIDS highlights the
importance of our funding and the potential impact it could have on
the health of people around the world.”
Thetrial was announced by Calimmune this morning. The company said,
first patient has begun treatment in a Phase I/II clinical trial
designed to determine whether a pioneering genetic medicine approach
can help to protect individuals infected with HIV from the effects of
the virus. The study, “Safety
Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1
Infection,”
utilizes a gene medicine called Cal-1, developed in the lab of Nobel
Laureate Dr. David
Baltimore and
by Calimmune.”
served on the CIRM board from 2004 until June 6, 2007. He resigned
from the board about
18 months before the application process began for the grant round
that ultimately funded Calimmune, a company he helped to found. He is currently chairman of the Calimmune board.
for comment, Jeff Sheehy, a member of the CIRM governing
board and communications director for AIDS research at UC San
Francisco, said,
"This
trial will hopefully offer several important insights into the safety
and feasibility of genetically modifying blood forming stem cells in
an HIV patient as a potential therapy. We are very early in
this research, and with this Phase I trial's goal of establishing
safety and the risks involved, I applaud the courage and altruism
demonstrated by the patients who are willing to participate in this
study."
press release said
the principal investigators on the clinical trial are Ron
Mitsayasu of
UCLA and Jacob
P. Lalezari of Quest
Clinical Research of
San Francisco. Quest is currently soliciting patients for the
clinical trial as well as UCLA. (Persons interested in participating
in the trial can find email contacts at
this website.
Twelve are needed.)
principal investigators on the CIRM award are Irvin Chen of
UCLA and Geoff Symonds of Calimmune.
Source:Stem Cell Therapy
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July 14th, 2013
Eggs and Cash: Stem Cell Agency Considering Easing Restrictions on Stem Cell Lines Derived Using Payments
By Dr. Matthew Watson
moving to remove an absolute ban on use of stem cell lines derived
from eggs from women who have been paid to provide them.
is headed for Gov. Jerry Brown's desk that would permit payments for
eggs to be used in research that is not funded by the agency. The measure (AB926) would not alter the separate ban on egg payments
involving research funded by the $3 billion stem cell agency.
approve the use of stem cell lines derived as a result of payment to
women. Board action would be based on whether stem cell lines would
“advance CIRM's mission” and would follow a staff evaluation
involving scientific and ethical issues.
researchers around the country have reported that they are not able
to obtain sufficient eggs without payment. And earlier this year,
paid egg providers were used in research in Oregon that cloned human stem cells, a feat that researchers have struggled with for years.
Oregon research has “generated scientific interest among CIRM
grantees and the desire to utilize derived SCNT lines. CIRM’s
current policy prohibits the use of the (Oregon) SCNT lines because
oocyte donors were financially compensated. CIRM requests the Medical
and Ethical Standards Working Group (SWG) revaluate this prohibition
with regard to CIRM grantees ability to utilize the resulting lines
in light of recent scientific and policy developments.”
Report queried the agency concerning earlier, sketchy information onthe CIRM blog about a possible change in its compensation rules. We
asked whether the agency was considering “sidestepping” the ban
on compensation. Kevin McCormack, a CIRM spokesman, said, “No, not
at all.” He said it would be premature to elaborate until a firm
proposal was ready.
July 24 said,
“Proposition 71’s 'prohibition on
compensation' compels the ICOC(the agency's governing board) to adopt
standards 'prohibiting compensation to research donors.' This
requirement has been consistently interpreted to prohibit the use of
CIRM funds to financially compensate oocyte (or other cell or tissue)
donors. In 2006, this interpretation was extended to exclude from
use, in CIRM-funded research, any stem cell line where research
donors were financially compensated, even if the derivation was done
without the use of CIRM funds. Proposition 71, however, does not
compel the ICOC (the agency's governing board) to prohibit the use of
stem cell lines where financial compensation is provided to the
oocyte donors, provided that CIRM funds are not used to compensate
the donors or derive the lines.”
Francisco. No remote teleconference locations have been announced. If approved, the changes would likely be considered July 25 by the full agency board.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/BF3kpSRnKXQ/eggs-and-cash-stem-cell-agency.html
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July 14th, 2013
California Legislation Removing Ban on Payments for Eggs for Research Heads to Governor
By Dr. Matthew Watson
California to be paid for their eggs for scientific research is on
its way to Gov. Jerry Brown following final legislative approval last
week.
fertility industry organization, expect the governor later this month
to sign the measure, which would go into effect next year.
Susan Bonilla, D-Concord, would repeal a ban on payments to women who
provide eggs for scientific research. However, the measure would not
affect the ban on payments to egg providers in research funded by the
$3 billion California stem cell agency. That ban is covered by a
separate legal provision. Stem cell researchers around the country have complained that they they cannot get eggs without payment.
providing eggs for reproductive purposes. According to a legislative analysis, payments can run as high as $50,000 for women with special
characteristics but average around $9,000 for each session, which can
generate more than one egg.
American Society for Reproductive Medicine of Alabama, whose members
represent a wide swath of the $5 billion-a-year fertility business.
The measure would open new business avenues for the industry.
research and would encourage more research into reproductive health issues.
egg production procedures has not been well-established including
their long-term impact. They also argue that allowing payment would
lead to exploitation of poor and minority women.
legislative approval on July 1 when the Senate passed it on a 24-9
vote.
Source:Stem Cell Therapy
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July 14th, 2013
California Legislation, Human Egg Sales and Profits
By Dr. Matthew Watson
California legislation to allow women
to be paid for their eggs for scientific research is sailing toward
final passage literally swaddled in motherhood and apple pie
arguments. Missing from the debate is a key reason behind
the bill – building profits for what some call the “baby
business.”
The legislation is touted as providing
equal treatment for women, permitting them to be paid for supplying
eggs for stem cell and other research, much as men are paid for
sperm. It also would put women who sell their eggs for research on an
equal economic footing with women who sell their eggs for fertility
treatments, which is currently permitted under state law. Payments to
those women range from an average of $9,000 to as much as $50,000,
according to a legislative analysis of the bill.
Assemblywoman Susan Bonillla,
D-Concord, author of the bill(AB926), says,
“It is time to let women, just as any
other research subject, make an informed decision as to
participation, and justly compensate them for doing so.”
has had serious impact on fertility research. In a legislative bill analysis, she says,
“It has led to a de facto prohibition
on women’s reproductive research in California, adversely
impacting the same women that the ban intended to protect. With few
oocytes donated, fertility research and fertility preservation
research has been at a standstill. This greatly affects women
suffering from fertility issues and women facing cancer who would
like to preserve their oocytes.”
behalf of an industry group, the American Society for Reproductive Medicine of Alabama. The fertility or baby business, which is largely
unregulated, brings in about $5 billion annually in the United
States from something like 500 clinics. It has grown rapidly over the
last couple of decades, but is likely heading for a soft spot.
on the Internet discussing the industry's economic challenges.
However, demographic studies show that the size of the key market
for fertility services is stagnating. A 2012 report by the federal
government projects that the number of women in the 35 to 44 age
group, prime consumers of fertility services, is likely to grow only
0.5 percent from 2010 to 2020. And since that forecast was made, the
Census Bureau has downgraded its projections for total population
growth.
a new, potential revenue stream for the industry. Fertility clinics
would be able to buy the eggs and then resell them to researchers,
adding premiums for eggs from women with special characteristics. The bill would also add a tool for bringing down the cost of fertility
treatments, which can run as much as $12,000 to $17,000 a round or
more and require several rounds, according to the NIH. Clinics could discount those prices for some women, bringing in
new customers, if they agree to authorize the use of excess eggs for
scientific research.
pernicious. What is pernicious is the absence of discussion of the
economics of the legislation. Without a full understanding of all
that is at stake, including economic issues and motivations,
legislators, the governor and the public are hard-pressed to make
good decisions about a significant change in California law.
raised serious questions about the treatment of women by fertility
clinics, noting that the bill would turn egg providers into “vendors”
– not patients of the clinics. The Center for Genetics and Society
in Berkeley has captured the arguments in opposition including
testimony before a Senate committee hearing early in June.
lost a 31-year-old daughter to cancer seven years after the younger
woman sold her eggs three times, told lawmakers,
“Unlike infertile women who are
considered patients, egg donors are treated as vendors( (her italics).
When they walk out of the IVF clinic, no one keeps track of them.
My daughter’s death was not reported. The long-term risks of egg
donation are unknown."
now a physician with a Ph.D. in biology, testified that she wound up
in an intensive care unit after 60 eggs were extracted from her in
2001. She said,
“I fear that cases like mine are
buried deep by fertility centers concerned about their image. An
industry thriving on profits and reputation has little incentive to
report adverse events, or protect the health and medical rights of
donors.”
cell agency on all this? The agency has not taken a position on the
bill nor have any major research organizations. The measure does not
change the law affecting agency-funded research, which bans the use of
compensation for eggs in its research. Enactment of the law, however, would
create a two-tier stem cell research standard in California, one for
scientists not constrained by the payment ban and another for those
who could use the full range of research tools. Some stem cell
researchers may well think that they have become disadvantaged as a
result.
(Editor's note: An earlier version of this article said the IVF business generated $4 billion in revenues annually. More recent estimates place it at $5 billion.)
Source:Stem Cell Therapy
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July 7th, 2013
Challenge to WARF hESC Patents Cites Recent U.S. Supreme Court Decision
By Dr. Matthew Watson
are being challenged in a new legal filing that cites the recent U.S.
Supreme Court decision that barred the patenting of human genes.
Wisconsin Alumni Research Foundation (WARF), which holds the patents on the
much-heralded work performed by Jamie Thomson at the University of Wisconsin. The lawsuit was filed
by the Public Patent Foundation of New York City on behalf of
Consumer Watchdog, a nonprofit group in Santa Monica, Ca. Jeanne
Loring, director of the Center for Regenerative Medicine at the
Scripps Research Institute, is also involved along with Alan
Trounson, president of the California stem cell agency. The agency
itself is not a party.
so-called Myriad decision last month by the nation's highest court which said,
“Myriad did not create anything. To
be sure, it found an important and useful gene, but separating that
gene from its surrounding genetic material is not an act of
invention.”
"WARF did not create or alter the
properties inherent in stem cells any more than Myriad created or
altered the genetic information encoded in the DNA it claimed.”
an earlier decision by the U.S. Patent Office. The Public Patent
Foundation, which was a successful party in the Myriad case, did the earlier legal work on the challenge to the WARF patents as well as this
week's appeal.
said the WARF patents have "put a severe burden on taxpayer-funded
research in California.”
“We don't want to do anything that
gets in the way of finding treatments for some of the biggest killers
today, so we feel that all patients with all kinds of diseases
deserve to have access to these kinds of cells.”
"Human embryonic stem cells hold
great promise for advancing human health, and no one has the ethical
right to own them.”
said,
“The best course if WARF truly
cares about scientific advancement would be to
simply abandon these over-reaching patent claims.”
Diego U-T cited intellectual property attorney Lisa Haile of DLA
Piper as saying,
“A successful use of the Myriad case
as a precedent for throwing out the foundation’s patent would open
the door to similar challenges in just about any biotech product
using material derived from life.”
WARF made no immediate comment.
appeared in the Milwaukee Journal, Genomeweb and the LaCross Tribune.
Source:Stem Cell Therapy
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July 7th, 2013
Cost of a Stem Cell Therapy? An Estimated $512,000
By Dr. Matthew Watson
and cures receive almost no attention in the media as well as
publicly from scientists and the biotech firms.
obliquely framed in the context of “reimbursement,” as if
industry is owed something instead of making a business decision
about what will make a profit. Euphemisms and jargon cloak unpleasant realities such as astronomical patient costs. But what reimbursement really involves are, in fact, pricing decisions and profit margins along with
lobbying campaigns for inclusion of
therapies in normal coverage of health insurance and Medicare.
for one stem cell treatment – appeared in the Wall Street
Journal . The story by Kosaku Narioka and Phred Dvorak dealt
with what would be the first-ever human study of a treatment that
uses reprogrammed adult stem cells.
preliminary approval on Wednesday from a key panel of the Japan
Health Ministry. The treatment involves a form of age-related macular
degeneration, which has also been targeted by the California stem
cell agency with different approaches.
article, with little other discussion, was this sentence:
“One eventual obstacle, even if tests
go well, could be cost: (Masayuki) Yamato (of Tokyo Women's Medical
University) says initial estimates for the treatment run around ¥50
million ($512,000) per person."
cell treatments has rattled around in the background for years
without much deep public discussion. One reason is that high costs of
treatments are controversial and can trigger emotional debate.
Another reason is that it is very early in the therapy development
process and estimates are not likely to be entirely reliable.
cell agency commissioned a study involving costs of stem cell therapies. The UC Berkeley report said,
“The cost impact of the therapy is
likely to be high, because of a therapy’s high cost per patient,
and the potentially large number of individuals who might benefit
from the therapy. This expense would put additional stress on
the Medicare and Medicaid budgets, cause private
insurance health premiums to increase, and create an incentive for
private plans to avoid covering individuals eligible for a therapy.”
welcomed. The agency sat on the 2009 study for seven months until it
was uncovered by the California Stem Cell Report in April 2010. Then
the agency was careful to say that the study did not reflect the view
of CIRM management or board leadership.
to both patient accessibility and therapy development. If companies
cannot make a profit on a possible therapy, it is virtually certain
not to appear in the marketplace.
background, it does not mean there is a lack of interest. The copy of
the Berkeley stem cell cost study that was posted online by the California
Stem Cell Report has been read 11,701 times since it was made
available in April 2010 on scribd.com.
Source:Stem Cell Therapy
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June 30th, 2013
Bluebird and Banking: Media Pluses for California Stem Cell Agency
By Dr. Matthew Watson
a couple of favorable publicity points last week as the result of a
successful stock offering by an award recipient and another piece
about creation of a stem cell bank in Northern California.
preferred spelling) of Massachusetts was a big winner for the
company, raising millions of dollars more than anticipated.
“Shares of the Cambridge life
sciences company bluebird bio Inc. soared almost 60 percent on their
first day of trading (last) Wednesday, an impressive debut for a
business that endured years of stagnation and another encouraging
sign for the biotechnology industry.
“The local gene therapy company
raised $101 million in an initial public offering priced at $17 per
share, higher than the $14 to $16 estimated by investment bankers.
Bluebird shares closed at $26.91 per share on Wednesday.”
a share at the time of this writing, which is good news generally for
the biotech industry.
award last fall from the $3 billion stem cell agency. The company has yet to receive any actual cash from the agency as both parties work
out final details of an agreement, a spokesman for the agency said
last week.
successful IPO in a blog item by that said,
“Bluebird Bio, one of the oldest
companies in the struggling gene therapy field, is having an
outstanding first day in the stock market today, and largely by
marrying its gene therapy technology with stem cell science. The
company’s financial milestone brings hope and excitement to both
fields.”
failed to mention the stem cell agency's involvement, which would
have been nice for the agency but was to be expected given the way
news is covered.
appeared on Xconomy, an Internet news service dealing with
technology. Written by Bernadette Tansey, a former San Francisco
Chronicle reporter, the piece dealt with the both business and science of stem cell banking. She wrote,
“One of the main goals of
California’s $3 billion stem cell research agency is to draw
companies into the state so they can vie for a share of the funding.
"With a recently funded $32 million
initiative, the California
Institute for Regenerative Medicine(CIRM) has attracted two of
the biggest US players in stem cell banking to Novato, CA, to form
one of the largest biobanks of induced pluripotent stem cells (iPS
cells) in the world.”
minor staple in recent news coverage of CIRM, surfacing in a number
of articles since the awards were approved. One of the reasons for that is that the project has a relatively straight-forward story line compared to many research efforts and the concept of "banking" is familiar to editors, writers and readers.
Source:Stem Cell Therapy
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June 30th, 2013
International team submits IND application
By Dr. Matthew Watson
On 18 June 2013, there was an announcement at the Princess Margaret Cancer Centre, Toronto. There was also a post on the California stem cell agency blog entitled: Clinical trial to thwart cancer stem cells may begin soon. An excerpt from the post:
The Prince Margaret Center announced the FDA filing, called an Investigational New Drug application (IND), at an event in Toronto recognizing the private donors. A press release about the announcement was picked up at this biotech news site.
The Principal Investigators present for the announcement were Dr. Tak Mak of the Princess Margaret Cancer Centre and Dr. Dennis Slamon of the University of California, Los Angeles (UCLA). What they have done is summarized in another excerpt from the blog post:
By working first to understand the various proteins that drive cells to divide, particularly in cancer, they were able to pinpoint an enzyme, that if blocked, could be the key to keeping cancer in check. They then discovered that this enzyme, called PLK4, can be derailed by a new drug they developed. In the lab, it has been shown to inhibit the growth of breast, ovarian, colorectal, lung, pancreatic and prostate cancer, as well as melanoma.
Information about the human PLK4 protein is available here.
Some background: In June 2008, it was announced that a partnership had been formed between Canada’s Cancer Stem Cell Consortium (CSCC) and the California Institute for Regenerative Medicine (CIRM) for international collaboration to advance cancer stem cell research. An excerpt from the CSCC's announcement:
It is proposed that one of the first initiatives to be launched by the CSCC will be a collaboration between Canadian and Californian scientists through CIRM's upcoming Disease Team Research Awards Competition, which will support multi-disciplinary teams of scientists in pursuit of therapies for specific diseases.The goal is to fund teams that will develop therapy or diagnostics for a particular disease or serious injury.Successful proposals will likely include a description of a path to an Investigational New Drug filing at the end of the four-to-five year grant.
Note the intent to file an IND by the end of the term of the grant.
The results of the Disease Team Research Awards Competition were announced on October 28, 2009. The award to Drs. Slamon and Mak is Grant number DR1-01477. See: Therapeutic Opportunities to Target Tumor Initiating Cells in Solid Tumors. As was stated in a page about Cancer Stem Cells on the website of the Canadian Institutes for Health Research (CIHR), this award was to one of two multi-disciplinary research teams co-led by Canadian and Californian scientists. The other team is co-led by Dr. John Dick of the University Health Network and Dr. Dennis Carson of the University of California, San Diego. My blog post (October 29, 2009) about the awards is entitled: Disease Team awards announced. The post ends with this Disclosure:
I'm a member of the Board of the CSCC, but also a staff member (emeritus) at the University Health Network. So, I was in conflict of interest, and was absent during all of the discussions, by the CSCC Board, about which Canadian applications should be considered for the Disease Team awards.
Source:
http://cancerstemcellnews.blogspot.com/2013/06/international-team-submits-ind.html
Pay-For-Eggs Legislation Draws More Media Attention
By Dr. Matthew Watson
to be paid for their eggs for scientific research generated several news articles this week as the measure neared final legislative
approval.
but did not amount to major attention from the mainstream media. And,
with one exception, the articles failed to report that the
legislation did not apply to research funded by the $3 billion
California stem cell agency, which bans compensation for egg
providers.
state Senate floor with a vote possibly coming as early as next
Thursday. A spokesman for the American Society for Reproductive
Medicine in Birmingham, Ala., an industry group sponsoring the bill,
said unequivocally that the Gov. Jerry Brown is expected to sign the
measure. (See the Senate floor bill analysis here and a press release on the bill here.)
 |
| Assemblywoman Susan Bonilla Photo Source -- Bonilla's office |
Assemblywoman Susan Bonilla, D-Concord, have appeared in the journal
Nature, the San Francisco Chronicle and the Huffington Post over the
past few days.
advocate writing on the Huffington Post, yesterday remarked that
women egg providers should be treated the same as men involved in
scientific experiments.
“After all, aren't we past the days
when we treat women like they are less capable than men of making
sound decisions for their own well-being? It's my body and my choice
if I want to donate a dozen of my eggs to science. Who knows -- maybe
it's my egg that will be used to find a cure for cancer.”
Chronicle on Sunday, said,
“That sperm-egg parity argument is so
bogus. When men donate sperm, they risk second thoughts about
unknown, random offspring, but they do not risk serious medical side
effects. Egg donation, on the other hand, can be hazardous to your
health. The New York Times reports, "Egg donors can suffer
serious side effects from the powerful hormones needed to generate
multiple eggs." And: "The most significant risk is ovarian
hyper-stimulation syndrome, which can cause bloating, abdominal pain
and, rarely, blood clots, kidney failure and other life-threatening
ailments."
on Tuesday, said,
“In practical terms, the bill would
bump up payments from hundreds to thousands of dollars. In Oregon —
which, like most states, does not have regulations governing egg
donation — women recently received $3,000–7,000 each for eggs
used in a study that created stem-cell
lines from cloned human embryos.”
come up for a vote during today's Senate floor session but could come
up next Thursday.
Source:Stem Cell Therapy
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June 23rd, 2013
Compensation for Human Eggs Approved by Key California Senate Committee, But Not For CIRM Researchers
By Dr. Matthew Watson
California to be paid for their eggs for scientific research
yesterday cleared a key state Senate committee and is likely headed
for the governor's desk.
Bonilla, D-Concord, was approved on a 6-1 vote by the Senate Health
Committee and now goes to the Senate floor. Earlier, it passed the
Assembly on a 54-20 vote.
scientists have chafed under state restrictions that bar compensation
for eggs while that the same time fertility clinics are paying an average of $9,000 a session for eggs, with some prices going as high as $50,000.
affect researchers using grants from the $3 billion California stem
cell agency. The agency's regulations bar compensation for eggs in
the research that it funds. That means that at least a two-tiered
research system would exist in California not to mention another tier
created by federal regulations that differ from both those of the
stem cell agency and those set by the legislation.
Proposition 71, which created the agency in 2004, and cannot be
changed without a 70 percent vote of the legislature. Bonilla's bill
requires only a majority vote.
American Society for Reproductive Medicine, the chief industry
group for the largely unregulated fertility industry.
committee session summarized Bonilla's arguments for the measure in
this fashion:
“This bill seeks to create equity in
the field of medical research compensation by removing the
prohibition on compensation for women participating in oocyte (egg)
donation for medical research. All other research subjects are
compensated for their time, trouble, and inconvenience involved in
participating in research. AB 926 ensures that women are treated
equally to all other research subjects - allowing them to actively
evaluate their participation in research studies. Unfortunately, the
ban on compensation has had serious unintended consequences. It has
led to a de facto prohibition on women’s reproductive research in
California, adversely impacting the same women that the ban intended
to protect. With few oocytes donated, fertility research and
fertility preservation research has been at a standstill. This
greatly affects women suffering from fertility issues and women
facing cancer who would like to preserve their oocytes.”
to the bill including the Center for Genetics and Society in Berkeley
and the Catholic Church. The bill analysis summarized some of the
opposition arguments in this fashion:
“Egg harvesting exposes healthy young
women to multiple synthetic hormones in order to produce many times
the normal number of eggs per cycle. One of the potential harms is
OHSS, which has resulted in hospitalizations and at least a few
documented deaths. These groups state that many experts remain
concerned about the long-term risks of these drugs, especially
their potential impact on infertility and various cancers.
Follow-up research on egg providers, which could establish the
frequency and severity of these adverse outcomes, is widely
recognized to be grossly inadequate.”
objections, opponents also argue that poor and minority women are
likely to be exploited by enterprises seeking their eggs to resell at
a profit.
organizations, including the California stem cell agency, have taken
a position on the bill. The legislation has received little public
attention, although The Sacramento Bee carried an article last March.
Ruha Benjamin, author of "People's Science" and assistant professor at Boston
University, also wrote about the measure in April on the Huffington
Post. Benjamin said,
Thompson compares egg
donation to 'other kinds of physically demanding service work,'
arguing for a 'salary negotiation between the state agency (or
relevant employer) and the donor.' This, she contends, is a 'sensible
and dignified recognition of [the donor's] work, time, and effort.'
And instead of refusing compensation to women, Thompson suggests that
we 'direct our efforts to understanding and minimizing' the risks.
redouble our efforts, because the market in eggs appears to be
expanding from private reproduction to public research, and
increasingly overseas, if the surrogacy
industry is any indication of how 'cheaper' women become a
reserve army of bio-labor in less regulated regions.”
Source:Stem Cell Therapy
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June 16th, 2013
Merksamer Makes Only Bid For Stem Cell Agency Lobbying Contract
By Dr. Matthew Watson
is interested in working for the California stem cell agency – at
least interested enough to put in a bid.
function of the small size of the contract – $65,000 – and the
entrenched nature of CIRM's existing lobbyist – Nielsen, Merksamer,
Parrinello, Gross & Leoni LLP – one of the state Capitol's
larger lobbying firms with $5 million in billings last year.
connection to the $3 billion agency in its 21-page proposal in
response to a CIRM RFA this spring. The firm has been with CIRM since
2005.
a couple of other interesting aspects of the continuing arrangement.
CIRM will run out of money for new grants in 2017, and Nielsen
Merkasamer said,
“Furthermore, as a premier
legislative advocacy and (Nielsen's italics) ballot measure
law ?rm, Nielsen Merksamer can actively and effectively assist CIRM
as it contemplates returning to the voters for additional funding.”
conceal information that normally would be public record. The firm
said,
“Another unique advantage offered by
Nielsen Merksamer is that, unlike the vast majority of lobbying ?rms,
since we are a full-service law ?rm, our relationships with our
clients are subject to the attorney-client privilege.”
“(N)o one understands CIRM’s 'total
picture' better than Nielsen Merksamer. Not only has Nielsen
Merksamer been representing CIRM before the Legislature for the past
decade, but Nielsen Merksamer was also one of the principal drafters
of the aforementioned Proposition 71—which brought CIRM to life.
The depth of Nielsen Merksamer’s familiarity with, and
understanding of, CIRM’s mission and structure, the challenges it
faces, and the promise it holds simply cannot be matched by any other
legislative advocate.”
$65,000 offered by CIRM but would charge only $49,200 annually, about the same as
it has been paid for several years. Steve Merksamer and Gene Erbin,
who drafted portions of Proposition 71, would handle most of CIRM's
affairs. John Moffatt and Missy Johnson would also be available.
instances where it successfully killed legislation opposed by CIRM.
You can read about them in their proposal below.
Source:Stem Cell Therapy
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June 16th, 2013
Cellular Dynamics: California Stem Cell Agency Recipient Plans $57 Million IPO
By Dr. Matthew Watson
beneficiary of more than $16 million from the California stem cell
agency today announced that it intends to go public to raise $57.3
million for its iPS cell ventures.
 |
| Jamie Thomson UCSB photo |
International, Inc., and was co-founded by internationally known stem
cell scientist Jamie Thomson of the University of Wisconsin, who is
currently the company's chief scientific officer. Thomson is also a professor
at UC Santa Barbara, where he is co-director of the Center for Stem
Cell Biology and Engineering.
agency awarded a $16 million grant to Cellular Dynamics to derive
three iPS cell lines from 3,000 individuals as part of the agency's
stem cell banking initiative. (Here is a link to the grant review summary.)
filings that it also will be the prime subcontractor on a $10 million
grant that the Coriell Institute for Medical Research of Camden,
N.J., received in the agency's stem cell banking round. Cellular Dynamics said
some of the funds from the IPO will be used to complete its
California laboratory in leased space at the Buck Institute in
Novato, north of San Francisco.
and sold its first commercial product in 2010. It reported revenues
of $6.6 million in 2012 and losses of $22.3 million. It has 115
full-time and part-time employees worldwide.
“During 2011 and 2012, we had three
large biopharmaceutical customers that individually accounted for
greater than 10% of our total revenue in one or both years. Eli Lilly
and Company (Lilly) accounted for 10% of total revenue in 2011 and
18% of total revenue in 2012. Hoffmann-La Roche Inc. (Roche)
accounted for 13% of total revenue in 2011 and GlaxoSmithKline plc
(GSK) accounted for 11% of our total revenue in 2012.”
filings,
“Our total revenue grew from $2.6
million in 2011 to $6.6 million in 2012, an increase of 154%. This
growth was driven by a 247% increase in sales of our iCell products
which grew from $1.5 million in 2011 to $5.2 million in 2012. At
December 31, 2011, our backlog of revenue expected to be recognized
in 2012 was $1.1 million. At December 31, 2012, our backlog of
revenue expected to be recognized in 2013 had grown to $4.1 million.
“For the three months ended March 31,
2013 our total revenue was $2.4 million, an increase of 109% over the
corresponding period in 2012. This growth was driven primarily by an
increase in iCell product sales, which grew from $0.6 million for the
three months ended March 31, 2012 to $1.8 million for the three
months ended March 31, 2013, an increase of 173%.”
Cellular Dynamics and Japanese researcher Shinya Yamanaka, who won the Nobel Prize last year for discovering how to reprogram adult stem cells into pluripotent cells (the iPS process).
"A
recent question is the issue of who has the intellectual property
(IP) rights to iPS cell technology. People have told me in the
past that they wondered if Cellular Dynamics has unambiguous rights
to develop all of these iPS cell-based products."
“This (the IPO) looks to
be very interesting and could transform the field as it develops.”
was light, but is more expected to surface tomorrow. Here is a link to the only story that had surfaced as of this writing.
the offering.
Source:Stem Cell Therapy
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June 9th, 2013