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Category Archives: Stem Cells

California’s $70 Million ‘Alpha’ Stem Cell Clinic Plan Headed for Approval Next Week

Alpha clinic organizational diagram
Graphic by CIRM
California's stem cell agency next week
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,
The proposal would create five centers
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.
A story in Nature Medicine said that
the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”
The clinics are expected to draw stem
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.
The Alpha clinics are aimed at creation
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.
The plan would fill a “profound gap”
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.”

The Alpha concept was first broached two years ago publicly by
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.
The plan has received little critical
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.”  

Elie Dolgin's July 8 piece in Nature
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.
Dolgin wrote,

“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.”

The question of the size of the demand
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.”

Reimbursement is the industry euphemism
for creating ways to generate profits for stem cell firms.
The proposal said applicants would have
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.”
Also up in the air was whether grant
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.
What is before the CIRM directors July
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.
In addition to the Burlingame meeting
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.
The California Stem Cell Report will
provide live coverage of the entire meeting, filing reports as
warranted based on the Internet audiocast.
Here are excerpts from CIRM's staff
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VhnrrutbBC0/californias-70-million-alpha-stem-cell.html

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Shestack Resignation Letter: Heartfelt and Eloquent

Jon Shestack(l) with J.T. Thomas, chairman of
CIRM, at a 2012 board meeting
California Stem Cell Report photo
Patient advocate Jon Shestack , who
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.
Shestack's appointment came as a result
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/BaaZlqP9Q4s/shestack-resignation-letter-heartfelt.html

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TV News Piece on Pay-for-Eggs Airs in Los Angeles, San Francisco

The California pay-for-eggs legislation
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.
The piece stands out because the
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.
Nannette Miranda, Sacramento bureau
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.
The legislation, AB926 by Susan
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 piece on the bill appeared in
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.”

Campbell continued,

“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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uMnWUVrymr8/tv-news-piece-on-pay-for-eggs-airs-in.html

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Sacramento Mental Health Advocate Appointed to Stem Cell Agency Board

Al Rowlett
Turning Point photo
Sacramento mental health advocate Al
Rowlett has been named to the governing board of the $3 billion
California stem cell agency, it was announced today.
Rowlett replaces Jonathan Shestack on
the 29-member panel. Shestack had served on the board since 2004,
when the agency was created by the Proposition 71 ballot initiative.
Rowlett is chief operating officer of Turning Point Community Programs in Sacramento. He was appointed to
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.
Rowlett is no stranger to public and
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.
CIRM's press release said Rowlett also
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.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/C2aH568yoco/sacramento-mental-health-advocate.html

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Veto Campaign Launched on California Pay-For-Eggs Bill

Opponents of the California
pay-for-eggs bill have kicked off a campaign to urge Gov. Jerry Brown to veto the industry-backed legislation.
The Center for Genetics and Society of
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.
Diane Tober, associate executive
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.”

Also making the same pitch is the
Alliance for Humane Biology, another San Francisco Bay area
organization.
The bill, AB926 by Assemblywoman Susan
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.)
However, stem cell scientists have
complained in past years about the lack of eggs for research,
declaring that women want to be paid.
The measure would not affect the ban on
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/OqoMeSiIO_c/veto-campaign-launched-on-california.html

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“Comfort News” for California’s Stem Cell Research Effort

The California stem cell agency has
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.
The $3 billion agency is
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.
CIRM, as the agency is known, requires
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.
There was enough so that the agency
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.
Another CIRM award winner,
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.
The “comfort news” for CIRM also included Monday's announcement that Capricor, Inc., a private Beverly Hills company benefiting from $27 million from the California stem cell agency, is merging with publicly traded Niles Therapeutic, Inc., of San Mateo. The merger is aimed at providing better access to capital.
And then there was Tuesday's news that a $20 million CIRM disease team award is paying off with the beginning of a clinical trial by Calimmune of Tucson, Az. for an HIV treatment.
All on top of the news in June when bluebird bio of Masschusetts brought in $101 million on its stock offering. Bluebird is the recipient of a $9.4 million CIRM award.
The rosy news comes amid a generally
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.”

Carroll's comments were echoed in a
piece by Peter Winter on Bioworld headlined “Bubbleology and Biotech's Bull Run.”
All of this plays into what some might
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.
Of course, there is always the caveat
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:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g8tqW1ynaMw/comfort-news-for-californias-stem-cell.html

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