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Archive for the ‘Stem Cells’ Category

Tracking the Fruits of California Stem Cell Agency Research

Sunday, September 1st, 2013
The California stem
cell agency yesterday shed some interesting light on the awards in its $41
million round this week and their pathway to actually producing a product that
can be used to treat persons who are suffering from diseases.

It is a difficult and
long journey to generate usable therapies, a process poorly understood by the
public, which was promised in 2004 that the stem cell agency would produce
cures for ailments afflicting half the population of the state.

Writing on the agency’s blog, Amy Adams, CIRM communications manager, dealt with the issue indirectly.
She said,

“Many scientists who
receive our early translation awards first got their idea for a therapy while
carrying out research with one of our other awards. In fact, eight of the
scientists in this round of funding had previous CIRM funding for an earlier
stage of research. If a scientist's early translation award provides good
results, the scientists are then able to apply for one of our disease team
awards, which fund the effort of compiling data to convince the Food and Drug
Administration
to allow them to test it in people.  Other organizations
fund only early discovery research or only preclinical research. Under those
conditions, researchers continually pause their projects to look for new
sources of funding as the project moves through the phases toward clinical
trial.

One of the virtues of
the California stem cell agency is its promise of a continued stream of
funding. Former Chairman Robert Klein used to tout that particular aspect of
the agency, particularly in light of limited federal resources.

Adams’ comments
implicitly raise important questions concerning CIRM’s entire portfolio. How
many CIRM grants have led to additional funding from CIRM? How many are
basically one-off shots that have not led to research that has advanced the
development of stem cell therapies, either via CIRM or other funding. What is the
therapeutic and scientific significance of the research that is linked by more
than one CIRM award?  What previously
funded CIRM research could be fruitfully funded again to advance the science
and not necessarily through the traditional grant rounds, which sometimes have
awkward timing?

Unmentioned in Adams’
item is an application from a UC Irvine researcher that came up at Wednesday’s
meeting of the governing board of the stem cell agency. The woman, whose name
was not clearly audible on the Internet audiocast, publicly appealed rejection
of her application by reviewers. She noted that it was an extension of work
that was previously funded by the agency. She also noted that the score on her
review was all but identical to work that was funded. The board, however,
turned her appeal aside, which had already been rejected behind closed doors by
CIRM staff.

Hers is not the only
such case in CIRM history. But they are virtually impossible to track systematically
because of the structure of the CIRM grant-making progress. It is also not
clear whether the agency itself is tracking its research awards to determine if
they result in continuing, fruitful research in a specific area. Nonetheless,
the matter deserves some public attention. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iPivfY1LHPk/tracking-fruits-of-california-stem-cell.html

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Stem Cell Agency Pays Tribute to the Late Duane Roth

Sunday, September 1st, 2013

The governing board of the California stem cell agency today paid tribute to the late Duane Roth, co- vice chairman of the agency, who died recently as the result of a bicycle accident.

With members of Roth's family present, CIRM Chairman J.T. Thomas characterized Roth, 63, as a "voice of reason" on the 29-member board. The video included testimonials from both staff and board members.

He was described as a "kind person" who could find "common ground" on difficult issues. Roth was deeply involved in San Diego affairs that went well beyond the stem cell agency. More than 1,000 persons attended memorial services for Roth earlier this month in San Diego.

CIRM President Alan Trounson said following the video that he will "miss (Roth) terribly" and expressed  "hope that his memory will lighten and brighten the day for all of us."

Jeanne Loring, a stem cell researcher at Scripps, said Roth "inspired us to do more than we thought we could do." She said he was an unusual kind of businessman who respected science.  "I wish I could thank him one more time," she said.Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Oq2mWojUfsQ/stem-cell-agency-pays-tribute-to-late.html

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$41 Million in California Stem Cell Grants Virtually Approved

Sunday, September 1st, 2013

Directors of the California stem cell agency today all but approved about $41 million in early translational grants, rejecting all appeals by applicants and accepting staff recommendations on marginal grants.

The roll call vote was held open this morning to record a vote by one board member who was not present at the time. It is virtually certain that the member will vote in favor of affirmative action on the applications in question.

One member of the board, Joan Samuelson, abstained from voting on any of the applications. She said she did not think the board had adequate information on its total grant portfolio, particularly in view of the declining amount of money available.

The agency has about $600 million in uncommitted funds and is scheduled to run out of cash for new grants in 2017.

The research acted on today is aimed at “proof of concept for development of a therapy candidate and/or studies to select a development candidate. The approved grants can be found on this CIRM website page and are listed in tier one and tier two.  Identities of the applicants are withheld by CIRM to avoid embarrassing rejected candidates and to avoid disclosing the names of applicants to board members before they vote. However, applicants often appear before the board, as they did today, and identify themselves.

Five applicants appealed negative decisions on their applications by grant reviewers. The agency declined to disclose the appeal letters or identify the applicants, information that was a public record under the previous appeal procedures. New processes were put in place this spring that moved the appeals behind closed doors and made them subject to staff instead of board review. Nonetheless, rejected researchers have a legal right to address the board on appeals or any other matters.

At the request of the California Stem Cell Report, the agency provided the numbers of the grants on which appeals were filed. They are: 06787, 06888, 06761, 06793 and 06830. Review summaries on the applications can be found here. 

We have asked the agency to provide its legal and policy justification for now withholding information that was once a public record.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QDuPoOEt0Xc/41-million-in-california-stem-cell.html

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UCLA Snags $3.6 Million from California Stem Cell Agency

Sunday, September 1st, 2013

UCLA scored today with at least two grants, totaling $3.6 million, from the California stem cell agency. 

Seeking the cash were Donald Kohn,  application 6823, and Gerald Lipshutz, application 6831. Both of the  grants are for $1.8 million each. 


Their applications were initially in the agency's tier two category, which means that CIRM's reviewers did not approve them outright for funding.  CIRM staff, however, did under a new procedure, and the agency's governing ratified the recommendation. 

Lipshutz also appeared before the board along with several patient advocates who made emotional appeals for funding. Lipshutz's research deals with urea cycle disorders, which occur in one out of 8,200 births. Current treatment is arduous and can involve liver transplants.  

Kohn's research deals with sickle cell disease, which afflicts primarily African-Americans. His efforts are aimed at correcting the sickle gene defect in the blood stem cells before transplanting them back into the patient.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/2AMVhKsdgfc/ucla-snags-36-million-from-california.html

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Stem Cell Agency Seeks Stronger Ties with Possible Industry Funding Partners

Sunday, September 1st, 2013

The California stem cell agency today triggered a new program aimed at recruiting major biotech and venture capital firms to assist in providing tens of millions of dollars for research by California enterprises.

The effort, part of an $80 million business-friendly initiative, was approved by the agency's governing board on a voice vote.

Participating companies will have a special relationship with the state agency, according to a staff document. The "industry collaborators" will have early input into concept funding proposals prior to their presentation to the agency's governing board. The companies will also be able to attend agency workshops and meetings involving hundreds of grant recipients. 
Other aspects of the proposal call for special event-hosting arrangements aimed at creating more collaborations along with posting of information from the selected collaborators on the CIRM website.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/TEKA-IbpQCo/stem-cell-agency-seeks-stronger-ties.html

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UCLA Takes Four of 13 Awards Today; One Business Wins

Sunday, September 1st, 2013

The California stem cell agency has
made it official, sending out its press release on the $41 million in grants
approved today for institutions throughout the state. 

Most of the 13 awards, as usual, went to organizations represented on the governing board of
the agency. Individual board members, however, are barred from voting on specific grants
to their organizations. 
UCLA topped the list with four grants. No other
institution received more than one, including only one business, Numerate, Inc., of San Bruno,
via John
Griffin
, the firm's chief scientific officer. The lack of awards
to businesses has long been a sore subject in the biotech community. 
 
The only news story so far was written by Bradley Fikes of the San Diego U-T, which circulates in an area that is a hotbed of biotech research. Institutions there snagged $12.6 million in four grants. Fikes also
identified one of the five researchers who lost their appeals on negative grant
review decisions. He is Evan
Snyder
,
 leader of stem cell research at Sanford-Burnham Medical Research
Institute
 in La Jolla, who
had a $5 million request before the agency.

The agency's press release can be found here with more information on the proposed research here.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/cdlc-HWVO2c/ucla-takes-four-of-13-awards-today-one.html

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Skin in California’s Stem Cell Game

Sunday, September 1st, 2013
The California stem cell agency’s road map to its
financial future makes a big, $200 million assumption.

The amount would be the agency’s skin in the game for a new,
public-private partnership to continue with the agency’s work after 2017, when
its cash basically runs out.

The $200 million figure is contained in the
assumptions for development of the proposed partnership, which is now in the very early stages of being crafted by a Marin County consultant, James Gollub.
He was told that whatever he comes up with can assume a onetime, $50 million to
$200 million public contribution.

The sixty-four-dollar question – to use a term from
the 1940s -- is how to raise that sort of cash. Consider two unappetizing possibilities.
The 29 members of the agency’s governing board could go to Sacramento and ask
lawmakers and the governor to give them the money, a prospect that most of them
would not relish. Such a move would open the door to tinkering or more with the
agency’s structure and operations.  Or
the board could seek more bond financing via a statewide election, requiring an
electoral campaign that would cost many millions to mount. In both cases, there
is no guarantee that funds would be forthcoming. Money is still tight in
California government, and voters may not fancy spending more on stem cell
research, especially if the agency has not delivered on the promises of the
2004 ballot campaign that created the $3 billion program.

A third possibility, however, exists, but it also could
be difficult considering pressures to spend all that the agency has. The
board of the California Institute for Regenerative Medicine (CIRM), as the agency
is formally known, has about $600 million in uncommitted cash. It could take
$200 million off the table and reserve it as seed money for whatever future
plans would involve. Or the board could simply roll back commitments it has
made for lower priority grant rounds – ones that have not yet been initiated.
Some are in concept stages, and others have not yet been posted as RFAs.

Scrimping on existing efforts is not going to suit
the condition of all board members. The question of priorities on spending came
up last month in connection with the agency’s generous, $69 million researcher
recruitment effort that benefits many institutions represented on the agency’s
board. Jeff Sheehy, who is a patient advocate member of the board but also a
communications manager at UC San Francisco, and others bridled at adding more money to the
recruitment program. Sheehy cited scarcity of funds and said it was a “distraction”
from more important efforts. His view, however, did not prevail.
Today the board is scheduled to act on a grant round that is budgeted for $70 million. However, grant reviewers have approved grants
totaling only $37 million. Board members, if they wish, could indicate that the
surplus $33 million be designated as a down payment on the future of the agency
– an organization in which they take great pride.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/H4C5-MLOao4/skin-in-californias-stem-cell-game.html

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California Gov. Jerry Brown Vetoes Pay-for-Eggs Legislation

Sunday, August 18th, 2013
California Gov. Jerry Brown today
vetoed a fertility industry-backed measure that would have permitted
women to sell their eggs for the purposes of scientific research.
In his veto message, Brown said,

“Not everything in life is for sale
nor should it be.”

The bill would have repealed a ban on
compensation of women who provide their eggs for scientific purposes.
The measure would not have changed existing law that allows women to
be paid for their eggs for IVF purposes with fees that range up to
$50,000. The bill also would not have affected the ban on compensation for
eggs for research that is financed by the $3 billion California stem
cell agency.
The legislation (AB926) by
Assemblywoman Susan Bonilla, D-Concord, was sponsored by the American
Society for Reproductive Medicine
and easily swept through the Democratic-dominated legislature. Bonilla said the measure would have placed women on an
equal footing with men, who are paid for their sperm contributions
for research. She also said that it would help to encourage more
research into fertility issues.
Some stem cell scientists have
complained that not enough women are willing to donate eggs without
compensation, but stem cell researchers were not publicly involved in
supporting the bill.
The fertility industry group had
confidently predicted that Brown, a Democrat like Bonilla, would sign the bill. The governor's
action could be overridden by a 2/3 vote of each house of the
Legislature. It is not clear whether Bonilla will make such an
attempt.
Here is the text of Brown's veto
message:

"Not everything in life is for sale
nor should it be.

"This bill would legalize the payment of
money in exchange for a woman submitting to invasive procedures to
stimulate, extract and harvest her eggs for scientific research.

"The questions raised here are not
simple; they touch matters that are both personal and philosophical.

"In medical procedures of this kind,
genuinely informed consent is difficult because the long-term risks
are not adequately known. Putting thousands of dollars on the table
only compounds the problem.

"Six years ago the Legislature, by
near unanimity, enacted the prohibition that this bill now seeks to
reverse. After careful review of the materials which both supporters
and opponents submitted, I do not find sufficient reason to change
course.

"I am returning this bill without my
signature."

You can read more about the bill and
its history here, here, here and here.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1eDn2Is8V8E/california-gov-jerry-brown-vetoes-pay.html

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Bonilla: Veto of Pay-for-Eggs Bill Shows Troubling Mindset

Sunday, August 18th, 2013
A Democratic state legislator today
assailed Democratic Gov. Jerry Brown's “mindset” as “particularly
troubling” in his veto of legislation that would have allowed women
to sell their eggs for scientific research.
The statement came from Assemblywoman
Susan Bonilla, D-Concord, in response to Brown's action on her
fertility-industry sponsored bill, AB926, which would have removed a
ban on compensation for women who provide eggs for research.
Susan Bonilla
Photo from California Legislature
Brown cited health risks and other issues and said in his veto message,

“Not everything in life is for sale
nor should it be.”

Alex Matthews, writing on Capitol
Weekly,
quoted Bonilla as saying,

“It (the governor's veto) shows a
glaring inconsistency...The veto statement was very overreaching in
the fact that it was making very broad statements about what women
should be able to do, and while it's not legislation it certainly
goes to a mindset that the governor has that I find particularly
troubling.”

Bonilla continued,

“Market-driven compensation of donors
by donor agencies and prospective parents continues unchecked.”

In a statement on her website, Bonilla
said the governor's veto “is a regressive action that denies
thousands of women the prospect of medical fertility breakthroughs.”
She said,

“Many women...will be denied hope and
the possibility of giving birth to a child because research on their
behalf has been halted in California.”

Bonilla has argued that women involved
in egg-related research, such as that involving stem cells, should
be compensated, just as men are for their sperm. Women who provide
eggs for fertility purposes can be legally compensated up to any
amount. The current market runs about $10,000 or so per egg cycle but can be much
higher.
Bonilla's measure would not have
affected a ban on compensation involving research funded by the $3
billion California stem cell agency. It would have taken a 70 percent
vote of each house to alter that restriction, compared to a simple
majority for Bonilla's bill. The super, super-majority requirement
was written into state law by Proposition 71, the measure that
created the stem cell agency.
Bonilla did not indicate whether she
would attempt to override the governor's veto, which would require a
2/3 vote of each house.
One of the opponents of the bill, the
Center for Genetics and Society in Berkeley, called the veto a
“welcome development.”
Diane Tober, associate executive
director of the center, said,

“It would be unconscionable to
expand the commercial market in women’s eggs without obtaining
significantly more information about the risks of retrieving them.” 

Here are links to other stories today
on the veto of the bill: Los Angeles Times, Sacramento Bee, an
additional story from late yesterday on Capitol Weekly, TheAssociated Press and National Review.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/j0Fm9p1Ac64/bonilla-veto-of-pay-for-eggs-bill-shows.html

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‘Butter and Eggs Money” and a Gubernatorial Veto

Sunday, August 18th, 2013
Nancy
Scheper-Hughes
, professor of medical anthropology at UC Berkeley and
director of Organ
s
Watch
, is one of the opponents of the legislation that would have
permitted women to sell their eggs for research. Today she filed the
following comment on the “troubling mindset” item on the
California Stem Cell Report.

Jerry Brown's
veto of AB
926
which would allow young women to be paid for multiple egg extractions
for scientific research is one for the gals.  In western Ireland
women secreted away their
'butter
and eggs
'
money in anticipation of hard times. In my day every smart girl had
her 'mad money' to escape a bad situation. Secret cash for young
women is a great idea, but not when it turns on multiple cycles of
pumping powerful hormones associated (in other contexts) with ovarian
cancer into young women's bodies to produce 30 or 60 eggs a month.
That's not promoting gender equity no matter what some of our best
Democratic women leaders have to say. Selling sperm and selling eggs
are a totally different matter. One  is pleasurable and safe,
the other is a complicated and invasive procedure. We need good
science and good research and  freedom of choice and action. We
also need protection from false advertising. There are no
evidence based, long term studies of the effects of these hormone
injections on women ten or twenty years after the fact. Let's fund
those needed longitudinal and cohort studies and hope for the best.
In the meantime, women had best stick to 'butter and eggs' money. It
doesn't pay a lot, but it's less painful and a heck of a lot safer.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/gMworjXp5x0/butter-and-eggs-money-and-gubernatorial.html

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A $6 Billion Question: Progress of the California Stem Cell Agency

Sunday, August 18th, 2013
The headlines march like legions across the
Internet and throughout the world.

“New type of stem cell helps your fingers regenerate”

“Stem cell technology can mass-produce cancer-killing cells to target tumours”

"Stem-cell
treatment restores sight to blind man

“Special stem cells could heal hearts”

But then there is this extraordinarily
rare headline that sounds a harshly different note:

“Stem cells: what happened to the radical breakthroughs?”

All these headlines go to address, in
one form or another, a request/question posed last month by an
anonymous reader of the California Stem Cell Report. The comment came
on an item about the California stem cell agency's $70 million plan
to establish a network of “Alpha” stem cell clinics in
California.
The reader said,

“It would be nice to have an overall
update on how much as been spent on California's stem cell research
project and what progress has been made.”

On the surface, the answer is easy. The
agency has given away $1.8 billion. The agency says it has made
tremendous progress and expects to make even more with the about $600
million it has left. The prestigious Institute of Medicine has said the
agency has “achieved many notable results.”
However, no thorough, rigorous
evaluation has been made of the details of the agency's scientific
contributions, specific grant awards or its impact on the field of
regenerative medicine. No one has attempted to genuinely assess
whether the work of the agency is or will be worth the roughly $6
billion(including interest) that California taxpayers will have paid
for the agency's ambitious efforts.
Then there is the question of “progress
towards what?” Is the progress to be measured against the promises
of the 2004 ballot campaign that resulted in creation of the stem
cell agency or more modest goals that eschew the hype of the
campaign?
The stem cell agency is burdened in a way that most science is not. The 2004 campaign
created a sort of contract with voters. They were led to
believe nine years ago that the cures for diseases that the campaign said afflict nearly
one-half of all California families were, in fact, right around the corner. Few,
if any California stem cell researchers were publicly warning that a
hard and long, long slog remained before therapies reached patients.
Last week, however, Simon Roach of the
British newspapers, The Guardian and Observer, shed some light on the
early, rosy promises of stem cell science compared to the world as it exists
today.
He wrote that in 1998,

“(B)iomedical engineer Professor
Michael Sefton declared that within 10 years, scientists would have
grown an entire heart, fit for transplant. 'We're shooting big,' he
said. 'Our vision is that we'll be able to pop out a damaged heart
and replace it as easily as you would replace a carburetor in a car.'

“Fifteen years on, however, we've had
some liver cells, eye cells, even a lab-grown
burger
, but no whole human organs. We could be forgiven for
asking: where's our heart? It does seem strange that a field stoking
so much excitement could be so far off the mark. Speaking last week
about the vision that he and his colleagues outlined in 1998, Sefton
said they had been 'hopelessly naïve.' As time plodded on and an
understanding of the biological complexity increased, the task seemed
bigger and bigger. Even now, a cacophony of headlines later, we are
not much further ahead.

Chris Mason is a professor of
regenerative medicine at University College London and believes that
concentrating on organ regeneration is missing a trick. 'These organs
are immensely complex,' he said. 'They've got nerves, blood vessels,
in the case of the liver, a bile system – there are huge degrees of
complexity. These things take a long time to grow in humans, let
alone in the lab without all the natural cues that occur in the
growing embryo.'"

The final paragraph in Roach's article
said,

“There's a tension in medical
research between the glory of the big discovery and the
assiduous commitment to real application. 'We're hoping the scope and
possibilities of this project will catch the public's imagination,'
Sefton concluded in 1998. It did, but perhaps the public's
imagination isn't always what science should be vying for.”

Little doubt exists that the California
stem cell agency has made a significant contribution to stem cell
science, although the size of that contribution – beyond dollars –
remains to be measured. For now, the key for the agency and the
public is to focus on activities that will generate the greatest value over the
next few years and advance the science that has already been financed
by the agency.
As the $700,000 Institute of Medicine
report said,

“The challenge of moving its research
programs closer to the clinic and California’s large biotechnology
sector is certainly on CIRM’s agenda, but substantial achievements
in this arena remain to be made.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/O78NzUdZE88/a-6-billion-question-progress-of.html

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Duane Roth: Ecumenical Innovator for San Diego and Biotech

Sunday, August 18th, 2013
The Xconomy news service today carried
a sterling look at the contributions that Duane Roth, co-vice
chairman of the California stem cell agency, made before his untimely
death as the result of a bicycle accident.
Reporter Bruce Bigelow pulled together
a host of comments concerning Roth's involvement in the San Diego
community, ranging from biotech to action sports companies. The
headline on the piece read, “The Connector Who Wired up a Regional
Innovation Economy.”
At the time of his death at the age of
63, Roth was CEO of Connect, a nonprofit organization that supported
technology and innovation and one that he was credited with reviving.
Bigelow also wrote,

“Once California voters approved a
2004 ballot proposition that authorized the issuance of $3 billion in
grants for stem cell R&D, (Mary) Walshok (associate vice
chancellor for public programs at UC San Diego) said Roth also played
a key role in bringing together UCSD, Scripps, Salk, and
Sanford-Burnham to create the Sanford Consortium for Regenerative
Medicine
. In fact, Walshok doubts whether anyone but Duane Roth could
have brought the four major research centers together.”

Another speaker at the memorial
services Friday attended by about 1,000 persons was Bill Walton, the
former UCLA and NBA great, who grew up in San Diego.
Bigelow wrote,

“Walton, the NBA Hall of Famer who
has led San Diego Sports Innovators as a division of Connect since
2010, said Roth became a business mentor to him. In his comments
Friday afternoon, Walton said Roth inspired him to be a better
person, and he counted Roth among the people who had the biggest
influence on his life—a list that included his own father, UCLA
coach John Wooden, sportscaster Chick Hearn, author David Halberstam,
and Jerry Garcia of the Grateful Dead.”

Bigelow described Roth as an ecumenical
and pragmatic advocate for innovation who could work with persons who
did not always agree with him on all issues. He was a conservative
and active Republican, but his co-vice chair at at the stem cell
agency, Art Torres, former chairman of the state Democratic Party, on
more than one occasion has lauded Roth's ability to work together.
Bigelow wrote about similar remarks
Friday by Don Rosenberg, an executive vice president and general
counsel at Qualcomm.

“'Duane and I were as different as
two people can be,' Rosenberg said during his eulogy at the Church of
the Immaculata
. 'Duane was born in Iowa, baptized in the Mennonite
church, a Republican. And me, raised in Brooklyn, Jewish, a Democrat.
We quickly learned we had more in common. We were kindred spirits. We
liked the same things: Bikes, biking, cars, and people.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g7BsEVSkzS0/duane-roth-ecumenical-innovator-for-san.html

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Stem Cell Agency’s Duane Roth Eulogized at Memorial Services

Sunday, August 18th, 2013
An estimated 1,000 persons attended
services last week for Duane Roth, co-vice chairman of the California
stem cell agency, who died at the age of 63 following a bicycle
accident.
The San Diego U-T reported,

“A Who’s
Who of San Diego’s technology, business and civic community
gathered Friday to bid farewell to Duane Roth.
The biotech entrepreneur, community leader and director of Connect
died last weekend of injuries sustained in a cycling accident.

“Among
attendees were Gayle and former Gov. Pete
Wilson
, who had just celebrated his upcoming 80th birthday
with former colleagues and friends in Sacramento, county
Supervisor Ron Roberts, former
Assemblyman Nathan Fletcher, Chamber
head Jerry Sanders, Preuss School
benefactors Peggy and Peter
Preuss
, SDG&E CEO Jessie Knight,
and many biotech and high-tech leaders. These included Irwin
Jacobs
Ted Waitt and Denny
Sanford
.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8V0OyzjYBEs/stem-cell-agencys-duane-roth-eulogized.html

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‘Paradigm Shift’ — Researchers as Patient Advocates?

Sunday, August 18th, 2013
It is not easy for a stem cell
scientist to break into “print” in that bastion of American
capitalism, Forbes magazine. Much less one from that perceived
antithesis of free enterprise, Reed College.
But researcher Paul Knoepfler of UC
Davis
has done just that.
John Farrell of Forbes wrote about Knoepfler on
Friday in the wake of the announcement Knoepfler will be honored with
a “national advocacy” award by the Genetics Policy Institute.
Paul Knoepfler -- Advocate for a "new ethos"
UC Davis photo
Knoepfler, who received a degree in
English literature from Reed in 1989, is being recognized for his
activities as a stem cell blogger since 2009.
Farrell quoted Knoepfler as saying in
an email,

“With many stumbles, face plants,
land mines, and even a few threats of litigation and career
retaliation along the way for the last three and half a years, I
turned my crazy idea into a reality.”

Farrell continued,

“But it was only possible,
(Knoepfler) added, with guidance from many patient advocates and
bloggers in other fields who generously helped him learn the ropes of
blogging.

“'I see this award as a validation of
the notion that advocacy by scientists has become a valued part of
the stem cell field,' he said.

“'My hope is to catalyze a continuing
paradigm shift whereby stem cell scientists and biomedical scientists
more generally have a new ethos that not just accepts, but also
deeply values advocacy.'”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tuEB7SGOuMQ/paradigm-shift-researchers-as-patient.html

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California Stem Cell Agency on Lacks: Informed Consent Cannot Remove All Questions

Sunday, August 11th, 2013
(Photo and caption from the stem cell agency blog item this morning.)
The $3 billion California stem cell
agency today weighed in on the Henrietta Lacks-NIH arrangement
restricting the use of her cell lines in research.
Writing on the agency's blog, Geoff
Lomax
, the agency's senior officer for its standards group, noted
that the DNA sequence of her cell line was published without the
knowledge of her descendants. Lomax said,

“The family was understandably upset
by the lack of consultation and in response the research team removed
the genome data from public access.”

Lomax continued,

“CIRM has benefited from these
efforts. We are currently supporting an initiative to collect tissue
samples from thousands of people with a range of incurable diseases
and create reprogrammed iPS cells from those tissues (here's
more about that initiative
). These cells will be a resource for
scientists worldwide working to understand and treat diseases. Part
of this initiative includes a consent process to make sure people who
donate fully understand how their cells will be used. (This process
is formally called informed consent.) 

“The informed
consent process includes a form that identifies the purposes of the
research and describes the way cells will be used. We are also
developing education materials that will help potential donors
quickly and easily understand the basic aspects of research that will
be conducted with those cells. The end result of this collaboration
with our grantees will be a process that is truly informative to
donors.

“The informed consent process can’t entirely
eliminate all future questions on the part of the donor, but it does
ensure that donors have a chance to understand how their cells will
be used and what information will be made public—something
Henrietta Lacks and her family never had.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8PQGYcYpszg/california-stem-cell-agency-on-lacks.html

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Skloots, Collins and More on Henrietta Lacks’ Cell Line Deal

Sunday, August 11th, 2013
More details about the unprecedented
arrangement involving Henrietta Lacks' cell line emerged today in a
wide range of publications, including a Nature journal piece that
said it was not a precedent.
The article was co-authored by Francis
Collins
, head of the NIH, and Kathy Hudson, deputy director for
science, outreach and policy at the NIH.

“It is important to note, however,
that we are responding to an extraordinary situation here, not
setting a precedent for research with previously stored,
de-identified specimens. The approach we have developed through
working with the Lacks family is unique because HeLa cells were taken
and used without consent, and gave rise to the most widely used human
cell line in the world, and because the family members are known by
name to millions of people.”

The restrictions on use of the cell
lines came about after a flap erupted about their recent use without
the knowledge of her descendants. (The California Stem Cell Report carried a commentary on it yesterday.) Rebecca Skloots, author of the
best-seller, “The Immortal Life of Henrietta Lacks,” wrote about
the controversy in a March 23 op-ed piece in the New York Times. She
said,
In the article, Skloots said,

“Imagine if someone secretly sent
samples of your DNA to one of many companies that promise to tell you
what your genes say about you. That report would list the good news
(you’ll probably live to be 100) and the not-so-good news (you’ll
most likely develop Alzheimer’s, bipolar disorder and maybe
alcoholism). Now imagine they posted your genetic information online,
with your name on it. Some people may not mind. But I assure you,
many do: genetic information can be stigmatizing, and while it’s
illegal for employers or health insurance providers to discriminate
based on that information, this is not true for life insurance,
disability coverage or long-term care.

“'That is private family
information,” said Jeri Lacks-Whye, Lacks’s granddaughter. “It
shouldn’t have been published without our consent.'”

Nature also carried a Q&A with Collins in which he said,

“This has wrapped in it science,
scientific history, ethical concerns, the bringing together of people
of very different cultures, a family with all the complications that
families have.”

In the Wall Street Journal this
morning, Ron Winslow described the arrangement with the NIH like
this.

“Under the pact, two descendants of
Ms. Lacks will serve on a six-member panel with scientists to review
proposals from researchers seeking to sequence the DNA of cell lines
derived from her tumor or to use DNA profiles of such cells in their
research. That gives family members a highly unusual voice in who
gets access to personal health information.

Terms call for controlled access to the
genomic data and credit to the Lacks family in papers and scientific
presentations based on the research done with the DNA data.”

In an interview in The Scientist,
Skloots, who was involved in the Lacks-NIH negotiations, said the
Lacks family asked for her participation.

“The only reason I was involved in
this is because scientists did this without the family’s consent
and then it got all of this press coverage, and no one asked the
question, 'Did the family give consent?' So I sort of waded back
in.”

She continued, 

“That OpEd that I
wrote was the first time I’d ever publicly expressed an opinion,
which was, 'Really?!? Are we going to continue to not ask the Lacks
family questions?' I was kind of shocked in a sense that nobody
thought to raise that issue.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7XRzMDgIWjo/skloots-collins-and-more-on-henrietta.html

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Memorial Services Friday for Duane Roth, Co-vice chairman of the California Stem Cell Agency

Sunday, August 11th, 2013
A memorial service for Duane Roth,
co-vice chairman of the California stem cell agency, will be held
Friday at 11 a.m. at Immaculata Church at the University of San
Diego.
Roth died Saturday from injuries
suffered in an accident last month while bicycling in the mountains
east of San Diego. He was 63.
San Diego has seen an outpouring of
tributes in the wake of Roth's death for his contributions to the
community in the life sciences, philanthropic and technology areas.
He had served on the stem cell agency board since 2006 and had been
scheduled to become of chairman of the Sanford-Burnham Institute this
fall. He was CEO of Connect, a non-profit organization aimed at
support entrepreneurship in the technology field.
Ted Roth, Duane's brother, remembered him in a piece in the San Diego U-T as the oldest of five sons growing up in Wayland, Iowa. Ted Roth wrote that their parents relied on Duane "to set an example for his brothers, and he
was the one they called upon in their later years. He was a lifelong
mentor and friend to his brothers, someone that was always there to
share in life’s experiences." 
Ted also wrote about his brother's involvement in technology and business.

 "Duane was captivated by the possibilities that innovation provides in improving the world in which we live." 

The
family
has
suggested that in lieu of flowers that donations be made
to the Otterson Fund at Connect, Challenged Athletes Foundation or the Copley-Price Family YMCA.
Here are links to some of the other recent
articles on Roth: San Diego U-T (see here and here), La Jolla Patch,
La Jolla Light.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Bui3CXvil70/memorial-services-friday-for-duane-roth.html

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Californians Top List of Stem Cell Honorees

Sunday, August 11th, 2013
Californians dominated the list of those to be honored at the World Stem Cell Summit coming up in San
Diego this December.
They include fellow blogger Paul
Knoepfler
, a stem cell scientist at UC Davis, and Roman Reed, the San Francisco Bay Area stem cell activist and son of another stem cell advocate, Don Reed. Both are among the 2013 Stem Cell Action Award honorees for this
year.
Others include Denny Sanford, a
philanthropist whose name now adorns the Sanford-Burnham Institute in
La Jolla, and Malin Burnham, who is also linked to the institute.
Also being honored is Mary Ann Liebert, whose firm publishes
peer-reviewed journals in science and biomedical research.
Malin is a San Diego businessman who
joined with an anonymous donor in 1996 to contribute $10 million to
the La Jolla Cancer Foundation. It was renamed to reflect that
contribution. In 2010, Sanford pledged $50 million to the
organization, and it was renamed again.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1ThJSyU8BBU/californians-top-list-of-stem-cell.html

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The Henrietta Lacks Story and Eggs, Money and Motherhood

Sunday, August 11th, 2013
The legacy of Henrietta Lacks popped up
again today in a piece in the New York Times that should
resonate among stem cell researchers and within the stem cell
industry.
It even has a current hook involving
California legislation to permit women to sell their eggs for the
purposes of scientific research – a bill that is now on the desk of
Gov. Jerry Brown.
The issues in the Lacks saga involve ownership of human
cells, trafficking in them and informed consent, all of which surface in one form or another in the state legislation.
But first a refresher on Henrietta
Lacks. She was an African-American woman who died in 1951 of cervical
cancer at the age of 31. Shortly before her death, physicians removed
some of her tumor cells, and, as recounted in today's NYTimes article
by Carl Zimmer,

“They later discovered that the cells
could thrive in a lab, a feat no human cells had achieved before.

"Soon the cells — nicknamed HeLa cells
— were being shipped from Baltimore around the world. In the 62
years since — twice as long as Ms. Lacks’s own brief life — her
cells have been the subject of more than 74,000 studies, many of
which have yielded profound insights into cell biology, vaccines, in
vitro fertilization and cancer.”

But Lacks never consented to her cells'
being studied, a situation not uncommon at the time, nor did her
family know about the situation until 1973. The complete story was
chronicled in 2010 in a best-selling book, “The Immortal Life of
Henrietta Lacks
," by Rebecca Skloot.
Zimmer noted in today's article,

“For 62 years, (Lacks') family has
been left out of the decision-making about that research. Now, over
the past four months, the National
Institutes of Health has come to an agreement with the Lacks
family to grant them control over how Henrietta Lacks’s genome is
used.”

The particulars involving her genome
are in Zimmer's story. But the article implicitly raises anew
questions that make many scientists uncomfortable. Often they contend
that the situation involving Lacks could not occur today because of
higher ethical standards. Standards ARE higher today. But problems
continue to arise in the scientific community, including the sale a few years ago of willed body parts at UCLA for $1.5 million to private medical companies.
Development of products based on human
stem cells promises even greater rewards, with billion-dollar
blockbuster therapies not out of the range of possibilities. Profit
and the desire to record a stunning research triumph are powerful
motivators. They can lead to short cuts and dubious practices, such
as seen in the Korean stem cell scandals of 2006.
So we come to whether women who donate
their eggs for stem cell research can give truly informed consent
when they surrender all rights to whatever products may result from
parts of their bodies, as is common on such consent agreements. Or
for that matter, what about the men who give up adult cells for
reprogramming to a pluripotent state? Can they really understand the
likelihood of a billion dollar product being generated with the help
of their contribution? On the other hand, can the donors also truly
understand that they are probably more likely to be struck by
lightning than have their body parts result in a medical blockbuster?
These considerations may seem
insignificant to some in science. But to grasp their full
implications, one only has to read a few of the nearly 200 reader
comments today on Zimmer's article today. Here is a sample.
From Frank Spencer-Molloy in
Connecticut:

“(T)the Lacks family was robbed.
Scores of companies profited to the tune of tens of millions of
dollars from products they made derived from Henrietta Lacks'
cancerous cells. Maybe this will provide some impetus to a wider
consideration of the rights patients are entitled to when their
tissues are cloned and disseminated to other researchers and
ultimately put to use in profit-making ventures.”

From Robbie in New York City:

“At the very least, this family needs
to be financially compensated for the anguish of their discovery and
for the time and energy they've put into pursuing their rights. In my
opinion, they also deserve a portion of any commercial gain that's
been made using the HeLa cells. It is only through having to give
away money that the powerful learn manners.”

From Julia Himmel in New York City:

“It is absolutely true that
scientists have had a blind spot when it came to the human element of
the HeLa cells.”

The pay-for-eggs legislation (AB926)
now before Gov. Brown requires informed consent from those who
provide eggs. Opponents of the measure, however, argue that truly
informed consent from some women could be actually impossible because
of economic pressures felt by the women. Writing in The Sacramento Bee last month, Diane Tober and Nancy Scheper-Hughes said,

“Allowing a market in eggs for
research would reach beyond the current pool to target women who may
be motivated by dire need. How many low-income women might consider
selling their eggs, multiple times, to feed their children or pay the
rent?”

Even the fertility industry group
sponsoring the legislation acknowledges that informed consent can be
problematic. A 2012 news release from the American Society for
Reproductive Medicine
said, 

“Prospective egg donors must
assimilate a great deal of information in the informed consent
process, yet it remains difficult to determine the extent of their
actual understanding of egg donation and its potential risks.”

The story of the treatment of Henrietta
Lacks and her descendants is a poor commentary on science and
medicine. Yet it resonates with the public, which is keenly sensitive
to scientific and medical abuses, even in situations that did not
appear to be abuses at the time.

Stem cell research already is burdened by its own
particular moral and religious baggage. With
commercialization of new, pluripotent stem cell therapies coming ever
closer, the last thing the field needs is contemporary version of the
Lacks affair. It would behoove researchers and the stem cell industry
to walk with more than normal care as they manipulate products that
are tied inextricably to visions of both motherhood and money.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oncdCzO4V18/the-henrietta-lacks-story-and-eggs.html

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CIRM’s Roth Dies Following Bike Accident

Sunday, August 11th, 2013
Duane Roth, co-vice chairman of the
California stem cell agency, died yesterday from brain injuries
suffered in a bicycle accident two weeks ago.
Duane Roth, Connect photo

Roth, CEO of Connect, a San Diego
organization aimed at fostering technology entrepreneurship,
succumbed yesterday afternoon at the UC San Diego Medical Center, the
San Diego U-T
reported. He was 63.
An avid bicyclist, Roth was injured
while biking in the mountains east of San Diego July 21. Roth hit an
outcropping and his helmet was broken in the accident.
Roth was a long-time member of the
29-person governing board of the $3 billion California stem cell
agency and was a strong advocate for industry. He chaired the
agency's loan task force, was vice chair of the Intellectual Property
and Industry Engagement Subcommittee
and a member of the executive
committee.
J.T. Thomas, chairman of the stem cell
agency, released the following statement this morning.

“On behalf of all the CIRM family, we
mourn the loss of our colleague and dear friend Duane Roth. 
Throughout his tenure with us, he was one of the true stewards of the
mission, offering countless insights on the role of industry in the
world of regenerative medicine and how best and efficiently to drive
therapies through to patients.  He was unfailingly a voice of
reason and optimism and always sought to find ways to make things
happen, refusing to take 'no' for an answer.  Though one of 29
Board members, his extensive participation as co-Vice Chair of the
Board, co-chair of Intellectual Property and Industry Engagement
Subcommittee and a member of our Executive Committee gave Duane a
singularly important and resonant voice in our organization. 
His passing will be deeply felt by all of us as well as by the many
patients and other CIRM stakeholders whom he touched over the years. 
We send our deepest sympathies to Renee, Duane's brothers and the
rest of the Roth family.”

Roth recently was involved in raising
funds for cancer, and reporter Bradley Fikes wrote in the San Diego
U-T,

“Contributions in Roth’s name can
be made to Pedal
the Cause
, a fund-raiser for cancer research that Roth supported.
More than $10,000 has been raised since Roth's accident."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/58gRzPR09kU/cirms-roth-dies-following-bike-accident.html

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