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Stem Cell Update from Panama 3 Years Later – Video

By Dr. Matthew Watson


Stem Cell Update from Panama 3 Years Later
I had my first stem cell treatment for Multiple Sclerosis in November 2008. After much research and education, I decided to leave the US and go to Cell Medicine in Costa Rica at the time. 3 years later the clinic has grown and consolidated their lab and facilities to Panama City. The treatment wasn #39;t a cure, but it worked amazingly well for me and gave me a second chance at life. My MS is progressive and I will continue to turn to stem cells for ongoing treatment of my disease. Hopefully one day very soon with continuing discussions with Gov. Rick Perry and others, we will see stem cell treatments more widely available in the United States. iLoveMyNewStemCells!From:Holly HuberViews:1636 12ratingsTime:05:28More inPeople Blogs

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Future Health Biobank Arabic video tour – Video

By Dr. Matthew Watson


Future Health Biobank Arabic video tour
Learn more about the services offered at Future Health: http://www.fhbb.ae Europe #39;s first accredited family stem cell bank and UK Queen #39;s Award winner, Future Health Biobank, is celebrating 10 years as a pioneer in the collection and cryopreservation of stem cells for potential future medical use with the news that it is opening a second laboratory in Switzerland to complement its established UK facility. The company, which is headquartered in Nottingham in the UK, was established to process and store cord blood stem cell samples for families in 2002 at a time when the idea of stem cell medicine was still more likely to be read about in science fiction books than in our daily newspapers and magazines. Future Health started by storing cord blood stem cells in 2003 and within four years it had stored its 10000th sample. Another five years on and the company #39;s purpose built cryogenic storage facility has over 50000 stem cell samples for families from more than 50 countries in its care. A cord tissue storage service was added in 2009 and now services to capture stem cells from other sources identified for potential medical use have been introduced. Future Health have also put time and resources into research. In the last four years the company have invested in a number of important study areas which could have an impact on the future effectiveness and use of stem cells in medical treatments. These include finding the optimum cryopreservation methods which maintain stem cell ...From:FHBioBankViews:140 0ratingsTime:13:05More inScience Technology

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Cord Blood Registry: Cord blood banking for peace of mind – Video

By Dr. Matthew Watson


Cord Blood Registry: Cord blood banking for peace of mind
Learn more about how cord blood is changing medicine here: cordbloodregistry.com As an expecting parent today, you have access to a medical resource our parents only dreamed of. Saving or "banking" your newborn #39;s cord blood and cord tissue is a one-time opportunity that may be lifesaving or life-changing for your family. Cord blood stem cells are used to treat many life-threatening diseases, such as leukemia and other cancers. In addition, cord blood is showing potential in research and clinical trials to treat conditions that have no cure today. This exciting new area of medicine is called regenerative medicine, where scientists are evaluating the use of a child #39;s own cord blood stem cells in experimental treatments for brain injury, cerebral palsy, and hearing loss. Only CBR consistently gives our client families first opportunities to participate in new areas of cord blood stem cell medicine. This includes four FDA-regulated clinical trials offered exclusively to CBR clients: bull; Hearing loss bull; Traumatic brain injury bull; Cerebral Palsy bull; Juvenile diabetes You can learn more about CBR #39;s role in advancing stem cell research through our Center for Regenerative Medicine, cordbloodregistry.com Ask your doctor about banking your baby #39;s cord blood with CBR today or call 1-888-932-6568 to speak with a Cord Blood Education Specialist. Use of cord blood stem cells will be determined by the treating physician. There is no guarantee that treatments being studied in the laboratory or ...From:cordbloodregistryViews:400 3ratingsTime:00:16More inPeople Blogs

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Science

By Dr. Matthew Watson


Science U!: Science and Aging
Tinabeth Pina explores how advances in science and medicine are contributing to all of us living longer lives. Lisa Beth Kovetz investigates stem cell medicine and its cutting edge breakthroughs in helping to cure disease and slow down aging. Marlene Peralta has the latest on the scientific advances in treating Parkinson #39;s disease. Carol Anne Riddell explains why exercise is one of the most effective things we can do for healthy aging. Ernabel Demillo looks at aging pets - and how we can help them through the process and learn something about our own aging. For More Information: STEM CELL RESEARCH (Lisa Beth Kovetz) http://www.us.penguingroup.com http://www.amazon.com PARKINSON #39;S DISEASE (Marlene Peralta) http://www.pdf.org http://www.brooklynparkinsongroup.org EXERCISE (Carol Anne Riddell) workout911.com http://www.cdc.gov http://www.cdc.gov AGING DOGS (Ernabel Demillo) http://www.hopevet.com http://www.humanesocietyny.org CAREGIVER INFORMATION http://www.aarp.org http://www.nyc.gov Taped: 10-23-12 Science U! explores the world of science, taking the headlines and information you need and showing its importance in our everyday life. From technology, research and health to kids, humor and the arts each program explores these topics in clear, concise and engaging presentations designed for audiences of all backgrounds and ages! Watch more Science U! at http://www.cuny.tv/show/scienceanduFrom:cunytv75Views:113 1ratingsTime:29:38More inScience Technology

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FAQ-6 of 19: In Stem Cell Therapy How Soon Do Stem Cells Start to Work? – Video

By Dr. Matthew Watson


FAQ-6 of 19: In Stem Cell Therapy How Soon Do Stem Cells Start to Work?
youtu.be When you choose stem cell therapy, and your board-certified doctor okays you for stem cell therapy, how soon can you expect effects? There #39;s no one-best-answer-fits-all, but this video gets across the gist of stem cell therapy. For more personalized information or more FAQ on stem cell therapy at the only licensed clinic in Thailand, visit StemCell-Asia.infoFrom:VeteransRecallViews:0 0ratingsTime:01:26More inEducation

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FAQ-9 of 19: In Stem Cell Therapy Are There Any Contraindications for Stem Cells? – Video

By Dr. Matthew Watson


FAQ-9 of 19: In Stem Cell Therapy Are There Any Contraindications for Stem Cells?
youtu.be There ARE some times and ways that stem cells should NOT be used, and this short video outlines them. For more personalized information, visit bit.ly or StemCell-Asia.info now.From:John PepperViews:0 0ratingsTime:00:54More inEducation

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A first: Stem cell therapy cures HIV patient in Germany

By Dr. Matthew Watson

By Philip C. Tubeza Philippine Daily Inquirer

Stem cell therapy might provide a remedy for acquired immunodeficiency syndrome (AIDS) after it was used on an HIV patient in Germany, the first person known to have been cured of the disease, a Department of Health (DOH) official said Tuesday.

Dr. Gerald Belimac, program manager of the DOH National AIDS/Sexually Transmitted Infection Prevention and Control Program, said American Timothy R. Brown, the so-called Berlin Patient who had been infected with the human immunodeficiency virus, was cured after getting stem cells in 2007 from a donor who was genetically resistant to the virus that caused AIDS.

However, he said that this procedure was very complex and was still under study.

It takes the right person, the right recipient, the right donor, for a stem cell transplantation particularly on HIV to be successful, Belimac said.

If it comes from other donors, there is really a high chance that the recipient would reject it, she added.

Brown was infected with HIV in 1995 and was later diagnosed with leukemia, or cancer of the blood.

He underwent a transplant of stem cells for the leukemia and it turned out that those stem cells had genes that were resistant to HIV, Belimac said.

Medical research has shown that almost 5 percent of Caucasians are genetically resistant to HIV, he said, but there are still no studies showing Filipinos having similar genes.

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Look For A Potential Short Entry In The iShares Nasdaq Biotechnology ETF (IBB … – ETF Daily News (blog)

By Dr. Matthew Watson


ETF Daily News (blog)
Look For A Potential Short Entry In The iShares Nasdaq Biotechnology ETF (IBB ...
ETF Daily News (blog)
As we have been saying the past few days, our focus is now on finding ETFs that are breaking down, then looking for short selling entry points on a substantial bounce into resistance. In yesterday's ETF newsletter commentary, we pointed out PowerShares ...
ETF Mid-Day Update: Markets Mostly Lower After Disappointing Results From ...NASDAQ

all 150 news articles »

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California Stem Cell Agency First: Big Pharma Hook Up

By Dr. Matthew Watson


BURLINGAME, Ca. – For the first
time, a Big Pharma company has hooked into the $3 billion California
stem cell agency, a move that the agency described as a “watershed”
in its efforts to commercialize stem cell research.

The involvement of GlaxoSmithKline
comes via a partnership with ViaCyte, Inc., of San Diego, Ca., in a
clinical trial, partially financed with a $10.1 million grant today
from the stem cell agency. The trial involves a human embryonic stem
cell product that has “the potential to essentially cure patients
with type 1 diabetes and provide a powerful new treatment for those
with type 2 disease,” ViaCyte said. Scientific reviewers for the agency, formally known as the California Institute for Regenerative Medicine(CIRM),  “characterized the goal of the proposed therapy as as the 'holy grail' of diabetes treatments.”
CIRM Director Jeff Sheehy, who is co
vice chair of the agency's grant review group, said the ViaCyte product
could be manufactured on a large scale and basically involves “taking
(small) pouches and popping them into patients.”
The stem cell agency's award triggered
arrangements between ViaCyte and Glaxo that will bring in financial
and other support from Glaxo. The exact amount of cash was not
disclosed. CIRM said Glaxo will “co-fund and, assuming success,
conduct the pivotal trial and commercialize the product.” Under the terms of the grant, Glaxo and ViaCyte will have to meet CIRM milestones in order to secure continued funding. 
Following board approval, Jason
Gardner
, head of the Glaxo stem cell unit, characterized the
arrangement as a partnership. He told the board that the company
intends to develop a “sustainable pipeline.”
Gardner credited CIRM President Alan
Trounson
with being instrumental in helping to put the arrangement
together, beginning with their first meeting three years ago.
Trounson said the deal will resonate not only in California but
throughout the world.
Paul Laikind, president of ViaCyte,
also addressed the board, stressing the importance of CIRM's
financial support for his company over past years. It has received
$26.3 million (not including the latest grant) from California taxpayers at a time when stem cell
funding was nearly dried up. He noted that small companies such as ViaCyte do not have the resources to carry a product through the
final stages of clinical trials and subsequent production. Gardner also said,

“When the commercial funding avenues
have become much more risk averse, CIRM support (has ensured) that
promising, innovative cell therapy technologies are fully explored.”

In comments to the California Stem Cell
Report,
Elona Baum, CIRM's general counsel and vice president for
business development, described the award as a “watershed” for
the eight-year-old agency, linking the agency with Big Phama for the
first time. Much of CIRM's current efforts are aimed at stimulating
financial commitments from large companies, which are necessary to
commercialize stem cell research.
Arrangements between Big Pharma and
small companies are not unusual and can vanish quickly. However, the
CIRM-ViaCyte-Glaxo deal sends a message to other Big Pharma companies
and smaller ones, perhaps clearing away concerns that have hindered
other deals that could involve the stem cell agency.
The stem cell agency is pushing hard to
fulfill the promises of the 2004 ballot campaign that created CIRM.
Voters were led to believe that stem cell cures were virtually around
the corner. None have been developed to date.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Jt1JalGURys/california-stem-cell-agency-first-big.html

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Trounson Going Halftime in January and February

By Dr. Matthew Watson


BURLINGAME, Ca. -- The president of the $3 billion California stem cell agency, Alan Trounson, will be working half-time while living in Australia during January and February of next year.

Trounson told the governing board of the agency of his plans at the beginning of its meeting here morning. He said he needs to spend more time with his family, which lives in Melbourne.

Trounson has an 11-year-old son with whom Trounson said he hasn't spend much time in the last 18 months.  Trounson said he intends to teach his son to surf. Trounson's daughter also will be getting married in February.

Meanwhile, directors are currently discussing approval of grants in its $20 million-plus strategic partnership round.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Qvgdz9k9XZ0/trounson-going-halftime-in-january-and.html

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Texas Science Flap Cited as California Stem Cell Agency Eyes its Own Processes

By Dr. Matthew Watson


OAKLAND, Ca. – Meeting against a
backdrop from Texas that involves conflicts of interest and mass
resignations of grant reviewers, a task force of the $3 billion
California stem cell agency today began a partial examination of its
own grant approval process, specifically focusing on appeals by
rejected applicants.

The president of the California
organization, Alan Trounson, told the task force that it was dealing
with a “very serious matter” that in some ways is similar to what
happened in Texas. He said the science community is “very much
concerned.”
The situation in Texas involves the
five-year-old Cancer Prevention and Research Institute, which like
the California stem cell agency, formally known as the California
Institute of Regenerative Medicine (CIRM)
, has $3 billion of borrowed
money to use to finance research.
The chief scientific officer of the
Texas organization, Nobel laureate Alfred Gilman, resigned Oct. 12
during a flap about its attempts “to simultaneously support basic
research and nurture companies.”
Gilman's departure was triggered by a
$20 million award made without scientific review. Reviewer
resignations followed with letters that accused the Texas group of
“hucksterism” and dishonoring the peer review process. (Writer Monya Baker has a good overview today in Nature.)
The situation in Texas came to a head
AFTER the governing board of the California research group created
its task force. The problems in Texas are bigger and not identical to
those in California, which mainly involve the free-wheeling nature of the appeal process, not an entire lack of scientific review.
Nonetheless, this past summer, directors of the California agency for
the first time approved an award that was rejected twice by
reviewers. The award went to StemCells, Inc., of Newark, Ca., which
now has won $40 million, ranking the company No. 1 in
awards to business from CIRM.
Earlier this month, Los Angeles Times
business columnist Michael Hiltzik characterized the StemCells, Inc.,
award as “redolent of cronyism.”
Today's session of the CIRM task force
focused primarily on an aspect of the agency's appeals process that
CIRM labels as “extraordinary petitions.” They are letters which
rejected applicants use to challenge decisions by grant reviewers.
The researchers follow up with public appearances before the
governing board, often trailing squads of patients making emotional
appeals.
Both researchers and patients have a
right under state law to appear before the CIRM board to discuss any
matter. CIRM, however, is trying to come up with changes in the
appeal process that will make it clear to researchers on what the
grounds the board might overturn reviewers' decisions. The agency is
also defining those grounds narrowly and aiming at eliminating
appeals based on differences in scientific opinion.
At today's meeting, CIRM Director Jeff
Sheehy
, a patient advocate and co-vice chair of the grants review
group, said peer review is an “extraordinary way of analyzing
science, but it is not always perfect.” However, he also said that
“as a board we are not respecting input” from scientists and thus
allow the perception that we can be “persuaded against the judgment
of scientists.”
CIRM Director Oswald Steward, director
of the Reeve-Irvine Research Center at UC Irvine, agreed with a
suggestion by Sheehy that board must act with “discipline” when
faced with appeals by rejected applicants. Steward said, 

“The
process has gotten a little out of hand.”

It was a sentiment that drew no dissent
at today's 90-minute meeting.
Missing from today's meeting, which had
teleconference locations in San Francisco, Irvine, La Jolla and Palo
Alto, were any of the hundreds of California scientists whose
livelihoods are likely to be affected by changes in the grant
approval process. Also absent were California biotech businesses,
along with the only representative on the task force from CIRM's
scientific reviewers.
Our comment? When researchers and
businesses that have millions at stake fail to show up for key
sessions that set the terms on how they can get the money, it is a
sad commentary on their professional and business acumen.
Bert Lubin, a CIRM director and
chairman of the task force, indicated he would like to have two more
meetings of the task force prior to making recommendations to a full
board workshop in January with possible final action later that
month. Lubin, CEO of Children's Hospital in Oakland, said the matter
is “really important for the credibility of our whole
organization.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A3HGGTzzso8/texas-science-flap-cited-as-california.html

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New Biotechnology Intern Program Offers Students Real-World Lab Experience – UConn Advance (blog)

By Dr. Matthew Watson


UConn Advance (blog)
New Biotechnology Intern Program Offers Students Real-World Lab Experience
UConn Advance (blog)
Two TIP companies, Chondrogenics Inc. and Synbody Biotechnology Inc., hosted the students participating in the new intern program, offering them hands-on lab experience alongside a mentor. The interns were able to see how a startup company works, ...

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Angel Biotechnology warns on 2012 earnings – MarketWatch

By Dr. Matthew Watson


Proactive Investors UK
Angel Biotechnology warns on 2012 earnings
MarketWatch
LONDON--Angel Biotechnology Holdings PLC , a biopharmaceutical manufacturing company, Friday warned it anticipates an adverse impact on earnings in the current year as it expects that a contract with TransGenRx Inc. will be delayed. MAIN FACTS: ...
Angel Biotechnology warns on full-year earningsBusiness7
Angel earnings warning sends share price downHerald Scotland
Angel Biotech sees upturn in volumes despite earnings warningProactive Investors UK
Stock Market Wire
all 5 news articles »

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Biotechnology on the Ballot – Wall Street Journal

By Dr. Matthew Watson


U.S. News & World Report
Biotechnology on the Ballot
Wall Street Journal
Daisy is only the latest example of the tremendous benefits of biotechnology. Last month, scientists reported in the American Journal of Clinical Nutrition that "golden rice"—a strain of rice genetically modified to produce more beta-carotene—is more ...
Cabinet of Ministers creates institute for GMO issuesKyiv Post
California to vote on GM food labelingChannel News Asia
Proposition 37 could have impact on farmers across the countryHigh Plains Journal
Huffington Post
all 105 news articles »

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CIRM addresses some tough questions. Is it all just glass towers and basic research?

By Dr. Matthew Watson

At an industry conference recently I heard several new grumbles from companies about CIRM's alleged heavy bias toward funding basic, pre-clinical, embryonic stem cell-focused, academic-based research over clinical-stage, adult stem cell-focused, industry-sponsored product trials, testing, and development.

I myself have shared some concern that for an agency with a key goal of bringing new medicines to the next generation, having less than a handful of projects at the clinical stage this far into its mandate and budget was falling short well of its timeline.

I'll also admit to occasionally harboring a similar sentiment to that of former Intel CEO, Andy Grove, who is, of late, a grumpy critic of the slow pace of life science research when he said of CIRM in a great piece by Jeffrey O'Brien in Fortune Magazine, "CIRM? "There are gleaming fucking buildings everywhere. That wasn't necessary." (The great stem cell dilemma. Fortune. Sept 28, 2012)  
So...I decided to try to hit these concerns and criticisms head on with my friends at the California Institute for Regenerative Medicine (CIRM).  

What follows is an online interview CellTherapyBlog.com (CTB) conducted with the California Institute for Regenerative Medicine (CIRM) the week of October 15, 2012.  In the interview that follows, we were particularly interested in addressing the degree to which CIRM is focused - moving forward - on funding clinical-stage research, industry-sponsored trials, and clinical/commercial-focused product development.  

CTB: Would you please remind us of CIRM’s mandate?

CIRM: “To support and advance stem cell research and regenerative medicine under the highest ethical and medical standards for the discovery and development of cures, therapies, diagnostics and research technologies to relieve human suffering from chronic disease and injury.”

CTB: What percentage of grants or grant money distributed to-date has gone to companies?

CIRM: For-profit entities have been and currently are eligible for CIRM funding covering stages of research which range from basic biology programs (in which industry has shown little interest) through Phase II clinical trials. Of these programs, 13% have been awarded to companies thus far. Having built 12 state of the art stem cell facilities and having seeded  the field with training and other types of grants of similar purpose, CIRM is now focusing on funding translational and clinical programs.  

This is where companies' primary interests are and we expect greater company participation in our translation and clinical Request for Application. The translation and clinical awards programs provide for much larger awards as compared to the basic research and the overall amount of later stage funding is significantly larger than the earlier basic research awards. The number of awards made in the translational and clinical development funding rounds is much less than in the basic science area. 

CIRM’s Strategic Partnership Funding Program is a cornerstone of our efforts to fund industry.   We expect to make awards through this program approximately every six months to assist companies whose financing demands is frequently at shorter intervals than academic institutions. These awards will be made following a robust peer review process ensuring that awards are made to projects that are based on sound scientific data and have a reasonable chance of success.

CTB: How many CIRM-funded projects will be in clinical trial this year?  How many anticipated to be in 2013?

CIRM: Four clinical trials that were fostered by CIRM funds are already in clinical trials for cancer and blood disorders. We expect one or more CIRM-funded projects to join that list in the next year. This includes projects that are in clinical trial already for which we have funded and are funding the follow on studies.

CTB: Is CIRM actively seeking applications for clinical-stage projects? from companies?

CIRM: Yes, we have recently held the first round of applications for our Strategic Partnership Awards that are designed specifically to attract applications from industry and include significant leveraged funding from multinational biopharmaceutical companies and/or venture capital. The first of these awards will be announced at an upcoming meeting of our governing board, the Independent Citizens Oversight Committee. Industry also accesses CIRM funding through the Disease Team awards, which include teams comprised of both academic researchers and industry as partners, consultants and advisors. 

CTB: In its funding to-date more CIRM funding has gone to pre-clinical over clinical science, embryonic over adult stem cell research, and infrastructure over labor.  Is that a fair assessment?

CIRM: No. We have awarded more basic research grants in numbers, but those grants are much smaller in dollars than those in our translational portfolio. That translational portfolio includes 75 projects that have been awarded nearly $600 million, well over half of the research dollars committed.

When CIRM funding was initiated in late 2006, there was a need to build intellectual and facility capacity because doubts about support from federal sources had limited the entry of scientists into the field and there was a need for “safe harbor facilities. “ Research into stem cells was also at an early stage and so it made sense for us to focus on the discovery phase of basic biology and pre-clinical work to enable more effective utilization of the potential that was evident.

Increasingly however we are moving towards clinical science, to enable a proper assessment of the value of cell therapies and related approaches for advancement of human medicine.

Our focus has always included all stem and progenitor cells. Pluripotential stem cells are immortal and develop into all cells of the body, so the potential is large and the available funding outside CIRM has been modest. We have concentrated on human rather than animal model cells because this is where the need has been greatest. Our goal is to fund transformational research with the highest potential benefit to patients, regardless of the stem cell type they utilize.

As for infrastructure, we spent $271 million in major facilities grants to help create new, state-of-the-art safe harbor research facilities in California which are essential for  delivering  the goals of CIRM. That investment was used to leverage almost $900 million in additional funds from private donors and institutions to help pay for those facilities. Each facility  attracted new researchers to the state,  employed local construction workers  and created expanded research facilities that will now be able to offer long-term employment for the high tech innovators in stem cell research, transformative new medicines  for intractable disease and deliver economic benefit for Californians.

CTB: Given the juxtaposition of the relative dearth of CIRM-funded clinical projects to-date and the mandate to support bringing therapies to the clinic, in the last half of its mandate does CIRM intend to emphasize funding of more clinical projects? 

CIRM: Yes, our focus in our new Strategic Plan does just that, emphasizing the increased focus on translation and clinical trials. As described above, we are investing strongly in this sector. But we firmly believe that advancement in medicine is dependent on the science that underpins the medical strategies. We will also  continue to support high quality basic science that can transform medical opportunities.  

CTB:  If so, do you anticipate more of those will involve the use of adult cells over embryonic just by virtue of the fact more of these are closer to or already in clinical testing?

CIRM: We are required by our statute to fund in those areas that are under-invested. Otherwise we are agnostic to cell type. We expect a mixture of embryonic (induced pluripotent stem cells as well when they are ready for clinical studies), fetal, adult, cancer stem and progenitor cells, as well as small molecules, biologics and other approaches, evolving from stem cell assays and research. We are most concerned with the ability to produce results for patients.

CTB: I understand CIRM has made efforts over the past couple year to ease the burden or restrictions on companies applying for funds, is that true? 

Yes, we have appointed a Vice President with business development responsibilities and are further strengthening this capacity with key staff. We are actively working with industry to develop sustainable partnerships in research, we hold webinars and face to face meetings with the FDA to better equip industry with the tools that can aid in their investigational new drug (IND) submissions . We also assist industry to better understand what they need to do to successfully apply for CIRM funding.

We have also made changes to our intellectual property regulations and loan regulations to make it even more attractive for companies  to partner with us in research.

CTB:  I have heard it said that CIRM is not interested in funding late-stage trials.  Is that outside CIRM’s mandate or is it simply a matter of not having enough money to fund a late-stage trial?

Our focus has been in moving promising research through the "Valley of Death" phase, from the lab through Phase 1 and 2 clinical trials. We are working with major industry and financial institutions to inform them of our developing portfolio with the belief that they will be interested in taking many of these products to the market place. We are probably unable to afford to do these late stage clinical trials alone and feel it is likely that commercial interests will provide the follow on funding. 

CTB: If CIRM’s $20M could be matched with another $20M to fund a late-stage trial, would that be appropriate and feasible to entertain?

CIRM: We are always interested in proposals that will enhance our mission. While this hypothetical has not been put to us we would have to assess the proposal on its merits and our available finances. 

CTB: For clinical-stage companies outside California, what legitimate ties to California can be put in place to make one eligible for CIRM funding?  Is a company required to have a Californian entity or is it enough to have collaborations with a Californian entity or key service providers located within the state such as a California-based manufacturer or clinical sites in California?  What about having some staff in California?  Other ways?

CIRM:  In our RFA’s we have provided guidance as to what entities qualify for CIRM funding.  Future requirments  are presently under review by our General Counsel. Certainly, companies will need to show genuine steps at the time of application  towards relocation of a significant component of their research activities to California in addition to establishing a California operation with California employees. CIRM funding would be largely limited to in-state  activities.



My synopsis:  

I'm willing to reserve judging CIRM's overall track record of funding of clinical-stage and industry-sponsored research based on what it has done to-date.

My assessment of CIRM's contributions to clinical-stage science and product development will be heavily weighted on what it does from this point forward.

There is a certain rationale at play here that says they had to spend the first part of the mandate building the research infrastructure and scientific underpinnings required to move successful clinical and product development forward in the last half of its mandate. It may not be a rationale you whole-heartedly endorse but it is credible and I, for one, and willing to give CIRM the benefit of the doubt on this one. 
Having said that, my expectations for CIRM in the latter part of its mandate are very high with respect to how much they are going to dedicate to clinical-stage, industry-sponsored research.  

However, CIRM cannot do this in a vacuum.  What is required is for companies to do what they can to work with CIRM.  Don't give up on them based on their past record or your past experience.  Let's work with CIRM to help them focus their resources on moving some meaningful clinical milestones forward.
____________

I hope this interview helps clarify for readers just how CIRM views its ongoing and future participation in clinical-stage and industry-sponsored regenerative medicine research, testing, and development.

I would be happy to entertain and channel further questions anyone might have about CIRM (excluding those pertaining to specific applications or projects).


Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/wzhx7dkP3vk/cirm-addresses-some-tough-questions-is.html

To Read More: CIRM addresses some tough questions. Is it all just glass towers and basic research?
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The 2012 Nobel Prize in Physiology or Medicine

By Dr. Matthew Watson

The Press Release from the Nobel Assembly at Karolinska Institute

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To Read More: The 2012 Nobel Prize in Physiology or Medicine
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BioTime Makes Bid for Geron’s Stem Cell Assets

By Dr. Matthew Watson


Biotime, Inc., and two men who were
leading players in history of Geron Corp. today made a surprise,
public bid for the stem cell assets of their former firm.

Michael West
West photo
Tom Okarma
AP file photo
The men are Michael West and Thomas
Okarma
. West founded Geron in 1990 and was its first CEO. West is
now CEO of Biotime. Okarma was CEO of Geron from 1999 to 2011.
Okarma joined Biotime on Sept. 28 to lead its acquistion efforts.
Both Geron, based in Menlo Park, Ca., and Biotime, based in Alameda,
Ca., are publicly traded.
West and Okarma sent an open letter this morning to Geron shareholders and issued a press release making
a pitch for the Geron's stem cell assets. Geron jettisoned its hESC
program nearly a year ago and closed its clinical trial program for
spinal injuries. The move shocked the California stem cell agency,
which just a few months earlier had signed an agreement to loan the
firm $25 million to help fund the clinical trial. The portion of the
loan that was distributed was repaid with interest.
At the time, Geron said it would try to
sell off the hESC program, but no buyers have surfaced publicly.
Personnel in the program have been laid off or found employment
elsewhere.
The West-Okarma letter to shareholders
said that under the deal,

“Geron would transfer its stem cell
assets to BAC(a new subsidiary of Biotime headed by Okarma), in
exchange for which you along with the other Geron shareholders would
receive shares of BAC common stock representing approximately 21.4%
of the outstanding BAC capital stock. BioTime would contribute to BAC
the following assets in exchange for the balance of outstanding BAC
capital stock:

  • “$40 million in BioTime common
    shares;
  • “Warrants to purchase BioTime
    common shares (“BioTime Warrants”);
  • “Rights to certain stem cell
    assets of BioTime, and shares of two BioTime subsidiaries engaged in
    the development of therapeutic products from stem cells.”
The letter asked Geron shareholders to
write the firm's board of directors to urge them to approve the
offer.
Geron had no immediate response to the
proposal. Asked for comment, Kevin McCormack, spokesman for the
California stem cell agency, said the deal “had nothing to do with
us.” However, in the past, CIRM has indicated that it could find a
way to transfer the loan to an entity that would continue spinal
injury clinical trial. CIRM President Alan Trounson was also involved
at one point in trying to assist in a deal.
Geron's shares rose 12 cents to $1.54
today while Biotime's shares lost four cents to $3.95.
Here are links to the two news stories
that have appeared so far on the proposed deal: Associated PressMarketwatch.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/v1bas6eGZF0/biotime-makes-bid-for-gerons-stem-cell.html

To Read More: BioTime Makes Bid for Geron’s Stem Cell Assets
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Los Angeles Times: StemCells, Inc., Award ‘Redolent of Cronyism’

By Dr. Matthew Watson


The Los Angeles Times this
morning carried a column about the “charmed relationship” between
StemCells, Inc., its “powerful friends” and the $3 billion
California stem cell agency.

The article was written by
Pulitzer prize winner and author Michael Hiltzik, who has been
critical of the agency in the past. The piece was the first in the major
mainstream media about a $20 million award to StemCells, Inc., that was approved in September by the agency's board. The bottom line of the
article? The award was “redolent of cronyism.”
Hiltzik noted that
StemCells, Inc., now ranks as the leading corporate recipient of cash
from the agency with $40 million approved during the last few months.
But he focused primarily
on September's $20 million award, which was approved despite being
rejected twice by grant reviewers – “a particularly
impressive” performance, according to Hiltzik. It was the first
time that the board has approved an award that was rejected twice by
reviewers.
Hiltzik wrote,

What was the company's
secret? StemCells says it's addressing 'a serious unmet medical need'
in Alzheimer's research. But it doesn't hurt that the company also
had powerful friends going to bat for it, including two guys who were
instrumental in getting CIRM off the ground in the first place.”

The two are Robert Klein,
who led the ballot campaign that created the agency and became its
first chairman, and Irv Weissman of Stanford, who co-founded
StemCells, Inc., and sits on its board. Weissman, an internationally
known stem cell researcher, also was an important supporter of the
campaign, raising millions of dollars and appearing in TV ads. Klein,
who left the agency last year, appeared twice before the CIRM board
this summer to lobby his former colleagues on behalf of Weissman's
company. It was Klein's first appearance before the board on behalf
of a specific application.
The Times piece continued,

But private enterprise
is new territory for CIRM, which has steered almost all its grants
thus far to nonprofit institutions. Those efforts haven't been
trouble-free: With some 90% of the agency's grants having gone to
institutions with representatives on its board, the agency has long
been vulnerable to charges of conflicts of interest. The last thing
it needed was to show a similar flaw in its dealings with private
companies too.”

Hiltzik wrote,

(Weissman) has also
been a leading beneficiary of CIRM funding, listed as the principal
researcher on three grants worth a total of $24.5 million. The agency
also contributed $43.6 million toward the construction of his
institute's glittering $200-million research building on the Stanford
campus.”

CIRM board approval of the
$20 million for StemCells, Inc., came on 7-5 vote that also required
the firm to prove that it had a promised $20 million in matching
funds prior to distribution of state cash.
Hiltzik continued,

The problem is that
StemCells doesn't have $20 million in spare funds. Its quarterly
report
 for the period ended June 30 listed about $10.4
million in liquid assets, and shows it's burning about $5 million per
quarter. Its prospects of raising significant cash from investors
are, shall we say, conjectural.

As it happens, within
days of the board's vote, the
firm downplayed
 any pledge 'to raise a specific amount of
money in a particular period of time.' The idea that CIRM 'is
requiring us to raise $20 million in matching funds' is a
'misimpression,' it said. Indeed, it suggested that it might count
its existing spending on salaries and other 'infrastructure and
overhead' as part of the match. StemCells declined my request that it
expand on its statement.
 

CIRM spokesman Kevin
McCormack
says the agency is currently scrutinizing StemCells'
finances 'to see what it is they have and whether it meets the
requirements and expectations of the board.' The goal is to set
'terms and conditions that provide maximum protection for taxpayer
dollars.' He says, 'If we can't agree on a plan, the award will
not be funded.'"

Hiltzik wrote,

The agency shouldn't be
deciding on the spot what does or doesn't qualify as matching funds.
It should have clear guidelines in advance.

Nor should the board
overturn the judgment of its scientific review panels without
clear-cut reasons....The record suggests that the handling of the
StemCells appeal was at best haphazard and at worst redolent of
cronyism.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6qvBfSLP3RE/los-angeles-times-stemcells-inc-award.html

To Read More: Los Angeles Times: StemCells, Inc., Award ‘Redolent of Cronyism’
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California Stem Cell Agency Boosting Disease Team Program to $543 Million

By Dr. Matthew Watson


Directors of the California stem cell
agency are set to give away $20 million next Thursday and authorize
a handsome addition to their signature disease team effort, bringing
its total to $543 million.

It is all part of the $3 billion
agency's push to develop therapies prior to running out of money for
new grants in 2017.
The $20 million is expected to go to
the first two winners in the agency's new strategic partnership
program. CIRM says the effort is aimed at
creating “incentives and processes that will: (i) enhance the
likelihood that CIRM funded projects will obtain funding for Phase
III clinical trials (e.g. follow-on financing), (ii) provide a source
of co-funding in the earlier stages of clinical development, and
(iii) enable CIRM funded projects to access expertise within
pharmaceutical and large biotechnology partners in the areas of
discovery, preclinical, regulatory, clinical trial design and
manufacturing process development.”
CIRM reviewed six applications with two winning approval. The agency's governing board is expected to ratify the decision next week. None of the applicants have been identified by the agency, which routinely withholds that information prior to
board action even when applicants have identified themselves.
Addition of a new $100 million
disease team round will come on top of the second, $213 million disease
team awards approved last this summer. The first round, awarded in
2009, totaled $230 million.  The size of the new round could be altered by CIRM directors prior to approval. Also before the board is a $40 million
proposal to expand the industry-friendly strategic partnership effort
into a second round.
The thrust of the disease team effort
is to speed the process of establishing clinical trials and to finance
efforts that might founder in what the biotech industry calls a
valley of death – a high risk financial location, so to speak,
where conventional financiers fear to tread.
The new disease team round will require
“co-funding” from applicants but the agency did not specify what
it means by the term. The matter of matching funds has become an issue in awards to StemCells, Inc., of Newark, Ca., in this summer's
disease team round.
Next week's agenda additionally
contains a plan to tighten review of proposed research budgets in
grant applications, making it clear that CIRM staff will be
negotiating such matters even after the board approves grants and
loans.
So far no researchers have testified in
public on the budget plan although it could well have a significant
impact on their future efforts.
Additional matters will discussed as
well at the meeting in Burlingame, which also has a teleconference
location in La Jolla that will be open to the public. The address
and additional material can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1gFmBSDEYCU/california-stem-cell-agency-boosting.html

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Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions

By Dr. Matthew Watson


The move by the $3 billion California
stem cell agency to curtail its free-wheeling grant appeal process
will undergo its first public hearing next week.

The proposals will mean that scientists
whose applications are rejected by reviewers will have fewer avenues
to pursue to overturn those decisions. The changes could take effect
as early as next year.
The move comes in the wake of a record
number of appeals this summer that left the board complaining about
“arm-twisting,” lobbying and “emotionally charged presentations.”
Among other things, the new "guidelines" attempt to define
criteria for re-review – “additional analysis” – of
applications involved in appeals, also called “extraordinary
petitions.” The plan states that re-review should occur only in
the case of a material dispute of fact or material new information.
(See the end of this item for agency's proposed definitions.)
In addition to alterations in the
appeal process, the CIRM directors' Application Review Task Force
will take up questions involving “ex parte communications.” The
agenda for the Oct. 24 meeting did not contain any additional
information on the issue but it likely deals with lobbying efforts on
grants outside of public meetings of the agency. We understand that
such efforts surfaced last summer involving the $$214 million disease
team round and Robert Klein, the former chairman of the stem cell
agency.
Klein appeared twice publicly before
the board on one, $20 million application by StemCells, Inc., the
first time a former governing board member has publicly lobbied his former
colleagues on an application. The application was rejected twice by reviewers – once
on the initial review and again later on a re-review – but it was
ultimately approved by directors in September on a 7-5 vote.
The board has long been troubled with
its appeal process but last summer's events brought the matter to a
new head. The issue is difficult to deal with because state law
allows anyone to address the CIRM governing board on any subject when
it meets. That includes applicants who can ask the board to approve
grants for any reason whatsoever, not withstanding CIRM rules. The board can also approve a grant
for virtually any reason although it has generally relied on
scientific scores from reviewers.
The proposals to restrict appeals are
designed to make it clear to scientists whose applications are
rejected by reviewers that the board is not going to look with favor
on those who depart from the normal appeals procedure.
While the board almost never has
overturned a positive decision by reviewers, in nearly every round it  approves some applications that have been rejected by reviewers. That has
occurred as the result of appeals and as the result of motions by
board members that did not result from public appeals.
Ten of the 29 board members are classified as patient advocates and often feel they must advance the cause of the
diseases that they have been involved with. Sometimes that means
seeking approval of applications with low scientific scores.
Here is how agency proposes to define
“material dispute of fact:”

“A material dispute of fact should
meet five criteria:(1) An applicant disputes the accuracy of a
statement in the review summary;(2) the disputed fact was significant
in the scoring or recommendation of the GWG(grant review group); (3) the dispute pertains
to an objectively verifiable fact, rather than a matter of scientific
judgment or opinion;(4) the discrepancy was not addressed through the
Supplemental Information Process and cannot be resolved at the
meeting at which the application is being considered; and
(5) resolution of the dispute could affect the outcome of the board’s
funding decision."

Here is how the agency proposes to
define “material new information:”

“New information should: (1)be
verifiable through external sources; (2) have arisen since the
Grants Working Group(grant review group) meeting at which the application
was considered; (3) respond directly to a specific criticism or
question identified in the Grants Working Group’s review; and (4)
be submitted as part of an extraordinary petition filed five business
days before the board meeting at which the application is
being considered."

Next week's hearing is scheduled for
Children's Hospital in Oakland with a teleconference location at UC
Irvine
. Addresses can be found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6sbxGqQJ77Y/researcher-alert-stem-cell-agency-to.html

To Read More: Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions
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