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FAQ-8 of 19: With Stem Cell Therapy Are There Any Stem Cell Side Effects? – Video

By NEVAGiles23


FAQ-8 of 19: With Stem Cell Therapy Are There Any Stem Cell Side Effects?
youtu.be The near-miraculous effects of stem cell treatments, when applied by qualified, licensed medical practitioners, is even more wonderful precisely because there are almost no known ill effects or side effects. So for more detailed and personalized information, go to StemCell-Asia.info to learn more on the Apply Now page httpFrom:John PepperViews:0 0ratingsTime:00:53More inPeople Blogs

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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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FAQ-7 of 19: In Stem Cell Therapy How Long Do Benefits of Stem Cells Last? – Video

By raymumme


FAQ-7 of 19: In Stem Cell Therapy How Long Do Benefits of Stem Cells Last?
youtu.be Briefly explaining how long the benefits of stem cell therapy last, when, why and for what conditions. For more detailed explanations, go to StemCell-Asia.info and find the #39;Apply Now #39; page, httpFrom:Harvey WallbangerViews:0 0ratingsTime:01:19More inEducation

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FAQ-7 of 19: With Stem Cell Therapy, How Long Do Stem Cell Benefits Last? – Video

By NEVAGiles23


FAQ-7 of 19: With Stem Cell Therapy, How Long Do Stem Cell Benefits Last?
youtu.be Briefly explaining how long the benefits of stem cell therapy last, when, why and for what conditions. For more detailed explanations, go to StemCell-Asia.info and find the #39;Apply Now #39; page, httpFrom:Karridine1Views:0 0ratingsTime:01:19More inPeople Blogs

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FAQ-8 of 19: Do Stem Cells Have Side Effects In Stem Cell Therapy? – Video

By daniellenierenberg


FAQ-8 of 19: Do Stem Cells Have Side Effects In Stem Cell Therapy?
youtu.be The near-miraculous effects of stem cell treatments, when applied by qualified, licensed medical practitioners, is even more wonderful precisely because there are almost no known ill effects or side effects. So for more detailed and personalized information, go to StemCell-Asia.info to learn more on the Apply Now page httpFrom:Karridine1Views:0 0ratingsTime:00:53More inPeople Blogs

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FAQ-8 of 19: Do Stem Cells Have Side Effects In Stem Cell Therapy? - Video

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

By LizaAVILA


FAQ-9 of 19: In Stem Cell Therapy Are There Contraindications for Stem Cells?
youtu.be Yes, there ARE some times and some ways that stem cells should NOT be used, so this short video outlines them for you. For more personalized information, visit bit.ly or StemCell-Asia.info now.From:Karridine1Views:0 0ratingsTime:00:54More inPeople Blogs

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market (2012-2017) (Neurodegenerative, cardiovascular, cancer …

By Sykes24Tracey

NEW YORK, Nov. 1, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Autologous Stem Cell and Non-Stem Cell Based Therapies Market (2012-2017) (Neurodegenerative, cardiovascular, cancer & autoimmune, skin and infectious diseases)

http://www.reportlinker.com/p01022392/Autologous-Stem-Cell-and-Non-Stem-Cell-Based-Therapies-Market-2012-2017-Neurodegenerative-cardiovascular-cancer--autoimmune-skin-and-infectious-diseases.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

Autologous cell therapies are new therapeutic intervention where it introduces or uses cells or tissues from the individual, cultured, expanded and re-introduced at the site of the disease of the donor. They are widely promoted as next pillar or advancement in medical care.

Growth of the market is very rapid especially in regulatory approvals, applications areas and rapid improvements in efficacy of treatment; it has enormous advantages over allogenic stem cell therapies. Autologous transplants are relatively safe procedures, with less rates of complications and infections compared with allogenic transplants. In many instances, much of the procedure can be done on an outpatient basis. It helps in treating various dreadful diseases by transplanting their own body cells where it results in meager chances of transplant rejection.

We have also profiled leading players of this industry with their recent developments and other strategic industry activities. These include: Neostem (U.S.), Tengion (U.S.), Brainstorm Cell Therapeutics (U.S.), Dendreon Corporation (U.S.), Georgia Health Sciences University (U.S.), Regenexx (U.S.), Regeneus (Australia), Cytori Therapeutics (U.S.), Tigenix (Belgium).

Scope of the Report

This research report titled "Autologous Cell Therapy (2012-2017)" provides details about various ACT based treatments and their application areas. Every health regulatory bodies will be expecting companies and universities to develop therapy treatments, which are safer, affordable, robust, rapid, easy to use, effective and deliverable to the end user. ACT treatments for particular application areas it is safe, experiencing robust growth, minimal steps of procedure to follow and rapid in deriving the results. As for now the treatments prices are not affordable, but by the intrusion of government bodies, it will definitely experience a immense market growth.

The report gives a detailed analysis about state of the art of autologous cell therapies. It includes the current advances and applications of the technology and trends in terms of market size and growth of autologous cellular therapies in medical treatments globally. It also consists of funding details of the innovative therapy and recent activities in terms of mergers & acquisitions of the company, revenue forecasting. It includes latest therapy details and products which are available for licensing and approvals from various regulatory bodies. Using drivers, restraints and challenges it is forecasted for a period of five years i.e. 2012-2017. Opportunity strategy evaluation has been included which gives information for investors.

Autologous Cell Therapy technology is changing the medicinal treatments by introducing various new therapies. Its scope is vast and promising for the future despite challenges.

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market (2012-2017) (Neurodegenerative, cardiovascular, cancer ...

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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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Stem cell therapy for muscle, sports injury alternative to surgery

By raymumme

By Erika Sauler Philippine Daily Inquirer

MANILA, Philippines This type of stem cell therapy does not claim to be the fountain of youth, but an alternative treatment to arthritis, muscle pain and tendon tear.

Two Filipino doctors who trained in the United States said in a media forum on Sunday that autologous stem cell therapy could speed up the healing of musculoskeletal and sports-related injuries, which could be an optional remedy before undergoing surgery.

Dr. Jeimylo de Castro explained that the procedure would involve taking stem cells from the patients blood, fat tissue or bone marrow and injecting them to the injured area of the same person. This type of therapy is different from the controversial embryonic stem cells which are harvested from animals or fertilized eggs.

With stem cell therapy being a current fad for anti-aging, the Department of Health has warned the public that the benefits of stem cell therapy are still under evaluation. The DOH will soon issue guidelines for the use of stem cell therapy and the licensing of facilities offering this service.

De Castro and Dr. Franklin Domingo are both fellows of the Philippine Academy of Rehabilitation Medicine. They underwent training for stem cell therapy under Dr. Joseph Purita of the Institute of Regenerative and Molecular Orthopaedics, and Dr. Sherwin Kevy of Harvards Immune Disease Institute.

If you have arthritis and you take anti-inflammatory drugs, you will not feel the pain so you will move around and further damage the cartilage. Whereas stem cells will regenerate tissues and ease the pain, making the damaged cells become young again, De Castro said.

Domingo likened the stem cells to high school students who have no career yet and could be trained to be professionals in a field where they are needed. So if the stem cells are injected into an injured knee, they will develop into tissues that hasten the recovery of the area.

According to Domingo, stem cell therapy is not for everybody and is not a quick-fix solution because it uses the bodys natural ability to heal.

Patients who have cancer and infection are not allowed to undergo stem cell therapy, and so are those under the influence of alcohol or who have taken blood-thinning medicine like Coumadin at the time of extraction.

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Stem cell therapy for muscle, sports injury alternative to surgery

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Stem cell therapy a cure-all? Not so fast

By daniellenierenberg

MANILA, Philippines Its supposed to cure various illnesses such as cancer, spinal cord injury and Parkinsons disease. Is stem cell therapy the cure-all that it is touted to be?

Health Undersecretary Teodoro Herbosa said it is important to note that stem cell treatments are still at the experimental stage.

"The advisory is very clear. This is still an investigative form of therapy. Anecdotal reports are not enough evidence to say there is treatment, he said in an interview on ANC's Talkback with Tina Palma.

He said there are only two standard stem cell therapies considered effective and acceptable to the medical community.

"To date, I can only name two cases that are considered standard therapy. That is bone marrow transplantation--one for severe cancer, blood cancer and the other one is bone marrow transplantation after chemotherapy for any type of cancer, he said.

Herbosa said the Department of Health cannot confirm yet if stem cell treatment is indeed effective against certain diseases.

Dr. Tranquilino Elicao Jr., an oncologist who availed of the treatment in April in Frankfurt, Germany, said stem cell therapy cured his high blood pressure, sugar, cholesterol and uric acid.

He had 12 injections of cells, which came from lambs.

After a month, I had my blood tests. Everything went down to normal, Elicao said.

Elicao also said he is not taking medication anymore because he has regained his health.

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Stem cell face lift: Does it work?

By NEVAGiles23

Doctors and researchers have long said that stem cell therapy has the potential to change the face of human disease. But what if stem cells could be used to reverse the aging process as well?

Plastic surgeons say they can use stem cells to make women look years younger without the pain of an invasive surgery.

"I lost weight, loss of volume in face, I looked gaunt and I said, so I said, 'okay what do we do to fix this?'" said Sarah, a patient.

The fix for this was a stem-cell face lift. Dr. Steve Szczerba of Chicago Aesthetic Surgery Institute recommended that Sarah undergo a procedure, where he'd use her own adult stem cells to turn back the clock.

"A stem cell facelift is rejuvenating the face using grafted fat. Grafted fat has stem cells in it," Dr. Szczerba explains.

Grafted fat is transferred fat. Dr. Szczerba typically gets it from the patient's abdomen or inner thigh during liposuction.

"During that process of liposuction, we save the fat and take the fat and prepare it for grafting by removing the fluid. And the stem cells along with other grafted fat cells are injected into the face," says Dr. Szczerba.

He says it's not simply a fat transfer. Dr. Szcerba believes the stem cells, which are specialized cells that self renew, are actually working to make collagen and rejuvenate the skin.

"You can actually see the surface of the skin change," says the doctor. "Similar to that a chemical peel or a laser peel accomplishes in order to see change in your cheek area."

Click for more from My Fox Chicago.

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Stem cell face lift: Does it work?

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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 »

Source:
http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNHhZrtOQrbhk4Fiqy_CORbjzAJJVw&url=http://etfdailynews.com/2012/10/26/look-for-a-potential-short-entry-in-the-ishares-nasdaq-biotechnology-etf-ibb-qqq/

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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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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 »

Source:
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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 »

Source:
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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, ...

Source:
http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNFHZ05h9w0T6yzhYxxTZj-twKY9Iw&url=http://today.uconn.edu/blog/2012/10/new-biotechnology-intern-program-offers-students-real-world-lab-experience/

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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:
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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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