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Bone marrow recipient meets donor who gave him gift of life

By daniellenierenberg

BOCA RATON—

A physician from Indianapolis met the woman who saved his life on Sunday morning, providing an emotional kick-off for the second annual Walk for Life, sponsored by the Gift of Life Bone Marrow Foundation.

"It's almost like a total out of body experience," said Scott Savader, 53, moments after he embraced former Sunrise resident Jill Rubin, who provided the stem cells that were transplanted into Savader's body nearly two years ago.

As the two met for the first time, about 300 people cheered before heading off on a 5K walk at Florida Atlantic University. The effort is part of a campaign to raise awareness and raise $100,000 for lab tests necessary to match donors and recipients.

Savader said receiving the transplant was "like being plucked from a fire or a sinking car. There is a bond there now that transcends just knowing somebody. If not for her generosity, I would have died."

Each year, 10,000 people in the U.S. are diagnosed with a disease treatable with a bone marrow transplant. Yet only about half find the donor who could save them, according to Jay Feinberg, the Delray Beach resident who started the foundation after he was diagnosed with an aggressive form of leukemia.

He received a transplant in 1995 and has since dedicated his life to making matches for others.

Savader, a radiologist, was diagnosed with myelofibrosis in 2008.

Rubin, 45, a physical therapist, said she registered as a bone marrow donor 10 years ago while attending a fair in Plantation. She and her family have since moved to Deland.

"This is very emotional for me," said Rubin as she and Savader posed for pictures.

After spending a little time with Savader and his family Sunday, Rubin said she felt even better about her gift to him.

She also learned that Savader grew up and went to high school in Cooper City. "Small world," she said.

Temperatures in the 40s and a chilly wind did little to dampen enthusiasm for the walk. Participants were inspired by Savader and Rubin and other success stories.

Among the latter were 6-year-old Matthew Welling, on hand with his parents Michael and Susie Welling of Port Chester, N.Y., and Boca Raton resident Jill Goldsmith, who donated the bone marrow that reversed the boy's osteoporosis in 2007.

"It was an amazing, life-changing experience," said Goldsmith, 50, as she watched Matthew dance happily around a field at the university.

"What I had to do to save a life was so easy," said Goldsmith. "And to see him now, well, I feel proud and honored and so blessed."

During last year's walk, more than 1,000 new donors were added to the registry and resulted in 14 matches for patients throughout the U.S. They joined a total registry of nearly 200,000, said Feinberg.

Volunteering to become a potential donor begins with an oral swab that is then tested for tissue type. Most of the foundation's money goes toward paying for those lab tests, which cost about $55 each, said Feinberg.

For information, go to mwclary@tribune.com">http://www.giftoflife.org.

mwclary@tribune.com or at 954-356-4465

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Scientists grow brain cells from human skin

By JoanneRUSSELL25

LONDON: British scientists are claiming a breakthrough after creating brain tissue from human skin.

The researchers have for the first time generated a crucial type of brain cells in the laboratory by reprogramming skin cells.

They say it could speed up the hunt for new treatments for conditions such as Alzheimer's disease, epilepsy and stroke.

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Until now it has only been possible to generate tissue from the cerebral cortex, the area of the brain where most serious neurological diseases occur, by using controversial embryonic stem cells, obtained by the destruction of an embryo. This has meant the supply of brain tissue available for research has been limited due to ethical concerns and limited availability.

Scientists at the University of Cambridge say that they have overcome this problem, showing for the first time that it is possible to re-program adult human skin cells so that they develop into neurons found in the cerebral cortex.

Initially, brain cells grown in this way could be used to help researchers gain a better understanding of how the brain develops and what goes wrong when it is affected by disease. They could also be used for screening new drug treatments.

Eventually, they hope the cells could be used to provide healthy tissue that can be implanted into patients to treat neurodegenerative diseases and brain damage.

Dr Rick Livesey, who led the research at the university's Gurdon Institute, said: ''The cerebral cortex makes up 75 per cent of the human brain. It is where all the important processes that make us human take place. It is, however, also the major place where disease can occur.

''We have been able to take reprogrammed skin cells so they develop into brain stem cells and then essentially replay brain development in the laboratory.

''We can study brain development and what goes wrong when it is affected by disease in a way we haven't been able to before. We see it as a major breakthrough in what will now be possible,'' said Dr Livesey, whose findings are published in the journal Nature Neuroscience.

The cerebral cortex is the part of the brain that is responsible for most of the high-level thought processes such as memory, language and consciousness.

Telegraph, London

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Human brain cells created from skin

By NEVAGiles23

Eventually they hope the cells could also be used to provide healthy tissue that can be implanted into patients to treat neurodegenerative diseases and brain damage.

Dr Rick Livesey, who led the research at the University of Cambridge's Gurdon [corr] Institute, said: "The cerebral cortex makes up 75% of the human brain, is where all the important processes that make us human take place. It is, however, also the major place where disease can occur.

"We have been able to take reprogrammed skin cells so they develop into brain stem cells and then essentially replay brain development in the laboratory.

"We can study brain development and what goes wrong when it is affected by disease in a way we haven't been able to before. We see it as a major breakthrough in what will now be possible."

The cerebral cortex is the part of the brain that is responsible for most of the major high-level thought processes such as memory, language and consciousness.

While human brain cells have been created from stem cells before, this has relied upon embryonic stem cells. Attempts to make them from skin cells have produced neurons that are not found in the cerebral cortex.

Dr Livesey and his colleagues were able to create the two major types of neuron that form the cerebral cortex from reprogrammed skin cells and show that they were identical to those created from the more controversial embryonic stem cells.

Dr Livesey, whose findings are published in the journal Nature Neuroscience, said this may eventually lead to new treatments for patients where damaged tissue could be replaced by brain cells grown in the laboratory from a sample of their skin.

He said: "You don't need to rebuild damage to recover function as the brain is quite good at recovering itself – it does this after stroke for example. However, it may be possible to give it some extra real estate that it can use to do this.

"We can make large numbers of cerebral cortex neurons by taking a sample of skin from anybody, so in principal it should be possible to put these back into the patients."

Dr Simon Ridley, head of research at Alzheimer's Research UK, which funded the study alongside the Wellcome Trust, added: "Turning stem cells into networks of fully functional nerve cells in the lab holds great promise for unravelling complex brain diseases such as Alzheimer's."

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Brain cells created from human skin

By LizaAVILA

London, Feb 12 (ANI): British scientists have for the first time generated crucial types of human brain cells in the laboratory by reprogramming skin cells, which they say could speed up the hunt for new treatments for conditions such as Alzheimer's disease, epilepsy and stroke.

Until now it has only been possible to generate tissue from the cerebral cortex, the area of the brain where most major neurological diseases occur, by using controversial embryonic stem cells, obtained by the destruction of an embryo.

This has meant the supply of brain tissue available for research has been limited due to the ethical concerns around embryonic stem cells and shortages in their availability.

However, scientists at the University of Cambridge now insist they have overcome this problem after showing for the first time that it is possible to re-programme adult human skin cells so that they develop into neurons found in the cerebral cortex, the Telegraph reported.

Initially brain cells grown in this way could be used to help researchers gain a better understanding of how the brain develops, what goes wrong when it is affected by disease and it could also be used for screening new drug treatments.

Eventually they hope the cells could also be used to provide healthy tissue that can be implanted into patients to treat neurodegenerative diseases and brain damage.

The cerebral cortex is the part of the brain that is responsible for most of the major high-level thought processes such as memory, language and consciousness.

"The cerebral cortex makes up 75 percent of the human brain, is where all the important processes that make us human take place. It is, however, also the major place where disease can occur," said Dr Rick Livesey, who led the research at the University of Cambridge's Gurdon [corr] Institute.

"We have been able to take reprogrammed skin cells so they develop into brain stem cells and then essentially replay brain development in the laboratory.

"We can study brain development and what goes wrong when it is affected by disease in a way we haven't been able to before. We see it as a major breakthrough in what will now be possible," he added.

Dr Livesey and his colleagues were able to create the two major types of neuron that form the cerebral cortex from reprogrammed skin cells and show that they were identical to those created from the more controversial embryonic stem cells.

He said this may eventually lead to new treatments for patients where damaged tissue could be replaced by brain cells grown in the laboratory from a sample of their skin.

"You don't need to rebuild damage to recover function as the brain is quite good at recovering itself - it does this after stroke for example. However, it may be possible to give it some extra real estate that it can use to do this," Dr Livesey said.

"We can make large numbers of cerebral cortex neurons by taking a sample of skin from anybody, so in principal it should be possible to put these back into the patients," he added.

Dr Simon Ridley, head of research at Alzheimer's Research UK, which funded the study alongside the Wellcome Trust, said: "Turning stem cells into networks of fully functional nerve cells in the lab holds great promise for unravelling complex brain diseases such as Alzheimer's."

The findings were published in the journal Nature Neuroscience. (ANI)

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from …

By NEVAGiles23

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell …

By raymumme

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell, said, "The JV is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor.”

Dr. Margolin continued, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine.”

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The company’s pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers such as leukemia and lymphoma, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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Dr. Levy Switzerland – Video

By Dr. Matthew Watson

18-01-2012 15:53 Dr. Phillip Levy explains the science behind the revolutionary new Dr.Levy Switzerland anti-aging brand WORLD-RENOWNED ESTHETIC DERMATOLOGY PIONEER LEADING FACIAL REJUVENATION EXPERT // Number 1 Botox private doctor in Switzerland In today's world, nobody wants to look their age anymore, and many people seek to restore their skin's natural beauty. So what is so unique and new about your products? Dr. LEVY Switzerland®'s revolutionary Booster Cream and Booster Serum, are the world's first cosmetics, scientifically proven in vitro, to activate and vitalize both Dermal and Epidermal stem cells. Skin stem cells, it's important to remember, have unique anti-aging properties since they renew themselves as well as repair, replace and regenerate damaged skin. What are the extraordinary scientific advances behind the development of these special products ? In the last 2 years there have been 3 major discoveries involving advanced stem cell technology. One, in Montpellier, France, researchers were able to regenerate 101 year-old skin cells. They proved that not only did skin cells retain the memory of their youth, but that old cells could actually become young again ! Two, cardiologists in the United States published a study showing that the heart could be repaired by stem cells, even after a severe heart attack. And finally, researchers in Toronto Canada discovered the exact location of dermal stem cells, the very cells which are at the source of the skin's natural anti-wrinkle system. So ...

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First U.S. Rules for Generic Biotechnology Drugs Set Out in Draft Proposal – Bloomberg

By Dr. Matthew Watson


USA TODAY
First U.S. Rules for Generic Biotechnology Drugs Set Out in Draft Proposal
Bloomberg
US regulators proposed guidelines for approving the first lower-cost copies of biologic drugs derived from living cells in a move that will help cut national health spending by an estimated $25 billion over a decade. The Food and Drug Administration ...
Biotechnology Drug Copies to Get New FDA RulesThirdAge
US Releases Draft Guidelines for Generic Biotechnology DrugsBusinessWeek
FDA sets draft rules for biotech drug copiesFox News
MarketWatch (press release) -NASDAQ
all 245 news articles »

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Aradigm to Present at the Biotechnology Industry Organization (BIO) CEO … – MarketWatch (press release)

By Dr. Matthew Watson


Proactive Investors USA & Canada
Aradigm to Present at the Biotechnology Industry Organization (BIO) CEO ...
MarketWatch (press release)
HAYWARD, Calif., Feb 08, 2012 (BUSINESS WIRE) -- Aradigm Corporation /quotes/zigman/401285 ARDM -3.57% (the "Company") today announced that President and Chief Executive Officer, Igor Gonda, Ph.D., will present at the 14th Annual BIO CEO & Investor ...
Lexicon Pharmaceuticals to Present at the 14th Annual BIO CEO & Investor ...PR Newswire (press release)

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Sight Seen: Gene Therapy Restores Vision in Both Eyes

By Dr. Matthew Watson

Gene therapy has markedly improved vision in both eyes in three women who were born virtually blind. The patients can now avoid obstacles even in dim light, read large print and recognize people's faces. The operation, researchers predict, should work even better in children and adolescents blinded by the same condition.

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Cracks in the Plaques: Mysteries of Alzheimer’s Slowly Yielding to New Research

By Dr. Matthew Watson

This has been a big week in Alzheimer's news as scientists put together a clearer picture than ever before of how the disease affects the brain. Three recently published studies have detected the disease with new technologies, hinted at its prevalence, and described at last how it makes its lethal progress through the brain.

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Is Life Sciences the New Frontier for Analytics?

By Dr. Matthew Watson

Via Scoop.itinPharmatics

pharmaceuticals Researchers say pharmaceutical and other life sciences companies are ramping up their uses of analytics…
Via smartdatacollective.com

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Internet on any Display Device, or internet on TV at low cost can it transform Healthcare or Clinical Research

By Dr. Matthew Watson

The invention of an internet set top box has nothing to do with healthcare or  clinical trial at first look. But if HP and other companies are capable of delivering the research, then internet on any display device could change the way clinical trial is practiced at-least beginning with EDC. Yes I agree it is bit far fetched wild thought, but why not. It can also perhaps bring some transformation into patient waiting rooms in hospitals. HP’s invention along with Microsoft Kinect for PC is capable of bringing some big changes to healthcare  practice, mostly notably in TeleHealth.

If nothing else it would atleast bring internet to the masses much faster and cheaper than Android, 3G, and LTE, WiMax all put together, for the simple reason that most of the households that are capable of benefiting from the internet has access to TV as well. atleast in India

Take a look at news coverage “ HP India Research Labs brings Internet TV for the masses with the help of a TV set top box that cost less than $150″ news by Times of India

HP Labs has recently came out with what they call as “Internet TV Set Top Box for the masses” the product is called  Vayu Internet Device or VInD. HP Labs India has created the product which was reviewed by Times of India News paper. The solution enables people to receive internet content on even the most basic TV sets and manage all screen operations using basic TV remotes.

More About HP Labs Vayu Experience Platform

The HP product offers the following solutions,

Task Genie: This is a store of  apps, Yes apple has tons of them , but how many of them are useful , and several of those apps are me too products. Before anyone shouts shoot him let me tell you I have an iPhone4 loaded with 319 apps, I don’t think any one can beat that, and yet I don’t use almost 300 of them at-least once in a month, despite the fact that except one or 2 games most  other are serious apps. Yes I agree among the 300 are several apps which are me too copy cat apps which offers same function, like contact management and duplicate remover, SMS apps, chat solutions. The point is more the apps the better is not true, its the quality that matters that’s were Android fails

Web Tuner: This allows the user to create web categories, such as say News or Tech or Nature, and within each he can have the particular websites he is most interested in

Libraries: allows users to store photos, videos, music and documents in the set-top box’s hard disk. Users can tag and share them with others who have similar set-top boxes.

Contacts and Whiteboard: Users can create and store a contacts list. They can share content or have a video-conference with others who have similar set-top boxes.

Pairing with mobile phone: The set-top box can be paired with mobile phones. So, if it is paired with the user’s phone,he  can send messages to his  TV

Sensor: VInD comes with a built-in Zigbee sensor network. VInD detects the motion and sends an alert to the paired phone.

Keyboard and mouse: Vayu, which uses aLinux  operating system, can also be used as a regular PC, with a keyboard and mouse with a browser and with the TV acting as the monitor. It can be a wired or a wireless keyboard and mouse. This is were I think ViND can bring some advantage in clinical research space, every clinical trial monitoring room has  a TV

Tech Specs#: VInD has 1 GB of built-in RAM, 8GB of flash memory and the ability to add an additional 300 GB hard-disk. It comes with built-in Zigbee sensor network, USB ports, Wi-Fi, ethernet and Bluetooth 2.1 and infrared connectivity. It connects to the TV via HDMI and regular AV channel ports. It also supports GPRS, 3G and HSDPA through the use of a USB modem. It has in-built microphone and speakers and a display

Microsoft has released the Kinect for PC. It was reported that Microsoft is keen to see kinect taking an active part in Healthcare industry. Doctors are using Kinect to help stroke patients regain movement full St0ry Here. Then later there was news that Microsoft and Asus have built a laptop with Kinect motion-sensing technology.

Of-course HP is not the first to come out with this kind of  technology,

 most of the existing expensive solutions are not  comprehensive and too focused on living room with limited or no net browsing capability.

iChip Technolgies has announced their solution called @Box which claimed to bring internet to any display device including even the office projector. @Box is smaller than palm and would be sold in standard package with a key board, track ball, power adaptor and a cable to connect to the TV and would cost less than $100

iChip Technologies which was based in India was later acquired by Techfarm Ventures US-based incubator and early stage investor in technology companies. Gordon Campbell, Chief Executive Officer of Techfarm, is also the CEO and Co-founder of Personal Web (PW) Systems, a company incorporated in the US.

Techfarm Ventures had earlier invested in PortalPlayer, which went in for an IPO in 2004, and subsequently got bought out by nVIDIA in January 2007. Techfarm has earlier incubated more than a dozen companies such as the first Ethernet chip and graphics controller

Neuros Technology produces a similar product that works on Ubuntu platform called Neuros LINK, which seems to be more closer to the HP solution

Logitech and Google has released Revue a solution based on Android

Apple is talking about Apple TV for sometime

UK based Telecom operator Vodafone has launched Webbox a product that seems to draw power from Vodafones EDGE/GSM/3G network using Opera Mini Browser

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Trounson Predicts — ‘Optimistically’ — Successful California Stem Cell Treatments in Five Years

By Dr. Matthew Watson


Alan Trounson, president of the $3 billion California stem cell agency, says he is "optimistic" that some stem cell treatments developed in California will prove successful in humans in the next five years.

Trounson was quoted in The Sacramento Bee today in an opinion piece written by David Lesher, government affairs director of the Public Policy Institute of California. Lesher provided something of an overview of the agency, including pluses and minuses. He wrote,

"Those who speculate say that the most advanced stem cell treatments are still probably a decade away from becoming available to patients. And the cost to get them there will far exceed California's $3 billion investment."

But Lesher, a former political writer for the Los Angeles Times, also wrote,

"...(T)he president of the state's stem cell agency said he is 'optimistic' that at least a few California treatments will prove successful in humans in the next five years."

Lesher said,

"That may mean a genetically modified stem cell treatment to cure AIDS, (Trounson) said; it may mean a treatment that eliminates the need for some diabetics to monitor or inject insulin; there might be a treatment to restore eyesight to those suffering from a major cause of blindness.

"'These are the kind of things we need to get through,' he said. 'I hope that we have a number of them showing proof by 2015 or 2016. I'm optimistic. The caveat is that nothing is guaranteed.'"

The stem cell agency will run out of cash for new grants in 2017 and will go out of business shortly thereafter unless voters approve another multibillion dollar bond measure or it manages to secure private financing.

Lesher discussed the difficult financial environment for private financing of stem cell therapies and how it has changed since the the stem cell agency was created by voters seven years ago.

"The hope was that California's bond (financing for CIRM) would jump-start a biotech industry by building the laboratories and seeding early research to a point where private support would take over.

"But that point of commercial viability is a moving target as private investors have grown more risk averse and the regulatory path for such radical new therapies is unpredictable. So the biggest question today in the stem cell field is not whether the science will work someday. The big questions are how will we pay for it, how will regulators know when it's ready and when will it happen?"

Lesher said,

"The problem is that even the most advanced experiments in (CIRM's) translational portfolio are still a couple of years away from the same point in the regulatory pipeline where high cost and uncertainty forced Geron out of the field. And there is still no clear answer about how to resolve those same challenges, although the cost-benefit calculation will be different for other treatments."

Lesher concluded,

"Unlike high-speed rail, which continues to have strong support from the governor, the stakes surrounding California's stem cell investment have been largely invisible. That's too bad, because stem cell science is a much smaller investment for taxpayers with a greater possible return."

Our comment? In what CIRM Chairman Jonathan Thomas has declared as a "war" for public support, today's piece in The Bee was a bit of a victory. Although the article did mention difficult issues, it was generally upbeat about CIRM. The piece focused on the wonders of the science and bypassed many of the negatives about CIRM, including its built-in conflicts of interests and its reluctance to correct long-identified problems. Also absent was a discussion of how CIRM signed a $25 million loan agreement with Geron only three months before the company abandoned its clinical trial. That omission could be considered a PR plus for the agency. Overall, however, the folks at CIRM should be pleased by the article.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: Trounson Predicts — ‘Optimistically’ — Successful California Stem Cell Treatments in Five Years
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California Stem Cell Agency Seeking More Help on Push for Cures

By Dr. Matthew Watson


The California stem cell agency has decided to put more manpower behind its push to drive therapies into the clinic.

The agency this week posted an opening for a senior development officer, who would be paid up to $226,108 annually.

The new hire would have a strong background in industry and an advanced degree. The job posting calls for a minimum of 10 years experience and expertise in "in developing, designing and assessing preclinical and early clinical safety and efficacy, within regulatory framework."

The position reports directly to Ellen Feigal, CIRM's VP for research and development. The job description says the person would "directly interact with investigators on CIRM’s clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives."

The $3 billion agency, which has yet to produce the cures promised to voters in 2004, is re-examining its strategies, particularly with an eye to backing a product that would actually be used on patients.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: California Stem Cell Agency Seeking More Help on Push for Cures
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A $25 Million ‘Cautionary Tale’: CIRM and Geron

By Dr. Matthew Watson


California's $25 million venture into the financing of what once was the first hESC clinical trial in the nation serves as a "cautionary tale" for states that use taxpayer dollars to boost technology, according to a New York public policy expert.

The comments by James W. Fossett, who directs the Rockefeller Institute of Government health, Medicaid studies and bioethics research programs, come midway through an Institute of Medicine examination of the performance of the $3 billion California stem cell agency. Its directors are also currently involved in a revision of of the agency's strategic plan.

Writing on the Rockefeller Institute's web site, Fossett analyzed the fallout from Geron's decision last fall to abandon its clinical trial after it determined the effort was too costly. Just three months earlier, the California stem cell agency had signed a $25 million loan agreement with Geron.

Fossett said,

"For the many states using taxpayer dollars to stimulate jobs in a wide range of technologies, this is a cautionary tale."

He wrote,

"(Geron's) decision has attracted widespread opprobrium from bloggers, stem cell advocacy groups, bioethicists and more than a few newspaper columnists — one blogger called it the 'stem cell misstep of the year.'

"This disapproval has also spilled over onto the California Institute for Regenerative Medicine (CIRM) — the state agency that operates the $3 billion California stem cell research program."

He continued,

"CIRM is coming under considerable political pressure to produce viable therapies to justify the large amount of money it’s been spending, and some have interpreted its hasty involvement with Geron as motivated by the desire to have something concrete to brag about."

Fossett said, however,

"There may be less here, however, than all the rhetoric would suggest. While Geron’s trial had acquired a lot of symbolic baggage because of its status as a 'first,' the decision to pull the plug only reflects one decision by one company about one therapy. The company was looking at having to spend a lot more money over a long period to get the therapy through the clinical trials process for what would likely be a small return.

"The political difficulties that Geron’s withdrawal have caused CIRM, however, have lessons for states proposing to spend significant amounts on biotechnology and other research in hopes of stimulating economic growth. Spending money on research intended to develop new therapies is highly risky. The science is difficult, expensive and evolves at a rapid pace that is difficult to integrate with earlier understandings. There are considerable cultural, political and financial obstacles to getting new products out of the lab and into the clinic."

Fossett suggested several approaches that might ease some of the risks. He cited the 2010 CIRM external review report that recommended adjusting priorities. Fossett said,

"States might experiment with providing more support to biotech companies and entrepreneurs with successful track records and less to basic research, which could increase the odds of short-term success."

At last month's CIRM board meeting, directors engaged in what CIRM is inclined to call a robust discussion of priorities for basic research vs. more focused funding for driving therapies into the clinic.

Fossett cited another external review recommendation that CIRM seek out research with a "high probability of clinical success that could 'come from either inside or outside CIRM-funded research, perhaps out of industry and even from outside of California.'" 

Fossett additionally mentioned the use of venture capital techniques that would give states "a chance to participate in the (financial) benefits of successful therapies."

Nonetheless, he wrote,

"Most products and most companies will likely continue to fail."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: A $25 Million ‘Cautionary Tale’: CIRM and Geron
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Last Public Hearing in California for CIRM Performance Evaluation Scheduled for April

By Dr. Matthew Watson


The blue-ribbon Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency will hold its final public hearing within the state on April 10 at UC Irvine.

No details have yet have been posted online about the matters to be discussed or the witnesses to be heard. So far, the panel has not heard publicly from a single independent witness. The panel's final report and recommendations are scheduled to be released this fall, following its only remaining public meeting, scheduled for Washington, D.C.

The IOM has also posted a list of documents provided to the panel during a closed session last month in South San Francisco, its only public hearing in California so far. Virtually all of documents came from the CIRM itself, which is paying the IOM $700,000 for the study.

One exception was the 2009 report by California's good government agency, the Little Hoover Commission.

In its report, the commission concluded,

"CIRM’s governance structure is not adequate to protect taxpayers’ interests or serve its own ambitious goals."

The commission recommended a number of changes to strengthen CIRM's governance structure, improve accountability and reduce conflicts of interest. They included restructuring and reducing the size of the 29-member board and eliminating the controversial dual executive arrangement at CIRM.

CIRM strongly resisted nearly all of the recommendations, some of which would have required legislative or voter approval. As of last week, the IOM panel had not contacted the Little Hoover Commission for testimony.

(Click on the "closed session summary" at this location to find the information about the documents that were provided.)

The IOM also has posted a list of topics discussed by its panel in closed session last month. They included a follow-up on bias and conflicts of interest, committee composition, discussion of the previous day's hearing and discussion of data needs.

The April meeting is being held at the Beckman Center at UC Irvine, which has received $77 million from CIRM. The agency's board of directors includes two top academicians from UC Irvine: Oswald Steward, who serves on the board as a patient advocate and is director of the Reeve-Irvine Research Center for Spinal Cord Injury, and Susan Bryant, associate executive vice chancellor for research at Irvine and who serves on the CIRM board as in her capacity as an executive officer from a UC campus with a medical school.

 

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

To Read More: Last Public Hearing in California for CIRM Performance Evaluation Scheduled for April
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“The Banks Can Do It, Why Can’t Hospitals?”

By Dr. Matthew Watson

Via Scoop.itinPharmatics

In other words, computing in the banking industry is perfected, so why can’t healthcare get its act together? (Irrespective of the sea change of difference between simple financial data and incredibly complex medical data.) …
Via hcrenewal.blogspot.com

Source:
http://microarray.wordpress.com/feed/

To Read More: “The Banks Can Do It, Why Can’t Hospitals?”
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One Way to Teach Your Boss About Social Media

By Dr. Matthew Watson

Via Scoop.itinPharmatics

Do you want your boss to realize the full potential of social media? Yesterday on Pixels & Pills we talked about John Mack’s observation that very few senior executives attend digital pharma conferences.
Via http://www.pixelsandpills.com

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Too Much Drinking May Raise Lung Cancer Risk: Study

By Dr. Matthew Watson

(HealthDay News) -- While smoking has long been linked to cancer, its frequent companion, drinking, may be as well, a new study suggests.

Three new studies presented at a medical meeting this week find a link between heavy boozing and a rise in risk for the number one cancer killer.

On the other hand, studies also suggest that heavier people are less likely to develop lung cancer than smaller folk, and black tea might help ward of the disease, as well.

The findings were to be presented at the annual meeting of the American College of Chest Physicians, Oct. 22-26, in Honolulu.

More Americans die from lung cancer than any other form, according to the U.S. Centers for Disease Control and Prevention (CDC). In 2007, the most recent year for which statistics are available, more than 203,000 people in the United States were diagnosed with lung cancer, and nearly 159,000 died. Read more...

Immunice for Immune Support

Source:
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To Read More: Too Much Drinking May Raise Lung Cancer Risk: Study
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