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The Afterlife of the California Stem Cell Agency: Venture Philanthropy and Big Pharma

By Dr. Matthew Watson


The $3 billion California stem cell agency, which is facing its possible demise in five years, is exploring an afterlife that dips into "venture philanthropy" on a national level as well as investment ties with Big Pharma.

The Golden State's unprecedented research program laid out those possibilities in a "transition plan" sent this week to Gov. Jerry Brown and the state legislature. The plan was required under a law passed two years ago. The agency's future direction was also aired at a meeting last month in Los Angeles.

The California Institute for Regenerative Medicine(CIRM) will run out of funds for new grants in 2017. Its only real source of funding is cash that the state borrows (bonds). CIRM says that only $864 million remains for new research awards, and some of its recent grant rounds exceed $200 million. The current position of the agency is that it is "premature" to consider asking voters in financially strapped California to approve another multi-billion dollar bond measure.

The venture philanthropy effort involves creation of a nonprofit organization. CIRM Chairman Jonathan Thomas said in January that he is "test-driving (the proposal) with some high net worth donors we know to be interested in the stem cell space." Thomas was addressing the Citizens Financial Accountability and Oversight Committee, the only state entity specified charged with overseeing the agency and its directors. He said,

"We're busily putting together in conjunction with a national organization called the Alliance for Regenerative Medicine the plans for a nonprofit venture philanthropy fund."

He said it would "would accept applications for awards from researchers and companies all over the country, not just those funded by CIRM, but those funded by NIH or the New York Stem Cell Foundation or the state of Maryland or whatever."

The Alliance for Regenerative Medicine is an industry-dominated lobbying group, based in Washington, D.C.  The group's executive director and co-founder is Michael Werner, a longtime pharma and health industry lobbyist, who is also a partner in the influential Washington law firm of Holland and Knight.

The "biopharma investment fund" proposed by CIRM is less well developed. CIRM said it plans to explore opportunities with companies to fund stem cell research in California. The transition document uses as an example an $85 million deal between Pfizer and UC San Francisco, which gives the company special access to biomedical research.

The transition plan also touches on other issues such as winding down grants after its new grant money runs out, along with protecting intellectual property.

The plan could be considered a marketing tool for the agency's afterlife efforts. The document devotes a good portion of its nine pages to recounting the history of CIRM and touting its accomplishments.

Thomas used the occasion of the submission of the plan as a springboard for a piece yesterday on the CIRM research blog.He concluded his item by quoting from the plan itself. CIRM's achievements during the past seven years, he wrote, "will allow California to continue world (stem cell) leadership in the coming decades."

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

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Text of IOM Statement on Efforts at Soliciting Comment on CIRM

By Dr. Matthew Watson


Here is the text of the questions submitted Feb. 12 by the California Stem Cell Report to the Institute of Medicine concerning its attempts to secure comments on the operation of the $3 billion California stem cell agency along with the IOM response.

The response from Christine Stencel, a spokeswoman for the IOM, follows these questions from the California Stem Cell Report.

"I will be writing a piece on Wednesday dealing with the online surveys that IOM has posted. For that piece, please tell me very, very  specifically what the IOM is doing to generate responses. For example, is the IOM buying ads in newspapers or online, asking the public to fill out the forms? Is it hiring a polling firm to call households for responses?  Also please tell me exactly what is being done to generate responses on all the other surveys that have been posted.

"Additionally, please tell me how many responses that the IOM has received so far in each category on the survey forms for CIRM grantees, industry partners and leadership. Thank you."

The IOM response on Feb. 15:

"The IOM has been obtaining and compiling lists of organizations and people to circulate the questionnaires as widely as possible among target groups. For example, IOM has sent a notice to some 300 stakeholder groups encouraging participation. We do not have the resources to hire a polling firm or place ads.

"The purpose of these questionnaires is to extend the committee's information gathering beyond in-person meetings and the standard listing of an email address or phone number for the study on the project website. Not all people who might have useful experiences or perspectives on CIRM may be able to attend the in-person meetings and not all may visit the project website and find the study contact information. This is a proactive effort to reach more people.

"Anyone who knows of individuals or organizations with information on CIRM that would be useful for the committee's knowledge can share the links to the questionnaires with them. This will help spread the word and get the committee insights they need.

"I don't have information on the number of responses so far. Ultimately, as noted at the top of each survey, the responses will be aggregated and de-identified and placed in the public access file in addition to being shared with the committee.

"I trust this will be useful for your readers."

The California Stem Cell Report then asked the following questions on Feb. 15.

"Thank you for your response. A few follow-up questions:
Regarding the 300 stakeholder groups, how are those defined? Please give me a few examples.

"Based on your response, is it correct to say that the IOM is not sending out questionnaires directly to all CIRM grant applicants, including those who were rejected?

"Is it correct to say that no special effort -- other than that described in your response -- is being made to seek responses from stem cell businesses?

"The failure to provide numbers on the responses so far would indicate that the numbers are so small that the IOM is choosing not to disclose them. If that is not the case, please email me the numbers. Thank you."

The IOM had not responded to the follow-up questions as of this writing on Feb. 21.

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

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Iran’s NIGEB holds international stem cell workshop – Press TV

By Dr. Matthew Watson


Press TV
Iran's NIGEB holds international stem cell workshop
Press TV
Iran's National Institute of Genetic Engineering and Biotechnology (NIGEB) has held an international stem cell workshop in the capital city of Tehran, Press TV reported. A number of university professors and researchers from Turkey, Iraq, ...

Source:
http://news.google.com/news?q=genetic-engineering&output=rss

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BrainStorm Featured on CNBC

By Dr. Matthew Watson

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a developer of innovative stem cell technologies for neurodegenerative disorders, announced that NurOwn™, its autologous stem cell therapy for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's Disease, was profiled yesterday on CNBC. In the Feature Story about the impact of Iran's nuclear threat, Israeli business and scientific leaders were interviewed about Israel's thriving economy and cutting edge technologies. Among those leaders that met with CNBC were Brainstorm’s President Mr. Chaim Lebovits and Prof. Dimitrios Karussis, Principal Investigator of Brainstorm's Phase I/II clinical trial currently underway at the Hadassah Medical Center in Jerusalem.

Brainstorm recently announced positive initial results from the clinical trial, resulting in approval from Hadassah's Helsinki committee to proceed with the trial. Accordingly, additional patients have been enrolled in the study, and Brainstorm will announce additional results in the coming months.

To see the video online, follow the link at: http://video.cnbc.com/gallery/?video=3000074883

To read the Feature Story online, follow the link at: http://www.cnbc.com/id/46484576

Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.

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BrainStorm Featured on CNBC

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More bone marrow donors sought

By Dr. Matthew Watson

Friday, Feb. 24, 2012

Japan has made great strides in the fight against leukemia in the last two decades that have seen bone marrow transplants increase, while the implementation of a nationwide donor program also has contributed significantly.

But the donor pool still needs to be expanded further to give more patients on the waiting list a chance of finding a marrow match, and a better shot at undergoing the life-saving surgery.

As of the end of 2011, about 400,000 potential donors were registered with the Japan Marrow Donor Program and around 13,700 patients in total had received bone marrow transplants since its inception in 1991. Approximately 34,600 patients have sought transplants since the program started.

But many patients still die before a suitable donor match is found, and the program is looking to expand the donor pool through raising public awareness about bone marrow donations. Undergoing a transplant in time can eradicate the cancer, which attacks the body's blood-forming tissues, including bone marrow and the lymphatic system.

"I wish more people would join the program and that all patients could be given the chance to survive," said former leukemia patient Chikako Kimura, 39, who had one of the early bone marrow transplants during the program's first years.

Kimura was diagnosed with acute myelogenous leukemia in 1991, a year after graduating from high school and starting to work. That spring, she felt constantly tired but shrugged it off as resulting from the rigors of her job.

That December, however, Kimura saw a doctor about swelling in her legs. She was immediately hospitalized and started to receive treatment, but didn't learn she had leukemia until several years later.

Kimura was not informed she had leukemia until spring 1993, when her doctor told her a donor with bone marrow matching her type had been found and encouraged to her to undergo a transplant. A year earlier, the doctor had put her on the waiting list of the fledgling bone marrow donor program.

Initially, she balked at the proposal as her condition had been stabilized through chemotherapy. But she eventually decided to take a chance.

"I was really lucky to find a matching donor so soon, given the small pool of donors at the time," Kimura recalled.

According to the foundation that set up the program, more than 527,000 people have registered as potential bone marrow donors since January 1992.

The donor pool swelled after a TV campaign was launched in July 2005 featuring Masami Ihara, a former captain of Japan's national soccer team, who appealed for more people to register. The high-profile campaign helped raise public awareness over the issue and led to a flood of inquiries to the four toll-free numbers the foundation set up.

"From the first day (of the TV ads), we had our hands full answering phone calls" from the public asking how to become donors, said Hidehiko Okubo of the foundation.

The TV campaign was later amended to use the images of actress Masako Natsume, who died of leukemia in 1985, and singer Minako Honda, who died in 2005.

The easing of criteria that must be met before being allowed to register as a donor and an increase in locations nationwide where people can register also helped to boost donor numbers.

The donor pool has now expanded to a level where more than 90 percent of leukemia patients on the waiting list can expect to find at least one suitable match.

But even if they find a potential donor, logistical or other reasons currently prevent about 40 percent of leukemia patients from actually receiving transplants. And it remains extremely difficult to find donors for some patients with rare white blood cell types.

The foundation's Okubo said trying to cure leukemia only by bone marrow transplants has its limits, and noted another kind of transplant was granted the green light in October 2010.

The procedure, which uses hematopoietic stem cells extracted from the blood of healthy people, had until 2010 only been allowed in Japan for transplants involving family members.

While 33 medical facilities are capable of performing such transplants, only two leukemia patients have been operated on so far.

The new procedure is expected to increase the number of people willing to become donors, as it involves fewer health risks than bone marrow transplants.

More than 18 years on from her transplant, Kimura now works as a nurse. "Many people have supported me. I wanted to be of some help to other people," she explained.

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More bone marrow donors sought

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Makucell™ Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate™

By Dr. Matthew Watson

 

 

SCOTTSDALE, Ariz., Feb. 21, 2012 /PRNewswire-USNewswire/ -- Makucell, Inc., a new life science company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions, has presented important pre-clinical and clinical information on its proprietary molecule, Asymmtate, at the 36th Annual Hawaii Dermatology Seminar, Waikoloa, Hawaii.  Asymmtate™ is the active key ingredient in Makucell's new topical skin care line Renewnt™ (pronounced "Re-new-int").

Asymmtate™ is a selective modulator of the Wnt (pronounced "wint") signaling pathway that encourages optimal signaling to stimulate skin stem cells to replenish themselves, keratinocytes, fibroblasts and other dermal cells, which produce collagen, elastic tissue, matrix and other substances to foster a more healthy, rejuvenated appearing skin.  Renewnt™ will be available through aesthetic dermatology professionals in April 2012.

Mark Dahl, M.D. Makucell's, Vice President and Chief Medical Officer, presented the two scientific poster presentations.   The presentation titles and conclusions are summarized below.

The Safety and Efficacy of Asymmtate – Asymmtate™ penetrates into human epidermis and dermis and remains active.  Asymmtate in its cream vehicles is non-mutagenic, non-irritating, and non-sensitizing.  Asymmtate™ Analog Mitigates Photoaging Effects of UVB in Mice – An analog of Asymmtate applied topically can mitigate the subsequent visible appearance of photoaging changes in mice after exposures of their skin to UVB.

In addition to the pre-clinical/clinical information presented this week, Makucell has initiated a 100 subject Use Study to evaluate the safety and efficacy of Renewnt™ for Hydration Day and Night Moisturizer in a real world setting.  This four-week study will include 12 investigator sites across the U.S.  "This large multicenter study is very important to validate aspects of clinical product performance of Asymmtate™ under real world conditions.  The diverse geographical study sites will allow us to evaluate effects on unique skin types in different climates," said Lawrence A. Rheins, President and CEO of Makucell.

The innovative technology that resulted in the formulation of Renewnt was developed by distinguished research scientist Michael Kahn, Ph.D. and colleagues at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California, Keck School of Medicine. "This is an exciting time for Makucell," said Makucell co-founder and inventor Michael Kahn, Ph.D.  "This technology will be utilized for commercial topical applications to address the challenges of photoaging skin and other hair and nail conditions."

For media and investment inquiries please contact please contact Lawrence Rheins, lrheins@makucellinc.com or 1-855-MAKUCELL.

About Makucell
Makucell (www.makucell.com) is a new life science technology transfer company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions in an entirely new way. Using a patent-pending new molecule, Asymmtate, Makucell has developed the Renewnt brand of non-prescription products that work with the skin's own stem cells to produce healthier, and more youthful appearing skin. This innovative technology was developed by researchers at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California Keck School of Medicine.  Makucell is financed through private investors and is not in receipt of government funding.

About the USC Stevens Institute for Innovation
The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a university-wide resource in the Office of the Provost at the University of Southern California that helps identify, nurture, protect, and transfer to the market the most exciting innovations from USC.  It also provides a central connection for industry seeking cutting-edge innovations in which to invest. As part of this role, the USC Stevens Institute manages the university's intellectual property portfolio stemming from its $560M annual research program. Furthermore, the USC Stevens Institute develops the innovator as well as innovations, through educational programs, community-building events, and showcase opportunities.

Media Contact:
Lawrence Rheins
lrheins@makucellinc.com
1-480-305-2061

SOURCE USC Stevens Institute for Innovation

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RELATED LINKS
http://www.stevens.usc.edu
http://www.makucell.com/

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Makucell™ Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate™

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Energy network within cells may be new target for cancer therapy

By Dr. Matthew Watson

Within each cell, mitochondria are constantly splitting in two, a process called fission, and merging back into one, called fusion. Before a cell can divide, the mitochondria must increase their numbers through fission and separate into two piles, one for each cell.

By reversing an imbalance of the signals that regulate fusion and fission in rapidly dividing cancer cells, researchers were able to dramatically reduce cell division, thus preventing the rapid cell proliferation that is a hallmark of cancer growth. Increasing production of the signal that promotes mitochondrial fusion caused tumors to shrink to one-third of their original size. Treatment with a molecule that inhibits fission reduced tumor size by more than half.

"We found that human lung cancer cell lines have an imbalance of signals that tilts them towards mitochondrial fission," said Stephen L. Archer, MD, the Harold Hines Jr. Professor of Medicine at the University of Chicago Medicine and senior author of the study. "By boosting the fusion signal or blocking the fission signal we were able to tip the balance the other way, reducing cancer cell growth and increasing cell death. We believe this provides a promising new approach to cancer treatment."

"This could be a potential new Achilles' heel for cancer cells," said the study's lead author, Jalees Rehman, MD, an associate professor of medicine and pharmacology at the University of Illinois at Chicago. "Many anticancer drugs target cell division. Our work shifts the focus to a distinct but necessary step: mitochondrial division. The cell division cycle comes to a halt if the mitochondria are prevented from dividing. This new therapy may be especially useful in cancers which become resistant to conventional chemotherapy that directly targets the cycle."

The researchers found that the mitochondrial networks within several different lung cancer cell lines were highly fragmented, compared to normal lung cells. Cancer cells had low levels of mitofusin-2 (Mfn-2), a protein that promotes fusion by tethering adjacent mitochondria, and high levels of dynamin-related protein (Drp-1), which initiates fission by encircling the organelle and squeezing it into two discrete fragments. The Drp-1 in cancer cells also tended to be in its most active form.

The researchers tested several ways to enhance fusion and restore the mitochondrial network, both in cell culture and in animal models. They used gene therapy to increase the expression of Mfn-2, injected a small molecule (mdivi-1) that inhibits Drp-1, and used genetic techniques to block the production of Drp-1. All three interventions markedly reduced mitochondrial fragmentation, increased networking and reduced cancer cell growth.

Although the authors identify mitochondrial fission and Drp-1 activation as a potential therapeutic target in lung cancer, "this is not a cure," Archer emphasized. The treatment drastically reduced tumor size but the tumors did not completely disappear. They continued to use high levels of glucose as fuel, a hallmark of cancer metabolism that can be seen on PET scans. "This remnant could be either a central cluster of cancer stem cells," Archer said, "or an inflammatory response, the immune system infiltrating the tumor."

"Inhibiting mitochondrial fission", Archer said, "did not show any significant toxicity in mice or rats, so we are quite optimistic that our findings can lead to the development of novel, clinically feasible therapies."

The substances used to block fusion are commercially available for research purposes, but they have not been tested in humans. Mdivi-1 has been used in animals to prevent kidney injury.

Although the focus on mitochondria is fairly new to cancer biologists—despite a flurry of interest in the 1920s stimulated by the German Nobel Prize laureate Otto Warburg—this organelle has long been a central focus for physicians and scientists interested in muscle biology, especially cardiac muscle.

Archer, a cardiologist, specializes in pulmonary hypertension. In this disorder, as in cancer, excessive cellular growth causes disease. The death of his cousin and close friend from lung cancer made him start thinking about the connections. Rehman is a German scientist and became interested in studying mitochondria after reading some of the historical Warburg papers in German.

The fact that two cardiologists, Archer and Rehman, decided to study cancer and collaborated with a team of basic scientists, a cancer physician and a pathologist is "an indicator of how interconnected modern biomedical research has become," Rehman said.

Provided by University of Chicago Medical Center

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Energy network within cells may be new target for cancer therapy

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E'shee Clinical Esthetic Launches High-Tech Skin Serum

By Dr. Matthew Watson

PHILADELPHIA, Feb. 21, 2012 /PRNewswire/ -- E'shee Clinical Esthetic announced this week a new addition to its product line of skin serums – Elixir of Life KI Therapy Serum – designed to deliver ultimate skin rejuvenation.

This new skin care product is based on a combination of stem cell and infra-red nano technology. It is the most potent skin care formula that combines gene therapy (FGF 1 peptide) and Far Infrared Powder (FIR) to rejuvenate and restore the beauty of damaged or aging skin.

This new Elixir of Life Serum helps to activate the body's stem cells to repair damaged tissue and skin regeneration.

"Results are proven. The FGF-1 peptide – the stem cell activator – helps to increase new skin cell growth at least 10-20 times faster than with other skin care products," says Nataly Giter, founder, E'shee Clinical Esthetic.

Elixir of Life is ideal for people with circulation problems due to external factors such as pollution, and physical problems due to illness, medications or smoking. It works to repair dark circles and broken capillaries; delays the overall skin aging process through skin repair and re-growth; and also works to properly heal and repair scar tissue.

People of all ages – men and women – will see physical results within 30 days. Skin will be healthier and firmer with a smoother and more even skin tone. 

"Ultimately, this new product helps to restore blood flow; aids with toxin removal; repairs broken capillaries; and reverses skin damage. We are very excited to offer this to anyone wishing to dramatically improve their skin care," says Giter. 

About E'shee Clinical Esthetic:

E'shee was launched in 2009 by Nataly Giter, a hands-on skin care professional with more than 20 years of experience. Through research and practical experience, she learned about the most effective ingredients for advanced skin care and became associated with Dr. Chiu, a professor from Ohio University and the first global pioneer to clone the human FGF 1 gene.

Together with Dr. Chiu and their combined connections to industry professionals, they utilized FGF 1 to create an extraordinary anti-aging product line, using 99 percent pure FGF 1 peptide - the best quality available outside of the human body.

For more information on E'shee Clinical Esthetic, visit: http://www.esheeesthetic.com or http://www.esheeesthetic.com/wordpress/.

* Photo 300dpi download for media: Send2Press.com/mediaboom/12-0221-eshee_300dpi.jpg
* Photo Caption:  Elixir of Life Serum.

This release was issued on behalf of the above organization by Send2Press(R), a unit of Neotrope(R). http://www.Send2Press.com

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Stem Cell Study in Mice Offers Hope for Treating Heart Attack Patients – Video

By Dr. Matthew Watson

08-02-2012 01:41 A UCSF stem cell study conducted in mice suggests a novel strategy for treating damaged cardiac tissue in patients following a heart attack. The approach potentially could improve cardiac function, minimize scar size, lead to the development of new blood vessels -- and avoid the risk of tissue rejection. In the investigation, reported online in the journal PLoS ONE, the researchers isolated and characterized a novel type of cardiac stem cell from the heart tissue of middle-aged mice following a heart attack. Then, in one experiment, they placed the cells in the culture dish and showed they had the ability to differentiate into cardiomyocytes, or "beating heart cells," as well as endothelial cells and smooth muscle cells, all of which make up the heart. In another, they made copies, or "clones," of the cells and engrafted them in the tissue of the mice who had had the heart attacks. The cells induced angiogenesis, or blood vessel growth, or differentiated, or specialized, into endothelial and smooth muscle cells, improving cardiac function. Because the cells were transplanted back into the mice from which they originated, the body did not reject them.

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Stem Cell Study in Mice Offers Hope for Treating Heart Attack Patients - Video

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Bone marrow stem cells versus cord blood stem cells : Prof.Dr. Virginia – Video

By Dr. Matthew Watson

09-01-2012 06:07 Bone marrow stem cells versus cord blood stem cells : Prof.Dr. Virginia

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Bone marrow stem cells versus cord blood stem cells : Prof.Dr. Virginia - Video

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Ghana’s Biosafety Law finally receives Presidential Assent – BusinessGhana

By Dr. Matthew Watson


Ghana Business News
Ghana's Biosafety Law finally receives Presidential Assent
BusinessGhana
The Law, from the Biosafety Act, 831, 2011 will enable Ghana to allow the application of biotechnology in food crop production involving Genetically Modified Organisms (GMOs) to enter food production. It will also ensure an adequate level of production ...
Ghana Now Has Biosafety LawPeace FM Online

all 5 news articles »

Source:
http://news.google.com/news?q=biotechnology&output=rss

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Wake Forest Biotech Place Will House Hundreds of Medical Researchers – WFMY News 2

By Dr. Matthew Watson


WFMY News 2
Wake Forest Biotech Place Will House Hundreds of Medical Researchers
WFMY News 2
Biotechnology and medical research is helping that happen. Wake Forest Biotech Place opens Tuesday in Piedmont Triad Research Park. It's called a state-of-the-art, world-class, 242000 square-foot, biotechnology research and innovation center.

and more »

Source:
http://news.google.com/news?q=biotechnology&output=rss

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Sound Shore Medical Center Resident Receives Young Scientist Award – Talk of the Sound

By Dr. Matthew Watson


Talk of the Sound
Sound Shore Medical Center Resident Receives Young Scientist Award
Talk of the Sound
Recently, she was in Barcelona, Spain to attend the World Congress on Debates & Consensus in Bone, Muscle & Joint Diseases where she presented her Abstract, “Molecular Genetics in the Diagnosis of Calpainopathy”. Even more impressive, Dr. Poste ...

Source:
http://news.google.com/news?q=molecular-genetics&output=rss

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privacy controlled social networking to connect patients with caregivers

By Dr. Matthew Watson

Via Scoop.itinPharmatics
Privacy controlled & safe social network for Healthcare launched by Jonathan Schwartz, Ex-CEO Sun Microsystems. The networks available at http://www.carezone.com  Connects Caregivers With family members and allows health-care workers share information about aging or ill parents, spouses and children
Via http://www.bloomberg.com

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

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SOCIAL CRM and its Impact on Pharmaceutical Industry

By Dr. Matthew Watson

Source:
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CIRM Contracting: $1.3 Million for IT, $887,282 for Legal

By Dr. Matthew Watson


The California stem cell agency this week performed its semi-annual public disclosure of its contracts with outside firms, the second largest item in its operational budget of $18.5 million.

The contracts are scheduled to run about $3.3 million this fiscal year, according to the budget approved last May. That figure is up about 18 percent from the previous year.

According to the contract information posted this week, the two largest contracting expenditures this year are for information technology work, including the ongoing struggles with the grants management system – $1.3 million – and legal help – $887,282. The figures were compiled by the California Stem Cell Report. CIRM did not provide totals.

Outside contracts are second to the cost of salaries and benefits at the agency. One reason for the size of the contracting expense is the small size of the CIRM staff, which is now about 50.

The contracting information will be presented to the CIRM directors' Governance Subcommittee next Friday. The committee is being asked to approve an increase in the contract with Kutir Corp., from $250,000 to $470,000. By the end of 2011, CIRM had already paid out $219,680 to Kutir. The firm provides software development services.

Infonetica, which provides technology advice, would also see an increase from $236,060 to $300,000, under the staff proposal.

A staff memo to the board said,

"(Kutir's) services are key as CIRM continues to progress in automating its grants management systems to meet the requirements of both new RFAs as well as ongoing reporting obligations.""

The public can participate in the Governance meeting at locations in San Francisco, Sacramento, Irvine, Los Angeles, South San Francisco and La Jolla. Specific addresses can be found on the agenda.

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

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ACT’s Top Scientist Sells $1.5 Million in Company Stock

By Dr. Matthew Watson


The mainstream media waxed enthusiastic last month when a California hESC clinical trial reported positive results dealing with blindness.

The report was first published account of a human trial of embryonic stem cell based therapy and involved Advanced Cell Technology, which is headquartered in Santa Monica, Ca. Despite a glowing reception of the trial's results, the firm is years away from being able to market the therapy at a profit – if it ever can do so.

The firm's chief scientific officer, Robert Lanza, moved quickly, however, to capture some monetary gain from the news, which was announced in a press release Jan. 23 by ACT.

On Jan. 23 and 24, Lanza sold 7.7 million shares in ACT for $1.5 million, according to SEC documents. He sold the stock at 18 and 19 cents a share. That compares to an ACT price of about 8 cents at the end of 2011. Lanza still holds 26 million shares in the firm. The acquisition price of the stocks is unknown.

There is nothing to suggest anything untoward about Lanza's sale. But it is a reminder that creating a successful stem cell therapy is about making money. Without a profit, there will be no therapy, as Geron reminded everyone last November when it dropped its longstanding hESC trial.

The California Stem Cell Report has asked Lanza if he has any comments about the sale of the stock. We will carry his remarks verbatim when we receive them.

The Seeking Alpha web site appears to have been the first to report the sale. Here is their complete item.

"Advanced Cell Technology, Inc. (ACTC.OB): ACTC is a development-stage biotech focused on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. On Wednesday, Chief Science Officer Robert Lanza filed SEC Form 4 indicating that he sold 7.7 million shares for $1.5 million, ending with 26.0 million shares after that sale. ACTC shares have rallied strongly since the beginning of the year, up from 8.2 cents at the end of last year to currently in 14-15c range after rising above 20c just earlier this week."

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

To Read More: ACT’s Top Scientist Sells $1.5 Million in Company Stock
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Stem Cell Agency on Bee Article and Voter Expectations

By Dr. Matthew Watson


The California stem cell agency today said the seven-year-old "audacious vision" of voters when they created the $3 billion research effort "is still possible."

The comment was made in an item on the agency's blog by Amy Adams, the agency's communications manager.

Her entry point was an opinion piece in The Sacramento Bee on Sunday exploring some of the ins and outs of the agency. Among other things, CIRM President Alan Trounson was quoted by writer David Lesher as "optimistically" predicting successful California stem cell treatments in five years.

Adams wrote,

"Lesher makes clear that there are many challenges ahead in bringing new therapies to patients: he said of the voters who created CIRM, 'It was pretty audacious of them in 2004 to try to create another economic driver like Silicon Valley and save lives at the same time.'

"And while the vote was audacious, we agree with his conclusion that despite risks and challenges that vision is still possible." 

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

To Read More: Stem Cell Agency on Bee Article and Voter Expectations
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Blue-Ribbon Panel Seeks Public Comment on California Stem Cell Agency

By Dr. Matthew Watson


The California public is being given a chance to weigh in with anonymous comments about what they think of the performance of the $3 billion California stem cell agency.

Their opinions are being sought by a blue-ribbon, Institute of Medicine panel. The IOM is being paid $700,000 by the agency to examine its operations.

The questions include the importance of stem cell research and CIRM's role, its openness and transparency, an assessment of its grant programs and how it should share information with the public, suggestions for improvements and more.

The online form was posted recently on the IOM web site and can be found here. The deadline for submissions is March 19.

The IOM also has survey forms for academic and non-profit CIRM grant recipients, CIRM grant recipients that are businesses(which the IOM calls "industry partners") and "leadership of CIRM-funded institutions." The deadline for those is March 19 as well.

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

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Synthetic protein amplifies genes needed for stem cells

By Dr. Matthew Watson

Public release date: 16-Feb-2012
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Contact: Tara Womersley
tara.womersley@ed.ac.uk
44-131-650-9836
University of Edinburgh

Scientists have found a way to generate and maintain stem cells much more efficiently by amplifying the effect of an essential protein.

Researchers from Denmark, Scotland and the USA have created synthetic versions of a protein, which manipulates adult cells ? such as skin cells ? so that they can subsequently revert to an earlier, embryonic like state. These reverted cells have the potential to become any cell in the body.

As well as reverting adult cells to this state ? known as induced pluripotent stem cells , the protein also plays a key role in maintaining embryonic stem cells in a pure form. If the protein ? Oct4 ? is not present, the embryonic stem cells will start to differentiate into specific cells.

In order to reprogamme adult cells to have stem cell properties viruses need to be added to cell cultures to trigger production of significant quantities of Oct4.

Oct4 plays a powerful role in regulating stem cell genes. However, while large quantities of Oct4 are needed too much of it can ruin the properties of stem cells.

Scientists, whose work is published in the journal Cell Reports, were able to overcome this by producing a synthetic version of Oct4 that amplified the effect of the protein in its natural form.

The synthetic version of Oct4 was much more efficient in turning on genes that instruct cells on how to be stem cells and, as a result, the cells did not need as much Oct4 for either reprogramming or to remain as stem cells ? thereby eliminating problems caused by too much Oct4.

In fact, the synthetic Oct4 could support stem cells under conditions that they do not normally grow. These findings could also help scientists find new ways generate stem cells in the laboratory.

The study showed that Oct4 was mainly responsible for turning on genes that instruct cells on how to become stem cells, rather than turning off genes that encourage the cells to differentiate.

"Our discovery is an important step towards generating and maintaining stem cells much more effectively," says Professor Joshua Brickman, affiliated with both The Danish Stem Cell Center (DanStem), University of Copenhagen and Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh.

"Embryonic stem cells are characterized, among other things, by their ability to perpetuate themselves indefinitely and differentiate into all the cell types in the body ? a trait called pluripotency. But to be able to use them medically, we need to be able to maintain them in a pure state, until they're needed. When we want to turn a stem cell into a specific cell, such as insulin producing beta cell, or a nerve cell in the brain, we'd like this process to occur accurately and efficiently. This will not be possible if we don't understand how to maintain stem cells as stem cells. As well as maintaining embryonic stem cells in their pure state more effectively, the artificially created Oct4 was also more effective at reprogramming adult cells into so-called induced Pluripotent Stem cells, which have many of the same traits and characteristics as embryonic stem cells but can derived from the patients to both help study degenerative disease and eventually treat them.."

Oct4 is a so-called transcription factor ? a protein that binds to specific DNA sequences, thereby controlling the flow (or transcription) of genetic information from DNA to mRNA. The synthetic version of Oct4 was created by using recombinant DNA technology whereby a gene was modified to produce new and more active protein. The modified gene was either introduced into stem cells or used to reprogram adult skin cells.

If scientists can exploit this programming of stem cell programs, it will improve the ability to generate stem cells directly from a patient. These cells could in turn potentially be used for individualised studies and for developing individualized therapies for degenerative diseases such as type 1 diabetes and neuro-degenerative diseases.

###

The paper "Transcriptional Activation by Oct4 Is Sufficient for the Maintenance and Induction of Pluripotency", is published in Cell Reports on February 16, 2012, 12:00 EST US time/18:00 Danish time/17:00 UK time. The study involved mouse embryonic stem cells, early embryonic progenitors cells in frogs as well as iPS cells from both mouse and human sources. The research was supported by grants from the Novo Nordisk Foundation (DK), the Medical Reseach Council and the Biotechnology and Biological Sciences Research Council (MRC and BBSRC, UK).

Contact: Tara Womersley, Press and PR Officer, University of Edinburgh, 44-131-650-9836 or 44-7791-355-804

Link to Cell Report: http://cellreports.cell.com/

Embargo: Until February 16 at 12:00 EST US time/18:00 Danish time/17:00 UK time

About DanStem

The Danish Stem Cell Center opened in the Summer 2011 as a hub for international basic, translational and early clinical stem cell research. Professor Brickman and his group joined DanStem in October 2011 to partake in the build-up the center.

DanStem address basic questions in stem cell and developmental biology, and develop novel stem cell based therapeutic approaches for diabetes and cancer. It is supported by two major grants from Novo Nordisk Foundation (DKK 350 million (? 47 million)) and the Danish Research Council for Strategic Research (DKK 64.8 million (? 8,7 million)), respectively. More information about DanStem at: http://danstem.ku.dk

About Medical Research Council Centre for Regenerative Medicine

The MRC Centre for Regenerative Medicine (CRM) is a world leading research centre based at the University of Edinburgh. Together we study stem cells, disease and tissue repair to advance human health. Our research is aimed at developing new treatments for major diseases including cancer, heart disease, diabetes, degenerative diseases such as multiple sclerosis and Parkinson's disease, and liver failure. http://www.crm.ed.ac.uk


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Synthetic protein amplifies genes needed for stem cells

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