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FierceBiotechResearch

February 5, 2013
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This week's sponsor is MPI Research.

eBook | Facing up to the Biosimilar Challenge:
Preclinical and Beyond

Faced with a continuing economic crisis and an aging and increasingly obese population, healthcare providers are seeing where they can cut costs. Generics saved the U.S. healthcare system $192 billion in 2011 alone. To read more on this timely topic, download this eBook today.


Today's Top Stories
1. Diabetes drug decreases lung cancer tumors in mice with gene mutation
2. Researchers find TB hiding in bone marrow
3. Gene discovery could provide relief for deadly staph infections
4. New target that stops metastasis could lead to safer cancer therapies
5. Merck Serono, Feinstein Institute form collaboration to find lupus treatments

Editor's Corner: Doctor calls for boost in cord blood stem cell research

Also Noted: Oracle
Spotlight On... New Alzheimer's drug clears amyloid tangles in mice
Anatabine for MS treatment?; New target found for Alzheimer's; and much more...

Top 10 device and diagnostic FDA approvals of 2012

Every year, devicemakers secure patents, toil in labs, pile heaps of data and, finally, head to the FDA in search of a premarket approval that can make years of work worthwhile. A rejection can send stocks tumbling and investors reeling, and approval can mean an instant soar on the Street. Suffice it to say, the FDA is a kingmaker in the medical device and diagnostics industries. We've compiled the 10 biggest PMAs of 2012, looking at devices that promise to turn around ailing giants, technologies that have put startups on the map and diagnostics that hope to push personalized medicine closer to the norm. Read the full feature >>

News From the Fierce Network:
1. Merck execs struggle with growing uncertainty over late-stage R&D
2. Merck Serono nabs an option on late-stage MS therapeutic vax
3. Bitter setback as TB vaccine fails to protect infants in key study


FierceBiotech Special Report: China's Rise Drives Investment in Biotech Drugs

The Chinese government's devotion to biotech has sparked major expansion efforts by some of the country's leading pharmaceutical players, also making it fertile ground for venture capitalists in the US.
Click here to download the complete report today.




Editor's Corner

Doctor calls for boost in cord blood stem cell research

By Emily Mullin Comment | Forward | Twitter | Facebook | LinkedIn

Embryonic stem cell research has yet to live up to all the hype. So far, human embryonic stem cells, or hESCs, haven't yielded any cures or therapies to treat diseases. That's not to say that hESC research isn't important, but some scientists think stem cell research needs a shift in focus, particularly to the promise of cord blood stem cells.

These cells are being used to treat patients with more than 75 diseases, including various cancers, traumatic brain injury, autism, pediatric stroke, cerebral palsy, Type 1 diabetes and blood, immune and metabolic disorders, said Dr. Mary Laughlin, a physician and expert in marrow and stem transplants at the University of Virginia School of Medicine. Laughlin thinks the future of stem cell research depends on better preservation of stem cells collected from newborns after birth.

That's because scientists have found cord blood stem cells, which are taken from a newborn's umbilical cord, to be tremendously useful. They possess regenerative properties that can assist in organ repair and can be tapped for therapeutics in medicine.

"I think that a lot of what has been out in the press has really confused the American public," Laughlin told FierceBiotechResearch. "The emphasis has been on embryonic stem cells, but knowing the nature of those cells, it would be a very long time, if ever, until those cells will be able to be used in humans safely."

Of course, the major concern with transplanting embryonic stem cells into patients as therapies is their ability to form tumors, including teratoma, which are tumor-like formations containing tissues belonging to all three germ layers.

Cord blood cells don't pose the same risks, Laughlin said. They're considered "better" stem cells because the cord blood cells are more immature and cause a lower frequency of host disease after transplantation. These young cells are also better suited to gene transfer, she said.

No doubt, advocates of hESC research might disagree with Laughlin, and still others believe that induced pluripotent stem cells are where it's at in studying regenerative therapies.

Therapies based on hESCs have moved slowly toward the clinic, without much activity to speak of besides Advanced Cell Technology's ($ACTC) early human trials of such treatments for eye diseases, according to the National Institutes of Health. But cord blood has been tried and true. NIH's National Center for Biotechnology Information estimated that 25,000 cord blood transplants have been performed since the first transplant about 20 years ago.

Laughlin said cord blood is only saved from about 4% out of all births. "Those are very useful cells that are going in the trash," she said.

It could be decades before embryonic stem cell therapies come to fruition. Meantime, Laughlin says more research dollars--both from the private and public sources--should be going toward cord blood stem cell research. -- Emily Mullin (email | Twitter)

Read more about: cord blood
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> eBook: Facing Up to the Biosimilar Challenge: Preclinical and Beyond
> eBook: Special Report: China's Rise Drives Investment in Biotech Drugs

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> Senior Clinical Trial Manager - Waltham, MA – TESARO
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Today's Top News

1. Diabetes drug decreases lung cancer tumors in mice with gene mutation

By Emily Mullin Comment | Forward | Twitter | Facebook | LinkedIn

While there's been mounting evidence over the past 10 years suggesting a link between cancer and metabolism, there has been little attempt to research metabolic drugs and their effect on cancer cells.

In 2003, Reuben Shaw, an associate professor at the Salk Institute for Biological Studies, discovered that a gene altered in lung cancer regulated an enzyme used in therapies in diabetes. For a decade, Shaw has wondered if drugs designed to treat metabolic diseases could also be effective at combating cancer.

In a new study, Shaw and his team found that phenformin, a derivative of the widely used oral Type 2 diabetes drug metformin, decreased the size of lung tumors in mice and increased the animals' survival. The study was published in the journal Cancer Cell.

In previous research, Shaw discovered that cells lacking a normal copy of the LKB1 gene fail to activate the metabolic enzyme AMPK in response to low energy levels. The result is that cells with mutated LKB1 run out of energy and undergo apoptosis, or programmed cell death, while cells with normal LKB1 are alerted to the crisis and re-correct their metabolism.

 "When cells lack this gene they don't know if they have enough energy or not. This is not a disaster to not have the gene, but it did suggest a therapeutic window," Shaw explained to FierceBiotechResearch. "If we could find a way to lower the energy levels of cells, normal cells would cope with that just fine whereas the tumors will have no idea that this drug is able to get in there and it would cause the cells to die."

Just like a car with a fuel gauge on empty, Shaw's team observed that the cells with mutated LKB1 shut down.

Researchers tested phenformin, a more potent form of metformin, in mice with lung cancer cells and observed tumor reduction in mice lacking the fuel gauge sensor--the LKB1.

"So to translate this to humans in the clinic, you'd want to treat lung cancer patients who have tumors that have alternations in that gene," Shaw said.

The findings may eventually provide a more personalized approach to treatment for the nearly 30 percent of patients with non-small cell lung cancer whose tumors lack LKB1.

- here's the study summary
- read the press release

Related Articles:
UC Davis team finds new lung cancer Rx target
Natural killer cells may be key to lung cancer susceptibility
Metabolic profiling offers new approach to personalized medicine

Read more about: metabolism
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This week's sponsor is PAREXEL.
UnboundID
Webinar: Orphan Drug Differentiation
Thursday, February 28th, 11 am ET/ 8 am PT

Join as we hear experts from orphan drug units explain how the commercial landscape of their field is changing and how orphan drug specialists have optimized patient access. Glean the latest insights on working with payers and reimbursement and get the pulse on the market and how competition brought key changes.
Register Today!


2. Researchers find TB hiding in bone marrow

By Emily Mullin Comment | Forward | Twitter | Facebook | LinkedIn

Bone marrow stem cells may provide a way to target and treat inactive tuberculosis, which can hide in the body and emerge later on down the road, well after aggressive drug therapy.

Researchers from the Forsyth Institute in Boston and Stanford University say they are the first to find evidence that tuberculosis bacteria can lay dormant and thrive in mesenchymal stem cells in the bone marrow of people treated for the disease.

"By gaining a greater understanding of latent TB, we can potentially save hundreds of thousands of lives each year," said lead researcher Antonio Campos-Neto, director of the Center for Global Infectious Diseases at the Forsyth Institute, in a statement.

Campos-Neto and his team conducted in vitro experiments, as well as in vivo using an animal model of latent TB, and  collected data from human patients treated for TB. They found that TB can infect and persist in a dormant state for long periods of time within mesenchymal stem cells--self-renewing cells that can differentiate into a variety of cell types. TB benefits from being inside these cells, which possess a special machinery to exclude external molecules such as anti-TB drugs from entering their cytoplasm.

The findings have been published in Science Translational Medicine.

Though TB isn't as prominent anymore in First World countries because of medicines that have been developed in the past 50 years, the infection is still widespread. More than 2.2 billion people--a third of the world's population--are infected with the deadly bacteria that causes TB.

- check out the Bloomberg story
- read the study abstract

Related Articles:
Biosignatures fingerprint tuberculosis and sarcoidosis
Gates Foundation funds TB biomarker research
Researchers report promising new TB vaccine

Read more about: Stem Cells
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3. Gene discovery could provide relief for deadly staph infections

By Emily Mullin Comment | Forward | Twitter | Facebook | LinkedIn

Up until now, most research on methicillin-resistant Staphylococcus aureus (MRSA) has focused on attributes like the amount of toxins or virulence factors that different strains make. A team of scientists at the University of North Carolina School of Medicine in Chapel Hill is taking a different approach.

The UNC researchers' attention is on the infection's sensitivity to polyamines--a novel target that could be key to developing new treatments against a particularly deadly strain of MRSA.

"Our work uncovers the molecular explanation for one strain's rapid and efficient spread to people outside of a crowded hospital setting," senior study author Anthony Richardson, assistant professor of microbiology and immunology at the UNC School of Medicine, said in a statement.

In the past 5 years, MRSA infections have been on the rise in places like hospitals, jails and schools where people come in close contact with one another. Staph infections account for a shocking 368,000 hospitalizations per year, according to government data, and their antibiotic-resistant nature makes them particularly difficult to treat, killing about 19,000 people annually.

Using a mouse model, researchers found a specific gene that causes one strain of the infection to stay on the skin longer than other strains, making it more contagious. This strain of MRSA--known as USA300--contains a chunk of genes that other staph strains don't have. In the past 10 years, USA300 has emerged outside of hospital walls as an extremely dangerous strain of MRSA because of its ability to progress rapidly and cause fatal disease like necrotizing pneumonia, severe sepsis and flesh-eating bacteria syndrome.  

The USA300 strain was the only strain out of hundreds tested that was not sensitive to polyamines, naturally occurring anti-inflammatory compounds that aid in wound repair by promoting tissue regeneration.

The study was published in the journal Host & Microbe.

- here's the study
- read UNC's news release

Related Articles:
Drugs rout MRSA by targeting bad bug enzymes
Pfizer, GSK and NovaDigm race to develop MRSA vaccine
Researchers 'unzip' MRSA's armor for possible vaccine

Read more about: MRSA
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4. New target that stops metastasis could lead to safer cancer therapies

By Emily Mullin Comment | Forward | Twitter | Facebook | LinkedIn

Zhi-Ren Liu--courtesy of GSU

A new target that disrupts a vital interaction between two types of cells could prevent the spread of cancer and pave the way for new cancer therapies, according to new research by scientists at Georgia State University.

Zhi-Ren Liu and Jenny Yang, professors at GSU, studied the interaction of two molecules--p68 RNA helicase and calcium-calmodulin--and their role in cell migration.

A fundamental process that involves the translation of cells from one location to another, cell migration can cause metastasis and other diseases when errors occur. Cancer at its originating site is not typically lethal--the killer is multi-organ metastasis, one of the hallmarks of a malignant tumor as opposed to a benign one.

Liu and Yang found that the interaction between p68 and calcium-calmodulin, which is essential for cell migration, inhibited metastasis in two mice studies. Yang told FierceBiotechResearch that they examined the interaction of the two cells in a derivative of colon cancer in one model and breast cancer cells in another model. In both cases, disrupting cell migration successfully stopped the spread of cancer cells and left mice with no adverse side effects. The findings were published recently in Nature Communications.

Jenny Yang--courtesy of GSU

"This could be an effective strategy at stopping metastasis and not cause much harm to regular processes in the body," Liu told FierceBiotechResearch.

Yang said there is more work to be done but is optimistic about the potential of the new target. "This is not a harsh treatment. This could be a lot safer of a way to treat cancer," she said.

Liu and Yang's teams have used the research to create two peptides, which, if modified, could be used to make a compound that mimics the peptides. Liu said he's interested in licensing the peptides to a pharma company for further development.

- here's the journal abstract
- read the press release

Special Report: 20 Major Pharma-Academic Alliances in 2012

Related Articles:
UC Davis team finds new lung cancer Rx target
'Abdominal imaging window' lets researchers crack cancer metastasis secrets
Roswell Park researchers spot versatile cancer treatment

Read more about: metastasis, Cancer
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5. Merck Serono, Feinstein Institute form collaboration to find lupus treatments

By Emily Mullin Comment | Forward | Twitter | Facebook | LinkedIn

Merck Serono and the Feinstein Institute for Medical Research have formed a partnership to develop antibodies to treat systemic lupus erythematosus (SLE), an unpredictable disease that has no cure.

A chronic inflammatory disease in which the immune system attacks the body's own tissues and organs, SLE can cause swollen, painful joints, skin rash, extreme fatigue and kidney damage. Far more women than men are affected by SLE, and anywhere from 322,000 to more than a million people in the U.S. could have the disease, the Centers for Disease Control and Prevention estimates.

"There is a very high unmet medical need for novel therapies to treat systemic lupus erythematosus. Over the last 50 years, only one new treatment option has been approved to treat the disease," said Bernhard Kirschbaum, executive vice president and head of global research and early development for Merck Serono.

The Darmstadt, Germany-based division of Merck KGaA and the Feinstein Institute, the research arm of North Shore-Long Island Jewish Health System in New York, will work together on a program that will zero in on the use of antibodies to inhibit the action of certain proteins that are to blame for inflammation in the pathogenesis of lupus.

Under the terms of the agreement, Merck Serono will fund a research program at the Feinstein Institute and will be responsible for the development and commercialization of any antibodies that come out of the collaboration. Neither party disclosed the financial terms of the agreement.

Finding effective therapies for SLE has proved challenging because there are various mechanisms by which the disease is caused, including genetic and environmental factors and abnormalities of both the innate and the adaptive immune system.

Merck Serono is investigating atacicept in Phase II of clinical development for the treatment of SLE. Atacicept targets B cells--which are thought to have a role in the pathogenesis of autoimmune diseases such as SLE--and inhibits their development.

In a statement, Merck Serono said the collaboration will allow it to further strengthen its research into alternative mechanisms for the treatment of SLE.

- see the press release

Related Articles:
Anti-inflammatory drugs that minimize infection risk appear possible
Vascular markers support lupus treatment
Researchers find two potential lupus vax treatments

Read more about: antibodies
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Also Noted

This week's sponsor is Oracle.

eBook: Knowledge Management: 5 Steps to Getting it Right the First Time
This eBook sets out 5 simple steps for optimizing customer service and support with an effective, best-practice-led knowledge management initiative. Download today!


SPOTLIGHT ON... New Alzheimer's drug clears amyloid tangles in mice

In the latest effort to find new treatments for Alzheimer's disease, researchers at the University of Lancaster in the U.K. have created a new drug that has reduced the number of senile plaques in the brain, caused by amyloid-beta protein buildup, the major hallmark of the disease. The drug was tested on transgenic mice containing two mutant human genes to imitate the effects of Alzheimer's in humans. In previous studies, antibody medications have shown moderate success at clearing these deposits, but they've caused serious brain inflammation in some patients. The new drug is designed to cross the blood-brain barrier and prevent the Aβ molecules from sticking together to form plaques. In mice, it also reduced the amount of brain inflammation and oxidative damage associated with the disease. Story | Release

Stem Cells

> 3-D printing is the latest advancement in stem cell research. Item

Neurological Diseases

> An experimental molecular therapy has reversed neurological lysosomal storage disease in mice. Release

Chronic Diseases

> Researchers have identified a new drug target for treating multiple sclerosis and Alzheimer's diseaseRelease

> Anatabine, an alkyloid found in tobacco and tomatoes, reduced neurological disability and improved motor coordination in mice with multiple sclerosis. Release

Personalized Medicine

> New stroke gene discovery could lead to tailored treatments. Release

And Finally... A stem cell hospital is coming to India. Story


Webinars


* Post listing: Click here.
* General ad info: Click here.

> Orphan Drug Differentiation - Thursday, February 28th, 11 am ET/ 8 am PT

Join as we hear experts from orphan drug units explain how the commercial landscape of their field is changing and how orphan drug specialists have optimized patient access. Glean the latest insights on working with payers and reimbursement and get the pulse on the market and how competition brought key changes. Register Today!

> The Basics of Biotech 101, 102 & 301 - Individual Session: $129, Full Series: $299

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Events


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> Lab-on-a-Chip European Congress - March 5-6 - Barcelona, Spain

Join us at Europe’s Premier Lab on a Chip Conference and Tradeshow. Here, leaders from both Academia and Industry will discuss innovations and developments in this exciting field, including presentations exploring the latest advances in Microfluidics and Microfabrication. Register today – 2 for 1 on Delegate passes for a limited time only.



Marketplace


* Post listing: Click here.
* General ad info: Click here.

> eBook: Facing Up to the Biosimilar Challenge: Preclinical and Beyond

Faced with a continuing economic crisis and an aging and increasingly obese population, healthcare providers are seeing where they can cut costs. Generics saved the U.S. healthcare system $192 billion in 2011 alone. To read more on this timely topic, download this eBook today.

> eBook: Special Report: China's Rise Drives Investment in Biotech Drugs

The Chinese government's devotion to biotech has sparked major expansion efforts by some of the country's leading pharmaceutical players, also making it fertile ground for venture capitalists in the U.S. Click here to download the complete report today.



Jobs


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> Director, Scientific Operations - Irvine, CA - Allergan

Allergan, Inc. discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets. The Director of Scientific Operations provides scientific, technical and administrative leadership for the Drug Safety Evaluation (DSE) Scientific Operations department by providing logistical support for other DSE departments. Ph.D. degree in one of the biological sciences with at least 8 years relevant management experience in industrial environment...Learn More.



> Clinical Data Manager/Senior Clinical Data Manager - Waltham, MA – TESARO

Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. This position will be responsible for providing data management expertise while working within Electronic Data Capture (EDC) environment for oncology clinical trials. The successful candidate will provide support for form design, specification review and effectively manage all aspects of the clinical trial data management process...Learn more.

> Senior Clinical Trial Manager - Waltham, MA – TESARO

Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. The Senior Clinical Trial Manager will lead the forecasting, planning and manage the implementation of the clinical operational plans in alignment with the company's strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. Demonstrated knowledge of FDA/EMA/GCP/ICH guidelines...Learn more.

> Clinical Scientist - Waltham, MA – TESARO

Tesaro is a growing publicly traded oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients. The Clinical Scientist is responsible for providing scientific support for all Medical Development activities. This cross-functional role includes assembling, evaluating, and presenting scientific and medical data, writing manuscripts (paper, abstracts, posters, etc.) and monitoring the competitive landscape and reviewing and summarizing relevant literature. Advanced, doctoral level degree preferred...Learn more.

> Teach Pharma In Japan - Tokyo, Japan - International Education Services

Pharmaceutical professionals with a minimum of three years work experience in various areas of the pharma/biotech industry needed to teach at big pharma companies in Japan. Teaching is in English to small groups of Japanese pharma executives. Annual contract and compensation with paid vacations, medical insurance, work visa sponsorship and training provided...Learn more.

> Scientist - Purification Development Job - Plainsboro, NJ, USA – Yoh

Yoh has a direct hire opportunity for a Scientist - Purification Development to join our client in the Plainsboro, NJ area. Our client is actively looking for a Scientist to join their Purification Development team. Reporting to the Head of Purification Development, the incumbent will be primarily responsible for supporting the development/optimization of purification processes for biopharmaceutical production. BS / MS in Chemical Engineering, Biochemistry, related Life Science discipline required...Learn more.

> Clinical Scientist Job - Danbury, CT, USA – Yoh

Yoh has a contract opportunity for a Clinical Scientist to join our client in Danbury, CT. This position will provide in house Local Clinical Monitor (CML) trial support for approximately 1-3 trials per person. Seven plus (7+) years' experience within the pharmaceutical industry supporting clinical trials required...Learn more.

> Associate Scientist - Analytical Development Job - Princeton, NJ, USA – Yoh

Yoh has a contract to hire opportunity for an Associate Scientist- Analytical / Formulations / Development Sciences to join our client in the Princeton, NJ area. Job responsibilities include development, qualification, and implementation of analytical methods for protein therapeutics. Minimum of one (1) year relevant experience in analytical sciences of protein biotherapeutics (mAbs, antibody fusion proteins, and other protein constructs) required...Learn more.

> Clinical Statistician Job - Fairfield, NJ, USA - Yoh

Yoh has a contract opportunity for a Clinical Statistician to join our client near Pine Brook, NJ. This is an exciting opportunity for a Mid-Senior level Biostatistician to join with one of the world's leading healthcare companies. The successful candidate will have an MS or PhD in Statistics or Biostatistics and over three to five (3-5) years of experience working with clinical trial data...Learn more.

> Senior Principal Informatician - Big Data Analytics - Waltham, Massachusetts, USA - AstraZeneca

AstraZeneca is a global, innovation-driven, integrated biopharmaceutical company seeking a talented Senior Principal Big Data Informatics Scientist to drive the vision and strategy of Big Data Analytics in R&D and provide advanced hands on support to R&D activities across all therapeutics areas and phases of the drug discovery and development pipeline. Proven in-depth experience in the field actively employing Big Data Analytics expertise required...Learn more.

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