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While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.

Today, Samsung formally announced that it would create a joint venture with America’s Biogen/Idec to develop market and manufacture biosimilar molecules. Under the terms of the agreement, Samsung will invest $255 million and garner a 85% stake in the venture which will be located in South Korea. Biogen/Idec will invest $45 million for a 15% stake in the joint venture. Samsung will take a leading role in developing and marketing the joint venture’s products whereas Biogen/Idec will contribute expertise in protein engineering and biomanufacturing. The joint venture will not develop biosimilar versions of Biogen/Idec’s proprietary, branded protein-based drugs which include Avonex (MS), Rituxan (oncology) and Tysabri (MS).

Biogen/IDEC is the first “big biotech” company to jump on the biosimilar train. The company joins Merck BioVentures and Sandoz (Novartis) as major players in the biosimilar marketplace. Teva, which began looking at biosimilars about eight years ago, is also widely believed to be a biosimilar player. While the financial fate of biosimilars is still uncertain in the US, these molecules are generally perceived as having a much higher financial upside in large emerging markets such as China, Korea, Brazil and Russia which are susceptible to government pricing controls.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Crowdsourcing—using the collective talent of the Internet to solve problems—has been increasingly used to solve problems and find solutions in the computer software and electronics industry. Over the past few years, several forward-thinking life scientists had proposed the idea that crowdsourcing could possibly be used to solve the molecular structure of proteins that could be used as drug targets. To bring this possibility to reality, in 2008 a team of scientists at the University of Washington created an online, interactive, protein-folding game call Foldit that showcased the principle and properties of protein biochemistry. The thought was that Foldit and its worldwide cadre of users could be used to solve the molecular structure of certain proteins. Since 2008, over 100,000 have downloaded Foldit software and turned into a large, worldwide, multiplayer competition.

Earlier this week a group of scientists reported in the journal Nature Structure & Molecular Biology that Foldit users helped them to determine the molecular structure of a simian HIV protease that had baffled scientists for 15 years. The actual three dimensional structure of the protein that was predicted by Foldit was confirmed by X-ray crystallography. According to the paper’s authors (that included the Foldit players who helped solve the protein’s structure),

“Although much attention has recently been given to the potential of crowdsourcing and game playing, this is the first instance that we are aware of in which online gamers solved a longstanding scientific problem. These results indicate the potential for integrating video games into the real-world scientific process: the ingenuity of game players is a formidable force that, if properly directed, can be used to solve a wide range of scientific problems.”

Crowdsourcing is a new concept that is beginning to be embraced by the life sciences community including academics as well as industrial scientists. To learn more about crowdsourcing and its use in drug discovery and design, please read an article that I wrote for LifeScienceLeader this past July.

Until next time...

Good Luck and Good Gaming!!!!!!!!! 

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Several weeks ago Bayer AG’s Chief Executive Officer Marijn Dekkers said that he would consider a “merger of equals” to bolster the company’s sagging healthcare division. The division, a minor revenue source for Bayer AG, posted $25.1 billion in sales last year.

Today, the company announced that by 2013 it would outsource the entire production of its blockbuster MS treatment Betaferon to its German arch rival Boehringer Ingelheim. At present, Betaferon sold in the US is manufactured at Bayer’s production facility in Emeryville, CA. Bayer will close that facility and about 540 jobs will be lost.

Boehringer already manufactures Betaferon sold in Europe and it recently received US Food and Drug Administration approval to also sell it in the US. A Bayer spokesperson said that “It is important for us that we can offer the product from a single source.” While that makes sense from a regulatory standpoint, the decision also suggests that Bayer Healthcare may indeed be positioning itself for sale. It also suggests that Bayer may be abandoning the US market for “greener pastures” in the emerging BRIC markets (Brazil, Russia, India and China).

For more insights into Bayer Healthcare check us this article in Life Science Leader.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has forced many small to mid-sized companies to rely again on American CMOs to manufacture their products. Unlike cash-rich, larger companies, US small to midsize companies generally lack the financial resources and personnel to effectively manage operations in Asia. Many industry analysts contend that the lower initial costs of Asia-based companies are usually offset by the money and resources need to oversee a project.

While business returning from Asia improved the financial outlook for some American CMOs, 2009 was a bad year for most firms that service small to mid-sized pharma and biotech companies. However, industry analysts expect 2010 to be better than 2009. More importantly, the return of biomanufacturing to the US may signal the beginning of a new trend in the biomanufacturing outsourcing industry.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

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While surfing the web, I came upon a cool website called Foldit. Foldit is an online competitive, interactive protein folding game that showcases the principles and properties of protein biochemistries.

The game, originally created by David Baker, Zoran Popović and David Salesin, works like this. Players are given a ribbon model of a protein made up of amino acids. Players use the cursor to grab, bend, pull, and wiggle the chain of amino acids anywhere along its length, folding the protein into its optimum shape. The only rules are based on physics—opposite charges attract, atomic bonds have limited angles of rotation, and the parts of the molecule that stick to water tend to point outward. The closer your model's properties adhere to those rules, the more points you get. The goal of the game was to get large numbers of players to work on potentially difficult protein folding problems to come up with possible solutions. And it seems to be working. More than 100,000 people have downloaded Foldit since its release in 2008, turning the game into a large, worldwide, multiplayer competition.  

Check out the YouTube Foldit video to learn how it works!

Please visit the Foldit site and blog for more information.

Until next time...

Good Luck and Good Protein Folding!!!!!!

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Does the smell of a fresh pot of coffee brewing get you going in the morning? Do you experience a rush of energy simply by getting a whiff of freshly-brewed joe? If you do, there may be a genetic explanation for it.

A group of scientists at Seoul National University in Korea exposed sleep-deprived rats to coffee bean aroma and then assessed the effects by performing genetic and protein analysis on their brain tissue. These results were compared with those obtained from sleep-deprived rats that were not exposed to coffee. Unstressed, non-coffee exposed and unstressed - coffee exposed rats served as controls in these experiments.

According to results published in The Journal of Agriculture and Food Science, the Korean scientists found that mRNA levels of 11 of 13 genes were elevated in the coffee-exposed rats: the levels of 2 others were decreased. They also found differential expression of proteins (using mass spectroscopy) in the two groups of rats. For example, a protein known to have an antioxidant effect was expressed at higher levels in the coffee-treated group.

So what does this all mean? According to the authors “the roasted coffee bean aroma changes the mRNA and protein expression levels of the rat brain, providing for the first time clues to the potential antioxidant or stress relaxation activities of the coffee bean aroma.” Will these observations hold true for humans? Only time will tell. That said, remember that the best laid plans of mice (rats?) and men often go astray.

Until next time…

Good Luck and Good Job Hunting (try Starbucks) !!!!!

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There are currently two injectable products on the market that are used to treat chronic Hepatitis C infections. Both products, PEG-INTRON (Schering Plough) and Pegasys (Roche) are PEGylated versions of the cytokine interferon-alpha that are used in combination with ribavarin (an orally-delivered small molecule drug) to treat patients infected with Hepatitis C virus.  

PEG-INTRON (peginterferon alpha-2b) was co-developed by Schering Plough and Enzon in the early 1990s and brought to market in 2000. Pegasys (peginterferon alpha-2a) , which use a different chemistry to attach PEG to interferon-alpha, was approved in early 2002 and quickly supplanted PEG-INTRON as a treatment of choice for Hepatitis C infections. Pegasys also gained approval in 2005 to treat chronic Hepatitis B infections.

The knock on PEG-INTRON was that it appeared to lose potency in liquid form (a claim that has always been denied by Schering and Enzon). Nevertheless, PEG-INTRON was supplied to patients as a sterile powder which had to be reconstituted prior to injection. In contrast, Pegasys was supplied in liquid form in pre-filled self injection pens to infected patients. This was possible because the PEG chemistry used to create Pegasys was found to be extremely stable (as compared with PEG-Intron?) in liquid form. Although there appeared to be no real differences in efficacy between PEG-INTRON and Pegasys to treat Hepatitis C infections, patients tended to prefer Pegasys over PEG-INTRON because it was easier and more convenient to use.

Schering Plough has been struggling for the past 5 years or so to recapture the market share that it lost following Pegasys’ introduction in late 2002. To that end, in 2003 the company received FDA approval for a pre-filled injection pen to administer PEG-INTRON. Further, to dispel any rumors regarding PEG-Intron’s efficacy relative to Pegasys, Schering decided to conduct two large head-to-head clinical studies that compared PEG-Intron or Pegasys in combination with ribavarin as treatments for Hepatitis C patients. Today, Schering-Plough announced the results of the first of these two large scale clinical studies called IDEAL. The results from the IDEAL study showed that PEG-Intron was just as effective as Pegasys for treating patients with Hepatitis C. Further, it appeared that fewer patients taking PEG-INTRON relapsed after treatment.

It is not clear whether Schering will win the war but the company certainly appears to have won this most recent skirmish!

Until next time…

Good Luck and Good Job Hunting (try Schering Plough)!!!!!!!!!

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