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European Biopharmaceutical Review

ebr
Summer 2009
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR.
   
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BioFinance and Management
The National Institute for Health and Clinical Excellence (NICE) in England and Wales has become the foremost appraiser of new medical technologies, although several of its decisions have been controversial. Joshua Cohen at the Tufts Center for the Study of Drug Development examines the NICE decision-making process and the impact it has had on the global pharmaceutical industry.  
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The first quarter of 2009 saw slow industry growth for the global pharmaceutical and biotech sectors, and sales of many of the top companies were down. Independent consultant Emile Bellott reviews the new product strategies and industry partnerships that are being initiated as companies aim to gain competitive advantage and manoeuvre to find the best position for success in the future.  
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BioBusiness Development
After the high-profile withdrawal of medicines with potentially fatal side effects, public concern over drug safety has reached a new level, and pharma companies must take this into consideration long before a product has been approved. William C Maier at REGISTRAT-MAPI explains the factors that affect risk perception, and suggests steps that can be taken to avoid negative media coverage.  
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Strong lifecycle management has become more crucial than ever for maximising and exploiting a drug's potential during the years of market exclusivity; as Jan Hendrick Sitz and Markus Thunecke at Catenion point out, a therapeutic expansion strategy may be the solution for creating value and counteracting poor R&D productivity.  
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BioResearch and Innovation
Most malignant tumours remain incurable, and there is an urgent need to develop novel therapeutics. Nick Charles of Mayo Clinic reports on the latest studies utilising the attenuated measles virus as a delivery device for fighting cancer, destroying tumour cells without damaging healthy tissue.  
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Millions of people bleed to death every year and, even in hospital situations, uncontrolled bleeding can present a serious challenge to medical professionals. Jaap Koopman and Jan Ohrstrom at ProFibrix review the current products available and discuss promising new haemostasis developments based on a combination of fibrinogen and thrombin that could answer market demand.  
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Discovery Technology
Daryl Fernandes at Ludger points out that detailed monitoring of glycans is essential during a drug's life cycle in order to highlight adverse clinical events. He believes that a quality by design inspired approach to selecting glycan florescent labels will produce the most reliable biopharmaceutical glycoprofiling, and provide benefits such as a lower regulatory burden.  
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The characterisation of N-glycosylation is extremely important for the development of a recombinant drug. manfred Teisen at PROTEODYNAMICS SARL discusses the use of mass spectrometry techniques to discover and compare N-glycan profiles of native and recombinant proteins.  
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The market for biological drugs is expanding remarkably, but a number of challenges are restricting their application. Dave Mead at Novozymes Biopharma discusses how albumin fusion technology can extend the bioavailability of biologics and improve efficiency by increasing their half-life.  
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BioDevelopment and Regulatory
Advances in scientific knowledge are continually improving the volume, efficacy and manufacturing processes of drugs. In light of this, Anita O'Connor at MDS Pharma Services weighs up the advantages and drawbacks of developing biosimilar or second generation monoclonal antibody drugs, and asks which type companies should be focusing on.  
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In December 2008, the European Commission published a proposal for a review of current legislation on the authorisation of human medicinal products. The results of the initial consultation showed that many experts feel the current process can be cumbersome and ineffective, explains Elisabethann Wright of Hogan & Hartson, and that updating the legislation surrounding pharmacovigilance could lead to a reduction in the number of deaths due to adverse drug reactions.  
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BioFormulation and Manufacturing
The vaccine industry is currently dominated by a few major players, but this situation is beginning to change: the industry is growing rapidly as pharma companies turn to alternative methods in order to increase revenue. Phil Ball and Maria Lusk at Eden Biodesign examine the vaccine 'renaissance' taking place in development and production, and the regulatory initiatives that are streamlining the entire process.  
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Anil Kumar, Stefan Egli, Jerold Martin, Charles Golightly and Ralf Kuriyel at Pall Life Sciences look at the recent trend of using large volumes of cell cultures with high expression levels to met demand for biopharmaceutical drugs. They also discuss the factors involved in filter selection, including contamination risks, process economics and operational simplicity.  
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BioRegional
Sandra Nordstrom at GöteborgBIO describes the research currently taking place in the Swedish city of Göteborg, highlighting its position at the forefront of stem cell research and drug safety testing.  
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
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