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European Biopharmaceutical Review

ebr
Summer 2010
   
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BioBusiness, Finance & Communication
Geographic ‘clusters’ of companies and institutions that share the same interests can prove to be a more fluid way of achieving desired targets when faced with global markets and competition, finds Christian Garbe at FIZ Frankfurt Biotechnology Innovation Center.  
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The pharma business model is changing, requiring companies to achieve a higher base level in core competencies and to adapt to the more complex demands of current deals and transactions, explain Andrew Jones and Leo Gribben at Ernst & Young.  
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In today’s world, pharmaceutical publicity offices must adapt to rapid media developments as they occur.Donna L LaVoie of LaVoie Group summarises strategic steps for integrated partner communications.  
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Malcolm Young at e-Therapeutics plc and Alan Whitmore at Lumemed Ltd discuss how awareness of the potential advances in research is essential if businesses want to access truly up-to-date technologies, and avoid being left behind in the marketplace.  
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BioResearch and Innovation
Autoimmune diseases are responsible for a significant share of the European pharma market, and offer a considerable opportunity to those willing to innovate and meet regulatory standards, argues Suraj Ramanathan at GBI Research.  
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Critical limb ischaemia and related conditions are facing a powerful weapon in the form of placentalderived mesenchymal stromal cells. William R Prather at Pluristem Therapeutics, Inc reports on the advances which are underway in this field.  
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Discovery Technology
Juliet A Ellis and Francesco Muntoni at University College, London review developments in current research in RNA therapy, and explain its importance in the treatment of rare genetically determined diseases, particularly those affecting the central nervous system and muscle groups.
 
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Repositioning offers a cost-effective shortcut in the drug discovery process, yet for a variety of reasons it is nowhere near as commonly employed as it should be, shows Raúl Insa at SOM Biotech through discussion of several key examples of successfully repositioned drugs.
 
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Protein aggregation can have a decisive part to play in the quality and stability of biopharmaceutical products, with nanoparticle tracking analysis giving manufacturers greater control over this factor, explain Bob Carr and Andrew Malloy at NanoSight Limited.
 
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Rohan A Thakur and Michael Koleto at Taylor Technology discuss mass spectrometry, providing a detailed view of its uses and advantages, and demonstrating its potential for fast pharmacokinetic and semi-quantitative analysis of metabolites.
 
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BioDevelopment and Regulatory
Rasika Ramachandran at Frost & Sullivan points out the benefits of using stratified medicine in drug discovery trials, and highlights how biomarkers have a big part to play in their effective implementation.  
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Eleanor Root and Patrick Kelleher of Bird & Bird outline the existing regulatory infrastructure of biotechnology patent, including European rules, and provide examples that highlight the key issues.  
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Lee Caffin and Vandana Mamidanna at Think IP Strategy assert the necessity of research into the patent background surrounding any discovery or innovation programme, and advise on how to spot risky situations.  
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BioFormulation and Manufacturing
There is massive potential for transgenic plants to assist in the production of pharmaceutical proteins. Kathleen L Hefferon at Cornell Research Foundation explains how plant-derived products can be safer, more effective, and cheaper to produce.

 
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Biopharmaceutical manufacturing provides more than just cost-effectiveness; Eric S Langer at BioPlan Associates, Inc discusses the range of benefits it has to offer and covers some of the developments in this area in the last year.
 
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Christopher Stewart at MPI Research outlines recent progress in biologics and offers some insight into the effect this has had on small molecule development, encompassing current regulations along the way.
 
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BioRegional
Steeped in a history of medical innovation and discovery, Scotland continues to be a prime location for the biotech and biopharmaceutical industries, as Rhona Allison at Scottish Enterprise reports.
 
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Timur Bondaryev and Svitlana Ivasenko at Arzinger show how, despite suffering as a result of the recent economic slump, Ukraine is making progress in the biotechnology sector, with plenty of examples of growth to be seen.
 
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July and October

News and Press Releases

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers

The Importance of ADCC in Assessing Clinically Relevant Differences

Sartorius Stedim BioOutsource Ltd

Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules.
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Industry Events

DIA 2018 Global Annual Meeting

24-28 June 2018, Boston, MA

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe. Designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need to do your job every day, your attendance will accelerate your growth and your organization's performance in the development ecosystem.
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