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| home > ebr > Summer 2010 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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| 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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| 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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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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| 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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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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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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News and Press Releases |
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Turkish Cargo includes Sheremetyevo Airport near Moscow to its cargo flights network.
As the fastest growing brand among the global air cargo carriers with
its extensive flights network, Turkish Cargo included Sheremetyevo
Airport (SVO), known as being the most important airport in Russia in
terms of cargo activities, to its direct cargo flight destinations
network.
More info >> |
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >> |
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Industry Events |
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Nordic Life Science Days 10/12 September 2019
10-12 September 2019, Malmo Sweden
Nordic Life Science Days is the largest Nordic partnering conference for the global Life
Science industry.
Bringing together the best talents in Life Science, offering amazing networking and
partnering opportunities, providing inputs and content on the most recent trends.
Nordic Life Science Days attracts leading decision makers from the Life Science sector,
not only from biotech, pharma and medtech but also from finances, research, policy and
regulatory authorities.
More info >> |
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