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European Biopharmaceutical Review

ebr
Autumn 2010
   
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BioBusiness, Finance & Communication
Trish Meek at Thermo Fisher Scientific and Dennis Fallen at Fisher BioServices discuss the importance of informatics tools in the translational science process, highlighting laboratory information management systems as an ideal solution for more effective collaboration.  
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Translational medicine is a new term for an old approach that has again become relevant to contemporary issues. However, its true value lies in the seamless integration of the public and commercial sector, explains Bob Damms and Ian Rhodes at PA Consulting Group.  
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As the opportunities for conducting trials in developing countries increases, Gary Muddyman at Conversis weighs up the risks and challenges involved in working in these countries given their unique cultures and little understanding of Western medical concepts.  
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BioResearch and Innovation
David Koos, Steven F Josephs and Ewa Carrier at Entest BioMedical, and Thomas E Ichim at Medistem Inc, look at the approaches being used to target the main cause of cancer: the tumour stem cell.  
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Reporting on the recent developments of anti-tumour immune response studies, Karl-Hermann Schlingensiepen at Antisense Pharma GmbH presents potential treatments emerging from a combination of traditional approaches.  
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Within the opening decade of the 21st century, biological products as therapeutics have taken their place in the ranks of the top 10 global pharmaceutical drugs. Consultant Emile Bellott looks at the impact this market growth has had worldwide.  
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Discovery Technology
The ability of RNA interference – the pathway through which protein synthesis can be blocked – to silence disease-causing genes effectively has placed it as one of the most promising technologies driving the future of the pharmaceutical market. Balasubramanyam Nistla at GBI Research looks at the technology’s potential in cancer care.  
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Manfred Gossen at BCRT, Berlin describes how Tet technology can facilitate the translation of scientific advancement into medical progress, giving examples in diabetes and cancer, and its vast innovative potential in advancing pharmacological and biomedical research.  
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Gregory V Goldmacher at ICON Medical Imaging makes the case for a centralised approach versus local readers when determining a subject’s suitability for a clinical trial, citing robust statistical results and cost savings as key benefits of using this method.  
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In contrast to the ‘one drug, one target’ model, recent approaches to reprofiling have revealed that many drugs act on more than one target. Daniel Auerbach, Lukas Baumann and Mandana Rezwan at Dualsystems Biotech look at the variety of technologies available for target identification and how this can be used to reposition marketed drugs to alternative indications.  
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BioDevelopment and Regulatory
Adaptive trial designs are the most cost-effective, efficient way to get the best out of a clinical trial endeavour, argues Shein-Chung Chow at Duke University School of Medicine, in his review of the range of different options available to today’s trial organisers.  
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As always, speed is of the essence in drug discovery, and methodologies that streamline the research process are very welcome. Ulf Landegren at Uppsala University shows how biomarker technologies are up to the challenge.  
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As the marketplace becomes more competitive, the technological demands of the research process can often become too great for individual CROs. Samantha James of Simbec Research introduces the idea of centralised laboratory services, which can offer the specialist skills required for the task.  
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BioFormulation and Manufacturing
While regulatory authorities are introducing guidelines to take biopharma through the 21st century, Hedley Rees at Biotech PharmaFlow argues that the problem of modernisation stems not from regulations, but from the management culture within the industry.  
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The integrity of data quality is fundamental to any research project; Diane Meakin and Janette Waterhouse at R5 Pharmaceuticals provide ways in which confidence in data can be controlled and improved.  
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Chris Ullman of Isogenica Ltd gives a detailed analysis of how phage display methods can assist the discovery process in a variety of ways, especially when it comes to finding new molecules for protein and peptide-based therapeutics.  
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BioRegional
As pharmaceutical investment in the Kingdom of Saudi Arabia continues to grow, Rani Abraham at ClinTec International details the challenges, regulations and cultural aspects that need to be considered.  
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Although still in its early growth phase, Satya Dash at the Association of Biotechnology Led Enterprises explains why the future of India’s presence in the global biotechnology market is dependent on the political landscape and government support.

 
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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

World-leading cancer stem cell expert joins Avacta Scientific Advisory Board

Developer of biotherapeutics and research reagents announces the appointment of Professor Gerard Evan to its Scientific Advisory Board
More info >>

White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events

ManuPharma 2017

6-7 December 2017, Steigenberger Frankfurter Hof, Frankfurt

Europe's first peer-led pharma event for Heads of Tech Ops, Heads of Manufacturing Ops and Site Leads.
More info >>

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