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European Biopharmaceutical Review

ebr
Winter 2011

   
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BioBusiness, Finance & Communication
Partnering is the lifeblood of the biotech and pharmaceutical industries and, as the industry expands, Robert Lee Kilpatrick from TVG discusses the ideal elements for successful collaborations.
 
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Neil Johnson, Ad Rietveld and Chloë Brown of RJW & Partners Ltd consider the benefits of thorough in-licensing evaluation and early understanding of payers' perspectives in guaranteeing launch success.
 
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Discovery Technology
Xavier Tizon at Oncodesign makes a strong case for the untapped potential of imaging biomarkers and how they can be applied in future drug development stages.
 
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Simon Webster from Avacta Group PLC considers the benefits of maintaining physical stability of candidate therapeutic proteins at an early stage in the discovery process, and highlights pioneering techniques for monitoring conformational and colloidal stability.
 
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BioDevelopment and Regulatory
For companies facing up to the move from proof-of-concept to proof-of-differentiation, Markus Thunecke from Catenion considers the three levels of evaluation that should be considered.
 
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Kai Lamottke at Bicoll GmbH, Christophe Ripoll at Naturalpha and Robert Walczak at Genfit SA consider if natural product programmes are ready to challenge the traditional drug cycle process.
 
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By encouraging others to develop their own drugs using a patented technology, the patent owner has the potential to develop substantial revenues, observe Michael R Ward,Otis Littlefield and Anita Choi from Morrison & Foerster LLP.
 
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Sekhar Medisetti at GlobalData takes a look at the niche market for Type 1 diabetes, the continuous challenge posed by patient compliance, and the problematic issue of delivery methods for insulin products.
 
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BioFormulation and Manufacturing
Bill Whitford of Thermo Scientific Cell Culture and BioProcessing analyses the advantages of single-use bioreactors and the supply and performance features they offer in process development.
 
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In response to the danger posed by bacterial retention testing, Martha Folmsbee, Morven McAlister and Jerold Martin at Pall Life Sciences compare and contrast the various tests for predicting and confirming retention.  
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Amin Omar at Innovotech highlights the need for finding the most suitable antimicrobial agent to avoid the potential problems of biofilm infections.
 
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BioRegional
Following the launch of the Smart SME Market Validation Programme, Rebecca Philpot from the State Government of Victoria, Australia, considers other ways in which the city is changing to better accommodate the biotech industry.
 
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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

Digital Health and Wearables

• Datwyler uses strategic partnerships to develop new solutions in the fields of wearables and digital health. • The company’s health care offering is always designed towards improving the comfort of patients during treatment. • The product portfolio and innovative healthcare solutions will be presented at several important trade fairs of the medical sector.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

Industry Events

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

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