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European Biopharmaceutical Review

ebr
Summer 2008
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
Sandrine Cailleteau at Michel Dyens & Co believes that consolidation in the biotech industry through mergers and acquisitions needs to accelerate in order to allow the biotech industry to grow and create value in today’s highly volatile financial markets  
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Gavin Weir and Isabella Roberts of Simmons & Simmons discuss the funding pitfalls that bioscience companies face as a result of worsening market conditions  
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BioBusiness Development
Jerona Noonan at Genesys Conferencing discusses the role of collaboration in driving ‘green’ performance  
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Bob Chandler and Gianfranco Chicco of Biosector 2 discuss how priorities are shifting for small companies, meaning they must tailor their communications to help establish themselves in an increasingly crowded market  
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BioResearch and Innovation
Jenny Littlechild at Bioapproaches discusses the commercial applications of robust enzyme catalysts, and potential platforms for future biocatalytic processes  
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Ronald G Jubin of PBL discusses the techniques currently employed to study interferon levels in order to help further comprehend what is a potentially very useful cytokine  
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With clinical trial analyses needing an update, Alan Phillips at ICON Clinical Research explores Bayesian methods for re-thinking biostatistics  
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Dr Jean-Yves Bonnefoy of Transgene considers the serious threat of SARS, bird flu and other highly infectious and potentially devastating diseases such as HIV and Hepatitis C. All have led big pharmaceutical companies to review their focus on the development of new vaccines  
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Gillian Byrne from Applied Cytometry explains how modern analysis software is dealing with the tide of data generated by a new generation of flow cytometers  
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Discovery Technology
Lisette Oversteegen and Clare Davies at Datamonitor predict that the autoimmune disease market is going to be one of the fastest growing therapy areas in terms of sales in the next few years  
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Disease prevention by vaccination saves millions of lives every year, yet millions more die worldwide due to inadequate vaccine supply, and the world faces increasing threats of pandemics such as influenza and SARS. Björn Lundgren at GE Healthcare discusses how these factors have highlighted a need for the development of new vaccines and improved manufacturing processes  
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BioDevelopment and Regulatory
Michael Rosenberg of Health Decisions examines the operational aspects of adaptive research – a traditionally overlooked component of clinical trials  
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Michael Gotz of MLG Consulting explores the regulatory responsibilities shippers face when transporting infectious pathogens by air  
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Ilesh Sanathra at Pharmalink Consulting Ltd discusses whether change control is an appropriate regulatory tool  
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Anthony Warnock Smith and Natalie Kingston at Morgan Lewis examine the Advanced Therapies Regulation, which was finally introduced by the European Commission in November 2007  
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BioFormulation and Manufacturing
Martin Shaw of Biotrin explores the potential benefits of using cell-specific biomarkers in human renal studies  
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Stephen Blatcher, Angus Forster, Jennifer Vondran and Ian Rhodes of PA Consulting explore the best methods with which to realise the commercial potential of combination products and convergence therapies  
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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

Nemeras preservative-free multidose eye dropper Novelia® approved for Santens Cosopt® for Glaucoma treatments in 29 European countries

Nemera is pleased to announce that its multidose eye dropper Novelia® has been approved for the preservative-free formulation Cosopt iMulti® (20mg/ml dorzolamide + 5mg/ml timolol eye drops, solution).
More info >>

White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
More info >>

Industry Events

Highly Potent Active Pharmaceutical Ingredients (HPAPI)

13-14 May 2019, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 3rd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 13th-14th May 2019. The HPAPI global market has developed rapidly in the past year and is continuing to expand into the future, with over a quarter of drugs in development worldwide being classified as highly potent. As a result, there is a growing demand for both pharmaceutical and contracted manufacturers to adapt to the evolving HPAPI landscape.
More info >>

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