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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

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA Europe in Basel

Today NDA Group announced their findings from its fifth annual comparison of drug approvals in Europe and the United States, in preparation for this year’s DIA Europe in Basel, Switzerland. The figures highlight the continued differences between the two regions, and the need for a global approach to drug development to ensure success across both continents.
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White Papers

Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models

DrugDev

For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality. One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
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Industry Events

Vaccine Manufacturing

23-25 April 2018, RAI, Amsterdam

Changing the shape of vaccine development, manufacturing and delivery.
More info >>

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