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European Biopharmaceutical Review

ebr
Spring 2011

   
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BioBusiness, Finance & Communication
A Watchful Eye

Michael Rosenberg of Health Decisions Inc explains why monitoring is the single most important safeguard for clinical studies and considers the methods available for accurately gauging the trajectory of a trial.
 
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Digital Directions

As the regulatory pressure on small and medium-sized companies increases, electronic document management system software is being tailored to maintain efficiency standards. Keith Williams of GxPi looks at how to implement these hosted systems to enhance functionality.
 
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Blockbuster Takeover

The acquisition of Genzyme grabbed headlines as the largest pharmaceutical company takeover in the industry for years. Daniel Bastide from Thomas Eggar LLP reports on the negotiations that made the purchase possible.
 
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Perfect Partnering

Ross McLennan of TMRI Ltd shows how a multitude of collaborations between industries can allow for stronger adaptive clinical designs, and details some of the initiates already in place that prove what they can offer.
 
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Software Solutions

The burden of the industry’s livelihood is dependent on the success of partnerships. Alison Shurell at IntraLinks explains how embracing new technology can effectively speed up the communication chain.
 
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BioResearch and Innovation
Standing at the Threshold

Contemplating revisions to the blockbuster ‘one-size-fits-all’ business model, Private Consultant Emile Bellott highlights the reasons why applying genetic-aware therapeutic strategies presents a compelling opportunity for the major industry players.
 
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Accelerating Innovative Vaccines

Scott Preiss, Alberta Di Pasquale, Marleen Mergaerts and Nathalie Garçon at GlaxoSmithKline Biologics discuss vaccines in common use and the factors that go into narrowing down their design goals.
 
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Learning from Experience

Using examples of exogenous virus contamination, Andy Bailey of ViruSure GmbH reviews the vulnerability of the biotech manufacturing process from sources yet to be identified.
 
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Mind the Messenger

Raymond Verhaert and Victor Schut of ProteoNic review the technology affecting translational activity, with specific focus on their application to the study of mammalian and yeast cell culture.
 
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Discovery Technology
Stem Cell Innovation

Vanessa Ott and Blake Anson of Cellular Dynamics International look at how the world of induced pluripotent stem cells has changed since it was discovered that they could be extended to human cells.
 
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Big Ideas on a Small Scale

The successful development of miniaturised, automated, speedy and reliable assays in the future will be heavily dependent on nanotechnology, suggests Mike Fisher at NanoKTN in this portrait of what is available currently.
 
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BioDevelopment and Regulatory
Best Practices

Nathalie A Compagnone of Innovative Concepts in Drug Development examines the role of regulatory agencies in diagnostic testing and biomarker development.
 
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New Horizons

Focusing on the rise of the ‘omics’ field, Gustavo Salem of Agilent Technologies, Inc considers the future of integrated biology and explains how a deeper understanding of cellular processes is set to alter the way we view therapeutics.
 
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BioFormulation and Manufacturing
From Lab to Clinic

When streamlining a business, often one of the strongest ways to ensure you have all the necessary expertise is to outsource. Angela Scott and Susan McKee of Angel Biotechnology evaluate the risks and benefits of biomanufacturing using external contractors.
 
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The Perfect Host

John Liddell and Ian Hodgson of MSD BioManufacturing Network demonstrate that if molecule expression can be achieved in E Coli, then lower costs and a faster speed to market will usually follow.
 
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Sustainable Standards

Yaniv Vardi at Sparta Systems Europe Ltd assesses how crucial the enterprise-wide quality management system is in the pharmaceutical and biotechnology industries.
 
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BioRegional
Dragon’s Den

In a comparison of the biotech industry’s US and Chinese workforces, Erik Lundh of J. Robert Scott draws on recent survey findings to report on top hiring issues and the international effect of the ‘brain drain’.
 
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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

CPI to showcase results from BioStreamline project developing novel biotherapeutics

CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
More info >>

White Papers

Shipping with Active Packaging Containers: Three Pre-flight Decisions that Impact the Success of High-value Global Shipments

World Courier

It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
More info >>

Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

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