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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

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

Bringing more control to temperature-sensitive logistics

UPS Supply Chain Solutions

By 2016, world sales of cold-chain drugs and biologics such as vaccines and blood plasma products will near $240 billion1. The increase has led to a surge in discussion about how to protect these products throughout the transportation logistics cycle. Industry experts are recommending that the term “cold chain” be eliminated from rules, guidance and best-practice documents. “Cold chain” now includes a broader spectrum of temperature ranges, such as controlled room temperature (CRT). This white paper focuses on the initial steps required to establish a temperature-sensitive supply chain.
More info >>

Industry Events

Outsourcing Clinical Trials Nordics 2018

30-31 October 2018, Copenhagen, Denmark

Following on from the success of the 2017 Outsourcing in Clinical Trials Nordics conference, Arena International is pleased to announce that the event will return for its 6th year in 2018. The 2018 event welcomes biopharmaceutical and medical device companies from across the Nordic region to share knowledge and challenges of outsourcing and clinical operations.
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