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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

Zenith Technologies Wins ‘Supplier of the Year’ at Pharma Industry Awards 2018

Zenith Technologies, a world leader in delivering manufacturing software to the life sciences industry, has been named ‘Pharma Supplier of the Year’ at the prestigious 2018 Pharma Industry Awards.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
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Industry Events

Drug Delivery Partnerships 2019

28-30 January 2019, PGA National Resort & Spa in Palm Beach Gardens, FL

For 23 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies. Year after year this event brings together top scientists and business development leaders from Biotech, Pharma, Generics, Specialty Pharma and Drug Delivery companies to share, discuss, and collaborate. If you work in drug delivery, commercialization/licensing, med device, formulation, biologics, biosimilars, and similar areas, you can’t miss this event!
More info >>

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