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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

Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
More info >>

White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
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Industry Events

3rd Annual Inhalation & Respiratory Drug Delivery Congress

8-9 May 2018, London, UK

Oxford Global are proud to present our hugely popular 3rd Annual Inhalation & Respiratory Drug Delivery Congress, 8th – 9th May 2018, London, UK. Over 300 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions will gather for over 20 presentations and case studies focused on the key issues in inhalation and respiratory drug delivery.
More info >>

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