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European Biopharmaceutical Review

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Summer 2012
   
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BioBusiness, Finance & Communication

Biobusiness

This Drug Went to Market

When establishing a market access strategy, early-stage biotechs should carefully consider market requirements and value-based pricing to demonstrate the best product value available, suggest Caroline Hall and David Alderson at GfK Bridgehead.

 
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Market Analysis

Hope on the Horizon?

Sri Rekha and Dina Rufo of GlobalData consider the current market for OCD therapeutics, and look at several developments that could open the field to new drug discoveries.

 
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BioResearch and Innovation

Biosimulation

Model Behaviour

Serge Bischoff of Rhenovia Pharma looks at how biosimulation can offer an effective means of modelling data on rare and orphan diseases, creating hope for new drug discoveries in complex and frequently challenging fields.

 
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Natural Products: Drug Discovery

Harnessing Nature’s Orphan Ligands

New opportunities are emerging to reincorporate natural products into mainstream drug discovery. Developments in marine microbiology offering a promising starting point, argues Guy T Carter of Carter-Bernan Consulting, LLC.

 
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Novel Therapeutics

Beating a New Path

The adverse side effects of levodopa therapy represent a serious problem to late-stage Parkinson’s disease treatment. Stephan Schann of Domain Therapeutics discusses research into candidates that could alleviate these symptoms.

 
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Research Models

The Right Approach

Many successful drugs act on membrane proteins to inhibit signalling processes. Gunnar von Heijne of Stockholm University suggests that Big Pharma can leverage cutting edge research in this area by collaborating with academic research centres.

 
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Discovery Technology

Stem Cell Research

In the Fast Track

Uma Lakshmipathy and Magnus Persmark of Life Technologies explore the recent developments in stem cell tracking and labelling, and how the process can assist in the fi elds of cell therapeutics and tissue engineering.

 
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Lab-on-a-Chip

Accelerated Research

Manufacturing breakthroughs in polymer-based smart chips have made the promise of lab-on-a-chip technology an affordable reality. Chris Mauracher of Sony DADC explains how drug discovery can benefit from these developments.

 
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Biomarker Discovery

Autopilot

When seeking to characterise autoantibodies for use in diagnostic biomarker panels, protein microarrays can offer a high-throughput, reliable alternative to traditional ELISA platforms, argue Michael McAndrew, Colin Wheeler and John Anson of Oxford Gene Technology.

 
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Immunoassays

Small is Beautiful

Karolina Österlund at Gyros AB investigates recent developments in microfluidic immunoassay technology, and calculates the cost- and time-saving benefits this can bring researchers from the lab to the clinic.

 
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Glycosylation

Right Reactions

With the rise of biosimilars, it is increasingly important for researchers to efficiently determine oligosaccharide structures. David Neville of Reading Scientific Services Ltd explores technological advances in this field, and suggests that a combination of HPLC, mass spectrometry and enzyme digests are needed.

 
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BioDevelopment and Regulatory

Pharmacovigilance

All Eyes on Europe

Sonia Araujo of Medidata Solutions offers a snapshot of European regulatory changes to pharmacovigilance, with an emphasis on patient participation and addressing the challenges of reporting adverse drug reactions.

 
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Model-Based Drug Development

A Safe Bet?

Joachim Grevel at BAST Inc Limited and Marc Lavielle at INRIA Saclay present model-based approaches to drug development that can help reduce risk and increase clinical success.

 
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BioFormulation and Manufacturing

Biomanufacturing

Rapid Response Unit

When testing for microbial contamination in pharmaceutical production processes, a combined approach using both membrane filtration and fluorescence-based staining offers quick, robust results, as Renaud Chollet and Yves Courties of Merck Millipore SAS demonstrate.

 
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INDUSTRY DYNAMICS

In Brief

Decade of Biologics

Kellie Medeiros and Emile Bellott, independent pharmaceutical consultants, outline regulatory changes set to rock the biosimilars market.

 
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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

BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.
More info >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
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Industry Events

10th Annual NGS & Clinical Diagnostics Congress

8-9 November 2018, London, UK

Oxford Global is proud to present its 10thAnnual NGS & Clinical Diagnostics Congress taking place on 8-9 November 2018 in London.  Part of the Genomics & Synthetic Biology Series UK, the congress will bring together over 600 end users representing internationally renowned research & academic institutions, clinical research institutions, healthcare organisations as well as leading pharmaceutical and biotech companies.
More info >>

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