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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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

Value-Added Processing and Quality By Design Principles Help Meet High-Quality Demands

West Pharmaceutical Services, Inc.

The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs in an effort to provide a product that meets the requirements of payers along with facilitating profitability in order to continue adequate business reinvestment.
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Industry Events

INTERPHEX 2019

2-4 April 2019, Javits Center, New York

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA). Dedicated to Innovation, Technologies and Knowledge, the show focuses on the entire product development life cycle.
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