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European Biopharmaceutical Review

ebr
Autumn 2015

   
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Editor’s Letter

Deborah O’Neil picks out a few of this edition’s focus features and comments on the need to balance market protection for the originators of novel therapies against wider healthcare access to biosimilar alternatives.
 
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Discovery Technology
MicroScale Thermophoresis

Method of Choice


2bind’s Thomas Schubert explores the wide application of MicroScale Thermophoresis – a novel technology that can be used to analyse the binding parameters of molecular interactions. Being fast and fl exible, it can help researchers in antibody characterisation and epigenetics.
 
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BioDevelopment
ADCC Assays

As Easy as ADCC


With many drug developers turning to ADCC assays to help get the measure of biosimilarity, Andy Upsall of BioOutsource recommends that scientists be prepared to use an orthogonal approach to better understand the therapeutic and how it fi ts with the clinical outcome.
 
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Biosimilar Analysis

Compare and Contrast


Responding to regulations governing the quality of biosimilars, BioPharmaSpec’s Andrew Reason and Howard Morris contemplate the range of analytical techniques on offer to prove the integrity of an active pharmaceutical ingredient following purification.
 
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BioDevelopment and Regulatory
Regulatory Spotlight

Western Influence


Despite following the EMA’s lead and adopting a stepwise comparability approach, Nick Beckett and Jane Lin at CMS believe that China still has some way to go before its biosimilar regulations can be brought in line with international practice.
 
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INTERVIEW
Industry Insight

The Power to Defeat Dementia

In his interview with EBR, Eric Karran from Alzheimer’s Research UK answers questions on the role of the Dementia Consortium and how it plans to bring together partners from both industry and academia.
 
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INDUSTRY DYNAMICS
In Brief

A Banner Year for Biopharma


Industry advisor Emile Bellott reflects on biopharma’s recent highs, praising the successes of 2014 and thinking ahead to what the coming months – and following years – may bring.
 
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MARKETPLACE
Market Focus: Biosimilars

Window of Opportunity


Molekule Consulting’s David Alderman thinks about life after the patent cliff. Although the biosimilar opportunity is robust and growing, market factors – including a lack of consumer knowledge, fierce competition and innovator companies' desire to defend their biologic assets – could mean that uptake is slow.
 
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RESEARCH AND DEVELOPMENT

Toxicity Studies

Don’t Forget the Kids

Traditionally considered an offshoot of reproduction toxicology, juvenile animal studies are emerging as a field in their own right. Sequani’s Emily Richmond looks into this area, which could lead to better researched and intelligently developed medicines for children.

 
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THERAPEUTIC DEVELOPMENT
Vaccine Development

Heal the World


As initial projects launch with rotavirus and HIV, it is only a matter of time before old prophylactic vaccines are finally replaced with innovative mRNA alternatives. CureVac’s Ingmar Hoerr investigates the many advantages of this new method of disease prevention.
 
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Genetically Engineered ADCs

Making Sense From Nonsense


Feng Tian at Ambrx examines how site-specific ADC technologies offer a new starting point for the rational design of drugs with optimised therapeutic windows. In particular, genetically engineered ADCs are well-positioned to improve targeted drug delivery.
 
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Alzheimer's Disease

Brain Power


Hamish McDougall
and Peter Murphy of BioPharm Insight report on the latest therapeutic approaches currently under development for Alzheimer’s disease. It may be a huge unmet medical need, but there is much debate on the appropriate drug combinations and mechanisms to target.
 
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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

Bigneat is awarded the Queen’s Award by Lord-Lieutenant of Hampshire

Bigneat Ltd, winner of a Queen’s Award for Enterprise earlier this year, received their Award from Nigel Atkinson Esq, HM Lord-Lieutenant of Hampshire on 16th October at the Bigneat factory in Waterlooville.
More info >>

White Papers

Mouse Models for Evaluation of Vaccines and Therapeutics Against Staphylococcal Infections

IBT Bioservices

Introduction Staphylococcus aureus (SA) is a ubiquitous, formidable Gram-positive pathogen associated with skin and soft tissue, as well as lifethreatening systemic infections. SA is a leading cause of hospital- and community-associated infections worldwide, affecting humans and animals. The wide range of pathologies reflects the diverse abilities of this microbe to escape the innate and adaptive immune response using virulence factors. Since its first emergence in the 1960s methicillin-resistant SA (MRSA) has become endemic in hospitals and healthcare settings worldwide. In the 1990s, community associated MRSA strains (CA-MRSA) emerged, and are spreading worldwide posing a major global challenge.
More info >>

Industry Events

Outsourcing in Clinical Trials Southeast 2018

13-14 March 2018, Durham, North Carolina

This year’s Outsourcing in Clinical Trials event builds on last year’s incredibly successful conference which will once again be returning to North Carolina with the aim of supporting trial sponsors and solution providers in the RTP and neighboring regions, ensuring trials are delivered on time and partnerships are bettered.
More info >>

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