spacer
home > ebr > Autumn 2015
PUBLICATIONS

European Biopharmaceutical Review

ebr
Autumn 2015

   
Text
PDF
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.

 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
   
spacer
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

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.
More info >>

White Papers

Running Smarter Trials With Data-Driven Monitoring

PAREXEL

Clinical monitoring remains one of the most important and most costly activities in the clinical research paradigm.  Monitoring provides the operational transparency required by investigators, sponsors, and regulators to make informed decisions about site performance, patient safety, and overall study progress. Yet unlike many clinical trial activities, which have been steadily transformed by technology, the monitoring function itself has changed little.
More info >>

Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement