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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

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

Shipping with Active Packaging Containers: Three Pre-flight Decisions that Impact the Success of High-value Global Shipments

World Courier

It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
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Industry Events

Biotech Showcase™ 2019

7-9 January 2019, Hilton San Francisco Union Square

Biotech Showcase™ is an investor and networking conference devoted to providing private and small- and mid-cap biotechnology companies an opportunity to present to and meet with investors and biopharmaceutical executives during the course of one of the largest annual healthcare conferences that attracts investors and biopharmaceutical executives from around the world.
More info >>

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