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| home > ebr > Autumn 2015 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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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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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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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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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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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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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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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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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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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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News and Press Releases |
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CPhI China opens with analysis pointing to a surge in growth in 2019
Shanghai, 23rd May 2019: New analysis released ahead of CPhI & P-MEC China (#CPhIChina and #PMECChina) – co-organized by Informa Markets, CCCMHPIE, and Shanghai Sinoexpo Informa Markets – forecasts that China will continue to grow strongly through 2019/20, thanks in part to a marked improvement in its global reputation.
More info >> |
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White Papers |
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Clinical Trials in Ukraine: Orange Paper Overview and 1st Half Year 2014
Synergy Research Group
The Orange Paper is an analytical report about the clinical trials
market in Russia, published quarterly by the contract research
organization Synergy Research Group. The first edition of Orange Paper
was released in 2006, and at the moment 31 issues have already
published. Now, thanks to Synergy Group Ukraine, obtaining information
about the market of clinical trials in Ukraine has become possible.
In
Ukraine, during the period from 1996 to 2013, applicants had obtained
3,864 positive conclusions about the possibility of conducting clinical
trials of drugs, both for domestic and foreign manufacturers, including
conduct of multinational multi-center clinical trials (hereinafter –
MMCTs)
More info >> |
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Industry Events |
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Nordic Life Science Days 10/12 September 2019
10-12 September 2019, Malmo Sweden
Nordic Life Science Days is the largest Nordic partnering conference for the global Life
Science industry.
Bringing together the best talents in Life Science, offering amazing networking and
partnering opportunities, providing inputs and content on the most recent trends.
Nordic Life Science Days attracts leading decision makers from the Life Science sector,
not only from biotech, pharma and medtech but also from finances, research, policy and
regulatory authorities.
More info >> |
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