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European Biopharmaceutical Review

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Autumn 2016

   
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EBR’s Editor Deborah O’Neil outlines October’s edition by underpinning recent pharma failures, and using them as a foundation upon which to build new R&D successes. Fresh research approaches and subsequent new therapies are gradually moving towards much needed cures and treatment.
 
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Drug Discovery
BC Platforms’ Timo Kanninen talks collaboration and harmonisation, as he explains the need for pharma companies to get the most out of their data – he recommends the use of biobanks to achieve this.
 
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NDA Group’s Beatriz Lima tells us that the advent of innovative technology that supports the identification of cellular responses could help to renew molecular biology studies, and tackle ongoing research concerns.
 
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There has been considerable growth in the use of virus-like particles across the whole pharma landscape, observes ARTES Biotechnology’s Volker Jenzelewski. These can aid new results and can contribute to safe and efficacious vaccines.
 
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Sabine den Hartogh, Stefan Braam and Maria Vlaming of Pluriomics believe that assessing the cardiac safety of drug candidates is vital for drug discovery – and human induced pluripotent stem cell-derived cardiomyocytes are key for this process.
 
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Preview
CPhI Worldwide returns, and will be taking place this year in Barcelona on 4-6 October 2016. The event offers networking opportunities, as well as encourages collaboration among pharma products and business solutions.
 
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INDUSTRY DYNAMICS
The UK’s decision to leave the EU has caused many pharma companies to reconsider their position within the sector. Industry advisor Emile Bellott looks into the impact the referendum result may have on these organisations.
 
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RESEARCH AND DEVELOPMENT
Understanding the mAb structure-function relationship is a crucial factor in biosimilar development, points out Dr Terry Gray at Sartorius Stedim. This way, it is possible to significantly reduce wasted resources in the manufacturing process.


 
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According to Dr Piotr Piotrowski and Dr Anna Baran at KCR, it is now more important than ever to stay on top of new regulations and trends – especially in the neuroscience field. Many of these, however, can generate more issues.


 
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According to Nicola J McCarthy and Jonathan D Moore at Horizon Discovery, the field of immuno-oncology is rapidly advancing due to the use of the CRISPR-Cas9 system. This technology can improve both treatment and patient benefit.
 
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It is evident that biosimilar clinical trials are growing in popularity, with one drug in particular – rituximab – leading the way. ICON’s Kyoo Jung Shim and Petra Roos explore its ongoing development.
 
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CELL-BASED RESEARCH
Patrick Harrison at University College Cork reveals that a breakthrough has been made: stem cell and gene-editing research could accelerate finding a cure for a variety of disease-causing mutations, as well as enabling tailored treatment.
 
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Sylvie Ponchaut of BioWin introduces the Belgian region of Wallonia and its excellence in cellular therapy studies; its business ventures, employment level and consistent results output make it a valuable location for research.
 
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CellGenix’s Bernd Leistler reminds the pharma community that rules and regulations continue to tighten, and that it is important to maintain high quality levels in raw materials, in order to ensure the safety and efficacy of any therapy.
 
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THERAPEUTIC DEVELOPMENT
Dr Carl J Christel of Sirion Biotech believes that there is potential for a fresh approach to R&D in the future; the instigation of adeno-associated virus design techniques could, with further optimisation, overcome many clinical challenges.
 
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Abbexa’s Connor McCay and Sabrina Calabressi discuss the role of antibody therapies and the ways in which they continue to develop and grow. In fact, recent research shows that these treatments may soon be able to cure inherited illnesses.
 
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Recent research suggests that ctDNA may be the best alternative to traditional liquid biopsy procedures, which are often intrusive and unreliable, say Paul Elvin and Glen Clack at Aptus Clinical.
 
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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

New Technologies for HPAPI Manufacturing and Containment

SMI Reports: With new technologies becoming available for the pharmaceutical industry, the HPAPI market is utilising these new innovations to simplify manufacturing processes reducing powder exposure and allowing a semi-continuous production. At this year's HPAPI USA Conference emerging manufacturing technologies will be one of the key points to be discussed along with containment issues, disaster management, Oncology Antibody-Drug Conjugates (ADCs) and staff training procedures.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

World Vaccine Congress Europe

28-31 October 2019, Barcelona, Spain

The 20th annual World Vaccine Congress Europe is taking place 28-31 Oct in Barcelona. It’s the biggest and most established European vaccine event with over 250 speakers, 700+ senior vaccine attendees, hundreds of networking hours. It cover key topics across the complete vaccine value chain bringing together: • Government • big pharma • big biotech • SME Biotech • academia and the wider service provider community and their partners to discuss scientific, clinical and strategic advances and opportunities. The event has already confirmed over 200 speakers from Human Vaccine Project, OECD, CEPI, European Commission, FDA, WHO, OECD, NIH, GSK and many more… There is a Super Early Bird offer available – Find Out More www.terrapinn.com/WVCEU/EBR
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