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| home > ebr > Winter 2016 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor's Letter
EBR’s Editor, Deborah O’Neil, summarises January’s main themes, and draws on articles that reference the latest industry news and discoveries.
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Feature
Q&A: eHealth
Mukhtar Ahmed at BioClinica talks to EBR about the thriving popularity of eHealth technologies, and how paperless systems can help to drive better research and patient engagement.
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Features
Spotlight
In an industry increasingly reliant on internet-based collaborations, new EMA guidelines requiring digital signatures on most electronic submissions are the way forward for the pharma industry, suggests SAFE-Biopharma’s Jon Weisberg.
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Features
Microindentation Testing
Markus Fabich at Olympus discusses microindentation analysis – a method for investigating the mechanical characteristics of bone – and how digital light microscopy can streamline this highly intricate process.
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Drug Development
Biopharma Outsourcing
Richard Hucker, Ian James, Scott Vincent and Carl Watson at A4P Consulting report a considerable rise in outsourcing activities within drug development among large biopharma and niche companies alike, and share their predictions on future trends.
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Regular Feature
Orphan Drugs
Industry advisor Emile Bellott reflects in depth on the recent boom in orphan drug approvals by the FDA, as well as what the next decade holds for this rapidly expanding sector.
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Regular Feature
In Brief
Antimicrobial resistance is an increasingly serious concern, and one which is a very real possibility in the 21st century – threatening the achievements of modern medicine and putting patients at risk. EBR Editor Deborah O’Neil looks at what pharma is doing to address a growing crisis
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Research Hubs
Leading Edge
With a £200 million funding boost and five newly established research hubs, the UK is taking its place as a world leader in the regenerative medicine market, says David Pan at the UKRMP.
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Drug Development
Implementing Automation
With the average cost of developing a new medicine estimated at $2.6 billion, cost reduction and reducing time to market have become an increasing focus. Implementing an automated quality management system can streamline processes, states MasterControl’s Lane Hirning.
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Drug Development
Time to Market
The rush to get a new drug approved does not have to mean a trade-off between cost and safety, believes Clinovo’s Glenn Keet, who reveals how current tech innovations can bolster safety while accelerating time to market.
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Drug Development
Early-Stage Development
The EMA's new Adaptive Pathways Network – designed to support early patient access to new medicines in areas of high unmet medical need – could significantly lower drug development costs, claims Karine Kleinhaus at Pluristem Therapeutics.
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Feature
Preclinical Safety Assessment
John Carter and Robert Guest at Envigo consider how in vitro assays are helping to steer the development of alternatives to animal-based toxicity testing.
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Therapeutic Advances
Q&A: Stem Cell Lines
Takara Bio Europe’s Kristina Runeberg describes iPS – a new technology that is able to derive hepatocytes from multiple induced pluripotent cells, and which subsequently shortens the drug development process.
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Features
Genetic Modification
2015 was a breakthrough year for biomedicine, thanks to the discovery of a new gene-editing tool, CRISPR/Cas9. Regina Au from BioMarketing Insight discovers how this revolutionary system could potentially wipe out numerous diseases.
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Cell Therapy
World View
Cecilia Van Cauwenberghe at Frost & Sullivan explores the potential of regenerative medicine in combatting major diseases, and finds that each market region approaches this lucrative sector very differently.
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Therapeutic Advances
Antibody Engineering
From
CDR grafting and phage display to transgenic mice approaches, the past
two decades have seen rapid advances in humanisation techniques to
reduce immunogenicity. So why are humanised murine antibodies still
being used in today’s labs? Andrew Glover at Fusion Antibodies
investigates.
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Therapeutic Advances
Viral Vector Techniques
Recent innovations in viral vector technologies are helping to tackle the challenges of traditional vaccination systems – including complex manufacturing processes. But certain obstacles need to be addressed before these methods can go to market, explains Carl Christel at Sirion Biotech.
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Regenerative Medicine
Lab Technology
From generating organs using 3D printing to lab-grown tissues, regenerative medicine has progressed significantly in recent years. BioMarketing Insight's Regna Au examines the key developments in a field that has contributed hugely to the fight against life-threatening diseases.
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News and Press Releases |
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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 >> |
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White Papers |
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Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.
Medpace
Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >> |
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Industry Events |
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PDA Europe Annual Meeting 2019
24 June 2019, Hilton Amsterdam
Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
More info >> |
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