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European Biopharmaceutical Review

ebr
Winter 2016

   
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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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Science and Innovation
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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Discovery Technology
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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MARKETPLACE
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 AND DEVELOPMENT
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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CELL-BASED RESEARCH
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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THERAPEUTIC DEVELOPMENT
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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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

Peli BioThermal Showcases New Products at Temperature Controlled Logistics Europe

Innovative new shipper systems and services aimed at setting new standards in the temperature-controlled packaging industry will be launched by Peli BioThermal at Temperature Controlled Logistics Europe.
More info >>

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?
More info >>

Industry Events

Temperature Maintenance of Pharmaceuticals in Distribution 2016

2-3 March 2016, Barcelona, Spain

Temperature maintenance has become an issue of vital importance in the pharma and biotech world. Key industry representatives will be attending the event to discuss current topics and provide solutions to specific issues, making this an outstanding opportunity to learn and network with your peers to ensure your maximum efficiency.
More info >>

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