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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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Published quarterly in
January, April,
July, and October

News and Press Releases

Wasdell Group strengthens PPFL business with ISO 13485 for medical devices

The Wasdell Group, a leading outsourcing partner to companies in the pharmaceutical and biotech sector, has today announced that its Dundalk, Ireland facility has been certified to comply with the ISO 13485 standard for medical device manufacturing. The ISO 13485 is an internationally recognised certification, ensuring that the company’s quality management system complies to customer and applicable regulatory requirements.
More info >>

White Papers

Clinical Trials in Emerging Markets: Goldmines or Landmines?

Pharm-Olam, LLC

Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.
More info >>

Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

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