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European Biopharmaceutical Review

ebr
Winter 2017

   
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Editor’s Letter

EBR’s Editor Dr Deborah O’Neil introduces January’s edition by reflecting on the year that has passed and looking forward to what 2017 and a transitioning geopolitical landscape might bring for the biopharmaceutical sector.
 
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Legal, Regulatory and Public Policy
The Impact of Brexit

Ripple Effect


The UK’s decision to leave the EU shook the entire country, but the pharma and biotechnology sectors were particularly affected. InstantGMP Inc.’s Kelly Waters explores some of the difficulties the industry experiences in the aftermath of the Brexit vote.
 
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Growth Strategies and Risk Management

Point of View


Daniel Stamm at Merck Life Science reminds us that pharma is undergoing numerous regulatory changes at present. He examines the results of a 2016 survey that reveals the attitudes of leading companies, including their expansion strategies, and how best to put these into practice.
 
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Regulatory Update

Standing Together

CONVIDIA clinical research’s Dr Beate Walter, together with Dr Christian van den Bos and Somaiah MN at Mares Ltd, discuss the challenges of curing genetic diseases while adhering to strict legislative guidelines. Many experts in the field, however, struggle to make significant progress.
 
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Cell Separation Technology

Capacity for Success


Stringent new regulations have had an impact on almost all areas of the pharma field, requiring many organisations to reduce cost and boost productivity. Thermo Fisher Scientific’s Ileana Place explores the stance of the bioproduction sector, explaining that it is vital to recognise the changes now and begin to adapt.
 
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INDUSTRY DYNAMICS
Skills and Technology

Upskilling Staff


According to Alwyn Jones of Siemens, the considerable shortage of able workers and the slow implementation of new technology are the two main obstacles now facing the pharma industry. However, this scarcity may lead to advancements in automation tools, thereby enhancing productivity.
 
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BUSINESS STRATEGY
In Brief

Time for Change


EBR Industry Advisor Emile Bellott outlines the effect that President-elect Donald Trump’s new administration could have on the future of pharma and biotech companies around the globe.
 
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RESEARCH AND DEVELOPMENT
Biomarkers and Simulation

Adapt to Win


With clinical trial failure rates soaring, something must be done in order to increase their success. Dr Bernard North at Exploristics investigates the utilisation of adaptive study designs, stating that these types of trials could optimise results and accelerate drugs reaching the market.
 
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Risk Mitigation in Therapy

The Rise of Registries


Dr Paola Antonini, Lorna Graham and Dr Michael Murphy at Worldwide Clinical Trials emphasise the importance of identifying risk in clinical studies for transformative therapies. According to them, the instigation of registries across the trial landscape could result in a significant shift for the sector.
 
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Q&A: Drug Repurposing

The Future of Formulation


EBR asks Dr Roberto Castangia at Biopharma Group about the decrease in the amount of new ‘blockbuster’ drugs brought to the market. He believes that this is due to the declining discovery of new molecular entities, and hypothesises that drug repurposing may be the solution to this challenge.
 
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Protein Quantification

Super Screening


HORIBA Scientific’s Fatima-Ezzahra Hibti and Dr Chiraz Frydman analyse the advent of new imaging technology and the possibility of detecting a biomarker in varying supernatants using only one injection. It is now more conceivable than ever to examine crude samples at high-throughput concentrations.
 
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Q&A: Genomics and Clinical Trials

A Promising Project

Medidata
’s Jason Mezey and Geoff Low talk to EBR about genomics and new data sequencing platforms, as well as a new scheme that could investigate several medical records at once. This capability might bring quicker diagnoses and offer improved treatment options for patients.
 
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Vaccine Development

Best of Both Worlds


According to Dr Michael Piontek at ARTES Biotechnology, it is essential that the delivery of new vaccines is efficient, safe and affordable. He discusses virus-like, particle-based vaccines, which could be the intelligent strategy and smart building blocks needed to meet today’s growing demands.
 
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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

Plasticell increases flow of stem cell therapy pipeline


More info >>

White Papers

Overcoming research challenges with Adaptive Trials

PCI Pharma Services

There has been cause for concern within the pharmaceutical industry over the last five years, regarding increasing research and development costs, combined with a fall in the number of new drugs brought to market. In an attempt to overcome this issue there has been a significant rise in the use of adaptive clinical trial designs, whilst saving time and money as well as facilitating more effective decision making. One of the biggest challenges that pharmaceutical companies have experienced has been delivering compliant clinical trials supplies across diverse patient populations in the relatively short timeframes that adaptive trial designs require, remaining focused on ensuring that patient compliance and product quality is in no way compromised. This demand has led to the launch of fast response services that support Research and Development in responding to changing dosing regimens mid-trial.
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Industry Events

Orphan Drugs and Rare Diseases Europe 2017

15-16 May 2017,

SMi is proud to announce the return of their 6th annual Orphan Drugs event to Berlin on the 15th -16th May 2017! The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019.
More info >>

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