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European Biopharmaceutical Review

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Winter 2017

   
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Editorís Letter

EBRís Editor Dr Deborah OíNeil introduces Januaryís 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 UKís decision to leave the EU shook the entire country, but the pharma and biotechnology sectors were particularly affected. InstantGMP Inc.ís 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 researchís 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 Scientificís 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 Trumpís 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 Ďblockbusterí 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 Scientificís 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
ís 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 todayís 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

NEUWAY Pharma and Cobra Biologics collaborate to develop GMP grade Engineered Protein Capsules (EPCs) manufacturing process

International CDMO of biologics and pharmaceuticals, together with a biopharma company developing drugs for orphan diseases, announce the conclusion of a Service Agreement relating to Engineered Protein Capsules
More info >>

White Papers

Running Better Trials Taking an Intelligent Monitoring Approach

Bioclinica

When it comes to implementing a risk-based monitoring program, it is not just about reducing monitoring visits and doing less Source Document Verification (SDV). Itís about bringing together your people, a solid process, and the right technology to run a better trial. Success with risk-based monitoring requires the ability to make sense of the thousands, if not millions, of data points captured by multiple disparate sources in a clinical trial. With the sheer volume of data generated on a daily basis comes complexity. How does one make sense of it all? Information overload burdens even the most experienced study teams who struggle to understand which data matters most and what it means.
More info >>

Industry Events

BioProcess International Conference & Exhibition (BPI)

25-28 September 2017, Hynes Convention Center, Boston, Massachusetts, USA

BioProcess International Conference & Exhibition (BPI) is the largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success.
More info >>

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