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European Biopharmaceutical Review

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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

Horizon Discovery Licenses Biomanufacturing Cell Lines to Centre for Process Innovation (CPI) and National Institute for Bioprocessing Research and Training (NIBRT)


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White Papers

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.
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Industry Events

12th annual Cold Chain Distribution Conference and Exhibition

13-14 December 2017, Copthorne Tara Hotel, London, UK

Responding to the evolution within the industry, SMi is proud to announce the return of its leading 12th annual Cold Chain Distribution event. Returning to London in December, this year's event will remain at the forefront of innovation
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