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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

BioGenes Establishes Scientific Advisory Board

Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production and a global leader in host cell protein (HCP) assay development, today announces the establishment of a Scientific Advisory Board which includes the following four renowned experts:
More info >>

White Papers

Successfully managing the unique demands of cell therapy supply chains

PCI Pharma Services

Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.
More info >>

Industry Events

9th Global Drug Delivery & Formulation Summit

12-14 March 2018, Maritim proArte Hotel Berlin

The DDF Summit brings the most interesting studies and exciting technologies to you. This year there will be 4 dedicated streams focusing on Small Molecules, Biologics, Technology & Innovation and for the first-time Device Development.
More info >>

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