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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

Biosimilar Drug Development the analytical strategy is keyfactor for your success

Heilbronn/Dortmund March 2019: The generation of analytical data for the comparison between a biosimilar and the originator product is the initial assumption in the development of biosimilars. Achieving Biosimilarity can be a controversial and complex topic when deciding the right time point and range of analytics.
More info >>

White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >>

Industry Events

Highly Potent Active Pharmaceutical Ingredients (HPAPI)

13-14 May 2019, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 3rd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 13th-14th May 2019. The HPAPI global market has developed rapidly in the past year and is continuing to expand into the future, with over a quarter of drugs in development worldwide being classified as highly potent. As a result, there is a growing demand for both pharmaceutical and contracted manufacturers to adapt to the evolving HPAPI landscape.
More info >>

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