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| home > ebr > Winter 2017 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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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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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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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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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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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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News and Press Releases |
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RoslinCT to Participate in the Northern Alliance Advanced Therapies Treatment Centre
RoslinCT, a UK-based cell and gene therapy contract manufacturing
organisation, is delighted to be part of the Northern Alliance Advanced
Therapies Treatment Centre (NAATTC) consortium. As an industry partner
within the consortium, RoslinCT will provide advice on the development,
manufacture and clinical supply of cell, gene and tissue engineered
therapies.
More info >> |
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White Papers |
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Clinical Trials in Ukraine: Orange Paper Overview and 1st Half Year 2014
Synergy Research Group
The Orange Paper is an analytical report about the clinical trials
market in Russia, published quarterly by the contract research
organization Synergy Research Group. The first edition of Orange Paper
was released in 2006, and at the moment 31 issues have already
published. Now, thanks to Synergy Group Ukraine, obtaining information
about the market of clinical trials in Ukraine has become possible.
In
Ukraine, during the period from 1996 to 2013, applicants had obtained
3,864 positive conclusions about the possibility of conducting clinical
trials of drugs, both for domestic and foreign manufacturers, including
conduct of multinational multi-center clinical trials (hereinafter –
MMCTs)
More info >> |
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Industry Events |
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SAPHEX 2018
1-2 November 2018, Gallagher Convention Centre, Midrand, South Africa
The SAPHEX exhibition and conference is now established as the “go-to”
networking and business event for anyone working in the South African
pharmaceutical manufacturing industry.
More info >> |
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