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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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Zenith Technologies Wins ‘Supplier of the Year’ at Pharma Industry Awards 2018
Zenith Technologies, a world leader in delivering manufacturing software
to the life sciences industry, has been named ‘Pharma Supplier of the
Year’ at the prestigious 2018 Pharma Industry Awards.
More info >> |
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White Papers |
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Conveying Medical Guidance in Clinical Trials – A Survey
Europital Medical Consultancy
With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project.
When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
More info >> |
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Industry Events |
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Digital Medicine & Medtech Showcase 2019
8-9 January 2019, Parc 55 San Francisco - a Hilton Hotel
The Digital Medicine and Medtech Showcase is the
dedicated home for the digital health and medtech communities during Biotech Showcase™ and one
of the healthcare industry’s biggest weeks. Taking place January 8–9, Digital
Medicine & Medtech Showcase includes two days of networking opportunities,
curated presentations, specialized sessions, one-to-one meetings scheduled by
partneringONE®, and full access to Biotech Showcase.
More info >> |
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