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European Biopharmaceutical Review

ebr
Autumn 2017

   
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Editor’s Letter

EBR Editor Dr Deborah O’Neil talks us through the latest innovative breakthroughs in drug discovery and explores the themes and issues covered by each of our contributors.
 
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BioFormulation and Manufacturing
Assay Platform Selection

Harnessing Hybrids

ARCINOVA’s Michael Blackburn asks firms to continually question what specifically is being measured and how data quality can be ensured when using hybrid liquid chromatography-mass spectrometry assays for peptides.

 
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Method Development

Definitive Screening Designs


Dr Srividya Suryanarayana at Cytovance Biologics discusses a recent case study that used a definitive screening design for imaged capillary isoelectric focusing method optimisation, thus gaining high-quality data.
 
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Regulatory Mycoplasma Testing

Rapid Methods


Nucleic acid amplification techniques are becoming the preferred option for rapid mycoplasma detection, say Professor Renate Rosengarten, Dr Carl-Ulrich Zimmerman and Dr Martina Sauert at Mycoplasma Biosafety Services.
 
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CANCER FOCUS
Basal-Like Breast Cancer

Signal Detection


Dr Partha S Ray and Dr Roberto Fagnani at 3N Diagnostics introduce a new biomarker for a basal-like breast cancer, an elusive disease type previously difficult to discover and diagnose at an early stage.
 
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DNA Damage and Immune Response

Firing Up


Dr Eileen Parkes at Queen’s University Belfast and Dr Nuala McCabe and Professor Richard Kennedy at Almac Diagnostics highlight the relationship between cancer cell behaviour and DNAdamage activated immune response.
 
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Transgene Expression

Size Matters

PlasmidFactory’s Tatjana Buchholz, Dr Marco Schmeer
and Dr Martin Schleef suggest that using minicircle DNA for transgene expression can help smooth the process by enabling improved nuclear entry.
 
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Robotic Surgery

Homing In


Gaining ground in treatments for prostate cancer, thereby improving clinical outcomes and cost-efficiency, could cement robotic surgery as an established and valuable therapeutic method, says Dr Andre Faure at Trod Medical.
 
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APPLIED RESEARCH, DEVELOPMENT AND PRODUCTION
Precision Medicines

New Strategy


David Bunton at ReproCELL Europe, Marian McNeil at Stratified Medicine Scotland and Pamela Brankin at Aridhia stress that early identification of genetic factors that influence efficacy in patient subpopulations is key to success.
 
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Considerations for Automation

Avoiding Data Overload

Peak Analysis and Automation’s Rob Harkness
uses a case study to highlight how promptly integrating automation with a flexible data handling package has a positive effect on workflow, raising the yield of high-quality data.
 
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THERAPEUTIC DEVELOPMENT
In Brief

Risk Ratio


Following the recent FDA approval of a cancer immunotherapy drug, Emile Bellott explores the utilisation and successes of CAR-T, nodding to the limitations that still plague such therapeutics.
 
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Industry Trends

Adapt to Survive

Peter Muller
at Schlafender Hase provides an overview of five trends that have dominated the life sciences industry over 2017, encouraging pharma firms to embrace change and inevitable adaptations.
 
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Patents for Stem Cell Therapies

A Fresh Look


Helen Henderson and Dr Nicholas Jones at Withers & Rogers get to grips with a regulatory update from the European Patent Office that could benefit organisations currently involved in early stage stem cell research.
 
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Special Feature: GDPR

EU Impact

Jon Weisberg
at SAFE-BioPharma Association, Industry Advisor to EBR, gathered expert views on the potential effects of the EU General Data Protection Regulation, which goes live in spring 2018.
 
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Boosting Cellular Therapies

Enhanced Effects

Dr Christian van den Bos
at Mares Ltd offers a new technique to enhance cellular viability, which involves co-application of small molecules that are known to improve survival of cells post-injection.
 
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Safety Testing

Revamping Regulations

NDA Group
’s Dr Paula Salmikangas argues that the safety information currently required for the clinical development of stem cell products is unclear and may require serious review to improve access to innovative therapies.
 
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Predicting P450 Metabolism

Driving Discovery


As well as outlining the state-of-the-art of computational approaches for predicting P450 metabolism, Matthew Segall at Optibrium Ltd identifies areas for future development.
 
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The Future of Organoids

Unleashing 3D

For Dr Colin Sanctuary at QGel, the breakthrough innovation of synthetically specialised extracellular matrixes will transform the use of organoids as a model for human disease and unlock unique possibilities for personalised medicine.
 
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Discovering New Medicines

Invaluable Influences


Collaboration between CROs and biotechnology firms is crucial for the discovery of new drugs, but Dr Richard Weaver FRSC at XenoGesis Ltd suggests success will also depend on the influence of drug metabolism and pharmacokinetics.
 
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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

Navigating the new Clinical Trial Regulation with DIA

For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will have a dramatic impact. The aim of the change in regulation is to increase the efficiency of all trials in Europe, as well as promoting research while avoiding the duplication of clinical trials
More info >>

White Papers

Working Towards a Standardised Identification Solution

PCI Pharma Services

The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
More info >>

Industry Events

BioTrinity 2018

23-25 April 2018, Novotel London West in Hammersmith

BioTrinity 2018 is taking place from 23-25 April at the Novotel London West in Hammersmith. Now in its 12th year, BioTrinity remains the leading life sciences biopartnering and investment conference in Europe, and is a must attend event for R&D companies, TTO’s and academia who are looking to meet, collaborate, partner and seek funding from Big Pharma, Investors and Associated Industry companies.
More info >>

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