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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

Distributor Oppurtunities

Have an appetite for success – Want to expand your product portfolio – Fancy being part of something special??
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White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
More info >>

Industry Events

ELRIG Drug Discovery 2019 – Looking Back to the Future

5-6 November 2019, ACC, Liverpool

Now in its 13th year, ELRIG’s flagship conference Drug Discovery 2019 will take place at ACC in Liverpool. This year’s focus, ‘A Look Back to the Future’ is planned to include plenary introductions assessing how we got to where we are now and setting the challenges for discovering the drugs of the future. These will be followed by cutting edge talks and examples of new directions in drug discovery. Our scientific programme will feature over 40 world-class speakers with 6 main session tracks. In partnership with key academic and charitable groups, we will also run joint disease and biology-oriented tracks focusing on the basic sciences that underpin successful drug discovery.
More info >>

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