spacer
home > ebr > Winter 2018
PUBLICATIONS

European Biopharmaceutical Review

ebr
Winter 2018

   
Text
PDF
Editor’s Letter
 
EBR Editor Dr Deborah O’Neil offers a summary of the issue’s contents and comments on the recent breakthrough in treating Huntington’s disease.
 
view
download pdf
bullet
BioResearch and Innovation
Novel Therapies and Pneumococcal Pneumonia
 
Back to the Future
 
Jonas Elliott Gerson, Dr Donald Gerson and Allison Turner at PnuVax SL Biopharmaceuticals detail how pneumococcal pneumonia could be cured in the developing world and the ways in which immunotherapeutic approaches can decrease antimicrobial resistance.
 
view
download pdf
Resistance Rates
 
Situation Critical
 
AMR Centre’s Dr Peter Jackson argues for a greater effort to combat antimicrobial resistance – a serious menace to public health that contributes to over 700,000 deaths globally.
 
view
download pdf
Antiseptics and Antibiotics
 
Fight Against Resistance
 
Antimicrobial resistance in humans and animals is raised through improper use of antibiotics or not controlling infection well enough. Dr Michele Barbour at Pertinax Pharma believes behavioural science should be employed
 
view
download pdf
Competency-Based Training
 
Training Day
 
Dr John Milne at the National Institute for Bioprocessing Research and Training demonstrates how competency-based training will be pivotal to improving the work of staff, with the rise of new types of product and manufacturing processes.
 
view
download pdf
bullet
Discovery Technology
Strategies to Mitigate Risk
 
Constant Vigilance
 
Tony Clarke at ICON delves into how anticipating risk management and ensuring safe design when employing connected medical devices during product lifecycles can lower financial and medical risks.
 
view
download pdf
BioDiscovery
New Treatments
 
Bridging the Gap
 
Dr Gregory R Stewart at Pairnomix posits, by way of a case study, that today’s advancements in genetics can reduce the delay between gene discovery and its use in real world treatments.


 
view
download pdf
BioDevelopment
Contamination Risk Management Strategies for ATMPs
 
Keeping It Clean
 
With the viral safety of biological medicinal products in regenerative medicine being essential, well-characterised cell banks can help avoid contamination and maintain quality, as Andy Bailey at ViruSure notes.
 
view
download pdf
bullet
Biodevelopment and Manufacturing
Patient Safety
 
Warning Letters
 
An unusual amount of warning letters issued by the FDA show that the manufacturing process is being increasingly monitored, as discussed by Søren Lund Kristensen and Dr Harm Otten at Particle Analytical.
 
view
download pdf
bullet
THERAPEUTICS FOCUS - VACCINES AND INFECTIOUS DISEASES
VLP-Based Polio Vaccine
 
Particle Acceleration
 
Methods employed in cryo-electron microscopy help to characterise the structure of new polio vaccines, as outlined by Professor Dave Stuart at Diamond Light Source.
 
view
download pdf
Lifesaving New Vaccines

Gut Feeling
 
Björn Sjöstrand at Scandinavian Biopharma details how new vaccines are being tested in clinical trials to combat the virulence of Enterotoxigenic Escherichia coli in the developing world.
 
view
download pdf
bullet
Drug Discovery
Sophisticated Drug Development
 
Under Lock and Key
 
Dr Misha Kapushesky at Genestack warns that, to maintain their integrity, a higher level of sophistication is needed in data management systems, especially as drug development agreements become more popular.

 
view
download pdf
Collaborating in Data Management
 
Discovery Decisions
 
To guarantee good data management, software creators must collaborate as much as possible with project leaders and decision makers to give them easy access to data. Dr Matthew Segall and Dr Chris Leeding at Optibrium explain.

 
 
view
download pdf
bullet
LICENSING AND REGULATORY
Q&A: Data Compliance
 
Utmost Integrity


EBR
asks Darren Barrington-Light at Thermo Fisher Scientific and Brian Alliston at Sterling Pharma Solutions to elaborate on the ways to achieve data integrity compliance using chromatography data systems.
 
view
download pdf
Global Compliance
 
Regional Requirements
 
Life sciences companies are making the most of globalisation and the standardisation of submission requirements. Key differences remain in regulatory needs between regions, as argued by Kimty Bui-Van at ProductLife Group.
 
view
download pdf
bullet
CELL-BASED RESEARCH
Three-dimensional Cell Culture
 
Cell-ebration
 
Professor Fredrik Johansson at Lund University and Maximilian Ottosson at Cellevate look over the systems utilised when researching three-dimensional cell culture.



 
view
download pdf
   
spacer
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

Envigo launches PATHWAY an optimized safety assessment solution to enable first in human clinical trials

11 March 2019, East Millstone, N.J. – Envigo, a leading provider of non-clinical contract research services and research models, announced today the launch of PATHWAY – an integrated solution that optimizes non-clinical safety assessment programs to enable first-in-human clinical trials. PATHWAY is designed to manage the complexity of the entire safety assessment process on behalf of the company’s pharmaceutical and biotechnology customers by integrating safety assessment study types and bioanalytical support with scientific and regulatory consulting, program design and project management.
More info >>

White Papers

Industry Events

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement