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European Biopharmaceutical Review

ebr
Winter 2019

   
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EBR’s Editor, Dr Deborah O’Neil, details all the innovations touched upon in this issue and how some can enhance cancer treatment.
 
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BioDiscovery
Biobanks and the Rise of Precision Medicines

Unlocking the Power of Data

Timo Kanninen at BC Platforms expresses the urgency surrounding data sharing, arguing that researchers need access to unique datasets if they wish to progress in personalised healthcare.
 
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Batch Releases and Brexit

The Impact of Brexit on the Pharma Industry

As Brexit negotiations become more pressing and the deadline continues to loom, ‘red lines’ navigation and plans for a ‘no-deal’ scenario must be established urgently. Lynne Byers at NSF International offers guidance on the potential challenges.
 
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Regional Focus: Scandinavia
Biopharma Investments in Scandinavia

Challenges for Small Businesses in the Global Pharma Market

The pharma industry has been forced to adapt over the years, going from a field deemed ‘safe’ and recession-proof to one of a constantly evolving and accelerating trajectory. Stephen McNeeney PhD at Potter Clarkson demonstrates how ever-increasing demands are moulding the industry.
 
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Scandinavia: What is in a Name?

Spot the Difference

Defining Scandinavia is a bigger question than most would realise. Tórben Thers Nørgaard at PharmaLex Nordics delves into the regional differences in compliance and packaging to highlight where gaps in expertise exist.
 
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Engineering Biopharmaceuticals to Address Intractable Diseases

Biopharmaceuticals for the Brain

Stephen James PhD, Erik Nordling PhD, and Stefan Svensson Gelius PhD at Sobi expand on how accomplishing therapeutically meaningful levels of biopharmaceuticals can be difficult to accomplish and why companies should consider exploring biological engineering to ease the process.
 
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DEVELOPMENT AND PRODUCTION
Drug Development Forecasts

Forecasting Development Stages to Stay Ahead of Compounds

Jamie Blackport and Chris Watson at Mirador Analytics recommend epidemiology-based forecasting to provide the best possible compound current value analysis available.
 
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RESEARCH AND DEVELOPMENT
Encapsulation and Microfluidics

Channelling the Future of Liposome Generation

Damiano Rossi at Dolomite Microfluidics and Anna Blakney at Imperial College review drug encapsulation, a drug delivery method that has signficantly increased in usage given the protection they can offer enclosed molecules.
 
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Drug Delivery to the Lungs

Thinking Throats with Anatomical Throat Models

The inhalation industry has largely welcomed anatomical throat models over the last few years. Samantha Holmes and Alex Slowey at 3M assess their utilisation, particularly in regard to in vivo testing.
 
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Analytical Tools
Computed Tomography Imaging

The Advent of Nanoparticle Contrast Agents

New methods, namely using nanoparticle and targeted contrast agents, are paving the way for better treatment efficiency and personalised treatment plans in the cancer arena, claims Dr Hannah Prebble at MARS Bioimaging.
 
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Innovations in Oncology
Minimal Residual Disease Assessment in Blood Cancers

Monitoring Malignancies Through Assay Development

Although progression in the drug development arena has improved prospects for blood cancers, companies should still consider assay-based methods to detect residual disease to ultimately improve patient care, suggests Ilan Kirsch at Adaptive Biotechnologies.
 
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Vaccines
The War Against Microbes

Vaccine Victories Against Microbial Resistance

Dr Donald F Gerson, Jonas Elliott Gerson, Allison Turner, and Dr Gail Meadows at PnuVax address the pressing issue that is antibiotic resistance, explaining that, though humans are definitely winning the battle, difficult organisms remain which are proving arduous to combat.
 
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Electron Beam- Sterilised Vaccines

Exploring Amino Acid-Based and Stable Spray-Dried Vaccines

Developing therapeutic biologics is no easy feat, as formulation issues act as a significant cause for drug development delays. The team at LEUKOCARE advise how best to approach the matter.
 
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Stopping the Spread of Infectious Diseases

The Value of Vaccines

Incidents of Lyme disease have rapidly increased over the last few decades, making it, globally, a significant risk. Thomas Lingelbach at Valneva presents the case for a vaccine against the illness.
 
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Drug Repurposing/Repositioning
Q&A: New Targeted Treatments

Embracing a New Lease of Life

Genea Biocells’Alex Kiselyov discusses with EBR the myriad advantages that are associated with drug repurposing, particularly in the realm of molecular biophysics and targets.
 
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Drug Repurposing for Infectious Diseases

Fighting the Damocles Sword of Infectious Diseases Through Drug Repurposing

Antimicrobial resistance poses a major challenge for the treatment of infectious diseases today. Andrés Pizzorno PhD at Signia Therapeutics explores how to address this from a drug repurposing perspective.
 
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Compliance and Regulation
Ethical Considerations in Human Biospecimens

Consent and Biospecimen Collection in Human Research

Informed consent is one of many ethical considerations that must be made when handling human research subjects. Tony Brown PhD and Kelly Sapsford at BioIVT lend their expertise on what factors to be aware of to meet regulations.
 
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Simplifying Regulatory Requirements

Compliance Complexity in the Data Management Landscape

Regulatory compliance may benefit from the adoption of a more holistic approach. Romauld Braun at AMPLEXOR is encouraging life sciences companies to review how they manage data in a time of increasing regulatory complexity.
 
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In Brief
In Brief

Gates and Doors

At the turn of the year, EBR’s Industry Advisor, Emile Bellott, reflects upon the progress made across biopharmaceutical sciences.
 
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News and Press Releases

Significant improvement in overall survival with ERLEADA®▼ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer

BEERSE, BELGIUM, May 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA®▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: Summary of Year 2013

Synergy Research Group

Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
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Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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