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European Biopharmaceutical Review

ebr
Spring 2020

   
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In Brief
New Viral Trend

As this issue goes to press, the world is focused on the challenges posed by a novel coronavirus – SARS-CoV-2. EBR Industry Advisor, Emile Bellott, offers his thoughts and prayers.
 
 
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Features
Eschewing the Escalation of Salaries as Safety Professionals Grow Scarcer

Alan White at Arriello

Qualified PV professionals are proving particularly hard to hang on to as demand for experienced safety talent soars. As such, it seems like a good time to look beyond financial remuneration as the key to keeping valued staff motivated and loyal.
 
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Transforming Cell and Gene Therapy Trial Design and Execution

Martin Lachs at ICON plc
 

With over 400 dedicated CGT professionals globally, ICON has developed tools and best practices to transform CGT trial design and execution
 
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Next-Generation Sequencing – Where We’ve Been and Where We’re Headed

Mirna Jarosz at Integrated DNA Technologies

Tracking the progress made through DNA sequencing in treating once uncurable health conditions may help us realise the untapped potential of sequencing.
 

 
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Patient-Centric Designs: A Likely Tipping Point for Biosimilar Adoption

George I’ons at Owen Mumford Pharmaceutical Services

Recent opportunities have arisen for biosimilar manufacturers to take hold of the pharma market; however, there are a number of challenges they should be aware of if they wish to properly utilise these opportunities
 
 
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CAR T Cell Therapy
Bridging the Gap in Personalised Medicine with CAR T Cell Therapies

Filippo Petti at Celyad

CAR T cell therapy holds a lot of potential in terms of serving as a viable treatment for cancer, and an alternative for standard treatment. However, there is still research to be done before any definitive statements are made.
 
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Overcoming the Remaining Hurdles

Dr Patrick Laroche at Janssen Oncology EMEA

Though still in its infancy, CAR T cell therapy has already presented with a great deal of potential; however, it would be wise to keep in mind all the obstacles that still need to be overcome for that potential to be reached.
 

 
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Computational Algorithms and Large- Scale Data for CAR T Cell Therapy Resistance

Dr Raul Elgueta, Dr Aida Moreno-Moral, and Dr Rodrigo Santos at Mogrify

CAR T cell therapy has already broken new ground in treatment for cancer patients, and largescale omics data integration and computational analyses are bound to shape the new generation of CAR T cells
 
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Immuno-oncology
Unlocking the Potential of Checkpoint Inhibitors – The Challenge for the Next Decade

Marisol Quintero at Highlight Therapeutics

Immunotherapy is an exciting weapon against cancer but many patients fail to benefit. Scientists are increasingly focused on maximising the potential of the immune system for everyone, perhaps in combination with one of the oldest cancer treatments: radiotherapy.
 
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Overcoming First- Generation Shortcomings in Cancer Therapies

Alexis Peyroles at OSE Immunotherapeutics

Immunotherapy is a field of cancer research that has had an impressive level of growth, and continues to present a level of promise that may prove game changing in research and treatment.
 
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Pain Management Research
50 Years of Pain Management

C Norman Shealy and Sergey Sorin at Shealy-Sorin Wellness Institute

From cranial electrical stimulation to pulsed electromagnetic field therapy, pain management has advanced exponentially over the last 50 years.
 
 
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The Science Is Stacking Up for Regenerative Medicine

Simon Checkley at The Regenerative Clinic

Numerous global studies are under way to evidence the outcomes of orthobiologics and mesenchymal stem cells.
 
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Contract Development Manufacture Organisations
The Trials and Tribulations of CDMOs

Dámaso Molero, CEO of 3P Biopharmaceuticals, talks with EBR about the role, challenges, and future possibilities of CDMOs.
 
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Deploying the Full Drug Development Armory to Overwhelm Complex Chemistry

Dr Jingyang Zhu, Dr Ke Chen, and Dr Sam Tadayon at WuXi STA, a WuXi AppTec Company (STA Pharmaceutical)

The demand for more diverse technologies in pharma and biotechnology can no longer be ignored, and CDMO companies are having to adjust accordingly.
 
 
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Alternative Antibody Drug Scaffolds
Monoclonal Antibodies and Beyond

Michael Foley at AdAlta

Although mAbs have proven to possess exceptional therapeutic properties in many disease areas, there are some limitations that have led to the development of alternative biological scaffolds
 
 
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Antibody Internalisation Assays

With breakthroughs in molecular engineering and antibody humanisation, antibody-based drugs are one of the fastest growing classes of biopharmaceuticals for multiple clinical indications.

 
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Published quarterly in
January, April,
July, and October

News and Press Releases

High Throughput Analytics Herald a Paradigm Shift in the Development of Biopharmaceuticals

Heilbronn/Dortmund August 2019: Biopharmaceuticals have revolutionized therapies of various diseases. In particular with regard to chronical and/or severe clinical conditions like multiple sclerosis, rheumatoid arthritis or cancer they are considered the future of treatment. Also economically biological drugs are on their way up: The global biopharmaceuticals market is anticipated to reach about 400 billion USD by 2025. Which strategic alignment will help best to fill a successful pipeline?
More info >>

White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
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Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

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