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PUBLICATIONS

European Biopharmaceutical Review

ebr
Winter 2010

European Biopharmaceutical Review (EBR) is a journal designed to fill a unique position in scientific publishing. Published quarterly, it provides a dedicated platform of communication and information for the European biopharmaceutical market across Europe, North America & the rest of the world.

   
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Business Development and Financing

Using case studies from major players in the pharmaceutical industry, Peter Thornton at Business Insights reviews strategies to revitalise R&D and boost flagging pipelines.

 
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Implementing a ‘roadbook-controlled project’ that takes into account the development process and financial and risk parameters can limit the waste of invested money through strategically placed ‘go/no go’ decision points, explains Roel Bellens at Strategus.

 
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John Nash, Alan Beresford and Dawn Yates at BioFocus argue that outsourcing ADME to CROs can eliminate potential development liabilities, cut costs by reducing time spent on unsuitable candidates, and provide access to a wide range of testing resources.

 
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There is currently global political and economic pressure to reduce the costs of healthcare. Michael F Swanick at PricewaterhouseCoopers examines the impact that rising tax rates will have on the biopharmaceutical industry over the next year.

 
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The European Commission released its final report on the Pharmaceutical Sector Inquiry in July this year, and it clearly aims to promote practices that increase the level of generic entries. Michael McFalls and Frances Murphy at Jones Day compare the report to US legislation and fear that it may lead to limitations that are a step too far.

 
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As companies expand globally, it is crucial that they maintain their efficiency and reputation through effective communication structures. Simone Lamont and Alison Lamb of CLS Communication AG point out the benefits of using the services of life science language specialists that fully understanding your business, ensuring seamless integration.

 
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BioResearch and Innovation

Matthew Sleeman and Fabio Magrini at MedImmune review developments in using antibodies to treat autoimmune diseases and in other areas of unmet medical need, and hope that this will continue to stimulate research into the pathogenic mechanisms of autoimmunity.

 
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Cervical cancer is the second most common cancer in women, and around 80 per cent of deaths resulting from it occur in developing countries. Julie Zhu at QIAGEN discusses how tools and technologies can be adapted for low-resource settings to ensure that women at risk can be identified worldwide.

 
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Discovery Technology

Technological advances have led to quantitative polymerase chain reaction (qPCR) becoming a quality validation method for a range of scientific and medical approaches. Tobias Hampshire at Thermo Fisher Scientific provides an overview of recent developments in probe-based technology.

 
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miRNAs are ideally suited for use as biomarkers due to their role in controlling cellular activity. By indicating the biological state of cells and tissues, Peer Staehler at febit argues that they are important to diagnostics and may have the potential to become therapeutic targets and tools.

 
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BioDevelopment and Regulatory

Andy Bailey at ViruSure GmbH reviews the latest regulations leading towards a new approach to virus safety for investigational biotechnology products.

 
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Quality assurance should be integral to clinical development and trials to ensure the accuracy of test results. Martin Crockard at Randox describes different types of analyses and explains that the choice of scheme should be dependent on the size, duration and complexity of the trial.

 
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BioFormulation and Manufacturing

William Downey at HighTech Business Decisions provides an overview of the results of an investigation into the criteria that directors of biomanufacturing companies believed to be most important when choosing a contract manufacturing organisation.

 
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The move towards personalised medicine has meant that a great number of samples are collected during clinical trials. In order to manage this data, a flexible information system that works in real-time should be employed, explains Jennifer Benner at BioStorage Technologies.

 
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BioRegional

Bob Smailes at LeidenUniversity outlines the research taking place at LeidenBioSciencePark, the leading life science park in the Netherlands.

 
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A new cGMP production centre is being built in Wallonia, allowing three companies who work in the field of regenerative medicines to come together to create one platform, where each will have their own production space and the support they need.

 
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Published quarterly in
January, April,
July, and October

News and Press Releases

ACG Acquires Significant Stake in Mumbai-Based IQGEN-X

3 November 2020 The investment is aimed at augmenting R&D and IP in drug development. The funds infusion will enable IQGEN-X to fast-track research on existing ANDAs and also setup a cGMP pilot facility in addition to the already existing R&D facility.
More info >>

White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

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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