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European Biopharmaceutical Review

ebr
Autumn 2011
   
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BioBusiness, Finance & Communication

Prepared to Launch

Mike Rea at IDEA Pharma considers the importance of product lifecycle decisions and explains how assessing commercial and regulatory risk, in addition to considerations of investment and time-to-market, can lead to a strong competitive advantage.

 
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App Potential

As the internet promotes customer satisfaction by encouraging feedback via online publications, the importance of maintaining a web presence is growing. Kelly Sladek at SCORR Marketing outlines the inevitable evolution of online promotions.

 
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Digital Exchange

A recent survey demonstrates an increasing dependence on electronic communication media within the biotech sector. Linda Bowers at IntraLinks evaluates the implementation of web-based document exchange solutions.

 
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BioFinance and Management

Trimming the Fat

Lean Six Sigma has been proven to be an effective and helpful tool for contract laboratories providing biopharmaceutical analysis. Melanie Dippel at Charles River Biopharmaceutical Services GmbH looks at benefi cial collaborations with an outsourcing partner.

 
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BioBusiness Development

The Biotechisation of Pharma

With the noticeable rise of ‘biotechisation’ in pharma companies in recent years, Flavia Botschen and Markus Thunecke at Catenion look at how this will affect all related branches of the densely interwoven biopharmaceutical industry.


 
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Discovery Technology

Protein Production

Igor A Kaltashov at the University of Massachusetts-Amherst assesses the advantages and challenges of mass spectrometry-based methods used for characterising protein as well as its broader impact on the production process.

 
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BioDiscovery

Flow Cytometry Outsourcing

Carla G Hill and Thomas W McCloskey at ICON Central Laboratories report on how the use of flow cytometry for clinical trial testing is set to increase, as accurate evaluation of cell-based biomarker assays becomes a necessity in the assessment of biologic drug candidates.

 
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BioDevelopment

Cause and Effect

Biomarkers are integral to improved diagnostics and novel therapeutics. Ioannis Amarantos, Thomas Laufer and Thomas Brefort at febit biomed GmbH study their four primary categories of application and discuss research case studies of miRNA development.

 
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Legal, Regulatory and Public Policy

Regulatory Challenges

The Survey Says

Alan Trounson and Elona Baum at the California Institute for Regenerative Medicine (CIRM) run through their research on current perspectives regarding regulatory uncertainty when facing challenges for commercialisation in the fi eld of regenerative medicine.

 
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Biodevelopment and Manufacturing

Single-Use Technology

At Your Disposal

Nicole O’Brien at Gallus BioPharmaceuticals discovers that the road to a fully disposable biomanufacturing process – from bench to commercial production – is just on the horizon, and offers an insight into how it is transforming biotherapeutics.

 
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BioFormulation and Manufacturing

Peptide Synthesis

Building Bonds

In-depth knowledge of peptide production methods to optimise yield and purity is critical to faster and more cost-effective commercialisation of peptidebased therapies, elaborates Gary Hu at the American Peptide Company.

 
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BioManufacturing

Drawn to Scale

Successful manufacturing of biopharmaceuticals relies on good process design, scale up and control strategies. Graham McCreath and Mahesh Shivhare at Fujifilm Diosynth Biotechnologies demonstrate the possibilities that small scale fermentation can offer.


 
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CANCER FOCUS

Setting Your Sites

While there are numerous challenges for the effective contact research management of most clinical trials, oncology studies pose even further complications. Erin Anderson and Daryl Ann Fallon of Premier Research Group Limited focus on the goals and objectives the biotechnology sector face today.

 
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Peptide Potential

Citing recent research into the potential of a synthetic peptide known as ‘p28’, Tapas K Das Gupta, David R Volk and Craig W Beattie at CDG Therapeutics, Inc relate how new findings on this peptide could alter future cancer therapies.

 
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APPLIED RESEARCH, DEVELOPMENT AND PRODUCTION

Express Delivery

siRNAs have proved their capacity to perform in a wide range of applications, from human diseases to plant pathogen resistance. Kathleen Hefferon at the University of Toronto explains how their development has been adapted within the medicinal and agricultural fi elds.

 
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REGIONAL UPDATES

The Future’s Orange

Annemiek Verkamman at Life Sciences Health looks at the social, technological and sector trends within the Dutch life sciences industry as these companies compete to be global players.


 
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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

Kloeckner Pentaplast Announces Plans for New Lamination Facility


More info >>

White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>

Industry Events

14th World Advanced Therapies & Regenerative Medicine Congress 2018

16-18 May 2018, Business Design Centre, London, United Kingdom

In May 2018 the World Advanced Therapies & Regenerative Medicine Congress, will bring together 800+ attendees and explore the rapidly developing world of ATMPs (Advanced Therapy Medicinal Products).
More info >>

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