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European Biopharmaceutical Review

ebr
Spring 2009
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR.
   
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BioFinance and Management
Bioanalysis: Getting the Right Result
Bioanalytical data can have a profound impact on drug development and early go/no go decisions. Independent consultant Ray J Briggs and John Allinson of Veeda Clinical Research urge companies to consider their management of bioanalytical outsourcing carefully in order to ensure data of the highest quality.
 
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Life After Blockbusters
As the supply of new drugs dwindles, many 'blockbuster' drugs are coming out of patent protection. Jon Howells of PA Consulting Group proposes initiatives to reduce waste and increase efficiency in order to help manufacturing companies survive the oncoming crisis.

 
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BioBusiness Development
The Big Buy
Alain J Gilbert and Meredith Edwards of Bionest Partners evaluate the problems facing the pharmaceutical industry in 2009, and argue that the solution lies in biotech partnering with big pharma to keep pipelines busy and inject cash into struggling companies.
 
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European Biotechnology on the World Stage
The biotech industry in Europe is in a very different position to its fast-growing US counterpart. Claire Skentelbery at the Council of European BioRegions looks at the shape of biotechnology in Europe and highlights the difficulties and partnerships linking small and ambitious companies.
 
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BioResearch and Innovation
Safety First
In the past, there have been rare occassions when clinical trials have had tragic results. Peter Thomas and Karen Corneillsen at Covance discuss safety planning and assessment strategies that are crucial during the development stage of high-risk medicines in order to minimise danger.
 
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Optimised Therapeutic Peptides - From Sequence to Drug
Peptides have huge potential as therapeutic agents, but many never make it to the early stages of development due to their instability and pharmacokinetic properties. Udo Haberl, Andreas Rybka and Hans-Georg Frank at AplaGen GmbH explain how peptide engineering can resolve many of these limitations.
 
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Personalised Medicine
Next-generation sequencing has completely changed genomic research: the entire human genome can now be sequenced in eight weeks, offering many advantages to biomedical studies. Peer Staehler at febit looks at its current position in the industry and the important role it has to play in personalised medicine and pharmacogenomics.
 
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In Vivo Alternatives
Zebrafish embryos are transparent and develop rapidly, allowing visual analysis of different structures and processes. Ainhoa Letamendia Urraca and Carles Carrol Massot at Biobide believe that a new automated system could overcome the limitations of zebrafish, and be the key to understanding cardiotoxic compound properties.
 
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Discovery Technology
RNAi Therapeutics: Promise, Speed and Challenge
Bob Brown at Dicerna Pharmaceuticals provides an overview of the current research into RNA interference (RNAi), and discusses some of the problems that need to be resolved to provide safe and effective delivery methods, in order for RNAi therapeutics to reach its full potential.
 
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Code of Conduct
Kevin V Morris at The Scripps Research Institute analyses the role of non-coding RNAs in gene expression and the latest theories relating to the human genome, believing that this has important implications for understand the 98 per cent of human DNA that was once considered 'junk DNA'.
 
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New Possibilities
Since the discovery of mammalian microRNA, the development of serum-based micro-RNA biomarkers has been eagerly awaited. Thomas D Schmittgen at the College of Pharmacy, Ohio State University examines recent studies, suggesting that these potential biomarkers could represent a new generation of diagnostics for cancer, cardiovasculature disease and psychiatric disorders.
 
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Spot Test
New technology means that a wider range of diagnostic tests can be performed in different environments, including general practitioners' clinics and patients' homes. Richard Luxton and Janice Kiely at the University of the West of England discuss the devices that are bringing point-of-care testing into the 21st century.
 
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BioDevelopment and Regulatory
Transportation Tips
Transport regulations need not be seen as a hindrance to drug discovery or clinical trial processes; Michael Gotz at MLG Consulting offers tips for complying with dangerous goods regulations and shipping biological samples and chemical compounds successfully, highlighting the dangers of regulatory ignorance.
 
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BioFormulation and Manufacturing
Dispersions Deliver Results
David T Vodak and Dwayne T Friesen at Bend Research Inc review solid form solubilisation techniques, focusing on spray-dried dispersions, nanoadsorbates and crystallised spray-dried dispersions, and suggest strategies for choosing the most suitable technology to enhance solubility for each compound.
 
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Expanding Expression
There is an urgent need for innovation within the biopharmaceutical sector, and its reliance on outdated systems is stifling the industry. New manufacturing technologies are vital for a company's survival. Eric Langer at BioPlan Associates, Inc argues that switching to new expression technologies will increase yield and save money.

 
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Large-Scale Transient Gene Expression
Transient gene expression has now been adopted by a number of companies as an alternative means of protein expression. Gaurav Backliwal and Florian M Wurm at ExcellGene SA demonstrate how combining process and metabolic engineering can greatly increase protein productivity.
 
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BioRegional

Scotland: the Helm of Life Sciences
Scotland has one of the fastest growing biopharmaceutical sectors in Europe. John Swinney of the Scottish Government highlights Scotland's postion in medical research and describes the advantages the region has to offer the life science industry.

 
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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

PCI Announces Expansion of its Industry-Leading Cold Chain Infrastructure with Dedicated Minus 40 degrees C Facility

Philadelphia, USA August 29, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, Clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce the completion of a purpose built -40C storage and distribution facility at its North American Clinical Services Center of Excellence.
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White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
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Industry Events

PDA Universe of Pre-Filled Syringes and Injection Devices

8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL

At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices.
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