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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

YHEC announces the promotions of Michelle Jenks and Rachael McCool to the role Project Director

YHEC is pleased to announce the promotions of Michelle Jenks from the Economic Modelling team and Rachael McCool from the Systematic Reviewing team to the role Project Director. Michelle has a Master’s degree (MSc) in health economics from the University of York and has conducted economic evaluations and systematic reviews for both public and private sector clients. Michelle is the lead modeller in YHEC’s role as an External Assessment Centre for NICE and has also led on a range of economic evaluations conducted for clients within industry, such as cost-utility models and budget impact models. She often leads the development of early economic analyses to inform clinical trial design and pricing strategy.
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White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
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Industry Events

INTERPHEX 2018

17-18 April 2018, Javits Center, New York, USA

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA).
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