spacer
home > ebr > Spring 2009
PUBLICATIONS

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.
   
Text
PDF
bullet
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.
 
view
download pdf

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.

 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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'.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf

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.

 
view
download pdf
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.
 
view
download pdf
bullet
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.

 
view
download pdf
   
spacer
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

2019 Pharmapack Awards

Pharmapack Europe have announced entries for the 2019 Pharmapack Awards are now open across both the ‘Exhibitor Innovation’ and ‘Health Products’ categories with a closing date of 30th November 2018. The Health Products category will include two winners with one for Patient-Centric Design – which is launched in partnership with HCPC Europe (Healthcare Compliance Packaging Council of Europe) – and a second introduced alongside Adelphe for Eco-design in health packaging and drug delivery devices. Pharmapack Europe have also announced that they’re accepting applications for the start-up hub which provides young start-up companies servicing the pharma industry with the benefit of valuable networking and learning opportunities at half the price of a regular stand.
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

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement