spacer
home > ebr > Autumn 2007
PUBLICATIONS

European Biopharmaceutical Review

ebr
Autumn 2007

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
Comparing methods of valuing biotech, Frédéric Desdouits and Catherine Pichereau of Bionest find that valuation remains as much an art as a science, in Net Profit  
view
download pdf
When selling out or buying into intellectual property, Hayley French at Novartis Pharma AG asserts that due diligence must not be underestimated. In Intellectual Property: Due Diligence for Biotech, she examines its potential to provide an investor, purchaser or licencee with detailed information that may affect the target’s pricing, along with other key elements of the transaction  
view
download pdf
The Rewards of Diligence sees Ben Rapinoja and Anne Korpi-Filppula of Borenius & Kemppinen explain the importance of legal due diligence, and discuss how to avoid key legal risks in the life science industry  
view
download pdf
bullet
BioBusiness Development
As competition continues to grow within the pharmaceutical industry, companies that trade on an international scale will need to find increasingly novel ways to view their market. Gary Muddyman of Conversis advises that we should Think Global, Act Local  
view
download pdf
The life science industry is in a state of constant flux – largely as a result of the unrelenting need for innovation and the threat of competition. To truly prosper in this challenging environment, Richard Barratt and Natalie Kingston at Morgan Lewis note that outsourcing companies should strive to offer flexible services, in Thinking Outside the Box  
view
download pdf
Dr John Hall and Duncan Birne at AAI Pharma raise concerns as to the current modus operandi for outsourcing in the biopharma sector. Recognising that the past decade has seen the growth of a scientifically sophisticated biotech industry, they pose the question: Outsourcing for Biotechs: The Need for a New Model?  
view
download pdf
Crossing the Pond explores the mutual benefits of transatlantic venture capital collaboration. Hanns-Peter Wiese and Dr Stephen J McCormack of Global Life Science Ventures chart the progress of the European biotech companies playing catch up with the US  
view
download pdf
bullet
BioResearch and Innovation
Dr Ole Jørgen Marvik and Dr Jutta Heix at HUNT Biosciences analyse the future development of biobanks and their impact on medical genomics, in Biobanking Potential  
view
download pdf
Around 2.9 million cases of cancer are diagnosed in Europe each year and this extensive disease burden results in over 700,000 annual deaths. In Anti-Tumour Agents: The Next Generation, Steve Dawber identifies current innovations and future developments in blood cancer-targeted pharmacotherapy, in search of significant prognostic improvements  
view
download pdf
bullet
Discovery Technology
Voula Kodoyianni at GWC Technologies, Inc and Richard Rouse at HTS Resources, LLC look at Tailor-Made Therapies – the rise of targeted, personalised therapeutics – and discover how unique genetic fingerprints can lead to more effective disease treatments  
view
download pdf
The past decade has witnessed a soaring increase in our knowledge of the human genome and the link between genes and disease. Henrik Ørum at Santaris Pharma reviews new developments in the field of antisense therapies and asks, Oligonucleotide Drugs – Within Sight of the Finish Line?  
view
download pdf
bullet
BioDevelopment and Regulatory
In Counteracting the Virus Threat, Dr Andy Bailey at ViruSure GmbH investigates current issues in the validation of biopharmaceuticals for virus clearance  
view
download pdf
Suzanne M Sensabaugh at MDS Pharma Services examines biomarkers within biopharmaceutical drug advancement programmes and finds that they are forces Driving Development  
view
download pdf
In Mass Spectrometry in Peptide Biomarker Discovery and Peptidomics, Rodion Demin at DIGILAB BioVisioN GmbH discusses the requirements of peptidomics technology related to mass spectrometry and the differences compared with proteomics in biomarker discovery  
view
download pdf
For investors, shareholders and executives alike, an abiding question is: how can a company speed time-to-market, lower costs and improve their success rate? John Avellanet at Cerulean Associates LLC recommends Quality By Design: Defining Your Preclinical Package  
view
download pdf
bullet
BioFormulation and Manufacturing
The Future of Liquid Chromatography sees Robert Plumb and Jeffrey R Mazzeo at Waters outline the crucial factors shaping the selection of a new liquid chromatography platform  
view
download pdf
Increased competition, shareholder influence and challenging targets are putting biopharmaceutical manufacturers under pressure. Eugène van Dijk at WCI Consulting Limited notes, in Quality Control Crosses into the Dead Zone, that whilst scaleability and productivity have become key drivers for selecting both cell lines and technology, when it comes to quality control these principles are not widely applied  
view
download pdf
Clemens Achmüller and Bernhard Auer at the Austrian Center of Biopharmaceutical Technology, Institute of Biochemistry, University of Innsbruck, Austria, investigate fusion protein technology for expression of therapeutic proteins and peptides in E coli, in The Protein Production Line  
view
download pdf
bullet
BioRegional
In A CEE of Opportunity, Bogdan Nietubyc of Hesperion Ltd explores factors influencing the increase in patient recruitment rates recently experienced by the CEE region and Russia  
view
download pdf
Nicola Watkinson at Invest Australia analyses Australia’s maturing biotech market, and finds that European companies are frequently considering Australia in the push to take drugs to market, in New Opportunities  
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

A New Era for Faster s.r.l. Air Safety Products in the UK.

In November 2018, Biopharma Group became the exclusive distributor of Italian brand, Faster S.r.l.’s clean air and laboratory range of products within mainland UK.
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

BioTrinity 2019

30 April - 1 May 2019, etc.venues 155 Bishopsgate, London EC2M 3YD

BioTrinity 2019 is taking place from the 30th April – 1stMay at etc.venues 155 Bishopsgatein London. Now in its 13th year, BioTrinity remains the leading Life Sciences Biopartnering and Investment conference in Europe, and generates unrivalled opportunities for life science companies, academics, investors, and major pharmaceutical players to come together to do deals and establish collaborations.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement