samedan logo

 
 
spacer
home > ebr > Autumn 2008
PUBLICATIONS

European Biopharmaceutical Review

ebr
Autumn 2008
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
Interim management has been a feature of biopharmaceutical management for the last 10 years. Geoff Newman at Interea discusses its history, examines its considerable impact on the industry, and predicts its increasing popularity.  
view
download pdf
As the prominence of biological products in the pharmaceutical industry has increased, so too has the demand for aseptic filling. Brian Dougherty of Specials Clinical Manufacturing analyses the developments within the industry, and compares various techniques for aseptic filling.  
view
download pdf
bullet
BioBusiness Development
Andreas Schneider at Innovatis AG encourages the use of process control as a method of increasing efficiency in biopharmaceutical practice, and discusses its usefulness in the context of the FDA’s PAT initiative.  
view
download pdf
It is feared that more than 30 per cent of drugs in the pharmaceutical supply chain may be counterfeit. Gary Noon at Aegate sees mass serialisation as an effective solution to counterfeiting, and considers the practice in the light of various international regulations.  
view
download pdf
As the pharmaceutical industry grows, the market for companies becomes increasingly international. Gary Muddyman at Conversis suggests that the value of cultural nuance in advertising and business communication is often overlooked, and advocates cultural customisation as a method of increasing global marketability.  
view
download pdf
Continuing the international theme, Emile Bellott, a consultant in drug development, assesses the forces shaping the global business environment, and the challenges and opportunities that they represent for pharmaceutical companies.  
view
download pdf
bullet
BioResearch and Innovation
Gina M DiGioia at PBL InterferonSource advocates the use of type I interferons in pharmaceutical treatments, suggesting that this one family of proteins could prove revolutionary in the fight against some of the most serious diseases.  
view
download pdf
The way in which antibiotics are developed within the pharmaceutical industry has evolved, and this has opened windows of opportunity for both smaller biotechnology companies and CROs, suggests Dave Griffin at Quotient Bioresearch.  
view
download pdf
Simon Skjřde Jensen and Jeppe Skytte Spicker of Bioneer investigate the unique role that dendritic cells can play in the development of immuno modulatory drugs, and hope that new strategies involving DCs might give rise to a whole new generation of treatments.  
view
download pdf
Capacity expansion is an inevitable aspect of the ever-growing biopharmaceutical industry, but less predictable are the differences in expansion between Europe and the US. Eric Langer at BioPlan Associates analyses these differences and what they signify for strategy planning.  
view
download pdf
bullet
Discovery Technology
Alain Gondinet of ReGen Lab investigates platelet rich plasma autologous cellular regeneration in cosmetic treatment, and finds that it is safe, sterile and efficient for use in a wide variety of pharmaceutical and cosmetic applications.  
view
download pdf
The pharmaceutical industry demands identification, quantification, validation of biomarkers and detailed protein characterisation. Herbert Thiele at Bruker and Martin Blüggel of Protagen AG suggest that the all-in-one solution of a bioinformatics platform is ideally suited to meet these demands.  
view
download pdf
Drug development is becoming increasingly more expensive, making the efficiency of chemical analysis key. Vehary Sakanyan at ProtNeteomix advocates the use of small molecule microarrays, and assesses examples of their various applications in drug discovery programmes.  
view
download pdf
One recent development in drug delivery technology is antibody mediated drug delivery. Francois Fay, Richard Buick, Shane Olwill and Christopher Scott at Fusion Antibodies give an overview of the technology, and describe its potential applications.  
view
download pdf
bullet
BioDevelopment and Regulatory
The US Cabinet and the European Commission are currently working together to provide a regulatory framework for drug development; Fabien Roy at Hogan & Hartson discusses.  
view
download pdf
In an uncertain market, the protection of one’s own products is fundamental – Adrian Tombling at Withers & Rogers discovers that the patent process for the pharmaceutical industry is a complex, yet crucial, one.  
view
download pdf
Robert Goldspink at Morgan Lewis urges pharmaceutical companies to put in place stringent compliance and governance systems in order to ensure they comply fully with international anti-corruption procedures.  
view
download pdf
Regulation of the biopharmaceutical industry is seeing a transition towards risk-based quality management.Andy Bailey at ViruSure GmbH discusses what this means for virus safety procedures during clinical trials.  
view
download pdf
bullet
BioFormulation and Manufacturing
Crystalline protein formulation has existed as a scientific process for more than 80 years, but its use in the pharmaceutical industry is yet to take off. Katja Palmunen and Kalevi Visuri of Macrocrystal Oy present crystalline formulation as a potential alternative to chromatographic separation and a future method for drug manufacture.  
view
download pdf
It is widely hypothesised that many of the failures during the latter stages of drug trials come about due to inefficiencies in the earlier phases.Karen Jones and Andrew Rankin at Pharmaceutical Profiles suggest that this problem can be significantly reduced by altering formulation strategies earlier in the drug design process.  
view
download pdf
bullet
BioRegional
Wallonia is a French-speaking region in southern Belgium. Philippe Janssens de Varebeke at AWEX and Frédéric Druck at BioWin give us an overview of this area as a bioregion and explain what makes it unique.  
view
download pdf
The Far East is a hotbed of exponentially-growing biopharmaceutical markets, one of which is in Singapore. Keat-Chuan Yeoh of the Singapore Economic Development Board discusses the rapid market development in Asia, and sees Singapore as its focal point.  
view
download pdf
   

spacer


Published quarterly in
January, April,
July, and October

News and Press Releases

Digitalisation solutions for a connected plant: Bridging the gap for Pharma 4.0

Digitalisation solutions for a connected plant: Bridging the gap for Pharma 4.0 Digital transformation is key in ensuring the flexibility, resilience and agility required in pharmaceutical manufacturing, but traditionally, the industry has been resistant to digitalisation. Now, regulatory bodies are pushing for manufacturers to embrace Pharma 4.0 and to incorporate automation into their operations. Here, Alexandra Hughes, Industry Sales Manager at automation software supplier, COPA-DATA UK, explains how its zenon automation integration layer (AIL) can support the digital transformation of pharmaceutical manufacturing and bridge the gap between brownfield and greenfield equipment.
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 >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement