European Biopharmaceutical Review |
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| 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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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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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. |
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| 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. |
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| 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. |
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| 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. |
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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. |
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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. |
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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. |
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| 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. |
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| 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. |
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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. |
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| 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. |
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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. |
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