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European Biopharmaceutical Review

ebr
Winter 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
Independent consultant Emile Bellott looks at the changing biotech landscape in light of the global financial crisis and considers the likely implications for the global pharmaceutical/biotech industry  
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Mark B Hassenplug and Kai Gindner at Ernst & Young examine ways in which pharmaceutical companies can maintain standards in supply chain management  
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BioBusiness Development
Pharma and biotech companies often manage scientific assets and equipment on their own. Bob Moore at GE Healthcare discusses why and how outsourcing scientific asset services can help to improve effectiveness in the lab  
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Catherine D’Arcy at PA Consulting Group describes the requirement for greater efficiency and effectiveness in R&D operations and how working closely with a global pharmaceutical company has prompted a review of key functions  
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Richard Barratt at Barratt Legal examines the proliferation of outsourcing operational practices in the industry, and tells us how to get the best out of it  
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BioResearch and Innovation
Mats Hellström and Björn Frendéus at BioInvent International examine the developments that are occurring in monoclonal antibody drugs, and discuss their future in the fight against cancer  
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Birgit Jehn at QIAGEN GmbH gives an overview on HLA-Typing or pre-therapeutic testing in AIDS patients  
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Discovery Technology
David Bunton and Lee Rankin at Biopta Ltd and Alistair Corbett at Glasgow Caledonian University discuss opioid receptors as drug targets in gastrointestinal disorders  
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Graham Lappin at Xceleron argues that microdosing can provide important information about a drug’s behaviour before Phase I, thereby reducing the likelihood of costly failures at a later stage  
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BioDevelopment and Regulatory
Ulrich Braumann at Bruker BioSpin and Herbert Thiele at Bruker Daltonik analyse structure verification of small molecules using integrated MS spectrometry and NMR spectroscopy  
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Josep Prous at Thomson Reuters introduces biomarkers, identifying them as a crucial factor in the evolution of drug research and development  
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LABALisette Oversteegen at Datamonitor discusses combination product market trends in the respiratory drug sector  
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BioFormulation and Manufacturing
R Keith Williams at The Clinical Biotechnology Centre, Bristol Institute for Transfusion Sciences, NHS Blood and Transplant and Angela Osborne of eXmoor pharma concepts ltd discuss small-scale biomanufacturing for clinical trials, cell and gene therapies in the UK market  
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Kate Westwell and Gina Wenham at Eden Biodesign explain how implementing the quality cycle can deliver product value  
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BioRegional
Jacques Lhomel of Biocitech tells how one of Europe’s high-profile life science parks has boosted resources for life sciences R&D  
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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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
More info >>

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