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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

MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita

MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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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.
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Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
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