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| home > ebr > Winter 2009 |
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 PUBLICATIONS |
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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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News and Press Releases |
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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.
More info >> |
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White Papers |
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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 >> |
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Industry Events |
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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.
More info >> |
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