Selecting a CDMO: How to Stop Partnering Ending in a Messy Divorce

Apr 28, 2012

Big changes have occurred recently in the pharmaceutical industry - not unlike other industries and the wider economy in response to globalisation - notably, that smaller biotech and life science companies are struggling to access capital, whilst many big pharma companies have downsized and outsourced research in order to drive down costs. Torkel Gren of Recipharm Pharmaceutical Development AB discusses the best approach to take, while selecting the right contract development and manufacturing companies. ...

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Sustainable High Technology Cooling Systems are Meeting the Need for Energy-Efficient Ultra Low Refrigeration

Apr 28, 2012

William B White, CEO, Offenberger & White, Inc highlights the reason why the process of purchasing ultra low temperature freezers and acknowledging impact on facility overhead budgets is forcing a transition in buying authority from a single user working on grant money to comprehensive evaluations by financial, environmental and sustainability departments throughout the institution. ...

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Managing the Extended Clinical Supply Chain in an Outsourced World

Apr 28, 2012

Most recent research on clinical trials focuses on the outsourced research and development (R&D) activities such as data delivery, site conduct and development. This article, by Petra Bielmeier of F. Hoffmann-La Roche Ltd, Geert Crauwels and Jim Williams of Lodestone Partner, describes, for both sponsors and contractors, the clinical supply chain and manufacturing operations, from the manufacturing of active pharmaceutical ingredients (APIs) through to the delivery of investigational medicinal products (IMPs) at the clinical site and on to the patient. ...

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Integrated Innovation – Genomic Biomarker Discovery, Development and Application

Apr 28, 2012

The significance of biomarkers as diagnostic and predictive tools with clinical utility and for monitoring and judgment of study progress probably cannot be overestimated. Co-development and extended use of biomarkers throughout the entire drug development process, referred to as `companion diagnostics´, are considered to yield significant increases in study effectiveness. Ioannis Amarantos, Thomas Laufer and Thomas Brefort of Febit Biomed GmbH explain how integrative, combinatorial approaches assessing multiple genomic biomarkers will potentiate the power and complement cellular, protein and metabolic biomarker data. ...

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Comparative Effectiveness Research – What’s Old is New Again

Apr 28, 2012

“Comparative effectiveness” has become a popular phrase in political and health policy circles worldwide since the US Congress passed the Patient Protection and Affordable Care Act of 2010. The current interest in comparative effectiveness research is driven by the desire to identify treatment options that are more effective than others and offer good “value for money”. While head-to-head research can yield valuable insights on effectiveness and cost-effectiveness, care must be taken to ensure comparability across the populations studied. Mason W Russell of PharmaNet discusses that once this data is collected, it can be used in conjunction with costs and other economic ...

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