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Issue 5 2006

The right approach to human therapy

Issue 5 2006 / 28 September 2006 / Dr Simone Hess, Max-Planck-Institute for Infection Biology

The RIGHT (RNA Interference Technology as Human Therapeutic Tool) consortium consists of 18 research institutions and four companies from nine European countries. The project has been funded as an integrated project by the European Commission’s Sixth Framework Programme for Research and Development (FP6) since January 2005. Thomas F. Meyer from the Max Planck Institute for Infection Biology in Berlin is coordinating this European research project that aims at exploiting the vast potential of RNA interference (RNAi) for human therapy.

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An essential role for the Michael Barber Centre

Issue 5 2006 / 28 September 2006 / Simon J Gaskell, Director of the Michael Barber Centre for Mass Spectrometry in the School of Chemistry and the Manchester Interdisciplinary Biocentre and Isabel Riba-Garcia, Research Fellow, Michael Barber Centre.

The development of proteomics has been based very heavily on the suite of analytical techniques encompassed by mass spectrometry and associated methods. It is therefore appropriate that the work of the Michael Barber Centre for Mass Spectrometry (MBCMS, named for the inventor of, inter alia, the fast atom bombardment ionisation method) should now be largely driven by the needs of proteomics research and the broader field of systems biology.

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The role of HTS in eADMET profiling

Issue 5 2006 / 28 September 2006 / Werner Stuermer, Altana Pharma

Historically (until the late 1980s), compounds discovered by phenotypical in vivo screens were at least characterised with implicit ADMET data. An attractive compound in these test systems was available at the (usually unknown) target; had a minimal toxicological profile (the animal did not die immediately) and gave phenotypical (High-Content) information in the animal used for the experiment.

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Bottlenecks and potential improvements

Issue 5 2006 / 28 September 2006 / Carlo E.A. Jochems and Stefan Herzig, Department of Pharmacology, Faculty of Medicine, University of Köln

Ion channels are membrane proteins that regulate the entrance and departure of specific ions from cells, thus influencing the physiology of all cells. These ion flows also underlie electrical impulses required for sensory and motor functions of the brain, control of contraction of heart, skeletal, smooth and vascular muscle, as well as nutrient uptake, hormone secretion, cell replication and foetal development.

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Wyeth forges ahead

Issue 5 2006 / 28 September 2006 / Graham Cook Ph.D., Director Technology and External Supply, EMEA, Wyeth

Is the pharmaceutical manufacturing environment of today becoming more challenging? There is increasing pressure to control or reduce costs because of the limitations on healthcare budgets. Asset utilisation, operating efficiencies and cycle times in the pharmaceutical industry generally compare unfavourably with other high technology industries. Despite the resources invested in compliance, many companies continue to struggle to meet the regulatory requirements, as evidenced by warning letters and consent decrees.

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Streamlining with automation and robotics

Issue 5 2006 / 28 September 2006 / Bart Hazes, Dept. of Medical Microbiology & Immunology, University of Alberta and Bernhard Rupp, q.e.d. life science discoveries, inc.

Protein crystallography has been embraced by the pharmaceutical industry to accelerate and rationalise the drug development process. In this role, success rates, throughput and turnaround times have become key competitive factors, and nearly every stage in the protein crystallography process has been targeted for automation using robotics and advanced software. However, it remains a challenge to combine available technologies, information infrastructure and work-flow protocols into a high throughput protein crystallography pipeline that takes account of the specific objectives and resources of an organisation. This article reviews process outlines and key decision making criteria to assist with the selection of a high throughput protein crystallography strategy.

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Cell-based imaging

Issue 5 2006 / 28 September 2006 / Jinghai J. Xu, Ph.D., Margaret C. Dunn, Arthur R. Smith, Pfizer Global Research and Development

­Traditionally, in vivo histopathological findings have been used as part of standard readouts for safety assessment of new chemical entities (NCEs). The process typically involves dosing animals with NCEs for varying amounts of time, harvesting their major organs at the end of the study, preparing tissue sections and slides and visual examination of these slides by trained pathologists.

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The right technology, at the right time

Issue 5 2006 / 28 September 2006 / EPR

The growing popularity of Electronic Data Capture (EDC) is indicative of a broad recognition that EDC as a method of data capture offers significant realisable benefits. Developers of drugs that use EDC within their clinical research processes will have a significant competitive advantage, bringing new drugs and therapies to market faster and cheaper.

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The current market and future trends for RMM

Issue 5 2006 / 28 September 2006 / Tony Cundell, Director, Pharmaceutical Sciences – Microbiology, Schering Plough Research Institute

Following on from our latest report in Issue 4 in which we outlined independent views on ‘solutions for the next stage’ in Rapid Microbiological Methods (RMM) from some of the industry’s leading names, Tony Cundell follows up with his own thoughts on this exciting field.

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Essential techniques for development

Issue 5 2006 / 28 September 2006 / Dr Danielle Giron, President, Swiss Society for Thermal Analysis & Calorimetry

Thermal analysis methods and coupled techniques are well established procedures in material science. Due to the different information delivered, thermal analysis methods are concurrent or complementary to other analytical techniques such as spectroscopy, chromatography, melting point determination, loss on drying, assay, for identification, purity and quantitation. They are basic methods in the field of polymer analysis and in physical and chemical characterisation of pure substances as well as for mixtures. They find best application for pre-formulation, processing and control of the drug product.

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Quantitative PCR assays in clinical drug development

Issue 5 2006 / 28 September 2006 / Michael E. Burczynski, Ph.D. and Ole E. Vesterqvist, Ph.D. Biomarker Laboratory, Clinical Translational Medicine, Wyeth Research

Biomarkers (biological markers) have become an integral part of both drug discovery and drug development and play an important role in the transition of potential new drugs from discovery into clinical drug development. In the past, most biomarkers were proteins/peptides and metabolites measured by technologies such as immunoassays, enzymatic assays, HPLC and mass spectrometry.

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