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Issue 4 2012



Opportunities for rapid methods discussions: where the experts are meeting!

3 September 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Over the past few years, a number of professional meetings have focused on strategies and case studies for the validation and application of rapid microbiological methods (RMM).…


The T cell druggable genome

3 September 2012 | By Jan Diekmann, Martin Löwer, John C. Castle, Sebastian Kreiter, Özlem Türeci and Ugur Sahin, Translational Oncology, Johannes Gutenberg Medical University of Mainz

The ‘druggable genome’ has been defined as those genes that can be pharmaceutically modulated; when intersected with disease-associated genes, the resultant set represents therapeutic targets for developing drugs to prevent and treat diseases. Historically, druggable therapeutic target genes have been defined by two features; (i) their significant contribution to the…


High dimensional flow cytometry comes of age

3 September 2012 | By Jonni Moore, Professor of Pathology and Laboratory Medicine, Director, Clinical Flow Cytometry, Hospital of University of Pennsylvania, Director, Abramson Cancer Center Flow Cytometry and Cell Sorting Shared Resource – Perelman School of Medicine of the University of Pennsylvania and Pascal Yvon, CEO, CytoVas

Technologies for single cell analysis have recently become prominent in the emerging life science sectors. The last few decades have seen an explosion in advancements in cytometric technologies encompassing instrumentation, probes and data analysis. In particular, flow cytometry has become a well-established and routine method in clinical laboratories. Recent developments…


Physiologicaly based pharmacokinetic modelling of transporters in drug discovery and development

3 September 2012 | By Pradeep Sharma and Katherine Fenner, Global DMPK, AstraZeneca R&D

Physiologically based pharmacokinetic (PBPK) models describe the different compartments (tissues) in the body linked via arterial and venous blood flow (Figure 1). The volume of each tissue and blood flows are available from literature data1-5 and PBPK models have been developed for many species including rat, mouse, dog, pig and…


G protein coupled receptors – exploiting flexible conformations

3 September 2012 | By Kathryn L. Chapman, Imperial Drug Discovery Centre, Imperial College London and John B.C. Findlay & Gemma K. Kinsella, Department of Biology, National University of Ireland Maynooth

G-protein coupled receptors (GPCRs) are a diverse super-family of proteins located within the plasma membrane of eukaryotic cells which have a common architecture consisting of seven-transmembrane (7-TM) segments, connected by extracellular (ECL) and intracellular (ICL) loops. They differ from other 7-TM proteins in their ability to activate guanine-nucleotide binding proteins…


Integrating preclinical data into early clinical development

3 September 2012 | By Vikash Sinha, Clinical Pharmacology Leader, Janssen Research and Development

One of the important goals in preclinical and early clinical drug development is to reduce attrition rates and to improve our ability to pick winners and drop potential loser drug candidates. By being able to efficiently translate preclinical data and observations into possible clinical outcomes, one can make the drug…


Under the microscope: Graeme Lowe, Catalent

3 September 2012 | By Helen Bahia, Editor, European Pharmaceutical Review

Graeme Lowe, Director of Development and Analytical Solutions at Catalent, discusses outsourcing pharmaceutical development and analytical solutions.