Clinical Development - Articles and news items

Takeda and M2Gen team up with ORIEN to speed drug development

Industry news / 17 June 2016 / Victoria White, Digital Content Producer

Takeda and M2Gen are to collaborate with ORIEN to speed the development of cancer therapeutics through health informatics…

Recent developments in the use of LCMS in process pharmaceutical chemistry

Chromatography, Issue 1 2012 / 28 February 2012 / Dr. Florence O. McCarthy, Department of Chemistry, Analytical and Biological Chemistry Research Facility, University College Cork

Liquid Chromatography Mass Spectrometry (LCMS) is a powerful technique that has recently undergone exponential growth in its application to pharmaceutical synthesis. This perspective will outline the general principles of LCMS, detail some recent approaches and the benefits to be derived from its use at an early stage of process development. Identification of the components in a mixture is the primary function of analytical chemistry and there are a range of techniques available. When the solution to this problem requires some structural identity, LCMS is the instrument of choice. Liquid Chromatography Mass Spectrometry is defined as the use of the separating properties of liquid chromatography combined with a detector capable of mass analysis (mass spectrometer: single quadrupole, triple quadrupole, ion trap, Time Of Flight, Q-TOF etc.). This combination may be configured in many ways, for a general scheme…

Flow Cytometry

Implementation of flow cytometric biomarker assays in clinical development

Flow Cytometry, Issue 3 2011 / 20 June 2011 / Dianna Y. Wu & Russell Weiner, Clinical Biomarkers and Diagnostics, Merck & Co

Biomarker research has become one of the integral aspects in drug discovery and development. It is broadly utilised to confirm drug mechanism of action (MOA), explore PK/PD correlation, support dose selection and predict response to treatment. Therefore, biomarker data provide valuable information to guide clinical decisions, support drug filings with regulatory agencies and ultimately increase the market value of the drug.

Flow cytometry is a powerful technology for the analysis of multiple biological parameters of individual cells within heterogeneous cell populations. It is widely being used in biomarker research to monitor development and differentiation of cell populations, evaluate target engagement and biomarker expression on/in the cells and assess cell functions and signalling events.

Integration is key

Issue 2 2006, Past issues / 24 March 2006 / E. Allen, T. Mant, C. Vose: Guy’s Drug Research Unit, Quintiles Limited

Drug development has become more complex and significantly more expensive. There has been an estimated 55% increase in the critical path development costs since the year 20001. More than 50% of these costs are incurred in later phase development (Phase IIb and III studies).


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