Case Study: Platelet function assays in phase II – site training and data analysis
Java’s client, a major pharmaceutical company, was developing a novel antiplatelet agent. As part of phase II studies, platelet function assessments were needed at sites worldwide to supply vital pharmacodynamic data.
Java installed specialised equipment and trained operators (many of whom had no laboratory experience) in a tailored platelet function assay (platelet aggregation) in sites throughout Europe, Russia, India, North and South America, Africa and Australia. In addition, Java developed a programme of ongoing training, operator validation and data quality review to ensure the analysis of high quality data in the study.
Java also provided additional support to this study, including assay troubleshooting, data management and consultancy. Based on our experience in this area, we analysed and interpreted the platelet function data and advised the client on the implications of the data for the future of the drug development programme.
Case Study: Delivering comprehensive customised assays in Phase I
Java’s client, a major pharmaceutical company, was developing a novel agent. As is common at this stage, there were considerable unknowns about the compound mechanism, cellular effects, and subject responses. Working with the client, Java developed a suite of customised assays to further characterise the compound in preclinical and phase I. This approach allows drug effects to be well characterised early in clinical research when overall costs are much lower.
The procedures developed for this study included some completely novel approaches in clinical research, some rarely used techniques customised to target areas of interest, as well as established assays tailored for the drug being studied.
Procedures (14 in total) included imaging, cell culture, transcriptomics, proteomics, biochemical and functional assays.
Java developed methodologies for all these techniques, implemented some in preclinical testing, and trained phase I staff in sample collection and processing. Samples were shipped to Java for analysis, some by our in-house scientific team. Others were subcontracted to our network of technology core facilities in local universities. This allows Java to provide high technology assays such as proteomics and next-generation sequencing in a controlled environment, under the aegis of an experienced Clinical Research Organisation.
As well as assay development and conduct, Java analysed data performed bioinformatics and advised the client on the significance of the results.