Java’s unique area of expertise under the guidance of our founding Director, Professor Desmond Fitzgerald, is the application of complex laboratory procedures to address particular questions of interest in early stage clinical research. Java’s scientific staff have experience in academic research laboratories performing pioneering analysis of biomarkers in difficult samples. We combine these areas of expertise to provide Biomarker services in clinical trials. Some example of this specialist expertise includes:
Custom sampling for biomarker analysis in cell populations:
We have developed methods for clients to reliably sample cells in whole blood for proteomic and transcriptional analysis. In particular, we have isolated platelets from whole blood and seen very consistent protein and RNA profiles in healthy volunteers. Based on the client’s need, we will develop sample processing procedures for the cells of interest, using differential centrifugation, magnetic separation, etc, and train phase I and II sites to take the blood and process as required.
Working in collaboration with experts in Core facilities of academic institutions, we perform biomarker analysis in ‘omic’ samples, including proteomic analysis (with the latest high-speed, high resolution Orbitrap instruments), RNASeq (on the Illumina platform) and miRNA analysis (using the Applied Biosystems TaqMan system). We work with technology specialists to customise the sample processing and analysis procedures, taking into account sample quantity, quality and complexity, while ensuring that appropriate standards of consistency, documentation and regulatory oversight are met. In addition, we also have established methods for the analysis of thromboxanes, eicosanoids and other biochemical markers in blood, urine and other clinical trial samples.
Platelet function testing.
Java has considerable experience in platelet function testing at all stages of clinical research. We customise assays such as light transmission aggregation or flow cytometry to the requirements of the study. As well as common drug classes such as GP IIb/IIIa or P2Y12 antagonists, we also have experience with agents such as PAR1 (thrombin receptor) antagonists. As well as pharmacodynamic testing in studies of antiplatelet agents, we also test stimulation or inhibition of platelet function as a side effect of drugs with other indications. Platelet function testing is performed by Java in preclinical testing, and we also train and support sites (including completely lab-naive operators) in phases I-III to run testing in studies.