Xbiom™ for Molecular Biomarker Research in Precision Medicine
There is a perfect storm brewing where advances in genomic screening, identifying molecular biomarkers and precisely targeted medicines and diagnostics, smart monitoring of patient vitals and physiology using devices such as smart phones and apps for clinical trials come together to change the landscape of the Pharmaceutical industry and healthcare itself. The increase in the number of biotech startups, the increase in approved biologics are all testament to this important trend in healthcare.
Assays on bio-samples are easily outsourced and the resulting NGS/WGS sequencing data can be further analyzed to derive the genomic mutations and their classifications. However the processes of generating sensitive results from data analysis, correlating with clinical findings and biomarker characterization and how that relates to treatment progress is a key intellectual property of the Bio-tech and Pharma company and that is better done in-house. This kind of analysis will require access to tools and IT solutions capable of handling both clinical trial data as well as biomarker data from the patient’s bio-samples. It will also require that such solutions provide researchers an easy way to look up data in public and subscribed registries for genes, proteins, RNA and pathways.
PointCross’ Xbiom™ solution integrates disparate salient data sets needed for a company developing a precisely targeted therapy based on genetic mutations that affect the proteins, or RNAs that may be implicated in the progress of a disease or serve as a reliable marker for diagnostics or therapy. When correlated to the actual clinical findings of highly stratified cohorts, Xbiom serves as a potent tool for developing therapeutic drugs for oncology, immunology, CNS or CV conditions.
Integrating biomarker-based development of medicines using translational analytics is not well aligned with the standard stage-gated clinical development processes. The kind of integrated clinical data analysis with genomic characterization is important for the biomarker scientists. Their research is punctuated by searches for a precise set of cohorts from an ongoing or legacy clinical trial where the selection is based on very specific medical history, disease stage, genomic profiles that show evidence of very specific molecular biomarkers – suspected or known, and the changes in traditional clinical findings. This type of analysis may need to be done iteratively.