STEPHANIE PASAS-FARMER
President and Founder, Ariadne Software, LLC, USA

Abstract

New drug modalities, time constraints and higher compliance standards are driving new innovation, automation of manual processes, augmented intelligence tools, remote access and increased reliance on biomarkers and hybrid assays. These trends have given rise to new tools and technologies, such as robotics, artificial intelligence, quantitative PCR techniques, flow cytometry, hybrid assays and microsampling, to name a few. Proving their potential, artificial intelligence tools now span across the value chain of pharma and are being used in predictive modeling, data mining, data analysis, and aggregating and synthesizing information. Likewise, hybrid assays are bridging the gap between existing technologies and the needs of large molecule analysis, and microsampling techniques are advancing bioanalysis by simplifying collection, transportation and processing of miniscule samples.

In the recent years, new drug modalities and an increase in reliance on biomarkers have amplified the complexity of drug development and created a void of unknown. As the field of bioanalysis continues to evolve to adapt to these changes, the bioanalysts are being asked more and more complex questions to understand the safety and toxicity of a project.

In answer to these questions and challenges, we have seen an emergence of novel technologies and bioanalytical platforms, such as digital drop polymerase chain reaction (ddPCR), microsampling and hybrid assays.

However, these novel technologies and platforms have, in turn, brought about their own questions and challenges to light, especially in the form of an increase in the difficulty level of the assays and the lack of specific guidance in regulated GLP and clinical labs. This often results in several regulatory grey areas that are left for subjective interpretation, thereby leading to further uncertainty. Current regulations focus on traditional bioanalytical platforms and practices, and there is little no regulatory guidance on biomarkers, molecular assays, flow cytometry and hybri ...