De-risking drugs in multiplex assays before progressing to clinical trials

Sheraz Gul, Head of Assay Development and Drug Repurposing at the Fraunhofer Institute, discusses the importance of performing comprehensive multiplex spatial and temporal profiling of drugs in pre-clinical research to decrease the risk of potentially undesirable events in later clinical studies.

The majority of small molecule therapeutics have been designed to potently act upon one specific protein target that is considered to be the root cause of a disease. Though largely accurate, the profile of any given drug across all proteins or even representatives of specific protein target classes is often lacking. The consequences of the unknown effects of drugs at the molecular protein level are then borne out in clinical trials, whereupon they fail in Phase I (safety) and Phase II/III (efficacy) studies where adverse events are reported. The comprehensive profiling of compounds using a wide range of in vitro multiplex spatial and temporal assays as part of the lead/candidate data package would be expected to de-risk them prior to their evaluation in the clinic.