blue U.S. Food & Drug Administration (FDA)
green European Medicines Agency (EMA)
PSTC is working to qualify non-invasive biomarkers for drug-induced vascular injury (DIVI) that can be used to monitor safety in nonclinical and clinical drug development. A major confounding factor is that DIVI seen in preclinical species is very dissimilar to histopathological observations in man. Additionally, sensitivity/susceptibility to DIVI from the same therapeutic varies widely from animals to humans. Thus observations of DIVI in nonclinical safety studies usually lead to termination of the program, as no mechanism for monitoring this injury currently exists for use in human clinical trials. This likely leads to the loss of many promising therapies that may have posed no risk for DIVI to humans. PSTC’s new biomarkers should enable the initiation of clinical trials where patient safety can be confidently monitored.