Most successful drug developments involve a careful balance between safety and efficacy. The FDA recognises the importance of biomarkers (including imaging biomarkers) in drug safety assessment. Imaging biomarkers of drug safety have played a major role in avoiding drug-induced harm to many important organ systems, including liver, lung, brain, heart, and the musculoskeletal system.
Bioxydyn has deep expertise in the role of imaging biomarkers in drug safety and has contributed to multiple reviews and position papers. Bioxydyn played a leading role in the IMI/IHI-funded public-private partnership “Translational Imaging in Drug Safety Assessment (TRISTAN)” in drug-induced interstitial lung disease and in drug-induced adverse liver transporter fluxes. This project focussed particularly on cross-site standardisation and biological validation, leading to acceptance of a liver MRI biomarker into FDA’s biomarker qualification program. Bioxydyn also has experience in imaging biomarkers in other common sites of drug toxicity, and offers each assay to the highest standards to drug developers.
Drug developers need always to minimise the risk of false-positive readouts in clinical trials. This is particularly important in drug safety assessment. Trial results should not falsely imply a safety concern. Bioxydyn’s attention to technical and biological validation, and its fully transparent and compliant VoxelFlow pipeline help clients avoid such risks.
While pharmacodynamic efficacy studies often measure expected change in the same patient before and after treatment, safety signals may occur sporadically, often without good baseline. Safety studies may therefore require meticulous cross-site standardisation. Bioxydyn’s world-leading imaging metrology ensures that imaging biomarkers measured in one hospital with one make and model of scanner are quantitatively comparable with measurements in different patients in different hospitals and scanners.
