Making Assays FAIR
Where are we with validation of assays to replace animals for product testing? The short answer: not very far. While many innovative platforms with potential as animal alternatives have been…
A recent paper from NTP showcases the application of mechanism-based NAMs for prediction of cardiotoxic potential. In a previous post, Getting Back on Track with NAMs at FDA, we encouraged…
Has FDA lost it’s way with NAMs? NAMs or New Alternative Methodologies is the term used by FDA for new regulatory tools to improve predictivity and help replace, reduce and/or…
A strong chain of translatability is crucial for successful drug discovery programs. The chain of translatability is a molecular-level association between the mechanisms that drive the assay phenotype, the preclinical disease…
Developing phenotypic assays that model human disease is a heavy lift. Our understanding of disease biology is limited. And there are so many variables, it’s hard to know where to…