Recent FDA Guidelines
“At Apredica, we often find that drug-discovery teams are confused about how and when to address preclinical ADME-Tox issues and about what the FDA guidance call for,” Dr. Tsaioun said. “I find that, in working with them, it’s important to review the clinical implications, starting with target product profile, to do what-if scenarios, to explain why the FDA would care, and to bring up the importance of following protocols that are developed following FDA guidelines.
“One of the most important things to understand about ADMET,” Dr. Tsaiou added, “is that one needs to start evaluating the drug-like properties of drug candidates early enough so that the discovery team has choices and is not committed to one molecule. Don’t get attached to a molecule. Fail fast and focus on the candidates most likely to succeed. This knowledge can save you time and resources.
“In the end, the more you know about your compound’s ADMET properties, the less complex or expensive your IND package is going to be.
“ADMET assays don’t kill compounds, decision-making groups do,” concluded Dr. Tsaioun.
“For those groups to make good decisions about compounds they need to closely collaborate and communicate. Biology must talk to chemistry and discovery scientists must communicate with development people, otherwise, good compounds get terminated and bad compounds are advanced for reasons that are not always scientific.”