Mark Ratain

Mark Ratain is a pioneer in oncology pharmacogenomics and rational dose optimization, having demonstrated that UGT1A1 polymorphisms predict irinotecan toxicity and should guide dose individualization, leading to the first FDA-mandated pharmacogenomic labeling for a cancer drug. His research challenged the maximum tolerated dose paradigm by showing that many oncology drugs are effective at lower doses with better therapeutic indices. He established that body-surface-area-based dosing for oral targeted agents is pharmacokinetically irrational and advocated for fixed dosing. His work on dose optimization has influenced regulatory approaches to oncology drug development.