The “Age of Individualization” is upon us, according to the FDA’s unofficial historian Robert Temple, but unlike the prior drug development eras of safety and efficacy, there has been no milestone legislation to set the ground rules. Metabolic differences between individuals had been an unknown concept, but they’re now routinely examined at the FDA, as are potential drug interactions, Pharmacokinetics, and population PK so more is known at the time of drug approval. Learn the milestone events leading to the Age of Individualization, and what Mr. Temple has to say about the future of AI and machine learning in the context of drug development, drug formulation, and prescribing.