In this talk, I will introduce model informed drug discovery, development, and utilization (MIDD), including recent examples, and will discuss the challenges and opportunities that the new era of artificial intelligence and machine learning (AI/ML) offers to clinical pharmacology and therapeutics. I also will provide an introduction to the International Society of Pharmacometrics (ISoP) and its role in advancing the science and impact of MIDD. As part of the latter topic, I will discuss highlights from the two recent joint FDA-ISoP Workshops on quantitative methods in dosage optimization of oncology products.