In this podcast episode, we explore how Artificial Intelligence (AI) is reshaping the Investigational New Drug (IND) submission process across therapeutic areas. Advanced tools such as Natural Language Processing (NLP) and generative AI are being deployed to streamline regulatory documentation, automate data integration, and enhance pharmacovigilance systems. These technologies have been shown to cut submission preparation time nearly in half while improving accuracy and compliance. However, they also raise challenges around model transparency, validation, and bias mitigation. Regulatory agencies like the FDA and EMA are now developing risk-based frameworks to guide responsible AI adoption, marking the beginning of a new era where AI not only accelerates innovation but also strengthens regulatory rigor. Produced by Dr. Jake Chen.