29 - Preclinical Preparation and IND Planning (S2E14)

This episode outlines the critical steps involved in ramping up from candidate selection to comprehensive IND-enabling studies. We will discuss the process of scaling up preclinical work, manufacturing pilot batches, and preparing the necessary regulatory dossiers. The conversation will also explore how regulatory strategy influences preclinical plans, providing real-world literature examples from OPR&D sources. This episode provides a practical roadmap for navigating the complex regulatory landscape of drug development.

We will also delve into the differences between in vitro and in vivo studies, highlighting the importance of both in understanding a drug's behavior. The challenges of scaling up drug production from the lab to a larger scale will be discussed, along with the role of pilot batch manufacturing in optimizing these processes. The episode will conclude with a look at the Investigational New Drug (IND) application process and the critical information that needs to be included in this comprehensive package.