Lost in Translation: Nonclinical Toxicology Lessons from the IND Front Lines

Course overview

Regulatory guidance defines the framework but it doesn't make critical decisions. For drug developers preparing IND or CTA submissions, the white space gap between guidance and execution, along with successful regulatory interaction, is where timelines slip, risks escalate, and programs can fail. This session is designed to close that white space gap. Join Charles River's scientific experts as they share practical lessons from the front lines of First-In-Human (IND- or CTA-enabling) programs. Drawing on decades of experience designing nonclinical strategies, executing identified studies, and supporting global regulatory submissions, including direct interaction with regulators, the speakers will walk through real-world scenarios that highlight key decision points, trade-offs, and potential pitfalls. Through case-based discussions and practical frameworks, you will learn how to conduct and present nonclinical data with optimal study sequencing, interpret and communicate difficult study findings, and proactively address issues that often attract regulatory scrutiny. Gain insights you can apply right away to lower risks and speed up your journey to the clinic.