FDA-NIH 2024: CDER Nonclinical Resources & FIH Guidance

This presentation provided comprehensive guidance on CDER's nonclinical resources for approaching First-in-Human (FIH) studies in oncology. The session emphasized using ICH S9 as a starting point and highlighted the importance of Good Laboratory Practice standards. Key recommendations included investing in quality GLP toxicology studies, considering regulatory consultants when needed, and requesting pre-IND meetings. The discussion addressed the substantial nonclinical data requirements for IND applications and outlined strategies to avoid common pitfalls in oncology drug development.

Timestamps

01:32 – Where to Start

02:06 – Typical Recommendations for Anticancer Drugs

05:01 – Good Laboratory Practice (GLP)

07:05 – Stumbling Blocks / Pitfalls

09:48 – Summary

Speaker:

Emily Wearne, PhD
Pharmacologist/Acting Nonclinical Team Leader
Division of Hematology Oncology Toxicology (DHOT)
OOD | OND | CDER

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024

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