FDA-NIH 2024: Nonclinical Assessment of Cell & Gene Therapy 🧬

This presentation provided guidance on nonclinical assessment of Cell and Gene Therapy (CGT) products to support IND applications. The session covered regulations governing nonclinical testing and outlined key nonclinical considerations for early phase trials. Strategic timing for early FDA interactions, including INTERACT and Pre-IND meetings, was discussed along with important FDA guidance documents to reference throughout the development process.

Timestamps

00:31 – What Regulations Govern Nonclinical Testing?

01:53 – General Expectations for a Nonclinical Testing Program for CGT Products

06:11 – Study Assessments and Endpoints

06:43 – Early meetings (The ‘INTERACT’)

08:00 – Summary

Speakers:

Devaveena Dey, PhD
Pharmacology-Toxicology Reviewer
Office of Pharmacology-Toxicology (OPT)
Office of Therapeutic Products (OTP) | CBER

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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