NAMs in DevTox Testing: Moving the Needle Forward to Regulatory Use

(A HESI DART workshop)
March 4 – 5, 2025

OpenGov Hub
1100 13th Street NW Suite 800
Washington, DC 20005

If you have any questions, please reach out to Dr. Connie Chen (cchen@hesiglobal.org) or Dr. Shermaine Mitchell-Ryan (smitchell-ryan@hesiglobal.org)

Abstract: New Alternative Methodology (NAM) Testing for Developmental Toxicity (DevTox) has been used for screening purposes by pharmaceutical and chemical companies for more than 20 years. However, despite the fact that the updated regulatory guidelines for chemicals and pharmaceuticals have created some opportunities to use NAMs for DevTox testing, these have been seldomly used in regulatory submissions. This HESI DART workshop will cover perspectives from the regulatory, industry and NAM developers with focused breakout group discussions designed to help map the next actional steps and a concrete strategy on increasing regulatory confidence and accelerate NAM acceptance). While specific DevTox NAMs will be discussed, a detailed introduction to the various NAMs assays will not be part of the workshop program. Participants should have a cursory understanding of the regulatory framework for DevTox testing and available assays.

AGENDA

Registration

Please keep your questions focused on DevTox (fertility, postnatal development, etc. NAMs are out of scope for this workshop)
In-person registration will be capped at 75
$0.00

Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403

740 15th Street NW, Suite 600
Washington, DC 20005

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