IMMUNOLOGY2026™ Conference Recordings For Attendees-Immune Safety in Pharmaceutical Development: Navigating Complexities and Embracing New Approach Methodologies

Immune Safety in Pharmaceutical Development: Navigating Complexities and Embracing New Approach Methodologies

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Video Summary

Nikki Marshall of GSK discussed new approach methodologies (NAMs) for immune safety in drug development. She explained why traditional animal studies are limited for increasingly complex, often human-specific therapies like CAR-Ts, bispecifics, and T-cell engagers. She highlighted the classic cytokine release assay as an important in vitro hazard-identification tool, but not sufficient for quantitative risk prediction. She reviewed major immune safety liabilities: immune activation, immune suppression, immunogenicity, and on-/off-target effects. She also described the T-cell dependent antibody response (TDAR) assay, a key in vivo tool for detecting immune suppression, and efforts to develop an in vitro TDAR. Finally, she emphasized FAIR data principles—making data findable, accessible, interoperable, and reusable—to support AI/ML modeling and improve prediction of patient risk and safety.

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Date April 16, 2026 9:45 AM - 11:15 AM

Room 104C

Session Bridging Immunology and Drug Safety: A New Paradigm, Sponsored by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee

Speaker Nikki Marshall

Track Immunology-adjacent fields

Year 2026

Keywords

new approach methodologies

immune safety

cytokine release assay

TDAR assay

FAIR data principles

April 16, 2026 9:45 AM - 11:15 AM

104C

Bridging Immunology and Drug Safety: A New Paradigm, Sponsored by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee

Nikki Marshall

Immunology-adjacent fields

2026