New Approach Methods (NAMs)

Non-animal model systems for drug discovery and development — including organoids, microphysiological systems (MPS), tissue explants, patient-derived material, iPSCs, and humanized transgenics. Discussed at Session I.

Current Status

• At UCB (Henry): organoids, tissue explants, and patient-derived material are routine and embedded prospectively at the front end of discovery
• FDA is actively evaluating NAMs, making human pathobiology-first approaches increasingly feasible
• Animal models persist where donor tissue is scarce (e.g., neuroscience)

Open Debate

Jay Hickman (Hesperos / MPS Society) argued at Session I that microphysiological systems aren’t being adopted at scale. Henry pushed back: NAMs are table stakes at UCB. The real question: what is this model actually modeling?

Cross-References

• Human pathobiology — the philosophical framework that NAMs enable
• Translation cliff — the failure mode NAMs are designed to prevent