Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
News|Videos|October 8, 2026
Manufacturing Intelligence: Why NAMs May Not Impact Development Pipelines
Author(s)Richard Jaenisch, Christopher Cole
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
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Richard Jaenisch and Chris Cole dig into whether New Approach Methodologies (NAMs) actually shorten the drug development pipeline, or simply redistribute where the burden of proof falls, in the latest clip from PharmTech's Manufacturing Intelligence series. The conversation centers on a scenario with real regulatory teeth: an in silico model powered by generative AI that hallucinates, and what happens when that hallucination becomes part of the official record.
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