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Regulatory review of software-defined products — Clarity Today

Topic

Regulatory review of software-defined products

The challenge of reviewing a treatment defined by a per-patient selection procedure rather than a fixed molecule, described by STAT as a regulatory and computational experiment.

Current clusters

science1 distinct publisher

Software picks the 34 neoantigens in Moderna and Merck's cancer vaccine

Intismeran autogene would arrive with a selection procedure where other drugs have a fixed molecule, and the outside expert STAT asked could not say what the software weighs. That makes the ranking code the hard part of any review.

Publishers:statnews.com

Reality

Evidence34
Adoption21
Hype gap+32
Incentives66

Confidence41