FAIR-by-Design Standardization for NAM Evidence
Damien Huzard, PhD · Neuronautix
11 May 2026 · 12 min
The gap
Assays improved. Interoperability did not.
Context trapped in prose
Lab-specific endpoint semantics
Legacy data hard to recover
Slow, manual reuse
Costly cross-study synthesis
Fragmented AI training corpora
Regulatory framing
Context of use, technical characterization, and fit-for-purpose are fundamentally metadata requirements.
FDA draft NAM guidance, 2026
Expensive reconstruction
Provenance gaps
Uneven record quality
Required fields at source
Validation at ingest
Immediate reuse readiness
Domain model
Schema-first vocabulary for NAM systems, evidence context, and interoperability.
Deployment
Assay execution -> Structured capture form -> Schema + term validation gate -> Versioned evidence record -> Reuse query and reviewer export
AI role
LLMs can draft mappings, but deterministic schema checks and human review decide acceptance.
Select one assay family
Define minimum metadata contract
Enforce validation before acceptance
Pilot historical-control reuse audit
White paper · PDF · Contact