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Data First

FAIR-by-Design Standardization for NAM Evidence

Damien Huzard, PhD · Neuronautix

· 12 min

NAM science is advancing faster than NAM data infrastructure

Assays improved. Interoperability did not.

The bottleneck is metadata, not assay novelty

Current state

  • Context trapped in prose
  • Lab-specific endpoint semantics
  • Legacy data hard to recover

Consequence

  • Slow, manual reuse
  • Costly cross-study synthesis
  • Fragmented AI training corpora

Regulatory framing is data-intensive

Context of use, technical characterization, and fit-for-purpose are fundamentally metadata requirements.

FDA draft NAM guidance, 2026

Design-time FAIR beats post-hoc FAIRification

Post-hoc

  • Expensive reconstruction
  • Provenance gaps
  • Uneven record quality

By design

  • Required fields at source
  • Validation at ingest
  • Immediate reuse readiness

NAMO provides a practical domain model

Schema-first vocabulary for NAM systems, evidence context, and interoperability.

Minimal deployment pattern

Assay execution
  -> Structured capture form
  -> Schema + term validation gate
  -> Versioned evidence record
  -> Reuse query and reviewer export

AI assists curation; validation enforces trust

LLMs can draft mappings, but deterministic schema checks and human review decide acceptance.

Compounding return

Standardize now and accumulate reusable evidence assets; delay and accumulate remediation debt.

Position paper synthesis with FAIR and NAM evidence anchors

Next step: one 90-day pilot

  • Select one assay family
  • Define minimum metadata contract
  • Enforce validation before acceptance
  • Pilot historical-control reuse audit