Luciana Bonnot

Neuroimaging Biomarkers · CNS Drug Development

From Imaging-Derived Signals
to Trial-Ready Endpoints

I'm Luciana Bonnot, PhD — scientific consultant in neuroimaging-derived digital biomarkers (NdDB) and Phase II CNS drug development. I help pharma teams make early, defensible decisions before protocol commitments, vendor lock-in, or costly trial amendments.

Based in France. Working internationally in English, French, and Portuguese.

Explore LuMMiens Consulting → Schedule a Call
Luciana Bonnot, PhD

Background

About

With a PhD in Neuroscience and 20+ years across research, multicentre imaging studies, and clinical development, I specialize in the governance and strategy of neuroimaging-derived digital biomarkers (NdDB) in Phase II CNS drug development.

I work across the full Phase II chain — sponsors, CROs, imaging core labs, and neuroimaging platforms — helping teams establish early readiness gates and defensible governance before protocol lock. My work spans neurology, psychiatry, and rare diseases.

In 2026 I developed the NdDB Readiness Map — a practical decision framework that became the foundation of LuMMiens Consulting.

Certified Innovation Path on Digital Medical Devices — EIT Health (MDR/IVDR, AI integration, device lifecycle governance).

Value

Why Work With Me?

Clinical context, first

Before governance applies, the clinical rationale must hold. I evaluate whether the NdDB measures something meaningful for this disease and trial role — the judgment no framework replaces.

Governance judgment

Knowing which failure mode is already in motion before protocol lock. Finding the cross-chain conflict between clinical intent, acquisition reality, and processing constraints.

Cross-chain oversight

Working across the full measurement chain — from acquisition through pipeline, vendor governance, and regulatory posture — without replacing any single function.

Expertise

Where I Work

Across the six governance dimensions that determine whether a NdDB program is trial-ready — or where the gaps are.

Endpoint role & governance readiness

Defining the NdDB's trial role, minimum evidence package, and cross-chain accountability before protocol and SAP commitments are locked.

Acquisition & pipeline readiness

Multi-site scanner harmonization, pipeline classification, traceability, and change-control assessed against the governance standard required for the trial role.

Regulatory posture & SaMD strategy

Distinguishing clinical validity from pipeline regulatory status. SaMD classification, intended use alignment, and AI/ML governance proportionate to the trial role.

The Consulting Practice

LuMMiens Consulting

The NdDB Readiness Map, the 6-dimension governance framework, and the self-assessment tool live at LuMMiens Consulting — the practice built on this work. Six dimensions, from acquisition to regulatory posture.

Visit LuMMiens.com → Take the NdDB Self-Assessment →

Publications

Papers

Practical tools and documentation shared publicly. Reuse encouraged with attribution (CC BY-NC 4.0).

NdDB Readiness Map — Phase II CNS Drug Development

A practical decision framework for evaluating neuroimaging-derived digital biomarkers: output classification, pipeline maturity grade criteria, and AI governance framework.

PDF · CC BY-NC 4.0 · 2026

Full framework and interactive tools at lummiens.com.

Download PDF Open in new tab

Collaborators

What you can expect

"Rapid understanding of complex topics"

— Clinical development director, CNS program

"Solid evidence, without the academic fog"

— Biotech sponsor, Phase II neurology

Writing

Scientific Insights

Perspectives on neuroimaging biomarkers, patient stratification, and CNS drug development.

Neuroimaging Biomarkers CNS Drug Development Phase I / Phase II

Garbage in, garbage out: the business gap behind neuroimaging biomarker strategies in CNS trials

Neuroimaging biomarkers are often treated as a scientific problem. The deeper issue is an incentive gap between Phase I and Phase II that transfers uncertainty rather than removing it.

June 2026 Read →
Neuroimaging Biomarkers Regulatory Science CNS Clinical Trials

Genetics, MRI, and patient stratification: where the regulatory risk begins

How far can neuroimaging advance through the clinical-development pathway before it becomes a regulatory commitment? A follow-up on the genetics–MRI stratification framework.

June 2026 Read →
Psychiatry Neuroimaging Biomarkers Patient Stratification

Can genetics and MRI help identify biological trajectories across the schizophrenia–bipolar spectrum?

Psychiatric MRI biomarkers are not yet ready for routine clinical use — but a genetics–MRI framework may help stratify patients by biological trajectory rather than diagnosis alone.

June 2026 Read →

Get in Touch

Let's Work Together

If you're working on NdDB integration in Phase II and need a structured, independent perspective — reach out.

I'll reply within 48 hours. Confidentiality assured. NDA available if needed.