Neuroimaging Biomarker Strategy

De-risking Brain Biomarkers
Before Trial Decisions Lock

I'm Luciana Bonnot, PhD — an independent neuroimaging biomarker strategist working on the sponsor side. The measurement chain behind a brain biomarker is rarely as visible as it appears — even from inside the organisation responsible for governing it. I make that chain legible: what the data can support, where it is fragile, and what must be resolved before protocol and vendor decisions lock it in.

20+

Years CNS imaging

5

CNS domains

3

Working languages

Luciana Bonnot, PhD — neuroimaging consultant

When This Matters

You do not need more biomarker enthusiasm.
You need a defensible decision.

Many neuroimaging biomarker programs do not fail because the signal is useless. They fail because no one owns the full chain between clinical intent, acquisition reality, processing logic, QC decisions, vendor outputs, and the endpoint claim. I help you close that gap early.

Situation 01

You are before protocol lock

You need to know whether the biomarker role is realistic before the protocol, SAP, vendor scope, and site requirements become expensive to change.

Situation 02

Your teams are not aligned

Clinical, imaging, statistics, regulatory, and vendor teams are using different definitions of what the endpoint must prove, control, and document.

Situation 03

Your measurement chain is not fully visible — even internally

Vendors control the pipeline, core labs own the QC, sites manage acquisition. No single internal role sees across all of them at once. Risks accumulate in the gaps between functions — invisibly, until commitments are already locked.

My role is to translate biomarker complexity into a clear sponsor decision: proceed, redesign, limit the claim, or stop before avoidable risk becomes embedded.

About

Independent scientific judgment,
before trial commitments harden

With a PhD in Neuroscience and more than two decades in multi-site neuroimaging across neurology and psychiatry, I work at the interface where biomarker science becomes a trial decision. I understand the signal, but also the acquisition, processing, QC, documentation, and governance conditions that determine whether that signal can support a credible endpoint role.

I work independently, which means no incentive to oversell any infrastructure. But the more relevant distinction is structural: two decades spent across the full measurement chain — acquisition governance, processing pipelines, QC design, regulatory alignment, and endpoint documentation — means I see what no single internal function is positioned to see. That cross-chain visibility is what sponsors need before decisions harden.

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

Neuroimaging biomarker strategy

Framing, context of use, and evidence pathways — what claims the data can realistically support.

Early-phase neuroimaging decisions

Feasibility, validation direction, and risk assessment before protocol lock.

Clinical and real-world imaging evidence

Decision-relevant endpoints and meaningful metrics that hold up under regulatory inspection.

Regulatory and device governance

SaMD lifecycle controls, change-control policy, and audit-readiness for imaging pipelines used as trial endpoints.

Services

How I help you make the decision

Feasibility & Evidence Readiness

Assess validation pathways, operational constraints, and endpoint-role risk before protocols or pilots are launched.

You leave with: a clear proceed / redesign / limit-the-claim decision and a risk map before protocol lock.

Clinical & Real-World Imaging Evidence

Interpret neuroimaging-derived endpoints and metrics in relation to clinical meaning, trial role, and real-world constraints.

You leave with: decision-ready interpretation, not just technical outputs.

Neuroimaging Strategy & Context of Use

Clarify whether neuroimaging is the right tool, which endpoint role is credible, and what claims the measurement chain can realistically support.

You leave with: a context-of-use narrative your teams can align around.

Flagship Framework

NdDB Readiness Map
Phase II CNS Drug Development

The NdDB Readiness Map is the backbone of my sponsor-side approach: a structured way to evaluate whether a neuroimaging-derived digital biomarker can move from promising signal to governed trial endpoint. It connects clinical intent, acquisition governance, pipeline maturity, regulatory posture, change control, and vendor oversight before commitments are locked.

Acquisition governance Pipeline validation Regulatory alignment Change control Vendor governance
See How the Readiness Map Works →

Engagement Paths

Start small, clarify fast, scale only if useful

Entry

Scientific Readiness Scan

A focused review of your biomarker idea, trial role, available data, and obvious failure points.

Best for: teams deciding whether the concept is worth developing further.

Core

NdDB Readiness Review

A structured review of endpoint role, acquisition feasibility, pipeline maturity, change-control needs, and vendor visibility.

Best for: Phase II programs before protocol, SAP, or vendor scope is locked.

Extended

Sponsor-Side Oversight Support

Ongoing independent input across biomarker governance, evidence alignment, vendor outputs, and decision documentation.

Best for: sponsors needing senior scientific judgment without building a new internal function.

Resource

A practical framework you can review first

Digital Neuroimaging Biomarker Readiness Map

From imaging-derived signals to trial-ready endpoints in CNS drug development.

PDF · 2026 CC BY-NC 4.0

Reuse is encouraged with attribution. If you adapt figures internally, please cite the document and keep attribution visible (CC BY-NC 4.0).

Contact

Bring me in before the decision hardens

Early, independent judgment around neuroimaging and brain biomarkers can prevent costly late-stage rework. Share your program context, the intended biomarker role, and where the uncertainty sits — I’ll reply within 48 hours.

  • Confidentiality assured
  • NDA available on request
  • Pharma sponsor, biotech, CRO, imaging vendor, academic centre
linkedin.com/in/bonnot-luciana