PD Biomarker and Target-Engagement Plan

Who it is for

A neuro or immunology program from lead optimization through Phase 1 that needs a pharmacodynamic and target-engagement plan ready for its clinical and regulatory team to review. This is the point where a discovery-grade assay stops being enough.

Scope

One program, in vitro and ex vivo through the first-in-human protocol decision. Not clinical operations, not assay execution.

Inputs

Mechanism and target, the candidate and its exposure profile, the indication and the clinical plan, any existing biomarker data, and the CRO or central lab you expect to use.

Deliverable

The PD Biomarker Plan:

• a biomarker hypothesis map: proximal target engagement, then pathway pharmacodynamics, then disease biomarker
• an assay list with the matrix for each one — whole blood, PBMC, plasma or CSF, by MSD or ELISA
• receptor-occupancy and phospho-flow designs
• an ex vivo whole-blood stimulation design for PK/PD modelling
• a fit-for-purpose validation plan covering precision, stability and donor variability
• sample logistics and the CRO handoff
• a decision memo on which readouts go into the first-in-human protocol

Timeline

Two to three weeks: kickoff, one working session, readout call.

What is excluded

Running assays, qualifying a central lab, and anything clinical-operations or CMC.

Referred out

Immunohistochemistry (IHC), live-animal imaging and electron microscopy readouts. The plan specifies the biology; the partner runs those readouts. No fee passes either way.