THE PRECLINICAL INTELLIGENCE ASSESSMENT
From evidence to decision.
Nine stages test whether an early-stage therapeutic asset justifies the next increment of development capital—and what should happen next.
The nine-stage method
Select a stage to explore the questions behind the assessment.
01Decision Definition
Define the asset, its stage, the decision horizon and the evidence needed to advance, pause, redesign or stop.
02Therapeutic Thesis Mapping
Map the logic from disease and mechanism to target engagement, biological effect and intended outcome. Identify what must be true for the program to succeed.
03Evidence Integrity Review
Separate direct evidence from inference, modeling, company claims and hypothesis. Examine replication, model relevance, human relevance and contradictory findings.
04Adversarial Scientific Challenge
Test the strongest biological, technical, delivery, exposure, safety and translational reasons the program could fail. Classify challenges by severity, including potentially fatal risks.
05Strategic Landscape Assessment
Assess competition, failed programs, differentiation, high-level IP and defensibility pressure, and the asset’s strategic reason to exist. Formal patent and freedom-to-operate opinions remain specialist work.
06Developability & Translation Review
Evaluate delivery, PK/PD, target engagement, safety, formulation, CMC, biomarkers and model translation: can this become a reproducible, clinically testable product?
07Critical Risk Register
Prioritize the five to ten risks most likely to determine value. Assess likelihood, impact, resolvability, mitigability and whether each threatens the core thesis.
08Decisive Experiment Design
Define the smallest credible set of experiments capable of changing the development decision. Prioritize falsification and major uncertainty reduction before optimization.
09Integrated Asset Decision
Synthesize the evidence into a PIA Score, decision classification, confidence, critical unknowns, prioritized next actions, advancement conditions and Capital Gate.
A clear decision record
PIA Score (0–100) · GO / GO WITH CONDITIONS / HOLD / NO-GO · Confidence Level
Critical Risk Register · Decisive Experiment Plan · Five highest-priority next actions · Capital Gate
Scope and boundaries
Scientific diligence and preclinical intelligence, grounded in the evidence available for the engagement. The work is analytical and advisory. It does not replace laboratory validation, patentability or freedom-to-operate analysis, regulatory counsel, medical advice, investment advice or valuation. No scientific, clinical, financing or commercial outcome is guaranteed.
Evidence is distinguished from inference and uncertainty is made explicit. The score informs the decision; it does not override a fatal flaw or unresolved critical gate.