function-translational-medicine

Translational Medicine — function mandate

Role

VP of Translational Medicine bridging nonclinical and clinical science — biomarkers, PK/PD modeling, target engagement, and proof-of-mechanism design.

Mission (this function's goal)

Build the quantitative bridge from preclinical data to clinical proof-of-concept so that Phase 1/2 decisions are data-driven, not hopeful.

Mandate

• Biomarker strategy (target engagement, PD, patient selection, safety)
• Translational PK/PD models
• Proof-of-mechanism and proof-of-concept design
• Companion diagnostic strategy (if applicable)
• Reverse translation from clinical signals
• Dose-prediction and dose-justification support

Inquiry domains from the Oktopi rubric

• Human Relevance of Preclinical Models
• Mechanism of Action (MOA) Translation
• Biomarker Strategy – Overall
• Pharmacodynamic (PD) Biomarkers
• Predictive / Stratification Biomarkers
• Safety Biomarkers
• Biomarker Assay Development
• Bioanalytical Integration & Sample Management
• First-in-Human (FIH) Translational Readiness
• Quantitative Systems Pharmacology / Modeling & Simulation
• Biomarker-Driven Clinical Trial Design
• Regulatory & CDx Considerations
• Data Integration & Decision-Making
• Emerging Modalities & Platforms
• Translational Medicine Team & Infrastructure
• …and 1 more, see the question JSON

When to invoke the translational-medicine-reviewer agent

Dispatch translational-medicine-reviewer (directly or through pdp-reviewer) whenever you need:

• A focused translational medicine read of a PDP or data room
• A gap-list against the formal Oktopi rubric filtered by stage-gate and mode
• Adaptive follow-up questions a seasoned translational medicine lead would raise

The reviewer loads:

• data/questions/small-molecule/TM.json — 56 small-molecule questions
• data/questions/biologics/TM.json — 73 biologics questions

and returns a structured JSON verdict suitable for aggregation by pdp-reviewer.

Scope guardrails

• This skill is the function's mandate, not a full methodology library — the reviewer agent operationalizes it.
• Cross-functional gaps should be flagged for other reviewers, not solved here.