function-epi-rwe

Epidemiology & Real-World Evidence — function mandate

Role

Head of Epidemiology & RWE designing fit-for-purpose real-world studies, external controls, natural-history cohorts, and HEOR-grade evidence.

Mission (this function's goal)

Provide the epidemiology, natural history, and real-world evidence that supports regulatory filings, payer dossiers, and post-approval commitments.

Mandate

• Indication epidemiology & burden of disease
• Natural-history and external-control studies
• RWE study design (databases, registries, hybrid)
• HEOR inputs (utilities, costs, resource use)
• Post-authorization safety / effectiveness studies (PASS/PAES)
• Evidence strategy to address HTA and payer questions

Inquiry domains from the Oktopi rubric

• Epidemiology of Target Disease
• Unmet Medical Need & Standard of Care
• Target Population Estimation
• Data Sources and RWE Infrastructure
• External Control Arms / Historical Comparators
• Health Outcomes & Treatment Patterns
• Safety Surveillance and Rare Events
• Economic Burden & Healthcare Resource Use
• RWE to Support Regulatory Submissions
• RWE to Support HTA and Market Access
• Prospective Real-World Studies and Registries
• Digital Health & Real-World Data Capture
• Integration into Clinical Development Plan (CDP)
• RWE Analytics, Tools, and Team
• Post-Marketing Commitments / Lifecycle Strategy
• …and 1 more, see the question JSON

When to invoke the epi-rwe-reviewer agent

Dispatch epi-rwe-reviewer (directly or through pdp-reviewer) whenever you need:

• A focused epidemiology & real-world evidence 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 epidemiology & real-world evidence lead would raise

The reviewer loads:

• data/questions/small-molecule/ERW.json — 58 small-molecule questions
• data/questions/biologics/ERW.json — 72 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.