When: waypoints/epidemiology.json exists, waypoints/biology_soc.json doesn't.
Understand the biology underlying this patient population and how they're currently treated. This covers Sections 2 (Disease Biology) and 3 (Standard of Care).
Step 1: Pathophysiology - Search pubmed MCP for recent review articles on the disease mechanism - Identify key biological pathways involved - Note which pathways are validated drug targets vs. emerging hypotheses - For complex multi-pathway conditions, focus on the pathways most relevant to therapeutic intervention
Step 2: Biomarkers - Diagnostic biomarkers: how is the condition confirmed? - Prognostic biomarkers: what predicts disease progression? - Pharmacodynamic biomarkers: what can measure drug effect? - Note which biomarkers are FDA-qualified vs. exploratory - This directly informs Section 4 (endpoints)
Step 3: Approved therapies - WebSearch site:fda.gov for approved drugs for this indication - For each approved therapy: mechanism, approval year, key limitations - Note if therapies are approved for this specific indication or used off-label - Identify major drug classes and their positioning (first-line, second-line, etc.) - For indications with no approved therapies: state this explicitly
Step 4: Treatment guidelines - WebSearch for specialty society guidelines (NCCN, AASLD, ATS/ERS, AGS, etc.) - Current standard of care algorithm - How guidelines differ between regions (US vs EU) if relevant - Recent guideline changes and their implications
Step 5: Unmet need - What does current therapy fail to address? - Patient populations underserved by existing treatments - Disease modification vs. symptom management gap - Quality of life impact not addressed by current therapies
Step 6: Write waypoints/biology_soc.json
Follow the schema from references/waypoint-schemas.md.