Each paper documents how the practice approaches a specific class of question — regulatory pathway analysis, target validation, CRL precedent reading, deal precedent — with sources, definitions, decision rules, and worked examples. The papers are how the practice teaches the practice.
The methodology Brioche uses for a Regulatory Intelligence Report — sources, retrieval discipline, decision rules for inferring pathway from precedent, and how a CRL pattern analysis is constructed. The same paper that scopes the engagement.
Druggability assessment, disease-target linkage, the published failure record, the competitive set, IP and freedom-to-operate. The decision rules that govern a Target Validation Sprint and the evidence each rule asks for.
The structure of a competitive read — the pipeline graph, the comparator set, trial-design lessons, label expansions, deal precedent. Sources and refresh cadence per layer of the read.
Reading the public deal record — SEC filings (10-K, 10-Q, 8-K), licensing agreement excerpts, milestone disclosures — into a comparable terms set. Decision rules for inferring deal economics from public filings.
USPTO PatentsView and Espacenet read methodology — landscape construction, claim-relevance scoring, freedom-to-operate inference for a given asset. Boundaries and known limitations.
The published failure record — discontinued programs, withdrawn submissions, terminated trials. Source coverage, attribution rules, and how a failure read informs a target validation or a comparator analysis.
ClinicalTrials.gov and trial registry read — endpoint selection, enrollment criteria, comparator arm choice, statistical-analysis-plan inference where disclosed. Decision rules for inferring trial-design lessons from precedent.