Methodology

Version & Changelog

BridgeLine frameworks evolve with new guidance, new data, and lessons from live engagements. The table below lists the current version of each framework and when it was last updated. Deprecated frameworks are retained below for transparency.

Retired frameworks

Frameworks are retired when newer guidance supersedes them or when engagement data no longer supports the original assumptions. The list is retained for transparency.

• Legacy IND Checklist v0.9 , retired 2025-10-15. Replaced by IND Roadmap Engine v1 with modality-specific sequencing. Prior users migrated automatically.
• Single-Axis Modality Score (2024) , retired 2025-09-02. Replaced by the multi-axis Modality Feasibility Matrix; single-axis rollup was oversimplifying platform-vs-product decisions.
• Naive CRO Day-Rate Estimator , retired 2025-07-28. Replaced by the Internal CRO Bid Database (real 2024-2025 bid data) which captures geography, modality, and species premia.
• Founder-Only Diligence Checklist (2023) , retired 2025-05-14. Superseded by pillar-split Investor Diligence Rubric which separates scientific, operational, and commercial readiness.

Framework Basis

Every tool in the BridgeLine suite is built on a combination of published frameworks, BridgeLine engagement experience, and public datasets. Specifically:

• Target validation: Plenge target validation hierarchy (Plenge, Nat Rev Drug Discov 2013) and Bunnage target selection framework (Bunnage, Nat Chem Biol 2011).
• Pitch narrative: BridgeLine Pitch Narrative Arc Framework v1 (20 failure patterns, 10 strong signals, calibrated against VC deck reviews).
• Operational + diligence experience: BridgeLine internal engagement notes and founder / operator experience at Spark Therapeutics (Roche) and StrideBio, plus buy-side diligence experience at Sarepta Therapeutics.

Data Source Attributions

Tools draw on the following public datasets and registries. Every material claim in a tool output is linked to the primary source where applicable.

• ClinicalTrials.gov - NIH/NLM registry of FDA-regulated clinical studies; used for competitive trial data, sponsor/phase distribution, endpoint benchmarks.
• Open Targets - target-disease association scoring and tractability data (Ochoa et al., Nucleic Acids Res 2023, DOI 10.1093/nar/gkac1046).
• NORD - National Organization for Rare Disorders; rare-disease patient population estimates and disease definitions.
• PubMed - NIH/NLM biomedical literature; primary literature, mechanism-of-action, and pharmacology references.
• SEER (NCI) - Surveillance, Epidemiology, and End Results oncology incidence, prevalence, and survival data.
• CDC MMWR - Morbidity and Mortality Weekly Report; US disease incidence and prevalence.
• IQVIA MIDAS - global sales / comparator drug revenue benchmarks (public reports and white papers).
• EFPIA - European Federation of Pharmaceutical Industries and Associations; pharma spend and pipeline benchmarks.
• BIO / Biomedtracker - clinical development success rates 2011-2020 (BIO, Biomedtracker, Informa; phase-by-phase transition probabilities by TA and modality).
• FDA, EMA, and ICH - regulatory guidance (ICH M3(R2), S6(R1), S-series; FDA pre-IND meeting guidance; EMA nonclinical CTA requirements) and precedent.

Versioning

Every framework ships with a semantic version and a last-reviewed date. Material changes (e.g., adding or removing a rubric dimension, updating a scoring rollup) bump the major version. Content updates (new failure patterns, expanded templates, updated regulatory references) bump the minor version. Formatting and copy edits bump the patch version. The MethodologyNote displayed under each tool's results carries the current version and last-reviewed date.

Tool Registry & Framework Sources

The table below is generated from the canonicalTOOL_REGISTRYin src/lib/tool-registry.ts. Every scored tool appears here automatically. Framework DOIs / canonical URLs link to the primary source where available.