PoS Benchmarks (BIO/QLS 2021)
Historical probability of success by indication and clinical stage, sourced from BIO/QLS/Informa 2021 (Thomas et al.) across 12,728 phase transitions. Evidence-based multipliers for biomarker strategy, genetic validation, orphan designation, and modality classes are applied via log-odds transformation. Methodology published in full; version-stamped on every signed export.
Baseline Stage-Transition Matrix
Phase-by-phase advancement probability per indication. Baseline cohort: small molecule × no biomarker strategy. Overall LoA = cumulative probability of approval from preclinical.
| Indication | Preclin | Ph I | Ph II | Ph III | NDA/BLA | Overall LoA |
|---|---|---|---|---|---|---|
| Oncology (Solid Tumor) | 4.0% | 62.0% | 24.0% | 40.0% | 85.0% | 0.81% |
| Oncology (Hematologic) | 7.0% | 72.0% | 42.0% | 63.0% | 90.0% | 1.2% |
| Rare Disease | 8.0% | 56.0% | 38.0% | 64.0% | 93.0% | 0.94% |
| Neurology | 4.0% | 46.0% | 20.0% | 47.0% | 88.0% | 0.15% |
| Immunology | 6.0% | 49.0% | 30.0% | 58.0% | 91.0% | 0.46% |
| Infectious Disease | 7.0% | 52.0% | 36.0% | 62.0% | 92.0% | 0.74% |
| Cardiovascular | 5.0% | 48.0% | 28.0% | 55.0% | 90.0% | 0.33% |
| Metabolic | 6.0% | 50.0% | 32.0% | 58.0% | 91.0% | 0.51% |
| Respiratory | 5.0% | 47.0% | 26.0% | 54.0% | 90.0% | 0.29% |
| Dermatology | 6.0% | 50.0% | 34.0% | 60.0% | 91.0% | 0.56% |
| Ophthalmology | 6.0% | 50.0% | 30.0% | 58.0% | 91.0% | 0.48% |
Modality- and biomarker-specific values (full 264-cell matrix, 11 indications × 8 modalities × 3 biomarker strategies) are exposed via the live lookup — see Section 03.
Evidence-Based Multipliers
Each multiplier is applied to the baseline PoS at the stages listed, via log-odds (logit) transformation. The source estimand (RR or OR) is disclosed alongside how the engine applies it.
| Factor | Value | Applied To | Estimand | Source |
|---|---|---|---|---|
| Biomarker Enrichment | 1.50× | Phase II, Phase III | RR → OR | Parker et al. 2015 ASCO; BIO 2021 |
| Companion Diagnostic | 2.00× | Phase II, Phase III | RR → OR | Parker et al. 2015 ASCO |
| Genetic Validation | 2.60× | Phase II, Phase III | RR → OR | Minikel et al. 2024 Nature |
| Orphan Designation | 1.50× | Phase II, Phase III | RR → OR | Mullard 2016 Nat. Rev. Drug Disc. |
| First-in-Class | 0.85× | Phase II, Phase III | RR → OR | BIO/QLS 2021 |
| CAR-T Modality | 1.73× | Phase I, Phase II | RR → OR | Tufts NEWDIGS 2023 |
| Gene Therapy (Orphan) | 1.41× | Phase I, Phase II | RR → OR | Tufts NEWDIGS 2023 |
Access the Live 3D Lookup
Full 264-cell matrix (indication × modality × biomarker strategy) with modifier toggles. Available via the in-product Benchmark Explorer, the MCP server, and an authenticated REST call.
Methodology Notes
- Baseline rows are small molecule × no biomarker. Modality- and biomarker-specific values are available via the POST /benchmarks/pos/lookup endpoint (in-product, via MCP, or via authenticated API call).
- Multipliers are applied via log-odds (logit) transformation. See the methodology page for the full derivation.
- Preclinical PoS is never adjusted by any multiplier; NDA/BLA approval rates reflect filing quality, not drug-specific clinical attributes.