RWE, HEOR, IIS, post-authorisation and registry projects; review governance and evidence-gap coverage (PRD §17). Study milestones from CTMS (INT-06, sync failed 13 Sep).
Spend vs budget
Approved vs rejected
Enrolment progress
Projects per stage in workflow order
Idea 1 · Scientific review 1 · Feasibility review 1 · Budget review 1 · Contracting 1 · Active 1 · Data collection 1 · Analysis 1 · Publication 1 · Rejected 1
Stacked by project type
Vantrexa 4 · Nephrada 2 · Lumeva 3 · Aurelin 1
| Evidence gap | Product | Plan | Linked objective | Projects addressing it | Coverage |
|---|---|---|---|---|---|
| Long-term overall survival beyond 36 months | Vantrexa | MP-2026-VTX-G | — | None | Uncovered |
| Sequencing after progression on vantrelimab | Vantrexa | MP-2026-VTX-G | SO-VTX-02 | EVP-0001Contracting | Covered |
| Outcomes in brain-metastasis subgroup | Vantrexa | MP-2026-VTX-G | — | EVP-0002Scientific review | In pipeline |
| Japanese subgroup safety data | Vantrexa | MP-2026-VTX-JP | — | None | Uncovered |
| Long-term eGFR slope data | Nephrada | MP-2026-NPH-G | SO-NPH-02 | EVP-0005Budget review | In pipeline |
| Head-to-head versus budesonide formulations | Nephrada | MP-2026-NPH-G | — | None | Uncovered |
| Pediatric data | Nephrada | MP-2026-NPH-G | — | None | Uncovered |
| Real-world persistence and switching patterns | Lumeva | MP-2026-LMV-G | SO-LMV-01 | EVP-0006Publication | Covered |
| Outcomes in patients with medication-overuse headache | Lumeva | MP-2026-LMV-G | — | EVP-0008Feasibility review | In pipeline |
| Long-term safety versus existing JAK inhibitors | Aurelin | MP-2026-ARL-G | — | EVP-0010Idea | In pipeline |
| Adolescent data | Aurelin | MP-2026-ARL-G | — | None | Uncovered |
| ID | Title | Type | Product | Evidence gap | Sponsor | Investigator / institution | Countries | Status | Contract | Ethics | Budget vs spend | Enrolment | Late milestones | Risk | Owner |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EVP-0001 | SEQUENCE-RW: Real-world treatment patterns after progression on first-line vantrelimab | Real-world evidence | Vantrexa | Sequencing after progression on vantrelimab | Company | Data partner: Meridian Health Analytics | US, DE | Contracting | In negotiation | Not required | $310k of $1.4M 21% | 0 / 1200 0% | 1 | High | NPDr. Nikolai Petrov |
| EVP-0002 | Vantrelimab in patients with treated and untreated brain metastases: pooled analysis and expanded cohort | Phase IV | Vantrexa | Outcomes in brain-metastasis subgroup | Company | — | US, GB, DE | Scientific review | Not started | Not required | $0 of $3.2M 0% | 0 / 90 0% | 0 | Medium | NPDr. Nikolai Petrov |
| EVP-0003 | Cost-effectiveness of vantrelimab versus pembrolizumab in PD-L1-high NSCLC (Germany) | HEOR study | Vantrexa | Health-economic value in EU markets | Company | — | DE | Analysis | Executed | Not required | $198k of $240k 83% | n/a | 1 | Low | NPDr. Nikolai Petrov |
| EVP-0004 | IIS: Vantrelimab in ECOG 2 patients — a single-centre prospective study | Investigator-initiated study | Vantrexa | Outcomes in elderly and ECOG 2 patients | Investigator | Dr. Hiroshi Hayashi · National Cancer Center Tokyo | JP | Active | Executed | Approved | $142k of $380k 37% | 17 / 40 43% | 0 | Medium | KWDr. Kenji Watanabe |
| EVP-0005 | GLOMERULAR-REG: Prospective multi-country registry of eGFR slope in IgA nephropathy | Registry | Nephrada | Long-term eGFR slope data | Company | — | US, DE, GB, FR | Budget review | Not started | Pending | $85k of $2.1M 4% | 0 / 600 0% | 1 | High | NPDr. Nikolai Petrov |
| EVP-0006 | PERSIST-3: Persistence and switching with lumevarin in three markets | Real-world evidence | Lumeva | Real-world persistence and switching patterns | Company | — | US, DE, ES | Publication | Executed | Not required | $298k of $310k 96% | n/a | 0 | Low | NPDr. Nikolai Petrov |
| EVP-0007 | Post-authorisation safety study: lumevarin hepatic safety in routine practice | Post-authorisation study | Lumeva | Long-term hepatic safety | Company | — | DE, GB, FR, IT, ES | Data collection | Executed | Approved | $1.2M of $1.8M 69% | 2410 / 3000 80% | 0 | Low | NPDr. Nikolai Petrov |
| EVP-0008 | IIS: Lumevarin in chronic migraine with medication-overuse headache | Investigator-initiated study | Lumeva | Outcomes in patients with medication-overuse headache | Investigator | Dr. Paola Castellano · Vall d'Hebron | ES | Feasibility review | Not started | Not required | $0 of $220k 0% | 0 / 60 0% | 0 | Medium | NPDr. Nikolai Petrov |
| EVP-0009 | External research request: nephradin biomarker sub-study | External research request | Nephrada | Predictive biomarkers of response | Collaborative | Prof. Benedikt Fischer · Charité Berlin | DE | Rejected | Not started | Not required | $0 of $150k 0% | n/a | 0 | Low | NPDr. Nikolai Petrov |
| EVP-0010 | Aurelinate long-term safety extension analysis plan | HEOR study | Aurelin | Long-term safety versus existing JAK inhibitors | Company | — | US | Idea | Not started | Not required | $0 of $180k 0% | n/a | 0 | Low | TFDr. Tomás Ferreira |
Projects per country (a project counts in each of its countries)
Germany 7 · United States 5 · United Kingdom 3 · Spain 3 · France 2 · Japan 1 · Italy 1