Risk register, issues, decision log and cross-record dependencies. Exposure is probability × impact on a 1–5 scale.
Open risks
Open issues
Decisions awaiting leadership
Dependencies blocked / at risk
Count of risks in the current filter by probability (columns) and impact (rows).
| Impact ↓ | P1 | P2 | P3 | P4 | P5 |
|---|---|---|---|---|---|
| I5 | 0 risks at exposure 5 | 1 risks at exposure 10 | 1 risks at exposure 15 | 0 risks at exposure 20 | 0 risks at exposure 25 |
| I4 | 0 risks at exposure 4 | 0 risks at exposure 8 | 1 risks at exposure 12 | 1 risks at exposure 16 | 0 risks at exposure 20 |
| I3 | 0 risks at exposure 3 | 0 risks at exposure 6 | 2 risks at exposure 9 | 1 risks at exposure 12 | 0 risks at exposure 15 |
| I2 | 0 risks at exposure 2 | 2 risks at exposure 4 | 2 risks at exposure 6 | 1 risks at exposure 8 | 0 risks at exposure 10 |
| I1 | 0 risks at exposure 1 | 0 risks at exposure 2 | 0 risks at exposure 3 | 0 risks at exposure 4 | 0 risks at exposure 5 |
Probability → · Exposure = P × I. High (≥ 12): 4 · Medium (6–11): 6 · Low (< 6): 2 · 12 risks shown.
| Risk | Category | Product | Initiative | Owner | P | I | Exposure | Status | Due | Residual | Decision | Mitigation |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
RSK-0001SEQUENCE-RW data-licensing negotiation fails, leaving the sequencing evidence gap open at EU launch.Show trigger, mitigation, contingency
| Evidence generation | Vantrexa | INI-0102 | NPDr. Nikolai Petrov | 4 | 4 | 16 · High | Escalated | 30 Sept 2026 | Medium | DEC-0007 | Escalate to Legal; evaluate alternative German registry par… |
RSK-0003GLOMERULAR-REG not funded in FY2027, leaving no eGFR slope data for HTA submissions.Show trigger, mitigation, contingency
| Budget | Nephrada | INI-0202 | MLDr. Marcus Lindqvist | 3 | 5 | 15 · High | Escalated | 15 Oct 2026 | High | DEC-0006 | Present NICE scientific-advice insight to leadership; re-pr… |
RSK-0002Japan Tier 1 KOL coverage below 60% at PMDA approval due to single-MSL capacity.Show trigger, mitigation, contingency
| Resourcing | Vantrexa | INI-0107 | KWDr. Kenji Watanabe | 4 | 3 | 12 · High | Escalated | 01 Nov 2026 | Medium | DEC-0009 | Approve expedited hire; interim support from APAC medical l… |
RSK-0008PMDA approval slips beyond Q4 2026, misaligning Japan medical activities with launch.Show trigger, mitigation, contingency
| Regulatory | Vantrexa | — | KWDr. Kenji Watanabe | 3 | 4 | 12 · High | Open | 20 Dec 2026 | Medium | — | Maintain flexible congress and education timeline. |
RSK-0010Recurrent-infection safety observation in nephradin OLE requires label discussion pre-approval.Show trigger, mitigation, contingency
| Regulatory | Nephrada | — | MLDr. Marcus Lindqvist | 2 | 5 | 10 · Medium | Open | 31 Oct 2026 | Medium | — | Pharmacovigilance handoff completed; monitor. |
RSK-0004Competitor TIGIT class scepticism reduces KOL willingness to adopt chemotherapy-free regimen.Show trigger, mitigation, contingency
| Scientific | Vantrexa | INI-0101 | PRDr. Priya Raman | 3 | 3 | 9 · Medium | Mitigating | 31 Oct 2026 | Low | — | Mechanistic differentiation module (completed); ESMO sympos… |
RSK-0007Lumeva MI SLA breaches increase as switching inquiries grow without a standard response.Show trigger, mitigation, contingency
| Medical information | Lumeva | INI-0303 | FAFatima Al-Sayed | 3 | 3 | 9 · Medium | Open | 10 Oct 2026 | Medium | — | Standard response SR-LMV-014 in development. |
RSK-0005Compliance review backlog delays plain-language summary and PLS-related launch content.Show trigger, mitigation, contingency
| Compliance | Vantrexa | INI-0105 | OBOliver Brandt | 4 | 2 | 8 · Medium | Mitigating | 30 Sept 2026 | Low | — | Add second compliance reviewer for launch period. |
RSK-0006Duplicate stakeholder records from Veeva sync distort coverage metrics.Show trigger, mitigation, contingency
| Data quality | Vantrexa | — | GNGrace Nakamura | 3 | 2 | 6 · Medium | Mitigating | 30 Sept 2026 | Low | — | Dedup rules in integration; weekly reconciliation. |
RSK-0011ECOG 2 IIS enrolment shortfall in Japan (17/40).Show trigger, mitigation, contingency
| Evidence generation | Vantrexa | — | KWDr. Kenji Watanabe | 3 | 2 | 6 · Medium | Open | 31 Dec 2026 | Low | — | Add second site. |
RSK-0009Aurelin dermatology KOL mapping vendor selection delayed, compressing pre-readout engagement window.Show trigger, mitigation, contingency
| Timeline | Aurelin | INI-0401 | TFDr. Tomás Ferreira | 2 | 2 | 4 · Low | Open | 15 Oct 2026 | Low | — | Use procurement fast-track. |
RSK-0012Over-contact of Tier 1 US oncologists (some engaged 6+ times in H1) risks stakeholder fatigue.Show trigger, mitigation, contingency
| Stakeholder | Vantrexa | INI-0101 | JWJames Whitfield | 2 | 2 | 4 · Low | Closed | 31 Oct 2026 | Low | — | Cadence rules in engagement plans. |
| Issue | Severity | Product | Detected | Owner | Immediate action | Root cause | Corrective / preventive | Due | Status | Escalated |
|---|---|---|---|---|---|---|---|---|---|---|
ISS-0001 Plain-language summary compliance review overdue by 3 weeks. | Major | Vantrexa | 25 Aug 2026 | OBOliver Brandt | Reviewer reassigned | Single compliance reviewer for launch content | Add second reviewer through Q4 Capacity model for launch content reviews | 19 Sept 2026 | In progress | Escalated |
ISS-0002 14 duplicate stakeholder records created by Veeva incremental sync. | Minor | Vantrexa | 02 Sept 2026 | GNGrace Nakamura | Sync paused for affected territory | Matching key changed after Veeva release | Update match rule to use Veeva ID + NPI Add regression check to integration monitoring | 20 Sept 2026 | In progress | No |
ISS-0003 Critical safety-flagged inquiry MI-2026-0812 breached 24-hour SLA. | Critical | Nephrada | 14 Sept 2026 | FAFatima Al-Sayed | Escalated to PV; interim response sent | Pending | — — | 16 Sept 2026 | Open | Escalated |
ISS-0004 Governance review for SEQUENCE-RW completed 2 weeks late. | Minor | Vantrexa | 14 Jul 2026 | NPDr. Nikolai Petrov | None | Committee quorum not met in June | Add alternate committee members Quarterly committee calendar | 15 Aug 2026 | Closed | No |
DEC-0004v1Nephrada
Include FACIT-Fatigue as a secondary endpoint in the registry protocol.
Patient-advocacy advisory board (INS-0012) identified fatigue as the top patient-relevant outcome.
Options considered
Follow-ups (2)
DEC-0006v2NephradaNeeds leadership
Reallocate $1.2M from Nephrada congress and agency lines to the eGFR-slope registry.
NICE scientific advice (INS-0044) indicates eGFR slope data is required for positive recommendation.
Options considered
Follow-ups (0)
None recorded.
DEC-0007v1VantrexaNeeds leadership
Accept Meridian's clause permitting de-identified secondary use, with Legal's proposed carve-outs.
Contract blocked since August; evidence gap is the top insight theme.
Options considered
Follow-ups (0)
None recorded.
DEC-0008v1Vantrexa
Approve platform v3.2 including TIGIT differentiation content.
Competitor class scepticism (INS-0022).
Options considered
Follow-ups (1)
DEC-0009v1VantrexaNeeds leadership
Approve expedited hiring with external recruiter for Japan oncology MSL.
Tier 1 coverage 52% vs 60% target; PMDA approval expected Q4.
Options considered
Follow-ups (0)
None recorded.
DEC-0010v1VantrexaNeeds leadership
Formally sponsor a Phase IV brain-metastasis study concept (EVP-0002).
INS-0047 and 6 related insights from US centres.
Options considered
Follow-ups (0)
None recorded.
DEC-0011v1AurelinNeeds leadership
Approve the revised Aurelin plan following Clinical Development review.
Plan in cross-functional review since 2026-09-08.
Options considered
Follow-ups (0)
None recorded.
2 blocked · 4 at risk · 2 on track · 0 resolved. Product filter does not apply to dependencies.
| ID | Dependent | Prerequisite | Type | Owner | Due | Status | Impact if delayed | Resolution plan | |
|---|---|---|---|---|---|---|---|---|---|
| DEP-0001 | SEQUENCE-RW RWE cohort Initiative · INI-0102 | Data-licensing clause decision Decision · DEC-0007 | Internal | NPDr. Nikolai Petrov | 30 Sept 2026 | Blocked | First data cut slips past EU launch | Leadership decision at 22 Sep review | |
| DEP-0002 | Japan Tier 1 engagement Initiative · INI-0107 | Second Japan MSL hire Decision · DEC-0009 | Internal | KWDr. Kenji Watanabe | 26 Sept 2026 | At risk | Coverage below target at PMDA approval | — | |
| DEP-0003 | GLOMERULAR-REG registry Initiative · INI-0202 | FY2027 budget confirmation (Finance) External · FIN-FY27 | Cross-functional | MLDr. Marcus Lindqvist | 15 Oct 2026 | Blocked | No eGFR data for HTA; access risk in GB/DE | — | |
| DEP-0004 | Germany launch Launch milestone · LM-8 | EC marketing authorisation Regulatory · LM-7 | Regulatory | SLDr. Sophie Laurent | 20 Nov 2026 | On track | Launch date moves | — | |
| DEP-0005 | Japan launch Launch milestone · LM-12 | PMDA approval Regulatory · LM-11 | Regulatory | KWDr. Kenji Watanabe | 20 Dec 2026 | At risk | Japan plan re-phased to Q1 2027 | — | |
| DEP-0006 | German HEOR manuscript Publication · PUB-0011 | Statistical review capacity (Biostatistics) Review · STAT-REV | Cross-functional | NPDr. Nikolai Petrov | 30 Sept 2026 | At risk | Submission slips 6 weeks | — | |
| DEP-0007 | MI response library Initiative · INI-0105 | Compliance review capacity Review · COMP-REV | Cross-functional | FAFatima Al-Sayed | 30 Sept 2026 | At risk | 4 infusion-reaction responses not approved pre-launch | — | |
| DEP-0008 | Brain-metastasis Phase IV Evidence project · EVP-0002 | Sponsor Phase IV concept Decision · DEC-0010 | Internal | PRDr. Priya Raman | 15 Oct 2026 | On track | Evidence gap remains open through 2027 | — |