Global Plan
Launch Date: 10 Aug 28
Status: Draft
Shape the Product
Shape the Market
Shape the Organization
| Task Title | Start & Due Date | Status | Strategic Drivers | Start Suc… | ||
|---|---|---|---|---|---|---|
|
SHAPE THE PRODUCT
|
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REGULATORY SUBMISSION
|
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EU Regulatory
|
13 Feb 26 | Completed | Access | |||
|
Map Local Regulatory Submission Requirements
|
13 Feb 26 | Completed | Access | |||
|
Prepare Regulatory Dossier
|
28 Jan 26 | Completed | Access | |||
|
Submit to EMA
|
5 Dec 25 | Completed | Access | |||
|
TARGET PROFILE & PATIENT JOURNEY
|
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Define Target Product Profile
|
18 Feb 26 | Completed | Evidence | |||
|
Map Patient Journey
|
10 Jan 26 | Completed | Evidence | |||
|
EVIDENCE GENERATION
|
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Clinical Data Package
|
10 Aug 25 | Not started | Evidence | |||
|
Real-World Evidence Strategy
|
22 Sep 25 | Not started | Evidence | |||
|
PRODUCT DIFFERENTIATION
|
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|
Competitive Positioning Statement
|
3 Mar 26 | Completed | Commercial | |||
|
Value Messages & Claims
|
15 Mar 26 | Completed | Commercial | |||
| Task Title | Start & Due Date | Status | Strategic Drivers | Start Suc… | ||
|---|---|---|---|---|---|---|
|
SHAPE THE MARKET
|
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|
MARKET UNDERSTANDING
|
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Current Treatment Algorithm |
10 Aug 25 | Not started | Commercial | |||
Competitive Scenario Planning |
10 Aug 25 | Not started | Commercial | |||
Epidemiology & Disease Burden |
20 Mar 26 | Completed | Evidence | |||
|
CONGRESS PLANNING
|
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Congress Plan |
8 Oct 25 | Completed | Commercial | |||
ESMO 2023 (Madrid) |
8 Oct 25 | Completed | Commercial | |||
|
MARKET ACCESS & PRICING
|
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Payer Value Dossier |
15 Nov 25 | Not started | Access | |||
Pricing Strategy Development |
1 Dec 25 | Not started | Access | |||
HTA Landscape Analysis |
22 Jan 26 | Completed | Access | |||
|
COMMERCIAL READINESS
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Launch in first country |
10 Aug 28 | In progress | Commercial | |||
Sales Force Training Plan |
15 Mar 26 | Not started | Commercial | |||
| Task Title | Start & Due Date | Status | Strategic Drivers | Start Suc… | ||
|---|---|---|---|---|---|---|
|
SHAPE THE ORGANIZATION
|
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ORGANISATIONAL BUILD & RECRUITMENT
|
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Establish Global Launch Team |
10 Aug 26 | Not started | Strategy | |||
|
SALESFORCE SIZE & STRUCTURE
|
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Define Sales Force Model |
15 Jan 27 | Not started | Commercial | |||
Territory Mapping & Sizing |
1 Mar 27 | Not started | Commercial | |||
Recruitment Plan & Timeline |
15 May 27 | Not started | Strategy | |||
Cancelled 0
No cancelled tasks
Not started 32
Current Treatment Algorithm
Medical Affairs
Competitive Scenario Planning
Commercial Operations
Clinical Data Package
Medical Affairs
Real-World Evidence Strategy
Medical Affairs
Payer Value Dossier
Market Access
In progress 1
Launch in first country
Commercial Operations
Completed 58
Congress Plan
Medical Affairs
ESMO 2023 (Madrid)
Commercial Operations
EU Regulatory
Regulatory Affairs
Map Local Regulatory Submission Requirements
Regulatory Affairs
Competitive Positioning Statement
Commercial Operations
Value Messages & Claims
Commercial Operations
August 2025
Mon
Tue
Wed
Thu
Fri
Sat
Sun
28
29
30
31
1
2
3
4
5
6
7
8
9
10
Current Treatment Algo…
Competitive Scenario…
Clinical Data Package
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Completed
In progress
Not started
Upcoming Due Dates
| 10 Aug 25 | Current Treatment Algorithm | Not started | Medical Affairs |
| 10 Aug 25 | Competitive Scenario Planning | Not started | Commercial Ops |
| 10 Aug 25 | Clinical Data Package | Not started | Medical Affairs |
| 22 Sep 25 | Real-World Evidence Strategy | Not started | Medical Affairs |
| 8 Oct 25 | Congress Plan | Completed | Medical Affairs |
| 8 Oct 25 | ESMO 2023 (Madrid) | Completed | Commercial Ops |
| 15 Nov 25 | Payer Value Dossier | Not started | Market Access |
| 13 Feb 26 | EU Regulatory | Completed | Regulatory Affairs |
| 13 Feb 26 | Map Local Regulatory Submission Req. | Completed | Regulatory Affairs |
| 3 Mar 26 | Competitive Positioning Statement | Completed | Commercial Ops |
| 15 Mar 26 | Value Messages & Claims | Completed | Commercial Ops |
| 10 Aug 28 | Launch in first country | In progress | Commercial Ops |
Gantt Chart
| Task | Department | Status | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 | Q3 '26 | Q4 '26 – Q3 '28 |
|---|---|---|---|---|---|---|---|---|
| Current Treatment Algorithm | Medical Affairs | Not started | ||||||
| Competitive Scenario Planning | Commercial Ops | Not started | ||||||
| Clinical Data Package | Medical Affairs | Not started | ||||||
| Real-World Evidence Strategy | Medical Affairs | Not started | ||||||
| Payer Value Dossier | Market Access | Not started | ||||||
| Congress Plan | Medical Affairs | Completed | ||||||
| ESMO 2023 (Madrid) | Commercial Ops | Completed | ||||||
| EU Regulatory | Regulatory Affairs | Completed | ||||||
| Map Local Regulatory Req. | Regulatory Affairs | Completed | ||||||
| Competitive Positioning | Commercial Ops | Completed | ||||||
| Value Messages & Claims | Commercial Ops | Completed | ||||||
| Launch in first country | Commercial Ops | In progress |
Completed
In progress
Not started
Today
Launch Roadmap
2025
Q3 — Jul–Sep 2025
Current Treatment Algorithm
Medical Affairs
Competitive Scenario Planning
Commercial Operations
Clinical Data Package
Medical Affairs
Real-World Evidence Strategy
Medical Affairs
Q4 — Oct–Dec 2025
Congress Plan
Medical Affairs
ESMO 2023 (Madrid)
Commercial Operations
Payer Value Dossier
Market Access
2026
Q1 — Jan–Mar 2026
EU Regulatory
Regulatory Affairs
Map Local Regulatory Submission Requirements
Regulatory Affairs
Competitive Positioning Statement
Commercial Operations
Value Messages & Claims
Commercial Operations
2028
Q3 — Jul–Sep 2028
Launch in first country
Commercial Operations
Risk Log
2
Critical
3
High
2
Medium
1
Low
2
Mitigated
| ID | Risk | Severity | Likelihood | Owner | Status | Mitigation | Updated |
|---|---|---|---|---|---|---|---|
| R-001 |
Regulatory submission delay
EU regulatory timeline at risk due to incomplete Clinical Data Package — currently not started with overdue deadline.
|
Critical | Very High |
RA Regulatory Affairs |
Open | Escalate to steering committee; assign dedicated resource to Clinical Data Package; weekly progress reviews. | 12 Feb 26 |
| R-002 |
Market access readiness gap
Payer Value Dossier not started; without it, pricing negotiations and reimbursement timelines may slip beyond launch window.
|
Critical | High |
MA Market Access |
Open | Fast-track dossier development; engage external HTA consultants; align with local affiliates on pricing corridors. | 10 Feb 26 |
| R-003 |
Competitive intelligence blind spot
Competitive Scenario Planning is overdue; competitor launches may catch the team unprepared.
|
High | High |
CO Commercial Ops |
Open | Commission rapid competitive landscape report; set up quarterly CI review cadence. | 8 Feb 26 |
| R-004 |
Real-world evidence gap
RWE Strategy not started; needed to support payer submissions and differentiation claims at launch.
|
High | Medium |
ME Medical Affairs |
Monitoring | Initiate retrospective study design; partner with CRO for observational study feasibility. | 5 Feb 26 |
| R-005 |
Treatment algorithm adoption risk
Current Treatment Algorithm task overdue; unclear positioning in treatment pathway may delay KOL endorsement.
|
High | Medium |
ME Medical Affairs |
Open | Convene KOL advisory board; map current treatment pathway; define target positioning by Q2 '26. | 3 Feb 26 |
| R-006 |
Launch country readiness variance
Launch in first country is in progress but spans to Aug 2028; prolonged timeline increases exposure to market changes.
|
Medium | Medium |
CO Commercial Ops |
Monitoring | Quarterly launch readiness assessments per market; maintain flexible go/no-go gates. | 1 Feb 26 |
| R-007 |
Salesforce recruitment timeline
Organisational build & salesforce sizing not yet started; late recruitment could impact pre-launch field activities.
|
Medium | Low |
HR HR / Launch Lead |
Open | Begin headcount planning in Q2 ’26; align with territory mapping deliverable. | 28 Jan 26 |
| R-008 |
Congress execution risk
ESMO 2023 completed successfully but future congresses not yet planned; gap in medical engagement pipeline.
|
Low | Low |
ME Medical Affairs |
Monitoring | Draft 2026–2027 congress calendar; secure budget allocation for key events. | 20 Jan 26 |
| R-009 |
EU regulatory pathway uncertainty
Previously at risk due to unclear local requirements; now resolved through mapping exercise.
|
Low | Very Low |
RA Regulatory Affairs |
Mitigated | EU Regulatory & Map Local Regulatory tasks completed; ongoing monitoring only. | 15 Feb 26 |
| R-010 |
Weak value proposition
Previously flagged; competitive positioning and value messages now completed and approved.
|
Low | Very Low |
CO Commercial Ops |
Mitigated | Competitive Positioning Statement & Value Messages completed; refresh scheduled for H2 ’26. | 18 Mar 26 |
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Launch Dashboard Global Plan Dashboard Contact André Moa