Project Charter — GLPI-103 Development Program
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The project charter — the founding document authorizing the development program and defining its objectives, scope, and governance.
Why it exists. Large programs need an agreed mandate: what success looks like, who is accountable, and the high-level scope and budget. The charter is the reference point the rest of the program is managed against.
How it is produced here. It is a program-management document: the planning, budgeting, and governance wrapper around the science — how the whole development program is run as a project.
Format & governing standard. —
Project Charter — GLPI-103 Development Program
| Field | Value |
|---|---|
| Document ID | PM-001 |
| Version | 1.0 |
| Status | Final (portfolio) |
| Effective Date | 2026-06-29 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Confidentiality | Confidential — portfolio use |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Project Mgmt | 초판 |
1. Purpose & Background
GLPI-103(GLP-1/APJ 이중작용제)을 T2DM 1차 적응증으로 비임상부터 NDA/MAA 제출까지 개발한다. 과학적 근거·전략은 CDP, 설계 파라미터는 REF-002, 비용은 PM-003을 정본으로 한다.
2. Objectives & Success Criteria
- T2DM에서 oral semaglutide 대비 HbA1c 우월성 입증(Phase 3 GLPI103-301).
- 심대사 바이오마커(NT-proBNP, hsCRP)로 APJ 차별점 확보.
- FDA·EMA·MFDS·PMDA 제출 가능한 eCTD 도시에 완성.
3. Scope
- In scope: 비임상, Phase 1 SAD/MAD, Phase 2 PoC, Phase 3 pivotal, CMC, 규제 제출(Module 1–5).
- Out of scope (lifecycle, 별도): Obesity, HFpEF, cardiometabolic syndrome 적응증 확장.
4. Key Deliverables & Milestones (요약 — 상세 PM-002)
TPP → CDP → Protocols/SAP → CSRs → IB → Module 2 요약 → RMP → eCTD 제출(목표 Q4 2031).
5. Governance & Roles (RACI 요약)
| Role | 책임 |
|---|---|
| Steering Committee | Phase-gate Go/No-Go 결정 |
| Project Lead (PM) | 일정·예산·리스크 총괄 |
| Clinical / Biostat / Regulatory / CMC Leads | 기능별 산출물 |
| Pharmacovigilance | 안전성·RMP |
- 상세 RACI·거버넌스: PM-005(추후). Phase-gate 기준: PM-003 §4.
6. Budget (요약)
프로그램 총계 개략 ~$121.5M (임상 $91.5M + 비임상/CMC ~$30M). 상세·가정: PM-003.
7. High-Level Risks
느린 등록, 높은 중도이탈, GI 내약성, APJ 관련 심혈관 신호, 경쟁 심화. 상세: PM-004.
8. Constraints & Assumptions
- 가상(portfolio) 프로그램. 비임상·CMC·일부 PK는
[MOCK]가정. - Phase 3 데이터는 CTAP 시뮬레이션 실측(randomized 679) 사용(Option A).
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