📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

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.

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About this document — a plain-language guide

What it is. The integrated program timeline and milestones — the schedule from nonclinical through submission.

Why it exists. Drug development spans years and many parallel workstreams. The timeline lays out phases, dependencies, and regulatory milestones so the program can be tracked and resourced.

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. —

Integrated Program Timeline & Milestones — GLPI-103

Field	Value
Document ID	PM-002
Version	1.0
Status	Final (portfolio)
Effective Date	2026-06-29
Confidentiality	Confidential — portfolio use

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Project Mgmt	초판. Phase-gate·마일스톤 일정 (illustrative)

일정은 illustrative [MOCK]. 대상자 수·비용은 REF-002 / PM-003 인용. 목표 제출 Q4 2031(CDP §9).

1. High-Level Schedule (Gantt 개요)

Year        2026  2027  2028  2029  2030  2031
Nonclinical [====]
CMC (dev)   [==========================...........]
Ph1 SAD 101    [==]
Ph1b MAD 102      [===]
   └ Gate 1/2 (PoC entry decision)  ▲
Ph2 PoC 201          [======]
   └ Gate 3 (Phase 3 invest decision)    ▲
Ph3 pivotal 301             [===========]   (52-wk treat + FU + DBL/analysis)
CSR / Module 2-5 authoring               [=====]
eCTD submission (FDA/EMA/MFDS/PMDA)             ▲ Q4 2031

2. Milestones & Phase Gates

#	Milestone	시점(목표)	Gate 결정	누적비용(PM-003)
M1	FIH 첫 투여 (101)	2026 H2	—	—
M2	SAD 완료 (N=40)	2027 H1	Gate 1: 안전성·PK → 1b 진행	~$3.5M
M3	MAD 완료 (N=40)	2027 H2	Gate 2: 조기효능 신호 → Ph2 진행	~$7.5M
M4	Phase 2 PoC 완료 (N=240)	2028 H2	Gate 3: 용량–반응 → Ph3 대규모 투자	~$23.3M
M5	Phase 3 LPLV (N=900계획/679실측)	2030 H2	—	~$91.5M
M6	Phase 3 DBL · CSR-301	2031 H1	제출 결정	—
M7	eCTD 제출	2031 Q4	—	—

3. Critical Path & 비용 연계

임계경로 = Phase 2 PoC → Gate 3 → Phase 3(최장·최고비용). Gate 3 이전 단계를 작고 빠르게(REF-002 보정 N) 가져가면 임계경로 진입 전 자본 소진을 ~$13M 줄인다(PM-003 §3).

4. 연계 문서