Program Budget & Cost Model (OBX-319)
π Part of the OBX-319 Regulatory Dossier β 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 β the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. Program Budget & Cost Model (OBX-319)
Why it exists. A program-management document: how the development program is planned and governed.
How it is produced here. It is a program-management document: the planning, budgeting, and governance wrapper around the science β how the whole development program is run as a project.
Format & governing standard. β
Program Budget & Cost Model (OBX-319)
Document ID: PM-003
Version: 1.0
Change History: 1.0 β Initial issue.
Standard(s): Program management
Program Budget & Cost Model β OBX-319
The development budget and cost model for the OBX-319 program: cost by function and phase, key assumptions and cost drivers, and the funding profile against the development plan and milestones.
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