1. Three Documents, One Baseline
A scope baseline is not a fourth plan. It is the approved state of three things taken together, and the word that matters is approved: this is the version the program is measured against, not the version anybody currently thinks is best.
| Component | Where it lives | What it contributes |
|---|---|---|
| Scope statement | §2 and §3 of this document | The boundary. What is in, what is deliberately out, and what completion means. |
| Work breakdown structure | WBS — 64 work packages under 11 control accounts | The decomposition, under the 100% rule. Not repeated here. |
| WBS dictionary | §4 of this document | What each control account produces, what closes it, and what it excludes. |
Frozen at Gate 30 June 2026 — Gate 4, not Gate 0. Before Phase 2 survives, the program is a funded option, and baselining an option produces variance reporting against a number nobody intended to be held to. This is the same anchor as the charter and the other two baselines in the project management plan.
A baseline that is updated whenever it becomes inconvenient measures nothing, because variance against a moving reference is always zero. The value is entirely in the friction: when the program wants to do something outside this document, it has to say so out loud, to a body with the authority to agree.
2. What Is In Scope
| # | In scope |
|---|---|
| 1 | Nonclinical safety and pharmacology sufficient to support a 505(b)(1) NME filing |
| 2 | Drug substance and drug product process development, scale-up, validation and registration batches |
| 3 | Phase 1 SAD/MAD, Phase 2 dose-ranging, and two Phase 3 pivotals with a cardiovascular sub-study |
| 4 | US regulatory strategy, agency interaction and NDA assembly through the action date |
| 5 | Launch readiness to first commercial shipment, including payer evidence generation |
| 6 | Post-marketing commitments and requirements accepted at approval |
Six lines, deliberately at the level of a program rather than a project. Each maps to control accounts in the WBS, and the mapping is what makes the 100% rule checkable: if something is in this list and not in the WBS, it is unfunded; if it is in the WBS and not in this list, it is unauthorized.
3. What Is Out of Scope
This is the more useful half, and it is the half most scope statements skip.
| Explicitly out of scope | Why, and where it goes instead |
|---|---|
| EU and Asia-Pacific submissions | Deferred to Year 4+ as a separate program. The Asian-population cohort added by CR-01 supports a later filing but does not constitute one. |
| Pediatric development beyond the agreed iPSP | PMR-1 covers ages 12–17 post-approval. Nothing below 12 is in this program. |
| A comparative tolerability claim against other GLP-1 receptor agonists | No head-to-head trial is run. The claim was assessed, sat fourth in a six-position testing hierarchy, and was not pursued. |
| Additional indications | Cardiovascular risk reduction, sleep apnea and NASH are all plausible and all out. The CV sub-study is powered to pre-empt a post-marketing requirement, not to support a claim. |
| Commercial operations after first shipment | The program closes 2030-06-30. Sales, marketing and lifecycle management are the business's, and the handover is a closure deliverable. |
| A second manufacturing site | Single-source at Aldergate for the life of the program. The risk is carried and named rather than mitigated by duplication, which would not fit the ceiling. |
Nothing on that list is a bad proposal. A second manufacturing site would reduce a real single-source risk. A head-to-head trial would answer a question payers actually asked. An additional indication would be worth more than the one being pursued. Every one of them would also have been added on the strength of being sensible, one at a time, by people acting in good faith.
The reason column is what makes the refusal survivable eighteen months later, when the person who made the decision has moved on and the person being asked has only the document.
4. The WBS Dictionary
One entry per control account. The dictionary is what turns a WBS from a picture into a contract — a node labelled “Clinical Operations” means nothing until somebody writes down what it produces and what would count as finishing it.
| Account | Name | Owner | What it produces | What closes it | What it excludes |
|---|---|---|---|---|---|
| 1.3 | Nonclinical Safety | Dr. M. Sørensen | GLP toxicology, safety pharmacology and the nonclinical written summaries | Study reports signed and the nonclinical overview accepted into the IND | Non-GLP exploratory pharmacology, which sits in research and is not funded here |
| 1.4 | Clinical Development | Dr. S. Aldridge | Protocols, medical monitoring, clinical study reports | CSR signed by the medical monitor and the statistician | Site payments and monitoring, which are Clinical Operations under 1.6 |
| 1.6 | Clinical Operations | Dr. R. Molyneux | Site activation, monitoring, enrolment and clinical supply across 260 sites | Last participant last visit, database lock supported, sites closed out | The CRO's internal staffing plan — the contract buys deliverables, not activities |
| 1.7 | CMC / Technical Operations | Dr. K. Oyelaran | Process, methods, scale-up, validation, registration batches and Module 3 | PPQ report approved and Module 3 accepted into the submission | Commercial supply beyond launch inventory, which transfers at closure |
| 1.9 | Regulatory Affairs | Dr. P. Raghunathan | Strategy, agency interaction, submission assembly and labeling negotiation | NDA filed and the action date reached without a major amendment | The agency's decision, which no work package can deliver |
| 1.11 | Program Management | C. Tyrrell | Governance, planning, risk, reporting and gate packs | Each gate tabled with evidence against criteria fixed before the gate | Functional line management — who does the work and how is the function head's |
Every exclusion above marks a boundary between two accounts that would otherwise both assume the other had it. Clinical Development does not pay sites; Clinical Operations does not write protocols. CMC does not own commercial supply. And Regulatory Affairs does not own the agency's decision — which is the only exclusion on the list that no amount of work could remove, and the one most often written as though it could be.
Six of the 11 accounts are shown. The remaining five follow the same structure and are held in the WBS alongside their work packages.
5. What Has Changed Since Gate 4
Two approved changes in the life of the program. Both went to the Development Committee, because scope is a Committee matter at any size.
| Ref | Approved | Change | Status | Effect on the baseline |
|---|---|---|---|---|
| CR-01 | 09 Oct 2024 | Add an Asian-population cohort to Phase 2 | Approved | Increases N by 50. Supports the later EU and Asia-Pacific strategy without a separate bridging study. |
| CR-02 | 20 Apr 2026 | Add a cardiovascular outcomes sub-study to Phase 3 | Approved | Adds $6,400,000 and six months to the Phase 3 window. Pre-empts a post-marketing requirement (D-06). |
That is a deliberate and slightly awkward choice. Folding CR-02's $6.4M into the Phase 3 clinical account would have been tidier and would have made the account's total look normal. Keeping it separate means the cost of the cardiovascular sub-study stays visible and decomposable for the rest of the program, and at closure somebody can still answer what did that decision cost us without reconstructing it from memory.
Scope changes absorbed into existing accounts become invisible within one reporting cycle. That is usually why they are absorbed.
Both changes are additive, and neither was traded against anything. That is worth stating plainly, because it is the less common case: the program's ceiling absorbed both, CR-02 through contingency and a six-month extension to the Phase 3 window that the schedule could carry. A program without that headroom would have faced the harder version of the same decision, where adding a sub-study means removing something else.
6. Scope Creep, and How It Actually Arrives
The two changes in §5 are not scope creep. They are scope changes — proposed, costed, argued and approved. Creep is the work that enters the program without any of that, and it never arrives labelled as a scope decision.
| How it arrives | What it looks like at the time | Where it is caught |
|---|---|---|
| Protocol amendments | An extra assessment at two visits, to answer a reviewer question nobody wants to leave open. Clinically sensible, individually trivial, and multiplied by 2,480 participants across 260 sites. | Amendment review costs the change before it is issued, not after. |
| Agency interaction | A commitment made in a meeting to satisfy an examiner. It becomes a submission obligation the moment it is minuted, and the minutes are the agency's. | Every meeting commitment is logged against a control account before the minutes arrive. |
| Vendor drift | The CRO does something helpful that was never contracted, then reasonably expects to be paid for it — or worse, absorbs it and stops doing something that was. | Change orders against the contracted scope, reconciled monthly. |
| Gold-plating | A third analytical method qualified because two felt thin. Better science, unbudgeted, and it sets an expectation for every subsequent transfer. | Control account variance with the owner asked to explain the underspend as well as the overspend. |
That is what makes creep hard. Nobody adds unnecessary scope on purpose; they add necessary scope without noticing it is scope. The defense is not vigilance, which does not scale, but the 100% rule: if a piece of work cannot be located in a work package, it is either not authorized or the baseline is wrong, and both of those are answerable questions.
The test is arithmetic, not judgment — which is the only kind of test that still works when the person applying it is tired and the person proposing the work is persuasive.
One asymmetry is worth naming. This program's scope pressure has been almost entirely additive, because every party to it — investigators, the agency, the CRO, the functions — is professionally motivated to do more rather than less. Nothing in the program's structure generates pressure to remove scope. The gate is the only mechanism that ever asks whether something should stop, and it asks about the program as a whole rather than about individual work packages, which is why the descoping conversation almost never happens at the level where it would be cheapest.
7. Acceptance Criteria
What it means for this program to be complete. Fixed at Gate 4, alongside the baseline, and deliberately not adjusted since.
| Criterion | What satisfies it |
|---|---|
| An approved NDA for the sought indication | Approval with the chronic weight management indication as filed. |
| A commercially manufacturable product | Validated process, released registration batches, and a passed pre-approval inspection. |
| A submission that survives review without a major amendment | A major amendment resets the review clock by three months; avoiding one is a scope acceptance criterion, not merely good practice. |
| Post-marketing obligations accepted and transferred | Every PMR and PMC assigned to a permanent function in writing before closure. |
There is no acceptance criterion for revenue, market share, formulary position or net price. Those are the benefits, they are measured for years after the program closes, and a program cannot be held to a criterion it cannot influence within its own life.
This is the distinction the closure report turns on. The program met every acceptance criterion above — approval, a manufacturable product, no major amendment, obligations transferred — and the commercial outcome came in 22.5% below plan. Both statements are true, and a scope baseline that had blurred them would have made the closure conversation impossible to hold honestly.
The counterpart obligation is that the program does not get to claim the benefits either. A closure report that cited a favorable launch as evidence of good program management would be committing the same error in the opposite direction — and would have no standing to say what it actually says, which is that the access assumption was under-resourced from Stage 2 and nobody caught it.