Vitalis Therapeutics Inc. — The work breakdown structure for the VitaFlow (VTX-401) program: eleven Level 2 control accounts mapping one-to-one to the budget cost pools, Level 3 decomposition of the two largest, the 109-person resource model across ten functions, and what is deliberately excluded.
11
Control accounts
64
Work packages
109
Headcount
191k
Hours
Contents
1. What a WBS Is For
A work breakdown structure decomposes the total scope of a program into deliverables, and then into work packages small enough that one person can own one and be held to it.
| Rule | Statement | Why it matters |
|---|---|---|
| The 100% rule | The WBS captures 100% of the scope and nothing outside it | If work is not in the WBS it is not in the program. This is the test that makes a WBS useful rather than decorative. |
| Deliverable-oriented | Nodes are things, not activities | “Registration batches” not “manufacture batches”. Activities belong in the schedule; the WBS defines what is produced. |
| Mutually exclusive | No scope appears in two places | Overlap makes cost roll-up meaningless and creates two owners for one deliverable. |
| Decomposed to a manageable package | Assignable, estimable, trackable | Decomposition stops where a single owner can be held accountable for a discrete result. |
| Control accounts at Level 2 | Where scope, schedule and cost intersect | Each Level 2 node has one accountable owner and one budget. |
The 100% rule is the one that makes a WBS load-bearing rather than decorative.
The structure captures all of the scope and only the scope. If work is not in the WBS, it is not in the program — and a program manager who finds work being done that has no WBS node has found either uncontrolled scope or an incomplete structure. Both are worth knowing about.
The second rule is the one people break most often. A WBS node is a deliverable, not an activity. “Registration batches” is a node; “manufacture the registration batches” is a schedule activity. Mixing the two produces a structure that is neither a scope definition nor a plan.
The structure captures all of the scope and only the scope. If work is not in the WBS, it is not in the program — and a program manager who finds work being done that has no WBS node has found either uncontrolled scope or an incomplete structure. Both are worth knowing about.
The second rule is the one people break most often. A WBS node is a deliverable, not an activity. “Registration batches” is a node; “manufacture the registration batches” is a schedule activity. Mixing the two produces a structure that is neither a scope definition nor a plan.
2. Level 2 — Control Accounts
| WBS | Deliverable | Scope | Budget | % of base |
|---|---|---|---|---|
| 1.1 | Nonclinical Package | Pharmacology, PK/ADME, safety pharmacology, GLP toxicology, genotoxicity | $8,500,000 | 3.9% |
| 1.2 | CMC — Early Development | Route selection, formulation, analytical method development, clinical supply | $6,200,000 | 2.9% |
| 1.3 | IND Package | Investigator's Brochure, Module 3/4 authoring, Form 1571, submission | $3,800,000 | 1.8% |
| 1.4 | Phase 1 Clinical | Protocol, single site, 64 volunteers, PK/safety read-out, CSR | $8,500,000 | 3.9% |
| 1.5 | Phase 2 Clinical | Dose-ranging, 480 participants, 36 weeks, dose selection for pivotal | $38,000,000 | 17.5% |
| 1.6 | Phase 3 Clinical | Two pivotals plus CV sub-study, 2,480 randomized, 260 sites, 68 weeks | $109,100,000 | 50.3% |
| 1.7 | CMC Scale-Up & Validation | Technology transfer, registration batches, PPQ, stability, method transfer | $9,200,000 | 4.2% |
| 1.8 | NDA Preparation & Review | Integrated summaries, datasets, publishing, review response, inspection support | $12,400,000 | 5.7% |
| 1.9 | Regulatory Affairs | Strategy, agency meetings, IND maintenance, labeling negotiation | $7,600,000 | 3.5% |
| 1.10 | Program Management | Governance, planning, risk, reporting, gate packages, vendor oversight | $5,300,000 | 2.4% |
| 1.11 | Advisors & Other | Regulatory counsel, scientific advisory board, user fees, insurance | $8,400,000 | 3.9% |
| 1.0 Program total | $217,000,000 | 100.0% |
These eleven nodes map one-to-one onto the eleven cost pools in the
Program Budget, and that is not a coincidence — it is
enforced.
The fact base asserts the mapping on load. Add a WBS node without a matching pool, rename one, or change a Level 3 figure so it no longer sums to its parent, and every artifact in this suite fails to build.
The point of that construction is to remove a recurring failure mode: a WBS and a budget that were consistent when written and drifted apart afterwards, so that scope discussions and cost discussions quietly stop being about the same program.
The fact base asserts the mapping on load. Add a WBS node without a matching pool, rename one, or change a Level 3 figure so it no longer sums to its parent, and every artifact in this suite fails to build.
The point of that construction is to remove a recurring failure mode: a WBS and a budget that were consistent when written and drifted apart afterwards, so that scope discussions and cost discussions quietly stop being about the same program.
Each Level 2 node is a control account — the level at which scope, schedule and cost intersect and where a single accountable owner sits. Below that, work packages are assignable and estimable. Above it, roll-up is to the program.
Note the concentration. Node 1.6 Phase 3 Clinical alone is
50% of base. The three largest nodes are
74%.
A WBS that decomposed all eleven nodes to equal depth would be a document nobody reads. Depth should follow value and risk — which is why 1.6 and 1.8 are decomposed below and the others are not.
A WBS that decomposed all eleven nodes to equal depth would be a document nobody reads. Depth should follow value and risk — which is why 1.6 and 1.8 are decomposed below and the others are not.
3. Level 3 — Complete Decomposition
64 work packages across all eleven control accounts. Every node decomposes; every set of children sums to its parent. The fact base asserts both.
1.1 — Nonclinical Package · 6 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.1.1 | Primary pharmacology | Receptor binding, in vivo efficacy models | $1,100,000 |
| 1.1.2 | Safety pharmacology | Core battery — CNS, CV, respiratory | $900,000 |
| 1.1.3 | Pharmacokinetics & ADME | Absorption, distribution, metabolism, excretion | $1,400,000 |
| 1.1.4 | GLP repeat-dose toxicology | Rodent and non-rodent. Extended after the Pre-IND meeting — +$1.2M, +11 weeks | $3,200,000 |
| 1.1.5 | Genotoxicity | Ames, chromosomal aberration, in vivo micronucleus | $700,000 |
| 1.1.6 | Reproductive toxicology | Fertility, embryo-fetal development | $1,200,000 |
| 1.1 total | $8,500,000 |
1.2 — CMC — Early Development · 5 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.2.1 | Route selection & process development | Synthetic route, scale demonstration, impurity profiling | $1,900,000 |
| 1.2.2 | Formulation development | Aqueous solution, excipient screening, pen compatibility | $1,300,000 |
| 1.2.3 | Analytical method development | Assay, purity, aggregation, identity — validated under ICH Q2 | $1,500,000 |
| 1.2.4 | Clinical supply, Phase 1–2 | GMP manufacture, labeling, distribution | $1,100,000 |
| 1.2.5 | Early stability | Supporting clinical use period only | $400,000 |
| 1.2 total | $6,200,000 |
1.3 — IND Package · 6 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.3.1 | Investigator's Brochure | First edition; the expectedness yardstick | $400,000 |
| 1.3.2 | Module 3 authoring | Quality — safety of clinical supply | $900,000 |
| 1.3.3 | Module 4 authoring | Nonclinical study reports | $1,100,000 |
| 1.3.4 | Module 2 summaries | Overviews and summaries | $700,000 |
| 1.3.5 | Publishing & submission | eCTD assembly, Form 1571, gateway | $400,000 |
| 1.3.6 | Pre-IND meeting | Briefing package, meeting, minutes reconciliation | $300,000 |
| 1.3 total | $3,800,000 |
1.4 — Phase 1 Clinical · 5 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.4.1 | Protocol & start-up | Single-site Phase 1 unit, IRB, contracting | $900,000 |
| 1.4.2 | Unit costs & conduct | 64 volunteers, 12 weeks, confinement periods | $4,800,000 |
| 1.4.3 | Bioanalysis | PK sample analysis, method validation | $1,200,000 |
| 1.4.4 | Data management & statistics | EDC, cleaning, PK/PD analysis | $800,000 |
| 1.4.5 | Clinical study report | ICH E3 CSR | $800,000 |
| 1.4 total | $8,500,000 |
1.5 — Phase 2 Clinical · 6 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.5.1 | Protocol & start-up | Protocol, SAP, eCRF, IRT, country selection | $3,100,000 |
| 1.5.2 | Site activation | Contracting, IRB, initiation — 48 sites | $4,200,000 |
| 1.5.3 | Enrolment & conduct | 480 participants, 36 weeks, per-participant and site payments | $21,400,000 |
| 1.5.4 | Investigational supply | Manufacture, labeling, distribution, accountability | $3,300,000 |
| 1.5.5 | Data management & biostatistics | EDC, lock, analysis, TLFs | $3,600,000 |
| 1.5.6 | CSR & dose selection | Dose selection for the pivotal program — the Gate 3 deliverable | $2,400,000 |
| 1.5 total | $38,000,000 |
1.6 — Phase 3 Clinical · 8 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.6.1 | Protocol & start-up | Protocol, SAP, eCRF, IRT build, country and site selection | $6,800,000 |
| 1.6.2 | Site activation | Contracting, IRB, regulatory documents, initiation — 260 sites | $11,400,000 |
| 1.6.3 | Enrolment & conduct | Per-participant costs, site payments, monitoring visits, central lab | $58,900,000 |
| 1.6.4 | Investigational supply | Manufacture, labeling, distribution, accountability, destruction — 41,600 kits | $9,300,000 |
| 1.6.5 | CV outcomes sub-study | CR-02 scope addition — 640 participants, adjudication committee | $7,200,000 |
| 1.6.6 | Data management & biostatistics | EDC, cleaning, coding, reconciliation, lock, analysis, TLFs | $8,600,000 |
| 1.6.7 | Safety & pharmacovigilance | Case processing, DMC, DSUR, signal detection | $4,100,000 |
| 1.6.8 | Clinical study reports | Two pivotal CSRs plus sub-study | $2,800,000 |
| 1.6 total | $109,100,000 |
1.7 — CMC Scale-Up & Validation · 6 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.7.1 | Technology transfer to Aldergate | Process transfer, engineering batches | $1,800,000 |
| 1.7.2 | Analytical method transfer | I-02 originated here — two of three methods failed first-pass acceptance | $900,000 |
| 1.7.3 | Registration batches | Three commercial-scale batches for the dossier | $2,400,000 |
| 1.7.4 | Process validation (PPQ) | Three consecutive qualification batches, media fills | $2,600,000 |
| 1.7.5 | Stability program | ICH Q1A long-term, accelerated, in-use, thermal cycling | $900,000 |
| 1.7.6 | Device design verification | Pen functional testing, human factors validation | $600,000 |
| 1.7 total | $9,200,000 |
1.8 — NDA Preparation & Review · 5 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.8.1 | Integrated summaries | ISS and ISE — new analyses, not compilations | $3,900,000 |
| 1.8.2 | Datasets & define.xml | SDTM, ADaM, reviewer's guides | $2,400,000 |
| 1.8.3 | Module authoring & publishing | eCTD assembly and technical validation | $2,700,000 |
| 1.8.4 | Review response | Information requests, meetings, amendments | $2,100,000 |
| 1.8.5 | Inspection support | Mock inspections, storyboards, PAI support | $1,300,000 |
| 1.8 total | $12,400,000 |
1.9 — Regulatory Affairs · 6 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.9.1 | Regulatory strategy & planning | Pathway, designations assessed, geographic scope | $900,000 |
| 1.9.2 | Agency meetings | Four Type B meetings: packages, conduct, minutes | $1,300,000 |
| 1.9.3 | IND maintenance | 99 submissions — amendments, safety reports, annual reports | $1,600,000 |
| 1.9.4 | Labeling development & negotiation | Proposed labeling through to agreed text | $1,400,000 |
| 1.9.5 | Pediatric plan (PREA) | iPSP preparation, agreement, deferral negotiation | $700,000 |
| 1.9.6 | Regulatory operations & publishing | Submission management, gateway, archive | $1,700,000 |
| 1.9 total | $7,600,000 |
1.10 — Program Management · 6 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.10.1 | Governance & gate management | Committee, gate packages, decision records | $1,200,000 |
| 1.10.2 | Planning & schedule control | WBS, schedule, baseline maintenance | $900,000 |
| 1.10.3 | Risk & issue management | RAID, conditions, contingency administration | $700,000 |
| 1.10.4 | Vendor oversight | CRO and CMO governance, KPI review, audits | $1,100,000 |
| 1.10.5 | Reporting & performance measurement | Dashboards, status reporting, EVM | $800,000 |
| 1.10.6 | Program closure | Handover, archive, closure report, team release | $600,000 |
| 1.10 total | $5,300,000 |
1.11 — Advisors & Other · 5 packages
| WBS | Work package | Scope | Budget |
|---|---|---|---|
| 1.11.1 | Regulatory counsel | Thorne & Vale LLP | $1,400,000 |
| 1.11.2 | Scientific advisory board | External expert input at key decision points | $900,000 |
| 1.11.3 | PDUFA user fee | Statutory application fee, paid at submission | $4,300,000 |
| 1.11.4 | Insurance & indemnity | Clinical trial liability across eight countries | $1,100,000 |
| 1.11.5 | Translation & localization | Protocol, consent and labeling materials | $700,000 |
| 1.11 total | $8,400,000 |
Three packages carry 39%
of the program between them — 1.6.3, 1.5.3 and 1.4.2, all “enrolment and
conduct”. They are per-participant cost.
That has a direct planning consequence. The program's dominant cost driver is participants dosed, not time elapsed. A schedule slip that does not change participant count barely moves these packages; a protocol amendment that adds a visit moves all three.
That has a direct planning consequence. The program's dominant cost driver is participants dosed, not time elapsed. A schedule slip that does not change participant count barely moves these packages; a protocol amendment that adds a visit moves all three.
Two packages are named after things that went wrong, and that is deliberate.
1.6.5 is the cardiovascular sub-study — scope that did not exist at Gate 4 and arrived from the End-of-Phase-2 meeting as CR-02. 1.7.2 is analytical method transfer, where I-02 originated.
Both could have been absorbed into larger packages. Keeping them discrete means the cost of a scope addition and the cost of a failed transfer stay visible for the life of the program instead of disappearing into a bigger number that nobody questions.
1.6.5 is the cardiovascular sub-study — scope that did not exist at Gate 4 and arrived from the End-of-Phase-2 meeting as CR-02. 1.7.2 is analytical method transfer, where I-02 originated.
Both could have been absorbed into larger packages. Keeping them discrete means the cost of a scope addition and the cost of a failed transfer stay visible for the life of the program instead of disappearing into a bigger number that nobody questions.
5. Resource Model
109 people across ten functions, 191,420 hours, representing $36,008,000 — 16.6% of base.
| Function | Headcount | Hours | % of roster | Scope | Note |
|---|---|---|---|---|---|
| Clinical Operations | 24 | 51,900 | 22.0% | Sites, monitoring, enrolment, clinical supply | Largest function. Scales with site count, not with program value — and it oversees a CRO rather than executing the trial itself. |
| Technical Operations / CMC | 16 | 30,200 | 14.7% | Process, analytical methods, scale-up, validation | Peaks late, when clinical is winding down. CMC gates the filing independently. |
| Clinical Development | 12 | 17,900 | 11.0% | Protocols, medical monitoring, clinical study reports | Small headcount, high rate — medical monitors are physicians. |
| Biostatistics & Data Management | 12 | 22,600 | 11.0% | SAP, EDC, database lock, analysis datasets | Under-resourced in most programs relative to what the filing actually needs. |
| Regulatory Affairs | 10 | 18,900 | 9.2% | Strategy, submissions, agency interaction, labeling | Highest blended rate in the program. Ten people carry every commitment made to the agency. |
| Pharmacovigilance & Drug Safety | 8 | 14,200 | 7.3% | Case processing, signal detection, DSUR | Carries an expedited-reporting clock that has no tolerance band. |
| Quality Assurance (GxP) | 7 | 12,800 | 6.4% | Audits, CAPA, GxP compliance, inspection readiness | Independent of every function it audits; the CQO reports to the CEO, not to this program. |
| Nonclinical Safety & Pharmacology | 5 | 9,400 | 4.6% | Toxicology, pharmacology, study oversight | Front-loaded — near zero after Gate 2, which is why headcount alone misstates its importance. |
| Program Management Office | 4 | 7,200 | 3.7% | Governance, planning, risk, reporting | 3.7% of headcount coordinating the other 96.3%. |
| Market Access & Commercial | 4 | 5,000 | 3.7% | Payer evidence, pricing, launch readiness | Joint-smallest, latest to staff, and lowest hours per head — while carrying the longest-lead assumption in the business case. |
| Total | 109 | 191,420 | 100% |
The single most important number on this page is that internal labor is only
16.6% of the program.
83% of the budget is external — the CRO, the contract manufacturer, the central laboratory, sites, advisors and fees. So a program manager who manages headcount tightly and vendor commitments loosely has optimized the small number.
It also means the resource plan is not primarily a staffing plan. It is a contracting plan with a staffing plan attached, which is why the CRO Oversight Plan carries more of this program's cost control than this document does.
83% of the budget is external — the CRO, the contract manufacturer, the central laboratory, sites, advisors and fees. So a program manager who manages headcount tightly and vendor commitments loosely has optimized the small number.
It also means the resource plan is not primarily a staffing plan. It is a contracting plan with a staffing plan attached, which is why the CRO Oversight Plan carries more of this program's cost control than this document does.
Read the last two rows together. Program Management is 4 people
(3.7% of the roster) coordinating the other 105.
Market Access & Commercial is also 4 people, staffed latest of any function
— and produced the largest single miss in the program's outcome.
That is not an argument for a bigger market access team. It is an observation that the function carrying the assumption with the longest lead time was the one resourced last, and that GC-03 was the governance system noticing exactly this and being unable to fix it with a condition.
That is not an argument for a bigger market access team. It is an observation that the function carrying the assumption with the longest lead time was the one resourced last, and that GC-03 was the governance system noticing exactly this and being unable to fix it with a condition.
6. What Is Deliberately Outside the WBS
- Commercial launch investment. Field force, marketing, distribution build. Separate authorization; not this program's scope (Charter §4).
- European filing. Explicitly out of scope. Deferred to Year 4+.
- Post-approval commitments. PMR-1 and PMR-2 report in 2034 and 2035, under permanent functions, after this program has closed.
- Second indication work. Platform option value is a benefit, not a deliverable.
- Line-function base costs. Quality systems, facilities and IT that exist whether or not this program does.
Naming the exclusions is part of the 100% rule, not separate from it. The rule says the WBS
contains all of the scope and only the scope — so a reader has to be able to see where
the boundary was drawn and on what basis.
The last exclusion is the one that causes arguments. Line-function costs are real and the program consumes them, but they are not caused by the program and would not disappear if it stopped. Loading them in would make the program look more expensive than it is and make its cost per deliverable incomparable with any other program.
The last exclusion is the one that causes arguments. Line-function costs are real and the program consumes them, but they are not caused by the program and would not disappear if it stopped. Loading them in would make the program look more expensive than it is and make its cost per deliverable incomparable with any other program.
7. How This WBS Is Used
| Use | How |
|---|---|
| Scope control | New work must be assigned a WBS node. Work that fits no node is a change, and goes to change control rather than into someone's week. |
| Cost roll-up | Actuals are booked to work packages and roll to control accounts and to the program. The budget and this structure are the same numbers. |
| Schedule development | Activities are derived from work packages, not invented alongside them. The schedule decomposes 1.x nodes into sequenced activities with durations. |
| Responsibility assignment | Each control account has one accountable owner. The RACI matrix maps functions to nodes. |
| Risk association | Every risk in the RAID Log attaches to a WBS node, so exposure can be read by deliverable rather than only by register. |
| Contingency reasoning | A draw is assessed against the node it protects. CR-02 sits at 1.6.5; I-02 at 1.7. |
The last two rows are what turns a WBS from a scope document into a management instrument.
When a risk attaches to a node, a program manager can answer “how much of the program is exposed to this?” with a number rather than an adjective. When a contingency draw is assessed against a node, the question “is this recovery or is it new scope?” has an answer — recovery restores a node to its planned state, new scope creates or expands one.
That distinction is the whole basis of the Contingency Register's discipline about what the reserve does and does not fund.
When a risk attaches to a node, a program manager can answer “how much of the program is exposed to this?” with a number rather than an adjective. When a contingency draw is assessed against a node, the question “is this recovery or is it new scope?” has an answer — recovery restores a node to its planned state, new scope creates or expands one.
That distinction is the whole basis of the Contingency Register's discipline about what the reserve does and does not fund.