Expert role · Commercial Strategy
The commercial case, built from public evidence.
Market size, unmet need against the standard of care, the price a payer would defend, and how much exclusivity you have left to earn it back in. Drafted from the commercial analyses, with the two or three assumptions that actually move the answer called out.
TAM to SAM to SOM, with the served market as the answer.
The job · the commercial strategy or new-product-planning lead who owns the market case
The number the board asks for, with its working shown.
Commercial assessments at this stage usually arrive as a deck with a peak-sales figure and a footnote. The figure is defensible right up until someone asks how the addressable population was derived, what the price assumption is anchored to, or what happens to the runway if the earliest patent falls. Rebuilding that chain by hand, per asset, is why the deck takes weeks.
This workspace drafts the chain instead of the conclusion. TAM narrows to SAM narrows to SOM with the epidemiology and eligibility arithmetic attached; the price corridor is argued against the standard of care rather than assumed; the exclusivity read names the filings it came from. You get a summary you can be cross-examined on — and a recommendation your team, not the software, signs.
What it covers
- Size the addressable market and peak-revenue ceiling (TAM → SAM → SOM)
- Read unmet need and competitive crowding against the standard of care
- Set the value-based price corridor a payer or HTA body would defend
- Assess the exclusivity runway and freedom to operate
- Roll the commercial analyses into one feasibility summary and memo
In the role registry
Market sizing, price corridor, exclusivity runway, commercial summary
What it drafts
Deliverables — drafts, until signed.
Each artefact arrives with its citations attached and its status explicit. Nothing below is final until a named human signs it.
Commercial feasibility summary
The five commercial analyses rolled into one read, with a deterministic attractive / conditional / unattractive framing derived from the risk-adjusted valuation, the unmet need and the freedom-to-operate risk — never from a free-text opinion.
Signed off by
a commercial strategy lead
Market-size build (TAM → SAM → SOM)
The addressable population narrowed step by step — prevalence to eligible to realistically served — with each narrowing traced to the source that justifies it, so a reviewer can disagree with a step rather than with a total.
Signed off by
a commercial strategy lead
Value-based price corridor
A price band argued against the current standard of care and the value the asset would have to add over it, rather than a single number with no defence behind it.
Signed off by
a pricing or market-access lead
Exclusivity & freedom-to-operate read
The patent landscape around the asset and the runway it leaves — what expires when, and where the freedom-to-operate risk sits.
Signed off by
a commercial lead, with IP counsel
Sensitivity note
The two or three assumptions that most move the commercial case, surfaced explicitly, so the review argues about the inputs that matter instead of the ones that do not.
Signed off by
a commercial strategy lead
What it reads
It drafts from the assessment, not from memory
The role has no private knowledge. Every claim it writes traces to an analysis in one of the six pillars, and through that to a public source record.
Commercial
These five analyses are the summary. The role aggregates them and shows the working, rather than restating a headline.
Verdict
A valuation that is not risk-adjusted is a wish. The directional probability of success is what turns a peak-sales figure into an expected one.
Cohort
The addressable market and the enrollable cohort are the same population read two different ways. They should not disagree.
Design
What else is in development for this indication is a commercial fact before it is a clinical one.
How it is governed
A role drafts. A human signs.
This is the part that matters, so it is stated without hedging: the role has no authority to approve anything, and its output has no standing until a qualified person puts their name on it.
The role drafts.
It produces a draft deliverable with its citations attached. A draft has no standing: it is not approved, not final, and not actionable. The role has no authority to change it into any of those things.
A named human reviews.
The draft lands as a task for a specific person on your team. They can edit it, reject it, or send it back for a re-draft against the current evidence. Nothing moves until someone with a name has read it.
Sign-off is a Part 11 electronic signature.
Approval is recorded as a 21 CFR Part 11 electronic signature — attributable to an authenticated identity, time-stamped, and bound to the exact version of the record that was signed.
The whole chain is hash-chained.
Every draft, edit, review and signature is appended to a tamper-evident, hash-chained audit trail. It is reproducible and exportable, so your QA team can reconstruct who approved what, on what evidence, and when.
Stale approvals are flagged.
If the underlying evidence later changes, the signed decision is automatically flagged for re-review. Nothing stays approved on data that has since moved.
This role does not replace a qualified commercial, pricing or market-access professional.
It is a drafting assistant working under human review. It is not an autonomous agent, it does not make regulatory decisions, and its drafts carry no regulatory standing of their own — the signature does.
Where it goes next
The signed record is the hand-off
Roles do not message each other informally. One role's signed output is the next role's input, which is why the chain can be replayed.
The rest of the team
Seven roles, one governed record
Protocol Design
Drafts the trial protocol synopsis from the verdict, design, and cohort analyses — every claim cited.
CMO / VP R&D
Portfolio-level valuation, decision-gate memos, and readout-risk framing for the go/no-go call.
Biostatistician
Statistical analysis plans, sample-size estimates, and data-monitoring-board materials.
Clinical Pharmacologist
Dose-selection memos, exposure–response modelling, and drug-interaction risk.
Study Start-up
Country activation tracking and contract groundwork for the sites the assessment ranked.
CRO Commercial
Bid-pipeline and portfolio views for CRO business development teams.
See a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.