For life sciences teams

A first commercial launch with nothing to inherit, and the governance decision that mattered more than any design choice.

Directing commercialization infrastructure for an emerging biotech, I built the roadmap to revenue, paired third-party logistics with specialty distribution, kept patient services in-house, and stood up an executive pricing committee so access decisions had a standing forum rather than an escalation path. The thing I would do differently is build patient identification into the infrastructure rather than alongside it.

Insmed · Commercial infrastructureArchitectureThe 5 Layers of GTN™ Layers 3 and 5

Decision context

An emerging company launching its first product does not adapt an existing commercial infrastructure. It builds one, at speed, while the clinical organization is still the center of gravity and while the systems in place were designed to track R&D spend and nothing else.

Building commercial infrastructure with nothing to inherit An emerging company launching a first product does not adapt an existing commercial infrastructure. It builds one at speed, while the clinical organization is still the center of gravity and the only systems in place were designed to track research spend. The choices were to pair third-party logistics with specialty distribution, to keep patient services in-house rather than outsourcing it, and to stand up an executive pricing committee so that access decisions had a standing forum rather than an escalation path. The governance decision mattered more than any individual design choice, and the thing worth doing differently is building patient identification into the infrastructure rather than alongside it. NOTHING INHERITEDA first launchSystems built to trackR&D spend and nothing else.DECISION3PL paired withspecialtyLogistics outsourced,distribution specialized.DECISIONPatient serviceskept in-houseThe one capability nothanded to a vendor.DECISIONPricing committeeA standing forum for access,not an escalation path.The governance decision mattered more than any single design choice.What I would do differently: build patient identification into the infrastructure rather than alongside it.
FIGURE 1. Three design decisions and one governance decision. The governance decision is the one that held.

My authority

This one was mine. My scope covered the commercialization infrastructure: the roadmap to revenue, the third-party logistics build, the specialty distribution network, Gross-to-Net, and in-house patient services inside a limited distribution model.

What I helped design

  • The roadmap to revenue, as an actual sequenced plan rather than a launch calendar.
  • The third-party logistics build and the specialty distribution network, designed together rather than contracted separately.
  • In-house patient services, kept inside rather than outsourced, on the argument that in a narrow indication the patient-level knowledge is the asset.
  • The specialty pharmacy selection process, which I supported rather than ran, and the operations that had to stand up behind it.
  • An executive pricing committee, so that access decisions had a standing forum rather than an escalation path. This is the piece I would defend hardest. A recurring decision that only exists as an escalation gets made late, by whoever is available, under pressure.
  • The first long-range scenario plan for an evolving pipeline, and portfolio governance that tied program decisions to financial sustainability rather than to advocacy.

The trade-off

Reach against visibility. A limited distribution model gives you control and data at the cost of convenience for prescribers and patients. In a narrow indication I would make that trade again, and I want to be clear that it is a trade rather than a free choice.

What I would do differently

I would have built the identification capability into the infrastructure rather than alongside it. Everything above serves a patient who has already arrived.

A finance function earns its seat by arriving with an architecture, not with a variance report.

Former employers and products referenced are matters of professional history. The views expressed are my own and are not made on behalf of any current or former employer, and no commercial outcome for any named product is attributed to me personally. All trademarks belong to their respective owners.

What gets built before approval day is in The Launch Begins Long Before Approval Day, and what happens after is in A Launch Does Not Fail in the Forecast. The ten places a patient can leave are on the philosophy page, with terms defined in the glossary. The patient-side view of the same ten exits is at Where did your treatment stop?

Disclosure: who pays for this work
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