For life sciences teams

What changes at approval is not the product and not the patient. It is who is looking at them, and what they are counted for.

Supporting a program from R&D finance through launch, I carried the clinical understanding of the patient into the commercial models, because the gap between how R&D understands a patient and how Commercial understands a customer was visible to me and almost nobody else. I should have documented that gap so it stopped being tacit.

Bayer HealthCare Pharmaceuticals · Oncology R&DDiagnosisThe 10 Exits of Therapy™ Exits 01, 02

Decision context

I came into pharmaceuticals through oncology R&D, supporting an alpha-emitting radiopharmaceutical, and followed its pivotal trial from the clinical side into commercial launch.

What actually changes at approval day Coming into pharmaceuticals through oncology research finance and following a pivotal trial from the clinical side into commercial launch, the product at approval does not change and neither does the patient. What changes is who is looking at that patient and what they are being counted for. Research finance understands a patient. Commercial understands a customer. Most finance people meet a product only after it already has a label, a forecast and a price, so that gap stays tacit rather than documented. IN R&DA hypothesisbeing testedIn men who had run outof other options.AT APPROVALThe product doesnot changeNeither does thepatient.WHAT CHANGESWho is lookingR&D understands a patient.Commercial understands a customer.ANDWhat they arecounted forThe same person, enteredinto a different model.Most finance people meet a product after it has a label, a forecast and a price.The gap was visible to me and almost nobody else. I should have documented it so it stopped being tacit.
FIGURE 1. The same person, carried across approval day, entered into a completely different model.

That sequence matters more than it sounds. Most finance people meet a product after it has a label, a forecast and a price. I met this one while it was still a hypothesis being tested in men who had run out of options.

My authority

None of the decisions here were mine to make. I was in R&D finance, supporting a program. What I had was access to both rooms during a period when almost nobody has access to both, and a choice about whether to carry what I learned in one into the other.

What I built

  • Continuity of assumption. The commercial model inherited the clinical understanding of the patient rather than replacing it with a market-sized abstraction.
  • A handoff that was not a handoff. I kept the R&D relationships after the program moved, so the questions that surfaced later had somewhere to go.

The trade-off

Staying close to a program past the point where your function’s involvement formally ends costs time that nobody has budgeted, and it is invisible in any performance review. I would make the trade again, but it is a trade.

What I would do differently

I would have written the difference down. The gap between how R&D understands a patient and how Commercial understands a customer was visible to me and to almost nobody else, and I treated it as something I understood rather than something the organization needed documented. It is where most of the friction in this industry is born, and I let it stay tacit for years.

The product does not change at approval. The patient does not change at approval. What changes is who is looking at them and what they are counted for.

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 happens to those patients after approval day is in A Launch Does Not Fail in the Forecast, and the access groundwork is in The Launch Begins Long Before Approval Day. 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?

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