A mapping & insights framework · biotechs entering Europe

From a KOL list to a strategy on who actually adopts, why and how.

A list gives you names. It does not tell you where an expert sits on the adoption ladder, or how to move them up it.

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Free · 9 sections · public-record proof only, no client names

The adoption ladder · move experts up, rung by rung

Rung 1Needs

Rung 2Supports

Rung 3Adopts

Rung 4Advocates

Reading who will adopt, defining the population you can defend, and reading the reimbursement gate are one job, held by one operator.

The gate

In Europe, approval is not the finish line. Reimbursement is.

A marketing authorisation asks whether it works and whether it is safe. The reimbursement gate asks whether it is better than what already exists, for whom, and worth paying for, in real patients rather than trial patients. Assets stall at the second gate, and the evidence that clears it has to be designed in long before submission.

Gate 1 · Marketing authorisation

Does it work, is it safe?

Internal validity, in trial patients. The regulator's question.

Gate 2 · HTA and payer

Is it better, for whom, at what price?

Real-world effectiveness, in real patients. This is where approved, physician-wanted therapies have still died in Europe.

Inside the framework

What a list will never answer, laid out in nine sections.

Mapping, done properly

The nodes that decide access

Purchased databases surface academic visibility and under-weight the clinicians and committee members who actually decide local access. Only 8 to 18 percent of opinion leaders come back when re-identified two years later.

Reading adoption

Who will say yes, and why

Get the right experts to weigh in early, even on early data, and read three things: who will adopt, why, and under what conditions. A board surfaces the group dynamic a single opinion never will.

Investigator to advocate

The local uptake effect

Patients in the lead investigator's own region were 36 percent more likely to receive a new cancer drug in its first years. The window is real, and it fades within roughly four years.

Transferability

One evidence story, two gates

The gap between efficacy in a trial and effectiveness in real life is the whole game. Across five European HTA agencies, indirect treatment comparisons were accepted 30 percent of the time, and zero percent in France.

Why now

The EU Joint Clinical Assessment turned early reading into a deadline.

From 12 January 2025, the Joint Clinical Assessment runs in parallel to EMA for new oncology medicines and all advanced therapy medicinal products, with a hard window to submit the assessment dossier.

100 days

to submit the assessment dossier

60 days

if the procedure is accelerated

Proof, from public record

Pedigree you can cite, without a single client named.

5 therapies

including 3 advanced therapy medicinal products, taken through European early access.

2 countries

where first patients were treated: Belgium and France.

National-authority hearings

prepared and defended. Paris Saclay: programmes selected within the Cancer Cluster.

Get the SPinsights Framework.

The SPinsights Framework, a nine-section guide

The full nine-section read on who adopts and how an asset clears the European reimbursement gate. Built for early-stage biotechs in oncology and rare disease, advanced therapies included.

Where every expert sits on the adoption ladder, and how to move them up
The weighting that a bought database cannot give you
How to turn investigators into advocates who carry the evidence
Transferability: one evidence story that clears both gates

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One asset on your desk, twenty minutes with the person who would do the work. No hard pitch.