TPP validation

    Test the assumptions behind your target product profile with the clinicians, payers and patients closest to the disease, and use what they tell you to refine it.

    Builds on the rare disease landscaping baseline.

    Target product profile validation and evidence gap analysis.

    TPP validation is target product profile benchmarking applied to your own profile. We test every attribute with treating clinicians, payers and patient representatives in Germany, France, Italy, Spain, the UK, the Netherlands and the Nordics, and set the results against the alternatives already in use. The result is an evidence gap analysis you can act on: which attributes hold up, which trade-offs stakeholders will resist, and which questions your development and evidence plan still has to answer.

    Tangible deliverables you can act on

    Attribute-by-attribute read

    How each TPP attribute lands with the clinicians, payers and patients we speak to.

    Trade-off map

    The compromises stakeholders raise, and where their views diverge.

    Stakeholder view of the profile

    How the full profile is heard, including the doubts and reframings raised.

    Revised TPP + evidence plan

    Clear recommendations for profile and evidence priorities.

    What TPP validation covers

    Attribute-level testing

    How each TPP attribute is perceived across clinical, payer and patient stakeholders.

    Stakeholder perception of the profile

    How clinicians, payers and patients hear the overall profile in their own framing, including the doubts and reframings a scored questionnaire tends to miss.

    Trade-offs

    Which compromises stakeholders say they would accept, which they would resist, and where they disagree with each other.

    Differentiation

    How your profile compares to the alternatives in stakeholders' own framing.

    Profile refinement

    Clear, evidenced recommendations for sharpening the TPP and the evidence plan behind it.

    How we work

    How the engagement runs

    Step 1

    Scope

    We align on the TPP, the stakeholder groups and the decisions the validation needs to inform.

    Step 2

    Validate

    We engage clinicians, payers and patients across priority markets to test each attribute in depth and surface unanticipated trade-offs.

    Repeat
    Step 3

    Refine

    We translate findings into a sharper TPP and clear implications for development, evidence and positioning.

    Outcomes

    What you walk away with.

    Engagement timeline

    Scope and timing are agreed around your research question, priority markets and stakeholder groups · deliverable: an attribute-by-attribute read of the profile and a revised TPP recommendation · requires your current TPP under CDA

    • An attribute-by-attribute read of how each element of the profile is understood by the stakeholders we speak to.
    • A documented map of the trade-offs stakeholders raise, including where they disagree with each other.
    • The reframings, doubts and open questions that rarely surface in internal review, recorded in stakeholders' own words.
    • Clear implications for refining the profile and prioritising evidence, with the uncertainty stated.
    Common questions

    TPP validation, answered

    What is TPP validation?

    TPP validation tests a target product profile with the clinicians, payers and patients who will decide whether to adopt the product. Each attribute is checked for relevance, credibility and competitive standing before development trade-offs are locked.

    How is it different from a payer advisory board or KOL interviews?

    Advisory boards and KOL interviews gather opinion on a topic. TPP validation is structured around the profile itself: every attribute is tested, trade-offs are forced, and the output feeds directly into development and evidence decisions.

    When should we commission it?

    Before phase III design or before major evidence trade-offs are committed. The earlier the profile is tested, the more cheaply it can still be changed.

    How do you go beyond standard attribute testing to capture real perception?

    We design conversations around the profile as a whole, rather than asking stakeholders to rate attributes in isolation. That tends to surface the reframings, doubts and open questions that a scored questionnaire misses. We record them as stakeholder views, not as predictions of what the market will do.

    What do we receive at the end?

    An attribute-by-attribute read of the profile, a documented view of the trade-offs stakeholders raise, a summary of how the whole profile is heard, a revised TPP and a focused evidence plan.

    Which stakeholders and markets do you cover?

    Clinicians, payers, diagnostics, and patient representatives across priority European markets. We can extend to other regions and to specialist stakeholders such as guideline authors on request.

    Discuss your research needs

    Tell us the disease area, the priority markets and the decision in front of you, and we will set out what a scoped engagement would cover.

    Discuss your research needs