Independent HEOR advisory support
Evidence architecture for pharmaceutical and biotech assets.
I help clinical, HEOR, and access teams make pivotal evidence decisions before they become expensive HTA problems.
- Comparator, endpoint, PRO, and economic-model strategy before lock-in
- Embedded HEOR support when teams need in-house technical depth
- JCA, HTA, dossier, and cross-market value-defence work
- Single-practitioner practice; analysis performed directly by Carl Haakon Samuelsen
Core consulting offer
Senior HEOR input where development choices are still shapeable: early value strategy, asset evidence planning, embedded team leadership, and the economic architecture that carries into HTA.
Early pipeline and asset shaping
Target product profile development, early value hypothesis, indication and sequencing logic, burden of illness, early economic case, and payer-relevant evidence strategy before pivotal design hardens.
Strategic development evidence architecture
Comparator strategy, endpoint and PRO alignment, subgroup logic, JCA/JSC readiness, evidence-gap analysis, and protocol pressure-testing across regulatory, payer, and commercial evidence needs.
Embedded strategic HEOR roles
Senior individual-contributor support inside cross-functional asset teams, interim HEOR leadership, evidence roadmap ownership, vendor briefing and review, budget ownership, and decision support for governance forums.
Health economics and HTA execution
Early and launch-stage CEA/CUA, budget-impact modelling, model adaptation and localisation, uncertainty strategy, value-dossier development, objection handling, and HTA defence.
A working call is worth booking if
- An asset approaching pivotal commitment in oncology, ATMP, gene therapy, or rare disease, where comparator, endpoint, PRO, and economic-model decisions are still open, and the architecture needs to be set before lock-in.
- A Phase I–II programme where the target product profile, burden of illness, and early economic case need to be built against payer and JCA requirements alongside the regulatory plan.
- A pre-submission or in-review dossier with unresolved comparator, model, or JCA exposure, and a fixed review window.
- A vendor-delivered economic model or dossier that needs independent technical quality assurance before it goes anywhere.
From recent practice
Across multiple early-stage assets at a top-20 global pharmaceutical company, developed target product profiles to steer clinical development before pivotal design. Translated payer, HTA, and launch requirements into comparator, endpoint, subgroup, and evidence-generation priorities so asset teams could decide which value claims were worth designing for.
For a development-stage asset, led full COA endpoint strategy from literature review through concept-of-interest definition, patient interviews, fit-for-purpose PRO selection, and MCID planning. Translated the patient-relevant evidence logic into FDA-facing endpoint rationale, Phase II endpoint strategy, and clinical trial report drafting so the programme could support both clinical interpretation and later payer evidence needs.
On a Phase I/II ATMP gene-therapy programme, the target product profile and early economic model were being built against a regulatory-only endpoint set. Restructured the evidence plan to embed payer-relevant secondary endpoints, JCA-aware comparator framing, and a real-world evidence design into the pivotal protocol. The submission package could then be defended without retrofitting.
Anonymised. Specifics held under NDA.
About
Carl Haakon Samuelsen
Health Economist. Fifteen years across the evidence chain. Global oncology HEOR leadership at a top-20 pharma, ATMP and gene therapy evidence strategy at a mid-cap pharmaceutical, and independent practice since 2019. Work spans oncology, ATMP, gene therapy, and rare disease, across EU5, Nordic, and major non-European markets.
MPhil Health Economics, University of Oslo. Data Science Specialization, Johns Hopkins. Twenty-two peer-reviewed publications, including in BMJ Open and the European Journal of Health Economics.
Outcomes Analytica has operated as an independent single-consultant practice since 2019. I scope engagements, perform the analysis, and defend submissions.
Fifteen years · Twenty-two peer-reviewed publications · NDA standard
Independent single-consultant practice. Limited capacity; book early for availability.
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