Engagements
Three models, organised by asset stage
Three engagement models, organised by the stage at which I come into the programme. In each, I perform the analysis myself and deliver a written evidence architecture the internal team can take forward. The work product stands on its own.
Evidence Architecture
Before clinical trial lock-in. The pivotal design is still open.
What this changes: The asset enters pivotal commitment with the regulatory, payer, and commercial/label evidence requirements reconciled against a single design. The questions HTA reviewers will ask years later are anticipated while the protocol still has flexibility.
This is where the leverage is highest. The engagement identifies the points at which the regulatory path diverges from what payers and HTA reviewers will need, then designs the corrections while the design still admits them. Comparator and endpoint choices, PRO instrumentation, subgroup pre-specification, and the shape of the eventual economic model are all considered together.
- Comparator and endpoint strategy assessed against payer and HTA requirements
- PRO endpoint selection across regulatory, payer, and label use
- Early economic model structure specified ahead of data lock
- Target product profile (TPP) development
- Burden of illness analyses
- JCA/JCS alignment for assets entering European review
On the structural nature of regulatory–payer divergence
Dossier Support
Pre-HTA / HTA Review. The asset is approaching filing or in the response window.
What this changes: The submission goes to committee with the comparator rationale, model structure, and value argument internally consistent and tested against the technical objections most likely to surface during review.
I either author the dossier or independently review one already drafted. The work treats the comparator rationale, the economic model, and the value argument as a single object and tests the internal consistency among them. Where the asset crosses jurisdictions, I localise the economic model and adjust the argument structure to the requirements of each review.
- Economic model review, sensitivity analysis, and uncertainty handling
- Comparator positioning and ITC / NMA framework
- Alignment between the clinical data, the quantitative argument, and the value narrative
- Anticipated objections from technical reviewers, including JCA/JCS-specific questions
- Response preparation for committee questions during the review window
- Cross-market model localisation
Embedded Strategic HEOR
Portfolio. Continuous senior input across several assets.
What this changes: A portfolio gets continuous senior evidence judgement from a named consultant who carries the analytical context across assets, indications, and submissions, without the re-briefing cycles that come with rotating teams.
Sometimes the requirement is not a single deliverable but sustained senior input across multiple programmes, or a strategic period during which an experienced consultant is integrated into day-to-day evidence decisions. The retainer is held against defined programmes, with engagement volume capped so that availability on any one of them remains meaningful.
- Cross-portfolio HEOR strategy and evidence governance
- Internal strategy reviews and working sessions with HEOR, clinical, and regulatory leads
- Rapid-turnaround analysis on payer and pricing questions as they arise
- Senior coverage during HEOR leadership transitions
Not sure which engagement fits?
Describe the asset, the development stage, and the markets in scope. Thirty minutes is usually enough to identify whether the practice is a fit and which engagement model would have most leverage.
Fifteen years · Twenty-two peer-reviewed publications · NDA on request
Independent single-consultant practice. Approximately six programmes per year.
Discuss Your Programme Or by email:Thirty minutes. Confidential. No obligation. The call is with me.