JCA success with one partner. EU‑wide.

Client need: End-to-end support for parallel EMA / HTA body (HTAB) scientific advice for an oncology asset

Solution: (i) Supported application and alignment on submission strategy; (ii) developed briefing book, response to list of issues and slide deck for the EMA / HTAB discussion meeting, provided meeting support, and summarised advice; (iii) discussed strategic implications

Results: The insights generated helped inform changes to the pivotal trial protocol, and allowed the client to better understand both converging and diverging HTAB and regulatory evidence needs

Client need: PICO prediction for two oncology pipeline assets, and strategic recommendations to optimize evidence generation

Solution: Assessed analogues and simulated the scoping process in line with the latest JCA guidance documents to predict likely PICOs; mapped planned evidence generation activities against PICOs to identify any gaps

Results: Asset-specific recommendations for evidence generation strategy, to optimise data package based on the anticipated PICOs

Client need: PICO simulation, JCA strategy, evidence generation (SLR, ITCs) and JCA dossier development for an oncology asset

Solution: Predicted PICOs, defined JCA strategy, conducted SLR and ITC analyses, and drafted JCA dossier; finalised the dossier following scope confirmation in line with refined JCA strategy, and provided post-submission support

Results: Full JCA end-to-end support from strategic advisory to execution, in line with the published JCA guidance

Client need: National dossier development for the client’s first two assets eligible for Joint Clinical Assessment (JCA), including strategic advice on relevant analyses for local HTA success and mitigation strategies; recommendation on best practices to incorporate local needs into regional and global JCA preparations

Solution: Planning and development of the ‘delta’ dossiers; strategic recommendations to shape new internal JCA processes to ensure local evidence requirements and dossier preparations are optimally aligned

Results: Support currently ongoing