Challenge
A European Biotech company with its lead product being developed for a rare oncology disease in Phase 1 wanted to understand how to optimize and evaluate the commercial potential of the drug, as well as how to instill and build a commercial culture and set of capabilities.
In addition, the client asked Alacrita to advise on whether a companion diagnostic should be developed and if so, how this may be best achieved.
Solution
Led by a project manger with experience in building early commercial capabilities and a commercial infrastructure from scratch, the Alacrita team studied the market landscape, disease epidemiology, patient journey, pricing environment and competitive field. This was validated by individual interviews with prescribers, payers and competitive companies and with focus groups of experts.
The information was used to work with an internal client team to build a Target Therapeutic Profile (TPP) and clinical development plan for the lead and follow-on indications, including the key efficacy endpoints and target levels of clinical benefit and Quality of Life needed.
To evaluate the need for a companion diagnostic, Alacrita assessed the importance of the biomarker in determining the patient population with the best benefit-risk profile and evaluated the technical and regulatory probability of success with and without the test.
All these inputs allowed the team to make a recommendation on the strategy, clinical development pathway, optimized TPP and to model a sales forecast, build a budget, estimate the project NPV and outline an action plan for a successful launch.
The work was done in multiple workshops with the client to ensure involvement and knowledge transfer. The deliverables included the handover of a forecasting model and presentation decks to be used for investor road-shows.