A European immune-oncology biotech with a proprietary platform had generated a broad and deep pipeline of oncology assets, which had demonstrated an advantage due to their ability to recruit T-cells to multiple cold and solid tumours that have proved intractable to the current leading cancer therapies and immunotherapies such as checkpoint inhibitors. The company was well-funded and looking to build a professional and leverageable commercial base for the portfolio. The lead asset was in Phase 2 clinical development for a rare condition with a high unmet medical need. Based on strong interim clinical data, the lack of good alternatives for patients with this disease and positive feedback from the FDA and EMA, the programme had the possibility of gaining early conditional licences in both Europe and the US through PRIME and Breakthrough designations. Therefore, it was anticipated that this would require earlier commercialisation than previously planned, and necessitated an acceleration of activities and budget to build licencing, launch and commercial capabilities.
Alacrita was asked to assist in building a launch strategy and plan to ensure successful and timely commercialzsation. The plan had to be cross-functional including Commercial, Market Access, Supply Chain, CMC, Medical, Safety, Regulatory, Legal and Financial aspects. It had to evaluate several possible scenarios in both the US and EU markets and consider both long and short-term implications for the lead asset’s success and the company’s. The plan also had to highlight and propose solutions to overcome bottlenecks and be immediately implementable. Where possible, practical proposals to parallel-track activities to aid a quick commercial set-up at reasonable cost to the company had to be made.
The work was conducted in 4 modules, with the geographical scope being the USA and the EU:
Module 1: Assess launch readiness and commercial fitness Alacrita’s proprietary COMM-FIT Scale considers cross-functional capabilities, resources and current facilities to check whether an organisation is ready for commercialisation. It assessed the extent to which the Company team could take on the additional challenges of Breakthrough and PRIME designation by looking at the legal entities in place, licences, quality systems, supply chain status and regulatory capacity to take on the additional intensive interactions, implement REMS/RMP programmes, commit to post-launch development obligations, manage pricing and reimbursement submissions/negotiations and launch an Early Access Programme. The Scale looked at what had been done to understand the market, disease and treatment pathway, and how close the Company was to the key opinion leaders and patient advocates.
Module 2: Agree launch strategy This module comprised a face-to-face Scenario Workshop to present the COMM-FIT results, gap analysis and high-level plan and to develop 2-3 accelerated launch scenarios, pros and cons and associated SWOT analysis. Using the output from this workshop, Alacrita create a Commercial Strategy Document in the form of a PowerPoint presentation deck that was subsequently presented at the Company’s annual Board Strategy working group.
Module 3: Outline high-level commercialisation and launch plan This module comprised drafting a high-level launch plan for both the US and EU markets including likely milestones and bottlenecks. The plan was presented in a meeting to a cross-functional Company team outlining the assumptions, risks and important considerations for each function. Importantly, this exercise helped the Company realise their strategy defined in Module 2, and their objective of accelerated, successful launch - identifying gaps, risks and bottlenecks in the process.
Module 4: Identify and implement key steps to achieve accelerated launch In parallel with the scenario development planning and Commercial Strategy Document creation, Alacrita begun implementation of obvious and practical acceleration steps that the Company would need to take regardless of whether PRIME and BREAKTHROUGH designations were awarded. This Short-term Action Plan prioritised low-cost tasks that could be rate-determining in achieving successful accelerated launch. The Alacrita team used the COMM-FIT assessment and the team members’ experience of commercialisation in similar accelerated/conditional approval situations to provide a Short-term Action Plan presentation for rapid internal approval and implementation.