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Challenge:

Alacrita was engaged by a biopharma company developing a therapeutic for a severe orphan disorder. With Breakthrough status designation from the FDA and a Prime designation from the EMA, the company was preparing for commercialization in both the US and Europe. A few offices had already been set up, and some work had been done to map specialist centers in the US and EU that would be targeted. A program was underway to complete the steps required to gain market access, however, a fully integrated plan taking into account tax, regulatory, legal and supply chain needs was not yet in place. With this requirement now fairly urgent, Alacrita was asked to develop a high-level infrastructural plan integrating all of these elements. Based on this, and further validation of the market access plans, the biopharma company also wanted a clear go-to-launch plan to realize the best possible launch for its product. In order to align the launch on a global basis and ensure successful launches in both the US and Europe, the company also wanted the supply chain outlined in the context of their planned US organizational structure.

Solution:

Alacrita delivered blueprints for a US and an EU organization to define and integrate the commercial, operational and supply chain structure with considerations for tax optimization, regulatory compliance, quality systems and SOPs and HR/legal considerations. In addition, a top-level go-to-launch, cross-functional process map was sketched out to plan the key activities and foresee any potential bottlenecks and manage activities on the critical path. The exercise in the EU focused on the top 5 markets – Germany, France, Italy, Spain and the UK. For the US, an analogous commercial organizational structure and map of the optimal supply chain was provided.

Each of the areas below constituted a component of the project and were evaluated as follows:

Regulatory: Review of the regulatory environment on a country by country basis, to verify personnel required, licenses required and systems mandated on a country level. This was done through local regulatory consultants within Alacrita’s network.

Quality Systems: A top-line definition of the SOPs and quality agreements needed were evaluated and outlined on both an EMA level and FDA level.

Tax Review: We conducted an analysis of the current tax laws governing distribution of EU goods through a Swiss HQ, with support from independent advisors, and any operational requirements – including minimum size of the headquarters in Switzerland. An analogous was also developed for the US.

HR/Labor law: An overview of HR/hiring considerations was included in the analysis based on current country-specific labor laws for both the EU and US. Recommendations included optimization of current office locations, trade-off of higher salaries in some territories versus stricter labour laws in other countries etc.

Supply Chain: Using the input from regulatory, tax, quality and license modules of the project, we outlined a supply chain to ensure 24-hour delivery to all centers and to optimize product and financial flow for the biopharma company. An evaluation of the USA supply chain needs was conducted through analysis of the centers to be reached, the manufacturing and secondary packaging site locations and the required product and financial flows.

Commercial Operations: The optimal country/regional organizational structure and number of FTEs was proposed by evaluating the coverage needed for the specialist centres already mapped, out as well as considering the tax and HR situation.

Market Access: Alacrita also worked with the biopharma company to define the market access strategy and pricing considerations in EU. These plans – including the timelines – were integrated into the go-to-launch project plan, the organizational structure and hiring plan.

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