Rapid market assessment and launch plan COVID-19

Supporting a Swiss biotech with mapping the access and launch pathway for a breakthrough COVID-19 therapy

This project utilised the Lightning Insights platform

Scope:

Europe

Therapy Area:

COVID-19

Client:

Swiss Biotech

The Challenge

After receiving positive signals from early clinical evidence in the US the client needed an extremely rapid review of the European COVID-19 landscape and environment to support a rapid launch of a potentially life saving COVID-19 treatment

In particular, the client had no commercial or clinical presence in Europe and needed a comprehensive assessment to inform commercialisation strategy

Project objectives

The objective was to empower the client with a clear launch and access strategy that included:

A review of the regulatory environment and the conditional and rolling review processes from the European Medicines Agency (EMA) level

Research analogues the current landscape for launch and funding of breakthrough COVID-19 therapies

Build an understanding of the pricing and reimbursement processes for breakthrough COVID-19 technologies benchmarking against the current Target Product Profile (TPP)

Approach

The team executed and rapid and targeted desk research programme & analogue analysis in parallel to the development of core primary research materials

Research materials were developed, with focus on the EU5, to directly address the emerging themes surrounding accelerated access for breakthrough COVID-19 therapies, long term evidence requirements and process challenges, alongside the testing of the TPP

All workstreams were synthesised into a final research report directly inputting into the commercial and launch plan

VALUE DELIVERED

The Lightning Health team was able to quickly adapt to the rapidly evolving landscape to execute the project from concept to final delivery in less than 3 weeks

The outputs from the research modules directly input into actionable recommendations that formed the basis of the evolving commercial plan to help the client navigate the European market quickly, understand potential avenues for rapid access and long-term requirements for sustained uptake

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