General

Never underestimate it - successfully launching a new medicine into major European markets is a complex and highly fragmented process that requires deep strategic planning and flawless execution.

Success hinges on early engagement with regulators, clinical stakeholders, and market access bodies to ensure that the chain of stakeholders is unlocked sequentially using the right data and arguments.

We asked senior members of the LUCENT team about their key recommendations for achieving this in Europe - based on experience and data, but just as importantly driven by their instincts born out of the dozens of new medicine launches undertaken by the team over the past decade.

1) Include EU-Relevant Clinical and Payor Endpoints

European regulators and HTA bodies prioritise specific clinical endpoints when evaluating new medicines. These are more-often-than-not different than those for the US.

2) Ensure EU Clinical Study Sites Are Included

Adding a handful of European clinical sites into Phase 3 trials provides multiple advantages: familiarity with investigators, region-specific clinical data, early buy-in, and a compelling reason for early physical entry to key EU countries.

3) Place At Least One MSL Into Each Major EU Market Around Phase 3

Establishing a physical presence in key EU markets during Phase 3 fosters early engagement with healthcare professionals, patient groups, reimbursement authorities and regulatory bodies.

4) Engage Early with Clinicians, Regulators and Reimbursement Bodies

The data from EU-based clinical sites and the presence of MSLs serve as critical assets in discussions with stakeholders.

5) Limit Risk by Hiring a Specialised EU Launch MSL Team

Given the uncertainties surrounding Phase 3 data and regulatory approvals, a stage-gated hiring strategy based around milestones and risk inflection points is key.

A successful European launch requires meticulous planning and early stakeholder engagement. By following these recommendations, companies can optimise their EU launch trajectory, ensure regulatory success and rapid adoption of their new medicine across Europe.

At LUCENT, we have well-established relationships with key stakeholders across the EU, UK and US, built over decades of working in the industry.