European country launch roadmap development for local vendor launch execution ​

• We had supported the company with the development of a global market access strategy for a new gene therapy​
• The client now required a detailed roadmap of key European level and country specific requirements within the global launch programme, to be implemented by selected local vendors​
• The company required close alignment between the global launch strategy and individual country actions/timelines ​

‍

• Clearly define the key actions, timelines and associated investments required for execution of country specific launch programmes for the new gene therapy across priority European markets​
• This should specify the lead/supporting functions within the global company and the local vendor responsible for each required action (within a RACI matrix)​
• Roadmaps should enable direct handover to local vendors for execution of the country launch programmes across priority European markets ​

‍

• We worked with the company to define the optimal launch sequence, and key global clinical/HEOR resources available for local adaptation​
• We profiled the cross-functional requirements for launch execution in each target country, covering value communication materials adaptation, stakeholder engagement, policy development, clinical reference centre/diagnostic pathway set up and execution of the HTA submission and pricing negotiation ​

• The client received detailed, user-friendly validated roadmaps for execution of cross-functional country launch programmes in line with the global market access strategy​
• This enabled the onboarding of local vendor teams for adaptation of global materials to meet local requirements, execution of the pre-launch market preparation/engagement activities and post-EMA approval HTA submissions and pricing negotiations  ​