Building a robust Launch Readiness capability for rapid patient access and revenue capture in excess of $1bn

Vision

Tried and trusted 

To maintain its position as a global leader in infectious diseases and a trusted partner to health authorities and health care providers (HCPs) worldwide, a Fortune 500 biotech company needed to build a robust launch readiness capability that could be applied across its entire portfolio and geographies. Maximizing the revenue opportunity within each seasonal window demanded seamless approval, production, and launch of its products to market.

Challenge

Mitigating risk to reap the rewards

With a rapid acceleration of its pipeline and the seasonality of its products, many people and functions had been involved in managing launches across North America, Europe, and Asia-Pacific. Teams had executed these to the best of their abilities, but they were applying their own ways of working, processes, and tools.  

Without consolidating the lessons learned into a highly coordinated, cross-functional launch capability, the company ran the risk of misaligned timelines and critical path delays in submissions, approvals, production, and commercialization. It needed to deliver products on time to maintain and maximize relationships with health authorities and HCPs and torealize the full seasonal revenue potential. 

Solution

Fresh learnings, immediate application

The Head of Strategic Programs felt it was time to define and roll out a centrally coordinated launch process. They partnered with Genioo given our experience in mapping and codifying global product launch preparations.

Bringing together recent launch learnings with a view to applying them to a critical seasonal launch in nine months, we facilitated gap assessment workshops with key stakeholders. Around the room, R&D, Regulatory, Commercial, Medical, Manufacturing, Supply Chain, and country-specific teams identified the strengths and gaps in current launch preparations. The request for a centrally coordinated launch capability came from teams directly and stakeholders aligned on the need for a robust team structure and governance along with a launch roadmap and toolkit. 

A framework for future launches

Partnering with the client’s internal PMO team, we strengthened their program management capabilities and brought in experts to deepen the discussions and share industry best practices. Together, we co-created a comprehensive launch readiness roadmap, as well as timelines specific to global functions and to each country. Mapping backwards from product release to submission, the team aligned critical tasks and milestones into a scalable and replicable global framework that could be tailored to local market and team needs. 

A confident and connected ecosystem 

A well-designed structure and governance ensured that this critical product launch had a central strategy and planning capability with clarity on roles and responsibilities. And it deepened cross-functional collaboration 

throughout the launch lifecycle to secure team buy in. Joining the dots between Regulatory, CMC, Commercial and Medical Affairs tasks helped smooth friction throughout production ramp up, submission, and commercialization program phases.

Improved transparency in daily huddles encouraged sharing of data and insights. This enabled functions to rapidly identify gaps and prioritize risk mitigation. A dashboard provided all stakeholders with a single source of truth. And a traffic light system meant that launch readiness could quickly be assessed across the launch lifecycle by gap status/priority, function, and market.

Robust governance and escalation enabled the PMO to share progress with leadership. And thorough preparation of supporting materials empowered teams to put risks on the leadership meeting agenda. Together, they tackled issues and made critical decisions with speed and confidence.

A global capability sharpens focus on local markets

Centralizing the global launch capability freed country teams to focus on local market needs, managing the submission and approval process effectively, gaining public and private market access, and preparing effective marketing and communications campaigns. Systems could be set up to track and pursue health authority and distributor procurement agreements, and setting up supply chain processes with wholesalers and providers to secure orders and maximize seasonal revenues. 

The power of a pilot plus playbook 

Running and building at the same time is never easy. But codifying an active launch preparation into a playbook allowed for real-time refinement and a move closer to launch excellence. And the validation of a successful launch helped build confidence and embed new ways of working. The playbook will serve as an ongoing resource for onboarding and training with documentation of processes, tools, and best practices, to be applied to future product launches.

Impact

Readiness and revenue

In just nine months, the PMO had taken lessons learned and applied them to achieve launch readiness for one of the company’s most critical product launches. Together we accomplished:

• An early assessment of gaps and an on-time removal of these obstacles to a successful launch. A critical internal post-mortem estimated that not addressing these gaps in time could have led to a 2 to 4 week delay in the launch
• A smooth and speedy launch of a new product in nine months to public and private markets across 12 countries across NA, EU, and APAC. 
• Capturing revenue opportunities in excess of of $1b, with renewed confidence in further accelerating organic sales growth by 2025. 
• The codification of a cross-functional framework for use across all future product launches including the launch of 10-15 new products in the coming 5 years. 

Benefits went way beyond KPIs to the experience of employees. In working together as One Team, the collaboration and community they built will carry on into their day-to-day operations and future programs and projects.