Case Studies

When a global biopharmaceutical company made a strategic pivot to explore early access programs (EAPs) outside the U.S., they faced a condensed timeline of 12 months and limited resources to build a new function from scratch. This initiative was driven by the need to accelerate patient access to innovative treatments while aligning with regulatory frameworks in select countries.

THS staff were brought in to guide the leadership team through this complex transformation by defining a clear and actionable strategy, addressing organizational concerns, and securing buy-in from key stakeholders, including the executive team. Despite the uncertainties around resource allocation, compliance, and market readiness, we were collectively able to construct a compelling proposal that provided a structured roadmap to move forward with the early access strategy.

Through a series of targeted workshops and collaboration sessions, we engaged cross-functional teams, ensuring that all perspectives were incorporated into the plan. THS helped the team to proactively mitigate risks by conducting an in-depth analysis of regulatory environments and stakeholder needs in the key markets. This led to the unanimous approval from the executive leadership to transition into the operational planning phase.

The outcome of this phase not only secured executive commitment but also positioned the company to provide access to patients with this novel therapy, thus preventing future poor outcomes. The plan consisted of several key milestones to be executed over a period of 6 to 12 months. The project’s success lies in our ability to synthesize complex inputs and align diverse organizational teams towards a common objective, setting the foundation for future global early access initiatives.