Achieving launch excellence through cross-functional collaboration

Launch excellence has long been positioned as the culmination of clinical development, but it’s a view that’s increasingly outdated. Today, success is defined by the ability to anticipate regulatory, payer and patient needs much earlier in the life cycle.

In reality, successful launches begin in early clinical development. The target product profile (TPP) defines what success looks like, aligning clinical ambition with the needs of prescribers, patients and payers. The best organisations bring commercial, medical affairs and market access input into this phase early – often from phase 2 – ensuring that evidence generation supports both regulatory approval and reimbursement.

This alignment is critical, as a therapy may have a strong clinical story, but without the right endpoints, comparators or supporting data, it can struggle to demonstrate value in practice. There is no single ‘blueprint’ for success, but best practice is clear: prioritise clinically meaningful endpoints accepted by HTA bodies; include quality-of-life and economic measures early, and select comparators that reflect real-world care.

A major shift has been the move away from siloed working, where historically, clinical, regulatory and commercial functions operated sequentially. Today, leading organisations bring these disciplines together early to shape both evidence generation and the value proposition.

At the core is a structured set of strategic activities: defining the global value proposition; conducting landscape analysis; shaping the TPP; identifying evidence gaps and developing early economic models. Trial programme planning is also more deliberate, ensuring endpoints align with regulatory, payer and patient expectations.

Together, these activities form an evidence generation road map that underpins launch success and, when developed cross-functionally, ensures that evidence translates directly into a credible value narrative at launch.

A growing proportion of launch failure now stems from access and adoption challenges. Companies must demonstrate not only clinical efficacy, but also economic value and real-world relevance, while delivering on early commitments to stakeholders. Strategic use of expanded access programmes can support this by generating early real-world insights and helping to de-risk access, pricing and launch sequencing decisions.

At the same time, regulatory and pricing dynamics are reshaping launch strategy, with the EU Joint Clinical Assessment increasing the need for HTA-ready evidence earlier in development, while pricing pressures require more deliberate decisions about where and when to launch.

This is evident in how launch sequencing is evolving, where traditionally, companies had a US-first approach, followed by Germany and wider Europe. Today, Germany is, in some cases, being sequenced later due to pricing and reimbursement dynamics for high-cost therapies, while other regions – including the Middle East – are prioritised earlier. This reflects a broader move towards globally coordinated strategies shaped by access and pricing considerations.

Despite the trend in earlier prioritisation of the value proposition of new launches, common pitfalls remain, mainly due to late stage ‘roadblocks’, that continue to undermine launches, including: weak comparator data; lack of a clear patient population or unrealistic pricing assumptions.

A muddled value proposition can weaken strong assets, often due to limited understanding of the patient journey or insufficient patient engagement. Failure to anticipate competition, combined with siloed execution, can further dilute impact.
Avoiding these risks requires true ownership across an integrated launch team centred around a clear value story, with aligned KPIs, clear decision-making authority and shared accountability.

As competition intensifies, the way value is communicated is becoming increasingly critical to optimising access to a therapy and supporting its early adoption.
More creative approaches are emerging to translate complex evidence into clearer, more compelling narratives.

This includes innovative pricing models, such as outcomes-based agreements, volume-based price caps, or managed access agreements, alongside more targeted engagement with policymakers, clinicians and patient communities. Organisations that demonstrate flexibility on the structure of payment models are more likely to build early traction.

Crucially, this creativity must remain grounded in credible evidence and cross-functional alignment.

With increasing complexity, partnering is now critical in de-risking launches, bringing expertise and market insight across regulatory strategy, market access and early access programmes.

More importantly, partnering enables organisations to operate as an integrated launch system, aligning evidence generation, stakeholder engagement and commercial planning.

At Uniphar, this approach is reflected in a cross-functional, partnership-led model that connects evidence, access and adoption.

Launch excellence is now defined by the quality of decisions made across the entire life cycle and, in a complex environment, those decisions cannot be made in isolation. Cross-functional collaboration that’s grounded in a clear evidence road map is the foundation for successful, sustainable launches.

For more information on the European launch environment as it enters this time of complexity and regulatory change, download Uniphar’s white paper, Navigating the new era – launch success in Europe’s evolving pharma landscape.