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excellence has long been positioned as the culmination of clinical development, but it’s a view that’s increasingly outdated.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.

New evidence from Remedy Edge’s global study, AI Usage in Clinical Decisions, shows just how far this shift has already gone. Across 15 specialties and 1,165 respondents in North America, Europe and China, 92% of HCPs say they use generative AI in clinical practice, 73% say it influences their treatment decisions and 85% expect usage to increase over the next 12 months.1 This is no longer a fringe behaviour. It is already widespread, frequent and influential.

That matters because AI is becoming a new front door to treatment information. Our study found adoption was high across all specialties surveyed, ranging from 85-98%, with particularly strong uptake among dermatologists, GP/PCPs, cardiologists and gastroenterologists.2 In other words, this is not a story about a few digitally adventurous clinicians. AI has crossed a more important threshold: from niche to normal.

Frequency makes this even more commercially significant. Nearly four in five HCPs use AI weekly or more, and the use cases are not limited to administrative tasks.3 Clinicians report using AI to review guidelines, summarise research and trial data, understand treatment options, compare therapies and think through specific patient cases. That pattern is decisional, not merely administrative.

The most commercially important finding may be this: the majority of HCPs say AI already influences their treatment decisions.4 Once AI begins shaping treatment consideration, brand presence in AI answers can no longer be treated as a passive by-product of digital content. It becomes something that must be understood, managed and improved with intent.

Importantly, HCPs are not using AI blindly. Concerns around accuracy, bias, references and outdated content remain prominent. Yet those concerns coexist with high satisfaction: more than 80% are satisfied or very satisfied with the quality of AI answers they receive.5 The implication is clear. Clinicians recognise the limitations, but they keep coming back because the value is already compelling.

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.