When global asset teams come together in the early commercialisation phase – right through to phase 3 design and governance – they’re typically packed with highly experienced specialists, each laser-focused on a single asset. But when it comes to the local agency representatives of different countries joining those same discussions, the dynamic shifts. These colleagues are juggling competing priorities, often dedicating only a sliver of their time to global projects while being deeply embedded in the existing portfolio needs of their own markets.
And yet, every pharmaceutical company recognises the same truth: the success of a global strategy depends on how well it’s shaped by real-life experiences translated into strategic foresight.
That’s why empowering local voices within global teams is mission-critical. It’s not just about having someone in the seat; it’s about having the right person. Someone who knows how to tap into the right network, who can speak up with confidence on behalf of their market, and who feels trusted enough to challenge the global position when necessary.
If we don’t get this balance right – if local input remains an afterthought – there’s a real risk of missed opportunities, misaligned plans, and exclusion from key priority markets. It’s time for both local and global leadership to think more carefully about representation, relationships, and the commercial consequences of leaving local insights on the sidelines, in six key areas:
1. Regulatory
There are often different regulatory body requirements within regions and countries. These nuances need to be front and centre of early development and commercial plans. While the US will remain the primary focus for global reach, other pivotal markets should be considered, and any risks, benefits, and synergies that need to be addressed in the clinical development and commercialisation process should be outlined. Local input will ensure clinical trials meet the diverse regulatory requirements, submission strategies, and data requirements.
2. Clinical approach and medical need
Within key markets, the clinical approaches to treating conditions could vary significantly. As a result, there could be a divergence of standards of care globally and, therefore, different unmet needs across regions and countries that a new asset needs to address. In extreme cases, an indication could be prioritised or deprioritised over other lifecycle indications based on the value it would bring to an individual healthcare system.
3. Epidemiology
The prevalence and incidence can also vary widely between countries and regions. Local market leads can give a specific opinion from multiple sources that will not only feed into forecast potential but also focus the clinical development plan structure and study sites. This insight is often inaccessible to global methods that rely heavily on consolidated datasets.
4. Access and pricing
Pricing, reimbursement, and access models differ globally. Having this information in the global team as early as possible is important, and only local teams can clearly lay out, with local analogues, what value evidence is critically required, enabling the global production teams to develop trials that generate the necessary efficacy and health outcome data with the appropriate comparators.
5. Global commercial positioning and differentiation
The global team will develop positioning and promotable claims within the programme for the priority market, usually the US. However, we often see local markets frustrated and spending considerable time trying to work out how to translate this effectively into their markets after the phase 3 data is available. With early input from pivotal markets, key endpoints, either primary, secondary, or exploratory, can be included in the studies with a statistical hierarchy that will allow optimal commercialisation across the world’s markets. This proactive alignment strengthens the global identity and ensures that both local-global partnership and direction are strategically unified.
6. Development programme and commercialisation synergies
Patient and clinician preferences and behaviours can vary between countries. Local input can ensure this is leveraged positively for the study designs and execution. A clear view of the willingness to conduct trials, along with the associated rationale, could be vital for establishing protocols and avoiding recruitment delays. Understanding investigator attitude to risk will also enable the clinical development team to predict any issues that could arise with country study leads and trial centres. Having these insights should enable commercial teams to identify significant cultural drivers or barriers to adoption, such as willingness to use new therapies, ultimately enhancing brand strength and service outcomes across regions.
Altering processes to gain early, meaningful local input into global teams should be a strategic imperative. When regional insights shape clinical development planning, regulatory strategy, pricing guidance and commercial positioning from the outset, assets are both scientifically robust and well differentiated. This can lead to faster adoption and better outcomes for patients across the globe through a cohesive development, network, and service strategy that connects global facilities with true local experience.
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